FDA Experts Endorse Covid Vaccine By Johnson & Johnson; Panel Meets Friday
The single-dose shot doesn't require special refrigeration. Although its level of protection against getting infected with covid is not as high as the Pfizer or Moderna vaccines, health experts stress that the J&J shot helps where it matters most: by preventing hospitalization and death.
NPR:
FDA Analysis of Johnson & Johnson COVID-19 Vaccine Finds It Safe, Effective
The Food and Drug Administration released an analysis of Johnson & Johnson's COVID-19 vaccine Wednesday morning that supports its authorization for emergency use. On Friday, a panel of advisers to the agency will meet to evaluate the vaccine and make a recommendation about whether it should be given the OK. If the agency goes on to authorize the Johnson & Johnson vaccine, it would be the third, after those made by Pfizer-BioNTech and Moderna, to be become available in the U.S. (Hensley, 2/24)
CNBC:
FDA Staff Endorses J&J’s Single-Shot For Emergency Use
The FDA staff said it determined that the clinical trial results and safety data were “consistent with the recommendations set forth in FDA’s guidance Emergency Use Authorization for Vaccines to Prevent COVID-19.” J&J submitted its Covid vaccine data to the FDA on Feb. 4. The vaccine’s level of protection varied by region, J&J said, with the shot demonstrating 66% effectiveness overall, 72% in the United States, 66% in Latin America and 57% in South Africa, where the B.1.351 variant is rapidly spreading. The company said the vaccine prevented 100% of hospitalizations and deaths. (Lovelace Jr., 2/24)
USA Today:
FDA Finds One-Dose J&J COVID Vaccine Meets Criteria As Safe, Effective
A Food and Drug Administration advisory committee is holding an all-day meeting Friday to review the data and is likely to give the vaccine a thumbs up, likely leading to an FDA authorization for the vaccine within the next few days. The J&J vaccine differs from the two already authorized, because only one shot is recommended, instead of two. (Weintraub, 2/24)
Also —
NPR:
Why The Johnson & Johnson Vaccine Has Gotten A Bad Rap — And Why That's Not Fair
In clinical trials, the Johnson & Johnson vaccine appears to be 66% effective at preventing moderate to severe cases of COVID-19 — compared to about 95% for Moderna and Pfizer. That has some people wondering if they should avoid the Johnson & Johnson vaccine. Absolutely not, says Dr. Ashish Jha, dean of the Brown University School of Public Health. "What I've been saying to my family is, as soon as the J&J vaccine is authorized, if that's what you can get, you should get it as soon as it's your turn in line," says Jha. (Shapiro, 2/22)
