FDA Analysis of Johnson & Johnson COVID-19 Vaccine Finds It Safe, Effective

A health care employee averted as she was inoculated with Johnson & & Johnsons COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa, on Feb. 18.

Phill Magakoe/AFP via Getty Images

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Phill Magakoe/AFP via Getty Images

A healthcare employee looked away as she was inoculated with Johnson & & Johnsons COVID-19 vaccine at Klerksdorp Hospital in Klerksdorp, South Africa, on Feb. 18.

Phill Magakoe/AFP via Getty Images

The permission of Johnson & & Johnsons vaccine might eventually assist broaden the supply of COVID-19 shots for Americans. Its availability wont make a big difference right away.

The most typical adverse reactions among more than 6,000 study participants who were queried about their experience were injection site pain (49%), headache (39%), tiredness (38%) and muscle discomfort (33%). These adverse effects were mostly moderate or moderate.

If the firm goes on to authorize the Johnson & & Johnson vaccine, it would be the 3rd, after those made by Pfizer-BioNTech and Moderna, to be become readily available in the U.S

. The Johnson & & Johnson vaccine has some advantages. Immunization with the Johnson & & Johnson vaccine needs only one shot, unlike the two-shot dosing for the vaccines from Pfizer and Moderna. The Johnson & & Johnson vaccine also does not require special refrigeration for shipment and storage.

The FDA evaluation noted that a worldwide research study of about 40,000 individuals, half of whom got the vaccine and half of whom got a placebo, discovered the companys vaccine to be 66% reliable overall in avoiding moderate to serious COVID-19 disease. The research study was performed in the U.S., Latin America and South Africa.

If the agency goes on to license the Johnson & & Johnson vaccine, it would be the third, after those made by Pfizer-BioNTech and Moderna, to be become available in the U.S

The effectiveness figures are lower than Pfizers 95% for preventing COVID-19 disease and 94% for Moderna. Over the course of the pandemic, the coronavirus has actually started to alter. Variations first seen in South Africa and Brazil, where the Johnson & & Johnson vaccine was evaluated, mutated in ways that assist them evade the immune response prompted by vaccines developed against the original type of the infection.

The firm also stated the vaccine has a “favorable safety profile” and that there were “no particular safety issues identified that would preclude issuance of an EUA.” This language mirrors the assessments for vaccines by Moderna and Pfizer-BioNTech, which were licensed in December for emergency usage.

In congressional testament Tuesday, a Johnson & & Johnson executive stated 4 million dosages of vaccine would be readily available in the U.S. when the FDA grants an emergency situation usage permission. A total of 20 million doses would be all set by the end of March, he said, and the business would be able to deliver an overall of 100 million doses by the end of June.

The Food and Drug Administration released an analysis of Johnson & & Johnsons COVID-19 vaccine Wednesday early morning that appears to support its permission for emergency use.

Versions first seen in South Africa and Brazil, where the Johnson & & Johnson vaccine was tested, altered in methods that assist them evade the immune action triggered by vaccines developed against the initial kind of the virus.

In the big medical trial that is the focal point of the companys application to the FDA, no one who received the vaccine needed hospitalization or died once the vaccine took full impact (28 days after immunization). “Johnson & & Johnson appears to be just as good as Moderna and Pfizer at preventing those,” Jha said.

. Immunization with the Johnson & & Johnson vaccine requires just one shot, unlike the two-shot dosing for the vaccines from Pfizer and Moderna.