FDA Authorizes Updated Covid-19 Vaccines With New Limitations

The FDA has approved a new COVID-19 vaccine for the upcoming fall season, but access will be limited to a small group of high-risk individuals.

The updated vaccines are authorized for people over 65, as well as for adults and children with at least one underlying health condition that increases their risk of severe illness.

Health and Human Services Secretary Robert F. Kennedy Jr. announced the decision on X, adding that the emergency use authorizations for COVID-19 shots have been rescinded.

Until now, the only vaccines that remained authorized were those for children 11 and under. The new restrictions, however, may limit access to shots for otherwise healthy children.

The president of the American Academy of Pediatrics AAP, Dr. Susan Kressly, described the decision “deeply troubling” in a statement.

Kreesly said the new restrictions will “create a dangerous vulnerability” for children and their families as we enter the respiratory virus season.

She added that these illnesses are particularly dangerous for toddlers and infants, whose lungs are still developing.

While doctors can still prescribe the COVID shots off-label to people not included in the FDA’s approval, it creates another barrier to access, as most individuals receive their vaccinations at pharmacies rather than in a doctor’s office.

The approval now heads to the CDC’s vaccine advisory committee, which will decide who should be eligible to receive the shots.

Previously, COVID-19 vaccines were recommended for everyone six months and older. Without insurance, a single dose can cost more than $140, according to the CDC’s vaccine price list.

So far, Kennedy has not specified which health conditions raise the risk of severe illness. However, the CDC lists dozens of such conditions, including cancer, diabetes, asthma, depression, and heart disease.

In recent weeks, several major medical organizations, typically aligned with CDC guidance, have issued their own vaccine recommendations.

Last week, the American College of Obstetricians and Gynecologists released updated guidelines, which recommended the COVID-19, RSV, and flu vaccines for pregnant women.

Earlier this month, the American Academy of Pediatrics also issued its own vaccination schedule, which included the COVID-19 shot.

The American College of Cardiology has also endorsed vaccines for COVID-19, RSV, and the flu for people with heart disease.

Driven by the new COVID variant, cases have been climbing in several parts of the U.S., particularly in the South and in California.

The CDC reports that hospitalizations and emergency room visits tied to COVID-19 have inched up in recent weeks, though levels remain far below those seen at this time last year.