F.D.A. Panel Vote Deals Setback to Biden’s Booster Shot Plan
Daily Covid Briefing
Sept. 18, 2021, 12:30 p.m. ET
Sept. 18, 2021, 12:30 p.m. ET
Image
The Biden administration’s push to make Covid-19 booster shots available to most fully vaccinated adults has been stymied for now by a Food and Drug Administration advisory panel’s recommendation that Pfizer boosters be made available only to those 65 and over and those at high risk of severe Covid.
However, the roiling debate over whether the shots are needed more broadly remains unsettled.
The panel of experts on Friday overwhelmingly voted not to recommend boosters for those over 16 after a tense, daylong debate that put divisions within the agency and the administration on public display.
Video
transcript
transcript
F.D.A. Panel Greenlights Pfizer Boosters for High-Risk Individuals
A Food and Drug Administration advisory panel recommended that Pfizer-BioNTech boosters be made available to people 65 and older and those at high risk of severe Covid, but voted against giving blanket boosters to people 16 and older.
-
“This is the voting question No. 2 that we will ask the committee to consider: Based on the totality of scientific evidence available, including the safety and effectiveness data from Clinical Trial C4591001: Do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech Covid-19 vaccine booster dose administered at least six months after completion of the primary series for use in individual 65 years of age and older, and individuals at high risk of severe Covid-19?” “We do have a unanimous 18 out of 18 who voted ‘yes’ for this question.”
The vote was a blow to President Biden, strengthening criticism of his effort to enhance the immunity of already vaccinated Americans at a time when most residents of poor nations have not even had first doses. The F.D.A. and the Centers for Disease Control and Prevention authorized third shots for some immunocompromised individuals more than a month ago, on the ground that the additional dose would simply lift their protection to the level other people achieve with two shots.
Some F.D.A. experts said that the data from Pfizer and elsewhere still seemed to show that two shots protected against severe disease or hospitalization for months afterward, and that there was not enough evidence that a third shot would stem the spread of infection. Some also criticized a lack of data that an additional injection would be safe for younger people.
The panel’s final recommendations left some room for the White House to argue that the core of its booster strategy remained intact. Depending on how “at high risk” is defined, tens of millions of Americans could conceivably be deemed eligible for additional shots of the Pfizer vaccine. And a small but growing number of people have stopped waiting for federal authorization and are finding ways to receive booster shots.
Before the panel met on Friday, the Centers for Disease Control and Prevention released data indicating that, for some people, the level of protection against Covid hospitalizations afforded by the Pfizer-BioNTech vaccine dropped significantly four months after full inoculation.
The C.D.C. study supported some others that suggest the Pfizer vaccine may offer less protection from hospitalization over time. The available data is far from unanimous, though so far it suggests that only older adults will need boosters. Participants in the C.D.C. study skewed older and it was unclear if the same waning of vaccine effectiveness happened among younger vaccinated people.
Other studies have shown that Pfizer’s effectiveness against hospitalization has remained above 90 percent, despite the rapid spread of the Delta variant and the passage of time. Pfizer has said that data from Israel suggests a falling effectiveness against severe disease, though it appears that Israel and the United States define “severe disease” differently.
The debate is playing out as the Delta variant continues ravaging less-vaccinated areas of the country. New coronavirus cases and Covid hospitalizations across the United States have started to show signs of decline, although they remain far higher than they were earlier in the summer. And the average number of daily deaths has been increasing since early July, from this year’s low of 175 to nearly 2,000 by the end of this week, according to a New York Times database. About one in every 500 Americans has died from the disease.
The pace of vaccinations remains relatively sluggish. Providers are administering about 775,000 doses per day on average, according to federal data, a fraction of the April peak but still more than 250,000 higher than the low point in July. About 54 percent of Americans are fully vaccinated, according to a New York Times database, the second lowest proportion among the Group of 7 wealthy nations — but Japan’s now aggressive vaccination campaign is likely to leave the United States last among the G-7 shortly.
The F.D.A. has the final word on vaccine approvals, and while it is not obliged to follow the advisory committee’s recommendations, it typically does. The agency will likely issue a decision on boosters by early next week.
— Ron DePasquale
Image
Advisers to the Food and Drug Administration on Friday questioned a key assertion by researchers in Israel and by the drug company Pfizer: that its coronavirus vaccine is waning in protection not just against infection, but against severe illness and hospitalization.
The advisers met to evaluate Pfizer’s application for approval of booster vaccine doses for all Americans over age 16. Among the details that surfaced during the lively debate: Israel and the United States define severe illness differently.
In Israel, anyone with an accelerated respiratory rate and an oxygen level of below 94 percent is severely ill. By contrast, the Centers for Disease Control and Prevention considers people who are sick enough to be hospitalized as having severe disease, Dr. Sara Oliver, a C.D.C. scientist, said at the advisory committee meeting.
