Johnson & Johnson's one-shot vaccine safe and effective in trials according to FDA

The J&J vaccine is pending emergency use authorization which could come as early as this week.

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Ari Hoffman Seattle WA
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The US Food and Drug Administration (FDA) announced Wednesday that Johnson & Johnson's (J&J) one-dose COVID-19 vaccine has been safe and effective in trials. The vaccine is pending emergency use authorization which could come as early as this week.

The vaccine can also be stored in normal fridges, in contrast to the Pfizer and Moderna vaccines which must be kept in freezers and require two doses.

According to FDA documents released, in advance of a Friday meeting of independent experts who will advise the agency on emergency authorization, the vaccine was 100 percent effective at stopping hospitalization 28 days after vaccination and there were no COVID-19 deaths among those who received the shot.

The vaccine was demonstrated to be 66 percent effective in preventing moderate to severe COVID-19 in a 44,000 person global trial.

The documents also indicated that the vaccine was 64 percent effective at stopping moderate to severe cases of COVID-19 after 28 days of trials in South Africa even with a new variant of the virus being discovered there.

J&J also said their vaccine cut down on asymptomatic infections, adding to growing evidence that COVID-19 vaccines may indeed stop transmission of the disease.

Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia and a member of the FDA committee that will make its recommendation on Friday, told Reuters that "you could still get protection against medically attended illnesses - meaning hospitalization, ICU admission and deaths from that vaccine against the South African strain, I thought that was really encouraging."

J&J said they expected to have 4 million doses ready to ship pending FDA approval and would ship 20 million doses by the end of March. J&J has promised the US 100 million doses by the end of June.

The J&J vaccine is already being supplied to 500,000 healthcare workers in South Africa.

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