CDC vaccine advisory committee recommends against flu vaccines containing thimerosal

(WASHINGTON) — In a major policy change, the Food and Drug Administration has announced a plan to limit access to future COVID-19 shots only to people over 65 years old or those with an underlying health condition.

This change would apply to any future updated versions of the vaccine, a spokesperson at the department of Health and Human Services told ABC News. For the past several years, COVID shots have been updated ahead of the winter respiratory virus season to better match the evolving virus.

But FDA Commissioner Dr. Martin Makary and FDA vaccine head Dr. Vinay Prasad argued this week that annual booster shots are not worth the risk for otherwise healthy people.

The FDA plans to impose these restrictions on future shots for younger, healthy people, unless vaccine makers are willing to pay for newer and and lengthy placebo-controlled trials.

“We are evaluating the details shared today and discussions with the FDA are ongoing,” Pfizer told ABC News in a statement.

“We appreciate the FDA’s clear guidance and remain committed to working with the Agency to provide the data they need to ensure access for Americans,” Moderna told ABC News.

Since the COVID-19 virus can mutate quickly, a lengthy clinical trial may result in a vaccine that no longer protects against currently circulating variants, experts cautioned.

“By the time you finish the trial, the strain that’s out there in the community is probably long gone. So, they’re basically saying, unless you’re in those higher-risk groups, you can forget about getting the COVID vaccine,” former acting CDC director Richard Besser, now president and CEO of the Robert Wood Johnson Foundation, told ABC News.

A spokesperson for HHS, which oversees FDA, told ABC News, “The COVID-19 public health emergency has officially ended, and we are entering a new phase in our response to the virus. A rubber-stamping approach to approving COVID boosters in perpetuity without updated clinical trial data under the Biden administration is now over.”

Last month, more than 300 people died each week from COVID, according to the latest CDC data. Death rates were even higher earlier this year as the virus was spreading, with nearly 1,000 Americans dying weekly in January.

The new policy comes as the FDA’s vaccine committee of independent advisers are set to meet on Thursday to discuss the latest data on vaccine safety and efficacy, including COVID shots. Typically, FDA leadership waits until after hearing the advice of its advisers before implementing a new approval or policy change.

Previously, updated COVID vaccines had been recommended annually by the CDC for everyone over the age of 6 months. The CDC has historically set vaccine recommendations, while the FDA determines which vaccines to authorize or approve after being deemed safe and effective.

“The FDA has kind of usurped the CDC’s recommending capacity. Usually, the FDA is a regulatory body. They say the vaccine can be sold, and the CDC says, ‘Jere’s the groups who should get it,’” Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told ABC News.

Added Besser: “It’s also not something the FDA would normally do. It’s something CDC would do. And so that’s a really important issue here.”

The new COVID vaccine framework would allow an estimated 33% of the U.S. population to be eligible for the shots, or at least 100 million people, FDA officials noted. It matches recommendations from other countries such as the U.K., Canada and Australia.

Experts say there is a real scientific debate about whether annual boosters are necessary for otherwise young and healthy children and younger adults, especially now that most Americans now have some immunity gained from past vaccination and infections.

In mid-April, the CDC’s vaccine committee of independent advisers had discussed whether to keep the recommendation that everyone over 6 months receive an annual COVID vaccine.

Some experts have argued an FDA restriction could create insurmountable barriers for those who no longer qualify but want to get vaccinated anyway to protect vulnerable family members. Officials at the FDA have called for more evidence on whether vaccines prevent transmission before providing that option.

“To date, there is no high-quality evidence that you getting a booster protects your grandma, beyond your grandma getting the booster herself,” Prasad said at an FDA press conference Tuesday. “Does it lead to less transmission? Does it lead to fewer instances of severe disease? Again, we are interested in evidence to inform this claim.”

Insurance coverage of future COVID vaccines will likely be determined based on recommendations from the CDC and the agency’s independent panel of advisers later this summer. A final recommendation on who should be eligible for updated shots will likely come from the CDC director later this year.

Insurance companies will “continue to monitor the forthcoming recommendations and guidance from ACIP and CDC. As of today, there is no change in how plans cover the existing vaccines for the previously recommended populations,” according to AHIP, a national organization representing insurance companies.

“The ultimate goal of the vaccine is to keep people out of the hospital. But people could reasonably say, moderate infections aren’t fun either, so I’m going to choose and get this vaccine,” Offit noted. “I think that’s fine. I think it’s a reasonable choice. I just hope that we’re not restrictive.”

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(NEW YORK) — Cases of the new COVID-19 variant NB.1.8.1, a descendent of the Omicron variant, are on the rise in some parts of the world, according to the World Health Organization (WHO).

