London Daily

Focus on the big picture.
Thursday, Oct 22, 2026

FDA, CDC advisers say to expect a lot of questions about AstraZeneca Covid-19 vaccine

FDA, CDC advisers say to expect a lot of questions about AstraZeneca Covid-19 vaccine

AstraZeneca is expected to apply in the next few weeks for emergency use authorization for its Covid-19 vaccine in the US, and if and when it does, advisers to the US Food and Drug Administration and the US Centers for Disease Control and Prevention will likely have questions.

Lots of questions.

In interviews with CNN, several vaccine advisers to the US government did not cast doubt as to whether AstraZeneca's vaccine would ultimately gain emergency use authorization from the FDA. They did, however, say the company's application will likely bring up issues that didn't arise when the three Covid-19 vaccines currently used in the United States -- made by Pfizer, Moderna and Johnson & Johnson -- were considered for their own emergency use authorizations.

"It's clear more questions have been raised about the AstraZeneca vaccine than about any of the other vaccines which are now authorized in the US," said Dr. Arnold Monto, acting chair of the FDA's Vaccines and Related Biological Products Advisory Committee, which reviews vaccine applications and advises the FDA on whether they should be authorized.

Those advisers -- who work at academic medical centers and not for the government -- said the reports of blood clots after vaccination, which caused more than a dozen western European countries to suspend use of the AstraZeneca vaccine, are not the only issue. Questions have been raised about other aspects of AstraZeneca's efficacy and safety data, too.

"It does feel different, and it felt different even before the whole blood clot kerfuffle," said Dr. William Schaffner, a liaison member of the CDC's Advisory Committee on Immunization Practices.

AstraZeneca expects to ask the FDA to authorize its Covid-19 vaccine for emergency use in March or early April, sources with knowledge of the company's ongoing clinical trial told Reuters last week.

Monto, Schaffner and other government advisers said they look forward to receiving the "dossier" of data about a vaccine's safety and efficacy that FDA publicly releases when a pharmaceutical company applies for emergency use authorization.

"I will bring an open mind to these deliberations," said Dr. Ofer Levy, a member of the FDA's vaccine advisory committee.

"I'll go where the data leads me," said another member, Dr. H. Cody Meissner.

As more and more European countries have suspended their AstraZeneca vaccine rollout, the company, as well as international health agencies, have defended the vaccine.

"The safety of all is our first priority," according to an AstraZeneca statement sent to CNN Wednesday. "Around 17 million people in the EU and UK have now received our vaccine, and the number of cases of blood clots reported in this group is lower than the hundreds of cases that would be expected among the general population."

The World Health Organization, UK health authorities and the European Medicines Agency have all voiced support for the AstraZeneca vaccine, saying its benefits outweigh any risks.

Despite this support, several US government advisers said they worry that after months of hearing about questions related to AstraZeneca's vaccine, many Americans may perceive it as problematic and won't want to take it.

"It's hard to unring that bell," Dr. Paul Offit, a member of the FDA advisory committee said. "Once people are scared, it's hard to unscare them."

New report on blood clots


According to an EMA statement issued Thursday, "the [AstraZeneca] vaccine is not associated with an increase in the overall risk of blood clots."

The statement noted that around 20 million people in the UK and the European Union, as well as Iceland, Liechtenstein and Norway, have received AstraZeneca's vaccine as fo March 16, and there had been reports of some specific types of rare clotting problems linked to low blood platelets.

The number of reports of those rare clotting problems "exceeds those expected, and causality although not confirmed, cannot therefore be excluded," according to the statement, which noted that labeling on the vaccine will be updated to include more information about these events.

One type of clot is mesenteric venous thrombosis, which is a clot in one or more of the major veins that drain blood from the intestines. Another is cerebral venous sinus thrombosis, where a clot forms in the brain's drainage system. A third is disseminated intravascular coagulation, which is blood clots in multiple blood vessels.

The EMA said that as of March 16, it had reviewed seven cases of disseminated intravascular coagulation and 18 cases of cerebral venous sinus thrombosis.

'One glitch after another'


AstraZeneca's vaccine, which was developed in partnership with the University of Oxford, started out with a reputation for being one of the world's most promising Covid-19 vaccines.

Last spring and summer, Oxford researchers talked it up as the front runner, although they would later sometimes backtrack and warn against over-promising.

Dr. Adrian Hill, one of the leading Oxford scientists, sometimes even insulted other vaccine makers, for example calling Modern'a Covid-19 vaccine technology "weird" and "unproven."

