Johnson & Johnson files COVID-19 vaccine application with U.S. FDA


Unlike the two currently authorised vaccines, J&J’sdoes not require a second shot or need to be shipped frozen.

Johnson & Johnson said on Thursday it has asked U.S. health regulators to authorize its single-dose COVID-19 vaccine for emergency use.

The drugmaker’s application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report in which it said the vaccine had a 66% rate of preventing infections in its large global trial.

Also read: EU approves Pfizer-BioNTech coronavirus vaccine

J&J’s single-shot vaccine could help boost supply and simplify the U.S. immunization campaign, amid concerns of fresh surges due to the more contagious UK coronavirus variant and the potential of lower vaccine efficacy against the variant that first emerged in South Africa.

Unlike the two currently authorised vaccines from PfizerInc/BioNTech SE and Moderna Inc, J&J’sdoes not require a second shot or need to be shipped frozen.

After the company’s application, regulators will need time to analyse the data and an advisory committee will need to meet. The company’s chief scientific officer said last month J&J was on track to roll out the vaccine in March.

Shares of Johnson & Johnson, Moderna and Pfizer were little changed in after-hours trade.

Also read: Pfizer and BioNTech vaccine appears effective against mutation in new coronavirus variants: study

The United States has an agreement to buy 100 million doses of J&J’s vaccine for $1 billion, and the option of purchasing an additional 200 million doses.

The company has said it has doses ready for delivery upon emergency approval. It aims to deliver 1 billion doses in 2021with production in the United States, Europe, South Africa and India.

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