Stimulus Check Up | Apr 8, 2022 | 0
F.D.A. Decision on Boosters Is Expected in Days
The Food and Drug Administration is likely to authorize Pfizer booster shots this week for many Americans at high risk of falling seriously ill from the coronavirus, now that a key advisory committee has voted to recommend the measure.
On Friday, a panel of experts endorsed offering Pfizer booster shots for ages 65 and older, and people 16 and over who are at high risk of getting severe Covid-19 or who work in settings that make them more likely to get infected.
The agency, which often follows the committee’s advice but is not required to, is expected to decide early this week. An advisory committee of the Centers for Disease Control and Prevention is scheduled to meet Wednesday and Thursday to discuss booster shots before that agency — which sets vaccine policy — issues its recommendations.
The decision on Pfizer booster shots is just one of a series of key questions that the agency is expected to consider in coming weeks. Officials have said they expect to soon have data on whether boosters are needed for people who got the Moderna and Johnson & Johnson vaccines.
Also expected this fall is a decision on a shot for children ages 5 to 11, an intensely watched issue given that about 48 million children are not yet eligible for a vaccine, but have largely returned to classrooms. Pfizer has said it plans to release the results of its children’s trial by the end of this month, and officials have said they expect results from Moderna’s children’s trial later this fall.
Interviewed on Sunday-morning news shows, Dr. Anthony S. Fauci, the nation’s top infectious disease doctor and an adviser to President Biden, asked Americans to be patient and not to get a booster shot until they were eligible. That includes people 65 and over who received the Moderna and Johnson & Johnson vaccines.
“We’re working on that right now to get the data to the F.D.A., so they can examine it and make a determination about the boosters for those people,” he said on NBC’s “Meet the Press.” “They’re not being left behind by any means.”
Last month, the Biden administration proposed a plan that would have made all vaccinated Americans eligible for a booster shot eight months after their second shot, or their first in the case of the one-shot Johnson & Johnson vaccine.
But the expert panel concluded that boosters were not necessary for most younger, healthier Americans, unless their jobs put them at special risk for infection.
Jobs in that category would include health care workers, emergency responders and teachers, according to Dr. Peter Marks, who oversees the F.D.A.’s vaccine division.
Whatever the F.D.A. decides about boosters this week, Dr. Fauci predicted it will likely be revised as more data comes in. “In real time, more and more data are accumulating,” he said on ABC’s “This Week.” “There will be a continual re-examination of that data, and potential modification of recommendations.”
Dr. Francis S. Collins, the director of the National Institutes of Health, echoed those remarks on CBS’s “Face the Nation,” saying that the category of who is eligible for an extra shot was likely to be expanded in the “coming weeks.”
F.D.A. officials will also spend the coming weeks and months evaluating vaccines for children under 12. On Sunday on ABC, Dr. Fauci said a decision on children’s vaccines would certainly come “this fall,” adding, “sometime in the mid- to late fall, we will be seeing enough data from the children from 11 down to 5 to be able to make a decision to vaccinate them.” A decision on vaccines for children under 5 would come after that.
The flurry of decisions comes as public health officials hope to avoid a repeat of last fall and winter, when a surge of infections led to peak levels of hospitalizations and deaths in the United States.
The extremely transmissible Delta variant now accounts for more than 99 percent of cases tracked in the country, according to the C.D.C. While hospitalizations and new cases have started to trend slowly downward, deaths have topped an average of 2,000 a day for the first time since March 1, according to a New York Times database. Vaccinations have been shown to protect against severe illness brought on by the variant.
Dr. Fauci said on Sunday that the key to avoiding a fall and winter surge would be encouraging adults who were eligible but still unvaccinated to change their mind.
“I believe if we get that overwhelming majority of the people vaccinated as we enter into the fall and winter, we can have good control over this and not have a really bad winter at all,” he said on “Meet the Press.”
New Zealand will ease coronavirus restrictions in Auckland, Prime Minister Jacinda Ardern said on Monday, ending nearly five weeks of the strictest lockdown in the country’s most populous city.
Some businesses, including restaurants and cafes, will be allowed to reopen for takeout and delivery beginning Tuesday night, and as many as 10 people will be permitted to gather in the city for ceremonies including funerals and weddings, Ms. Ardern told reporters. In New Zealand’s four-tier system of Covid rules, Auckland will now be at Level 3, the second most restrictive. The rest of the country has been under Level 2 for the past two weeks.
The measures have frustrated residents and shuttered businesses, as the country remained one of the few committed to completely eliminating the Delta variant of the coronavirus. There were 22 new cases reported on Monday, down from a peak of 83 during this outbreak. New Zealand began slowly relaxing some of the world’s strictest antivirus measures earlier this month, aiming to reopen borders to foreigners some time next year.
“We keep doing the job of stamping out Covid,” Ms. Ardern said. “We are not stepping out of Level 4 because the job is done. Nor are we moving because we don’t think we can achieve the goal of stamping out Covid-19.”
Other nations in the Asia Pacific region have begun to reopen despite rising numbers of new cases, acknowledging that strategies that aim to eliminate the virus may be untenable. Australian authorities have said that country will begin to reopen once 70 percent of the eligible population is vaccinated. Singapore has loosened quarantine rules for some travelers. In Vietnam, businesses are reopening, although cases are still high.
Ms. Ardern insisted that the change in rules for Auckland should be considered a cautious step. Across the rest of New Zealand, restrictions at indoor gatherings, including restaurants and bars, will be further eased, allowing 100 people to gather. The new restrictions will remain in place for at least two weeks, and will be reassessed on Oct. 4.
At a virtual summit on Wednesday, while the annual United Nations General Assembly meeting is underway, President Biden will urge other vaccine-producing countries to balance their domestic needs with a renewed focus on manufacturing and distributing doses to poor nations in desperate need of them.
The push, which White House officials say seeks to inject urgency into vaccine diplomacy, will test Mr. Biden’s doctrine of furthering American interests by building global coalitions. Covax, the United Nations-backed vaccine program, is so far behind schedule that not even 10 percent of the population in poor nations is fully vaccinated, experts said. And the landscape is even more challenging now than when Covax was created in April 2020.
Some nations in Asia have imposed tariffs and other trade restrictions on Covid-19 vaccines, slowing their delivery. India, home to the world’s largest vaccine maker, banned coronavirus vaccine exports. And an F.D.A. panel on Friday recommended Pfizer booster shots for those over 65 or at high risk of severe Covid, meaning that vaccine doses that could have gone to low and lower-middle income countries would remain in the United States.
Officials said Wednesday’s summit would be the largest gathering of heads of state to address the coronavirus crisis. It aims to encourage pharmaceutical makers, philanthropists and nongovernmental organizations to work together toward vaccinating 70 percent of the world’s population by the time the U.N. General Assembly meets in September 2022, according to a draft document the White House sent to the summit participants.
Experts estimate that 11 billion doses are necessary to achieve widespread global immunity. The United States has pledged to donate more than 600 million — more than any other nation — and the Biden administration has taken steps to expand vaccine manufacturing in the United States, India and South Africa. The 27-nation European Union aims to export 700 million doses by the end of the year.
But on the heels of the United States’ calamitous withdrawal from Afghanistan last month that drew condemnation from allies and adversaries alike, the effort to rally world leaders will be closely watched by public health experts and advocates who say Mr. Biden is not living up to his pledges to make the United States the “arsenal of vaccines” for the world.