Vaccine experts call for clarity on UK’s 12-week Covid jab interval

British Society for Immunology calls for a robust programme monitoring the body’s immune response

Experts have called for greater clarity on the monitoring in place to assess the 12-week dosing interval for Covid-19 vaccines, as the row over delayed second doses continues.

The UK’s coronavirus vaccination programme was shifted late last year to prioritise administering the first dose of jabs to as many at-risk people as possible. As a result, the interval between the two doses of the jab was increased to up to 12 weeks.

Related: Doctors call for shorter gap between Pfizer Covid vaccine doses in UK

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Vaccine experts call for clarity on UK’s 12-week Covid jab interval

British Society for Immunology calls for a robust programme monitoring the body’s immune response

Experts have called for greater clarity on the monitoring in place to assess the 12-week dosing interval for Covid-19 vaccines, as the row over delayed second doses continues.

The UK’s coronavirus vaccination programme was shifted late last year to prioritise administering the first dose of jabs to as many at-risk people as possible. As a result, the interval between the two doses of the jab was increased to up to 12 weeks.

Related: Doctors call for shorter gap between Pfizer Covid vaccine doses in UK

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I’ve had my first vaccine jab. It gives me hope of liberation… but not yet

Exactly a year after his first story about coronavirus, our science editor received the Pfizer injection last week. Here he reflects on a remarkable scientific achievement

I marked a grim anniversary in an unexpected manner last week. On 18 January last year, I wrote my first story about a mysterious disease that had struck Wuhan, in China, and which was now spreading around the world. More than two million individuals have since died of Covid-19, almost 100,000 of them in the UK.

Remarkably, 12 months to the day that the Observer published my story, I was given my first dose of Covid-19 vaccine, allowing me to follow nearly six million other newly immunised UK residents who are set to gain protection against a disease that has brought the planet to a standstill. It was a rare, comforting experience after a year of unremitting sadness and gloom.

Related: World’s poor need action, not Covid ‘vaccine nationalism’, say experts

Related: The pandemic one year on: 100,000 dead in the UK from coronavirus

Related: UK bosses set up IT systems to track Covid vaccine status of staff

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Vaccine experts defend UK decision to delay second Pfizer Covid jab

Medics told they risk undermining public confidence by querying policy of three-month gap between doses

Leading vaccine experts have backed the government’s decision to delay the second dose for up to three months, after doctors warned that the strategy was proving “ever-more difficult to justify”.

The British Medical Association (BMA), which represents doctors, has suggested that the UK has become “increasingly isolated internationally” by deciding that the second dose of the Pfizer vaccine can be delayed, and called for a maximum delay of six weeks. However, several prominent scientists backed the government’s plan to maximise the number of people receiving their first dose.

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World’s poor need action, not Covid ‘vaccine nationalism’, say experts

Nations outbidding each other creates an ‘immoral race towards the abyss’

Pharmaceutical companies should do more to transfer vaccine technology to prevent the poorest countries falling behind in the distribution of Covid-19 vaccines, according to an expert.

The warning came from Dag-Inge Ulstein, the co-chair of the global council trying to speed up access to Covid vaccines for the world’s poor, known as the Act (Access to Covid-19 Tools) Accelerator. Ulstein, Norway’s international development minister, oversees the drive to ensure vaccines reach the poor – the Covax programme.

Increased transparency on the vaccine deals, including the number of vaccines, the delivery date and price.

Full value for money on the collective funds that the world has given to purchase these vaccines for the world’s poorest so they are purchased at cost price, and not to make a profit.

Increased production of vaccines can be boosted internationally by technology transfer and sharing by pharma companies to local and regional manufacturing firms.

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MHRA and vaccine makers in talks over new Covid variants

Scientists start work on steps needed for potential rapid development of a modified vaccine, AstraZeneca says

The UK medicines regulator is in discussions with coronavirus vaccine manufacturers about “potential modifications” that may be needed to ensure their jabs protect against new variants of the virus.

The Medicines and Healthcare products Regulatory Agency (MHRA) said there was no evidence that vaccines failed to work against the new variants that emerged in recent months, but said it had made the issue a priority.

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South Africa paying more than double EU price for Oxford vaccine

Health ministry quotes says premium is because government did not pay into research and development effort

South Africa will have to buy doses of Oxford-AstraZeneca’s Covid-19 vaccine at a price nearly 2.5 times higher than most European countries, the country’s health ministry has said.

The African continent’s worst virus-hit country has ordered at least 1.5m shots of the vaccine from the Serum Institute of India (SII), expected in January and February.

Related: ‘South Africa is going to get a third wave of coronavirus, even a fourth’

Related: Global immunisation: low-income countries rush to access Covid vaccine supply

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Single Covid vaccine dose in Israel ‘less effective than we hoped’

Surge in infections dampens optimism over country’s advanced immunisation programme

Israel’s coronavirus tsar has warned that a single dose of the Pfizer/BioNtech vaccine may be providing less protection than originally hoped, as the country reported a record 10,000 new Covid infections on Monday.

In remarks reported by Army Radio, Nachman Ash said a single dose appeared “less effective than we had thought”, and also lower than Pfizer had suggested.

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EU’s Covid vaccination debacle is down to institutional inflexibility

Supply delays underline there was no legal or economic justification for central planning

A storm is raging over the EU’s failure to have ordered more of the approved Covid-19 vaccines ahead of time. Stéphane Bancel, the CEO of the US pharmaceutical company Moderna, which gained approval for its vaccine shortly after Pfizer/BioNTech, claims that the EU has relied too much on “vaccines from its own laboratories”.

Did the European commission prioritise supporting its own pharmaceutical industry over protecting human lives? In fact, matters are not as simple as that. Contrary to what Bancel wants us to believe, the EU has actually ordered too little of its own vaccine. After all, the vaccine that is being administered most widely across the west was developed by a German company, BioNTech, and thus comes from the EU (though it was tested and partly produced in partnership with Pfizer in the US and with Fosun Pharma in China).

Related: The $2,000 stimulus cheques alone won’t work – the US needs better infrastructure

EU member states were wrong to entrust the European commission with the purchase of vaccines last summer

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Australia’s chief medical officer defends AstraZeneca’s Covid vaccine amid efficacy concerns

Australia has secured 54m doses of the vaccine some experts say is inferior to Pfizer’s mRNA vaccine, which Australia has bought just 10m doses of

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  • Australia’s chief medical officer Professor Paul Kelly and infectious diseases experts have defended securing 54m doses of a Covid-19 vaccine made by Oxford University and pharmaceutical company AstraZeneca, amid concerns the vaccine will not be effective enough to achieve herd immunity.

    The president of the Australian and New Zealand Society for Immunology, Prof Stephen Turner, told Nine media that Australia should halt the AstraZeneca vaccine rollout because it has “lower efficacy”.

    Related: Australia’s Covid vaccines: everything you need to know

    The choice we have is not whether to use one or the other, it is whether to use what we have

    Related: ‘How dare you leave’: confusion remains for some Victorians stranded interstate

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    Netanyahu touts Pfizer deal after 20% of Israelis get Covid jab

    Country will share data on its rapid vaccination campaign as ‘global model’, says PM

    One in five Israelis have been given first doses of coronavirus vaccines, roughly ten times higher than the UK and US, with the country aiming to have inoculated all eligible age groups within two months.

    Israel’s lighting-fast vaccine campaign had been expected to slow down this week as the first batches of Pfizer/BioNTech doses ran low.

    Related: Palestinians excluded from Israeli Covid vaccine rollout as jabs go to settlers

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    EU plans video summit after doubling supply of Pfizer Covid vaccine

    Bloc agrees deal for a further 300m doses as hopes are raised for speedier rate of inoculations

    EU leaders are to hold a pandemic video summit on 21 January after the bloc said it had reached a deal with Pfizer and BioNTech for 300m more doses of their Covid-19 vaccine, giving the EU nearly half the firms’ global output for 2021.

