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FDA advisers to consider EUA recommendation for single-dose Johnson & Johnson Covid-19 vaccine this week

February 23, 2021. Summarized by summa-bot.

Compression ratio: 23.6%. 2 min read.

Vaccine advisers to the US Food and Drug Administration will meet Friday to discuss whether to recommend Johnson & Johnson's Covid-19 vaccine for emergency use authorization.

On Tuesday, Johnson & Johnson's Dr. Richard Nettles will say that the plan "is to begin shipping immediately upon emergency use authorization, and deliver enough single-doses by the end of March to enable the vaccination of more than 20 million Americans," according to prepared remarks to be delivered before a House Committee on Energy & Commerce subcommittee. Still, clinical trial investigators are confident that the Johnson & Johnson vaccine will be authorized quickly, as happened with the Pfizer/BioNTech and Moderna Covid-19 vaccines.

Carson said he's eager to see more data about the vaccine; details about what was submitted to the FDA should be available online no later than Wednesday, according to the agency.

While the Pfizer vaccine showed an efficacy of 95% at preventing a symptomatic Covid infection after a person got two doses and the Moderna vaccine was 94. 1% effective, scientist said it's not fair to compare vaccines, since they weren't tested against one another.

Dr. Aditya Guar, one of the investigators with the St. Jude arm of the trial, said people need to understand that the J&J vaccine does its job very well.

"It is effective with one dose of the vaccine and it works. "

Carson said patients and friends have been asking him if they should take the J&J vaccine when it is available.

That's what matters the most, to get protected," Carson said. All the vaccine makers are looking into whether a booster dose could provide better protection against coronavirus variants.

J&J also has an ongoing late stage trial testing a two-dose vaccination program; the company is expected to have those results in the second half of 2021.

"The Company's EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints," a J&J spokesperson said in an email to CNN.

"If you think about it on a population basis, the J&J vaccine can offer more protection," said Dr. Philip Grant, a lead investigator for the J&J trial at Stanford University Medical Center.

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