Pfizer says that its coronavirus vaccine is safe and 95% effective and that it will seek regulatory review within days
The coronavirus vaccine being developed by Pfizer and German biotechnology firm BioNTech is 95 percent effective at preventing illness, according to an analysis performed as a trial of the experimental shot reached its endpoint. The study also notched a safety milestone, with two months of follow-up on half of the participants, and Pfizer said it plans to submit an application for emergency authorization within days.
Among people older than 65, a group at high risk of severe illness, the vaccine was 94 percent effective.
“We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Pfizer chief executive Albert Bourla said in a statement. What you need to know about the Moderna and Pfizer coronavirus vaccines U.S. government officials anticipate having 40 million doses of both vaccines — each requires two doses — by the end of the year, enough to vaccinate 20 million people. Pfizer aims to create 50 million doses globally, and about half will go to the United States. The frenetic speed of the vaccine development process is infusing the regulatory part of the process, which now moves to the fore. Even before receiving applications from the vaccine makers, the FDA has asked its advisory panel to keep Dec. 8, 9, and 10 open for possible meetings on Pfizer. The session might take up only one of those days. The panel might consider data from Moderna, which is running about a week behind Pfizer, the following week. The FDA would not comment on the timing of the meetings. In advance of the committee meetings, the FDA will electronically send the panel — called the Vaccines and Related Biological Products Advisory Committee — voluminous briefing packets with reams of safety and efficacy data. The packets also will contain FDA and company views on the information. Getting ready for a committee meeting requires extensive work by FDA staff, said Norman W. Baylor, president, and chief executive officer of Biologics Consulting and former director of the FDA’s Office of Vaccines Research and Review. “They are literally swamped,” he said. “Plus, the pressures are coming from all sides. It will be very intense.” Often, the FDA staff examines vaccine data for a year — or years — before consulting with its advisory committee, experts said. “If someone says, ‘We are not rushing,’ that is not true,” Baylor said. “They are rushing.” The FDA will be asking the committee whether the safety and efficacy data of the vaccines justifies the granting of emergency use authorizations, he added. The agency doesn’t have to follow the recommendations of the advisory committee but often does. FDA officials have said it could take a couple of weeks for the agency to make a final decision after the advisory committee meets. Emergency use authorizations, which are not full approvals, require much fewer data and can follow more lenient standards. The FDA has used an emergency authorization only once for a vaccine — for anthrax — and that was under sharply different circumstances. Some experts have expressed qualms about using an emergency authorization for a coronavirus vaccine that will be given to hundreds of millions of people, but those criticisms have become more muted as the pandemic has raged, killing thousands of Americans a week. Peter Marks, director of the FDA center that oversees vaccines, has said he would insist on an emergency standard for a vaccine roughly equivalent to what’s needed for full licensure. Even so, the available safety data — two months follow-up on half of the trials’ participants after their second shots — is shorter than traditional trials. And some questions, such as the duration of protection, can’t be answered now, with those data collected as the trials continue. Earlier this week, the FDA said it would publicly disclose reviews of the scientific data used to authorize drugs and vaccines. That followed criticism, most notably from the Government Accountability Office, that the FDA had not been sufficiently transparent in disclosing the data used to decide whether to grant or revoke authorizations involving covid-19 treatments. Eric Topol, director of the Scripps Research Translational Institute, said the vaccine data, along with other developments in recent days mean “things are looking up. It’s a really good turning point right now. We are hitting on all cylinders.” In addition to the vaccine data from Pfizer and Moderna, he mentioned the FDA’s authorization of an at-home coronavirus test and its recent greenlight of the first monoclonal antibody treatment, which is designed to keep people with mild disease out of the hospital.