Alaska's largest hospital implements crisis standards of care; Florida makes death data public after secrecy: COVID-19 updates
Alaska’s largest hospital applies rations care, prioritizing resources to those patients who have the potential to benefit the most. COVID-19 updates.“While we are doing our utmost, we are no longer able to provide the standard of care to each and every patient who needs our help,” Dr. Kristen Solana Walkinshaw, chief of staff at Providence Alaska Medical Center, wrote in a letter addressed to Alaskans distributed Tuesday.
Advisers to the Centers for Disease Control and Prevention voted Thursday to recommend that certain at-risk groups of people should receive a third dose of the Pfizer-BioNTech vaccine for added protection against Covid-19.
All people ages 65 and up and those in long-term care facilities who were initially vaccinated with the Pfizer vaccine should receive a booster dose, the advisory panel said. People ages 50 to 64 with underlying medical conditions should also get a booster. The additional shots would be administered at least six months after people complete their initial vaccination series.
Why Fauci and the NIH backed Covid-19 vaccine boosters before the FDA and CDC
In January — long before the first jabs of covid-19 vaccine were even available to most Americans — scientists working under Dr. Anthony Fauci at the National Institute of Allergy and Infectious Diseases were already thinking about potential booster shots. © Robyn Beck/AFP/Getty Images A nurse marks a coronavirus vaccination card with a third "booster" dose of Pfizer, at a vaccine clinic hosted by The Tournament of Roses and the Pasadena Public Health Department, August 19, 2021 at Tournament House in Pasadena, California.
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The advisers stopped short of a full endorsement for other groups of at-risk individuals, instead recommending that they may choose to get the booster shot if they feel they need it, in consultation with their physician. Those individuals include people ages 18 to 49 with underlying health conditions. The committee voted against recommending a booster for people ages 18 to 64 who have a high risk of being exposed to the virus at work, including health care workers and teachers.
The Advisory Committee on Immunization Practices’ recommendations partially mirrored the Food and Drug Administration’s emergency use authorization granted for the third Pfizer dose Wednesday.
The committee’s votes will now go to CDC Director Dr. Rochelle Walensky for final signoff. If Walensky endorses the committee's recommendations, shots can start being administered immediately. The recommendations will apply only to people who have received the two-dose Pfizer vaccines.
US panel backs COVID-19 boosters only for seniors, high-risk
WASHINGTON (AP) — Dealing the White House a stinging setback, a government advisory panel overwhelmingly rejected a plan Friday to give Pfizer COVID-19 booster shots across the board, and instead endorsed the extra vaccine dose only for those who are 65 or older or run a high risk of severe disease. The twin votes represented a heavy blow to the Biden administration's sweeping effort, announced a month ago, to shore up nearly all Americans' protection amid the spread of the highly contagious delta variant.
At least 13 million people who are 65 or older will be eligible for a booster dose.
Committee members and the CDC stressed that these are interim recommendations that will be updated as more data come in.
The committee members expressed significant concern about a booster shot for younger people due to lack of evidence about safety and whether there was a clear benefit against severe disease. © Provided by NBC News Image: Pfizer vaccine (Watchara Phomicinda / MediaNews Group via Getty Images file)
The votes come after several weeks of confusing messaging about a vaccine booster, which was set off when the Biden administration announced in August that it was planning to begin giving an extra shot to all people in the U.S. eight months after they had been fully vaccinated, starting the week of Sept. 20.
However, an advisory group to the FDA rejected that broad recommendation last week, narrowing the group of people eligible to those 65 and older and those at high risk of severe illness. The timing of the booster shot also changed, from eight months after the second dose to six months.
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Meanwhile, California's rate of transmission is an average of 94 cases per 100,000, which is considered "substantial" by the CDC. More COVID updates.It is the only state in the country reporting transmission levels considered "substantial" by the CDC, along with the territory Puerto Rico. All other states currently have "high" levels of transmission." High transmission consists of 100 or more cases per 100,000 people in the last week.
The CDC noted that the recommendation of a booster dose would not change the definition of who is considered fully vaccinated. That is, people are considered fully vaccinated two weeks after getting their second dose of either the Pfizer or the Moderna vaccines or their first dose of the Johnson & Johnson vaccine.
Who gets a booster?
Thursday’s recommendation only applies to the Pfizer vaccine, and people who were initially vaccinated with the Pfizer vaccine.
That leaves out, for the moment, vast swaths of fully vaccinated people in the U.S. who received the Moderna or the Johnson & Johnson vaccines initially.
Moderna has submitted its application to the FDA for its booster dose and could receive authorization within weeks. Johnson & Johnson has provided data to the agency on booster dose effectiveness and safety, but declined to say when it would formally apply for emergency use authorization.
Evidence was strongest for a booster dose in people ages 65 and older, the CDC’s Dr. Sara Oliver said. Vaccine effectiveness against infection and severe disease has waned in this group.
