Morning Briefing
Summaries of health policy coverage from major news organizations
In Step Toward Approval, FDA Confirms Efficacy And Safety Of Pfizer's Vaccine
The coronavirus vaccine made by Pfizer and BioNTech provides strong protection against Covid-19 within about 10 days of the first dose, according to documents published on Tuesday by the Food and Drug Administration before a meeting of its vaccine advisory group.The finding is one of several significant new results featured in the briefing materials, which include more than 100 pages of data analyses from the agency and from Pfizer. Last month, Pfizer and BioNTech announced that their two-dose vaccine had an efficacy rate of 95 percent after two doses administered three weeks apart. The new analyses show that the protection starts kicking in far earlier. (Weiland and Zimmer, 12/8)
In briefing documents published ahead of an advisory meeting Thursday to review Pfizer鈥檚 vaccine, FDA staff also said data submitted appeared to show the vaccine provided protection after the first dose. Pfizer鈥檚 vaccine requires two doses about three weeks apart. Two doses of the vaccine were 鈥渉ighly effective鈥 in preventing confirmed cases of Covid-19 at least seven days following the second dose, the agency said. 鈥淎s such, FDA has determined that the Sponsor has provided adequate information to ensure the vaccine鈥檚 quality and consistency for authorization of the product under an EUA,鈥 the agency wrote in documents posted on its website. (Lovelace Jr., 12/8)
In addition, the FDA said another benefit was reduction in the risk of confirmed Covid-19 after the first dose and before the second dose. Another clear benefit, the agency said, was 鈥渞eduction in the risk of confirmed severe Covid-19 any time after dose 1.鈥 The reference to reduction in confirmed severe disease was important, as early critics of some of the vaccine trials were concerned that only mild to moderate disease was prevented. (Burton and Hopkins, 12/8)
On Thursday, a group of advisers to the FDA will meet for a full-day public meeting to discuss the data and make recommendations on whether the vaccine merits authorization for immediate use. A decision, informed but not dictated by that debate, is expected to come within days of the meeting. The first doses are expected to be shipped within hours, with a target of 6.4 million doses distributed in the first week. (Johnson, McGinley, Alcantara and Steckelberg, 12/8)
