A health care worker took a dose of Johnson & Johnson’s COVID-19 vaccine from a vial at Klerksdorp Hospital in Klerksdorp, South Africa on Feb. 18. Phill Magakoe / AFP via Getty Images hide the caption
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Phill Magakoe / AFP via Getty Images
A health care worker withdrew a dose of Johnson & Johnson’s COVID-19 vaccine from a vial at Klerksdorp Hospital in Klerksdorp, South Africa, on February 18.
Phill Magakoe / AFP via Getty Images
In a unanimous 22-0, an advisory panel recommended the Food and Drug Administration to approve the COVID-19 vaccine developed by Johnson & Johnson for emergency use in adults during the pandemic.
The vote for the vaccine, which requires only one shot to protect, was made to answer this question: Do the benefits of the Johnson & Johnson vaccine outweigh the risks for use in people aged 18 and over?
The FDA usually follows the advice of its professional advisor. If the agency agrees, the Johnson & Johnson vaccine would be the third approved for use in the United States
A quick decision is expected given the state of the pandemic. The FDA approved the Pfizer-BioNTech and Moderna COVID-19 vaccines a day after the same panel recommended them for release in separate meetings last December.
The Johnson & Johnson vaccine was tested in an international study on approximately 40,000 people, half of whom received the vaccine and half of whom received a placebo. The study found that the company’s vaccine was 66% overall effective at preventing moderate to severe COVID-19 illnesses. For a disease judged to be severe or critical, the effectiveness was 85%. The study was carried out in the United States, South America, and South Africa.
The main study included in the company’s application found that the Johnson & Johnson vaccine prevented hospitalizations and deaths related to COVID-19 for 28 days or more after immunization.
Overall efficacy scores are below 95% for Pfizer for COVID-19 disease prevention and 94% for Moderna.
With the outbreak of the pandemic, the coronavirus mutated. Variants first observed in South Africa and Brazil, where the Johnson & Johnson vaccine was tested, mutated in a way that helps them evade the immune response triggered by vaccines developed against the original form of the virus .
Of more than 6,000 study participants surveyed within a week of vaccination, the most common side effects were injection site pain (49%), headache (39%), fatigue (38%), and muscle pain (33%). . These side effects were mostly mild or moderate.
Approval of Johnson & Johnson’s vaccine would help expand the range of COVID-19 shots available. The company said 4 million doses of vaccine would be available in the US once the FDA gives its OK. A total of 20 million cans are expected to be ready by the end of March, and Johnson & Johnson is committed to delivering 100 million cans by the end of June under its contract with the federal government.
