Covid FDA Recommends Authorization of Janssen Single Dose Vaccine: The vaccine advisory committee of the United States Food and Drug Administration (FDA) approved this Friday to recommend the emergency authorization of the single-dose vaccine against Covid-19 from Johnson & Johnson. The US Vaccine Related Biological Products Advisory Committee began evaluation of the vaccine following the laboratory request, a request that has also been made to Europe.
The FDA advisory group of experts had already given a positive assessment to the approval of Janssen’s vaccine against Covid-19. As has already happened with the Covid-19 vaccine from Pfizer and Moderna, the FDA Vaccine Committee heard the positive assessment of its group of experts, which is why this same situation is repeated now.
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In the document, published two days ago by FDA experts, it is ensured that the Johnson & Johnson vaccine is safe and effective against the coronavirus. “The analysis has supported a favourable safety profile without specific problems that prevent the issuance of an Emergency Authorization,” the group of experts said.
Covid Janssen vaccine: 85.4% efficacy
Regarding the efficacy of this new vaccine, FDA experts recognize that it offers protection against the coronavirus of 66.9 percent, after 14 days after vaccination, and 66.1 percent after 28 days. In addition, analysis of secondary endpoints showed an efficiency of 76.7 percent after 14 days, and 85.4 percent after 28 days.
This document also refers to the fact that in the group over 60 years of age or in those with previous pathologies, a “lower efficiency” was observed compared to the general population group. Even so, they detail that there were no “deaths related to Covid-19 and no cases of Covid-19 requiring medical intervention 28 days after vaccination among participants aged 60 and over with medical comorbidities.”
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