J&J requests FDA emergency use authorization

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

If J&J’s application is approved, it will be the third Covid-19 vaccine authorized for emergency use in the United States, behind vaccines developed by Pfizer-BioNTech and Moderna. The Pfizer vaccine was authorized by the FDA on December 11, and Moderna was authorized a week later.

American officials and Wall Street analysts are eagerly awaiting authorization for the J&J vaccine, which could happen as early as this month. President Joe Biden is trying to accelerate the pace of vaccinations in the United States and experts say his government will need a series of drugs and vaccines to defeat the virus, which killed more than 450,000 Americans last year.

Unlike Pfizer and Moderna vaccines, which require two doses administered three to four weeks apart, the J&J vaccine requires only one dose, facilitating logistics for healthcare professionals.

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

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

Dr. Anthony Fauci, the country’s leading infectious disease specialist, said the most important finding from J&J data was that the vaccine appeared to be 85% effective in preventing serious illnesses.

“The most important thing, more important than preventing someone from having pain and sore throat, is to prevent people from” contracting serious illnesses, “said the director of the National Institute of Allergy and Infectious Diseases in a call with reporters on January 29. “This will greatly relieve stress, human suffering and death in this epidemic.”

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

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

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

This is a developing story. Please check again for updates.

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