Currently, there are not enough cases in the United States to register in the Centers for Disease Control and Prevention’s COVID variant tracker.

Symptoms appear to be similar to other variants of COVID-19 and the public health risk remains low, WHO information shows.

The earliest sample of the NB.1.8.1 variant was collected on Jan. 22 and it was designated a variant under monitoring — which may require prioritized attention and monitoring — on May 23 by the WHO.

Since the omicron variant was detected in 2021, new cases of COVID have been dominated by hundreds of its descendent subvariants, though none have led to the rise in cases once seen during the peak of the pandemic.

As of May 18, there were 518 NB.1.8.1 cases detected from 22 countries, according to WHO. While still only comprising 10.7% of the global cases at the end of April, this is a significant rise from 2.5% four weeks prior.

“Remember, we’ve seen summer surges. One thing that COVID has done is it’s been able to surge in the summer, and it’s been able to surge in the winter, and that’s very different than respiratory viruses we’ve dealt with in the past. But we still don’t know if this is going to be the virus that leads to a summer surge, it’s just too early to know,” Dr. Todd Ellerin, chief of infectious diseases at South Shore Health, told ABC News.

While there are increases in reported cases and hospitalizations in some of the countries with the highest proportion of NB.1.8.1 circulating, there are no reports to suggest that disease severity is higher in this latest variant than other circulating variants of the virus.

“With each new variant, what we’ve seen is severity doesn’t really change so far, we’re not seeing it have more severe complications,” said John Brownstein, chief innovation officer at Boston Children’s Hospital and ABC News contributor. “What we know is that when a virus is more transmissible, it will ultimately infect more people and when you infect more people … you’ll have more cases of severe illness, hospitalization, and unfortunately death. “

Data from China and elsewhere doesn’t seem to show anything unique about the variant other than increased transmissibility, Brownstein added.

Some of the variant’s mutations found on the surface proteins of the virus could increase its transmissibility and potentially make it somewhat harder to treat compared to current variants in wide circulation, according to the WHO.

Approved COVID-19 vaccines are expected to remain effective against this variant, according to the WHO.

“This is the natural path we’ve seen with every variant, and so the guidance doesn’t really change at the end of the day,” Brownstein said. “It’s making sure people are up to date with their vaccines and boosters … and then of course, those that are immunocompromised or in high-risk groups may want to layer in other types of interventions like masking or being careful about large group settings where there could be increased risk of transmission.”

Niki Iranpour, MD, is an internal medicine resident at NewYork-Presbyterian/Weill Cornell Medical Center and a member of the ABC News Medical Unit.

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(WASHINGTON) — Health and Human Services Secretary Robert F. Kennedy Jr., one of the nation’s most publicly recognized vaccine skeptics, took a softened approach on vaccines when he answered questions before a House committee Wednesday morning, avoiding sharing his personal views and instead deferring to the doctors running the National Institutes of Health and Centers for Disease Control and Prevention.

Kennedy also defended the massive cuts to the department’s workforce and laid out his priorities for the Trump administration’s proposed budget.

After he appeared before the House Appropriations Committee Wednesday morning, he will head to the Senate Health, Education, Labor, and Pensions (HELP) Committee in the afternoon. The appearances mark the first time Kennedy has testified before Congress since his confirmation hearings in late January, and force him to confront statements he made that critics say are evidence of promises broken.

Kennedy says his ‘opinions about vaccines are irrelevant’

During the House hearing, Kennedy avoided sharing his own thoughts about vaccines — which have previously invited skepticism.

Asked by Democratic Rep. Mark Pocan if he would today vaccinate his own children for measles and chickenpox, Kennedy said “probably” for measles, but that “what I would say is my opinions about vaccines are irrelevant.”

“I don’t want to seem like I’m being evasive, but I don’t think people should be taking advice, medical advice from me,” Kennedy said.

He said he has directed NIH Director Jay Bhattacharya to try to “lay out the pros and cons, the risks and benefits, accurately as we understand them, with replicable studies,” for people to “make that decision.”

His comments mark a departure from his strong opinions about vaccines before taking office as HHS secretary.

During his confirmation hearing in January, Kennedy said that he supports vaccines, although he refused to unequivocally say that vaccines don’t cause autism, despite numerous existing studies already showing there is no link. However, in March, the HHS confirmed that the CDC will study whether vaccines cause autism.

Shortly after Kennedy said people should not take his medical advice, some public health experts criticized the comments — one of whom said that giving people guidance “is [Kennedy’s] job.”

