AstraZeneca may have included “outdated information” in U.S. trial results for its COVID-19 vaccine, providing an “incomplete view of the efficacy data,” a U.S. federal health agency said early on Tuesday.
On Monday, drug company AstraZeneca
said that interim data from a major late-stage trial found the vaccine was 79% effective in preventing symptomatic COVID-19 and 100% effective at preventing people from falling seriously ill.
In a rare statement, the National Institute of Allergy and Infectious Diseases (NIAID) said it had been notified by the Data and Safety Monitoring Board (DSMB), an independent committee overseeing the U.S. trial, that it was “concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”
“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the NIAID said. “We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible.”
NIAID, headed by U.S. infectious-diseases expert Dr. Anthony Fauci, is part of the National Institutes of Health.
In a statement, AstraZeneca said that the numbers it published on Monday were based on a prespecified interim analysis with a data cutoff of February 17.
“We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis,” the company said, adding that it will “immediately” engage with the DSMB to share its primary analysis with the most up -to-date efficacy data.
It intends to issue results of the primary analysis within 48 hours.
U.S.-listed shares of AstraZeneca dropped 2% in premarket trading, while shares fell more than 1% in London.
‘Likely a very good vaccine,’ says Fauci
In an appearance on ABC’s “Good Morning America” early on Tuesday, Fauci explained that the use of possibly outdated information was an “unforced error” and that “this is very likely a very good vaccine.”
“When the data from the trial that was conducted predominantly in the U.S. was analyzed by the DSMB, together with the company, what happens is the company put out a press release giving data and making some conclusions about the efficacy,” he said.
“When they [DSMB] saw that press release, they got concerned and wrote a rather harsh note to them and copied to me saying that they felt the data that was in the press release was somewhat outdated and might, in fact, be misleading a bit, and wanted them to straighten it out,” he added.
Fauci said his agency then put together Tuesday’s statement “telling the company to get back with the DSMB and make sure the correct data get put into a press release.” Acknowledging some potential public concerns over the vaccine, he said any final decisions on its usage will be made by the Food and Drug Administration (FDA), which will “independently go over every bit of data themselves.”
The concerns may cast doubt on whether AstraZeneca will be able to seek U.S. emergency use authorization for the shot, which was developed in collaboration with the University of Oxford, in the coming weeks as planned.
The trial also showed there were no safety issues regarding blood clots.
Read: U.S. doubts hit AstraZeneca COVID-19 vaccine just as Europe resumes its rollout
AstraZeneca said on Monday that it will prepare for the primary analysis from its U.S. trial to be submitted to the FDA for emergency use authorization in the coming weeks. The analysis will also be submitted for publication in a peer-reviewed journal.
Data from the Phase 3 trial involved more than 32,000 volunteers, mostly in the U.S. but also in Chile and Peru.
The NIAID statement said authorization and guidelines for use of the vaccine in the U.S. will be determined after thorough review of the data by independent advisory committees.
If AstraZeneca’s vaccine is approved, it will be the fourth to be authorized by the U.S. following the greenlighting of vaccines developed by Germany’s BioNTech
with its U.S. partner, drug company Pfizer
; biotech Moderna
; and healthcare company Johnson & Johnson
Earlier, the rollout of the AstraZeneca vaccine was temporarily paused in some countries, including Finland, Norway, Denmark and Sweden, over concerns about blood clots in a number of recipients.
Read: EU regulator declares AstraZeneca vaccine ‘safe’ after blood clot investigation
Countries including Germany, Italy and Spain have restarted inoculations with the AstraZeneca vaccine since the European Medicines Agency declared it “safe and effective” after its own investigation found no link to blood clots. France is limiting use of the shot to those aged over 55.
The U.S. trial also showed there were no safety issues regarding blood clots.
Read: AstraZeneca says occurrence of blood clots is no higher than in the general population
AstraZeneca has said its own review of safety data of more than 17 million people vaccinated in the U.K. and European Union had shown no evidence of an increased risk of blood clots.
The World Health Organization last week urged countries to keep their inoculation campaigns going, as it said the benefits of AstraZeneca’s vaccine still outweigh the risks.
‘Another own goal’ for AstraZeneca, says Citi
The latest hiccup for AstraZeneca is just another headache for shareholders, said a team of Citi analysts led by Andrew Baum, in a note to clients. Tuesday’s public statement suggests “an extraordinarily high level of friction” between the DSMB and the drug company, he added.
“The implication of the DSMB feedback is that AZN may have overstated the efficacy of the vaccine in at least a subgroup of the patients,” he said.
Baum said the company’s missteps are likely due to several factors: lack of prior expertise in vaccine manufacturing and development; “late-stage opt in to a suboptimal academic-designed clinical trial program; “extraordinary political pressures” worsened by Brexit, and “likely internal exceptionalism” linked to the “pro-bono” nature of the program.
“While the vaccine does not economically contribute to AZN’s P&L [profit and loss], AZN’s multiple missteps with the vaccine have contributed to the ongoing multiple compression since 4Q 2020,” said Baum. Citi rates AstraZeneca a buy.