FDA Docs Show Johnson & Johnson’s One-Shot Covid-19 Vaccine To Be Safe And Effective At Preventing Severe Disease

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Topline

Documents released by the FDA today show that Johnson & Johnson’s Covid-19 vaccine is effective at preventing severe Covid-19 and hospitalizations relating to Covid-19.

Key Facts

The documents state that the vaccine is overall about 66% effective at preventing Covid-19, with protection starting as early as two weeks after the shot.

The vaccine also seems to be effective against new strains of Covid-19; it is 73% effective at preventing severe Covid-19 caused by the 501Y.V2 variant in South Africa.

The vaccine is also highly effective at preventing Covid-19-related hospitalizations and deaths — no one who received the Johnson & Johnson vaccine was hospitalized or died after 28 days.

The documents were released ahead of Friday’s meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).

The VRBPAC will review the Johnson & Johnson vaccine and make a recommendation to the FDA about whether the vaccine should be granted Emergency Use Authorization. 

Key Background

The Johnson & Johnson vaccine could be the third vaccine granted Emergency Use Authorization by the FDA, following vaccines made by Moderna and Pfizer/BioNTech. But the J&J vaccine is different from the already authorized mRNA vaccines in several ways. It works by using a genetically modified virus, called an adenovirus, to deliver DNA into cells. Once it is inside, the DNA instructs the cell to create replicas of the SARS-CoV-2 spike protein. These spike proteins teach the immune system to be on the lookout for Covid-19, which has the same spike proteins on its surface. 

The Johnson & Johnson vaccine is hardier than the mRNA vaccines created by Moderna and Pfizer. It can be stored at normal refrigeration temperatures, instead of the ultra-cold freezers that the other vaccines need. It also requires just one shot, instead of two. 

Big Number

20 million. That’s how many vaccine doses J&J will have out the door by the end of March, according to testimony by Richard Nettles, the company’s vice president of U.S. Medical Affairs, gave to Congress on Tuesday. The company expects to have over 100 million doses distributed by the end of June.

Crucial Quote

“A century ago, Johnson & Johnson played a leading role in combatting the 1918 flu pandemic, and our history of confronting global healthcare challenges continues to the present day,” Nettles said in his written testimony.

Further Reading

Johnson & Johnson Files For Covid Vaccine Emergency Use Authorization (Forbes)

Johnson & Johnson CEO: Our Covid-19 Vaccine Will Keep You From Getting ‘Very, Very Sick’ (Forbes)

How the Johnson & Johnson Vaccine Works (New York Times)

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