Fauci defends boosters
U.S. sets meeting on vaccine distribution
Dr. Anthony Fauci, the nation’s top infectious-disease expert, defended President Joe Biden’s decision to announce the availability of covid-19 booster shots before regulators had weighed in, though Fauci on Sunday urged vaccinated Americans to wait until they are eligible for an extra shot before getting one.
The remarks by Fauci, director of the National Institute of Allergy and Infectious Diseases, came after a Friday vote by an advisory panel to the Food and Drug Administration, which recommended that those who received the Pfizer vaccine get a booster dose if they are over 65 or are at high risk of developing severe cases of covid-19.
The panel’s recommendation represented a more limited plan than the one Biden had announced last month, in which he said that beginning today, all Americans who had been fully vaccinated would be eligible for booster shots
eight months after their last dose.
Biden’s announcement worried regulators at the FDA, given that it came before the agency had evaluated the data on whether the shots were needed. Two top vaccine officials soon announced that they would depart the agency this fall, in part over the issue.
Speaking on NBC’s “Meet the Press,” Fauci said Biden “wasn’t getting ahead of the science.”
Fauci defended the administration’s messaging on booster shots but acknowledged there could be confusion.
“The president was very clear, as was the medical group when we said we are planning to do this,” Fauci said on CNN’s “State of the Union,” noting that in all official statements by administration officials, the rollout of boosters was always noted as pending and conditional on examination of the data by the FDA.
“I think people are not understanding the difference of planning for something and actually what element of that, what proportion of it, you’re actually going to roll out,” he said. “And that’s exactly what happened.”
The panel’s members decided there is not yet enough data to recommend the extra shots for younger, healthier people, given evidence that the vaccine continues to protect against severe disease and deaths in that group.
The FDA is expected to make a decision on boosters in the coming days. It usually follows the recommendation of its advisory committees but is not required to do so.
Fauci said he did not believe the panel made a mistake in its recommendation.
“The one thing people need to realize is data are coming in literally on a daily and weekly basis,” he said on “State of the Union.” “They are going to continue to look at this literally in real time.”
The debate over boosters has arisen during a surge of the highly transmissible delta variant, which now accounts for more than 99% of virus cases tracked in the country, according to data from the Centers for Disease Control and Prevention. While hospitalizations and new cases have started to trend slowly downward, deaths have topped an average of 2,000 per 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 delta variant.
Fauci asked Americans to be patient and wait until they are eligible for an additional shot, adding that it will be only weeks before data is seen on whether an extra shot of the Moderna and Johnson & Johnson vaccines is needed.
“We’re working on that right now to get the data to the FDA so they can examine it and make a determination about the boosters for those people,” he said. “They’re not being left behind by any means.”
Fauci, who is 80 and will be eligible for a booster if the FDA approves it for those over 65, added that he “certainly” plans on getting another dose. He also emphasized that the public should expect “an evolution of this process” in the coming weeks and months.
As more information comes in about how the original vaccines are working, Fauci said, he expects to see the plan for boosters change.
“In real time, more and more data are accumulating,” he said on ABC’s “This Week.” “There will be a continual reexamination of that data and potential modification of recommendations.”
Dr. Francis Collins, the director of the National Institutes of Health, echoed those remarks on CBS’ “Face the Nation,” saying the category of who is eligible for an extra shot will likely be expanded in the “coming weeks.”
Collins said he supported the FDA panel’s recommendation, adding that the evolving nature of guidance on boosters meant the scientific process was working as intended.
“In a certain way … this is the way it ought to be,” Collins said. “Science sort of playing out in a very transparent way, looking at the data coming from multiple places, our country, other countries and trying to make the best decision for right now. That’s what they did.”
In addition to his comments on booster shots, Fauci also confirmed that the timeline for the authorization of vaccines for children under 12 continues to be this fall. About 48 million children in the United States are under 12 and are therefore still ineligible for vaccination.
