AstraZeneca Battles Supply Chain Issues, Denies Claims Its Covid-19 Vaccine Is Largely Ineffective In Seniors

Pharma giant AstraZeneca could face strict new export rules from the European Union that could restrict supply of its Covid-19 vaccine outside the bloc, as officials pressure the company to explain production shortfalls, while the company denies claims in German media that its vaccine is mostly ineffective in seniors.

Key Facts

Citing government sources, two German papers reported Monday that the efficacy of the vaccine AstraZeneca developed with the University of Oxford was “less than 10%” and 8% in those over 65.  

AstraZeneca said the claims are “completely incorrect” and go against published data from its clinical trials which showed a significant response in over-65s..

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Oxford University , which developed the vaccine with AstraZeneca, told the Financial Times there is “no basis for the claims of very low efficacy.”

The German health ministry also rejected the reports Tuesday, suggesting that the newspapers had got confused with the statistics. 

The confusion comes as tensions between AstraZeneca and the European Union soar to new levels, with the bloc furious at the company’s apparent inability or refusal to explain why it cannot honor its agreements and threatening to introduce new export rules for vaccines leaving the Union. 

Forbes has contacted  AstraZeneca to find out whether its supply chain issues and export rules could threaten vaccine supply to other parts of the world.

Key Background

On Friday, AstraZeneca informed Brussels that production issues meant it would be unable to honor its contractual commitments to provide doses to the EU. The vaccine is expected to be approved shortly and the delays mark another setback for the bloc’s vaccination efforts, which are already being hampered by a temporary reduction in deliveries from Pfizer while it makes changes to its production site.  

Chief Critic 

The EU stopped short of directly accusing AstraZeneca of reneging on its contracts in order to sell doses elsewhere, but said: “The European Union wants to know exactly which doses have been produced by AstraZeneca and where exactly so far and if or to whom they have been delivered,” Stella Kyriakides, the European Commissioner for Health and Food Safety, said in a statement.

Later, Kyriakides tweeted that discussions with the pharma giant “resulted in dissatisfaction” and there was a “lack of clarity and insufficient explanations.

What To Watch For

The EU may follow through on its threat to implement new vaccine export rules. This would require companies to seek permission before exporting internationally.   

Big Number 

31 million. This is how many doses the bloc is now expecting before the end of March, an EU official told Reuters. That amounts to a 60% cut.

Further Reading

Enraged at AstraZeneca over shortfall, EU calls for vaccine export controls (Politico)

AstraZeneca: German reports on low efficacy on over-65s ‘completely incorrect’ (DW)

Full coverage and live updates on the CoronavirusFollow me on Twitter. Send me a secure tip

Robert Hart

Robert Hart

I am a London-based reporter for Forbes covering breaking news. Previously, I have worked as a reporter for a specialist legal publication covering big data and as a freelance journalist and policy analyst covering science, tech and health. I have a master’s degree in Biological Natural Sciences and a master’s degree in the History and Philosophy of Science from the University of Cambridge. Follow me on Twitter @theroberthart or email me at rhart@forbes.com

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CNBC Television

AstraZeneca has received more than $1 billion from the U.S. Health Department’s Biomedical Advanced Research and Development Authority (BARDA) to develop a coronavirus vaccine from the University of Oxford. Pascal Soriot, CEO of AstraZeneca, joins “Squawk Box” and CNBC’s Meg Tirrell to discuss the company’s efforts to develop a Covid-19 vaccine. For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2JdMwO7​ » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision​ » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC​ » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic​ Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. Connect with CNBC News Online Get the latest news: http://www.cnbc.com/​ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC​ Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC​ Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC​ Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

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What’s The Difference Between Covid-19 Coronavirus Vaccines

Coronavirus COVID-19 single dose small vials and multi dose in scientist hands concept. Research for new novel corona virus immunization drug.

The world can’t return to normal without safe and effective vaccines against the SARS-CoV-2 coronavirus along with a coordinated global vaccination programme.

Researchers have been racing to develop potential drugs that could help end the ongoing Covid-19 pandemic. There are currently around 200 vaccine candidates and about a quarter passed preclinical tests and are now undergoing clinical trials.

