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FDA approves new Covid shots with limits on who can get them under RFK Jr.

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FDA approves new Covid shots with limits on who can get them under RFK Jr.


Pfizer’s Covid vaccine Comirnaty, seen at a CVS Pharmacy in Eagle Rock, California, Sept. 14, 2023.

Irfan Khan | Los Angeles Times | Getty Images

The Food and Drug Administration on Wednesday approved the latest round of Covid vaccines in the U.S., but set new limits on who can get them.

The agency ended its broader authorization of the shots, only clearing them for people at higher risk of severe illness. That includes those 65 and up and younger adults with at least one underlying condition that puts them at higher risk.

The move could complicate access to the shots for millions of Americans, and raises questions about whether insurance plans will still cover them for healthy adults.

“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Health and Human Services Secretary Robert F. Kennedy Jr. said in a post on X.

“The American people demanded science, safety, and common sense,” he said. “This framework delivers all three.”

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It follows several efforts by Kennedy, a prominent vaccine skeptic, to change immunizations in the U.S. The new limited authorizations are a break from U.S. vaccine policy in previous years, which recommended an annual Covid shot for all Americans 6 months and up.

A key panel of vaccine advisors to the Centers for Disease Control and Prevention must vote to recommend the Covid shots. But Kennedy earlier this year gutted that panel and named new members, some of whom are widely known vaccine critics.

In the post, Kennedy said the shots are available for all patients who choose them after consulting with their doctors. But it’s unclear how easily patients without high-risk factors will be able to get a Covid vaccine.

Kennedy said the FDA has authorized Moderna‘s shot for those 6 months and up, Pfizer‘s vaccine for people ages 5 and up, and Novavax‘s jab for those ages 12 and up, but only for those specifically at higher risk of getting severely sick from the virus.

Adults ages 65 and up are at higher risk of severe Covid, and so are younger adults who are immunocompromised or have underlying medical conditions such as cancer, obesity, diabetes, chronic kidney disease and heart diseases, according to the CDC‘s website.

The end of the so-called emergency use authorizations means that Pfizer’s shot is no longer cleared for children ages 6 months to 4 years. It comes after Pfizer in August said it has requested that the FDA keep that authorization in place for the upcoming fall and winter season.

In a release, Pfizer confirmed that the FDA had cleared its updated Covid shot for use in adults 65 and above and those ages five through 64 with at least one underlying condition that puts them at high risk for severe illness. The company will begin shipping the shot immediately, and it will be available in pharmacies, hospitals and clinics nationwide “in the coming days.”

In a separate release, Moderna also confirmed that its updated Covid shot is approved for those 65 and up and people 6 months through 64 years of age who are at higher risk of severe illness. The company added that its new, next-generation Covid vaccine is approved for older adults and high-risk patients ages 12 through 64. Moderna said it expects the shots to be available in the coming days.

Shares of Pfizer and Moderna were trading slightly higher Wednesday afternoon, while Novavax shares dipped.

In May, the CDC dropped the recommendation that pregnant women and healthy children receive Covid shots. But the American Academy of Pediatrics diverged from the agency earlier this month, recommending Covid shots for children between 6 months and 2 years old.

In a statement on Wednesday, Dr. Susan Kressly, president of the American Academy of Pediatrics, called the FDA’s more limited approval “deeply troubling.” She said respiratory illnesses like Covid can be “especially risky for infants and toddlers, whose airways and lungs are small and still developing.”

“Any parent who wants their child vaccinated should have access to this vaccine,” she said. “Today’s unprecedented action from HHS not only prevents this option for many families, but adds further confusion and stress for parents trying to make the best choices for their children.”

She said the AAP urges the administration to “allow these choices to remain with medical experts and families.”

The American College of Obstetricians and Gynecologists also advised pregnant women to get the Covid vaccine to protect themselves and their infants, who cannot be immunized until they are 6 months old.

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Netflix co-founder Reed Hastings to step down as chairman

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Netflix co-founder Reed Hastings to step down as chairman



Hastings set up the company in 1997, when it rented DVDs to customers and delivered by post.



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Trump nominates Erica Schwartz as CDC director amid turmoil around leadership, vaccine policy

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Trump nominates Erica Schwartz as CDC director amid turmoil around leadership, vaccine policy


Rear Admiral Erica G. Schwartz.

U.S. Department of Health and Human Services

President Donald Trump on Thursday nominated Erica Schwartz to serve as director of the Centers for Disease Control and Prevention, concluding a monthslong effort to choose a permanent leader of the embattled health agency. 

Schwartz, who will have to be confirmed by the Senate, would take over the role as Health and Human Services Secretary Robert F. Kennedy Jr. oversees a string of controversial health policy changes at the agency, including an overhaul of childhood vaccine recommendations.

Schwartz served as deputy surgeon general during the first Trump administration, where she played a major role in the U.S. response to the Covid-19 pandemic. She spent more than 20 year in uniform, including as rear admiral and chief medical officer of the Coast Guard.

