Richard H. Hughes, IV, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in The Hill, in “What to Know About COVID Vaccines for Children, Pregnant Women After RFK Jr.’s Change,” by Nathaniel Weixel.
Following is an excerpt:
The Department of Health and Human Services did not respond to questions about why the department bypassed the CDC panel and what will happen at its next meeting.
Kennedy made the announcement in a 58-second video posted to social platform X. He was flanked in the video by FDA Commissioner Marty Makary and Jay Bhattacharya, head of the National Institutes of Health (NIH).
The NIH is not involved in vaccine regulation.
Absent from the group was anyone representing the CDC, which may or may not have an acting director with the authority to sign off on vaccine recommendations. Susan Monarez, who had previously been acting director, is awaiting Senate confirmation and isn’t allowed to serve as acting director at the same time.
The HHS secretary isn’t typically involved in vaccine decisions. But without an acting CDC director, Kennedy personally signed off on the panel’s recommendations for chikungunya vaccines earlier this month.
He has not acted on the other recommendations from the same meeting, including the use of a meningitis vaccine and an expansion of RSV vaccines to high-risk adults ages 50-59. Reuters reported earlier this month that a Kennedy aide has questioned the RSV and meningitis vaccines.
Physicians say decision shouldn’t be cut and dried
There are no mandates for anyone to get the COVID-19 vaccine, and the number of people getting vaccinated has fallen sharply in recent years.
According to the latest CDC estimates, just 13 percent of eligible children and 14.4 percent of eligible pregnant women received the latest version of the coronavirus vaccine. As Makary and Bhattacharya noted, some other countries don’t recommend routine COVID shots for most healthy children.
But experts said the vaccines still provide a benefit, and the administration’s move left little room for nuance or debate about unintended consequences.
Cutting the shot from the CDC’s list of routine vaccines will make it much more difficult for people who want the shot to get it. Insurance companies will no longer have to cover it, and government programs such as Medicaid won’t either.
While COVID-19 is not at the top of the public’s mind, the CDC has said pregnant women and infants remain at high risk of complications from the disease. Vaccinating pregnant women extends the protection to their unborn child until the child is about 6 months old.
According to the CDC, maternal vaccination during pregnancy reduced the risk of COVID-19-related hospitalization by around 54 percent among infants during the first three months of life.
The American College of Obstetricians and Gynecologists (ACOG) in a statement said it was “concerned” and “extremely disappointed” by the move.
“As ob-gyns who treat patients every day, we have seen firsthand how dangerous COVID-19 infection can be during pregnancy and for newborns who depend on maternal antibodies from the vaccine for protection. We also understand that despite the change in recommendations from HHS, the science has not changed,” ACOG President Steven Fleischman said.
The Infectious Diseases Society of America said in a statement the move “does the opposite of what Americans have been asking for when it comes to their health—it takes away choices and will negatively impact them.”
As of Wednesday, the CDC still promoted the COVID shot on its website.
Administration sends mixed messages
Tuesday’s announcement came on the heels of a new framework for narrowing the approval of updated COVID vaccines, which the FDA rolled out last week.
Under the plan, new COVID-19 vaccines intended for healthy children and adults will need to go through lengthy placebo-controlled clinical trials before they can get approved. The updated vaccines will continue to be greenlighted for people aged 65 and older and people with at least one health condition that puts them at high risk for severe disease.
But Kennedy’s announcement is seemingly at odds with that policy.
A New England Journal of Medicine article, written by Makary and Vinay Prasad, the FDA’s top vaccine regulator, explicitly listed “pregnancy and recent pregnancy” as risk factors that put people at high risk for severe COVID-19 outcomes.
The CDC to date hasn’t published any clarifying information, including what conditions would make a pregnant person or child healthy or unhealthy. In the video announcement, none of the officials mentioned why they think pregnant women don’t need a COVID-19 shot.
According to the Infectious Diseases Society of America, “pregnancy is a well-established risk factor for severe COVID-19 complications, including preterm labor and birth, preeclampsia, heart injury, blood clots, hypertension and kidney damage. Infants and children may also develop severe disease and may suffer from prolonged symptoms due to long COVID, which can negatively impact their development.”
Move confirms, fuels fears around RFK Jr.
Kennedy has a long history of opposition to vaccines, and he petitioned the FDA in 2021 to revoke the emergency use authorizations of the COVID-19 vaccines. He also threatened to sue the agency if it authorized COVID vaccines for children.
Public health experts said his end-run around the CDC raises serious concerns about pulling back on even more vaccines.
“In my view, this marks the beginning of an era of vaccine recommendation scrutinization that extends far beyond COVID vaccines,” Richard Hughes IV, an attorney at Epstein Becker Green and former vice president of public policy at coronavirus vaccine manufacturer Moderna, wrote in an email.
“This is a concerning step by an HHS Secretary into directly determining which vaccines should and should not be recommended.”
