J&J requests FDA emergency use authorization
Johnson & Johnson filed with the Food and Drug Administration for emergency approval to use its coronavirus vaccine after data was released last week showing that protection against the virus was about 66% effective.
If the application is approved by J&J, this will be the third Covid-19 vaccine approved for emergency use in the US after that developed by Pfizer-BioNTech and Moderna. Pfizer’s vaccine was approved by the FDA on December 11, and Moderna’s vaccine was approved a week later.
“Today’s filing for the emergency approval of our single vaccine COVID-19 is a critical step in reducing the burden of disease for people around the world and ending the pandemic,” said Dr. Paul Stoffels, Scientific Director of J & J., in a statement.
“With our emergency COVID-19 vaccine approved, we will be ready to begin shipping,” he said. “With our filing with the FDA and ongoing reviews with other health authorities around the world, we are working urgently to make our investigational vaccine available to the public as soon as possible.”
The FDA has scheduled a meeting of its Advisory Committee on Vaccines and Related Biological Products on Feb.26 to discuss emergency approval.
“A public discussion by the members of the Advisory Committee on the data submitted in support of the safety and effectiveness of the COVID-19 vaccine by Janssen Biotech Inc. will help ensure that the public has a clear understanding of the scientific data and information, which the FDA will review to make a decision on whether to approve this vaccine, “Acting FDA Commissioner Janet Woodcock said in a statement. “The FDA continues to seek to keep the public informed of our analysis of the COVID-19 vaccine data so that the American public and medical community have confidence in FDA-approved vaccines.”
US officials and Wall Street analysts are eagerly awaiting J & J’s vaccine approval, which could come as early as this month. President Joe Biden is trying to speed up the pace of vaccination in the US, and experts say his government will need a range of drugs and vaccines to beat the virus that killed more than 450,000 Americans last year at Johns Hopkins University .
Unlike Pfizer and Moderna’s vaccines, which require two doses three to four weeks apart, J & J’s drugs only require one dose, making logistics easier for healthcare providers.
J&J said on Jan. 29 that its vaccine was 66% overall effective against Covid-19. However, the vaccine appeared to be less effective 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 discovered the first known US case of this strain last month.
Infectious disease experts suggest that J & J’s numbers cannot be used as a direct comparison with Pfizer and Moderna 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 study came about when there were more infections and new, more contagious variants.
Dr. Anthony Fauci, the nation’s leading infectious disease expert, said the key finding from the J&J data was that the vaccine was 85% effective at preventing major diseases.
“The most important thing, which is more important than preventing someone from getting a pain and a sore throat, is preventing people from getting serious illnesses,” said the director of the National Institute of Allergies and Infectious Diseases, speaking to reporters on Jan. January. 29. “This will alleviate so much stress and human suffering and death in this epidemic.”
The FDA has announced that it will approve a vaccine that is safe and at least 50% effective. In comparison, the flu vaccine generally reduces people’s risk of influenza by 40% to 60% compared to people who are not vaccinated, according to the Centers for Disease Control and Prevention.
J&J has announced that it will ship the vaccine at 36 to 46 degrees Fahrenheit. In comparison, Pfizer’s vaccine must be stored in ultra-cold freezers that keep it between minus 112 and minus 76 degrees Fahrenheit. Moderna vaccine must be delivered between 13 and 5 degrees Fahrenheit.
The Department of Health and Human Services announced in August that it had signed a contract 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 opportunity to order another 200 million cans, according to the announcement.