EU eyes tighter COVID-19 vaccine exports as access gets ugly

The EU has hit back at AstraZeneca’s plan to provide fewer doses of its COVID-19 vaccine than expected, saying it wants to see exactly where supplies have been delivered so far.  

Moreover, it plans to rush through legislation requiring that all companies producing vaccines against COVID-19 in the EU have to notify the Commission when they want to export to third countries, according to Commissioner Stella Kyriakides, who is in charge of the EU vaccine rollout.

That would include the Pfizer/BioNTech vaccine – which is made in Belgium – and has sparked concerns that supplies of that vaccine destined for the UK could be held back as a retaliatory move.

In a statement, Kyriakides said AZ’s responses to enquiries “have not been satisfactory so far”, and another meeting of EU27 member states has been scheduled for Wednesday to discuss the matter further.

On Friday, AZ told the Commission it was falling behind on its supply targets because of production delays, following in the footsteps of Pfizer/BioNTech, which has also had to reduce supplies due to capacity constraints at the Belgian plant.

To recap, the AZ vaccine – developed in conjunction with Oxford University – hasn’t yet been approved in the EU, although the Commission says that should occur “by the end of this week”.

The EU has ordered 300 million doses and has an option on 100 million more, but a Reuters report says first-quarter deliveries to the EU could be 60% lower than expected at around 31 million.

The combative stance taken by the EU has led some to suggest it is diverting attention from criticism of a much slower-than-expected rollout of vaccines, a process which is being managed centrally by the Commission, by some member states including Germany.

Other countries, including Australia and Thailand, have also been informed of a reduction in supply of the AZ shot, according to the BBC, which suggests that problems at a plant in Belgium run by one of AZ’s manufacturing partners is at the root of the issue, although other reports point to spoiled batches and problems sourcing some raw materials.

A spokesperson for AZ said: “While there is no scheduled delay to the start of shipments of our vaccine should we receive approval in Europe, initial volumes will be lower than originally anticipated due to reduced yields at a manufacturing site within our European supply chain. We will be supplying tens of millions of doses in February and March to the EU, as we continue to ramp up production volumes.”

The EU’s target is to vaccinate 70% of the adult population of EU countries by the summer, which looks unlikely if supply issues persist. The UK government has said it is confident the supply of vaccines will not be disrupted by the EU’s export plans.

Meanwhile, AZ has also been forced to defend its vaccine after an unsourced report in German financial newspaper Handelsblatt claimed that it only has efficacy of 8% in people aged over 65.

The company says that is “completely incorrect. In the UK, the JCVI [Joint Committee on Vaccination and Immunisation] supported use in this population and MHRA included this group without dose adjustment in the authorisation for emergency supply.”

It goes on: “In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose.”

Moderna takes on new strains

Moderna meanwhile has said that its vaccine seems to be effective against the emerging UK and South African variants of SARS-CoV-2, but appears less effective against the latter when it comes to stimulating the production of antibodies.

The company it is starting a trial of a new vaccine against the B1351 variant, which is more transmissible and may also be associated with higher mortality, saying it wants to make sure that a shot will be available in the next few months as a precautionary measure.

The current shot produces antibodies that are six-fold lower against the SA variant than the original form of SARS-CoV-2, but are still at levels expected to be protective, said the US biotech.

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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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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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AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK


  • The MHRA has provided authorization for an emergency supply of AZD1222, for the active immunization of individuals aged ≥18yrs. The approval recommends 2 doses administered with an interval of between 4 & 12wks
  • The authorization is based on independent advice from its CHM following a rolling review of trial data that included an interim analysis of the P-III program led by the University of Oxford
  • AstraZeneca aims to supply millions of doses in Q1 as part of an agreement with the government to supply ~100M doses in total. The company will continue the regulatory interactions across the globe for the next approvals

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: Express Pharma

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AstraZeneca Reports Results of AZD1222 in Interim Analysis of P-lll Program for COVID-19


  • The results of an interim of P-III program demonstrated that AZD1222 is safe & effective at preventing symptomatic COVID-19 and hospitalization. The interim analysis for efficacy was based on ~11,636 participants accruing 131 symptomatic infections from the P-III UK and Brazil trials
  • The 1EPs based on the pooling of two dosing regimens showed vaccine is 70.4% effective at preventing COVID-19 occur >14days after receiving 2 doses of the vaccine. 2EPs of prevention demonstrated no cases of severe infections in the vaccine group
  • A further analysis showed that vaccine efficacy was 62.1% and 90.0% in participants who received a half dose followed by a full dose. Regulatory submissions are underway to support approval of vaccines

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: US News & World Report

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‘Mistake’ led to AZ’s more effective lower-dose COVID-19 shot

AstraZeneca’s research chief has said that the more effective dosing regimen of its coronavirus vaccine was discovered by accident.

