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CDC boosters advice, FDA's differ by a bit

Health agency panel favors no 3rd shots tied to job risk by Compiled Democrat-Gazette Staff From Wire Reports | September 24, 2021 at 7:07 a.m.
Vials of the Pfizer/BioNTech covid-19 vaccine lie in a box during preparations at the Vaccine Village in Ebersberg near Munich, Germany, in this March 19, 2021, file photo. (AP/Matthias Schrader)

WASHINGTON -- A day after federal regulators authorized Pfizer-BioNTech coronavirus booster shots for Americans at risk of severe covid-19, scientific advisers to the Centers for Disease Control and Prevention on Thursday recommended the booster shots for a wide portion of the country, including tens of millions of older Americans and those with certain medical conditions. But the panel excluded those at risk because of their jobs.

The Food and Drug Administration on Wednesday authorized boosters for older and high-risk recipients of the Pfizer vaccine at least six months after their second injection, as well as for people whose jobs leave them exposed to the virus, including health workers, teachers and grocery workers.

The CDC's science advisers unanimously supported the booster after six months for adults older than 65 and for residents of long-term-care facilities. And 13 of the committee's 15 members also endorsed the shots for people ages 50-64 with medical conditions that leave them at risk for severe covid-19.

But the panel declined to make the same recommendation for younger people, saying those 18-49 years old with underlying medical conditions may assess their own risk and choose to get boosters if they want them.

Some members urged the committee to include some flexibility for people under 50 to obtain boosters, based on their individual benefit and risk. But others pointed -- with considerable frustration -- to a lack of data supporting the need in the other groups.

In a 9-6 vote that generated the most debate, the panel declined to recommend a booster for people at risk of illness because of their jobs, a break from what the FDA authorized Wednesday. This measure would have applied to health care workers, teachers and other workers who do not meet the other criteria.

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Some members of the CDC panel said there was little evidence to suggest that vaccinated teachers, and even health care workers, are at risk of repeated exposure to the virus.

Pablo Sanchez, a pediatrician at Ohio State University, voted against it because he said it would open the door to anyone who wanted to get a vaccination.

"We might as well just say give it to anyone 18 and over," Sanchez said. "We have a really effective vaccine, and it is like saying that it is not working, and it is working."

Others, including Grace Lee, a pediatrician at Stanford University School of Medicine and chairman of the panel, voted in favor of the recommendation, saying it would provide access to people who believe they need the boosters.

The advisers also grappled with the lack of clarity on the goal of the vaccines: Is it to prevent all infections, or only to forestall severe illness and hospitalization? Many suggested that it should be the latter, and that thwarting all infections was a foolhardy goal.

Several members of the committee pointedly questioned why federal health agencies were focusing on booster shots for Pfizer recipients to begin with, given the higher risks facing the unvaccinated.

"We may move the needle a little bit by giving a booster dose to people," said Dr. Helen Talbot, an associate professor of medicine at Vanderbilt University. But, she added, "the hospitals are full because people are not vaccinated."

Pfizer scientists had argued to the committee that waning antibody levels in people who had received the shot indicated that their immunity was dropping.

Some committee members doubted the wisdom of looking only at antibody levels to gauge immunity. The antibodies needed to prevent infection may naturally wane a few weeks to months after the injection, but the immune cells that prevent illness from progressing -- but are harder to measure -- remain stable many months after the second dose, according to data presented by one CDC scientist.

DIFFICULT DECISIONS

CDC Director Rochelle Walensky is expected to endorse the recommendations of its scientific advisers soon, and people who meet the criteria could start getting the shots immediately afterward at locations where the Pfizer vaccine is already being administered, including pharmacies, health departments, clinics and some doctor's offices.

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"You are tasked with difficult decisions -- weighing the risks and benefits, extrapolating from sometimes a wealth and sometimes a paucity of data available, applying an equity lens to your actions, and doing all of this while reflecting on your own experiences on the pandemic front lines," Walensky told committee members before they began deliberations. "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."

She added: "Like you, I am approaching this decision with an interest in doing what is right for public health. And, like you, I can't close my eyes to my experience as a clinician. 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 also said the administration's collective goal is to protect as many people as possible from infection, hospitalization and death.

MIX-AND-MATCH

Because the FDA authorization pertains only to third doses of the Pfizer-BioNTech vaccine, and federal guidance encourages consumers to get boosters from the maker of their original doses, many policy questions remain about implementation. State health officials, hospital administrators and clinicians need guidance now, they say, on whether they can mix-and-match booster shots from the two other authorized vaccines, from Moderna and Johnson & Johnson.