What’s the difference between the various candidate vaccines?

A pie chart of candidates can be cut several ways. One is to slice it into six uneven pieces according to the technology (or ‘platform’) that’s used to produce the drug. Those six technologies can be grouped into three broader categories: dead or disabled viruses, artificial vectors, and viral components.

Dead or disabled viruses

Traditional vaccines contain a dead or disabled virus, designed to be incapable of causing severe disease while also provoking an immune response that provides protection against the live virus.

1. Live-attenuated viruses

Attenuated means ‘weakened’. Weakening a live virus typically involves reducing its virulence — capacity to cause disease — or ability to replicate through genetic engineering. The virus still infects cells and causes mild symptoms.

For a live-attenuated virus, an obvious safety concern is that the virus might gain genetic changes that enable it to revert back to the more virulent strain. Another worry is that a mistake during manufacturing could produce a defective vaccine and cause a disease outbreak, which once happened with a polio vaccine. MORE FOR YOUJapan Has Opened Hayabusa2’s Capsule, Confirming It Contains Samples From Asteroid RyuguDonald Trump’s Presidency Will End On The Day Of A Comet, A Meteor Shower And A Total Eclipse Of The SunIn A New Epidemiological Study, Daily Doses Of Glucosamine/Chondroitin Are Linked To Lower All-Cause Mortality

But using a live-attenuated virus has one huge benefit: vaccination resembles natural infection, which usually leads to robust immune responses and a memory of the virus’ antigens that can last for many years.

Live-attenuated vaccines based on SARS-CoV-2 are still undergoing preclinical testing, developed by start-up Codagenix and the Serum Institute of India.

2. Inactivated viruses

Inactivated means ‘dead’ (‘inactivated’ is used because some scientists don’t consider viruses to be alive). The virus will be the one you want to create a vaccine against, such as SARS-CoV-2, which is usually killed with chemicals.

Two Chinese firms have developed vaccines that are being tested for safety and effectiveness in large-scale Phase III clinical trials: ‘CoronaVac’ (previously ‘PiCoVacc’) from Sinovac Biotech and ‘New Crown COVID-19’ from Sinopharm. Both drugs contain inactivated virus, didn’t cause serious adverse side-effects and prompted the immune system to produce antibodies against SARS-CoV-2.

Sinopharm’s experimental vaccine has reportedly been administered to hundreds of thousands of people in China, and both drugs are now being trialled in countries across Asia, South America and the Middle East.

COVID-19 vaccine landscape (left) and platforms for SARS-CoV-2 vaccine development (right)
The global COVID-19 vaccine landscape (left) and Vaccine platforms used for SARS-CoV-2 vaccine … [+] Springer

Artificial vectors

Another conventional approach in vaccine design is to artificially create a vehicle or ‘vector’ that can deliver specific parts of a virus to the adaptive immune system, which then learns to target those parts and provides protection.

That immunity is achieved by exposing your body to a molecule that prompts the system to generate antibodies, an antigen, which becomes the target of an immune response. SARS-CoV-2 vaccines aim to target the spike protein on the surface of coronavirus particles — the proteins that allows the virus to invade a cell.

3. Recombinant viruses

A recombinant virus is a vector that combines the target antigen from one virus with the ‘backbone’ from another — unrelated — virus. For SARS-CoV-2, the most common strategy is to put coronavirus spike proteins on an adenovirus backbone.

Recombinant viruses are a double-edged sword: they behave like live-attenuated viruses, so a recombinant vaccine comes with the potential benefits of provoking a robust response from the immune system but also potential costs from causing an artificial infection that might lead to severe symptoms.

A recombinant vaccine might not provoke an adequate immune response in people who have previously been exposed to adenoviruses that infect humans (some cause the common cold), which includes one candidate developed by CanSino Biologics in China and ‘Sputnik V’ from Russia’s Gamaleya National Research Centre — both of which are in Phase III clinical trials and are licensed for use in the military.

