February 25, 2021

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J&J requests FDA emergency use authorization

4 min read

Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine after releasing data last week showing it was about 66% effective in protecting against the virus.

If J&J’s application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the U.S. behind those developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was authorized by the FDA on Dec. 11, and Moderna’s was authorized a week later.

“Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” J&J’s chief scientific officer, Dr. Paul Stoffels, said in a statement.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping,” he said. “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.”

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26 to discuss the emergency use authorization.

“A public discussion by the advisory committee members about the data submitted in support of safety and effectiveness of Janssen Biotech Inc.’s COVID-19 vaccine will help ensure that the public has a clear understanding of the scientific data and information that FDA will evaluate in order to make a decision about whether to authorize this vaccine,” acting FDA Commissioner Janet Woodcock said in a statement. “The FDA remains committed to keeping the public informed about our evaluation of the data for COVID-19 vaccines, so that the American public and medical community have trust and confidence in FDA-authorized vaccines.”

U.S. officials and Wall Street analysts are eagerly anticipating the authorization of J&J’s vaccine, which could happen as early as this month. President Joe Biden is trying to pick up the pace of vaccinations in the U.S. and experts say his administration will need an array of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans over the last year, according to data compiled by Johns Hopkins University.

Unlike Pfizer’s and Moderna’s vaccines, which require two doses given about three to four weeks apart, J&J’s medication only requires one dose, easing logistics for health-care providers.

J&J said on Jan. 29 that its vaccine was 66% effective overall in protecting against Covid-19. The vaccine, however, appeared to be less potent against other variants. The level of protection was just 57% in South Africa, where a new, highly contagious strain called B.1.351 is rapidly spreading. South Carolina officials detected the first-known U.S. case of that strain last month.

Infectious disease experts point out that J&J’s numbers can’t be used as a direct comparison with Pfizer’s and Moderna’s vaccines, which were found to be 95% and 94% effective, respectively. That’s because J&J’s vaccine is a single dose and the company’s trial was conducted when there were more infections and new, more contagious variants, they said.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the most crucial finding of the J&J data was the vaccine appeared to be 85% effective in preventing severe disease.

“The most important thing, more important than whether you prevent someone from getting aches and a sore throat, is preventing people” from getting severe disease, the director of the National Institute of Allergy and Infectious Diseases said on a call with reporters on Jan. 29. “That will alleviate so much of the stress and human suffering and death in this epidemic.”

The FDA has indicated it would authorize a vaccine that’s safe and at least 50% effective. The flu vaccine, by comparison, generally reduces people’s risk of getting influenza by 40% to 60% compared with people who aren’t inoculated, according to the Centers for Disease Control and Prevention.

J&J has said it plans to ship the vaccine at 36 to 46 degrees Fahrenheit. By comparison, Pfizer’s vaccine needs to be stored in ultra-cold freezers that keep it between negative 112 and negative 76 degrees Fahrenheit. Moderna’s vaccine needs to be shipped at between negative 13 and 5 degrees Fahrenheit.

The Department of Health and Human Services announced in August that it reached a deal with Janssen, J&J’s pharmaceutical subsidiary, worth approximately $1 billion for 100 million doses of its vaccine. The deal gives the federal government the option to order an additional 200 million doses, according to the announcement.




2021-02-04 21:18:53


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