“The problem is that is his job — the top line of his job description — is the nation’s chief health strategist. That is the top line of every health official, federal, state, local leader. That is his job, is to give people the best advice that he can. I believe that he’s giving up on, in my view, his chief responsibility,” Georges Benjamin, executive director of the American Public Health Association, told reporters on a call in which he and other health leaders responded to Kennedy’s testimony in front of the House Appropriations Committee.

Benjamin pointed out that Kennedy has, in fact, seemed to advise people on how to treat measles, leading them toward unproven remedies.

‘Because of these cuts people will die’

Kennedy continued to maintain that widespread cuts at HHS have not impacted key health programs, saying he has not withheld any funding for lifesaving research at NIH and continues to prioritize pillars such as Head Start, Medicare and Medicaid.

But in a tense back-and-forth with Democratic Rep. Rosa DeLauro, ranking Member of the House Appropriations Committee, she demanded Kennedy’s assurance that he would not cut programs that have been approved and funded by Congress, which has “the power of the purse” ascribed to it in the Constitution.

Kennedy said he would spend appropriated money — which drew repeated exasperation from DeLauro, who pointed to $20 billion in cuts to NIH.

In April, HHS began laying off about 10,000 workers and consolidating 28 institutes and centers into 15 new divisions.

Including the roughly 10,000 people who have left over the last few months through early retirement or deferred resignation programs, the overall staff at HHS is expected to fall from 82,000 to around 62,000 — or about a quarter of its workforce.

Kennedy said his goal at HHS is to focus on the chronic disease epidemic and deliver effective services for those who rely on Medicare, Medicaid and other services by cutting costs to taxpayers.

“We intend to do more, a lot more with less. The budget I’m presenting today supports these goals and reflects two enduring American values, compassion and responsibility,” Kennedy said in his opening statement.

DeLauro slammed Kennedy and the Trump’s administration for the cuts to HHS, including the elimination of entire divisions.

“Mr. Secretary, you are gutting the life-saving work of the Department of Health and Human Services and its key agencies while the Republicans in this Congress say and do nothing,” DeLauro said. “Because of these cuts people will die.”

DeLauro also finished the hearing with an impassioned plea for Kennedy to stop cutting programs, telling him he does not have the authority to go against what Congress allocated in the budget.

“You do not have the authority to do what you are doing,” she said.

Kennedy defends measles outbreak response

Kennedy rebuked criticism of his agency’s response to the measles outbreak.

“We are doing a better job at CDC today than any nation in the world controlling this measles outbreak,” Kennedy said.

DeLauro hit back, saying that Kennedy’s comparison of the U.S. response to measles to the response of other countries was unfair.

“Mr. Secretary, you keep comparing the U.S. to other countries, compare us to Europe, but the Europe you are referring to is the WHO European region has 53 countries in Europe and in Asia, including those with low vaccine vaccination rates like Romania and that has never eliminated measles,” she said. “If you compare us to western Europe countries that we often compare ourselves to, like Great Britain, they have seen no measles death.”

Kennedy argued that the U.S. is doing better than other countries in the Americas with smaller populations, including Canada and Mexico.

DeLauro scolded Kennedy for promoting vaccine skepticism in the wake of a measles outbreak spreading across the U.S.

In the wake of several ongoing measles outbreaks across the U.S. and over 1,000 cases so far this year, Kennedy has shared contradicting views about vaccines.

In a post on X on April 6, Kennedy said that the “most effective way to prevent the spread of measles” is to receive the measles, mumps, rubella (MMR) vaccine. However, in a post later that evening, he said more than 300 children have been treated with an antibiotic and a steroid, neither of which are recognized treatments or cures for measles.

Dentist questions Kennedy’s fluoride comments

Kennedy’s controversial moves on fluoride came up with Republican Rep. Mike Simpson, a dentist, telling Kennedy he was concerned about the secretary’s comments on it.

Last month, Kennedy said he plans to assemble a task force and ultimately change the CDC’s guidance to stop recommending adding fluoride to drinking water and other products. He has claimed that fluoride in drinking water affects children’s neurological development.

The Food and Drug Administration said it will conduct a scientific review of fluoride-containing supplements sometimes used to strengthen children’s teeth by late October with the aim of removing them from the market.

“I’ve seen the benefits having been a practicing dentist for 22 years. … You don’t prevent cavities by fluoride killing the bacteria in the mouth,” Simpson said. “What it does is make the enamel more resistant to decay. So, I want to see the studies on this and where we’re headed with this.”

Previous reviews by public health experts and dental professionals have not shown any serious health risks with the addition of fluoride.

ABC News’ Sarah Beth Hensley and Anne Flaherty contributed to this report.

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