The National Institute of Allergy and Infectious Diseases (NIAID) has announced concerns with data from AstraZeneca’s COVID-19 vaccine trial.
NIAID, a wing of the National Institutes of Health (NIH), said in a statement today that it was concerned that information the company released from its AZD1222 vaccine clinical trial may be outdated.In turn, that may have provided an incomplete view of the efficacy data, NIAID said.
“We urge the company to work with the [Data and Safety Monitoring Board (DSMB)] to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” NIAID wrote in the statement.
AstraZeneca yesterday published results from the trial, revealing that the vaccine developed in collaboration with Oxford University was 79% effective in preventing symptomatic COVID-19 and 100% effective in preventing severe disease and hospitalization.
Buoyed by the results, the company said it would soon use the data to pursue FDA emergency use authorization (EUA) to become the fourth approved vaccine in the U.S. It has already been approved across Europe, where issues arose surrounding potentially related blood clots and several European countries paused use after reports of such issues.
European medical authorities have since determined that there is little connection between the vaccine and blood clots but noted that “the vaccine may be associated with very rare cases of blood clots associated with thrombocytopenia, i.e., low levels of blood platelets.”
According to the NIAID statement, the FDA and CDC will determine authorization and guidelines for AstraZeneca’s vaccine after a thorough review of the data by independent advisory committees.
The company issued a statement saying that the data was based on a pre-specified interim analysis with a data cut-off of February 17, 2021.
“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,” AstraZeneca said. “We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up-to-date efficacy data. We intend to issue results of the primary analysis within 48 hours.”
NIAID director Dr. Anthony Fauci told ABC News’ Good Morning America that the concerns were born out of potentially misleading data in AstraZeneca’s public statement regarding the trial results, with the way the company presented the data in its Monday press release causing the NIH arm to make a statement.
Fauci added that the “unforced error” was “unfortunate” as vaccine hesitancy is still looming large over the U.S. and posing a potential threat to reaching levels of immunity that would move the country out of the pandemic that has been going on for more than one year.
“This is likely a very good vaccine,” Fauci told GMA. “If you look at it, the data really are quite good, but when they put it into the press release, it wasn’t completely accurate.”
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease