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J & J seeks urgent permission from FDA for single-dose COVID-19 vaccine

(Reuters) — Johnson & Johnson said Thursday that it sought approval from US health regulators for a single dose. COVID19 vaccine For emergency use.

The drug company’s application to the US Food and Drug Administration (FDA) follows a January 29 report stating that the vaccine has a 66% chance of preventing infection in its large global trial.

The Food and Drug Administration has asked independent advisors to publicly discuss all the data behind single-dose shots before deciding whether to turn the third vaccine option in the United States into a green light. The panel will meet on February 26th.

J & J’s single-shot vaccine will increase supply amid new surge concerns from the more contagious British coronavirus mutant and potentially reduced vaccine efficacy against the first mutant to emerge in South Africa , May help simplify vaccination campaigns in the United States.

Unlike the two vaccines currently approved by Pfizer Inc / BioNTech SE and Moderna Inc, J & J does not require a second shot and does not need to be shipped frozen.

After applying for a company, regulators need time to analyze the data and an advisory board needs to meet. The company’s chief scientific officer said last month that J & J plans to roll out the vaccine in March.

Shares of Johnson & Johnson, Moderna and Pfizer remained almost unchanged during non-business hours trading.

The United States has agreed to buy 100 million doses of J & J vaccine for $ 1 billion, with the option of purchasing another 200 million doses.

The company said it was ready for administration at the time of emergency approval. It will be administered in 1 billion doses in 2021 and is targeted for production in the United States, Europe, South Africa and India.

© Copyright Thomson Reuters 2021

J & J seeks urgent permission from FDA for single-dose COVID-19 vaccine

Source link J & J seeks urgent permission from FDA for single-dose COVID-19 vaccine

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