EMA says AstraZeneca’s COVID-19 shot could be approved on 29 January

The European medicines Agency (EMA) said this morning it has received a marketing application from AstraZeneca for its COVID-19 vaccine, already rolling out in the UK, and could give it the go-ahead later this month.

The filing for conditional marketing approval is scheduled for review by the EMA’s CHMP human medicine committee at a meeting on 29 January, and if all goes well it could be authorised on that day, according to the regulator.

The European Commission will then fast-track its decision-making process, says the EMA, with a view to granting a conditional marketing authorisation “within days”, a timeframe which was welcomed by Commission President Ursula von der Leyen.

AZ’s AZD1222 shot – which was developed with Oxford University – was cleared by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on 30 December, and since then it has also been given emergency approval in several other countries including India.

The filing comes as the EU is facing criticism for the slow roll-out of its coronavirus vaccination programme as infection rates soar in the 27 member states.

While individual EU countries make the decisions about who to vaccinate, the Commission is coordinating the acquisition and allocation of supplies, and there have been complaints the process is taking too long.

The US and Britain have both vaccinated 1%-2% of their populations, according to an Economist report citing figures from the Our World in Data website, while Israel is leading the field at 16%. In contrast, Germany has managed just 0.4%, France didn’t cross the 1,000 threshold until 4 January, and the Netherlands only started vaccinating until 6 January.

So far the EMA has conditionally approved two coronavirus vaccines – Pfizer/BioNTech’s Comirnaty last month and Moderna’s candidate last week – and swift approval of the AZ vaccine should allow an acceleration in vaccination rates in the EU.

As it stands, the UK has vaccinated more people than the entirety of the EU combined, with the latest government figures indicating 2.3 million people have now received the first of two required doses, saying it plans to immunise all adults in the country by the autumn.

So far the effect of vaccination is imperceptible, however, as the UK recorded more than 46,000 new cases of COVID-19 yesterday, and 529 deaths, with NHS capacity creaking under the weight of over 32,000 people hospitalised with the infection.

The EU has 400 million doses of the AZ vaccine on order, part of a procurement programme that so far extends to 2.3 billion doses.

Last week the Commission said it intended to order an additional 200 million doses of the BioNTech/Pfizer, with the option to acquire another 100 million doses, taking its total to 600 million doses.

It has also agreed deals for the supply of 160 million doses of the Moderna shot, 400 million apiece for candidates in testing at Johnson & Johnson and CureVac, and 300 million of a Sanofi/GlaxoSmithKline candidate that has been delayed by clinical trial snags.

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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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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

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AZ COVID-19 vaccine cleared in UK, dosing to start next week

The UK has approved AstraZeneca and Oxford University’s COVID-19 vaccine AZD1222 in another significant step forward in the fight against the pandemic, with first doses due to be administered on Monday.

The UK government has already ordered 100 million doses of the adenovirus-based shot, enough to vaccinate 50 million people, adding to the 40 million dose order of the Pfizer/BioNTech shot – now known as Comirnaty – that was approved earlier this month.

The UK is the first country to approved AZD1222, and AZ says it is preparing to provide “millions of doses” in the first quarter of 2021, while building capacity for three billion doses for delivery worldwide by the end of the coming year.

The emergency approval comes as millions more people in the UK are facing tighter lockdown restrictions after another daily record of more than 53,000 confirmed new coronavirus cases yesterday.

Health Secretary Matt Hancock warned that while the rollout of AZD1222 brings forward the end of the pandemic, mass vaccination will take time and people should “hold their nerve” to avoid swamping the NHS in the first few months of 2021.

He told the BBC this morning that he now has “a high degree of confidence that we can be out of this by the spring.”

The Joint Committee on Vaccine and Immunisation (JCVI) has set out priority groups who will receive the vaccine, and as with the Pfizer/BioNTech jab first in line will be the over-80s and health and social care workers. So far, more than 600,000 people have received Comirnaty since dosing started on 9 December.

AZ chief executive Pascal Soriot said that millions of doses of AZD1222 have already been produced and are being filled, ready to ramp up supply as the UK immunisation programme gathers pace.

Soriot confirmed that AZ should be able to provide enough vaccine to meet the UK government’s target of a million doses per week “very rapidly” with the first doses due to be delivered to clinics “today or tomorrow.”

He also said that AZD1222 provides a reasonable level of protection from the coronavirus after a single dose, and as the second dose only needs to be given within 12 weeks, that provides an opportunity to immunise more people, more quickly.

In turn, that should start to reduce mortality and hospitalisation from COVID-19 and ease pressure from the NHS as cases continue to surge.

