Panel Recommends FDA Authorize Johnson & Johnson Vaccine For Emergency Use
In a unanimous 22-0, a panel of advisers to the Food and Drug Administration recommended that the COVID-19 vaccine developed by Johnson & Johnson be authorized for emergency use in adults during the pandemic.
The vote in favor of the vaccine, which requires only one shot for protection, was taken to answer this question: Do the benefits of the Johnson & Johnson vaccine outweigh its risks for use in people 18 years of age and older.
The FDA typically follows the advice of its expert advisers. If the agency agrees, the Johnson & Johnson vaccine would be the third one cleared for use in the U.S.
A quick decision is expected given the state of the pandemic. The FDA authorized the Pfizer-BioNTech and Moderna COVID-19 vaccines one day after the same panel recommended them for clearance during separate meetings last December.
The Johnson & Johnson vaccine was tested in an international study of about 40,000 people, half of whom got the vaccine and half of whom got a placebo. The study found the company's vaccine to be 66% effective overall in preventing moderate to severe COVID-19 disease. For disease judged severe or critical, the effectiveness was 85%. The study was conducted in the U.S., South America and South Africa.
The main study included in the company's application found that 28 days or more after immunization, the Johnson & Johnson vaccine prevented hospitalizations and death related to COVID-19.
The overall efficacy figures are lower than Pfizer's 95% for preventing COVID-19 disease and 94% for Moderna.
As the pandemic has drawn on, the coronavirus has mutated. Variants first seen in South Africa and Brazil, where the Johnson & Johnson vaccine was tested, mutated in ways that help them evade the immune response prompted by vaccines developed against the original form of the virus.
Among more than 6,000 study participants who were queried within a week of vaccination, the most common side effects were pain at the site of injection (49%), headache (39%), fatigue (38%) and muscle pain (33%). These side effects were mostly mild or moderate.
The authorization of Johnson & Johnson's vaccine would help expand the supply of COVID-19 shots. The company said 4 million doses of vaccine would be available in the U.S. as soon as the FDA gives its OK. A total of 20 million doses would be ready by the end of March, and Johnson & Johnson has committed to deliver 100 million doses under its contract with the federal government by the end of June.
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