According to Reuters, the AstraZeneca development team made a minor mistake that made them realise they could significantly boost the success rate of the vaccine, codenamed AZD1222.

Results announced earlier this week showed that by giving a half dose, followed by a full dose a month later, the vaccine’s efficacy could be boosted from 62% to around 90%.

AZ originally planned for trial participants in the UK to receive two full doses but researchers found that certain side effects such as fatigue, headaches or arm aches were milder than predicted.

Mene Pangalos, executive vice-president of biopharmaceuticals R&D at AZ, said: “The reason we had the half dose is serendipity.

Mene Pangalos

“So we went back and checked…and we found out that they had underpredicted the dose of the vaccine by half.”

Researchers decided to continue with the half dose group and administer the second booster shot as previously planned.

Results showed that in the group treated with the half dose, the vaccine was 90% effective, leading to an overall efficacy of 70% across the two dosing schedules.

“That, in essence, is how we stumbled upon doing half dose-full dose. Yes, it was a mistake.”

The error could make all the difference, cutting the amount of vaccine required for a strong therapeutic effect and allowing greater coverage.

Although at 90% effectiveness AZ’s shot would lag slightly behind RNA-based rivals from Pfizer/BioNTech and Moderna, AZD1222 is easier to handle and can be stored in fridges instead of at ultra-cool temperatures.

The revelation means that the stronger regimen could be added to a growing list of medicines discovered by accident – Alexander Fleming famously discovered penicillin after noticing a mould producing the compound was killing bacteria in a petri dish.

Pfizer’s erectile dysfunction drug Viagra was initially trialled as an angina drug before scientists at Pfizer’s laboratory in Sandwich, Kent, stumbled upon its other properties in a story so famous that Spike Lee is to direct a musical about the discovery.

It’s still not clear whether AZ’s vaccine discovery will be celebrated in popular culture as regulators have not yet approved it, but the incident shows the unpredictable nature of drug R&D and that after years of painstaking research good fortune is sometimes needed to get projects over the line.

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Russian Sputnik COVID-19 vaccine ‘will cost less than $10 a dose’

The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot.

Sputnik V’s efficacy has remained high at 91.4% according to the latest analysis, which comes from almost 19,000 subjects who were assessed seven days after the second dose of the vaccine, administered 28 days after the first.

Preliminary data from a smaller group of patients 21 days after the second shot suggests an efficacy of 95%, according to a press release from the Gamaleya Institute and Russian Direct Investment Fund (RDIF).

That puts the efficacy of the adenovirus-based vaccine ahead the 70% overall efficacy seen with AstraZeneca/University of Oxford’s AZD1222 jab – also based on an adenoviral vector – although AZ said yesterday there was a protective efficacy of 90% among patients receiving the vaccine as a half dose, followed by a full dose at least one month later.

AZ’s trial also had a higher number of confirmed cases of COVID-19 to power the analysis, at 131 cases, while there were 39 cases in the Russian study by the latest data cutoff. The next analysis for Sputnik V will be made when there are 78 confirmed coronavirus cases.

Sputnik V’s developers say its high level of efficacy comes from the use of two different adenoviral vectors which “allows for a stronger and longer-term immune response as compared to the vaccines using one and the same vector for two doses.”

At the moment scientists only have the top-line data from press releases to go on so it is impossible to make any judgments about the relative efficacy of the two vaccines, or indeed the two mRNA-based shots from Pfizer/BioNTech and Moderna that have also shown efficacy rates above 90% in clinical trials.

The RDIF has echoed the position voiced by AZ that its adenoviral vaccine will be cheaper than the mRNA shots – by two to three times – and also has the advantage of being stored using regular refrigeration temperature of +2 to +8 degrees Celsius.

Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.

