FDA approves fall Covid shots, but with new restrictions

The updated Covid shots are approved for adults 65 and older as well as for kids and adults with at least one medical condition that puts them at risk of severe illness.
Kennedy announced the approval in a post on X.
“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” Kennedy wrote. “These vaccines are available for all patients who choose them after consulting with their doctors.”
Kennedy also said that emergency use authorizations for the vaccines had been rescinded.
The only shots that had been still been authorized under an EUA were kids ages 11 and under. The move could hinder access to shots for healthy kids.
In a statement, Dr. Susan Kressly, president of the American Academy of Pediatrics AAP, called the decision “deeply troubling.”
“As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing,” Kressly said.
Doctors will still be able to prescribe the vaccines off-label, to people not specified in the FDA approvals. However, that adds yet another barrier to access as many people get their shots at the pharmacy, not prescribed through a doctor.
The approval is expected to go to the Centers for Disease Control and Prevention's vaccine advisory committee, which will make a recommendation on who should be able to get the shots. In June, Kennedy fired all 17 members of the panel and replaced them with his own picks, including several Covid vaccine skeptics.
The new restrictions — which were expected — are likely to affect what insurers cover for people who don’t qualify for the updated Covid shots.
Prior to this change, the CDC recommended Covid shots for everyone 6 months and older.
A Covid shot can cost up to $140 without insurance, according to the CDC’s vaccine price list.
In his post, Kennedy did not specify which medical conditions put a person at a higher risk of severe illness. However, the CDC website lists dozens of conditions either linked to or suggestive of higher risk, including asthma, cancer, heart conditions, diabetes, disabilities and depression.
…

7 comments

So dumb. I hate that these morons are dictating that I can't protect myself with a vaccination unless I get my doctor to prescribe it and pay for it out of pocket.
- profit. it is always about profit.
- At least, for the moment, they're still allowed
  Soon the FDA will no longer allow them because the worm told them so
- Then make sure this is what guides your vote in upcoming elections and not whether the non-Trump candidate hates Israel enough.
I love that my ass with an autoimmune disease will suffer more because of these assholes
The updated Covid shots are approved for adults 65 and older as well as for kids and adults with at least one medical condition that puts them at risk of severe illness.
Kennedy announced the approval in a post on X.
“FDA has now issued marketing authorization for those at higher risk: Moderna (6+ months), Pfizer (5+), and Novavax (12+),” Kennedy wrote. “These vaccines are available for all patients who choose them after consulting with their doctors.”
Kennedy also said that emergency use authorizations for the vaccines had been rescinded.
The only shots that had been still been authorized under an EUA were kids ages 11 and under. The move could hinder access to shots for healthy kids.
In a statement, Dr. Susan Kressly, president of the American Academy of Pediatrics AAP, called the decision “deeply troubling.”
“As we enter respiratory virus season, any barrier to COVID-19 vaccination creates a dangerous vulnerability for children and their families. Respiratory illnesses can be especially risky for infants and toddlers, whose airways and lungs are small and still developing,” Kressly said.
Doctors will still be able to prescribe the vaccines off-label, to people not specified in the FDA approvals. However, that adds yet another barrier to access as many people get their shots at the pharmacy, not prescribed through a doctor.
The approval is expected to go to the Centers for Disease Control and Prevention's vaccine advisory committee, which will make a recommendation on who should be able to get the shots. In June, Kennedy fired all 17 members of the panel and replaced them with his own picks, including several Covid vaccine skeptics.
The new restrictions — which were expected — are likely to affect what insurers cover for people who don’t qualify for the updated Covid shots.
Prior to this change, the CDC recommended Covid shots for everyone 6 months and older.
A Covid shot can cost up to $140 without insurance, according to the CDC’s vaccine price list.
In his post, Kennedy did not specify which medical conditions put a person at a higher risk of severe illness. However, the CDC website lists dozens of conditions either linked to or suggestive of higher risk, including asthma, cancer, heart conditions, diabetes, disabilities and depression.
…
- even those who get vaccinated are still going to be exposed to a higher viral load from the increased number of people who won't be able to get vaccinated