London Daily

Focus on the big picture.
Friday, Nov 06, 2026

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

After Admitting Mistake, AstraZeneca Faces Difficult Questions About Its Vaccine

Some trial participants only got a partial dose of AstraZeneca’s vaccine. Experts said the company’s spotty disclosures have eroded confidence.

The announcement this week that a cheap, easy-to-make coronavirus vaccine appeared to be up to 90 percent effective was greeted with jubilation. “Get yourself a vaccaccino,” a British tabloid celebrated, noting that the vaccine, developed by AstraZeneca and the University of Oxford, costs less than a cup of coffee.

But since unveiling the preliminary results, AstraZeneca has acknowledged a key mistake in the vaccine dosage received by some study participants, adding to questions about whether the vaccine’s apparently spectacular efficacy will hold up under additional testing.

Scientists and industry experts said the error and a series of other irregularities and omissions in the way AstraZeneca initially disclosed the data have eroded their confidence in the reliability of the results.

Officials in the United States have noted that the results were not clear. It was the head of the flagship federal vaccine initiative — not the company — who first disclosed that the vaccine’s most promising results did not reflect data from older people.

The upshot, the experts said, is that the odds of regulators in the United States and elsewhere quickly authorizing the emergency use of the AstraZeneca vaccine are declining, an unexpected setback in the global campaign to corral the devastating pandemic.

“I think that they have really damaged confidence in their whole development program,” said Geoffrey Porges, an analyst for the investment bank SVB Leerink.

Michele Meixell, a spokeswoman for AstraZeneca, said the trials “were conducted to the highest standards.”

In an interview on Wednesday, Menelas Pangalos, the AstraZeneca executive in charge of much of the company’s research and development, defended the company’s handling of the testing and its public disclosures. He said the error in the dosage was made by a contractor, and that, once it was discovered, regulators were immediately notified and signed off on the plan to continue testing the vaccine in different doses.

Asked why AstraZeneca shared some information with Wall Street analysts and some other officials and experts but not with the public, he responded, “I think the best way of reflecting the results is in a peer-reviewed scientific journal, not in a newspaper.”

AstraZeneca was the third company this month to report encouraging early results on a coronavirus vaccine candidate. At first glance on Monday morning, the results looked promising. Depending on the strength at which the doses were given, the vaccine appeared to be either 90 percent or 62 percent effective. The average efficacy, the developers said, was 70 percent.

Almost immediately, though, there were doubts about the data.

The regimen that appeared to be 90 percent effective was based on participants receiving a half dose of the vaccine followed a month later by a full dose; the less effective version involved a pair of full doses. AstraZeneca disclosed in its initial announcement that fewer than 2,800 participants received the smaller dosing regimen, compared with nearly 8,900 participants who received two full doses.

The biggest questions were, why was there such a large variation in the effectiveness of the vaccine at different doses, and why did a smaller dose appear to produce much better results? AstraZeneca and Oxford researchers said they did not know.

Crucial information was also missing. The company said that the early analysis was based on 131 symptomatic Covid-19 cases that had turned up in study participants. But it did not break down how many cases were found in each group of participants — those who received the half-strength initial dose, the regular-strength initial dose and the placebo.

“The press release raised more questions than it answered,” said John Moore, a professor of microbiology and immunology at Weill Cornell Medical College.



Adding to the confusion, AstraZeneca pooled the results from two differently designed clinical trials in Britain and Brazil, a break from standard practice in reporting the results of drug and vaccine trials.

“I just can’t figure out where all the information is coming from and how it’s combining together,” said Natalie Dean, a biostatistician and an expert in vaccine trial design at the University of Florida. She wrote on Twitter that AstraZeneca and Oxford “get a poor grade for transparency and rigor when it comes to the vaccine trial results they have reported.”

With AstraZeneca’s shares declining on Monday, company executives held several private conference calls with industry analysts in which they disclosed details that were not in the public announcement, including how the Covid-19 cases broke down across different groups. Such disclosures to analysts are not uncommon in the industry, but they often generate criticism about why the details were not shared with the public.

Bigger problems soon surfaced.

Mr. Pangalos told Reuters on Monday that the company had not intended for any participants to receive the half dose. British researchers running the trial there had meant to give the full dose initially to volunteers, but a miscalculation meant they were mistakenly given only a half dose. Mr. Pangalos described the error as “serendipity,” allowing researchers to stumble onto a more promising dosing regimen.

To many outside experts, that undercut the credibility of the results because the closely calibrated clinical trials had not been designed to test how well a half-strength initial dose worked.

The company’s initial announcement didn’t mention the accidental nature of the discovery.