“Such a regime enables the distribution of the vaccine in international markets, as well as expanding its use in hard-to-reach regions, including areas with tropical climates,” it said.

Russia will provide Sputnik V to its domestic population free of charge, so the $10 per dose price applies to international markets.

Capacity to make the vaccine is currently enough to immunise 500 million people per year, and the first international deliveries will be made to customers in January. Other orders will start to be fulfilled from March.

Russia approved Sputnik V in August, making it the first coronavirus vaccine worldwide to be licensed worldwide.

So far it has accepted orders for 1.2 billion doses from more than 50 countries, including Brazil, India, Mexico and Hungary – the latter deal reportedly putting the EU member state at odds with the European Commission as Sputnik V hasn’t yet been approved by the EMA.

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AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19


  • Interim analysis results of COV002 & COV003 study of AZD1222 in the UK & Brazil showed the vaccine is effective in preventing COVID-19 and no hospitalizations/ severe cases of the disease were reported
  • One dosing regimen showed an efficacy of 90% when AZD1222 was given as a half dose, followed by a full dose of at least 1 mos. apart & another dosing regimen showed 62% efficacy when given as 2 full doses at least 1 mos. apart. The combined analysis from both dosing regimens resulted in the efficacy of ~70%
  • AZ will plan regulatory submission of the data across the globe and will seek an Emergency Use Listing from the WHO for an accelerated pathway to vaccine availability in low-income countries

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: NBC News

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AZ, J&J COVID-19 vaccine trials okay to restart in US

US trials of AstraZeneca’s experimental COVID-19 vaccine AZD1222 have been cleared to restart by the FDA, several weeks after testing was suspended following a serious adverse reaction in one patient who received the shot.

Separately, Johnson & Johnson has also announced it is resuming recruitment in a phase 3 trial of  its coronavirus candidate JNJ-78436735, which has also suspended after one study subject fell ill.

AZ confirmed the FDA’s move in a statement, saying that regulators in the US, UK, Brazil, South Africa and Japan have now said that trials of the Oxford University-partnered shot are safe to continue.

The FDA took a lot longer to reach its conclusion however, as recruitment into studies restarted just a few days after the halt elsewhere.

AZ chief executive Pascal Soriot said: “We should be reassured by the care taken by independent regulators to protect the public and ensure the vaccine is safe before it is approved for use.”

On 6 September, AZ said it had put trials of AZD1222 on temporary hold because of a potential safety issue involving one patient in the UK, who had become ill after taking the vaccine with what at the time was reported to be transverse myelitis – an inflammation of the spinal cord that can be associated with viral infections as well as neurological conditions like multiple sclerosis.

“It is not unusual that in large scale vaccine trials, some participants will become unwell, and every case has to be evaluated to ensure the careful assessment of safety,” said AZ, which hasn’t confirmed the nature of the adverse reaction.

A report in the Wall Street Journal suggests that the FDA has reviewed two cases of potential neurological side effects in patients receiving AZD1222. One was subsequently found to be in a patient with MS, but the US regulator couldn’t either identify or rule out a clear link to the vaccine in both cases.

A death has also occurred in a patient enrolled onto an AZD1222 study in Brazil, although that has not been linked to the vaccine and is believed to have occurred in a subject who did not receive the shot.

AZ is now expecting to have results from the trials before the end of the year – analysts at Jefferies think it could occur in mid-November – and rolling regulatory  reviews of AZD1222 are already underway in some markets including the EU.

J&J meanwhile said that the independent data safety monitoring committee overseeing the phase 3 ENSEMBLE trial of JNJ-78436735 had found no clear cause behind a “serious medical event” – reported to be a stoke – in one subject that caused the study to be placed on hold earlier this month.

“After a thorough evaluation of a serious medical event experienced by one study participant, no clear cause has been identified,” said the drugmaker in a statement indicating the findings had been shared with the FDA. “There are many possible factors that could have caused the event.”

The suspension of studies for AZD1222 and JNJ-78436735 has put two coronavirus vaccines from BioNTech/Pfizer and Moderna in the lead in the US, with top-line efficacy results due within the next 4-5 weeks, although safety data will take a little longer to come in.

The resumption of the two stalled studies means that AZ and J&J will now not be too far behind.

