Nursing homes and long-term care pharmacies eager to give booster shots to residents and workers moved a step closer in the administrative process after the federal government secured a key regulatory approval Friday.
That’s when Pfizer’s COVID-19 booster shot was unanimously approved by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee. The narrow recommendation supports giving Pfizer’s shot only to seniors 65 and older, healthcare workers and people with immuno-compromised systems received unanimous support from an advisory panel under the Food and Drug Administration on Friday.
The decision came after the panel voted 16 to 2 against a broader recommendation to approve the booster 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, possibly very quickly. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) is also scheduled to meet this week to decide who should be allowed to receive COVID booster shots.
It’s expected ACIP will consider all three vaccines this week, according to Chad Worz, PharmD, CEO of the American Society of Consultant Pharmacists.
“The call today revealed some insight into how experts are looking at boosters. There was clearly a strong response that we just don’t have enough good data,” Worz told McKnight’s Long-Term Care News on Friday. “The rationale for moving the booster forward in those over 65 years old had more to do with the risk-benefit than actual data showing that older adults don’t mount strong immunity after exposure to COVID or after the initial vaccine series.”
Worz added that, intuitively, people who work in long-term care always felt a booster would make sense in people over 65, and especially those in long-term care settings.
“Still unknown will be the timing and potentially the dose for Moderna and potentially for Johnson & Johnson. The FDA advisory board accepted the Pfizer application for a booster at six months. Moderna’s data seems to lean toward eight months and we can’t speculate on J&J at this point,” Worz said.
He also noted that as the industry continues to prepare for booster shots in long term care, the complexity may be the most important factor in a successful roll out.
“Maintaining the vaccine series the patient started with, half doses vs whole, six months versus eight, and the ease of looking up reporting history, as well as documenting new data, will all play a role on how quickly, easily and successfully boosters can be delivered,” he said. “The co-administration with flu vaccine is also an opportunity that could make the roll out smoother and possibly even more impactful on the care of residents and staff.”
Worz added that fortunately long-term care pharmacies are all engaged and have the flexibility from CDC in working with their long-term care facilities on delivery, administration and reporting.
“These key relationships have never been more critical and it is positive that we are heading into this phase planning ahead,” he said.