As UF Health vows to follow federal regulatory approval, COVID-19 booster shots might soon be mass distributed.
The U.S. Food and Drug Administration will consider follow-up vaccines in a meeting Sept. 17. For now, while full approval is not established, only those who are immunocompromised have access to the boosters at UF Health.
Neither the Centers for Disease Control and Prevention or the FDA have assured approval, but the target date for third Pfizer doses is set for the week of Sept. 20. UF Health will offer the third Pfizer shot as early as the boosters are approved.
Less testing data has been available since Saturday. UF Health had about a 90% decrease in overall reported tests from Sept. 11-13 compared to Sept. 8-10. There are days with little testing data because there was no testing available or few people scheduled an appointment to get tested those days, UF Health spokesperson Ken Garcia wrote in an email.
As of Monday, 85% of UF Health patients were unvaccinated.
With recent stability in COVID-19 hospitalizations, Shands doesn’t have to create more beds or reassign staff, Jimenez said, leaving staff feeling hopeful.
“It gives us a glimpse into maybe we’re going to get over the hump,” Jimenez said. “Anytime you have that stability, that’s a helpful thing.”
Despite a packed stadium at the Gators’ first game, recent numbers don’t show any impact in case load. Jimenez said the outdoor setting, vaccinations among attendees and mask wearing could have prevented an outbreak.
If approved by Sept. 20, boosters will be available eight months after receiving the second dose of the Pfizer vaccine.
Moderna doses may not get approved until later, said Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, as they may not get regulatory approval in time.
UF Health has already been offering a third shot of Pfizer or Moderna to immunocompromised patients, UF Health Shands CEO Ed Jimenez, said at a press conference. Boosters were made available at UF Health pharmacies and local pharmacies Aug. 13 for those who qualify, he said.
Vaccines still continue to be extremely important in combating COVID-19, according to experts. While vaccinated people have strong immunity at first, they become more vulnerable to the Delta variant over time.
However, there’s currently no evidence that boosters would be safe or protect against severe or mild infection, Longini, a UF professor of biostatistics and member of the Emerging Pathogens Institute, said. He and his co-authors have analyzed observational studies comparing people who got boosters to those who didn’t, Longini said, but they argue the results may be too selective and possibly inaccurate.
“People who get boosters might have different risks than people who don’t get boosters,” Longini said. “You don’t get clean, clear answers from observational studies.”
Careful scrutiny of the evolving data will be needed to ensure decisions on boosting are informed by reliable science rather than politics, according to the preprint.
“Rolling out booster doses on a large scale, and we don’t know even if they’re safe and effective, is the opposite direction we want to be going, both in the U.S. and globally,” he said.
Longini said this is because people don’t know boosters’ safety or efficacy, the degree to which they prevent disease and transmission. There could be risks if boosters are widely distributed too soon or frequently, such as myocarditis, inflammation of the heart.
If unnecessary boosting causes adverse reactions, it could harm vaccine acceptance, so widespread boosting should be allowed only if there’s clear evidence it’s needed, he said
Vaccines should be directed to lower-income countries with low vaccination rates, he said, as there’s a severe shortage of vaccines in most of the world. Even if boosting were shown to lower the risk of serious disease, the preprint notes “current vaccine supplies could save more lives if used in previously unvaccinated populations than if used as boosters in vaccinated populations.”
“If we didn’t give boosters, that would be tens of millions of extra doses that could be donated elsewhere,” Longini said.
COVAX is an organization that’s working to give low-to-middle income countries equitable access to vaccines, along with COVID-19 tests and therapies.
More variants besides Delta are rising, such as the mu variant, which has mutations that have the potential to evade immunity provided by a previous COVID-19 infection or vaccination, Longini said. As long as most of the world’s population is unvaccinated, more variants will emerge, each one possibly more dangerous than previous ones, he said.
Fauci contradicted Longini, saying three shots of Pfizer led to a 68% reduction in risk of infection seven to 13 days after the booster compared to just two doses. A 70% to 84% reduction in infection risk was found 14 to 20 days after a third dose.
However, Longini and the other authors noted flaws with Israel’s data. The study followed up with patients after only one week, they wrote, and “a very short-term protective effect would not necessarily imply worthwhile long-term benefit.” Patients should instead be followed up on after at least several months, Longini said.
“If you weigh the totality of evidence, I would argue he’s incorrect,” Longini said. “There is currently not compelling data showing that boosters increase efficacy against the outcome of interest, which is preventing severe disease.”
However, Longini noted vaccines give people less protection from mild infection over time.
On Sept. 8, the World Health Organization called for a hold on the use of boosters until at least the end of 2021 to enhance vaccine access in poorer countries.
Several countries have ignored the WHO moratorium so far, including the U.S. WHO Director-General Tedros Adhanom Ghebreyesus acknowledged boosters might be necessary for immunocompromised people. However, WHO experts said there isn’t strong evidence supporting boosters for healthy people yet, and a third shot hasn’t acquired regulatory approval.
Contact J.P. Oprison at firstname.lastname@example.org. Follow him on Twitter @JOprison.
JP is a fourth-year journalism major with a minor in history. He is currently the health reporter for The Alligator, focusing on how the pandemic is affecting Alachua County and the thousands of students in Gainesville. In his free time, JP likes to exercise at the gym and relax on the beach.