To maximize the chance of provoking immune responses, some vaccines are built upon viruses from other species, so humans will have no pre-existing immunity. The most high-profile candidate is ‘AZD1222’, better known as ‘ChAdOx1 nCoV-19’ or simply ‘the Oxford vaccine’ because it was designed by scientists at Oxford University, which will be manufactured by AstraZeneca. AZD1222 is based on a chimpanzee adenovirus and seems to be 70% effective at preventing Covid-19.

Some recombinant viruses can replicate in cells, others cannot — known as being ‘replication-competent’ or ‘replication-incompetent’. One vaccine candidate that contains a replicating virus, developed by pharmaceutical giant Merck, is based on Vesicular Stomatitis Virus (VSV), which infects guinea pigs and other pets.

4. Virus-like particles

A virus-like particle, or VLP, is a structure assembled from viral proteins. It resembles a virus but doesn’t contain the genetic material that would allow the VLP to replicate. For SARS-CoV-2, the VLP obviously includes the spike protein.

One coronavirus-like particle (Co-VLP) vaccine from Medicago has passed Phase I trials to test it’s safe and has entered Phase II to test that it’s effective.

While there are currently few VLPs being developed for Covid-19, the technology is well-established and has been used to produce commercial vaccines against human papillomavirus (HPV) and hepatitis B.

Viral components

All vaccines are ultimately designed to expose the immune system to parts of a virus, not the whole thing, so why not deliver just those parts? That’s the reasoning behind vaccines that only contain spike proteins or spike genes.

5. Proteins

Protein-based vaccines can consist of the full-length spike protein or the key part, the tip of the spike that binds the ACE2 receptor on the surface of a cell — ACE2 is the lock that a coronavirus picks in order to break into the cell.

Manufacturing vaccines containing the protein alone has a practical advantage: researchers don’t have to deal with live coronaviruses, which should be grown inside cells within a biosafety level-3 lab.

A vaccine against only part of the protein — a ‘subunit’ — will be more vulnerable to being rendered useless if random mutations alter the protein, known as ‘antigenic drift‘, but full-length proteins are harder to manufacture. The immune system can recognize either as an antigen.

One candidate vaccine based on protein subunits is ‘NVX-CoV2373’ from Novavax, where the spike subunits are arranged as a rosette structure. It’s similar to a vaccine that’s already been licensed for use, FluBlok, which contains rosettes of protein subunits from the influenza virus.

6. Nucleic acids

Nucleic-acid vaccines contain genetic material, either deoxyribonucleic acid or ribonucleic acid — DNA or RNA. In a coronavirus vaccine, the DNA or RNA carries genetic instructions for producing a spike protein, which is made within cells.

Those spike genes can be carried on rings of DNA called ‘plasmids’, which are easy to manufacture by growing them in bacteria. DNA provokes a relatively weak immune response, however, and can’t simply be injected inside the body — the vaccine must be administered using a special device to force DNA into cells. Four DNA-based candidates are in Phase I or II trials.

The two most famous nucleic-acid vaccines are the drugs being developed by pharmaceutical giant Pfizer, partnered with BioNTech, and Moderna. Pfizer’s ‘BNT162b2’ and Moderna’s ‘mRNA-1273’ both use ‘messenger RNA’ — mRNA — to carry the spike genes and are delivered into cells via a lipid nanoparticle (LNP). The two mRNA vaccines have completed Phase III trials and preliminary results suggests they’re over 90% effective at preventing Covid-19.

As the above examples show, not only there are many potential vaccines but also various approaches. And while some technologies have already provided promising results, it remains to be seen which will actually be able to defeat the virus.

Full coverage and live updates on the CoronavirusFollow me on Twitter or LinkedIn. Check out my website or some of my other work here

JV Chamary

JV Chamary

I’m a science communicator specialising in public engagement and outreach through entertainment, focusing on popular culture. I have a PhD in evolutionary biology and…

