New Covid-19 Vaccine Guidelines Leave Many with Questions
The FDA Commissioner recently revealed new guidelines for Covid-19 vaccines at a town hall meeting. No questions were allowed.
On May 20th, 2025, Marty Makary, the new FDA Commissioner, and Vinay Prasad, the new head of the Center for Biological Evaluation and Research (CBER), which regulates vaccines, sat in front of a crowd at a town hall meeting to discuss their new guidelines for Covid-19 vaccines. They recommended that everyone over 65 receive the yearly vaccine. For those less than 65, however, they recommended the yearly vaccine only for those in high-risk groups, even though the vaccine has been shown to offer some benefit to all groups. Typically, the FDA, which is a regulatory body, licenses vaccines; the CDC, which is a recommending body, determines who should get them. Now the FDA had usurped the CDC’s role.
Makary and Prasad argued that recommending the Covid vaccine for high-risk groups younger than 65 was in line with other countries. However, other countries haven’t restricted licensure to only high-risk groups. By restricting the license for yearly Covid vaccines, the FDA has made use in healthy younger people “off label,” which will likely affect insurance coverage. Although Makary and Prasad didn’t allow questions, here are some that might have been asked:
“I am a pharmacist who gives dozens of Covid-19 vaccines every day. Am I supposed to determine whether someone is in a high-risk group before I give the vaccine? And how could I possibly know whether people are telling the truth. Will I get into trouble if I give a Covid vaccine to a healthy young person?”
“My child is a healthy five-year old. He has never received a vaccine and never been naturally infected. I’m worried as the virus that causes Covid continues to circulate. Can he get the vaccine?”
“My best friend is 35-years old and otherwise healthy. She had been vaccinated a couple of years ago but recently suffered a Covid infection, which caused her to stay home for a few days with coughing, chills, muscle aches, and a high fever. Like her, I am young and healthy but want to avoid this infection. Can I still receive the Covid vaccine? And, more importantly, will my insurance company pay for it now that technically it is an “off-label” use.”
“I take care of my elderly grandparent, who is disabled. I want to decrease the chance that I catch Covid and give it to him. I am less than 65 and otherwise healthy. Can I still get this vaccine? Also, Secretary Kennedy has said that getting a Covid vaccine was a “personal choice.” It seems to me that the FDA has taken that choice away from me.”
“I am a single, working mom who cares for 5 children. I am young and otherwise healthy. I can’t afford to miss any more time from work. The yearly Covid vaccine, along with the yearly flu vaccine, lessens the chance that I will miss work. Why won’t the FDA allow me to receive this vaccine?”
“I am the mother of a child who is suffering from cancer. Because of his weakened immune system, he can’t be effectively vaccinated. By getting a yearly Covid vaccine, I can protect him against this occasionally deadly infection. Although I am young and otherwise healthy, why isn’t my situation included in your list of high-risk categories?”
“I’ve read that vaccines reduce the risk of long Covid. A friend of mine has long Covid and she was quite debilitated. Like my friend, I am young and otherwise healthy. It seems to me that you don’t have to be in a high-risk group to get long Covid. Am I allowed to receive the yearly Covid vaccine?”
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During their town hall meeting, both Drs. Makary and Prasad used the word “transparency” several times. Nonetheless, they made their decisions about Covid-19 vaccines without input from their own advisory committee, without allowing for public comment, and without making themselves available for questions from the media or medical groups. RFK Jr. talks endlessly about ushering in a new era of “radical transparency.” Regarding these new recommendations, however, the opposite appears to be true.
For insurance, I suggest people start writing to their *state* legislators to ensure continued coverage of covid (and other) vaccines. The states have primary jurisdiction over insurance in the US, because of the McCarran-Ferguson Act of 1945.
Vaccines have been one of the greatest medical advances of all times. Jefferson wrote Jenner a congratulatory letter predicting his vaccination would eliminate smallpox. It was a long time coming, but on that point Jefferson was right. Anti vaccination thinking has been present throughout the history of vaccination. Yet vaccines continue to prevent disease and save lives. The development and testing of vaccines has improved, and the Covid-19 vaccines have been more intensely studied than older vaccines and found to be safe and effective. Now we are dealing with a regime that questions vaccines, but has not the training or perspective to understand the issues. Bias and misinformation at least are guiding their decisions. Pathways to recommendations, such as the FDA bypassing advisory boards and the CDC, are revised to eliminate expertise and transparency. There are clearly those in the FDA who are still there who could point out to the public the danger to public health, which is shared by all, and it’s implications to health and demonstrate the autocratic take over of all levels government. Government is for public good as is public health, this administration is an opponent of each.