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FDA Says Johnson & Johnson’s One-Dose Vaccine Is Safe and Effective

US regulators just released detailed data on Johnson & Johnson’s coronavirus vaccine.

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This story originally appeared on Business Insider

Johnson & Johnson’s single-dose coronavirus vaccine just got one step closer to reaching the public, as US regulators released documents showing the shot was safe and confirming that it can help prevent COVID-19.

The Food and Drug Administration’s review of the data found the shot to be effective and safe, and regulators said there were no identified safety issues that would prevent an emergency OK.  

J&J’s vaccine is widely expected to become the third COVID-19 vaccine to reach the American public. The healthcare giant has said it will have nearly 4 million doses ready to ship upon emergency authorization and is on track to deliver 100 million doses to the US by the end of June.

Like the two other US-authorized vaccines, those doses will be available at no cost to individuals in the US. The US government agreed in August to pay $1 billion to J&J for 100 million doses and the healthcare giant has pledged not to sell doses for a profit during the pandemic.

On Friday, the FDA will convene a panel of independent experts to debate and ultimately vote on whether or not to recommend J&J’s jab for a regulatory OK. Experts widely expect the committee to vote in favor, and for the FDA to greenlight the shot in the following days. 

J&J’s vaccine was 66% effective overall, but offered greater protection against severe disease

In late-January, J&J announced success with its 44,000-volunteer clinical trial. In a press release, it said that the one-dose vaccine was 66% effective at preventing moderate and severe cases of COVID-19. The documents released on Wednesday confirmed this finding.

That figure is markedly lower than the 94% and 95% efficacy rates shown by Moderna’s and Pfizer’s two-dose vaccines, but it’s difficult to directly compare the studies, as they happened at different stages in the pandemic and across different geographies.

J&J’s study tested the shot in several countries when variants of the virus are circulating widely. The shot was 72% effective in the US, 66% effective in Latin America, and 57% effective in South Africa. Nearly all of the South African infections came from the B.1.351 variant.

Other vaccine developers, including Moderna, Pfizer, and Novavax, have started research on potential booster shots tailored to better neutralize the B.1.351 variant.

J&J has emphasized the vaccine was strongly protective against severe disease, a benefit that held true across age groups and geographies. The ability of J&J’s shot to prevent hospitalizations and deaths doesn’t seem to be diminished by B.1.351 or other variants.

Other vaccines haven’t been tested as extensively against the variants, though some evidence suggests they may offer less protection.

Public-health experts are eagerly awaiting J&J’s vaccine, not just to expand US supply but also for its simplicity. The one-dose jab can be stored at typical refrigerator temperatures for several months.

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