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US FDA panel gives go-ahead to Johnson & Johnson's COVID-19 vaccine

ANI | Updated: Feb 27, 2021 18:44 IST


Washington [US], February 27 (ANI): A US Food and Drug Administration (FDA) advisory panel on Friday endorsed Johnson & Johnson's coronavirus vaccine and recommended the agency grant emergency authorisation.
According to The Hill, this would be the country's third vaccine one step closer to getting into Americans' arms.
The panel voted 22-0 that the benefits outweigh the risks for adults age 18 and older. FDA could give the green light to the single-dose vaccine as early as Saturday.
Vaccinations will begin once a US Centers for Disease Control and Prevention (CDC) panel recommends the vaccine and the CDC accepts that recommendation. The CDC panel is scheduled to meet on Sunday.
The Johnson & Johnson vaccine is different from the other two already on the market --- Pfizer/BioNTech and Moderna --- could be a potential game changer as it is administered in a single dose and does not need to be frozen when shipped and stored.
"We need vaccines that are effective and well-tolerated. And importantly, ones that are simple to deploy," said Gregory Poland, director of the Mayo Clinic's vaccine research group, who spoke to the panel as part of Johnson & Johnson's presentation as quoted by The Hill.
The vaccine was 66 per cent effective in protecting any cases of moderate to severe illness. It was 85 per cent effective against severe cases of COVID-19 and completely prevent hospitalizations and death four weeks after inoculation.
The outlet reported that the endorsement from the regulatory body panel of experts comes as federal officials are warning about the effect of recent highly contagious variants of the coronavirus, urging people not to grow complacent. Officials say that the rise of variants make vaccination more important than ever.
CDC epidemiologist Adam MacNeil said he expects the B.1.1.7 variant, first found in the United Kingdom, has likely spread throughout the entire US and could become the dominant virus in mid-to-late March.
"We may not ever know the full situation in terms of what is going on with the virus," MacNeil said according to The Hill and added, "These variants are probably much more widespread through the country. These variants could probably exist throughout the entire United States."
MacNeil said that while the pace of vaccinations has been steadily increasing, the US is still "nowhere close" to herd immunity and emphasized the effectiveness of current strategies including masking and physical distancing.
A vaccine by Pfizer/BioNTech and another by Moderna were both authorized in December. Pfizer has only shipped about 40 million doses, while Moderna has shipped about 45 million doses.
The Hill reported that Johnson & Johnson's vaccine will only be available at a relative trickle at first. The company will only have about 4 million doses available to ship immediately upon authorization, but that number will increase to 20 million by the end of next month.
White House COVID-19 coordinator Jeff Zients said this week that the company has a deal with the U.S. government to supply 100 million doses of its vaccine by the end of June, and the federal government will do "everything we can" with the company to ramp up production.
The company asked the FDA to authorise the use of the vaccine in people aged 18 and older, but there were some concerns over the lack of data on recipients older than 75, The Hill reported.
There were also concerns over the effectiveness in people over the age of 60 with certain pre-existing conditions, like obesity and diabetes.
The Johnson & Johnson vaccine hasn't been tested yet in children and teens under the age of 18, so it was not authorized for their use. A trial to study the safety and efficacy of the company's vaccine in teens aged 17 and younger will begin late next month or early April, the outlet reported further.
The FDA said on Wednesday that Johnson and Johnson's single-dose COVID-19 vaccine has met the requirements for emergency use authorisation.
CNN, citing the company's analysis, reported that the efficacy of the Johnson and Johnson vaccine against moderate to severe/critical COVID-19 across all geographic areas was 66.9 per cent at least 14 days after the single-dose vaccination, and 66.1 per cent at least 28 days after vaccination. (ANI)

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