FDA Authorizes Updated COVID Vaccines With Restrictions

by Grace Chen

The Food and Drug Administration on Wednesday greenlit updated COVID-19 vaccines, but with a catch: their use is restricted for most age groups. Crucially, the agency rescinded the emergency authorization that had made shots available for healthy young children, meaning there’s no longer a COVID vaccine authorized for healthy kids under 5 years old.Pfizer’s shot previously filled that role.

This move leaves Pfizer, Moderna, and Novavax vaccines approved for all seniors. Though, for younger adults and children, availability is now limited to those with underlying health conditions. This creates notable hurdles for healthy individuals seeking vaccination.

For younger children, the situation is particularly stark: Moderna’s vaccine is only approved for those with health conditions, and Novavax’s isn’t available for anyone under 12. A Pfizer spokesperson stated last week that the decision was “not related to the safety and efficacy of the vaccine which continues to demonstrate a favorable profile.”

Did you know? – The FDA‘s decision restricts COVID-19 vaccine access for healthy children. This means no authorized vaccines for healthy kids under 5. Availability is now limited to those with underlying health conditions, creating hurdles for healthy individuals.

Conflicting Guidance Fuels Confusion

The FDA’s decision arrives as public health recommendations diverge. The American academy of Pediatrics (AAP) released its own vaccine guidance on Aug. 19,diverging from U.S. government advice for the first time in three decades. The AAP is “strongly recommending” COVID-19 shots for children ages 6 months to 2 years, with recommendations for older children left to parental discretion.

In contrast, the Centers for Disease Control and Prevention (CDC), under Health Secretary Robert F. Kennedy Jr., dose not recommend COVID-19 shots for healthy children of any age. Instead, the CDC suggests that children “may get the shots” in consultation with a physician. Kennedy had previously stated in May that the shots would no longer be recommended for healthy kids, a stance that health experts have deemed scientifically unfounded. The AAP, though, continues to endorse COVID-19 shots for children over 6 months old.

Pro tip: – Confused about vaccine recommendations? Consult your pediatrician. The AAP recommends shots for children 6 months to 2 years, while the CDC offers a more cautious approach. Discuss your child’s health with a doctor to make an informed decision.

dr.Céline Gounder, a medical contributor and public health editor, noted the “lot of noise out there” regarding vaccines. she advised parents to “stick the course and make sure that their children get all of the routine childhood vaccinations.”

Without the emergency use authorization for healthy children, families wishing to vaccinate their children may face out-of-pocket costs of around $200, as insurers typically cover only federally recommended vaccines. Though, some health systems and insurers, such as Blue Shield of California and Kaiser Permanente, have committed to continuing coverage for all age groups.

New Variants Emerge

The updated vaccines target the LP.8.1 strain, which has been prevalent in the U.S. and othre regions since earlier this year. With increased summer travel, CDC wastewater monitoring data indicates that the XFG variant, nicknamed “Stratus,”

Reader question: – What are your thoughts on the conflicting vaccine guidance? Do you find it confusing? Share your experiences and concerns about the availability and recommendations for COVID-19 vaccines for children in the comments.

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