Covid19. US regulator recommends Johnson & Johnson vaccine | Coronavirus

The panel of experts from the Food and Drug Administration (FDA), the American agency that regulates drugs, voted this Friday to approve the Johnson & Johnson vaccine against Covid-19 for emergency use, which is an important step in that direction the USA. It’s likely that the FDA will approve the single-dose vaccine soon after receiving the team’s recommendation, making it the third in the US.

This decision comes after the positive results of the vaccine. This Wednesday, the team presented new data on the Johnson & Johnson (J&J) vaccine. According to this agency, the vaccine is safe, promotes a good immune response with a single dose, and has been shown to be 66% effective against multiple variants. These conclusions are the result of a global test of nearly 44,000 people.

The effectiveness of the vaccine varied by 72% in the US, 66% in Latin America, and 57% in South Africa – where a new variant has spread – although it was generally 85% effective in preventing serious illnesses. The study also showed that people over 60 with risk factors like heart disease or diabetes had a 42.3% lower effectiveness. However, that number was the result of a large statistical uncertainty, explains the FDA.

The vaccine was effective in reducing the risk of Covid-19 and preventing infection with the new coronavirus, which was confirmed by CRP tests at least 14 days after vaccination, the FDA said. Three patients who received the vaccine had serious side effects during the tests. However, the FDA said the analysis did not raise any specific safety concerns that would prevent it from being approved for use.

This vaccine also has side effects that are noticeably milder than the Pfizer and Moderna vaccines and with no reports of serious allergic reactions such as anaphylaxis.

Back to top button