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Johnson & Johnson applied for an emergency use authorization from the Food and Drug Administration for its coronavirus vaccine, after publishing data last week showing that it was about 66% effective in protecting against the virus.
If the J&J application is approved, it would be the third Covid-19 vaccine authorized for emergency use in the United States behind those developed by Pfizer-BioNTech and Moderna. The Pfizer vaccine was approved by the FDA on December 11, and Moderna was authorized a week later.
“Today’s submission for the emergency use of our single-injection COVID-19 research vaccine is a key step in reducing the burden of human disease globally and ending the pandemic,” said J & J’s scientific director. Dr. Paul Stoffels in a statement.
“Once our COVID-19 research vaccine is authorized for emergency use, we are ready to begin transportation,” he said. Through 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 soon as possible.
U.S. officials and Wall Street analysts are looking forward to the release of the J&J vaccine, which could take place as early as this month. President Joe Biden is trying to pick up vaccinations in the United States, and experts say his administration will need a series of drugs and vaccines to defeat the virus, which has killed more than 450,000 Americans in the past year, according to data compiled by Johns Hopkins University.
Unlike Pfizer and Moderna vaccines, which require two doses given every three to four weeks, J&J drugs require a single dose, facilitating the logistics of healthcare providers.
J&J said on January 29 that its vaccine was generally 66% effective in protecting against Covid-19. However, the vaccine 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 found the first known case of the strain in the United States last month.
Infectious disease experts point out that J & J’s numbers cannot be used as a direct comparison with Pfizer and Moderna vaccines, which have been shown to be 95% and 94% effective, respectively. This is because the J&J vaccine is a single dose, and the company’s study 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 important finding in the J&J data was that the vaccine appears to be 85% effective in preventing severe disease.
“The most important thing, more important than preventing someone from getting sore and sore throats, is to prevent people” from getting seriously ill, “said the director of the National Institute of Allergy and Infectious Diseases in a January reporter call. 29. “This will alleviate so much stress, suffering and human death in this epidemic.”
The FDA has indicated that it will authorize a safe and at least 50% effective vaccine. The flu vaccine, by comparison, generally reduces the risk of people 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 intends to deliver the vaccine at 36-46 degrees Fahrenheit. By comparison, the Pfizer vaccine should be stored in ultra-cold freezers, which keep it between 112 and 76 degrees Fahrenheit negative. The Moderna vaccine should be transported between 13 and 5 degrees Fahrenheit negative.
The Department of Health and Human Services announced in August that it had reached an agreement with Janssen, J & J’s pharmaceutical subsidiary, worth about $ 1 billion for 100 million doses of vaccine. The agreement gives the federal government the option to order another 200 million doses, according to the announcement.