J&J Seeks FDA Emergency Authorization For World’s First Single-dose Covid-19 Vaccine

Johnson & Johnson (JNJ) has filed for emergency use authorization of its single-dose Covid-19 vaccine. It could be the world’s first single-dose Covid-19 vaccine.

Moderna and Pfizer vaccines, which are now being distributed in the US, are administered as two doses, and the Pfizer vaccine requires ultra-cold storage.

Johnson & Johnson’s application to the US Food and Drug Administration follows its January report in which it said the vaccine candidate was 66% effective overall in preventing moderate to severe Covid-19, 28 days after vaccination.

As per phase 3 ENSEMBLE clinical trial results, the vaccine candidate was 85 percent effective in preventing severe disease across all regions studied, 28 days after vaccination in all adults 18 years and older. The vaccine candidate showed complete protection against Covid-related hospitalization and death, 28 days post-vaccination.

If authorized, the company’s investigational single-dose vaccine is estimated to remain stable for two years at minus 20 degree celsius, at least three months of which can be stored in most standard refrigerators at temperatures of 2 degree Celsius to 8 degree Celsius.

The company plans to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021.

The company noted that it has initiated rolling submissions with several health agencies outside the U.S., and will submit a Conditional Marketing Authorisation Application with the European Medicines Agency in the coming weeks.

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