COVID-19 vaccines approved by FDA solely for individuals at ‘high risk’

FDA Updates Approval for Covid-19 Vaccines

On Wednesday, the Food and Drug Administration (FDA) greenlit an updated version of the Pfizer and Moderna Covid-19 vaccines for this respiratory season. However, it has restricted approval, focusing mainly on older adults and those considered at high risk for severe infections, which, perhaps, narrows the eligibility considerably.

Moderna has confirmed that its updated SpikeVax vaccine received FDA approval, specifically aimed at the LP.8.1 variant of SARS-COV-2.

According to the company, “The updated SpikeVax formula is currently approved for individuals between the ages of 6 months and 64 who have at least one underlying condition that puts them at high risk for severe Covid-19 outcomes, as well as for all adults aged 65 and over,” as noted in their press release.

Pfizer’s updated vaccine, known as Comirnaty, has been authorized for adults over 65 and individuals aged 5 to 64 who also have at least one underlying health condition, putting them at risk for severe complications from the virus.

In explaining the updated shot, Pfizer mentioned in a statement that “The application also included data from preclinical models suggesting that the LP.8.1-ADAPTED MONOVALENT COVID-19 vaccine induces stronger immune responses against various circulating SARS-COV-2 sublineages.” This seems to indicate that it’s more effective compared to prior vaccines.

This update also encompasses patients from last year who were vaccinated at least six months ago; they are now eligible for a dose of either the Moderna or Pfizer vaccine.

Secretary of Health and Human Services (HHS), Robert F. Kennedy Jr., has taken steps to limit the vaccine’s availability mainly to high-risk groups. Earlier this year, he announced that the Centers for Disease Control and Prevention (CDC) would no longer recommend vaccinations for children with underlying conditions or for pregnant women.

Kennedy reiterated his stance when the FDA said it had withdrawn its emergency use authorization for the Covid-19 vaccine. “The FDA is currently granting marketing approvals to individuals at higher risk: Moderna (6+ months), Pfizer (5+), Novavax (12+),” he stated on a social media platform. “These vaccines can be accessed by patients after consulting their doctors.”