“The reality is, it could end up being quite a useful mistake,” Mr. Pangalos said in the interview with The New York Times on Wednesday. “It wasn’t putting anyone in danger. It was a dosing error. Everyone was moving very fast. We corrected the mistake and continued on with the study, with no changes to the study, and agreed with the regulator to include those patients in the analysis of the study as well.”

He added, ““What is there to disclose? It actually doesn’t matter whether it was done on purpose or not.”

In the statement attributed to Oxford, Ms. Meixell, the AstraZeneca spokeswoman, said the error stemmed from an issue, which has since been fixed, with how some of the vaccine doses were manufactured.

Then, on Tuesday, Moncef Slaoui, the head of Operation Warp Speed, the U.S. initiative to fast-track coronavirus vaccines, noted another limitation in AstraZeneca’s data. On a call with reporters, he suggested that the participants who received the half-strength initial dose had been 55 years old or younger.

Mr. Pangalos confirmed that on Wednesday, saying the participants received the half-strength dose over a matter of weeks before the error was discovered.

The fact that the initial half-strength dose wasn’t tested in older participants, who are especially vulnerable to Covid-19, could undermine AstraZeneca’s case to regulators that the vaccine should be authorized for emergency use.

Stephanie Caccomo, a spokeswoman for the Food and Drug Administration, declined to comment on whether the dosing error would hurt the vaccine’s chances of being authorized. The F.D.A. has said it expects vaccines to be at least 50 percent effective in preventing or reducing the severity of the disease, a bar that the vaccine appears to have cleared even in the group that got the two full doses.

AstraZeneca’s shares have fallen about 5 percent this week, while broader stock indexes have climbed to record highs. Investors seem to be disappointed with the murky results, especially compared with the much clearer data released by two of AstraZeneca’s chief rivals in the race for a coronavirus vaccine.

Pfizer and Moderna said this month that their vaccines, which use a technology known as “messenger RNA,” appear to be about 95 percent effective. Both offerings seem nearly certain to win emergency authorization from the F.D.A. in the coming weeks.

The AstraZeneca vaccine, which uses a different approach involving a chimpanzee virus to provoke an immune response to the coronavirus, had all the hallmarks of a blockbuster.

It was inexpensive — only a few dollars per dose — and easy to mass-produce. Unlike Pfizer and Moderna’s vaccines, AstraZeneca’s could be stored for months in normal refrigerators. The company has estimated it will be able to produce some three billion doses next year, enough to vaccinate nearly one-fifth of the global population.

Compared to most of the other leading Covid-19 vaccine developers, AstraZeneca is inexperienced when it comes to vaccines. And even before the chaotic release of results, the company was under scrutiny for its handling of the testing process.

In September, AstraZeneca paused clinical trials worldwide after a participant fell ill — but the company didn’t promptly announce the decision publicly. AstraZeneca also came under fire for providing details about the nature of the illness on a private conference call with investors hosted by the investment bank J.P. Morgan, rather than disseminating the information to the public. Both of those developments were first reported by STAT, which covers health and science news.

Ever since the Oxford-AstraZeneca team emerged as front-runners in the race to develop a vaccine this spring, Prime Minister Boris Johnson of Britain has embraced the effort. The government preordered 100 million doses and cast the research as one of the country’s most important contributions to fighting the pandemic.

Basking in the results on Monday, Mr. Johnson said the vaccine “has the makings of a wonderful British scientific achievement.”

In the United States, which has ordered at least 300 million doses of AstraZeneca’s vaccine, the regulatory path forward is unclear. AstraZeneca was circumspect on Monday about its plans for seeking regulatory approval. The company said it would seek guidance from the Food and Drug Administration on whether it should formally submit its findings to apply for emergency authorization.

AstraZeneca has not been testing the promising half-strength initial dose in its ongoing United States trial. The company said it would work with the agency to add it as quickly as possible to that trial.

Mr. Pangalos said the company is planning a global trial to compare the two dosing regimens. The number of participants it will enroll hasn’t yet been determined, but it will be in the thousands.

“The only way they’re going to find out is by specifically and deliberately testing this serendipitous observation,” Professor Moore said. “The onus is on them to prove the speculation.”