The discrepancy might help explain why the two countries have reported vastly different outcomes in people who are fully immunized.
Israeli researchers said they have seen large numbers of hospitalized patients who had received two doses months earlier. But in the United States, the C.D.C. has reported that vaccinated patients make up just 2 percent of people hospitalized for Covid-19.
It is just one of many scientific discrepancies that came to light this week.
On Monday, in the journal The Lancet, an international team of scientists analyzed dozens of studies and concluded that boosters are not yet needed by the general population, and that the world would be better served by using vaccine doses to protect the billions of people who remain unvaccinated.
On Wednesday, scientists at the F.D.A. posted an assessment online hinting that they, too, are unconvinced that there’s enough evidence that boosters are needed.
“Overall, data indicate that currently U.S.-licensed or authorized Covid-19 vaccines still afford protection against severe Covid-19 disease and death in the United States,” according to their executive summary.
But some F.D.A. leaders have publicly endorsed booster shots. “The need for an additional dose at six months to provide longer-term protection should not come as a surprise, as it’s likely necessary for the generation of a mature for immune response,” Dr. Peter Marks, one of the agency’s top officials, said in the meeting on Friday.
Alarmed by the rise in cases, Israeli officials have offered third doses of the vaccine to everyone older than 12. Researchers from Israel published early results from that rollout on Wednesday in the New England Journal of Medicine — but few outside scientists found the study convincing.
The team collected data on the effects of booster shots from the health records of more than 1.1 million people over age 60. At least 12 days after the booster, rates of infection were elevenfold lower — and rates of severe disease nearly twentyfold lower — in those who received a booster compared with those who had received only two doses, the researchers found.
The results are unsurprising, experts said, and do not indicate long-term benefit.
Image
“We have known for some time that the vaccines elicit less robust immune responses in the elderly,” said Dr. Celine Gounder, an infectious disease specialist at Bellevue Hospital Center and a former adviser to the Biden administration. “Recommending additional doses of vaccine for the elderly isn’t controversial.”
Vaccination remains powerfully protective against severe illness and hospitalization in the vast majority of people in all of the studies published so far, experts said. But the vaccines do seem less potent against infections in people of all ages, particularly those exposed to the highly contagious Delta variant.
The cumulative data so far suggest that only older adults will need boosters, a view underscored by the F.D.A.’s advisory committee, which voted on Friday to endorse boosters only for Americans aged 65 and older, and those who are at risk for severe illness.
Image
Last fall, as coronavirus cases climbed and the world hoped for vaccines, health experts feared influenza and Covid-19 would combine for a devastating “twindemic.”
While pandemic measures appeared to keep the flu at bay, this year experts are again concerned, especially as some countries and state authorities roll back lockdown rules. Many officials and experts are urging the public: Do not dismiss the danger of the flu, and seek a flu vaccine.
“This year we are guaranteed to have the flu, and we are going to have some version of a twindemic,” said Dr. William Schaffner, the medical director for the National Foundation for Infectious Diseases. “It could really further strain an already extraordinarily stretched, strained, tired-to-the-bone health care system.”
In the United States, flu activity was significantly lower during the 2020-21 season than during any previous flu season since at least 1997, the first for which data is publicly available.
Scientists said pandemic precautions most likely played a role, as many people adopted masking, social-distancing and hand-washing habits.
But the relative lack of flu cases over the last 18 months could also mean that population-level immunity to the flu is lower this season, said Lynnette Brammer, the leader of the C.D.C.’s domestic influenza surveillance team.
And while it is still uncertain how the season will play out, she added, relaxed pandemic measures in some places will “likely result in the resumption of seasonal flu virus circulation.”
“This all could set us up for a potentially severe flu season,” she added.
The C.D.C. advises that everyone over the age of 6 months old receive a flu shot, with a few exceptions. It takes about two weeks for protection to develop after vaccination, so experts recommend getting vaccinated from September through the end of October, but even after that it is better to get the vaccine than not.
Image
Hospital systems across the United States are being strained to their breaking points by the highly contagious Delta coronavirus variant. Nationwide, new cases and hospitalizations have declined slightly in recent weeks, but much of the progress seen in hard-hit Southern states is being offset by growing outbreaks in the Upper Midwest and Mountain West.
One in four hospitals across the country reports that more than 95 percent of its intensive care beds were occupied as of the week ending Sept. 9, up from one in five hospitals last month. Experts say hospitals may have difficulty maintaining standards of care for the sickest patients when all or nearly all I.C.U. beds are occupied.