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TODAY

Dr. Ashish Jha, dean of Brown University’s School of Public Health, joins the 3rd hour of TODAY to break down the differences between Moderna’s and Pfizer’s coronavirus vaccine candidates. He also comments on speculation of another national shutdown and whether families should still get together over Thanksgiving. » Subscribe to TODAY: http://on.today.com/SubscribeToTODAY » Watch the latest from TODAY: http://bit.ly/LatestTODAY About: TODAY brings you the latest headlines and expert tips on money, health and parenting. We wake up every morning to give you and your family all you need to start your day. If it matters to you, it matters to us. We are in the people business. Subscribe to our channel for exclusive TODAY archival footage & our original web series. Connect with TODAY Online! Visit TODAY’s Website: http://on.today.com/ReadTODAY Find TODAY on Facebook: http://on.today.com/LikeTODAY Follow TODAY on Twitter: http://on.today.com/FollowTODAY Follow TODAY on Instagram: http://on.today.com/InstaTODAY Follow TODAY on Pinterest: http://on.today.com/PinTODAY#COVID19Vaccines#AshishJha#TodayShow

Billionaire Eric Lefkofsky’s Tempus Raises $200 Million To Bring Personalized Medicine To New Diseases

On the surface, Eric Lefkofsky’s Tempus sounds much like every other AI-powered personalized medicine company. “We try to infuse as much data and technology as we can into the diagnosis itself,” Lefkofsky says, which could be said by the founder of any number of new healthcare companies.. But what makes Tempus different is that it is quickly branching out, moving from a focus on cancer to additional programs including mental health, infectious diseases, cardiology and soon diabetes. “We’re focused on those disease areas that are the most deadly,” Lefkofsky says. 

Now, the billionaire founder has an additional $200 million to reach that goal. The Chicago-based company announced the series G-2 round on Thursday, which includes a massive valuation of $8.1 billion. Lefkofsky, the founder of multiple companies including Groupon, also saw his net worth rise from the financing, from an estimated $3.2 billion to an estimated $4.2 billion.

Tempus is “trying to disrupt a very large industry that is very complex,” Lefkofsky says, “we’ve known it was going to cost a lot of money to see our business model to fruition.” 

In addition to investors Baillie Gifford, Franklin Templeton, Novo Holdings, and funds managed by T. Rowe Price, Lefkofsky, who has invested about $100 million of his own money into the company since inception, also contributed an undisclosed amount to the round. Google also participated as an investor, and Tempus says it will now store its deidentified patient data on Google Cloud. 

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“We are particularly attracted to companies that aim to solve fundamental and complex challenges within life sciences,” says Robert Ghenchev, a senior partner at Novo Holdings. “Tempus is, in many respects, the poster child for the kind of companies we like to support.” 

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Tempus, founded by Lefkofsky in 2015, is one of a new breed of personalized cancer diagnostic companies like Foundation Medicine and Guardant Health. The company’s main source of revenue comes from sequencing the genome of cancer patients’ tumors in order to help doctors decide which treatments would be most effective. “We generate a lot of molecular data about you as a patient,” Lefkofsky says. He estimates that Tempus has the data of about 1 in 3 cancer patients in the United States. 

But billing insurance companies for sequencing isn’t the only way the company makes money. Tempus also offers a service that matches eligible patients to clinical trials, and it licenses  de-identified patient data to other players in the oncology industry. That patient data, which includes images and clinical information, is “super important and valuable,” says Lefkofsky, who adds that such data sharing only occurs if patients consent. 

At first glance, precision oncology seems like a crowded market, but analysts say there is still plenty of room for companies to grow. “We’re just getting started in this market,” says Puneet Souda, a senior research analyst at SVB Leerink, “[and] what comes next is even larger.” Souda estimates that as the personalized oncology market expands from diagnostics to screening, another $30 billion or more will be available for companies to snatch up. And Tempus is already thinking ahead by moving into new therapeutic areas. 

While it’s not leaving cancer behind, Tempus has branched into other areas of precision medicine over the last year, including cardiology and mental health. The company now offers a service for psychiatrists to use a patient’s genetic information to determine the best treatments for major depressive disorder. 

In May, Lefkofsky also pushed the company to use its expertise to fight the coronavirus pandemic. The company now offers PCR tests for Covid-19, and has run over 1 million so far. The company also sequences other respiratory pathogens, such as the flu and soon pneumonia. As with cancer, Tempus will continue to make patient data accessible for others in the field— for a price. “Because we have one of the largest repositories of data in the world,” says Lefkofsky, “[it is imperative] that we make it available to anyone.” 

