The argument for narrowing the use of the updated COVID-19 vaccines likely stems from collected safety and efficacy data. Regulators believe that the vaccines are most beneficial for certain age groups or high-risk populations, while the risks or limited benefits for others, particularly young children, may outweigh the advantages.
[snip]
The new vaccines from Pfizer, Moderna, and Novavax are authorized for all seniors. For younger adults and children, however, the Food and Drug Administration limited eligibility to those with at least one high-risk health condition, such as asthma or obesity.
A Novavax spokesperson projected its vaccine would arrive in early fall.
Pfizer’s vaccine will no longer be available for children under five, as the FDA revoked its emergency use authorization for that age group. However, pro-vax parents can still turn to Moderna, whose mRNA vaccine, Spikevax, retains FDA approval for children as young as six months. With Pfizer, its use is now restricted to children with at least one serious health condition.
[snip]
The new distribution guidelines, first outlined by FDA officials in May, represent a major departure from the previous U.S. policy, which recommended annual COVID-19 mRNA shots for everyone aged six months and older.
“The American people demanded science, safety, and common sense. This framework delivers all three,” Kennedy stated on social media.
Novavax’s COVID-19 vaccine is authorized only for individuals 12 and older and is subject to the same risk-based restrictions now applied to Moderna and Pfizer. It remains the nation’s sole traditional, protein-based COVID-19 shot.
Some medical organizations, including the American Academy of Pediatrics, have since criticized the restrictions, warning they might “limit access” for families seeking to “protect their children.”
[snip]
Earlier this year, Kennedy Jr. shook up the CDC advisory panel by bringing in more critically thinking doctors and researchers known for questioning the safety of mRNA vaccines. Kennedy Jr. has also frequently portrayed himself as a “critical thinker” regarding vaccines — framing his stance as a challenge to a scientific consensus compromised by conflicts of interest.
The panel is set to meet in September, though officials have yet to release any plan.
[snip]
On Wednesday, Kennedy announced that the government had not only revoked the emergency use authorization of Pfizer’s COVID-19 vaccine for young children but also withdrew the remaining authorizations for all other pandemic-era vaccines, as well as convalescent plasma, a therapy once used to treat hospitalized patients before the advent of antiviral drugs.
* Original Article:
FDA authorizes ‘updated’ COVID-19 vaccines, with restrictions for certain groups