Struggling to cope with a flood of patients, Idaho officials activated “crisis standards of care” across the state on Thursday, allowing overwhelmed facilities to ration treatment if needed. If the situation worsens, hospital may have to decide which patients will get priority for limited supplies of oxygen or ventilators.
Alaska’s largest hospital announced Tuesday that a relentless outbreak driven has left emergency room patients waiting hours in their vehicles and forced medical teams to ration care. At Providence Alaska Medical Center in Anchorage, the hospital said it was now operating under “crisis standards of care” — procedures put in place to prioritize resources in a way that may leave some patients with substandard care.
State officials in Mississippi tried to outsource “I.C.U.-level-care patients” to Kentucky. And in North Dakota, an executive at the state’s largest health care system said it could use as many as 300 additional nurses to help treat Covid-19 patients. All I.C.U. beds are full in Alabama.
Here’s what else happened this week:
-
A scientific advisory committee to the Food and Drug Administration on Friday recommended booster shots for recipients of the Pfizer-BioNTech coronavirus vaccine who are 65 or older or are at high risk of severe Covid-19, at least six months after the second shot. The panel also overwhelmingly recommended against approving a Pfizer booster for people 16 and older. The Biden administration had been hoping the F.D.A. and the Centers for Disease Control and Prevention would approve a third shot of the Pfizer vaccine in time to begin rolling out boosters for Pfizer recipients next week.
-
Both elation and caution were palpable in New York City on Monday when the country’s largest public school system resumed full in-person classes for the first time since March 2020. But with the virus tearing through unvaccinated populations in the city and much of New York’s school-age population still ineligible for vaccination, disruptions are likely.
-
The longest shutdown in Broadway history is over. Some of the biggest shows in musical theater, including “The Lion King,” “Wicked” and “Hamilton,” resumed performances on Tuesday night, 18 months after the coronavirus pandemic forced them to close.
-
President Biden met on Wednesday with top executives from Microsoft, the Walt Disney Company, Kaiser Permanente and other companies that have endorsed vaccine mandates, days after he announced a federal effort to require employees of large companies to be vaccinated against the coronavirus or be tested regularly. Vaccinations have divided the work force and many businesses fear the requirements may cause labor shortages.
-
In the Australian city of Melbourne on Saturday, 235 people were arrested and six police officers were injured during a violent protest against the country’s pandemic lockdown rules, the police said. An additional 193 people at the protest were fined, according to Acting Sergeant Melissa Seach, a spokeswoman for the Victoria Police. One video shared widely on Twitter shows hundreds of protesters running down a street after breaking past a handful of police officers, several of whom were knocked to the ground.
Image
Peering at a sea of white flags blanketing the National Mall, Dr. Laura A. Valleni recalled the scores of pregnant women who had contracted Covid-19 at her hospital in South Carolina. Babies have been born prematurely, mothers have died and a surge of children has overwhelmed the pediatric unit for the past two months, she said.
“I’ve been grappling with when it became OK for even one person to die of preventable illness,” said Dr. Valleni, a neonatal physician at Prisma Health Children’s Hospital–Midlands in Columbia, S.C. “There’s such tremendous grief.”
She was one of dozens who flocked to the opening on Friday morning of “In America: Remember,” an art installation of hundreds of thousands of flags planted along the mall that honor the more than 670,000 people in the United States who have died from the coronavirus.
The secretary of the interior, Deb Haaland, and the mayor, Muriel E. Bowser, were in attendance as visitors walked among the rows of white flags covering 20 acres of federal park land bordering the White House, the Washington Monument, the National Museum of African American History and Culture and the World War II Memorial.
Angelica Rivera, 33, a call center agent for a health care facility in New Jersey, dedicated a flag to a colleague, Karla Pope, a nurse who died of the virus in January. “I love you! Thank you for everything you did for all of us. My forever work mom,” she wrote.
“We were one of the first health care centers to get vaccines in New Jersey, and she was administering the shots, and then a little while later then she got sick,” Ms. Rivera said. “She got Covid and passed away. Her husband also passed away, and her kids were left without a mom and a dad.”
Other names and messages on flags paid tribute to loved ones: Marshall J. Ciccone, a dedicated husband; Bruce Allen Hutcheson, a health care hero; Betty L. Fox, whose daughter aches for her.
The artist behind the installation, Suzanne Brennan Firstenberg, planted 267,000 flags in Washington last fall to recognize what was then the death toll of the coronavirus in the United States.
Video
transcript
transcript
England to Ease International Travel Restrictions
Britain announced it would relax and simplify rules on international travel in and out of England starting on Oct. 4, citing the success of its vaccination rollout.