Lefkofsky plans to use capital from the latest funding round to continue Tempus’ expansion and grow its team. The company has hired about 700 since the start of the pandemic, he says, and currently has about 1,800 employees. He wouldn’t comment on exact figures, but while the company is not yet profitable he says Tempus has reached “significant scale in terms of revenue.” 

And why is he so sure that his company’s massive valuation isn’t over-inflated? “We benefit from two really exciting financial sector trends,” he says: complex genomic profiling and AI-driven health data. Right now, Lefkofsky estimates, about one-third of cancer patients have their tumors sequenced in three years. Soon, he says, that number will increase to two-thirds of patients getting their tumors sequenced multiple times a year. “The space itself is very exciting,” he says, “we think it will grow dramatically.” Follow me on Twitter. Send me a secure tip

Leah Rosenbaum

Leah Rosenbaum

I am the assistant editor of healthcare and science at Forbes. I graduated from UC Berkeley with a Master’s of Journalism and a Master’s of Public Health, with a specialty in infectious disease. Before that, I was at Johns Hopkins University where I double-majored in writing and public health. I’ve written articles for STAT, Vice, Science News, HealthNewsReview and other publications. At Forbes, I cover all aspects of health, from disease outbreaks to biotech startups.

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Eric Lefkofsky

To impact the nearly 1.7 million Americans who will be newly diagnosed with cancer this year, Eric Lefkofsky, co-founder and CEO of Tempus, discusses with Matter CEO Steven Collens how he is applying his disruptive-technology expertise to create an operating system to battle cancer. (November 29, 2016)

For access to live and exclusive video from CNBC subscribe to CNBC PRO: https://cnb.cx/2JdMwO7 » Subscribe to CNBC TV: https://cnb.cx/SubscribeCNBCtelevision » Subscribe to CNBC: https://cnb.cx/SubscribeCNBC » Subscribe to CNBC Classic: https://cnb.cx/SubscribeCNBCclassic Turn to CNBC TV for the latest stock market news and analysis. From market futures to live price updates CNBC is the leader in business news worldwide. Connect with CNBC News Online Get the latest news: http://www.cnbc.com/ Follow CNBC on LinkedIn: https://cnb.cx/LinkedInCNBC Follow CNBC News on Facebook: https://cnb.cx/LikeCNBC Follow CNBC News on Twitter: https://cnb.cx/FollowCNBC Follow CNBC News on Instagram: https://cnb.cx/InstagramCNBC

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Dosing Error By Researchers In The AstraZeneca-Oxford University Vaccine Trial Boosted Its Success Rate To 90%

  • AstraZeneca scientist Mene Pangalos says ‘serendipity,’ led to a break through 
  • ‘Mistake’ helped scientists discover half-dose was more effective than a full one 
  • More analysis needed to explain why an initial lower dose was more effective

A dosing error by researchers on the AstraZeneca-Oxford University Covid vaccine trial led to a huge boost in the jab’s success rate, the pharmaceutical company’s vice president has revealed.

Dr Mene Pangalos, head of AstraZeneca’s biopharmaceutical research, said the discovery that giving a half-dose at the start worked better was a lucky accident. He said: ‘The reason we had the half dose is serendipity.’ 

Volunteers were expected to receive two full doses of the vaccine. What happened with these participants would then be compared with the other half of the study group, who received a placebo.

Dr Pangalos said researchers were confused when they noticed volunteers in the vaccine group were reporting much milder side effects, such as fatigue, headaches and arm aches, than they originally predicted.  

He said: ‘So we went back and checked … and we found out that they had underpredicted the dose of the vaccine by half.’

Study results published yesterday showed that Oxford’s vaccine appeared to be up to 90 per cent effective in people who received the vaccine as a half-dose followed up by a full dose weeks later, compared to a lower 62 per cent when they were given two full doses.

Scientists explained this could be because the first smaller dose effectively prepared the immune system by showing it a small sample of the coronavirus, and then the full dose later on triggered a full-blown immune response.

