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FDA backs Pfizer COVID-19 boosters for seniors, high-risk amid spread of Delta variant

The ruling represents a drastically scaled back version of the Biden administration's sweeping plan to give third doses to nearly all American adults to shore up their protection.

Published: 23rd September 2021 02:25 PM  |   Last Updated: 23rd September 2021 02:25 PM   |  A+A-

A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic at the Reading Area Community College in Reading

A syringe is prepared with the Pfizer COVID-19 vaccine at a clinic at the Reading Area Community College in Reading (Photo | AP)

By PTI

WASHINGTON: The US moved a step closer Wednesday to offering booster doses of Pfizer's COVID-19 vaccine to senior citizens and others at high risk from the virus as the Food and Drug Administration signed off on the targeted use of extra shots.

The FDA authorized booster doses for Americans who are 65 and older, younger adults with underlying health conditions and those in jobs that put them at high risk for COVID-19.

The ruling represents a drastically scaled back version of the Biden administration's sweeping plan to give third doses to nearly all American adults to shore up their protection amid the spread of the highly contagious delta variant.

However, more regulatory hurdles lie ahead before the dispensing of boosters can begin.

Advisers to the Centers for Disease Control and Prevention opened a two-day meeting Wednesday to make their own, more specific recommendations about who should get the extra shots and when.

And in their first day of discussions, some experts were so perplexed by the questions surrounding the rationale for boosters that they suggested putting off a decision for a month in hopes of more evidence.

The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.

The FDA decision Wednesday was expected after the agency's own panel of advisers last week overwhelmingly rejected the Biden plan.

The panel instead recommended boosters only for those most vulnerable to severe cases of COVID-19.

FDA acting commissioner Dr. Janet Woodcock said in a statement that the FDA authorization would allow for boosters in health care workers, teachers, grocery workers and those in homeless shelters or prisons.

"As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed," Woodcock said.

Under the FDA authorization, vaccinated Americans are eligible for a third dose six months after receiving their second Pfizer shot.

That's different than the Biden proposal announced in August, which called for boosters after eight months.

"Today's FDA decision is a major step forward in our effort to provide Americans with additional protection from COVID-19," White House press secretary Jen Psaki tweeted Wednesday night.

"We have been preparing for weeks to administer booster shots to eligible Americans and are ready to do so following CDC's final recommendation later this week."

The timing of the FDA decision was highly unusual given that the agency typically takes action before the CDC convenes its own experts.

The CDC panelists heard a series of presentations Wednesday outlining the knotty state of science on boosters.

On one hand, the COVID-19 vaccines continue to offer strong protection against severe illness, hospitalization and death.

On the other hand, there are signs of more low-grade infections among the vaccinated as immunity wanes.

Ultimately the committee must decide who is considered at high enough risk for an extra dose.

Data provided by Pfizer and the Israeli government suggests a strong case for boosters in people 65 and older, but there is less evidence that extra shots provide much benefit for younger people with underlying health conditions.

Several CDC advisers agreed boosters are also important for keeping health care workers on the job.

"We don't have enough health care workers to take care of the unvaccinated," said Dr. Helen Keipp Talbot of Vanderbilt University.

"They just keep coming."

The CDC has already said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.

The World Health Organization and other global health advocates are opposed to wealthy nations dispensing a third round of shots when poor countries don't have enough vaccine for their first doses.

And many independent scientists say that the vaccines continue to perform well against the worst effects of COVID-19 and that their ability to curb the overall trajectory of the epidemic is uncertain.

U.S. regulators will decide at a later date on boosters for people who have received the Moderna or Johnson & Johnson vaccines.

They indicated the Pfizer shots would not be recommended for people who got a different brand of vaccine initially.

The across-the-board rollout of boosters proposed by the White House was supposed to have begun this week.

Some questioned whether President Joe Biden had gotten ahead of the science by announcing his plans before government regulators had reached any conclusions.

Despite the resistance in recent days, some top U.S. health officials said they expect boosters to eventually win broader approval in the coming weeks or months.

Dr. Anthony Fauci said over the weekend that "this is not the end of the story."

Other administration officials noted that the FDA decision covers tens of millions of Americans and that seniors and other high-risk groups would have been the first to get boosters even if extra shots had been authorized for the entire population.

Seniors were in the first group of Americans eligible for vaccination last December.

The U.S. has already authorized third doses of the Pfizer and Moderna vaccines for certain people with weakened immune systems, such as cancer patients and transplant recipients.

Other Americans, healthy or not, have managed to get boosters, in some cases simply by asking.