-
Today, we’re announcing a new, simpler, easier system, which will decrease the burden on people traveling and stay in place at least till the new year. It means you won’t have to take a pre-departure test. The Day 2 P.C.R. test will be scrapped in favor of a lateral flow, and all of this is only available because so many people have been vaccinated. Nine out of 10 adults in this country are there, and its enabled us to scrap the traffic light system and make travel easier for people once again while still maintaining that protection for everybody’s health. If you’ve not been vaccinated and I don’t mean for a medical reason, but just because you choose not to be vaccinated, then, of course, you would have to carry on taking the additional test, which does involve the extra money. Most people will say nine out of 10 adults have been vaccinated in this country, so this simply doesn’t apply to most people. And actually, the other thing I’m announcing today is there’s going to be over 50 countries where we’re going to recognize their vaccine programs in addition to the E.U. and the United States. So, many other countries now will come into that regime where people can come here and they won’t need to take P.C.R. tests and self-isolate.
Citing the success of Britain’s vaccine rollout, government authorities announced on Friday that coronavirus restrictions on international travel in and out of England would be eased beginning at 4 a.m. local time on Oct. 4.
The current three-tier, traffic-light-inspired system, which was introduced in May, caused confusion among Britons and the travel industry. The system going into place next month replaces that with a single “red” list of countries and territories that present the highest coronavirus risk, and simplified travel measures for arrivals from the rest of the world.
The changes were announced in a statement from Britain’s departments of Transport and Health and Social Care; the health secretary, Sajid Javid; and the transportation secretary, Grant Shapps. Mr. Shapps said it represented a simpler, more straightforward system, “one with less testing and lower costs, allowing more people to travel, see loved ones or conduct business around the world while providing a boost for the travel industry.”
The statement announced other changes as well: Starting on the same day, fully vaccinated passengers will no longer be required to take a coronavirus test before arriving in England from a country that is not on the red list, and that the test they must take on the second day after their return can be a rapid test, which is less expensive than the more accurate PCR test.
However, anyone testing positive will be required to isolate and receive negative results from a PCR test, which will be free to the traveler. The samples will be “genomically sequenced to help identify new variants,” the government’s statement said.
A negative test ahead of arrival will still be required for unvaccinated passengers, and they will also still be required to have PCR tests two and eight days later. Unvaccinated people arriving in England from red list countries will have to quarantine in a government-approved hotel for a mandatory 10 nights at their own cost.
And next week, eight countries will be removed from England’s red list: Turkey, Pakistan, the Maldives, Egypt, Sri Lanka, Oman, Bangladesh and Kenya.
Sixty-six percent of the population of the United Kingdom is fully vaccinated, and an additional 6 percent have received a first dose. But average daily deaths have risen 24 percent over the last two weeks.
And the pandemic is playing out differently across the four U.K. nations — England, Scotland, Wales and Northern Ireland — which operate independently on pandemic travel restrictions, as in many other areas of governance.
On Friday, the BBC reported that the government of Wales, where average daily cases are up 19 percent over the last two weeks, said it would follow England’s lead in adjusting its red list, and that it would “carefully consider” the proposed changes on testing.
Scotland, where average daily cases have fallen by 30 percent over the last two weeks, said that it was also easing travel restrictions, but would maintain the requirements for Day 2 and Day 8 PCR tests for vaccinated arrivals to minimize “the risk of importing variants of concern.”
The government of Northern Ireland website did not offer new guidance on its travel restrictions; cases are flat there. England’s cases are dropping off from a recent spike.
So far, 73 percent of people in Britain have received a single dose of a coronavirus vaccine, while 66 percent have received two doses, according to data collated by The New York Times.
Image
Asking wedding guests to leave their children at home used to be among the thornier requests a couple could make.
Now, Covid precautions are adding more sensitive appeals to wedding invitations.
Tucked inside many embossed envelopes, along with dinner choices and directions to the reception, are politely worded notes telling guests they must be vaccinated, get a Covid test or do both, according to wedding planners.
Couples are not shy about asking guests about their vaccination status, said Jamie Bohlin, a wedding planner and owner of Cape Cod Celebrations in Yarmouth Port, Mass.
“I don’t get an email saying, ‘Should I ask our guests if they’re vaccinated?’” she said. “They just say, ‘We’re asking our guests.’”
In a survey of 1,400 couples last month, 22 percent said they were requiring guests to be vaccinated, according to The Knot, a wedding planning site. That was a jump from the spring, when only 3 percent of couples surveyed said they would make vaccinations a requirement, said Lauren Kay, executive editor at The Knot.
Many couples are taking measures like setting up mobile testing sites the day before their weddings; informing guests that they will need to wear masks throughout the reception; and providing color-coded bracelets that indicate which guests are fine with hugging and which want to keep their distance, according to wedding planners.
Source: https://www.nytimes.com/live/2021/09/18/world/covid-delta-variant-vaccine/