Dr Pangalos said that despite the error the team decided to press ahead with the half-dose group, and to administer the second, full dose booster shot at the scheduled time.

The results showed the vaccine was 90 per cent effective among this group, while a larger group who had received two full doses produced an efficacy read-out of 62 per cent, leading to an average efficacy of 70 per cent across both dosing patterns, Dr Pangalos said.

‘That, in essence, is how we stumbled upon doing half dose-full dose (group),’ he told Reuters. ‘Yes, it was a mistake.’

It is now likely that doctors will be advised to use the 1.5 dose regimen of the vaccine rather than the full two doses because it appears to be more effective.

This will also mean that the jab, expected to cost around £2 per dose, will stretch further.

The 100million doses pre-ordered by the UK, for example, would have covered 50million people using a full two-dose system, but could now stretch to the entire population of 66million.

Although the clinical trial’s early results were published yesterday, the study is not completed.

Oxford researchers said they intend to publish the full results of the trial in a medical journal in the coming weeks and will then submit an application to the drugs regulator, the MHRA, for a licence to use the vaccine on members of the public.

This process could then take days or weeks for the MHRA to decide whether the jab is good enough to use before it can start to be given out – this is currently expected to be completed in December. 

The vaccine uses a harmless adenovirus to deliver genetic material that tricks the human body into producing proteins known as antigens that are normally found on the coronavirus’s surface, helping the immune system develop an arsenal against infection.

Dr Pangalos said more analysis was needed to explain why an initial lower dose bolstered protection. 

One possible explanation was that lower antigen levels to begin with triggered an overall better immune system build-up, he added.  

Oxford University confirmed its cheap, easy to store and simple to deliver jab could be approved by regulators in as little as a fortnight and start to be administered next month. 

Britain has ordered 100million doses, with almost 20million due by Christmas.

Professor Andrew Pollard, head of the Oxford Vaccine Group and a professor who has spent two decades running clinical trials, said that while speed of the Covid-19 vaccine’s development was in some ways extraordinary, 2020 had ‘been a very long year’ since the team started work on the vaccine in January.

That culminated this past weekend, Pollard said, in having ‘an enormous mountain to climb to pull all of the information together’ to be able to issue the early phase three trial results.

He added: ‘The last few weeks have been pretty exhausting. The feeling is absolutely one of extreme fatigue and tiredness at this point.

‘If the results have not met those regulatory requirements, they would have told us just to carry on with the trial. So it was a great relief.’

By Luke May For Mailonline and Sam Blanchard Senior Health Reporter For Mailonline

Source: DailyMail

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Oxford & AstraZeneca are Resuming Coronavirus Vaccine Trials After a Participant Fell Ill

Clinical trials for the coronavirus vaccine being developed by AstraZeneca and the University of Oxford have resumed in the United Kingdom, the company said Saturday in a press release.

The statement said the UK Medicines Health Regulatory Authority approved trials to resume after an independent review of data “triggered a voluntary pause” on September 6. STAT reported on September 8 that the company had paused the Phase 3 study after a “suspected serious adverse reaction” in a UK-based participant and The New York Times cited a person familiar with the situation to report that the participant was diagnosed with an inflammatory condition that affects the spinal cord and is “often sparked by viral infections.” 

The company did not acknowledge reports of an adverse reaction in its statement on resuming trials, but said “the UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.”

Temporary halts are common in vaccine trials, but the pause on the front-runner for the coronavirus raised eyebrows earlier this month as at least 176 ongoing research efforts as medical leaders in countries across the world race to deliver a vaccine to get a hold on the coronavirus pandemic.

AstraZeneca’s CEO Pascal Soriot said last week that despite the halt in trials, it “is still feasible” the company’s vaccine will be ready by the end of the year.

Soriot said Thursday that AstraZeneca is “on track for having a set of data that we would submit before the end of the year,” Business Insider previously reported.

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SEE ALSO: There are 176 coronavirus vaccines in the works. Here’s how top drugmakers see the race for a cure playing out in 2020 and 2021 and when the first shots might be available.

Read More: Business Insider

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