    The move raised hopes for speedier inoculation across the continent as the European regulator, which this week approved the Moderna shot, said it would authorise six doses from each vial of the BioNTech/Pfizer vaccine, increasing available jabs by 20%.

    The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

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    Moderna Covid vaccine approved for use by UK medicines regulator

    Britain’s third jab to receive clearance for public use will not be available until the spring

    The Moderna coronavirus vaccine has been approved for use in the UK.

    The jab is the third to be given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA), along with the Covid-19 vaccines from Pfizer/BioNTech and Oxford/AstraZeneca. But unlike the previous jabs, the Moderna vaccine will not be available for use straight away, with the first doses not expected to arrive until the spring.

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    Third Covid vaccine set for UK approval next week but arrival delayed by Brexit

    Moderna jab won’t be available in Britain until April but fourth vaccine may soon come online

    A third Covid vaccine is likely to be approved for use in Britain next week but it will not be available until April because the UK is no longer part of the EU.

    Britain has ordered 7m doses of the Moderna vaccine, which has been approved by regulators in the EU and US. But UK authorisation will not help the government towards its goal of vaccinating the most vulnerable by mid-February.

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    Britain could be mass-producing its Covid shot. Shame we junked our industrial base | Aditya Chakrabortty

    The dire state of UK manufacturing has left us dependent on other nations. We may soon find out why some call this a ‘national security risk’

    Everything now hinges on a vaccine: how many more Britons die, whether the NHS finally breaks, how long the UK stays locked down. All depends on how fast the country can get vaccinated against this plague. Yet we’re in this position in large part because of government failure. When the prime minister imposes lockdowns late and with a sulky grumble; when we haven’t fixed our £22bn test-and-trace system (which, by the way, now bankrolls more outside consultants and contractors than the Treasury has actual civil servants); and when the Dominics and Stanleys are allowed to carry on as if rules are for the little people. If Boris Johnson blunts every political instrument he can lay his pale and meaty hands on, pretty soon a syringe is the only resort.

    Vaccines were always going to be how the world limped out of this pandemic; but as Taiwan and New Zealand show, even without inoculation it is possible to drive the number of Covid cases significantly down. Compare their record with the UK – which is on course to hit 100,000 Covid-related deaths before January is out, and where a staggering one in 30 Londoners is today infected. The lecterns from which Johnson and his top advisers gave their press conference this week read “Stay Home. Protect the NHS. Save Lives” – exactly as they did at the start of all this last March, as if to confirm how little progress they have made in almost a year.

    Related: For mRNA vaccines, we should stick to the schedule | Angela Rasmussen and Ilan Schwartz

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    UK vaccine minister vows ‘massive uplift’ in number of jabs this week

    Nadhim Zahawi says ‘absolute focus’ is to get 13.9 million people inoculated by mid-February

    The UK vaccine minister, Nadhim Zahawi, has pledged a “massive uplift” in the number of coronavirus vaccinations carried out this week as he said reaching the government’s target of 13.9m jabs offered by February would be “challenging”.

    Zahawi, the minister responsible for the vaccine rollout, told BBC Radio 4’s Today programme: “My absolute focus is to get to 13.9 million … offered a vaccine by the middle of February, that is my target and I’m confident the NHS has a plan and we will meet that target.”

    The government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19 in the UK. The list is:

    Related: What obstacles stand in the way of UK’s Covid vaccine rollout?

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    No data to support UK delay of vaccines’ second dose, says WHO

    Move to postpone second jab by up to 12 weeks is not supported by scientific evidence, experts find

    There is no scientific evidence for a delay of more than six weeks in administering the second dose of the Pfizer/BioNTech vaccine against Covid, say experts from the World Health Organization.

    The UK is planning to postpone giving the second dose of both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccines by up to 12 weeks – twice the length of time for which there is data, according to the WHO.

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    Analysis: is it wise for England to mix and match Covid vaccines?

    US experts warn against plan to give different second jab if supplies run low

    The UK is setting the pace around the world in the approval and use of Covid vaccines but, while other countries watch intently, not all are yet prepared to embrace what looks like public health pragmatism rather than strict adherence to evidence.

    Britain is the first country in the world to approve and use the Oxford/AstraZeneca vaccine, just as it was first with Pfizer/BioNTech’s. In a further trailblazing decision, it is giving everyone a first shot of either of those vaccines, with the second shot delayed to 12 weeks afterwards instead of the three- or four-week interval in the trials.

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    How is the Oxford Covid vaccine being deployed in England?

    With jab to be administered to public for first time, we look at key questions about its rollout

    The biggest vaccination programme in the UK’s history will receive a major boost on Monday, with the first use of the Oxford/AstraZeneca Covid vaccine. We answer some key questions around how it will be deployed in England.

    Related: UK hospitals receive Oxford/AstraZeneca Covid vaccine for Monday rollout

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    The Oxford Covid jab is delivered this week. But when will vaccines bring results?

    Fall or rise in coronavirus cases will not initially be a good measure of efficacy, say scientists devising ways to audit progress

    People in Britain are set to get their first shots of the Oxford/AstraZeneca vaccine on Monday, with millions of doses being given over the next few months. The mass vaccination of the UK’s population should bring an end to the country’s Covid-19 misery, but how long will it take for this immunisation programme to make a difference to our lives – and what will be the first signs that salvation is on the way?

    These key issues will be anxiously pursued as the battle against Covid proceeds and daily cases involving the new virus variant continue to spread. However, scientists have warned that simply waiting for a reduction in new cases it not the way to tell whether the vaccine is starting to have an impact.

    Related: Symptomless cases in schools could be key driver in spread of Covid-19

    Related: Why is Britain delaying second doses of Covid vaccines?

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    What difference will Oxford/AstraZeneca vaccine make in UK?

    We look at how the introduction of a new vaccine in the fight against Covid will work

    The Oxford/AstraZeneca vaccine is central to the government’s plans for ending social distancing in the UK and returning to some sort of normality. It has invested in seven different vaccines, but the biggest order is for 100m doses of the AstraZeneca jab, most of which will be manufactured in the UK. While the prime minister was jubilant that the UK was first in the world to approve the Pfizer/BioNTech vaccine, he is now able to claim a British triumph. More to the point is the ease of use of the AstraZeneca vaccine. Unlike Pfizer’s, it does not have to be kept in the long term at -70C. Pfizer’s vaccine can be stored in a fridge for five days, but AstraZeneca’s can be kept for months at fridge temperature, which is 2-8C and will be easy to take to care homes to administer to residents, the first priority group for vaccination.

    Related: BioNTech criticises EU failure to order enough Covid vaccine

    Related: World leaders urged to make Covid vaccine available to millions of refugees

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    Change in vaccine policy is a high-stakes gamble | Letters

    The effectiveness of delaying the second dose of Covid vaccines must be carefully monitored, argues Dr Grizelda George, while Jan Mortimer and Jenny van Tinteren fear the move will increase distrust and uncertainty

    The manufacturer of the Pfizer/BioNTech vaccine has said its efficacy has only been assessed for two doses given three weeks apart. Therefore the idea that a single dose will be protective beyond three weeks is speculative (Covid vaccine: chief medical officers defend rescheduling of second doses, 31 December). It would be truly tragic to vaccinate millions of recipients with the Pfizer/ BioNTech vaccine (at considerable effort and financial cost) with a twelve-week gap between doses if this doesn’t give them protection.

    It is worth noting that there is likely to be a correlation between the antibody response and protection from infection. Therefore volunteers who have already completed two doses could be asked to give a small sample of blood to check the level of neutralising antibodies present four weeks from the first dose. Recipients whose second dose has been postponed after 4 January could give a similar sample from 11 January onwards to check their levels at the four-week point. A relatively small number of volunteers (perhaps 20 or 30 in each group) might settle this.

