#FDA; #JohnsonandJohnsonCOVID19vaccine, #Authorization; #EmergencyUse
Washington/Canadian-Media: Emergency use of Johnson and Johnson’s (J&J)'s single-dose COVID-19 vaccine was authorized on Saturday by the U.S. Food and Drug Administration (FDA), making it available as the third vaccine in the United States (U.S.) and the first that only takes one dose to protect against the coronavirus, FDA reported.
Johnson and Johnson vaccine. Image credit: www.jnj.com
Unanimous endorsement of the one-dose vaccine was done on Friday by an FDA panel of U.S. health advisers. FDA says single-dose shot from J&J prevents severe cases of COVID-19.
Shipping of a few million doses of the new vaccine could begin as early as Monday.
“The authorization of this vaccine expands the availability of vaccines...through our open and transparent scientific review process...using the agency’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” said Acting FDA Commissioner Janet Woodcock, M.D.
J&J’s vaccine protects against the worst effects of COVID-19 after one shot, and it can be stored up to three months at refrigerator temperatures, making it easier to handle than the Pfizer and Moderna vaccines, which must be frozen.
“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use...At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.
J&J vaccine was 85 percent protective against the most severe COVID-19 and 66 percent effective in moderate cases as against 95% effectiveness of the two-dose Pfizer and Moderna against symptomatic COVID-19
Vaccine Adverse Event Reporting System (VAERS) for Janssen COVID-19 Vaccine, being a part of the authorization, Janssen Biotech Inc. and vaccination providers reported the following to the serious adverse events, cases of Multisystem Inflammatory Syndrome and cases of COVID-19 that result in hospitalization or death.
Reporting all vaccine administration errors to VAERS for which they become aware and for Janssen Biotech Inc. is mandatory for vaccination providers including a summary and analysis of all identified vaccine administration errors in monthly safety reports submitted to the FDA.
An agreement has been made by the United States to buy 100 million doses of J&J’s vaccine for $1 billion, and the option of purchasing an additional 200 million doses.
J&J said it aims to deliver 1 billion doses in 2021 with production in the United States, Europe, South Africa, and India.
While applauding the news in a statement Saturday, U.S. President Joe Biden also urged Americans not to let their guards down in preventing the spread of the virus.
“Today, after a rigorous, open, and objective scientific review process, the Food and Drug Administration issued an emergency use authorization for a third safe and effective vaccine to help us defeat the COVID-19 pandemic — the Janssen COVID-19 (Johnson & Johnson) vaccine,” Biden said. “This is exciting news for all Americans and an encouraging development in our efforts to bring an end to the crisis.”
Speeding up vaccination efforts is expected by the third vaccine, amid setbacks caused by winter storms across the country.