The Food and Drug Administration announced Tuesday that data from Pfizer’s coronavirus vaccine trials are in line with the agency’s recommendations for emergency use approval. The vaccine is highly effective and has not raised any particular safety concerns.
In documents released ahead of a Thursday consultation to review Pfizer’s vaccine, FDA officials also said the data submitted showed the vaccine was 82% effective after the first dose. Pfizer’s vaccine recommends two doses about three weeks apart. The agency added that two doses of the vaccine are “highly effective” in preventing confirmed cases of Covid-19 at least seven days after the second dose.
The FDA has announced that it will approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces the risk of developing influenza by 40% to 60% compared to people who were not vaccinated, according to the CDC.
“As a result, the FDA has determined that the sponsor has provided adequate information to ensure the quality and consistency of the vaccine for approval of the product under an EEA,” the agency said on its website.
The FDA is expected to decide within a few days whether Pfizer’s vaccine should be approved. The UK began mass immunization with the vaccine on Tuesday based on approval of emergency use.
The documents released on Tuesday provide a glimpse into the FDA’s view of the vaccine. The agency is expected to hold a meeting of its Advisory Committee on Vaccines and Related Biological Products, a group of outside medical experts, on Thursday to review Pfizer’s Covid-19 vaccine with German drug maker BioNTech for an emergency.
Approval for emergency use means that the FDA will allow some people to receive the vaccine as the agency continues to evaluate data. This is not the same as a full approval, which can typically take months. The FDA granted emergency approval for Gilead Sciences’ remdesivir in May before granting full approval in late October.
If Thursday’s meeting goes well and the advisory panel officially recommends the vaccine, the FDA could announce its approval “in a matter of days,” Alex Azar, secretary of health and human services, told ABC News This Week on Sunday. “But it will be the FDA gold standard process and I will make sure it does,” he added.
The FDA does not have to follow the advisory board’s recommendation, but the agency often does. Furthermore, the FDA’s positive evaluation of the vaccine doesn’t mean the committee will take the same stance at its meeting on Thursday.
Pfizer submitted its Covid vaccine data to the FDA on November 20. A final analysis of its Phase 3 clinical trial of more than 43,000 participants found the vaccine to be 95% effective against Covid, safe, and appeared to fight off serious illness. The vaccine uses messenger RNA or mRNA technology. It’s a new approach to vaccines that uses genetic material to trigger an immune response.
Approval of the vaccine would be a pivotal moment in the pandemic as health officials say the US is likely to face the worst public health crisis in history this winter. Hospitals in the U.S. already have higher numbers of Covid patients than ever before, and the country’s outbreak is poised to break even worse records this week.
US officials say they will distribute the vaccine within 24 hours of approval. Starting doses of the vaccine will be limited as production begins. Leading U.S. health officials predict it will take months to vaccinate anyone who wants to be vaccinated against Covid in the U.S. The vaccine will likely be distributed in phases with the Centers for Disease Control and Prevention, which prioritize healthcare workers and nursing homes.
There is currently insufficient data to draw any conclusions about the safety of the vaccine in children under 16, pregnant women and people with compromised immune systems, the FDA said Tuesday.
The agency also wrote that patients with Covid-19 may still be at risk of re-infection and could benefit from the vaccine.