Nursing homes and long-term care pharmacies keen to give booster shots to residents and workers took one more step in the administrative process after the federal government obtained key regulatory approval on Friday.
It was at this point that Pfizer’s COVID-19 recall was unanimously approved by the Food and Drug Administration’s Advisory Committee on Vaccines and Related Biologics. Narrow recommendation supports giving Pfizer’s vaccine only to people 65 years of age and older, healthcare workers and people with compromised immunity received unanimous support from a Food and Drug Administration advisory group on Friday .
The decision came after the panel voted 16-2 against a broader recommendation to approve the recall for people 16 and older.
The FDA, which does not have to follow the panel’s recommendation, is expected to make a decision on the matter this week, perhaps very quickly. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is also due to meet this week to decide who should be allowed to receive COVID booster shots.
ACIP is expected to review all three vaccines this week, according to Chad Worz, PharmD, CEO of the American Society of Consultant Pharmacists.
âToday’s call revealed a glimpse of how experts think about boosters. There was clearly a strong response that we just don’t have enough good data, âWorz said. McKnight Long Term Care News Friday. “The rationale for advancing the booster in people over 65 had more to do with risk-benefit than actual data showing older people do not develop strong immunity after exposure to COVID or after the series. initial vaccine ”
Worz added that, intuitively, people who work in long-term care have always felt that a recall would make sense in people over 65, and especially those in long-term care facilities.
âThe timing and potentially the dose for Moderna and potentially for Johnson & Johnson will still be unknown. The FDA advisory board accepted Pfizer’s request for a six-month recall. Moderna’s data appears to be leaning towards eight months and we can’t speculate on J&J at this point, âWorz said.
He also noted that as the industry continues to prepare for booster injections in long-term care, complexity may be the most important factor for a successful deployment.
âMaintaining the series of vaccines the patient started with, half doses versus full, six months versus eight, and the ease of retrieving report history, as well as documenting new data, will play a role. all play a role in the speed, ease and success of recalls. be delivered, âhe said. âCo-administration with the flu vaccine is also an opportunity that could make the deployment more fluid and perhaps even more impacting on the care of residents and staff. ”
Worz added that luckily the long-term care pharmacies are all engaged and have the flexibility of the CDC to work with their long-term care facilities on delivery, administration and reporting.
“These key relationships have never been so critical and it is positive that we are entering this planning phase ahead,” he said.