But fast forward a year, and it's AstraZeneca that has faced challenges. Twice it put its clinical trials on hold when participants who received the vaccine became ill -- both times it was restarted when it was determined the illnesses were not related to the vaccine.

Then in November, questions arose about the company's efficacy data, and it was revealed that a mistake was made in the trial and some participants received the wrong dose. Oxford told CNN at the time that a "difference in the manufacturing process" had led to the error.

"I've done lots of clinical trials with vaccines over the past couple of decades and that's never happened," said Meissner, a member of the FDA's vaccine advisory committee. "I've read in their Lancet paper how they explained it, but it was a little bit torturous."

Menelas Pangalos, executive vice-president for biopharmaceuticals R&D at AstraZeneca, told the Wall Street Journal in November that "the mistake was actually irrelevant" and that the vaccine "meets the threshold for approval with a vaccine that's over 60% effective."

Then last month, South Africa paused its rollout of the AstraZeneca vaccine after a study showed it offered less protection against the coronavirus variant that was first identified there. That study, later published in the New England Journal of Medicine, found the AstraZeneca vaccine "did not show protection against mild to moderate Covid-19" due to the variant.

Currently, more than a dozen European countries have suspended use of the vaccine over concerns about blood clots.

"It's so ironic - last summer there were these usually rather reticent British dons beating their own drums - 'We're going to be first, we're going to be the best' - and this is the vaccine that's had one glitch after another," Schaffner said.

An AstraZeneca spokesperson pointed CNN to the Lancet study published in January that found the vaccine had "an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19."

An AstraZeneca news release on Sunday said that out of 17 million people who received their vaccine in the European Union and the UK, there were 15 events of deep vein thrombosis and 22 events of pulmonary embolism, based on information the company had received as of March 8.

"This is much lower than would be expected to occur naturally in a general population of this size," according to the company's statement, which added that there was "no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia, in any defined age group, gender, batch or in any particular country."

The news release did not mention the rare types of clotting events discussed by the European regulators Thursday.

Agreements for 300 million AstraZeneca doses


AstraZeneca already has agreements with the US government to deliver 300 million doses, according to prepared remarks delivered to Congress by the company last month.

While the government advisers said more vaccine is better, they say it's unclear what role AstraZeneca's doses would play if its vaccine is authorized.

There will be more than enough vaccine from Pfizer, Moderna and Johnson & Johnson to vaccinate every American adult by the end of May, White House Covid coordinator Jeff Zients said earlier this month.

The government advisers CNN spoke to said if the AstraZeneca vaccine is distributed in the US, they worry Americans may perceive it as being inferior to the three that are already being distributed.

"I'm really concerned there are going to be a lot of people who are going to say 'thanks very much but no' to AstraZeneca because of all this publicity," said Schaffner, the CDC adviser.

He said if there's not enough demand for it, the US could donate some of its AstraZeneca supply to developing countries, where it would be particularly useful because it's easier to transport and store than Pfizer or Moderna's vaccines.

The Biden administration has already announced plans to send a few million doses of AstraZeneca to other countries.

"I can confirm that we have 7 million releasable doses available of AstraZeneca," White House press secretary Jen Psaki said at Thursday's White House press briefing. "2.5 million of those, we are working to finalize plans to lend those to Mexico and 1.5 million to Canada."

"We could be Solomon-like and cut the baby in half and say we've contracted to buy these doses, and we'll use a third of them and give the rest away to developing countries and do a little bit of vaccine diplomacy," Schaffner said. "That's a possibility."

