Equipo Nizkor - CDC panel authorizes COVID-19 vaccine boosters for high-risk people, those over 65.

A Centers for Disease Control and Prevention (CDC) advisory panel on Thursday recommended booster doses of the Pfizer-BioNTech coronavirus vaccine for people at least 65 years old, paving the way for boosters in a large swatch of the American population.

The CDC Advisory Committee on Immunization Practices (ACIP) voted 15-0 to recommend a booster dose for Americans age 65 and older and people in long term care facilities.

ACIP also fully recommended giving a single booster dose to people between the ages of 50 and 64 with certain high-risk conditions, by a vote of 13-2.

The panel was much more divided on the question of whether to recommend, based on individual benefit and risk, a booster dose for people between the ages of 18 and 49 with underlying medical conditions. The recommendation narrowly passed by a vote of 9 to 6.

The panel did not define what the qualifying underlying conditions are, but the CDC is expected to make that determination.

ACIP said this specific type of recommendation is more nuanced, and allows for flexibility when the evidence of risks and benefits across different populations isn't clear — essentially, if someone in this category wants a booster, they can talk to a physician.

Though the panel ultimately endorsed boosters for a narrow population, members were torn about whether the recommendations were still too broad.

As a result, members voted 9 to 6 against recommending a booster dose for people aged 18 to 64 who are at risk of COVID-19 due to their occupation or living situation.

This means people like health workers, grocery workers or teachers would not be eligible, though the Food and Drug Administration's (FDA) emergency use authorization on Wednesday included such populations.

The FDA granted emergency use authorization for Pfizer booster shots to people over 65, those at high risk of severe complications from COVID-19 infections, and those at high risk of infection because of their jobs.

Research in the U.S. indicates that immune response does wane over time, but the current COVID-19 vaccines still afford protection against severe COVID-19 disease and death.

In addition, nobody yet knows what the minimum level of antibodies is before someone's risk of infection dramatically increases.

A CDC analysis showed the benefits of giving booster doses are much higher for people 65 and older than for younger people, but there was no significant evidence of vaccine efficacy waning over time for people with certain underlying conditions.

The recommendations are not binding, and CDC Director Rochelle Walensky can decide to modify them. ACIP can also vote again at another time.

After Walensky signs off on the recommendations, booster shots may be given immediately. According to CDC, 13.6 million people over age 65 would be eligible for a booster dose of Pfizer-BioNTech's vaccine.

CDC's advisory panel grappled with many of the same issues that complicated a separate FDA panel meeting last week, another sign that the Biden administration's plan to widely distribute boosters beginning this week has become much more complicated than health officials anticipated.

The question about occupational exposure drew the most debate, though some panel members felt the question about boosters for anyone other than people over 65 was not useful, because the largest spreaders of COVID-19 are the unvaccinated.

“I worry we're getting distracted by the question of boosters and Pfizer when we have bigger and more important things to do in the pandemic,” said Helen Keipp Talbot, an associate professor of medicine at Vanderbilt University. “And along those lines – we’re fighting a pandemic and it’s not because people got two doses of vaccine. It’s because people are unvaccinated."

In an unusual move last month, President Biden and top health officials, including Woodcock, Walensky and Surgeon General Vivek Murthy publicly announced a booster shot program for all three vaccines would begin the week of Sept. 20, well before the FDA and CDC examined the evidence.

While officials have been careful to say the booster program is contingent on the FDA and CDC giving the green light, they were criticized by some public health experts for speaking as if the approval was a given.

At the start of the meeting, Walensky expressed her support for the panel members, and told them to follow the science.

“What has been your north star, and what drives my own thinking every day, is a commitment to follow the science to improve the health of as many Americans as possible," Walensky said.

She also offered some guidance on who the panel should consider as eligible for boosters.

"Collectively, we want to do what is right for the millions of Americans over the age of 65 or in long term care facilities who are at high risk for severe complications of COVID-19. And like you, I’m also thinking about the 25-year-old man with cystic fibrosis who may walk into our clinic, nervous about his risk of one more hospitalization. And, also of the 35-year-old pregnant resident physician, working in a Tennessee ER, and with a 1-year-old at home," Walensky added. "It is in these complicated decisions where ACIP has always led, valuing safety, equity, and access for those at risk, and it’s here where I am grateful for your guidance."

23Sep21

CDC panel authorizes COVID-19 vaccine boosters for high-risk people, those over 65

[Source: By Nathaniel Weixel, The Hill, Washington, 23Sep21]

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