FDA backs Johnson & Johnson COVID-19 vaccine as safe and effective
FDA backs Johnson & Johnson COVID-19 vaccine as safe and effective
By Noah Manskar
February 24, 2021 8:45am Updated
https://nypost.com/wp-content/upload...trip=all&w=744A pharmacy technician prepares a dose of the Johnson & Johnson COVID-19 vaccine for a clinical trial.Michael Ciaglo/Getty Images
The Food and Drug Administration backed Johnson & Johnson’s single-dose coronavirus vaccine as safe and effective on Wednesday as the agency weighs whether to clear the shot for emergency use.
FDA staff affirmed J&J’s finding that the vaccine was 66 percent effective overall at warding off moderate and severe COVID-19 cases and 85 percent effective at preventing the most serious infections.
While not as strong as Pfizer and Moderna’s two-dose vaccines, that efficacy rate could still make J&J’s shot a helpful weapon in the battle against the pandemic. It’s also expected to be easier to distribute because it only requires a single dose and can be stored in standard freezers without ultra-cold temperatures.
New Jersey-based J&J’s clinical trial of nearly 44,000 people also produced no significant safety concerns that would prevent the FDA from granting an emergency use authorization for the vaccine, agency officials said. The side effects were “predominately mild” and included muscle pain, headache, fatigue and pain at the injection site, staffers said.
The FDA released its analysis of the shot before a Friday meeting of its Vaccines and Related Biological Products Advisory Committee, a panel of experts that will recommend whether to clear the J&J vaccine for emergency use.
The FDA granted emergency approvals for the Moderna and Pfizer vaccines in December following positive recommendations from the advisory panel.
The 62-page report offered a detailed look at the J&J vaccine as health officials and drugmakers around the world grapple with highly contagious COVID-19 variants.
Like the findings J&J released last month, the FDA’s analysis pointed to some caveats about the vaccine’s efficacy. For one, it varies by region — the shot was 72 percent effective against moderate to severe COVID-19 in the US, but that rate dropped to 64 percent and 68.1 percent, respectively, in South Africa and Brazil, where new strains of the virus have been identified.
While the shot generally worked similarly well regardless of age, race, ethnicity or health history, it appeared to be less effective in people older than 60 who had underlying health issues, according to the FDA.
But the vaccine appears to be a bulwark against COVID-19 hospitalizations and deaths. FDA officials noted that none of the seven people in J&J’s clinical trial who died from the virus had received the shot, and the company said it was 100 percent effective at preventing hospitalizations four weeks after vaccination.
If the FDA clears it for emergency use, J&J’s vaccine would be the third shot rolled out across the country. The pharmaceutical giant has pledged to supply 100 million doses by late June and expects to deliver 20 million doses by the end of March.
FDA backs Johnson & Johnson COVID vaccine as safe, effective (nypost.com)
