US FDA approved Johnson & Johnson Covid-19 Vaccine for Emergency Use

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On Saturday, the US Food and Drug Administration announced that it had issued an emergency use authorization for the Johnson & Johnson COVID-19 vaccine, the third overall. The acting commissioner of FDA, Dr. Janet Woodcock said, “The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States. The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization”. The FDA also said that tests on the Janssen Biotech Inc., a vaccine was about 67% effective in preventing moderate to severe cases within 14 days after dosing and 66% effective against severe to critical cases after 28 days.

Point to be noted that it takes just one shot which is more effective compared to the previous vaccines. Janssen is a pharmaceutical subsidiary of Johnson & Johnson. The jab developed from an adenovirus vector formula, unlike the vaccines created by Moderna and Pfizer-BioNTech which were created using mRNA technology and have already seen emergency use approval. It was found to have a favorable safety profile with no specific concerns identified that would preclude the issuance of the EUA. Recipients of an emergency use authorization are required to file safety reports and inform the FDA of any serious issues, side effects, hospitalizations, or deaths as a result of their product. The FDA based its decision on a study of the Janssen vaccine on more than 39,000 people in multiple countries, including the US.

It is noteworthy that the Pfizer and Moderna vaccines require 2 doses and these are 95% and 94.1% effective, respectively. But the Johnson & Johnson single-dose vaccine is also easier to store and has a longer shelf life at higher temperatures. The CDC’s ACIP (Advisory Committee on Immunization Practices) has voted to recommend Johnson & Johnson’s COVID-19 vaccine for emergency use for individuals ages 18 and older in the United States. On Saturday, the 12-0 vote with one recusal for a potential conflict of interest comes following an official emergency use authorization by the Food and Drug Administration. The ACIP is a group of independent health experts that advises the CDC on the types of populations and circumstances for which vaccines should be used. The group made the recommendation after an emergency session was called to review the vaccine’s data.