CDC ends Covid vaccine recommendation for healthy kids and pregnant women

The Centers for Disease Control and Prevention will no longer recommend routine Covid shots for healthy children and pregnant women, Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday.

“We are now one step closer to realizing @POTUS’s promise to Make America Healthy Again,” he said in a post on X.

Kennedy said the vaccine would no longer be recommended for “healthy pregnant women,” but it was unclear who would qualify as pregnancy itself is considered a risk factor for Covid complications.

The change from the CDC comes a week after Food and Drug Administration Commissioner Dr. Marty Makary announced the agency planned to restrict the use of Covid shots to older adults and children and adults with underlying medical conditions.

New Covid shots for healthy children and adults will need to go through lengthy placebo-controlled clinical trials before they can get approved.

Kennedy has a long history of opposition to a variety of vaccines, including the Covid shot. In 2021, he filed a citizen petition requesting that the FDA revoke the authorization of the vaccines. The same year, he described the Covid vaccines as “the deadliest vaccine ever made,” specifically due to rare cases of myocarditis in young men. Studies have found that the risk of myocarditis is higher in people with a Covid infection and usually more severe than after vaccination. 

Under Kennedy, the FDA slow-walked the approval of Novavax’s shot before approving it earlier this month. In an unusual move, the FDA limited its use to people 65 and older and teens and adults with at least one condition that puts them at risk for severe illness.

There are no mandates in the U.S. for anyone to get the Covid shot.

But experts say that millions of people, even those who have had a previous Covid infection, still may need another dose because they are vulnerable to severe disease from the virus, particularly older adults, people with weakened immune systems and pregnant women. 

At the height of the Covid pandemic, doctors reported an unprecedented surge in pregnant women hospitalized and in critical condition after a Covid infection.

Changes in a woman’s immune system during pregnancy increases the risk of complications like pneumonia from many respiratory viruses, including Covid. Last month, researchers at Brown University School of Public Health published a study finding that maternal deaths spiked when the pandemic hit.

While Covid cases, including related hospitalizations and deaths, are currently low, the virus is still circulating.

“We still have children in our emergency department with Covid. When we see them, they have bronchiolitis or bronchitis,” said Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Pennsylvania. “Do they consider that not worthy of prevention?”

The CDC previously recommended Covid vaccines across the board for everyone 6 months and older.

“One of the things that I relied on as a pediatrician was an assurance that the recommendations that came to me were based on the best available science and evidence, and came from the work of the expert advisors to the CDC,” said Dr. Richard Besser, former acting director of the CDC and president of the Robert Wood Johnson Foundation.” This is clearly not coming from that direction, and that’s greatly concerning.”

There are concerns among infectious disease and vaccine experts whether Covid vaccines will be available at all for fall. In 2024, boosters were approved by August and they were widely available by October.

The FDA’s vaccine advisory committee met Thursday to make a recommendation on which strains should be included in the next round of shots. Summer waves of Covid have occurred each year since 2020 before rising again in the fall and winter during the typical flu season.

There’s no indication yet that the U.S. is entering a wave this summer, but experts are keeping a close eye on the latest variant, called LP.8.1.

The variant is an Omicron offshoot. In February, the World Health Organization said that it was monitoring LP.8.1. As of May 10, it made up 70% of Covid cases in the U.S. The CDC was expected to provide a more current look at the variant breakdown May 24, but hasn’t yet done so.

The WHO is also monitoring another variant, NB.1.8.1, which has been reported in several states.

The anticipated rollout of the shots this fall might be at risk after a significant change under guidance from Kennedy and Makary in how the vaccines are tested.

Under the change by Kennedy, all new vaccines will need to go through placebo-controlled clinical trials — where some people get the actual shot and others get something inactive, like a saline shot — to compare the results. 

The original Covid vaccines, from Pfizer and Moderna, approved in late 2020, went through placebo-controlled trials.

If the FDA deems Pfizer’s and Moderna’s updated vaccines as “new” products, requiring fresh trials, it’s extremely unlikely doses would be ready for the fall for anyone, including seniors or the severely immunocompromised.

The CDC’s recommendation is crucial because it guides insurance companies on which vaccines to cover at no cost to patients.

Pfizer and Moderna are charging up to $150 per dose for a Covid vaccine, according to the CDC’s vaccine price list. The agency doesn’t list the cost of the Novavax vaccine, which was fully approved earlier this month.

Medicare and Medicaid require that the vaccines are free for patients. The Affordable Care Act, more commonly known as Obamacare, requires private insurers to cover all vaccines that are recommended by the CDC’s vaccine committee and director.

Children without insurance can get free vaccines through the government-run Vaccines for Children Program. But massive cuts to health care funding unveiled in March forced some local and state health departments to lay off staff and cancel vaccine clinics.

If the CDC stops recommending Covid vaccines for children or pregnant women, the question arises: Will private insurance or Medicaid continue to cover the cost of the new boosters?

“It will be a cascade of events,” Offit said. “It’ll be insurance companies may not pay for it, the vaccine for children’s program may not pay for it, but therefore more expensive, less available and less used.”