FDA ends routine COVID shots for healthy young Americans

The Trump Administration announced yearly COVID-19 vaccines for healthy young adults and children will no longer be routinely approved.

In a major and controversial policy shift, the Federal Food and Drug Administration (FDA) announced in a New England Journal of Medicine article that updated COVID-19 vaccines will now require randomized, controlled trials for approval in healthy individuals from ages 6 months to 64 years.

This marks a departure from previous, decades-long practice where annual updates were approved based on immune response data, similar to the approach for influenza vaccines.

Under the new guidelines, only older adults and people with high-risk medical conditions will have access to updated COVID-19 vaccines, a change that will affect vaccine availability for over a 100 million Americans.

Dr. Bob England, Former Director of Maricopa County’s Department of Public Health, joined “Arizona Horizon” to discuss the FDA’s sudden policy change on the vaccine.

Dr. England discussed the change and how it affects vaccine licensing, or who will and won’t have normal access to updated COVID shots.

“They made an announcement that from now on the vaccine would only be licensed for only people over 65 years of age or people who had certain chronic conditions,” Dr. England said.

However, who the FDA is defining as at-risk is somewhat confusing.

“People who are obese are still on the list, people who are overweight who are also at higher risk were not included,” said Dr. England. “People who take care of very susceptible people at home, caregivers, were not on the list.”

The change in approval process for vaccines for those not on the high risk list will result in a much slower process, according to Dr. England.

“If a manufacturer wants their vaccine to be licensed to younger, healthier, maybe even somewhat high risk people but not on the list, they’re going to have to do a clinical trial with clinical end points,” said Dr. England.

“Often, it’ll be a different variant every year so far, so the point is you can’t do that trial until it’s circulating,” Dr. England said. “That’s going to be the next big respiratory disease season. You’ll get your data, you’ll submit it to the FDA, and by the time it’s approved, it’s a different variant.”

The concerns for Dr. England are bigger than just how COVID vaccines will be handled going forward.

“My biggest concern with this is that the very same logic, if you want to say that you need a full blown clinical trial to clinical end points for each variant of COVID, the same logic could apply to flu,” said Dr. England. “So that the next shoe to drop, maybe you’re going to have to study your flu vaccine from the beginning specific to this year’s circulating flu virus, by which time, it’s a different one.”