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AstraZeneca Resumes P-III Study of AZD1222 Against COVID-19 in the US


  • The US FDA authorizes the restart of the P-III clinical study in the US following the resumption of trials in other countries in recent weeks. The FDA reviewed all safety data from studies globally and concluded it was safe to resume the trial
  • A voluntary pause across all global studies was triggered on Sept 06, 2020, to allow the examination of safety data by independent monitoring committees. AstraZeneca has resumed the clinical trials across the globe with regulators in the US, UK, Brazil, South Africa, and Japan confirming that it was safe to do so
  • While trials are ongoing, AstraZeneca and Oxford University will continue to provide information to regulators, study investigators, and participants according to clinical trial and regulatory standards

Click here ­to­ read full press release/ article | Ref: AstraZeneca | Image: The Indian Express

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European regulators begin rolling review of AZ’s COVID-19 vaccine

European regulators have started a first ‘rolling review’ of a COVID-19 vaccine, which is being developed by AstraZeneca in collaboration with the University of Oxford.

It’s an historic announcement, bringing hope that the vaccine could be approved in the near future, although the European Medicines Agency did not say how long the process will take.

Confirming press reports, the EMA said that large scale clinical trials from the vaccine codenamed AZD1222 involving several thousands of people are ongoing and results will become available over “the coming weeks and months”.

The rolling review, which is designed to speed up the assessment of a promising vaccine or drug by the EMA’s CHMP scientific committee, will continue until there is enough evidence available to support a marketing authorisation.

But this does not mean that the CHMP is ready to make a conclusion on the safety and efficacy of the vaccine.

All that the agency has is preliminary data from pre-clinical and early clinical studies suggesting the vaccine triggers the production of antibodies and T-cells that target the virus.

In a separate announcement, AstraZeneca said that a trial of the vaccine has resumed in Japan after a safety scare in the UK.

Trials have already restarted in the UK, Brazil, South Africa and India after one patient in the UK developed a potential side-effect that was deemed serious enough to cause the trial to be paused.

Discussions are still ongoing with the FDA, which has asked for further information before making a decision about resuming a trial in the US.

AZD1222 was co-invented by the University of Oxford and its spin-out company, Vaccitech.

It uses a replication-deficient chimpanzee viral vector based on a weakened version of an adenovirus that that causes common cold infections in chimpanzees and contains the genetic material of the SARS-CoV-2 virus spike protein.

After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

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Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19


  • Emergent will provide CDMO services for AstraZeneca’ AZD1222. The agreement valued ~174M through 2021 and follows an $87M agreement signed in June for development services, performance and process qualification, raw materials, and an initial capacity reservation
  • The two companies may enter additional commercial manufacturing agreement as the candidate progresses over three years through Emergent’s flexible capacity deployment model. The agreement follows CDMO partnership b/w Emergent and the BARDA signed in June to pave the way for OWS high-priority innovators
  • The University of Oxford and its spin-out company, Vaccitech co-invented AZD1222 and was licensed to AstraZeneca. The vaccine is under clinical trial for COVID-19

Click here ­to­ read full press release/ article | Ref: Emergent | Image: PharmaShots

AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19


  • The P-II/III COV001 designed to determine the safety, immunogenicity, and efficacy of the AZD1222 (single dose or two doses of AZD1222 at 5×1010 viral particles) vs single dose of meningococcal conjugate vaccine (MenACWY) as control vaccine in up to 1,077 healthy adults aged 18-55yrs. in 5 trial centers in the UK
  • The study demonstrated that a single dose of the AZD1222 resulted in 4 times increase in Abs to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection. A T-cell response was induced in all the participants, which was maintained two months after vaccination, as per the interim results. The peak response was noted by day 14
  • 91% of participants showed neutralizing Abs against SARS-CoV-2 following a single dose of AZD1222 and 100% following a second dose. The levels of neutralizing Abs seen in participants receiving either one/ two doses were in a similar range to those seen in convalescent COVID-19 patients

Click here to read full press release/ article | Ref: AstraZeneca | Image: Bloomberg

Related News: Daiichi Sankyo in Talks with AstraZeneca for the Supply of AZD1222 to Combat COVID-19 in Japan

AstraZeneca Covid-19 vaccine shows antibody levels comparable to recovered patients

The company announced the publication of interim data from the Phase I/II study of a vaccine it is developing with the University of Oxford. The news comes the week after Moderna announced the publication of data for its vaccine.