FDA approves updated COVID vaccines, limits eligibility to high-risk groups

In an unprecedented move, the Food and Drug Administration (FDA) has approved the next round of COVID-19 vaccines, but has limited its eligibility criteria.

The new imposed restrictions include limiting the updated COVID shots that target the LP.8.1 Omicron subvariant to the individuals aged 65 and older and those with specific health conditions that make them highly vulnerable to serious complications.

This marks a significant shift from previous guidelines, which didn’t place any restrictions on the age group, but instead made the vaccine accessible to all Americans aged 6 months and older.

The Health and Human Services Secretary (HHS) Robert F. Kennedy Jr. announced this decision. 

He said, “FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+). These vaccines are available for all patients who choose them after consulting with their doctors.”

This announcement is expected to make it far more difficult for healthy children and younger adults to get vaccinated ahead of the anticipated winter surge.

The move has generated widespread confusion and apprehension, with health professionals warning it could lead to more cases of increased hospitalizations and deaths.

Commenting on these restrictions, Dr. Tina Tan, president of the Infectious Disease Society of America at Northwestern University stated, “I’m worried that this puts the entire American population at risk.”

The shift in policy also highlights that the insurance companies may no longer cover the cost of the vaccine for those outside the approved groups, and pharmacists may be unable to administer shots without a prescription.

Doctors can still prescribe the vaccine as “offlabel” but it still creates a major barrier to access.

According to the major U.S. medical groups, including the American Academy of Pediatrics and the American College of Obstetricians and Gynaecologists, have criticized the new restrictions as “deeply troubling” and “unscientific,” issuing contradictory guidelines of their own that continue to recommend vaccination for all age groups and vulnerable populations, including pregnant women and young children.