Pfizer’s experimental coronavirus vaccine is highly effective and poses no safety risks that would prevent it from being cleared for emergency use, Food and Drug Administration scientists said Tuesday.
FDA staffers detailed their findings in a 53-page report ahead of a Thursday meeting where the agency’s vaccine advisory committee will consider Pfizer’s application for an emergency use authorization, which could pave the way for millions of high-risk Americans to be inoculated by the end of the year.
The FDA analysis of data from Pfizer’s large-scale clinical trial involving roughly 44,000 people affirmed the Manhattan-based drugmaker’s finding that the shot was 95 percent effective at preventing COVID-19 infection after two doses. The scientists also found the vaccine was similarly effective regardless of the recipient’s age, gender, race or ethnicity and among people with underlying medical issues that put them at risk for severe coronavirus infections.
While no serious safety concerns emerged from the data submitted by Pfizer and its German partner, BioNTech, the FDA noted that people who took the vaccine reported common side effects including headaches, muscle pain, chills, fatigue and pain at the injection site.
But there isn’t yet enough data to prove whether the shot can prevent vaccinated people from carrying and spreading the virus or whether it can ward off asymptomatic infections, the FDA said. The agency also couldn’t say how well the vaccine works in kids younger than 16 or whether it can prevent long-term health effects of COVID-19.
“Demonstrated high efficacy against symptomatic COVID-19 may translate to overall prevention of transmission in populations with high enough vaccine uptake,” the FDA scientists wrote. However, they added, “asymptomatic cases in combination with reduced mask-wearing and social distancing could result in significant continued transmission.”
Despite the limitations, the data offered the public an in-depth look at how well the Pfizer jab works before Thursday’s highly anticipated meeting of the FDA’s vaccine advisory panel. The agency could formally grant Pfizer an emergency use authorization within days if the committee gives the vaccine a positive recommendation, The Wall Street Journal reported.
The meeting will come as the COVID-19 pandemic rages through a deadly new phase in the US. The virus killed more than 15,600 people across the country over the last seven days and the nationwide infection count is approaching 15 million, according to Johns Hopkins University data.
The FDA also released Pfizer and BioNTech’s own 92-page analysis of the vaccine’s effectiveness and safety. The companies became the first to seek emergency approval for a coronavirus shot in the US last month, and the UK began administering their vaccine to British patients on Tuesday.
“In response to the current global health crisis, the Pfizer-BioNTech COVID-19 vaccine … development has ensured the highest compliance and quality standards while progressing expeditiously to address this urgent and unmet medical need,” the drugmakers wrote in their report.
The FDA vaccine panel is scheduled to discuss Moderna’s COVID-19 shot at a separate meeting on Dec. 17. The Massachusetts biotech firm applied for an emergency use authorization last week after finding the shot was 94.1 percent effective in a clinical trial.
Article posted on nypost.com