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At 0-22 unanimously, a panel of Food and Drug Administration advisers recommended that the Johnson & Johnson-developed COVID-19 vaccine be allowed for emergency use in adults during a pandemic.
The vaccine, which requires only one injection for protection, has been voted in to answer this question: Do the benefits of the Johnson & Johnson vaccine outweigh the risks of using it in people 18 years of age or older.
The Food and Drug Administration usually follows the advice of its expert advisors. If approved by the agency, the Johnson & Johnson vaccine will be the third vaccine allowed for use in the United States
A quick decision is expected given the pandemic situation. The FDA approved the Pfizer-BioNTech and Moderna COVID-19 vaccines, one day after the same committee recommended that they be removed during separate meetings last December.
The Johnson & Johnson vaccine was tested in an international study of nearly 40,000 people, half of whom got the vaccine and half got a placebo. The study found that the company’s vaccine is 66% effective overall in preventing moderate to severe COVID-19 disease. For disease judged severe or serious, the efficacy was 85%. The study was conducted in the United States, South America, and South Africa.
The main study included on the company’s app found that after 28 days or more of vaccination, the Johnson & Johnson vaccine prevented hospitalization and death related to COVID-19.
Overall effectiveness figures are below 95% for Pfizer for preventing COVID-19 and 94% for Modena.
As the epidemic approaches, 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 stimulated by vaccines developed against the original form of the virus.
Of the more than 6,000 study participants asked within a week of vaccination, the most common side effects were pain at the injection site (49%), headache (39%), fatigue (38%), and muscle pain (33%). These side effects were often mild or moderate.
The acquisition of a Johnson & Johnson vaccine will help increase the supply of COVID-19 shots. The company said that 4 million doses of the vaccine will be available in the United States once approved by the FDA. A total of 20 million doses will 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.