The National Institute of Allergy and Infectious Diseases (NIAID) early on Tuesday expressed concern that AstraZeneca “may have included outdated information” in its initial data of the U.S. arm of Covid-19 vaccine trials, just a day after the drugmaker announced its shot was 79% effective against symptomatic Covid disease and is 100% effective against severe illness and hospitalization.
The Data and Safety Monitoring Board (DSMB)—the independent group of experts which monitored the trial—was “concerned” by the information released by AstraZeneca, the NIAID said in a news release.
The DSMB said AstraZeneca may have included outdated information, which may have provided an incomplete view of the vaccine’s effectiveness.
NIAID has asked the drugmaker to work with the DSMB to review the vaccine’s effectiveness and ensure the “most accurate, up-to-date efficacy data” is released publicly as soon as possible.
The U.S. has not yet approved the AstraZeneca shot for emergency use, however, the drugmaker has said it is preparing to seek the U.S. Food and Drug Administration’s (FDA) approval in the coming weeks.
79%. That’s how effective AstraZeneca claimed its vaccine was in preventing symptomatic Covid disease, citing preliminary analysis of its large-scale Phase-III U.S. trial data. The company also noted that the vaccine was 100% effective in preventing severe illness, hospitalizations and death from Covid-19.
On Monday, AstraZeneca announced the results of its U.S. trial which featured 32,449 participants of which two-thirds received two doses of the vaccine with a four week interval between doses. AstraZeneca noted that the trials showed the vaccines were safe and effective across all age groups and ethnicities. The drugmaker has said the DSMB identified no safety concerns related to the vaccine, but made no mention of their “concern” over the trial data. AstraZeneca said the DSMB conducted a specific review of potential clotting events including cerebral blood clots and found no increased risks of clotting among the 21,583 participants receiving at least one dose of the vaccine. The vaccine had been temporarily suspended by several nations in Europe over concerns that it was causing blood clots. Most countries have since resumed the rollout of the vaccine after the European Medicines Agency (EMA) ruled out a broad link to blood clotting last week.
What To Watch For
It’s unclear how the NIAID’s concerns will affect the AstraZeneca vaccine’s potential emergency use approval by the FDA, but it is likely to delay the process further. The vaccine has stumbled several times in the U.S. starting with the release of botched global trial results in November. A manufacturing error had led to the use of two separate dosing regimens of the vaccine in the global trials last year. Even as it awaits approval, AstraZeneca plans to have 30 million shots ready in the country at the beginning of April.