FDA authorizes Pfizer booster for people 65 and over; Iowa sets new 2021 high for coronavirus hospitalizations: COVID-19 updates
Health care workers, teachers and grocery workers are among the high-risk workers eligible for a Pfizer booster. The latest COVID-19 updates:Individuals 18 and up who are at high risk for severe COVID-19 were also included in the authorization, which only covers those who are at least six months out from their second dose of the COVID-19 vaccine.
The committee also supported a booster dose for people 18 and older in long-term care facilities, as well as people ages 50 to 64 with underlying medical conditions. Younger people, ages 18 to 49, with underlying conditions may choose to get a booster. Those conditions will likely be similar to the ones listed in the initial vaccine rollout, such as cancer, diabetes, pregnancy, obesity and heart conditions.
However, there is less evidence of waning immunity for people with underlying medical conditions, Oliver said.
Committee members struck a skeptical tone about the booster shot during public discussions Wednesday and Thursday, stressing that the biggest issue remains vaccinating the unvaccinated.
In a presentation Wednesday, Oliver summarized what’s known about the Pfizer booster shot. She noted that the safety of the extra shot, and the effect it appears to have on enhancing protection against the virus, are “reassuring,” but added that a number of questions remain.
One question that was revisited several times: What is the goal of a booster shot? Is it to prevent all infections, or is it to prevent hospitalizations and death?
Preventing all infections — which would occur if the vaccines induced what’s known as sterilizing immunity — is not feasible, said committee member Dr. Sarah Long, a professor of pediatrics at Drexel University College of Medicine in Philadelphia.
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Wisconsin reports more COVID cases in kids than any other age group. Florida schools receive federal aid after defying state mandates. COVID updatesCDC Director Dr. Rochelle Walensky signed off on a series of recommendations from a panel of advisers late Thursday, hours after the advisers said boosters for the Pfizer-BioNTech COVID-19 vaccine should be offered to people 65 and older, nursing home residents and those ages 50 to 64 who have risky underlying health problems. The extra dose would be given once they are at least six months past their last Pfizer shot.
Dr. Kiepp Talbot, an associate professor of medicine at Vanderbilt University in Nashville, Tennessee, agreed.
“One of the things that we need to begin to understand is that we will likely prevent hospitalizations and deaths, and hopefully symptomatic lower-respiratory tract infections, but it is unlikely that we will prevent everything,” she said.
It’s also unclear what level of antibodies are needed to maintain protection. Although there has been much focus on waning antibody levels in people who received the Pfizer vaccine, Long noted that the “key question” is not whether the levels wane, but “what is the minimum you have to have to have protection?”
That remains unknown. Pfizer scientist Dr. Bill Gruber, who presented Wednesday, said that the company has yet to identify so-called correlates of protection — cutoff levels of surrogate measurements like antibodies or T-cells that would indicate when someone needs a booster.
“It’s going to be very challenging” to define these cutoffs, he said. “It’s clear that protection is multifactorial,” meaning that antibody levels are not the only aspect of it.
On safety, committee members noted, only a small number of people — 306 — were included in the U.S. analysis, none of whom were under 18 years old. “Based on those numbers, we would be unable to determine the risk of rare side effects such as myocarditis after a booster dose,” Oliver said, referring to a type of heart inflammation.
Additional safety data from Israel, where more than 2.8 million people have been given a third dose, was also presented Wednesday. There, only one case of myocarditis has been reported to date. But younger people there — for whom the risk is higher — have just started getting their third shot, so it may not reflect the full scope of cases.
More than 20M Americans are eligible for Pfizer-BioNTech booster shots. Should you get one?
More than 20 million Americans are now eligible for the booster shots, including those over 65 and many with underlying conditions.Although those who got other vaccines are not yet eligible, boosters may soon be extended to those who received the Moderna and Johnson & Johnson shots.
Megan Wallace, a CDC epidemiologist, said in a presentation Thursday that the risk of myocarditis after a third shot is unknown, though the risk is likely greater for younger people, particularly men.
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The benefit of a booster is expected to be greatest for adults ages 65 and up, though the third shot is estimated to also help prevent hospitalization and infection in younger people, Wallace said.
Another top concern for committee members was the FDA authorization only applies to the Pfizer vaccine, and those who were initially vaccinated with it.
“That’s going to leave half of people immunized being told that they’re at risk now of waning immunity and hospitalization and unable to get a booster dose. That’s a big public health panic,” Long said.
CORRECTION (Sept. 23, 2021, 5:55 p.m. ET): A previous version of this article misstated the number of older adults eligible for a Pfizer booster shot. It is at least 13 million people, not 27 million people.
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Majority of Unvaccinated Americans Believe Boosters Prove COVID Vaccines Don't Work .
62 percent of all respondents said booster shots show "scientists are continuing to find ways to make vaccines more effective."The survey from the Kaiser Family Foundation also found 33 percent of all respondents said the need for boosters proves the vaccines are not working as well as promised, including 19 percent of vaccinated Americans.