The AZ vaccine can also be stored, transported and handled at normal refrigerated conditions for at least six months making it more suitable for delivery to parts of the world with less sophisticated healthcare systems than the Pfizer/BioNTech shot, which requires colder storage.

Soriot also reiterated his view that AZD1222 should provide protection against the new, more transmissible strain of the SARS-CoV-2 virus that causes COVID-19.

The first case of that has now been identified in the US, along with dozens of other countries, but new research suggests that while it is easier to transmit it isn’t any more likely to cause severe disease.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of AZD122, which has a top-line protective efficacy of 62%, as it decided there wasn’t enough data on a half dose/full dose combination that seemed to be more effective in trials with 90% protection rate.

The British Medical Association’s council chair Dr Chaand Nagpaul, welcomed the approval, but warned the rollout will require a massive step up in immunisation capacity.

“It is now crucial that supplies of this vaccine are given to as many GP practice sites and hospital hubs as possible and that this happens as quickly as possible so that we can begin vaccination en masse,” he said.

“We need to see a step change in distribution so that doctors can protect their patients and communities, beginning with those most at risk, and crucially this must include health and social care workers as they confront the virus on the front line.”

The BMA has previously said it is concerned about patchy access to the Pfizer/BioNTech vaccine by healthcare workers across the country.

EU orders another 100m doses of Comirnaty

The EMA is still reviewing the AZ vaccine, but yesterday exercised an option to acquire another 100 million doses of Comirnaty for distribution in the EU in 2021, taking the tally to 300 million doses.

Pfizer and BioNTech say they will be able to meet that order, agreed just two days after the first vaccinations against COVID-19 started in EU member states. The companies have previously said they will be able to supply up to 1.3 billion doses worldwide by the end of 2021.

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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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Covid vaccines: US regulator sceptical over AstraZeneca model

Vaccine developed in Oxford criticised by FDA with efficacy rates and trials delaying official take-up

For a man presenting landmark results from trials of a vaccine that it is hoped will save the world from a devastating pandemic, Sir Menelas Pangalos did not look cheerful on Wednesday.

Pangalos, executive vice-president of biopharmaceuticals R&D at AstraZeneca, and his colleagues are undoubtedly exhausted, having been working round the clock on the coronavirus vaccine with Oxford University since April. But they are now dealing with a sizeable new headache – the doubts of the US regulator.

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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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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

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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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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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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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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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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 Covid vaccine trial suspension: what happens next?

Tests have been paused after a UK volunteer became ill. How will it affect the search for a cure?

One of the volunteers in the UK has become ill and it is crucial that the researchers find out whether this could be related to the vaccine. This is not uncommon in vaccine trials – and in fact it is said to be the second time it has happened with this vaccine . Very large trials are essential to pick up any rare side-effects. Something that affects one in 10,000 people, for instance, will probably not be detected in the early trials of just a few thousand.

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The Oxford University AstraZeneca Covid-19 vaccine trial has been paused – should we be worried?

Is this the end for hopes of an early breakthrough in the race to find a coronavirus drug?

The halt in development of the University of Oxford’s Covid-19 vaccine due to a possible adverse reaction in a trial participant has triggered fears of a delay in finding a solution to coronavirus restrictions.

A spokesman for AstraZeneca, the company working with the academic team to produce the vaccine, said the voluntary pause is “routine”.

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

Related: Why are Australian church leaders opposing the Oxford coronavirus vaccine?

Related: Covid-19: ‘possible’ Oxford vaccine data will be put before regulators this year

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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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Here’s everything you need to know about the potential Oxford University Covid vaccine

The vaccine is designed to mimic the coronavirus and train the immune system to react if a person is later infected

The vaccine developed and tested by a team at Oxford University is one of the most promising of the many candidates being developed around the world to protect against Covid-19. Australia has now signed a letter of intent with pharmaceutical company AstraZeneca to supply Australians with the vaccine if it clears safety and effectiveness trials, with the prime minister now saying it won’t be compulsory but will be encouraged.

Here’s what you need to know about the vaccine.

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

Related: Global report: WHO warns against dangers of ‘vaccine nationalism’

A Phase II/III trial aims to enrol up to 10,560 adults and children across the UK.

A Phase III trial in the US is looking for 30,000 participants.

Brazil started a Phase III trial of the vaccine in June, which will enrol 5,000 volunteers.

A team in South Africa is looking to enrol 2,000 people to trial the vaccine.

Related: Will a vaccine or recovery from the virus give us long-term immunity to Covid-19?

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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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