PITTSBURGH (TNS) — There isn’t enough data yet to suggest that the general public — those who are healthy — need a COVID-19 booster shot, local public health and vaccine experts said Monday as the debate continued between the federal government and its public health agencies over the efficacy of a third jab.
Much will depend on what happens Friday, though, as advisers to the Food and Drug Administration meet to consider whether they will authorize an extra shot for everyone 16 and older, like they did for immunocompromised people in mid-August. The White House has started to plan for boosters if both the FDA and the Centers for Disease Control and Prevention give their approval.
So far, there hasn’t been enough evidence to show that a third shot would be effective or safe, said Dr. Walid Gellad, director of the University of Pittsburgh Center for Pharmaceutical Policy and Prescribing. But he said he’ll be watching Friday to see what data Pfizer and the FDA reveal.
”The vaccine itself has overall been very safe, but when you have not seen anything about a third dose, that’s something you need to understand before you recommend a therapy,” Dr. Gellad said.
This comes as an international group of scientists — including two leading vaccine reviewers at the FDA who are stepping down this fall — wrote on Monday that they don’t believe the average person needs a COVID-19 booster yet.
Having reviewed the studies of the vaccines’ performance, the experts — writing in The Lancet — concluded the vaccines are working well despite the spread of the extra-contagious delta variant, and continue to work against severe disease.
”Even in populations with fairly high vaccination rates, the unvaccinated are still the major drivers of transmission” at this stage of the pandemic, said the scientists, who include leading vaccine researchers in the U.S., Britain, France, South Africa and India.
The debate in the U.S. — which already offers a third dose of the Pfizer or Moderna vaccines to those with severely weakened immune systems — centers around whether boosters should be administered even though the original vaccines are successful in protecting against severe disease. Some scientists hope, with a booster, of preventing milder “breakthrough” infections among the fully vaccinated.
The unvaccinated were 4.5 times more likely to get infected than the fully vaccinated, over 10 times more likely to be hospitalized and 11 times more likely to die as the delta variant surged, CDC Director Dr. Rochelle Walensky said last week. But scientists are also considering hints that protection is waning among older adults who were vaccinated in late 2020.
Dr. Matt Moffa, an infectious disease specialist with the Allegheny Health Network, said the vaccines were great — in original trials — at protecting against symptomatic infection and against severe illness, hospitalization and death. Since then, scientists have seen a dip in protection against symptomatic infection, he said.
Some immunologists say they believe that giving a third dose 5 to 8 months after a person’s last shot actually may lead to longer-lasting protection, Dr. Moffa added. But that can’t be proven without more data down the road, he said.
If the FDA does authorize the booster, it likely won’t be to every single person, Dr. Moffa said — but rolled out with an age cutoff, or to those in long-term care facilities, or to health care workers to reduce worker shortages at hospitals, among other designations.
Boosters for everyone is a premature conversation without more data, Dr. Gellad said. He said to measure its efficacy, scientists would have to undertake a randomized trial where some participants get the booster and some don’t. The participants would then be observed over time in an attempt to get data about infections, hospitalizations and deaths, he said.
Other countries have shared data about the booster that suggests they are beneficial. The writers of Monday’s report in The Lancet reviewed worldwide studies and said “none of these studies has provided credible evidence of substantially declining protection against severe disease.”
Gradual drops in antibody levels, they wrote, don’t necessarily mean overall effectiveness is dropping, and “reductions in vaccine efficacy against mild disease do not necessarily predict reductions in the (typically higher) efficacy against severe disease.”
{p class=”krtText”}At Friday’s meeting, the FDA and vaccine companies likely will present evidence on the efficacy of boosters, Dr. Gellad said. The advisers won’t really consider the ethical debates — like whether the fully vaccinated should get a third dose when so many across the world are unvaccinated, he added. The FDA will consider the risks and benefits of the booster to the public.
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