February 24, 2021
2 min read
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The FDA reviewed the data on Johnson & Johnson’s one-time COVID-19 vaccine and found no issues that would prevent approval for the emergency. This comes from an information document intended for the panel of experts that will review the vaccine this week.
The Advisory Committee on Vaccines and Related Biological Products (VRBPAC) will meet on Friday to make a recommendation on whether the shot should be the third COVID-19 vaccine to receive an EEA Approval in the US.
An FDA review found no issues that would prevent Johnson & Johnson from obtaining an emergency clearance for the COVID-19 vaccine.
Photo credit: Adobe Stock
In the new information document, the FDA said the clinical trial data submitted “supported a favorable safety profile with no specific safety concerns that would preclude the issuance of an EEA” and that the safety and efficacy data “are consistent with the recommendations presented in the FDA guidance [on] Emergency approval for vaccines to prevent COVID-19. “
“As a result, the FDA has determined that the sponsor provided adequate information to ensure the quality and consistency of the vaccine for approval of the product under an EEA,” the agency wrote.
An EEA requires that the known and potential benefits of a product outweigh the known and potential risks. In December, the VRBPAC recommended that the emergency vaccines manufactured by Pfizer-BioNTech and Moderna be approved, followed in both cases by the FDA-issuing FDA.
Both vaccines are given in two shots 21 or 28 days apart. The Johnson & Johnson vaccine has been heralded as a potential game changer for the US response because it is administered in a single shot and can be stored for months at normal refrigeration temperatures rather than in extremely cold stores.
Johnson & Johnson previously announced Phase 3 data showing that the vaccine was 85% effective at least 28 days after vaccination and was 66% effective overall at preventing moderate to severe or critical illness. Efficacy was reported to be 72% in the US, 66% in Latin America and 57% in South Africa, with 95% of the COVID-19 cases occurring during the trial being from the B.1.351 variant of SARS-CoV-2 .
However, according to Phase 3 data, the vaccine was 100% effective in all regions to prevent hospitalization from COVID-19 at least 28 days after vaccination. Two COVID-19 hospital stays occurred in vaccine recipients who started at least 14 days after vaccination, but both occurred in participants with comorbid conditions who were 60 years of age or older, according to the FDA.
“The data is very strong. The J&J vaccine offers robust efficacy across all populations and variants. and shows increasing protection in line with over time [the] I think it triggers a strong T cell response, ”said the former FDA commissioner Scott Gottlieb, MD, tweeted.
A Johnson & Johnson executive said this week that the company is on track to ship 100 million cans in the U.S. by the end of June and there were indications that the cans may be ready sooner.
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