CDC chief overrules panel, clears them for front-line staff

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The head of the Centers for Disease Control and Prevention on Friday overruled an advisory panel by approving the distribution of Pfizer and BioNTech’s Covid-19 booster vaccinations to a wide range of workers in the United States

CDC director Dr. Rochelle Walensky signed a number of the panel’s recommendations, including distributing the recordings to older Americans and adults with underlying medical conditions at least six months after their first series of recordings. But she broke off the panel by also releasing boosters to those in high-risk professional and institutional settings in an unusual decision that is likely to fuel protests from anti-vaccine advocates.

“As CDC director, it is my job to identify where our actions can have the greatest impact,” Walensky said in a statement. “At CDC, our job is to analyze complex, often imperfect data in order to make specific recommendations for optimizing health. In a pandemic, even when there is uncertainty, we must take measures that we expect will be of most benefit. “

The highly unusual move coincides with the FDA approving the shots earlier this week, she noted.

Millions of Americans at greatest risk of Covid can now get a Pfizer BioNTech booster shot to increase their protection as the highly contagious Delta variant continues to rupture across the country.

Hours earlier, the Agency’s Advisory Committee on Immunization Practices endorsed the administration of Pfizer third vaccinations to people 65 and older, nursing home residents, and those aged 18 to 64 with pre-existing conditions such as pregnancy, HIV, cancer, diabetes, obesity, or heart disease.

However, Walensky overturned a decision that was rejected by the panel on Thursday evening. The panel voted 9 to 6 against giving a booster vaccination to adults who are at higher risk of exposure to the virus because of their workplace or institutional setting.

While the FDA and CDC only reviewed the data for the Pfizer vaccine, Walensky said they would implement recommendations for Moderna and J&J boosters “with the same urgency” as soon as those data became available. Moderna submitted its booster application on Sept. 1, and J&J said Wednesday that it had also submitted its data showing that an extra dose of its vaccine increases protection against infection by 94%. The FDA, which is reviewing these applications before the CDC, has not yet announced when it will review the data.

Here’s what the CDC recommends:

  • People aged 65 and over and residents in long-term care facilities should receive a booster dose of the Covid vaccine from Pfizer-BioNTech at least six months after the Pfizer BioNTech Primary Series;
  • People between 50 and 64 years of age with previous illnesses should receive a booster shot from Pfizer-BioNTech at at least six months after their Pfizer BioNTech primary series;
  • People between 18 and 49 years of age with previous illnesses can Receive a booster dose of Pfizer BioNTech vaccine for at least six months after the Pfizer BioNTech Primary Series, based on individual benefit and risk;
  • Individuals between the ages of 18 and 64 who are at increased risk of exposure and transmission of Covid-19 due to their professional or institutional environment can Receive a booster dose of Pfizer BioNTech vaccine at least six months after the Pfizer BioNTech Primary Series, based on their individual benefits and risks.

“I believe we can best serve the country’s public health needs by serving the elderly, people in long-term care facilities, people with underlying diseases and adults at high risk of illness from professional and institutional exposure to COVID-19,” she said.

Earlier Thursday, the CDC Advisory Board grappled with the controversial proposal to give a boost to a broad segment of the US population. By breaking away from the panel, Walensky paved the way for the shots to be distributed to nursing home staff, people who live or work in prisons and homeless shelters, frontline health workers, unpaid caregivers, teachers and other key workers.

“I mean, we might as well say just give it to anyone over 18,” said committee member Dr. Pablo Sanchez before voting against the proposal.

Lisa Wilson receives a syringe of the Pfizer vaccine at a mobile COVID-19 vaccination center in Orlando, Florida.

Paul Hennessy | SOPA pictures | LightRakete | Getty Images

Dr. Leana Wen, emergency doctor and former Baltimore health commissioner, called the CDC panel’s vote to reject boosters more generally a “mistake”.

“Really, are we not allowing health workers, many of whom were vaccinated back in December, to be boostered? What about teachers in cramped classrooms that don’t require masks? ”She tweeted, adding that CDC Director Dr. Walensky should override the recommendation.

The CDC’s final decision enables President Joe Biden to win. The government said it plans to start giving booster injections to people aged 16 and over this week. While the CDC panel’s recommendation doesn’t give the Biden government everything it wanted, boosters will be on the way for millions of Americans who originally received Pfizer’s shots.

On Wednesday, the Food and Drug Administration issued emergency clearances to many Americans to give third Pfizer shots six months after completing the first two doses. Although the CDC committee’s recommendation is not binding, Walensky was expected to accept the committee’s approval.

Walensky addressed the committee on Thursday ahead of the vote, thanking them for their work and setting out what is at stake.

“These dates are not perfect, but together they paint a picture for us, and they are what we have right now to make a decision about the next phase of this pandemic,” she said.

Before the vote, some committee members said they feared the wide range of boosters on offer could affect efforts to get vaccinations to unvaccinated people or possibly reduce confidence in the vaccines’ effectiveness. Others were frustrated that only Pfizer recipients were eligible to receive the vaccinations, leaving out millions of Americans who received the Moderna and Johnson & Johnson vaccines.

The vote came at the end of a two-day meeting during which CDC advisors listened to several presentations of data to support the widespread use of booster vaccinations, including one from a Pfizer manager showing data showing a third Injection appears to be safe and increases antibody levels in recipients.

During a presentation on Thursday, CDC officer Dr. Sara Oliver observational studies from Israel in which officials began vaccinating the country’s population in front of many other countries and offering third vaccinations to their citizens in late July.

The Israeli data has been criticized by at least one FDA official for being based on so-called observational studies, which do not meet the same standards as formal clinical studies.

“We can use Israel’s experience to reinforce our knowledge of booster safety,” Oliver said, adding that the country reported only one case of a rare heart infection known as myocarditis out of nearly 3 million third doses administered .

– CNBC’s Robert Towey contributed to this report.

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