Dr. Jay Bhattacharya had been acting director of the CDC — a title that expired last month under federal law. That law, called the Vacancies Act, limits the amount of time an acting officer can serve in place of a Senate-confirmed official to 210 days. 

Late last month marked 210 days since the most recent CDC director, Dr. Susan Monarez, was fired

A sign sits outside of the Centers for Disease Control and Prevention (CDC) Roybal campus in Atlanta, Georgia, U.S. March 18, 2026.

Megan Varner | Reuters

She has so far been the only person to serve as a confirmed CDC director during Trump’s second term, holding the role for under a month last summer. In congressional testimony in September, Monarez said she was fired after refusing Kennedy’s demands to approve vaccine recommendations she believed lacked scientific support.

It is unclear how Schwartz’s views on vaccines or other key public health policies compare with Kennedy’s.

Also on Thursday, Trump said he chose Sean Slovenski as deputy CDC director and chief operating officer, and Jennifer Shuford as deputy CDC director and chief medical officer. Shuford, as head of the Texas Department of State Health Services, led the state’s response to a massive measles outbreak last year, and credited vaccination and testing in declaring it over.

Schwartz’s nomination comes after a tumultuous several months for the agency, which is reeling from the leadership upheaval, plummeting morale, significant staff turnover and controversial changes to U.S. vaccine policy. Ahead of leadership departures last year, staff members were shaken by a gunman’s attack on the CDC’s Atlanta headquarters on Aug. 8. 

Last month, a judge blocked a critical vaccine panel’s efforts to overhaul U.S. immunization policy. That includes an effort to reduce the number of recommended childhood shots from 17 to 11.

Trust in federal health agencies has plummeted during Kennedy’s tenure as Health and Human Services secretary, according to a February poll from health policy research group KFF, with declines across the political spectrum.

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RFK Jr.’s peptide policy could boost Hims & Hers as its GLP-1 business evolves

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RFK Jr.’s peptide policy could boost Hims & Hers as its GLP-1 business evolves


Piotr Swat | Lightrocket | Getty Images

As its high-margin compounded GLP-1 business evolves, Hims & Hers Health may be finding a new opportunity in peptides.

Shares of the telehealth company jumped Thursday after HHS Secretary Robert F. Kennedy Jr. announced Wednesday that the FDA plans to convene a Pharmacy Compounding Advisory Committee meeting to review peptides for potential inclusion on the 503A bulk list, a designation that allows drugs to be compounded on an individual prescribed basis rather than mass producing.

For Hims, the bigger story is how expanding compounding for peptides could unlock new revenue streams as it directs members toward branded rather than more profitable compounded GLP-1 drugs. The telehealth company has been building toward a peptide business for years.

Peptides are short chains of amino acids — think of them as small building blocks of proteins — that are being explored for a wide range of health and wellness uses. They’re controversial because scientific evidence on their long-term safety and effectiveness is limited, and their production remains largely unregulated.

Hims & Hers made a significant move into the space in February 2025 when it acquired a California-based peptide facility. At the time, CEO Andrew Dudum called peptide demand “future-facing innovation.”

“Many use cases have yet to be launched,” said Dudum. “Peptide innovation is at the forefront of so many categories we’re excited to start offering.”

Following Kennedy’s announcement on Wednesday, Hims Chief Medical Officer Dr. Patrick Carroll applauded the news as a move away from the “gray market,” saying the goal is to bring peptide therapy into regulated, physician-led care.

“Our medical team believes certain peptide therapies hold meaningful potential in helping Americans live healthier lives, and we are actively exploring how to expand access in a way that will be aligned with FDA guidance,” Carroll said.

Leerink Partners called the news that the FDA will review peptides for the compounding list a positive outcome that could give Hims a clearer regulatory path to scale peptide therapies. Even so, the firm said it will take time for peptides to boost the company’s bottom line.

“This would not immediately translate into revenue, but would seemingly be a growth avenue that HIMS would push hard on,” said Leerink analyst Michael Cherny, who has a hold-equivalent rating on the stock and a $25 price target. It was trading around $26 a share Thursday.

For now the opportunity is still early, and clinical evidence supporting many peptide therapies is still limited.

Of the dozen peptides listed by Kennedy for consideration on the compounding bulk list, one — MK-677 — is often treated as an illegal drug when sold for human consumption. The growth hormone has also been banned by the World Anti-Doping Agency.

Other peptides on the list, such as GHK-Cu and Semax, which are used for cosmetic or cognitive enhancement, are generally viewed as less controversial, but still lack robust scientific backing.

Kennedy — who has supported many medical treatments and food options outside of those backed by mainstream science — was asked about his plans for expanding peptide therapies during a House Ways and Means Committee hearing Thursday.

“Peptides were not supposed to be regulated,” Kennedy said, arguing the Biden administration restricted the use of peptides due to safety concerns that he considers unfounded.

The FDA process is just beginning, and the July meeting will be advisory only, so change is not expected to be immediate.

Even so, investors are already focusing on what replaces GLP-1 driven growth for Hims, and peptides are emerging as one of the clearest candidates so far.

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