The U.S. is dispensing around 760,000 vaccinations per day on average, down from a high of 3.4 million a day in mid-April.

About 180 million Americans are fully vaccinated, or 64% of those who are eligible.

President Joe Biden is set to announce that the United States is doubling its purchase of Pfizer's COVID-19 shots to share with the world to 1 billion doses as he embraces the goal of vaccinating 70% of the global population within the next year.

The stepped-up U.S. commitment is to be the cornerstone of the global vaccination summit Biden is convening virtually Wednesday on the sidelines of the U.N. General Assembly, where he plans to push well-off nations to do more to get the coronavirus under control.

World leaders, aid groups and global health organizations are growing increasingly vocal about the slow pace of global vaccinations and the inequity of access to shots between residents of wealthier and poorer nations.

The U.S. purchase, according to two senior Biden administration officials who spoke on the condition of anonymity to preview Biden's remarks, will bring the total U.S. vaccination commitment to more than 1.1 billion doses through 2022.

At least 160 million shots supplied by the U.S. have been distributed to more than 100 countries, representing more donations than the rest of the world combined.

The latest purchase reflects only a fraction of what will be necessary to meet a goal of vaccinating 70% of the global population, and 70% of the citizens of each nation, by next September's U.N.meeting.

It's a target pushed by global aid groups that Biden will throw his weight behind.

The White House said Biden will use the summit to press other countries to "commit to a higher level of ambition" in their vaccine sharing plans, including specific challenges for them to meet.

The officials said the White House will publicly release the targets for well-off nations and nonprofits after the summit concludes.

The American response has come under criticism for being too modest, particularly as the administration advocates for providing booster shots to tens of millions of Americans before vulnerable people in poorer nations have received even a first dose.

"We have observed failures of multilateralism to respond in an equitable, coordinated way to the most acute moments. The existing gaps between nations with regard to the vaccination process are unheard of," Colombian President Iván Duque said Tuesday at the United Nations.

More than 5.9 billion COVID-19 doses have been administered globally over the past year, representing about 43% of the global population.

But there are vast disparities in distribution, with many lower-income nations struggling to vaccinate even the most vulnerable share of their populations, and some yet to exceed 2% to 3% vaccination rates.

In remarks at the U.N., Biden took credit on Tuesday for sharing more than 160 million COVID-19 vaccine doses with other countries, including 130 million surplus doses and the first installments of more than 500 million shots the U.S. is purchasing for the rest of the world.

Other leaders made clear in advance it was not enough.

Chilean President Sebastian Piñera said the "triumph" of speedy vaccine development was offset by political "failure" that produced inequitable distribution.

"In science, cooperation prevailed; in politics, individualism. In science, shared information reigned; in politics, reserve. In science, teamwork predominated; in politics, isolated effort," Piñera said.

The World Health Organization says only 15% of promised donations of vaccines, from rich countries that have access to large quantities of them, have been delivered.

The U.N. health agency has said it wants countries to fulfill their dose-sharing pledges "immediately" and make shots available for programs that benefit poor countries and Africa in particular.

COVAX, the U.N.-backed program to ship vaccines to all countries has struggled with production issues, supply shortages and a near-cornering of the market for vaccines by wealthy nations.

The WHO has urged companies that produce vaccines to prioritize COVAX and make public their supply schedules.

It also has appealed to wealthy countries to avoid broad rollouts of booster shots so doses can be made available to health care workers and vulnerable people in the developing world.

Such calls have largely gone ignored.

COVAX has missed nearly all of its vaccine-sharing targets.

Its managers also have lowered their ambitions to ship vaccines by the end of this year, from an original target of some 2 billion doses worldwide to hopes for 1.4 billion now.

Even that mark could be missed.

As of Tuesday, COVAX had shipped more than 296 million doses to 141 countries.

The 70% global target is ambitious, not least because of the U.S. experience.

Biden had set a goal of vaccinating 70% of the U.S. adult population by July 4, but persistent vaccine hesitance contributed to the nation not meeting that target until a month later.

Nearly 64% of the entire U.S. population has received at least one dose and less than 55% is fully vaccinated, according to data from the Centers for Disease Control and Prevention.

U.S. officials hope to increase those figures in the coming months, both through encouraging the use of vaccination mandates and by vaccinating children once regulators clear the shots for the under-12 population.

Aid groups have warned that the persistent inequities risk extending the global pandemic, and that could lead to new and more dangerous variants.

The delta variant raging across the U.S. has proved to be more transmissible than the original strain, though the existing vaccines have been effective at preventing nearly all serious illness and death.



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