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    BioNTech criticises EU failure to order enough Covid vaccine

    Firm races to fill potential gap left by bloc’s gamble on several vaccines being approved

    BioNtech has criticised the EU’s failure to order more doses of its coronavirus vaccine, saying it is now racing with its US partner Pfizer to boost production amid fears of a European “gap” left by the lack of other approved vaccines.

    The Pfizer/BioNTech vaccine was the first to be approved by the bloc late last month, after being accepted by the UK, Canada and the US. They and other countries have also since approved the Moderna or Oxford/AstraZeneca vaccine, leaving the EU trailing behind.

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    Questions hang over UK’s rollout of Oxford/AstraZeneca jab

    Analysis: regulator surprises by approving 12-week gap between first and second shots of vaccine as well as Pfizer/BioNTech shot

    It’s a pragmatic solution to an incredibly urgent problem – how to immunise very large numbers of people at risk from a rampaging variant of Covid-19 in the shortest possible time. The answer that government advisers have come up with is to give them all – more than 20 million of them – a single shot of the Oxford/AstraZeneca vaccine so that they have some protection and postpone the second dose to three months afterwards, when hopefully there will be plenty of vaccine available for boosters.

    Related: How well does the Oxford vaccine work? What we know so far

    Related: The vaccine miracle: how scientists waged the battle against Covid-19

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    ‘Happy vaccine day’ at Welsh factory proudly preparing Oxford doses

    Staff at Wockhardt in Wrexham buzzing at news of approval after working over Christmas

    Most of the sprawling industrial estate on the edge of Wrexham was quiet. There was little sign of activity at the engineering firms or in the self-storage units or greasy spoon cafes.

    But behind the wire fence of the Wockhardt UK plant, the laboratories and production lines were buzzing as scores of staff worked on the final part of the manufacture of the Oxford/AstraZeneca vaccine.

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    NHS doctors ‘scrabbling’ to get vaccine amid alarm at Covid variant

    Many medics ‘frustrated’ about low priority given to frontline staff at high risk of infection

    Frontline NHS staff have been denied the Pfizer/BioNTech vaccine, leaving doctors alarmed and “scrabbling” to get immunised.

    A new survey reveals that almost two-thirds of medics who responded to it have still not had the vaccine, half believe its delivery to the NHS frontline has been “ad hoc” and a third have no idea when they will be offered it. They fear the government’s decision to prioritise over-80s and care home staff above health workers has left them at risk of catching the disease, especially given the emergence of the coronavirus variant, which is 70% more transmissable.

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    Belgian minister tweets EU’s Covid vaccine price list to anger of manufacturers

    Pharmaceutical companies complain of breach of confidentiality after amount EU has agreed to pay for leading vaccines goes public

    A Belgian minister has inadvertently blown the lid off a sensitive and commercial secret – the price that the EU has agreed to pay for the leading Covid vaccines.

    Belgium’s budget state ecretary, Eva De Bleeker, posted the price list on Twitter, with the amounts of each vaccine that her country intends to buy from the EU. The tweet was quickly deleted, but not soon enough to prevent interested parties taking screenshots, which have now made it public knowledge.

    Oxford/AstraZeneca: €1.78

    Johnson & Johnson: $8.50

    Sanofi/GSK: €7.56

    Pfizer/BioNTech: €12

    CureVac: €10

    Moderna: $18

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    Scheme to get Covid vaccine to poorer countries at ‘high risk’ of failure

    Risk assessment documents say cost, delays and shortages could lead to billions not vaccinated until 2024

    The global scheme to deliver Covid-19 vaccines to poorer countries faces a “very high” risk of failure, potentially leaving billions of people with no access to vaccines until as late as 2024, internal documents say.

    The Covax scheme has been beset by a number of issues, including a shortage of doses of approved vaccines, and a decision by India’s Serum Institute, which was initially earmarked to supply Covax, saying it would prioritise supplying India first.

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    Tensions mount over handling of UK Covid vaccine rollout

    With overall costs for vaccinating the UK population at £12bn, the public accounts committee flags ‘highly unusual’ arrangements

    Vaccinating the population against Covid-19 will cost up to £12bn, Whitehall’s spending watchdog has disclosed, amid details of tensions between health bodies over the rollout.

    The National Audit Office said the government would spend up to £11.7bn on purchasing and manufacturing Covid-19 jabs for the UK before deploying them in England.

    Related: Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

    Related: Kate Bingham: well-connected but under-fire UK vaccines chief

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    GSK/Sanofi Covid vaccine delayed until end of next year

    Trials reveal vaccine failed to produce a strong immune response in older people

    A coronavirus vaccine being developed by GlaxoSmithKline and its French partner, Sanofi, will be delayed until the end of next year after trials revealed it failed to produce a strong immune response in older people.

    The drug companies hoped to have regulatory approval for the candidate vaccine in the first half of 2021, but interim results from a phase 1/2 trial showed an “insufficient” response in the over-50s, the age group most vulnerable to severe Covid-19.

    Now that the UK has authorised the first Covid vaccine, who will get it first?

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    Can the UK deliver on the Covid vaccine rollout? | Stephen Buranyi

    The challenge of delivering vaccines on this scale are hard, but are firmly within the world of logistics, engineering, and politics

    The UK has become the first country to approve one of the coronavirus vaccines that the entire world has been desperately waiting for. And on Tuesday it delivered the first dose, to 90-year-old Margaret Keenan in Coventry. We should be very pleased about this. But, as with every other stage of the pandemic, the final stretch brings a new set of unprecedented challenges. The world is watching as the UK becomes the first test case of our collective ability to manufacture, ship, and deliver an entirely new class of vaccines, on a scale and speed that no previous vaccination drive in history has ever approached.

    The thing everyone knows about the Pfizer-BioNTech vaccine is that it needs to be extremely cold. The mRNA that makes up the vaccine payload is the same stuff your cells use to send short-lived genetic instructions. It’s a messenger that isn’t supposed to stick around, as temporally fragile as a Snap on Snapchat. The vaccine is happiest at -70C, and after thawing can be kept at between 4C and -8C – the temperature of a regular fridge – for just five days before it degrades. Most logistics providers aren’t set up to ship at -70C, and while university labs and large hospitals generally have some -70C freezers, GP surgeries and smaller centres do not. The temperature for shipping and storage has been identified as one of the biggest challenges in getting this vaccine out.

    The Pfizer/BioNTech Covid jab is an mRNA vaccine. Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins.

    Stephen Buranyi is a writer specialising in science and the environment

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    Hackers accessed vaccine documents in cyber-attack on EMA

    Papers relating to Pfizer/BioNTech vaccine reportedly targeted in attack on European Medicines Agency

    German biotech firm BioNTech said on Wednesday that regulation documents related to the Covid-19 vaccine it has developed with Pfizer were “unlawfully accessed” after a cyber-attack on Europe’s medicines regulator.

    Earlier, the European Medicines Agency (EMA) – which is responsible for assessing and approving vaccines for the European Union – said it had been targeted in a cyber-attack. It gave no further details.

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    Nine out of 10 in poor nations to miss out on inoculation as west buys up Covid vaccines

    Billions unlikely to get jabs as rich countries secure 53% of most promising vaccines

    Nine out of 10 people in 70 low-income countries are unlikely to be vaccinated against Covid-19 next year because the majority of the most promising vaccines coming on-stream have been bought up by the west, campaigners have said.

    As the first people get vaccinated in the UK, the People’s Vaccine Alliance is warning that the deals done by rich countries’ governments will leave the poor at the mercy of the rampaging virus. Rich countries with 14% of the world’s population have secured 53% of the most promising vaccines.

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    Covid vaccine arrives in UK hospitals ready for first jabs

    Medical director warns of great hurdles in largest vaccination campaign in UK history

    Batches of the Covid vaccine have begun to arrive in hospitals around the UK, ready for the first jabs on Tuesday in what NHS England’s medical director warned would be the largest and most complex vaccination campaign in the country’s history.

    The UK’s record-breaking approval of the vaccine and the rapid start of immunisation against Covid-19 did not mean the end of the pandemic was in sight, said Prof Stephen Powis. It would be a marathon and not a sprint, he said.

