The Food and Drug Administration of the United States (FDA) has approved updated vaccines updated for this fall, but with new restrictions that should limit access, especially for young children.
The Secretary of Health and Social Services Robert F. Kennedy Jr. made this announcement via the X social media platform, claiming that “the FDA has now issued marketing authorization for people more at risk …. These vaccines are available for all patients who choose them after consulting their doctors.”
The FDA has reduced its vaccine recommendations
The FDA now restricts cocovated shots updated to adults aged 65 and over as well as people under the age of 65 who have at least one underlying medical condition that makes them more sensitive to serious illnesses.
- Pfizer-biontech (Cournaty) for 5 to 64 years
- Modern (Spikevax) for 6 months to 64 years
- Novavax (Nuvaxovid) for 12 months to 64 years
Who is considered a high risk of severe covid-19?
- Cancer
- Chronic kidney disease
- Chronic liver disease
- Chronic pulmonary disease
- Cystic fibrosis
- Dementia
- Diabetes
- Handicap
- Heart disease
- HIV
- Be overweight or have obesity
- Smoking
- Have a compromise immune system
Policy change can particularly affect young children
Before that announced the change of FDA, federal health officials had largely recommended coastal vaccines for all people over 6 months old, including healthy children.
Now, the FDA under-secretary, Kennedy, no longer advises shots for healthy children, but says that the decision to obtain the vaccine should be the result of a “shared clinical decision” between parents and pediatricians.
Anyone can get a “out -of -label” updated vaccine, including for their children, if their doctor agrees. But fewer doctors may be willing to go against FDA recommendations, explains Andrew Pavia, MD, head of the pediatric infectious disease division, auxiliary professor of medicine at UTA University in Salt Lake City and spokesperson for the infectious Society for America.
“I expect this action from the FDA and RFK Jr. to limit access considerably, and it is not motivated by any change in security data or efficiency,” explains Dr. Pavia.
“If we have a major increase in the virus this winter, I expect that we will see more children become very sick with Covid,” he adds.
When will vaccines be available and will insurers pay?
“”The updated vaccine should start to be distributed fairly quickly, ”says Pavia.
Pfizer has announced that the shipment will immediately start “to ensure a solid supply and quick access to the pharmacies, hospitals and clinics of this season.”
The CDC has not yet approved for the new FDA COVI-19 vaccine policy, a decision that generally triggers insurance coverage.
Pavia says that if the CDC supports the new FDA directives, insurance companies may decide not to cover the cost of vaccination for healthy children and adults under the age of 65.
“The Lord only knows when the action of the CDC on this subject comes,” explains Pavia.
