Need For Moderna Booster Not Clear-Cut To FDA Scientists
Ahead of meetings Thursday and Friday of the Food and Drug Administration's vaccine advisory panel, documents were released by agency scientists reviewing the case for the half-dose booster shot suggested by Moderna.
AP:
Next On FDA's Agenda: Booster Shots Of Moderna, J&J Vaccines
On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first stage in the process of deciding whether extra doses of the two vaccines should be dispensed and, if so, who should get them and when. The final go-ahead is not expected for at least another week. After the FDA advisers give their recommendation, the agency itself will make a decision on whether to authorize boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get them. Its decision is subject to approval by the CDC director. (Neergaard and Perrone, 10/12 )
Stat:
FDA Scientists Neutral On Moderna Covid-19 Vaccine Booster
Food and Drug Administration scientists did not take a clear position as to whether the agency should authorize booster doses of the Moderna Covid-19 vaccine in documents released Tuesday. Posted ahead of a two-day meeting convened by the FDA on booster shots of both the Moderna and Johnson & Johnson vaccines, the documents laid out the case for authorizing Moderna’s proposed booster — a half dose of the existing vaccine — but also noted that data so far make it unclear that the third dose is needed. (Herper, 10/12)
Reuters:
U.S. FDA Staff Says Moderna Did Not Meet All Criteria For COVID-19 Boosters
Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc. had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high. (Erman and Steenhuysen, 10/13)
CNN:
Moderna Urges FDA To Authorize A Half-Size Booster Dose Of Its Covid-19 Vaccine For Some Adults
Moderna is urging the US Food and Drug Administration to authorize a half-size booster of its Covid-19 vaccine, according to a briefing document posted Tuesday, ahead of a key meeting of the agency's vaccine advisers. The company is asking for authorization for a 50-microgram booster dose -- half the size of the 100-microgram doses used in the primary series of the two-dose vaccine. The company says halving the dose increases protection against the coronavirus while helping the worldwide Covid-19 vaccine supply. (Gumbrecht, 10/12)
In news about the Johnson & Johnson shot —
Axios:
Mix-And-Match Boosting For Johnson & Johnson COVID Vaccine — NIH Data
Data collected by the National Institutes of Health show that people who received a shot of Johnson & Johnson's coronavirus vaccine have a stronger neutralizing antibody response if they receive an mRNA shot instead of a second J&J one, according to a person who has seen the data. J&J has asked the FDA to authorize a second shot of its own vaccine, which could make any attempt to authorize mix-and-matching vaccines confusing for the public. (Owens, 10/12)
In other news on the vaccine rollout —
Axios:
Low Vaccination Rates Exacerbate America's Caregiving Crisis
American families shouldered an enormous burden caring for family members even before the pandemic, and a shortage of professional caregivers now is only likely to make that burden heavier. Nursing homes and other long-term care settings have seen a staff exodus both during and after the pandemic, especially when they've imposed vaccine mandates — poking new holes in a system that was already full of them. (Reed, 10/13)
The New York Times:
Covid Has Killed Hundreds Of Police Officers. Many Still Resist Vaccines
Over the last year and a half, a majority of the roughly 40 police officers who patrol Baker, La., a suburb of Baton Rouge, tested positive for the coronavirus. All of them recovered and went back to work — until Lt. DeMarcus Dunn got sick. Lieutenant Dunn, a 36-year-old shift supervisor who coached youth sports and once chased down someone who fled the police station after being arrested, died from Covid-19 on Aug. 13. His wedding had been scheduled for the next day. (Smith, 10/12)
AP:
NHL Commissioner Bettman Says Just 4 Players Unvaccinated
NHL commissioner Gary Bettman said the league has only four unvaccinated players as it opens up the 2021-22 season. Bettman was in attendance for the regular-season opener between the back to back Stanley Cup champion Tampa Bay Lightning and the Pittsburgh Penguins on Tuesday night. “Everybody banding together to do the right thing,” Bettman said. “Maybe that’s why hockey is the ultimate team sport.” (10/13)