The CDC panel was not asked to judge whether people who received the Moderna and Johnson & Johnson vaccines should receive booster shots.

Several experts nevertheless supported a mix-and-match strategy, and signaled that they would revisit the issue as new data emerges.

Federal officials have suggested that clearance of booster shots for Moderna and Johnson & Johnson could happen in a few weeks.

An estimated 26 million people are at least six months past their second Pfizer dose, according to the CDC. About half are 65 and older. An additional 23 million people are at least six months past their second Moderna shots, and about 3.3 million people are at least six months past their one shot of the Johnson & Johnson vaccine.

The Biden administration had been hoping it could offer boosters beginning this week to any fully vaccinated adults eight months after their second shot, to reduce viral transmission and curb the pandemic. That broad plan ran into opposition from outside experts and some of the government's own vaccine scientists, who argued that two doses of the vaccines still offer robust protection against serious illness and hospitalizations, even if some data indicates waning protection against less serious cases.

Administration officials said Thursday that they were privately hoping the CDC and its advisers would make a recommendation similar to, or at least compatible with, the FDA's authorization so that the government did not deliver differing, confusing messages on who should get the boosters and when.

Federal health officials have already authorized a third shot of Pfizer and Moderna vaccines for people with weakened immune systems, such as cancer patients and organ transplant recipients.

VACCINATIONS DOWN

On Wednesday, before the CDC panel discussed the need for boosters, the agency released data showing that the number of Americans receiving their first doses of a coronavirus vaccine has dropped significantly in recent days, worrying health officials as flu season approaches.

The seven-day moving average of daily first doses was about 272,000 by the end of last week, according to the CDC, making it the slowest week of first-dose immunizations since mid-July. On Tuesday, fewer than 21,000 individuals were injected with their first shots, tentative figures from the CDC show, potentially making it the slowest day since Christmas 2020.

This slowdown is partly because millions of Americans have already been either fully or partially vaccinated. About 55% of Americans are fully vaccinated, while about 64% have received at least one dose of a coronavirus vaccine. But it also comes amid an unwelcome comeback of infections and deaths across the country, and as the U.S. falls behind in overall vaccination rates globally, despite having had a months-long head start in immunizing its population.

Vaccination rates mostly rose from December 2020 through April in America as more people became eligible for vaccination, the CDC data show. At the peak, April 8, nearly 2.6 million people received their first shots. Rates fell again until July, when the highly transmissible delta variant increased coronavirus case numbers, pushing more people to get vaccinated. In August, vaccination rates started dropping again.

The hardest-hit regions in the U.S., in terms of deaths, hospitalizations and infections per capita, are also where vaccination rates are low, according to figures compiled by The Washington Post.

Alabama, where deaths have risen by 200% from last week, has the fourth-lowest vaccination rate among the 50 states, the District of Columbia and five U.S. territories. The U.S. as a whole saw deaths rise by 7% over the same period.

West Virginia has the highest hospitalization rate in the country, with about 58 people per 100,000 hospitalized for covid-19. The state has the lowest vaccination rate in the country with about 40% of the population being fully vaccinated. The national average for hospitalizations is 27 per 100,000 people.

Alaska, where new daily case rates are among the worst in the country and where "crisis standards of care" were activated in hospitals this week, has fully vaccinated less than half its population.

With the approach of flu season, health officials are bracing for an increased strain on medical systems that are already reaching the breaking point. The common flu has killed between 12,000 and 61,000 Americans per year in the past decade, according to CDC estimates. It has also hospitalized hundreds of thousands.

"On any given day, between 85[%] to 90% of the hospitalized covid-19 patients right now are unvaccinated," Cindy Knall, a professor of immunology at the University of Alaska at Anchorage, said in an email. The needs of those patients mean resources will be limited for flu patients who need hospital-level care, she said.

Although flu infections and deaths fell to record lows during the previous flu season, the likely reasons for those drops cited by the CDC, such as social distancing and mask-wearing, have diminished. More people are gathering in large numbers, and more schools have returned to in-person learning. Mask-wearing has become less common, and travel has rebounded.

Knall said she expects this coming flu season to resemble more closely those of the pre-pandemic years.

"I'm trying to stay hopeful, so I won't use the term dire, but things are not good here," Knall said. "I see it in the eyes of my colleagues who are working in the hospitals. I hear it in the catch of their voices. I don't think the public wants to know what Crisis Standard of Care could mean for their loved one who needs care."

Information for this article was contributed by Lena H. Sun, Laurie McGinley and Andrew Jeong of The Washington Post; and by Benjamin Mueller and Apoorva Mandavilli of The New York Times.

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