Second federal panel approves COVID vaccine boosters — who will get it first?

3 weeks ago 9

In an effort to bolster the nation’s waning immunity against the surging COVID-19 virus, a panel of independent experts advising the Centers for Disease Control and Prevention voted Thursday to recommend the Pfizer-BioNTech vaccine “booster” for people who are risk of disease due to age or underlying medical conditions.

Vaccine providers could begin administering this third dose as soon as the recommendation is approved by CDC director Dr. Rochelle Walensky and state public health officials, which is likely to be imminent.

Eligible people must be at least six months past their second dose of the vaccine.

The panel, called the Advisory Committee on Immunization Practices, voted against use of the booster for people in high-risk jobs, such as health care workers, first responders and frontline essential workers. Members said there was no evidence of waning immunity in this group, and worried that verification of employment would be too challenging. They will likely meet again within the next several weeks to revisit that decision and whether other groups should receive boosters.

In what is likely to cause confusion among the public and vaccine providers, the panel’s recommendation varies from the authorization issued by the U.S. Food and Drug Administration Wednesday night, which did include boosters for people working in high-risk jobs.

Of the 182 million Americans who are fully vaccinated, an estimated 27 million are at least six months past their second Pfizer dose and would be eligible, according to the CDC. Of these, about half are age 65 or older.

“If you’re not in a group that is universally recommended for boosters, it’s because we think you’re well protected,” said ACIP member Dr. Matthew F. Daley, a senior clinician investigator at Kaiser’s Institute for Health Research. “The decision we’re making today will be reevaluated as circumstances change.”

The two-dose regimen remains extraordinarily safe and effective in preventing severe disease, hospitalization and death. The pandemic is a disease of the unvaccinated: during the two-day, 30-hour meeting, about 2,500 unprotected Americans died of COVID-19.

But there is emerging evidence that immunity begins to fade after five to six months, especially in elders. A Sept. 17 CDC report showed that four months after recipients got their second dose of the Pfizer vaccine, the effectiveness in preventing hospitalization fell from 91% to 77%. Effectiveness of the Moderna vaccine remained stable, falling from 93% to 92%. While not enough participants had received the one-shot Johnson & Johnson vaccine, it has been 71% effective in preventing hospitalization.

The booster is as safe as the first and second doses, experts said. And a third-dose booster dramatically increases the level of protective antibodies, providing a four- to 10-fold increase in immunity, according to Pfizer data presented at the meeting. Recent Israeli research published in last week’s New England Journal of Medicine showed that a booster for those age 60 and over reduced the rates of severe illness, hospitalization and deaths.

The CDC panel decided that:

Only certain groups are eligible for the booster. They include:

People age 65 or older. These elders were prioritized because they show the most dramatic dropoff in immunity six months after their second dose, so face the greatest risk of severe illness and death. But this age cutoff means that many at-risk Black and Latinos aren’t eligible, according to Stanford University infectious disease epidemiologist Dr. Yvonne Maldonado. About 39% of Latino deaths and 31% of Black deaths occurred in those under age 65, as compared to 15% in whites, she said.

People with underlying illnesses that put them at risk of severe COVID-19, such as cancer, cerebrovascular disease, heart disease, diabetes, lung disease or kidney disease.

People who live in long-term care facilities or other group institutions.

Younger and healthier people aren’t eligible.

That’s because they are still protected from serious illness by the vaccine, the panel agreed. Additionally, most of these people haven’t yet hit their six-month mark since their second vaccine.

Their immunity is likely to wane over time, the experts agreed. But even if they suffer mild or moderately “breakthrough” infections, they will remain well protected from serious illness.  And they are more likely to experience a rare adverse event, such as a heart inflammationm or myocarditis.

Nearly 9,000 people between the ages of 18 and 29 would need to be boosted to prevent one hospitalization, according to data presented at the meeting. In contrast, only 491 people age 65 and older would need to be boosted to prevent one hospitalization.

Expect similar risks and side effects.

Like the first and second doses, there is risk of severe allergic reaction. Also like earlier doses, the booster may pose a potential risk of myocarditis in young men.

Side effects are similar. Research shows that after the third dose, these symptoms were experienced: fever, 8.7%; fatigue, 63.7%; headache, 48%; chills, 29%; muscle pain, 49% and joint pain: 25%.

You’ll won’t have to prove that you’re eligible.

Boosters will require only self-verified ‘attestation’ that you meet the criteria due to age or health status.

Pharmacies will be the major providers. 

An estimated two-thirds of vaccines are distributed by pharmacies like CVS, Walgreens and a network of a dozen other pharmacies.

There was no decision on “mixing and matching.” 

The CDC panel did not vote on whether people who received the Moderna or Johnson & Johnson vaccines could get the Pfizer vaccine. At this point, there is insufficient evidence to prove the safety and efficacy of this strategy, it said.

The FDA is still awaiting submission of J&J booster application. It is reviewing Moderna’s application; there is no date yet for a decision.

But because the Pfizer vaccine is FDA-approved, any doctor is legally allowed to prescribe an “off label” shot for recipients of the Moderna or J&J — especially if waiting for those vaccine boosters approvals is judged is too big a risk.

It will be free for consumers.

This means it’s expensive for health departments and health systems — but they will be reimbursed by insurers and the federal government.

You don’t have to reschedule your flu vaccine.

It is safe to get your booster at the same time as other vaccines,  said the CDC’s Dr. Kathleen Dooling.

There are plenty of vaccines left for the unvaccinated.

“Supply for Pfizer vaccine is not an issue right now,” said the CDC’s Dr. Sara Oliver. “There is plenty of vaccine to continue to give the primary series, as well as the booster dose.”

The CDC’s first priority will continue to be on getting people their initial series, she said.

There’s no rush.

You don’t need to get your booster at precisely six months, said the CDC’s Oliver. While protection starts to wane, most people are still very protected.

“Many people may choose to get a booster dose at ten months, eight months or seven months,” she said. “It’s not protection that everybody needs next week.”

 

 

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