Newsletter

Related Articles

0:00
0:00
Close
Parliamentary Inquiry Highlights Urgent Need to Address Housing Shortage as Scottish Completions Hit Eleven-Year Low
United Kingdom and Singapore Sign Comprehensive Financial Agreement to Deepen Digital and Sustainable Market Ties
Greggs Announces Plan to Close Four Manufacturing Facilities and Cut Seven Hundred and Forty Jobs
International Monetary Fund Raises United Kingdom Economic Growth Forecast While Warning of Inflationary Pressures
Energy Security and Net Zero Committee Urges Government to Shift Policy Costs Onto Gas to Lower Household Bills
Housebuilding Across Scotland Plummets to Eleven-Year Low Despite Government Pledges to Tackle National Housing Emergency
Greggs Announces Factory Closures Across Northern England and Scotland Affecting Seven Hundred Forty Jobs
United Kingdom and Singapore Conclude Eleventh Financial Dialogue in Singapore to Deepen Cooperation on Digital Finance and Capital Markets
Energy Security and Net Zero Committee Urges Government to Shift Policy Costs to Gas Bills and Tap Windfall Profits to Lower Consumer Prices
British Broadcasting Corporation Announces Major Cost-Cutting Overhaul to Close Linear Broadcast Services for Television Channels BBC Three and BBC Scotland Alongside Digital Radio Station BBC Radio Four Extra
London Capital Markets Face Renewed Scrutiny After High-Profile Offerings Underperform Post-Listing
Green Party Wins Historic First Westminster Parliamentary By-Election in Gorton and Denton
Environment Secretary Emma Reynolds Unveils Sweeping Regulatory Overhaul for English Water Industry
United Kingdom Health Security Agency Confirms Thirty-Four Cases in Kent Meningitis Outbreak
Ministry of Defence Prepares Heat Pump Subsidy Cuts to Fund Urgent Military Modernization
British and European Union Officials Schedule Long-Awaited Bilateral Leaders Summit for November Twentieth
Bank of England Governor Andrew Bailey Urges Strict Fiscal Credibility to Protect British Bond Markets
United Kingdom Inflation Rises to Three Point One Percent Driven by Escalating Fuel Costs
Profit Warnings Among London-Listed Companies Reach Two-Year High Amid Global Energy Shocks
Chancellor John Healey Signals Targeted Tax Changes on Banks and London Corporate Offices Ahead of Budget
British Government Reallocates Twenty-Five Per Cent of International Climate Finance to Global Biodiversity Projects
Initial British Carbon Border Taxes Set to Undercut Parallel European Union Tariffs on Industrial Imports
Whitehall Prepares National Zero-Interest Loan Initiative to Accelerate Domestic Heat Pump and Solar Adoption
European Union Offers British Automakers Access to Hybrid Vehicle Trade Protections Subject to Strict Regulatory Alignment
British Probation Officers Threaten Widespread Industrial Action After Rejecting Five Per Cent Government Pay Offer
Microsoft Abandons Major British Artificial Intelligence Data Centre Citing Severe National Grid Power Constraints
United Kingdom Inflation Accelerates to Three Point Four Per Cent Ahead of Chancellor John Healey's Inaugural Autumn Budget
Surging Cloned Number Plates Severely Complicate Traffic Enforcement and Police Investigations
Mounting Opposition Challenges Planned Rollout of Autonomous Taxis Across London
Influential Think Tank Urges Rejoining European Union to Navigate Geopolitical Crises
Government Review Recommends Slashing Benefits to Fund Youth Employment Initiatives
Senior Minister Shabana Mahmood Seeks New Law Enforcement Pact With European Union
Airbus Executive Warns Britain Risks Losing Crucial Role in European Space Industry
Exorbitant Electricity Costs Push British Steelmakers to Worst Competitive Position in Three Years
British Food and Beverage Exports to European Union Collapse by Over a Third Since Brexit
Up to Twenty English Maternity Units Face Impending Closure Due to Safety and Staffing Crises
Government Declares Severe Drought Across Southern England Following Record Dry Spell
Corporate Profit Warnings Reach Two-Year High Amid Middle East Conflict and Rising Costs
International Monetary Fund Warns Chancellor John Healey Against Proposed Bank Tax Raid
Northern Ireland Secures Favorable Agricultural Export Agreement with European Union
Scottish Government Approves Major Offshore Floating Wind Farm Near Aberdeenshire
High Speed Two Rail Project Faces Three Billion Pound Cost Escalation on Initial Phase
National Health Service Warns of Winter Capacity Crisis Across English Hospitals
Tata Steel Confirms Two Thousand Job Cuts at Port Talbot to Fund Green Transition
Global Microchip Developer Announces Three Billion Pound Semiconductor Plant in Cambridge
United Kingdom Artificial Intelligence Safety Institute Proposes Mandatory Licensing for Generative Models
United Kingdom Commits Additional Long-Range Weapons and Air Defenses to Ukraine
British Chancellor Overhauls Infrastructure Financing to Bypass Borrowing Constraints
Bank of England Holds Benchmark Interest Rate at Four Point Five Percent
First Minister Rhun ap Iorwerth Confirms Constitutional Discussions Over Welsh Independence During Initial Bilateral Call with Prime Minister
×