FDA Limiting COVID Vaccines to High-Risk Groups Due to Waning Immunity

The US Food and Drug Administration (FDA) has approved the next round of COVID-19 vaccines, but with new restrictions on who can receive them. The updated shots will only be available to individuals at risk for serious complications due to age 65 or older or underlying health conditions.

This decision is expected to make it harder for healthy children and younger adults to get vaccinated ahead of the anticipated winter COVID surge. The Centers for Disease Control and Prevention (CDC) will likely weigh in soon with guidance on who should receive the vaccine, but has already dropped guidelines recommending vaccinations for all healthy children and pregnant women.

Federal health officials argue that most people have built up immunity, which is why they are limiting vaccination eligibility to those at high risk. However, many public health experts disagree, saying the new restrictions are unwarranted and may put vulnerable populations at risk.

The FDA has approved three vaccines: Moderna’s mRNA vaccine for ages 6 months+, Pfizer-BioNTech’s mRNA vaccine for ages 5+, and Novavax’s vaccine for ages 12+. While these vaccines will be available to all patients who consult with their doctors, insurance coverage may no longer apply. Doctors, pharmacists, and pharmacies may also face challenges in administering the vaccines due to limited training and resources.

Experts warn that this decision could lead to an increase in severe COVID-19 cases and hospitalizations, particularly among vulnerable populations such as newborns, pregnant women, and young children. The CDC still recommends vaccinations for all pregnant women, despite the new guidelines.

The new restrictions come as the US is experiencing a surge in COVID-19 cases and hospitalizations, with over 100 deaths attributed to the virus each week. As vaccination rates remain low, experts are concerned that confusion and conflicting messages may deter people from getting vaccinated, exacerbating the crisis.

Source: https://www.npr.org/sections/shots-health-news/2025/08/27/nx-s1-5515503/fda-covid-vaccines-restricted