Hours after COVID-19 vaccine collaborators AstraZeneca and Oxford University released data on their large clinical trial, federal officials said that information may have been missing a month’s worth of data.
The pair touted their vaccine trial results Monday in a news release and news conference, saying the two-dose shot would prevent 79% of symptomatic cases of COVID-19 and 100% of all severe cases and hospitalizations.
But a few minutes after midnight, the federal government took the unusual step of issuing its own news release saying the data may have been based on “outdated information.”
According to the statement, late on Monday, an independent review board that examined the AstraZeneca-Oxford data told the government and the company “that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.”
That independent group, called the Data Safety Monitoring Board or DSMB, “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data. 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.”
Early Tuesday, Dr. Anthony Fauci, head of the government agency that released the information, said on Good Morning America the company released data available only through Feb. 17, while presenting it as if it were current information.
It’s unclear how much the up-to-date information may change the previously reported effectiveness rate.
“It really is unfortunate that this happened,” said Fauci, head of the National Institute of Allergy and Infectious Diseases, said. “This is very likely a very good vaccine.”
He said such missteps can contribute to hesitancy about vaccination. “It was not necessary,” he said. “If you look at it, the data really are quite good, but when they put it into the press release, the data wasn’t quite accurate.”
Fauci also complimented the monitoring board’s decision to go public when it saw the information AstraZeneca and Oxford had put out.
That body is one of many “safeguards” in place to ensure the public it is getting transparent, accurate information about vaccines, he said. “The DSMB picking up this discrepancy was an example of a safeguard.” Another, he said, is the Food and Drug Administration, which will review the data again, as will an independent advisory committee to the FDA.
For its part, AstraZeneca said Tuesday it had released a “pre-specified interim analysis with a data cut-off of 17 February.” In its previous news release, the company had referred to the data as “interim,” but did not explain that it was out of date. Read Full Article >