    Related: How does the Pfizer/BioNTech vaccine work and who will get it?

    Related: How vaccine approval compares between the UK, Europe and the US

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    Covid-19 vaccine ‘very safe and highly effective’, UK health chief says

    Vaccine safety message ‘vitally important’, head of medicines regulator tells Andrew Marr Show

    Public health messaging that people can have faith in the safety of coronavirus vaccines is “vitally important”, the leader of the body that has approved the Pfizer jab has said.

    Dr June Raine, the chief executive of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), said of the Pfizer treatment that there “should be no doubt whatever that this is a very safe and highly effective vaccine”.

    Related: The vaccine miracle: how scientists waged the battle against Covid-19

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    The vaccine miracle: how scientists waged the battle against Covid-19

    We trace the extraordinary research effort, from the discovery of the virus’s structure to the start of inoculations this week

    In the early afternoon of 3 January this year, a small metal box was delivered to the Shanghai Public Health Clinical Centre addressed to virus expert Prof Zhang Yongzhen. Inside, packed in dry ice, were swabs from a patient who was suffering from a novel, occasionally fatal respiratory illness that was sweeping the city of Wuhan. Exactly what was causing terrifying rises in case numbers, medical authorities wanted to know? And how was the disease being spread?

    Related: ‘I worked so hard in the lab. I cried when the news came’

    What Zhang did was critical … Without the information he provided no one could have started working on vaccines

    Related: Team behind Oxford Covid jab start final stage of malaria vaccine trials

    Related: NHS staff no longer at front of queue for Covid vaccine after rethink

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    Oxford controversy is the first shot in international battle over vaccine efficiency

    Trials will not reveal all the facts on prevention for each new drug – that process could last for years

    In a few days, researchers plan to solve a medical mystery that threatens to erupt into a major transatlantic battle. Scientists at Oxford University say they intend to publish full, peer-reviewed data, in the journal Lancet, about trials they have completed on their Covid-19 vaccine.

    The information, they say, should end mounting controversy about the vaccine’s effectiveness and explain apparent inconsistencies in trial results. Opponents, most of them American, say this is unlikely, and insist new phase 3 trials now need to be restarted from scratch to restore confidence in the vaccine.

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    Different age groups may get different Covid vaccines, experts say

    Oxford/AstraZeneca planning new trial of lower-dose jab to see how well it works in older people

    Concerns around the efficacy of the Oxford University/AstraZeneca coronavirus jab in older people could lead to different age groups being given different vaccines, experts have said.

    The partners announced last week that the vaccine had a 70% efficacy overall. For most trial participants – given two full doses, spaced a month apart – the efficacy was 62%, but for 3,000 participants mistakenly given half a dose for their first jab, the efficacy was 90%. No participants, regardless of dosing, developed severe Covid or were hospitalised with the disease.

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    BioNTech’s Covid vaccine is a triumph of innovation and immigration | Hans-Werner Sinn

    Pioneered by a Turkish-German couple, its significance exceeds its practical value

    The world took note when the German startup BioNTech announced its breakthrough in the development of a new type of vaccine to combat Covid-19. After testing tens of thousands of people, BioNTech’s vaccine has been shown to be 95% effective in providing protection for those who would otherwise have been infected. The company was the first to apply for emergency use authorisation for a coronavirus vaccine in the US and it has announced it will soon take similar steps in Europe.

    Antiviral vaccines are usually made with devitalised viral materials fabricated outside the body but BioNTech has pursued a new method of injecting genetically modified RNA into the patient. This prompts the patient’s cells to produce a characteristic protein of the relevant Sars-CoV-2 virus themselves, enabling the body’s immune system to build up an effective response before it encounters the real virus.

    Related: Uğur Şahin and Özlem Türeci: German ‘dream team’ behind vaccine

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    Will everyone in the world have access to a Covid vaccine? – video explainer

    The hunt for a coronavirus vaccine is showing promise but it is premature to say the end of the pandemic is nigh. Several rich countries have signed a ‘frenzy of deals’ that could prevent many poor nations from getting access to immunisation until at least 2024. Also, many drug firms are potentially refusing to waive patents and other intellectual property rights in order to secure exclusive rights to any cure.

    Michael Safi, the Guardian’s international correspondent, explains why ‘vaccine nationalisation’ could scupper global efforts to kill the virus and examines what is being done to tackle the issue

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    Here’s how to tackle the Covid-19 anti-vaxxers | Will Hanmer-Lloyd

    Do not demonise. To optimise the vaccine rollout, all of us must show respect to those who are unsure about inoculations

    • Will Hanmer-Lloyd is a behavioural strategist

    The Covid-19 vaccines, which are up to 95% effective, have the potential to save millions of lives in the UK and many more around the world.

    Yet creating the vaccines is just the first step. We now need to produce them as quickly as possible, work out the logistics of distribution and administration and – most importantly – ensure as many people as possible take them. And as the history of vaccines shows, that is not as easy as some might assume. You only have to look at the fall in uptake of the measles, mumps and rubella (MMR) vaccine after it was falsely linked with autism.

    Related: Vaccine results bring us a step closer to ending Covid, says Oxford scientist

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    A vaccine revolution | podcast

    Results from clinical trials have shown that the world has three apparently highly effective vaccines for Covid-19. With the race now on for regulatory approval, production and distribution, is the end of the pandemic within reach?

    After a gruelling year of successive waves of Covid-19 infections and national lockdowns there has been a burst of good news this month, with three separate vaccine candidates performing extremely well in clinical trials.

    First, Pfizer and Moderna announced that their vaccines were testing at an efficacy of around 95%. Then came the news that the AstraZeneca vaccine (the one pre-ordered in bulk by the UK government) was hitting 90%. It marks not just a new phase in the Covid-19 pandemic but potentially a revolution in vaccine technology itself.

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    Vaccine results bring us a step closer to ending Covid, says Oxford scientist

    Latest breakthrough comes as PM says he hopes most at-risk could be immunised by Easter

    The world is moving a step closer to ending the coronavirus pandemic, the scientist behind Britain’s first vaccine has declared, as Boris Johnson said he hoped the majority of those most at-risk could be immunised by Easter.

    Successful trial results for the Oxford University/AstraZeneca vaccine, suggesting it could protect up to 90% of people, are the third set of promising findings in as many weeks. Before this year, there had never been a vaccine for a coronavirus.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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    Oxford/AstraZeneca vaccine ‘likely first to be widely used in UK’

    Experts say Pfizer/BioNTech product faces more logistical challenges and obstacles

    The Oxford vaccine is likely to be the first Covid jab that large numbers of Britons receive, despite Pfizer’s candidate already being analysed by the medicines regulators, experts say.

    The fact that the Oxford vaccine can be kept in normal fridges, whereas Pfizer’s product has to be stored at -75C , may see it enter widespread usage ahead of the latter.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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    ‘It’s a great day’: Oxford coronavirus vaccine volunteers on trial data

    Trial participants react to news that Oxford AstraZeneca Covid vaccine has up to 90% efficacy

    Dan McAteer describes his reaction more as a sense of relief than elation when his phone pinged on Monday morning with a push alert reporting that the Oxford AstraZeneca vaccine has up to 90% efficacy.

    Several months on from becoming one of thousands of volunteers in trials of the Covid-19 vaccine, the 23-year-old student is trying to comprehend the news that people could be vaccinated as early as next month

    Related: Oxford AstraZeneca Covid vaccine: everything we know so far

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    Oxford AstraZeneca results open up Covid vaccine to developing countries

    Jab can be kept in fridge and is part of global initiative to distribute doses at limited cost

    The efficacy of the Oxford University/AstraZeneca vaccine opens the way for a cheap and more easily transportable vaccine to be made available to some of the world’s poorest countries.

    Unlike the Pfizer-BioNTech vaccine, AstraZeneca’s experimental vaccine is already a part of Covax, the global initiative which hopes to distribute some 2bn doses to 92 low- and middle-income countries at a maximum cost of $3 a dose.

