J&J's COVID-19 vaccine is safe, effective, FDA review shows

Johnson & Johnson's COVID-19 vaccine had an overall efficacy rate of 72 percent in U.S. trials, meaning it provides strong protection against severe illness and death from the virus, according to an FDA analysis posted Feb. 24, The New York Times reported. 

The U.S. clinical trial showed the vaccine was 86 percent effective against severe forms of COVID-19, and a South African clinical trial showed it was 82 percent effective against severe disease there, where a more contagious variant called B.1.351 emerged and is causing most COVID-19 cases, according to the Times. The vaccine had an overall efficacy rate of 64 percent in South Africa. 

The FDA's vaccine committee is set to meet Feb. 26 to vote on whether to recommend the agency authorize the vaccine, and authorization could come as early as Feb. 27, according to the Times

Johnson & Johnson's vaccine requires a single dose, as opposed to two doses required by Moderna and Pfizer's vaccines, and it can be stored at normal refrigeration temperatures for at least three months, according to the Times

Access to the vaccine will be severely limited at first, if approved Feb. 27. Richard Nettles, vice president of U.S. medical affairs for the drug development arm of Johnson & Johnson, said Feb. 23 that nearly 4 million doses would be ready to be shipped after the FDA authorizes the vaccine. But White House officials said the same day that only about 2 million doses would be available next week if the vaccine is authorized, the Times reported. 

The drugmaker said Feb. 22 that it would have 20 million doses shipped to the U.S. government by the end of March. 

Side effects reported in clinical trials of the vaccine were noticeably milder than Pfizer and Moderna's vaccines, the Times reported. There were no reports of anaphylaxis.

Headaches, fatigue, muscle pain and injection site pain were the most common side effects reported, according to CNBC. Injection site pain was reported by nearly half of clinical trial volunteers; headaches were reported by about 40 percent; and fatigue was reported by about 38 percent. More than 33 percent of volunteers reported muscle pain, CNBC reported. 

Most of the adverse reactions occurred in people ages 18 to 59, and the FDA said most side effects went away a couple days after receiving the vaccine, according to CNBC.

More articles on pharmacy:
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Lawsuit alleges Icy Hot, Salonpas patches are marketed deceptively

 

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