- The FDA has approved updated, more restricted COVID-19 shots targeting high-risk groups.
- Existing vaccination mandates have been rescinded as part of vaccination policy changes.
- The new CDC advisory committee, including vaccine skeptics, will determine future vaccine recommendations.
Health and Human Services Secretary Robert F. Kennedy Jr. announced Wednesday that the U.S. Food and Drug Administration has approved updated COVID-19 shots, but they’ll be available with more restrictions than in the past.
In a post on X, Kennedy said the emergency use authorization for COVID-19 vaccines “are now rescinded” and vaccine mandates are no more. Instead, there are now marketing authorizations with age requirements and the vaccines are intended solely for those “at higher risk” of developing severe COVID-19 symptoms without vaccination.
According to the Associated Press, “That presents new barriers to access for millions of Americans who would have to prove their risk — and millions more who may want to get vaccinated and suddenly no longer qualify."
Under the new authorization, Moderna’s vaccine will be available to those at least 6 months old, while Pfizer-BioNTech’s cannot be given to those younger than 5. The Novavax vaccine, which is not an mRNA vaccine like the others, is for those 12 and older. But there are health restrictions. They are no longer intended for healthy children or adults younger than 65.
Still, Kennedy said in the post that “these vaccines are available for all patients who choose them after consulting with their doctors.”
Per AP, “Parents will still be able to seek out shots from rival drugmaker Moderna, the other maker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem.”
Kennedy’s post also touted that the vaccine manufacturers will have to do placebo-controlled trials.
Extra steps and less access?
Some have interpreted Kennedy’s announcement to mean folks who aren’t at least 65 will have to visit their doctor and either get the vaccine or a prescription for it, rather than booking directly with a pharmacy. Axios pointed out that it’s also not clear whether insurance will generally pay for the vaccines. And AP noted that “many states limit vaccinations by pharmacists to those recommended by the CDC panel.”
That’s another twist. The vaccines still need to be recommended by the CDC advisory panel that deals with vaccine questions. Kennedy fired the entire panel and replaced it with new members, including some who have shown vaccine skepticism. The panel is supposed to meet in September, but so far no specific date or agenda has been released.
The New York Times reported that efforts to rein in who has access to the vaccines “have been tempered, to some degree, by the White House, where President Trump remains proud of Operation Warp Speed, which was widely recognized as an impressive feat of science, organization and execution to develop and deliver vaccines that helped bring the pandemic to an end.”
The article noted that during a cabinet meeting Tuesday, the president said, “Operation Warp Speed, people say, is one of the greatest achievements ever in politics or in the military — because it was almost a military procedure.”
In its own news release, Pfizer and BioNTech said shipping of their vaccine would begin immediately to pharmacies, hospitals and clinics across the country. Their COVID-19 vaccine, the company said, was approved “for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
Who’s at higher risk?
The CDC in February published a list of conditions that it says place someone at high risk of severe COVID-19, noting age is the biggest risk factor. That list was created to provide guidance to health care providers. Besides older adults, it said that “patients with one or multiple certain underlying medical conditions are also at higher risk.” And it added that "being unvaccinated or not being up to date on COVID-19 vaccinations also increases the risk of severe COVID-19 outcomes."
Clearly some of the general thinking within Health and Human Services has changed, which could contribute to uncertainty or confusion.
According to the February CDC guidance — which may no longer apply — high-risk conditions that have undergone a systematic review to determine if they increase risk include asthma, cancer, cerebrovascular disease, chronic kidney disease, several but not all lung diseases, several but not all liver diseases, cystic fibrosis, type 1 and type 2 diabetes, certain disabilities including Down syndrome, heart conditions, HIV, mood disorders and schizophrenia spectrum disorders, dementia, Parkinson’s disease, obesity, physical inactivity, pregnancy and recent pregnancy, primary immunodeficiencies, past or current smoking, organ or blood stem cell transplantation, tuberculosis and use of immunosuppressive medications.
Since that was published, Kennedy and his colleagues have indicated that, among other things, they don’t believe pregnant women should automatically seek a vaccine.
The list of disabilities said to increase severe COVID-19 risk is long, but many disabilities are not on the list.
There are also conditions that might impact severity, such as epilepsy or substance use disorders, as well as some with mixed or little evidence they could make COVID-19 worse.
Professionals pushing back
Meanwhile, professional health groups have been issuing their own — and contradictory — advice. The American College of Obstetricians and Gynecologists said it still advises pregnant women to get the COVID-19 vaccine, to protect themselves and their unborn children, who will be too young to get the vaccine themselves.
And as Deseret News has reported, the American Academy of Pediatrics said it will continue to recommend COVID-19 vaccines for children over 6 months old.