The Food and Drug Administration is set to release detailed analyses of the first Covid-19 vaccine being considered for U.S. distribution, providing the foundation for Thursday's pivotal meeting of a panel that will advise on its possible approval for emergency use.
The agency is expected Tuesday to release two separate analyses, one from its own staff scientists and one from the vaccine's manufacturers, Pfizer Inc. and German partner BioNTech SE.
Both are likely to number in the hundreds of pages, and will document findings that show the vaccine's effectiveness. Pfizer reports its vaccine is 95% effective at protecting against symptomatic Covid-19, and the U.K. approved its use last week.
Among other issues, the data are expected to show how the vaccine works with different age, ethnic and other demographic groups. The FDA has advised vaccine companies that these subgroup analyses will help overcome any hesitancy among Americans to be vaccinated.
A positive recommendation from the advisory panel is likely to lead to the FDA's formally granting an emergency-use authorization of the vaccine in a matter of days.
There is limited information available about the vaccine's safety and efficacy beyond Pfizer's announcement last month, which was made via press release. The data hasn't been published in a medical journal, as Pfizer says it will monitor subjects in the 44,000-person study for two years to assess how long protection provided by the vaccine may last.
The analysis released Tuesday could include more insight into the two months of safety data on about 19,000 study subjects requested by the FDA. No serious side effects were observed in the late-stage study, and the vaccine appears to be well tolerated, Pfizer has said.
The efficacy was determined after 170 subjects in the 44,000-person trial became sick with symptomatic Covid-19, triggering an analysis by an outside panel of experts that found that most of those subjects had received a placebo rather than the vaccine. Researchers looked at how well the shots worked seven days after a study volunteer got a second dose.
The sick participants included 10 whose cases of Covid-19 were severe. Nine had received the placebo and one the vaccine.
The FDA has held advisory-committee hearings on hundreds of products over the years, but rarely has there been the kind of intense interest as in this week's planned hearing. This is largely due to the fast increase in cases of the illness, which has created the largest pandemic in a century.
Johns Hopkins University on Monday reported that U.S. cases were approaching 15 million, and that U.S. deaths already topped 283,000.
The FDA has sped up its traditional monthslong approval processes by considering Pfizer's Covid-19 vaccine for emergency-use authorization. These authorizations, in essence, involve balancing risks and benefits.
But because vaccines, unlike most drugs, are given to healthy people, the FDA has still insisted on rigorous standards--including opening this Thursday's meeting to the public and making public the companies' and agency's analyses.
The FDA insisted it wouldn't consider a vaccine unless it lowered the rate of disease by 50% or more when compared with a placebo. And it said that half of patients in any vaccine study would need to be followed for at least two months after inoculation to ensure that major side effects didn't occur and that the vaccine's effectiveness lasted.
Federal officials have estimated that U.S. vaccine deliveries during December will be enough for about 20 million people. That compares with 24 million people in the U.S., such as health-care workers and residents of long-term care facilities, who are in priority groups for vaccines.
A second vaccine from Moderna Inc. is set for a similar review next week.