Newsletter

Related Articles

0:00
0:00
Close
Office for National Statistics Reports Stable Consumer Confidence and Modest Retail Growth Heading into Winter
Welsh Government Launches Strategic Regional Transport Initiative to Modernize Rail Links Across South Wales
Home Office Expands Digital Border Security Controls and Electronic Travel Authorisations for Inbound Visitors
Scottish Government Announces Emergency Housing Investment Package to Tackle Urban Homelessness Crises
Northern Ireland Executive Reaches Bipartisan Consensus on Public Sector Pay Reform and Budget Allocations
Automotive Manufacturing Sector in the West Midlands Welcomes New Electric Vehicle Supply Chain Investments
Department for Energy Security and Net Zero Approves Offshore Wind Expansion in the North Sea
HM Treasury Finalizes Regulatory Framework for Stablecoins and Digital Asset Markets in London
National Health Service Unveils Comprehensive Digital Integration Strategy to Slash Hospital Waiting Lists
Bank of England Leaves Interest Rates Unchanged Amid Persistent Wage Growth and Inflationary Pressures
United Kingdom and Caribbean Nations Agree to Establish Formal Diplomatic Dialogue Following Reparations Discussions
Cambridge University Appoints Senior Barrister to Lead Independent Review into Death of Academic Jason Arday
Historic Hastings Castle and Kent Dickens Chalet Added to National Heritage at Risk Register Amid Deterioration Concerns
Incoming British Ambassador to Japan Calls for Deepened Bilateral Cooperation on Artificial Intelligence and Semiconductors
Milburn Review Urges Employment Revolution to Unlock Workforce Opportunities for Young Disabled Britons
British Healthcare Worker Evacuated from Democratic Republic of Congo to United Kingdom Following Ebola Exposure
United Nations Refugee Agency Criticises Government Proposal for Thirty-Year Earned Settlement Pathways for Asylum Seekers
Parliamentary Inquiry Warns United Kingdom Remains Exposed to Chinese Critical Mineral Dependencies
Bank of England Prepares Interest Rate Decision as Inflation Pressures Prompt Expectation of Four Percent Benchmark
Department for Business and Trade Overhauls Protection Standards for Digital Animation and Moving Image Files
Intellectual Property Office Introduces Thirty-Month Grace Period for International Product Launches
Intellectual Property Office Targets Anti-Competitive Filings With New Powers to Verify Novelty Before Registration
Creative Industries Minister Ian Murray Praises Regulatory Reforms to Safeguard Small Businesses and Micro-Enterprises
Government Unveils Major Design Framework Overhaul to Protect British Creators and Boost Economy
Global Asset Management Reports Surge in British Dividend Payouts Driven by Strong Financial and Mining Sectors
HM Treasury Confirms Strongest Group of Seven Growth Figures as Fiscal Consolidation Plans Progress
Department for Energy Security and Net Zero Approves Construction of New North Sea Offshore Wind Hub
Northern Ireland Executive Finalizes Public Sector Pay Agreements Following Months of Inter-Agency Negotiations
Welsh First Minister Eluned Morgan Secures Cross-Party Support for Regional Clean Energy Infrastructure Bill
Competition and Markets Authority Launches Formal Investigation Into Dominant Artificial Intelligence Cloud Partnerships
United Kingdom Foreign Secretary David Lammy Concludes High-Level Diplomatic Mission to Washington and Ottawa
Scottish Government Announces Emergency Housing Investment Package to Address Escalating Urban Homelessness
Chancellor Rachel Reeves Finalizes Corporate Tax Adjustments Ahead of Upcoming Business Investment Summit
National Health Service England Unveils Emergency Winter Resilience Plan to Combat Projected A&E Overcrowding
Bank of England Monetary Policy Committee Votes to Hold Base Interest Rate Steady at Four Point Seven5 Per Cent
UK Gross Domestic Product Expands by Zero Point Four Per Cent in Third Quarter Driven by Resilient Services Growth
Northern Ireland Executive Agrees on Multi-Year Public Sector Pay Restructuring Framework at Stormont
Department for Transport Confirms Acceleration of Electric Vehicle Charging Infrastructure Rollout Along Strategic Motorways
Welsh Government Announces Emergency Funding Package to Support Agricultural Sector Facing Severe Weather Impacts
High Court Rules in Favor of Environmental Coalition Over Government Carbon Reduction Plan Deficiencies
Office for National Statistics Reports Stable Retail Sales Growth Supported by Strong Digital Commerce Volumes
Scottish First Minister John Swinney Secures Cross-Party Support for Renewable Energy Export Expansion
National Health Service Digital Reports Major Breakthrough in Reducing Elective Waiting Lists Across England
Chancellor Rachel Reeves Outlines Infrastructure Spending Reforms to Boost Regional Economic Growth Across Northern England
Bank of England Holds Baseline Interest Rate at Five Percent Amid Persistent Core Inflation Pressures
House of Lords Advances Representation of the People Bill to Modernize Electoral Law Ahead of General Election
Financial Markets and Private Equity Assess Tax and Corporate Realignment Following Recent Chancellor Budget Adjustments
Justice Committee Warns Legal Aid Is a Service in Managed Decline Due to Inadequate Government Funding Responses
Royal Navy Intercepts Russian Intelligence Vessel and Warships Across Intensive North Sea Operations
Business and Trade Committee Slams Government Policy on China as Fragmented and Lacking Strategic Direction
×