    Related: Latest vaccine success is good news but high price may restrict access

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    The Guardian view on coronavirus and vaccine scepticism: time to act | Editorial

    Plans for mass immunisation against Covid-19 are developing fast, but concerns must be addressed

    In the 1960s, academics studying rumours drew inspiration from epidemiology. They noted how such stories spread through communities, “infecting” some individuals while others seemed immune, and how more resistant populations could stop their spread.

    Their insights have in turn been taken up by health professionals. Hearsay can be useful, helping to catch disease outbreaks. It can also be deadly. Though vaccine hesitancy is as old as vaccines themselves, it has risen sharply in many countries in recent years. Unfounded scare stories about the safety of immunisation programmes have contributed to growing scepticism and outright refusal, with fatal consequences. In her new book Stuck: How Vaccine Rumours Start – and Why They Don’t Go Away, Prof Heidi Larson notes the paradox: we have better vaccine science, more safety regulations and processes than ever before, yet a doubting public.

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    Do mRNA vaccines for Covid signal a new era in disease prevention? | Adam Finn

    No one knew whether mRNA technology would work against this virus – but it does. It’s an extraordinary moment for science

    The past few months have brought a number of scientific terms to public attention. We’ve had to digest R (a virus’s reproduction number) and PCR (the polymerase chain reaction method of testing). And now there’s mRNA. This last one has featured heavily in recent news reports because of the spectacular results of two new mRNA vaccines against coronavirus. It stands for “messenger ribonucleic acid”, a label familiar enough if you studied biology at O-level or GCSE, but otherwise hardly a household name. Even in the field of vaccine research, if you had said as recently as 10 years ago that you could protect people from infections by injecting them with mRNA, you would have provoked some puzzled looks.

    Essentially, mRNA is a molecule used by living cells to turn the gene sequences in DNA into the proteins that are the building blocks of all their fundamental structures. A segment of DNA gets copied (“transcribed”) into a piece of mRNA, which in turn gets “read” by the cell’s tools for synthesising proteins. In the case of an mRNA vaccine, the virus’s mRNA is injected into the muscle, and our own cells then read it and synthesise the viral protein. The immune system reacts to these proteins – which can’t by themselves cause disease – just as if they’d been carried in on the whole virus. This generates a protective response that, we hope, lasts for some time. It’s so beautifully simple it almost seems like science fiction. But last week we learned that it was true.

    Related: What has to happen before a Covid vaccine can be used?

    Adam Finn is professor of paediatrics at the Bristol Children’s Vaccine Centre, University of Bristol

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    Trials to begin in UK for Covid antibody cocktail drug treatment

    Scientists say jab could be used to protect those who cannot be given vaccines

    Major trials will begin this weekend of an antibody cocktail that scientists hope will protect people against Covid-19 and could be swiftly used in care homes or on cruise ships in the event of an outbreak.

    A UK volunteer will be given the first dose of a drug that is expected to give vulnerable people immediate protection. The jab into the muscle of the arm takes effect straight away and could last for six months to a year. If it works as well as scientists predict, it could be used to protect those who cannot be given vaccines because of their state of health.

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    First Americans may get Covid vaccine in December if US approves Pfizer request

    Pharmaceutical partners submitted bid to the FDA for vaccine to be reviewed and emergency authorization may occur within weeks

    It could take as little as three weeks for US regulators to approve Pfizer and partner BioNTech’s emergency authorization request for their Covid-19 vaccine – with the first Americans being offered the first inoculation outside clinical trials in early December.

    The major turning point in the worsening coronavirus pandemic came on Friday morning when the pharmaceutical partners submitted their bid to the Food and Drug Administration (FDA) for their vaccine to be reviewed.

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    UK faces calls to drop opposition to patent-free Covid vaccines

    Request will be made at WTO meeting in order to allow mass production of treatments

    The UK will be asked to reconsider its opposition to waiving intellectual property rights for Covid-19 vaccines and treatments at a World Trade Organization meeting on Friday, a move that would allow mass production of treatments and inoculations against the disease and could significantly shorten the length of the pandemic, campaigners say.

    India and South Africa have proposed that WTO member states be allowed to waive patents and other intellectual property (IP) rights on any treatments and tools related to Covid-19 until the end of the pandemic, including for the Moderna and Pfizer/BionNTech vaccines that are expected to be approved for use in the coming weeks.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    Pfizer Covid-19 vaccine has 95% efficacy and is safe, further analysis shows

    Among first 170 Covid cases in trial, eight had received vaccine and 162 were in placebo group

    The Pfizer/BioNTech vaccine against Covid-19 performs even better than previously thought, with 95% efficacy, equalling the early results from Moderna on Monday, according to an analysis of the final data from their trials, which paves the way for regulators to grant an emergency licence and vaccination campaigns to begin.

    The news will excite scientists, public health experts and politicians. Pfizer/BioNTech say they also have the necessary safety data that regulatory bodies require, and will submit the vaccine for emergency approval within days to the US Food and Drug Administration and other regulators around the world.

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    Moderna vaccine’s effectiveness bodes well for Oxford/AstraZeneca jab

    Phase 3 success rate of 95% for US firm’s treatment is promising for UK vaccine trial

    Hopes are rising for the Covid jab being developed by Oxford University, after Moderna became the second company to reveal impressive results from its vaccine trials.

    Interim results from phase 3 clinical trials of the Covid vaccine from US company Moderna has revealed it to be almost 95% effective at preventing the disease. The news followed an announcement last week from Germany-based Pfizer and BioNTech that their vaccine was more than 90% effective.

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    It’s the ‘vaccine hesitant’, not anti-vaxxers, who are troubling public health experts | Gaby Hinsliff

    To make vaccination work, we must reach out to the naturally cautious – a bigger proportion than you might assume

    Lydia Guthrie is not very daring by nature. A psychotherapist and mother of two from Oxford, she couldn’t be persuaded into bungee jumping for all the money in the world, and even shudders at skiing. “I’m very risk averse and a bit of a coward. I can’t even watch horror films.” Yet nonetheless, earlier this year she volunteered to be injected with an experimental Covid-19 vaccine as part of a clinical trial in the city, a partnership between the university, the NHS and drug company AstraZeneca.

    Like all the guinea pigs, she doesn’t yet know if she got the real thing or the meningitis vaccine used as a dummy. She had a headache afterwards and felt exhausted for a couple of days, but has never regretted taking part. She trusts the university’s ethics panel, having encountered it through her own degree research, and was also swayed by gratitude towards the city’s John Radcliffe hospital, where she had her own children. “If it hadn’t been for the NHS we might all have died. I feel I owe them.”

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    Moderna Covid vaccine candidate almost 95% effective, trials show

    US-based biotech firm is latest to reveal impressive results from phase 3 trials of jab

    The race for a coronavirus vaccine has received another shot in the arm with the US biotech firm Moderna becoming the latest to reveal impressive results from phase 3 trials of its jab.

    An interim analysis released on Monday, and based on 95 patients with confirmed Covid infections, found the candidate vaccine has an efficacy of 94.5%. The company said it now plans to apply to the US regulator, the Food and Drug Administration, for emergency-use authorisation in the coming weeks. In the trial, 90 of the patients received the placebo with the remaining five the vaccine.

    Related: Here are the major hurdles ahead for Covid-19 vaccine distribution in the US

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    BioNTech vaccine scientist says jab could halve Covid transmission

    Uğur Şahin ‘very confident’ vaccine candidate developed with Pfizer will cause big reduction in cases

    The scientist behind the first potential Covid-19 vaccine to clear interim clinical trials says he is “very confident” the jab will reduce transmission of the disease, perhaps by 50%, resulting in a “dramatic” reduction in cases.

