UPDATED 2/26 at 6:10 p.m. ET: The FDA advisory committee has unanimously recommended Johnson & Johnson’s single-shot COVID-19 vaccine for emergency use.
“We are extremely grateful to the VRBPAC members for their extensive review of the data supporting emergency use of Johnson & Johnson’s single-shot COVID-19 vaccine candidate,” Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said in a press release. “We believe our COVID-19 vaccine candidate has the potential to help change the trajectory of the pandemic and stand ready to make it available to protect the public as soon as possible.”
It’s important to note that Friday’s recommendation is non-binding, as the FDA will make the final decision on whether to grant an EUA for the vaccine. The Wall Street Journal reports the agency is expected to announce its decision on Saturday.
See the original story below.
Johnson & Johnson’s COVID-19vaccine candidate, which is unique in that it’s a single-dose option, has been confirmed by scientists with the Food and Drug Administration to be effective and safe to use.
On Wednesday, analysis from regulators was released that—per the Associated Press—paves the way for a final decision on the single-dose vaccine. Typically, a recommendation from the Vaccines and Related Biological Products Advisory committee is followed swiftly by action from the FDA, i.e. emergency use authorization. That committee is set to meet on Friday to make the call regarding the authorization the was previously requested by Johnson & Johnson. For more on what’s on the agenda for Friday’s meeting, read this.
FDA scientists have confirmed the single-dose vaccine to be about 66 percent effective in the prevention of moderate to severe COVID-19 cases, and was previously announced by the Johnson & Johnson team to be very effective against the most serious instances of COVID-19 symptoms.
The Johnson & Johnson vaccine was announced last month to boast a 72-percent protection level against moderate to severe infection in the U.S., with protection lives in Latin America and South Africa confirmed at the time to be 66 percent and 57 percent, respectively.
The company announced its submission of an application to the FDA for an emergency use authorization earlier this month.
“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping, Paul Stoffels, M.D.—the vice chairman of the executive committee and chief scientific officer at Johnson & Johnson—said at the time. “With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”
By the end of March, assuming the vaccine candidate is given the go-ahead for emergency use this week, Johnson & Johnson is expected to have provided 20 million doses in the U.S. And later this summer, that number is projected to be as high as 100 million.
