London Daily

Focus on the big picture.
Thursday, Nov 13, 2025

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 AstraZenecavaccine 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
UK Upholds Firm Rules on Stablecoins to Shield Financial System
Brussels Divided as UK-EU Reset Stalls Over Budget Access
Prince Harry’s Remembrance Day Essay Expresses Strong Regret at Leaving Britain
UK Unemployment Hits 5% as Wage Growth Slows, Paving Way for Bank of England Rate Cut
Starmer Warns of Resurgent Racism in UK Politics as He Vows Child-Poverty Reforms
UK Grocery Inflation Slows to 4.7% as Supermarkets Launch Pre-Christmas Promotions
UK Government Backs the BBC amid Editing Scandal and Trump Threat of Legal Action
UK Assessment Mis-Estimated Fallout From Palestine Action Ban, Records Reveal
UK Halts Intelligence Sharing with US Amid Lethal Boat-Strike Concerns
King Charles III Leads Britain in Remembrance Sunday Tribute to War Dead
UK Retail Sales Growth Slows as Households Hold Back Ahead of Black Friday and Budget
Shell Pulls Out of Two UK Floating Wind Projects Amid Renewables Retreat
Viagogo Hit With £15 Million Tax Bill After HMRC Transfer-Pricing Inquiry
Jaguar Land Rover Cyberattack Pinches UK GDP, Bank of England Says
UK and Germany Sound Alarm on Russian-Satellite Threat to Critical Infrastructure
Former Prince Andrew Faces U.S. Congressional Request for Testimony Amid Brexit of Royal Title
BBC Director-General Tim Davie and News CEO Deborah Turness Resign Amid Editing Controversy
Tom Cruise Arrives by Helicopter at UK Scientology Fundraiser Amid Local Protests
Prince Andrew and Sarah Ferguson Face Fresh UK Probes Amid Royal Fallout
Mothers Link Teen Suicides to AI Chatbots in Growing Legal Battle
UK Government to Mirror Denmark’s Tough Immigration Framework in Major Policy Shift
UK Government Turns to Denmark-Style Immigration Reforms to Overhaul Border Rules
UK Chancellor Warned Against Cutting Insulation Funding as Budget Looms
UK Tenant Complaints Hit Record Levels as Rental Sector Faces Mounting Pressure
Apple to Pay Google About One Billion Dollars Annually for Gemini AI to Power Next-Generation Siri
UK Signals Major Shift as Nuclear Arms Race Looms
BBC’s « Celebrity Traitors UK » Finale Breaks Records with 11.1 Million Viewers
UK Spy Case Collapse Highlights Implications for UK-Taiwan Strategic Alignment
On the Road to the Oscars? Meghan Markle to Star in a New Film
A Vote Worth a Trillion Dollars: Elon Musk’s Defining Day
AI Researchers Claim Human-Level General Intelligence Is Already Here
President Donald Trump Challenges Nigeria with Military Options Over Alleged Christian Killings
Nancy Pelosi Finally Announces She Will Not Seek Re-Election, Signalling End of Long Congressional Career
UK Pre-Budget Blues and Rate-Cut Concerns Pile Pressure on Pound
ITV Warns of Nine-Per-Cent Drop in Q4 Advertising Revenue Amid Budget Uncertainty
National Grid Posts Slightly Stronger-Than-Expected Half-Year Profit as Regulatory Investments Drive Growth
UK Business Lobby Urges Reeves to Break Tax Pledges and Build Fiscal Headroom
UK to Launch Consultation on Stablecoin Regulation on November 10
UK Savers Rush to Withdraw Pension Cash Ahead of Budget Amid Tax-Change Fears
Massive Spoilers Emerge from MAFS UK 2025: Couple Swaps, Dating App Leaks and Reunion Bombshells
Kurdish-led Crime Network Operates UK Mini-Marts to Exploit Migrants and Sell Illicit Goods
UK Income Tax Hike Could Trigger £1 Billion Cut to Scotland’s Budget, Warns Finance Secretary
Tommy Robinson Acquitted of Terror-related Charge After Phone PIN Dispute
Boris Johnson Condemns Western Support for Hamas at Jewish Community Conference
HII Welcomes UK’s Westley Group to Strengthen AUKUS Submarine Supply Chain
Tragedy in Serbia: Coach Mladen Žižović Collapses During Match and Dies at 44
Diplo Says He Dated Katy Perry — and Justin Trudeau
Dick Cheney, Former U.S. Vice President, Dies at 84
Trump Calls Title Removal of Andrew ‘Tragic Situation’ Amid Royal Fallout
UK Bonds Rally as Chancellor Reeves Briefs Markets Ahead of November Budget
×