    The German company BioNTech and the American pharmaceutical firm Pfizer announced to worldwide acclaim last week that their jointly developed vaccine candidate had proved 90% effective in stopping people from falling ill.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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    Vaccination hesitancy is about lack of trust. Compulsion is not the answer | Kenan Malik

    Better to build social solidarity than to dismiss reluctance to be immunised as ignorance

    “If a strain as deadly as the 1918 influenza emerges and people’s hesitancy to get vaccinated remains at the level it is today, a debilitating and fatal disease will spread.” So wrote Heidi Larson in 2018. Larson is director of the London-based Vaccine Confidence Project and probably the most knowledgeable person on the question of “vaccine hesitancy” – the unwillingness of some to get vaccinated.

    Two years after Larson wrote those words, we do have a pandemic that so far has taken more than a million lives, including at least 50,000 in the UK. We also have the possibility of a vaccine, the first of a number that could transform the Covid-19 landscape. Whether they do depends not just on how effective they are, but also on the willingness of people to be vaccinated. In the US, just half the population seems so inclined. In Britain, the figure is higher – about 70% – but still probably insufficient to generate herd immunity.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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    Speedy work on Covid gives the vaccine industry a shot in the arm

    Pfizer was first with the news, but biotech firms, governments, banks and NGOs are all involved in the search for a jab to prevent coronavirus infectionThe leading candidate to become the world’s first Covid-19 vaccine, developed by the US pharmaceutical company Pfizer and Germany’s BioNTech, had its genesis in late January 2020. Uğur Şahin, chief executive of the Mainz-based biotech, read about coronavirus in the Lancet and worried that the outbreak could grow into a pandemic.

    Şahin summoned colleagues to tell them that the company would shift its focus from cancer treatments to finding a vaccine for the deadly virus. It would use a method based on mRNA, whereby a stetch of genetic material from the coronavirus is injected into the body, resulting in human cells producing its so-called spike protein. This in turn triggers an immune response. Pfizer stepped in to help with development and distribution costs.

    ‘Here in the US, a recent poll showed that more than half of people said they wouldn’t take a Covid-19 vaccine’

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    BioNTech chief rejects Trump claim it delayed Covid vaccine news

    Exclusive: Ugur Şahin says he and Pfizer CEO received results night before announcement

    The scientist behind the BioNTech/Pfizer coronavirus vaccine has defended his company from Donald Trump’s accusation that it deliberately delayed news of its rapid progress until after the election, saying “we don’t play politics”.

    BioNTech, a German company, and the US pharmaceutical giant Pfizer announced on Monday that their jointly developed vaccine candidate had exceeded expectations in the crucial phase 3 vaccine trials, proving 90% effective in protecting people from coronavirus infections.

    The UK government’s joint committee on vaccination and immunisation has published a list of groups of people who will be prioritised to receive a vaccine for Covid-19. The list is:

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    Scientist behind BioNTech/Pfizer vaccine says it can end pandemic

    Exclusive: BioNTech’s CEO Uğur Şahin says he is confident vaccine can ‘bash the virus over the head’

    The scientist behind the first Covid-19 vaccine to clear interim clinical trials says he is confident his product can “bash the virus over the head” and put an end to the pandemic that has held the world hostage in 2020.

    The German company BioNTech and the US pharmaceutical giant Pfizer announced via a press release on Monday that their jointly developed vaccine candidate had outperformed expectations in the crucial phase 3 trials, proving 90% effective in stopping people from falling ill.

    Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    The Covid vaccine will benefit humanity – we should all own the patent | Owen Jones

    The pharmaceutical industry has long made exorbitant profits by free-riding on research carried out by the public sector

    Hooray for Pfizer! As news of a vaccine potentially offering 90% protection against Covid-19 offers a life raft for lockdown-weary humanity, perhaps those home-drawn posters on people’s windows thanking the NHS will soon be applauding big pharma instead.

    The hope of a successful vaccine to liberate us from protracted economic misery should be embraced – but we should be sparing with the bunting for the pharmaceutical industry. If you want a particularly egregious case study of “socialism for the rich”, or of private businesses dependent on public sector research and innovation to make colossal profits, look no further than big pharma.

    Related: The race to find a coronavirus treatment has one major obstacle: big pharma | Ara Darzi

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    Why a Covid vaccine doesn’t mean the end of face masks yet | David Salisbury

    Despite the Pfizer breakthrough, social distancing and remote working won’t disappear overnight

    The news this week that the Pfizer/BioNTech vaccine protected more than 90% of recipients is of huge importance. The vaccine efficacy is higher than we had hoped for.

    There appear to be no safety concerns, although the final safety data along with other data on manufacturing and the full efficacy results will need to be submitted to the Medicines and Healthcare products Regulatory Agency (MHRA) to review whether it’s safe enough to grant temporary authorisation. This would allow the vaccine to be rolled out before a full product licence is issued.

    Related: Speed trumps efficacy in UK’s Covid vaccine rollouts, says adviser

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    Pfizer chief sold $5.6m of shares on day Covid vaccine was announced

    Pfizer said sale of shares by Albert Bourla was automated under plan set up in August

    Pfizer’s chief executive sold shares in the company worth $5.6m (£4.2m) on the day the drugmaker announced that its Covid-19 vaccine was more than 90% effective in protecting people from transmission of the virus, triggering a surge in the company’s stock.

    Albert Bourla sold 132,508 shares at $41.94 a share, equivalent to 62% of his shareholding in Pfizer, according to filings with the US Securities and Exchange Commission (SEC). This is close to the $41.99 peak the share price hit on Monday.

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    Pfizer and BioNTech could make $13bn from coronavirus vaccine

    Johnson & Johnson and AstraZeneca pledged to make their vaccines available on a not-for-profit basis

    The US drugmaker Pfizer and the German biotech firm BioNTech stand to bring in nearly $13bn (£9.8bn) in global sales from their coronavirus vaccine next year, which will be evenly split between the two companies, according to analysts at the US investment bank Morgan Stanley.

    Pfizer’s half would be more than the US pharmaceutical group’s bestselling product, a pneumonia vaccine that generated $5.8bn last year.

    Related: Pfizer and BioNTech’s vaccine poses global logistics challenge

    Related: 6 key questions about the Pfizer/BioNTech Covid-19 vaccine

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    The Guardian view on the Covid vaccine breakthrough: making it work | Editorial

    At last, there is hope of an end to this pandemic. Scientists appear to have performed an amazing feat, the rest of us must do our best too

    Medicine is only partly a matter of science; it is, very much, the business of people. The inspiring news that a Covid vaccine appears within reach, with interim results showing the Pfizer/BioNTech candidate has 90% efficacy in protecting people from illness, reflects the extraordinary efforts of scientists this year. The speed with which this one has been developed – with others close behind – is remarkable. Detailed data has yet to be published, and much remains unknown, including how long individuals may be protected, whether it prevents infection and how effective it will be for older people, who are most vulnerable to Covid-19. There are still no guarantees it will be used, though manufacturing has begun. Nonetheless, this is a potentially transformative moment.

    Now it is up to the rest of us to do our part. If this vaccine becomes available from the end of the year, as now looks likely, and others soon follow, the deployment will matter as much as its discovery. As one scientist has noted: “Vaccines don’t save lives. Vaccinations save lives.” Pfizer and BioNTech hope to make 50m doses available this year, but each patient requires two doses, and with the US, EU, UK and others all having placed advance orders, each country will get a tiny fraction of those it ultimately needs. Even if production of this vaccine is scaled up as planned, others will still be needed. The UK has a clear plan for who will be protected first, beginning with the oldest in society and those who care for them and thus might transmit the virus to them. Professor John Bell told MPs that there is a 70%-80% chance of having the most vulnerable covered by Easter if authorities “don’t screw up the distribution”. Mass inoculation will be a challenge; NHS England is planning seven-day services.

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    6 key questions about the Pfizer/BioNTech Covid-19 vaccine

    There are grounds for optimism but also several unknowns around this coronavirus vaccine

    Hopes that the end of the coronavirus pandemic has become nearer have soared after the news that a coronavirus vaccine was found to be 90% effective in global trials.