Pfizer has said it expects to announce the results of its children’s vaccine trial before the end of the month. Fauci said the results from Moderna’s trial will likely come a few weeks later.
“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,” he said.
SHOT-SHORTAGE SUMMIT
Even as the U.S. looks at giving booster doses to millions of fully inoculated Americans, Biden this week plans to set a new course for global vaccine allocation, hosting a summit on the shortage of shots in poorer countries.
The U.S. plan for boosters has angered nations where many people are still struggling to obtain their first shots.
As world leaders gather for the U.N. General Assembly in New York this week, Biden plans to hold a virtual summit Wednesday to propose a target of fully vaccinating 70% of the world by September 2022.
The U.S. has exported more doses of vaccines than any other country, and Biden’s team wants other wealthy nations to increase their donations to offset any strain on supply from the U.S. booster program. The administration is negotiating with Pfizer to buy an additional 500 million doses to donate globally, which would double the U.S. commitment to helping lesswealthy countries.
But the U.S. government’s booster policy could instead put political pressure on other countries to follow suit with their own plans for extra doses, further exacerbating global inequities.
“It’s like you and I have a life jacket, and they are throwing us one or two more when more than half the planet doesn’t have one,” said Tom Hart, acting chief executive of the ONE campaign, which advocates for vaccine exports to low-income nations.
“Not only is that morally outrageous, it doesn’t make any sense epidemiologically,” he said. “The best way to protect Americans is to extinguish this fire elsewhere as quickly as possible.”
Biden’s team, speaking on a private briefing call last week, said Wednesday’s summit isn’t meant to be a one-day event, but instead the start of a months-long process to set clear international vaccination targets and paths to achieve them, people familiar with the call said. The Pfizer deal is expected to be announced ahead of the meeting.
At the panel hearing Friday, FDA scientists acknowledged the political pressure building around the booster plan. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, began the hearing by asking the panel to focus on the science of booster shots without veering into “issues related to global vaccine equity.”
The U.S. used hundreds of millions of doses made on its soil before pivoting to exports once domestic demand slowed. So far, the U.S. has donated and shipped more than 140 million doses abroad.
But the world needs billions of doses to curb the pandemic — a tough goal to meet with donations alone. Many advocates for greater global vaccine equity say Biden should relax legal protections for vaccine formulas and forge deals between manufacturers and facilities in other countries.
U.N. Secretary-General Antonio Guterres warned against any U.S. plan for booster shots that would mean fewer vaccine doses abroad.
“If to have booster shots in one country means that others will not have shots, of course this is not the best way to deal with the disease,” he said.
U.S. donations have shipped daily or near daily. From the time of production, there is a 96-hour window to pack, ship and deliver frozen doses before they spoil. Trucks, planes and even Coast Guard ships are making the deliveries.
“We’re feeling proud of all the work that the U.S. government has done to fulfill the president’s commitment to share vaccines with the world, and we’re looking forward to doing more,” Natalie Quillian, a senior White House official involved in the covid response, said in an interview last month.
But U.S. officials acknowledge that more needs to be done. The vaccine industry was built to produce between 4.5 billion and 5 billion doses per year, and it now needs much greater capacity, one U.S. official said.
Surgeon General Vivek Murthy pushed back on criticism that the U.S.’ booster program runs counter to helping vaccinate the rest of the world.
“The notion that somehow us providing adequate protection for the American people is not right; I don’t accept that premise,” Murthy said. “We have to do both. We can’t choose between one and the other.”
But Lawrence Gostin, a Georgetown University law professor and director of the World Health Organization’s Collaborating Center on Public Health Law & Human Rights, faulted Biden’s booster plan and Murthy’s argument.
“It defies common sense to suggest that, in the face of extreme global scarcity, that if you use a lot more vaccine at home, that it’s not going to impact the ability to vaccinate abroad,” Gostin said. “The overwhelming reason for the injustice is supply scarcity.”
The FDA is expected to make a decision on boosters in the coming days. It usually follows the recommendation of its advisory committees but is not required to do so.