WASHINGTON, Nov. 19 (BUS) – US regulators moved Friday to open booster COVID-19 footage to all adults, expanding the government’s drive to boost protections and anticipate rising coronavirus cases that could worsen with the holidays.
Pfizer and Moderna announced the FDA’s decision after at least 10 states began making the boosters available to all adults. A final measure is to simplify what has hitherto been a confusing list of who is eligible by allowing anyone 18 and older to choose either company’s booster six months after their last dose — regardless of which vaccine they got first.
But there’s one more step: The Centers for Disease Control and Prevention must agree to expand Pfizer and Moderna boosters to include even healthy young adults. The Associated Press (AP) reported that its scientific advisors are scheduled to discuss later on Friday.
If the CDC approves, tens of millions of Americans could get three doses of protection before the new year. Anyone who has received a single dose of the Johnson & Johnson vaccine can already get a booster dose.
The three COVID-19 vaccines used in the United States offer strong protection against severe illness including hospitalization and death without boosters, but the protection against infection can wane over time.
Previously, the government had authorized boosters of the Pfizer and BioNTech vaccine, as well as the similar Moderna vaccine, only for vulnerable groups including older Americans and people with chronic health problems.
But Pfizer last week asked the U.S. Food and Drug Administration to extend that decision to everyone, citing new data from a study of 10,000 people. Ultimately, the Food and Drug Administration decided that there was insufficient evidence, from studies and actual use of boosters, to support the expansion of both Pfizer and Moderna.
“Simplifying the eligibility criteria and making the booster doses available to all individuals 18 years of age or older will also help eliminate confusion about who may receive a booster dose and ensure that booster doses are available to everyone who may need a dose,” said FDA Vaccine Chief, Dr. Peter Marx said.
The move to expand comes as new COVID-19 cases have risen steadily over the past two weeks, especially in states where cold weather is driving people indoors.
These troubling trends sparked some states, and they didn’t wait for federal officials to act. Utah and Massachusetts were the latest states to announce last week that they are opening reinforcements to all adults.
Reinforcements for all were the original goal of the Biden administration. But in September, a panel of FDA advisors voted overwhelmingly against that idea based on the vaccines’ continued effectiveness in most age groups. Instead, they approved an additional dose of Pfizer for the most vulnerable groups only.
Last month, with the support of its advisory committee, the FDA approved Moderna’s boosters — using half the dose people received in the first two shots — for the same vulnerable groups.
But there has been some frustration within the White House and among the president’s allies that the lengthy and public regulatory process has contributed to disinformation and confusion about the reinforcements and may mean that the nation will not be optimally protected before the holiday season.
Administration officials, including Dr. Anthony Fauci, have continued to make the case for broader use of boosters, noting that even milder infections in young adults can cause “prolonged COVID” and other complications.
“I don’t know of any other vaccine as we’re only concerned about keeping people out of the hospital,” Fauci said at a news briefing on Wednesday.
But the administration has vowed that the decision will ultimately rest with the scientists. This time, the FDA did not consult its advisors, saying that the scientific issues surrounding Pfizer and Moderna’s boosters “do not raise questions that could benefit from additional discussion.”
The regulators concluded that the overall benefits of the added protection outweighed the risks of rare side effects from Moderna or Pfizer’s vaccines, such as a type of heart infection that often appears in young adults.
Pfizer and its German partner BioNTech have argued that broader boosters could help curb infection at a critical period.
“We have absolutely no chance in the current situation of controlling the epidemic without providing reinforcements to everyone,” BioNTech CEO Ugur Sahin told reporters during a visit to Washington last week.
The companies studied 10,000 adults of all ages and found that the booster restored protection against symptomatic infections to about 95% even while the highly contagious delta variant was increasing.
It’s too soon to know if this high level of protection will last longer after the third shot than after the second, something Shaheen said the companies will follow carefully.
In support of this evidence, Britain released factual data showing the same leap in protection once it began offering reinforcers to middle-aged and older adults.
Israel credits boosters on a large scale for helping to stave off another wave of the virus in that country.
More than 195 million Americans have been fully vaccinated, defined as having received two doses of Pfizer, Moderna or a single dose of Johnson & Johnson. More than 30 million have already received a booster dose.
Prior to the expansion, people who received the Pfizer or Moderna vaccines were eligible for a third dose if they were elderly or at risk of contracting COVID-19 due to health problems, their jobs or their living conditions.
Because the J&J injection has not been shown to be as effective as its two-dose competitors, any J&J recipient can get a booster dose after at least two months.
But people who don’t meet the criteria can get an extra shot because many vaccine sites don’t check qualifications.
The FDA has previously ruled that people who get a booster dose can get a different brand of the vaccine they initially received.
Some experts worry that all the attention to boosters could harm efforts to reach the 60 million Americans who are eligible to be vaccinated but who do not get vaccinated. There is also growing concern that rich countries provide boosters on a large scale when poor countries cannot vaccinate more than a small part of their population.
“In terms of priority No. 1 to reduce transmission in this country and around the world, that remains to get people the first series of vaccines,” said Dr. David Dowdy of the Johns Hopkins Bloomberg School of Public Health.
NS