A board of independent experts to monitor the data and safety of AstraZeneca’s COVID-19 vaccine trial raised a red flag over the company’s press release on Monday, trumpeting that the vaccine was 79 percent effective in treating symptomatic COVID. 19 to prevent.
In the early hours of Tuesday morning, the National Institute of Allergy and Infectious Diseases released an unusual statement indicating that the Data Protection and Safety Board (DSMB) was in touch with the federal agency as well as the company. The statement reads:
The DSMB expressed concern that AstraZeneca might include outdated information from the trial, which could provide an incomplete overview of the efficacy data. We call on the company to work with the DSMB to review the efficiency data and ensure that the most accurate, most recent efficiency data is released as soon as possible.
In an interview with Good Morning America on Tuesday morning, NIAID director and top expert in infectious diseases, Anthony Fauci, tried to give more context to the situation. He noted that the DSMB, which has access to all the data from the AstraZeneca trial, was surprised by what the company said in its press release.
“When [the DSMB] saw the press release, got them worried and wrote a rather hard letter to them and copied it to me, ‘Fauci said. “They were of the opinion that the information in the press release was somewhat outdated and could in fact be misleading.”
The unusual dispute is just the latest hurdle for AstraZeneca’s COVID-19 vaccine, which has been plagued by doubts and disappointing results. Last week, more than a dozen countries in Europe and elsewhere temporarily suspended the vaccination over the concern that it causes life-threatening blood clots in a very small number of people.
Health experts, including the World Health Organization, have urged countries to resume vaccine use, noting that the benefits of COVID-19 protection outweigh the risk of rare blood clots. Many countries have followed the advice and started the vaccinations again, but doubts remain about the vaccine. The new dispute over the data in the US press releases is likely to add only doubt.
“It’s really unfortunate that this happened,” Fauci told GMA this morning, calling the press release debacle an “unforeseen mistake” that could further raise doubts and contribute to vaccine hesitation. “The fact is that it is most likely a very good vaccine,” Fauci added. “If you look at the data, it’s really good, but when they put it in the press release, it was not entirely accurate.”
In a press release early Tuesday, AstraZeneca addressed the controversy, and apparently currently stands for its effectiveness:
The figures published yesterday were based on a predetermined interim analysis with a data cut-off of 17 February.
We reviewed the preliminary assessment of the primary analysis and the results are consistent with the interim analysis. We are now validating the statistical analysis.
We will immediately consult with the Independent Data Security Monitoring Board (DSMB) to share our primary analysis with the latest efficiency data. We aim to issue the results of the primary analysis within 48 hours.