    Although there is definite reason to be optimistic, experts have cautioned that the data from the trials conducted by Pfizer and BioNTech are not final, and there remain plenty of unknowns.

    Related: Covid vaccine could be ready for rollout next month, says Hancock

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    What does the Pfizer Covid vaccine breakthrough mean for Australia?

    Interim results show vaccine to be 90% effective, but findings have not been peer-reviewed, Australia has only secured enough for five million people, and there are concerns around its storage temperature

    • Pfizer says vaccine is 90% effective
    What has Pfizer’s vaccine trial found?
    Vaccine announcement is cause for cautious celebration

    News that pharmaceutical giant Pfizer and partner company BioNTech have developed a vaccine that proved 90% effective in protecting people from Covid-19 in global trials has been heralded a “breakthrough”. Pfizer chief executive, Dr Albert Bourla, described the results as “a great day for science and humanity”.

    But what do the findings mean for Australia, and for the other Covid-19 vaccines being researched?

    Related: Hopes rise for end of pandemic as Pfizer says vaccine is 90% effective

    Related: The race for a Covid vaccine: inside the Australian lab working round the clock to produce 100m doses

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    Pfizer/BioNTech vaccine announcement is cause for cautious celebration

    Interim trial results are encouraging as scientists welcome news

    It is not yet the end of the pandemic, but the announcement by Pfizer/BioNTech that their vaccine has been 90% successful in the vital large-scale trials has got even the soberest of scientists excited.

    These are interim results and the trial will continue into December to collect more data. The two companies – a tiny German biotech with the big idea and the giant pharma company Pfizer with the means to develop it – have not yet published their detailed data, so it is all on trust. And yet, nobody is suggesting the results have been over-egged. It looks as though the vaccine not only works, but works better than anyone hoped.

    Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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    BioNTech’s Covid vaccine: a shot in the arm for Germany’s Turkish community

    Couple who set up and run firm are children of long-maligned ‘guest workers’ from Turkey

    When the German biotechnology company BioNTech picked a street called An der Goldgrube or At the Goldmine in the western city of Mainz for its headquarters, the couple behind it could not have predicted how prophetic the address would turn out to be.

    The company’s shares shot up 23.4% on Monday morning after the Covid-19 vaccine it is developing with the US pharma giant Pfizer became the first candidate worldwide to show positive results in phase 3 trials, the crucial final stage of testing.

    Related: Covid-19 vaccine candidate is 90% effective, says Pfizer

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    What has Pfizer’s Covid vaccine trial found and is this a breakthrough?

    Early results from phase 3 trial look promising but there are still many questions to be answered

    Pfizer and the German biotech company Biontech said on Monday that they had had encouraging early results from a phase 3 clinical trial of their coronavirus vaccine. The trial is assessing how well the vaccine works in preventing humans from becoming infected. Although details are scant, the news is positive.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    Oxford Covid vaccine works in all ages, trials suggest

    Vaccine being trialled by Oxford University and AstraZeneca offers hope for all age groups

    One of the world’s leading Covid-19 experimental vaccines produces an immune response in both older and young adults, raising hopes of a path out of the gloom and economic destruction wrought by the novel coronavirus.

    The vaccine, developed by the University of Oxford, also triggers lower adverse responses among elderly people, said the British drug maker AstraZeneca, which is helping to manufacture the vaccine, on Monday.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Related: At 75, I’ve volunteered for a Covid vaccine trial. It could set people free

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    Are we near to having a vaccine for Covid-19?

    Even a once bullish PM is now not so optimistic but there are promising signs of a vaccine on the horizon

    In March, Boris Johnson said we would turn the tide in 12 weeks and “send the coronavirus packing” and by May ministers were boasting of having a vaccine by September. Last week the prime minister sounded far less confident, telling MPs that there was still no vaccine for SARS, 18 years after it emerged. A vaccine may not be far away though.

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    Johnson & Johnson pauses Covid vaccine trial over participant’s ‘unexplained illness’

    Company is unclear about whether patient was receiving vaccine or placebo in 60,000-patient study

    Johnson & Johnson has paused its Covid-19 vaccine trial due to an “unexplained illness” in a participant, the company confirmed.

    The pharmaceutical giant was unclear if the patient was administered a placebo or the experimental vaccine, and it’s not remarkable for studies as large as the one Johnson & Johnson are conducting – involving 60,000 patients – to be temporarily paused.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    UK doing more than most to help poor get Covid vaccine, study finds

    Campaign scoring countries for global access efforts calls for more British transparency

    The UK is doing more than most countries to support access to Covid vaccines for the poorest populations in the world, but it is not transparent enough about the deals it is doing at home, according to an international aid organisation launching a tracker.

    The One campaign has given countries and pharmaceutical companies scores for the efforts they have made to ensure the poorest get vaccines. In the vaccine access test no country or company scores green, the top rating, classed as aiding global access to vaccines.

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    Pharmacies in England pause online flu jab bookings as demand soars

    Boots, LloydsPharmacy and Well Pharmacy report unprecedented take-up and many chemists run out of stock

    Pharmacies across England are struggling to keep up with the demand for the flu vaccine, pausing online bookings and limiting it to those most in need.

    The country’s three largest pharmacy chains – Boots, LloydsPharmacy and Well Pharmacy – have all reported unprecedented demand after a government vaccination campaign to reduce the pressure on the NHS during a second wave of Covid-19.

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    Beware of big pharma in rush for Covid-19 vaccine | Letter

    Heidi Chow on why the pharmaceutical industry must not be left in the driving seat to supply an effective Covid-19 vaccine

    The biggest gamble that governments are taking is not on specific vaccine candidates, but on the pharmaceutical industry itself (The Covid-19 vaccine gamble: where bets have been placed and why, 11 September). The pharmaceutical industry has long been criticised for defending intellectual property rights and profiteering. For decades, countless patients the world over have been denied access to life-saving treatments and vaccines because of high prices propped up by patent monopolies.

    Once an effective vaccine is discovered, we will need open sharing of the technological process so that as many suppliers as possible can make it, to ensure an adequate supply across the world. This is not a time for monopolies. While governments leave big pharma in the driving seat, there will be vaccine scarcity and the global race to hoard vaccines will deplete global stocks, leaving very little – if any – for the WHO to supply to poorer countries. This is not just morally wrong, it is also counterproductive, because we will only be safe if everyone is safe.
    Heidi Chow
    Global Justice Now

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    Oxford University resumes Covid-19 vaccine trials

    Trials of vaccine being developed with AstraZeneca had been paused after participant fell ill

    The closely watched trial of an experimental Covid-19 vaccine that was halted after a participant fell ill is to resume in the UK.

    The University of Oxford, which has partnered with pharmaceutical giant AstraZeneca to pilot the study, said that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had recommended that its trials resume after an independent committee review of safety data triggered a pause last week.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    Show more empathy to boost confidence in vaccines, scientists told

    Expert behind vaccine confidence report points to halting of Oxford Covid trial as example

    Doctors and scientists need to show more empathy towards volunteers in coronavirus vaccine trials who fall ill if the public is to have full confidence in the safety of the vaccines being developed, say experts.

    The temporary halting of the Oxford University/AstraZeneca trial after one volunteer in the UK was admitted to hospital was good news, not bad, said Heidi Larson, who leads the Vaccine Confidence Project at the London School of Hygiene and Tropical Medicine, as it showed that scientists and the company were putting safety first.

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    Oxford Covid-19 vaccine is still possible this year, says AstraZeneca chief

    Pharmaceutical firm’s boss says 2020 deadline possible if regulators move fast

    AstraZeneca’s coronavirus vaccine could still be available by the end of the year, or early next year, according to the company’s chief executive, Pascal Soriot, despite clinical trials being paused after a volunteer fell ill.

    AstraZeneca and Oxford University, which are jointly developing the vaccine and testing it on 50,000 to 60,000 people around the world, halted trials on Wednesday to investigate the “potentially unexpected illness” of one participant.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

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    Oxford University Covid vaccine trial put on hold due to possible adverse reaction in participant

    A spokesman for AstraZeneca, the company working on the coronavirus vaccine, said pausing trials was common during vaccine development

    The development of a promising Covid-19 vaccine has been put on hold due to a possible adverse reaction in a trial participant.

    A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian the trial has been stopped to review the “potentially unexplained illness” in one of the participants.

    Related: Covid vaccine tracker: when will a coronavirus vaccine be ready?

    Related: Let’s get real. No vaccine will work as if by magic, returning us to ‘normal’ | Jeremy Farrar

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    GSK and Sanofi to start human trials of potential Covid-19 vaccine

    World’s largest vaccine makers to begin testing on people in US with eye on rollout in early 2021

    GlaxoSmithKline and Sanofi are to start testing their protein-based Covid-19 vaccine on humans for the first time, following promising results in earlier studies.

    GSK, the world’s largest vaccine maker, and the French drugmaker Sanofi joined forces in April to work on an effective treatment to halt the devastating pandemic.

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    Italian vaccine makers in race to produce flu doses before winter

    Authorities order 50% more doses than in 2019 in bid to avoid hospitals being overwhelmed

    Italian vaccine manufacturers are scrambling to produce millions of flu vaccination doses amid concern there will not be enough to meet demand this autumn and winter.

    The country’s 20 regional authorities have so far ordered 17m doses between them – almost 50% more than in 2019 – as they seek to prevent the country’s health services from becoming overwhelmed if they also have to deal with a serious resurgence of Covid-19.

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    AstraZeneca starts Covid-19 antibody drug trial in UK

    Volunteers are receiving doses of drug, which has potential both as a vaccine and a treatment

    The pharmaceutical group AstraZeneca has started a clinical trial of a drug to help prevent and treat Covid-19, with the first volunteers already receiving doses.

    The company, which is separately developing a potential Covid-19 vaccine together with scientists at Oxford University, said the drug, known as AZD7442, is a combination of two monoclonal antibodies.

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    Oxford University Covid-19 vaccine firm denies Trump talks

    AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US

    The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.

    With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.

    Related: Covid vaccine tracker: when will we have a coronavirus vaccine?

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    ‘Vaccine nationalism’ stands in the way of an end to the Covid-19 crisis | Stephen Buranyi

    Russia is not the only country pursuing domestic politics over global cooperation in the fight against coronavirus

    We’re all waiting for a coronavirus vaccine, but when Russia announced earlier this week that it would be the first country to approve one, nobody rejoiced. Scientists pointed out clinical testing wasn’t complete, the vaccine had been tested on fewer than 100 people. Anthony Fauci, director of the US National Institute for Allergy and Infectious Diseases, said he had “serious doubts” it would work. It was a transparent and potentially dangerous PR stunt. “It’s ridiculous,” the head of Russia’s Association of Clinical Research Organizations told the magazine Science, “I feel only shame for our country”.

    The mysterious vaccine may turn out not to be dangerous. The technology is similar to several approved vaccines, and Russia has said its release will be limited to healthcare workers and other at-risk populations until further trials are completed. China similarly approved an in-trial vaccine for military use with essentially no fanfare. But it’s unlikely to work – most vaccines don’t. The point for Russia appears to be to pass off a limited-release in-trial vaccine as completed in order to score a little nationalistic dopamine hit. (The project is even named Sputnik V, suggesting it is a successor to the Soviet rockets that bested the US in the space race.)

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    UK ‘95% sure’ Russian hackers tried to steal coronavirus vaccine research

    Minister says Britain and allies confident Russian intelligence was behind cyber-attacks

    The UK security minister James Brokenshire has said Britain is “more than 95%” sure that Russian state-sponsored hackers targeted UK, US and Canadian organisations involved in developing a coronavirus vaccine.

    Brokenshire said the National Cyber Security Centre (NCSC) and its counterparts in the other countries were confident “Russian intelligence agencies” were responsible for the attacks on drug companies and research groups.

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    Oxford offers best hope for Covid-19 vaccine this year, MPs told

    University is leading rivals but first drugs may not work fully, says vaccine taskforce chair

    Oxford University is leading the world in developing a vaccine against Covid-19 and offers the best chance of having something protective against the virus as we go into winter, MPs have been told.

    Kate Bingham, chair of the UK vaccine taskforce, said she expected to have a vaccine “early next year” from one or more of the candidates, although it was possible the first vaccines might only “help alleviate the symptoms” so that people have a less serious bout of disease, rather than fully protecting them.

    Related: ‘I felt guilty’: volunteer on signing up for Oxford Covid-19 vaccine trial

    Related: The Lancet’s editor: ‘The UK’s response to coronavirus is the greatest science policy failure for a generation’

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    How will the world’s poorest people get a coronavirus vaccine? | Achal Prabhala and Kate Elder

    Rich countries’ governments are putting all their trust in a marriage of markets and philanthropy called Gavi

    Vaccines for Covid-19 are coming. Billions of dollars are flowing in, over 100 efforts are under way, and at least 13 leading candidates are already being tested on humans. But how will these vaccines reach the poorest people on the planet? This question haunts the fate of more than half the world’s population. It is the central question of our time. The failure to address this question in the past has resulted in millions of unnecessary deaths – and yet, some believe there is a simple answer. Ask pharmaceutical corporations about how they will ensure access to Covid-19 vaccines, and they say “Gavi”. Ask the wealthiest governments in the world what they are doing to ensure global equity, and they too say “Gavi”.

    Gavi, the Vaccines Alliance, is a 20-year old public-private partnership that believes the marriage of markets and philanthropy will bring vaccines to everyone in the world. The numbers are impressive: every year, Gavi sends out 500 million vaccine doses against 17 different diseases. The sums of money pumped into Gavi are equally impressive. At the Global Vaccine Summit held earlier this month, Gavi raised a record-breaking $8.8bn. With £330m committed annually for the next five years, the British government is their single largest donor, alongside other wealthy countries and the Gates Foundation. At the summit, Gavi launched its newest initiative, a fund for future Covid-19 vaccines – the Covax Facility – which invites countries to invest in a wide portfolio of potential vaccines, pool their risk, and gain dedicated access to eventual products.

    Related: UK plans £38m centre to start production of coronavirus vaccine

    Related: Covid-19 vaccine may not work for at-risk older people, say scientists

    Achal Prabhala is the coordinator of the AccessIBSA project, which campaigns for access to medicines in India, Brazil and South Africa. Kate Elder is the senior vaccines policy adviser at the Médecins Sans Frontières Access Campaign

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    ‘The wondrous map’: how unlocking human DNA changed the course of science

    Thanks to the success of the Human Genome Project, 20 years ago this week, scientists can track biology and disease at a molecular level

    Twenty years ago this week, an international group of scientists announced it had put together the first genetic blueprint of a human being. After 10 years of effort, the team – made up of thousands of scientists working on both sides of the Atlantic – revealed it had pinpointed all 3bn units of DNA that make up the human genome.

    The result was “the most wondrous map ever created by humankind”, US President Bill Clinton told a special White House ceremony to mark the event. A parallel event, hosted by Tony Blair in Downing Street, also featured glittering praise for the effort.

    DNA studies have helped to develop new drugs for conditions ranging from cystic fibrosis to asthma

    We are sequencing samples of Sars-Cov-2 from different sources to see if the virus is mutating significantly

    Related: Human code fully cracked

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    Demand for flu vaccine soars as countries plan for second Covid-19 wave

    Manufacturers warn they will struggle to meet demand as governments seek to ease pressure on health services

    Fears of a second wave of coronavirus have sparked a global scramble for influenza shots from countries that hope to vaccinate great swathes of the population to reduce pressure on their health services.

    Health officials in the UK are considering whether to offer flu shots to everyone as part of planning for a resurgence of coronavirus in the autumn, but with other countries hitting on the same strategy, demand for flu vaccines has soared.

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