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Scientists say Biden jumped the gun with COVID booster plan

The Biden administration’s plan to make COVID-19 booster shots available next month has drawn a collective scream of protest from some members of the scientific community.

As they see it, the announcement is rash and based on weak evidence, and they worry it could undercut confidence in vaccines while offering no clear benefit of controlling the pandemic.

Plus, more information is needed on potential side effects or adverse effects from a booster shot, they say.

Perhaps even worse, the announcement has fueled deeper confusion about what Americans need to do to protect themselves against COVID-19.

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“I think we’ve scared people,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an advisor to the National Institutes of Health and the Food and Drug Administration.

“We sent a terrible message,” he said. “We just sent a message out there that people who consider themselves fully vaccinated were not fully vaccinated. And that’s the wrong message, because you are protected against serious illness.”

As of Friday, 51.1% of the U.S. population was fully vaccinated, according to data from the Centers for Disease Control and Prevention shows.

Biden administration officials ― citing data from Israel, a study from the Mayo Clinic that is not yet peer-reviewed and new CDC studies ― say it’s necessary to plan for boosters to prevent a worsening of the pandemic as the Delta variant powers a surge in cases and overwhelms hospital intensive care units.

In essence, officials are caught between a rock and a hard place ― trying to be prepared while simultaneously not undermining messaging about how well the existing vaccines work.

Officials must weigh two unknowns: the risks of moving ahead aggressively with booster shots versus the risks of waiting to learn much more about the virus and the lasting power of the vaccines.

The government’s normal path to regulatory approval is, by design, slow and deliberate. The virus has its own schedule, fast and unpredictable.

“Arguably, I think that the federal government is simply trying to stay ahead of the curve,” said Dr. Joshua Barocas, associate professor of medicine at the University of Colorado. But, he said, “I have not seen robust data yet to suggest that it is better to boost Americans who have gotten two vaccines than invest resources and time in getting unvaccinated people across the world vaccinated.”

Beginning in late September, boosters would be made available to adults eight months after they received the second dose of a Pfizer-BioNTech or Moderna COVID-19 vaccine, Biden said. But his plan comes with big caveats: It does not yet have the blessing of a CDC advisory panel, and the FDA has not authorized boosters for all adults.

The urgent question is whether the vaccines are losing their power against COVID-19.

“We are concerned that this pattern of decline we are seeing will continue in the months ahead, which could lead to reduced protection against severe disease, hospitalization and death,” Surgeon General Vivek Murthy said.

But many scientists and public health experts say the data doesn’t demonstrate a clear benefit to the public in making booster shots widely available, and the administration’s message confuses people about what the COVID-19 vaccines were designed to do.

“They’re not a force field. They don’t repel the virus from your body. They train your immune system to respond when you become infected … with the goal of keeping you out of the hospital,” said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health.

Meanwhile, questions abound. Will boosters for fully vaccinated adults make the virus less transmissible ― that is, slower or less likely to spread?

“I certainly hope that’s the case … but the bottom line, with full transparency, we don’t know that right now,” said Dr. Anthony Fauci, Biden’s chief medical advisor.

What about side effects?

“We don’t have any reason to believe, based on the safety profile of the vaccine itself, that we’re going to see significant adverse events with booster shots,” Barocas said. However, those things are “just now being studied.”

The concerns are real. While serious side effects from COVID-19 vaccines have been rare, some have caused alarm ― including vaccines being linked to cases of myocarditis, or inflammation of the heart.

“At the individual level, we need to know the side effect profile of a 3rd dose, especially in younger people,” Dr. Jeremy Faust, an emergency medicine physician at Brigham and Women’s Hospital in Boston, wrote in a blog post outlining why he was skeptical about a plan to give boosters to everyone.

Even in light of the new CDC studies, experts say one thing is clear: The vaccines still work very well at what they were meant to do, which is to protect people against the worst outcomes of getting infected with the virus.

One study, relying on data from 21 hospitals in 18 states, found no significant change in the vaccines’ effectiveness against hospitalization between March and July, the period of time during which Delta became the country’s most prevalent coronavirus strain.

Another, using data from New York, also found the vaccines highly effective in preventing hospitalization, even as there was a decline in effectiveness against new infections.

The third, evaluating the Pfizer and Moderna vaccines in nursing home residents, saw a drop in how effective they were at preventing infection. But that research didn’t distinguish between symptomatic and asymptomatic cases.

“It’s like we’re engaged in friendly fire against these vaccines,” Nuzzo said. “What are we trying to do here? Are we just trying to reduce overall transmission? Because there’s no evidence that this is going to do it.”

Fauci highlighted data showing that antibody levels decline over time and that higher levels of antibodies are associated with higher vaccine efficacy. But antibodies are only one component of the body’s defense mechanisms against infection.

When the antibodies decrease, the body compensates with a cellular immune response. “A person who has lost antibodies isn’t necessarily completely susceptible to infection, because that person has T-cell immunity that we can’t measure easily,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel.

John Wherry, director of the Penn Institute of Immunology at the University of Pennsylvania, recently published a study finding that the two-dose vaccines provoked a strong response by the immune system’s T cells, which researchers said could be a more durable source of protection. Wherry is working on a second study based on six months of data.

“We’re seeing very good durability for at least some components of the non-antibody responses generated by the vaccines,” he said.

For protection against serious disease, “really all you need is immunological memory, and these vaccines induce immunological memory and immunological memory tends to be longer-lived,” Offit said. Federal scientists also are studying T-cell response, Fauci said.

Pfizer and Moderna have said they think COVID-19 boosters will be necessary. But it’s up to the government to authorize them. Federal officials say they are sifting through new data from the companies and elsewhere as they become available.

Pfizer this week announced it has submitted phase 1 clinical trial data to the FDA as part of an evaluation for future approval of a third dose. The company said phase 3 results are “expected shortly.”

Pfizer said its preliminary trial results showed a third dose was safe and increased antibody levels against the original virus as well as the Delta variant. Moderna found a third dose had safety results similar to a second dose and produced a strong antibody response.

Typically, any distribution of shots would occur after the CDC’s Advisory Committee on Immunization Practices developed recommendations. But with the Biden administration’s announcement about boosters, public health experts worry the message suggests the outcome is preordained.

“They’ve left them no choice,” said Dr. Nicole Lurie, a former senior Health and Human Services official in the Obama administration and U.S. director of the Coalition for Epidemic Preparedness Innovations, the global epidemic vaccines partnership. “If there’s no booster program, FDA gets blamed, and that’s not appropriate.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation).

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