The Food and Drug Administration (FDA) has announced a new stance on who should receive the COVID-19 vaccine, limiting approval to adults 65 years of age and older, as well as those with one or more risk factors for severe COVID-19 outcomes. These risk factors include medical conditions such as asthma, cancer, chronic kidney disease, heart disease, and diabetes.
The FDA is shifting away from universal recommendations that suggested everyone ages 6 months and older receive a yearly COVID-19 vaccine. Instead, the agency will take a risk-based approach based on public health trends, including declining booster uptake, limited evidence of repeated boosters improving health outcomes for healthy individuals, and widespread natural immunity from past infections.
The FDA aims to ensure the vaccine is backed by solid clinical trial data, particularly for low-risk groups. However, this new policy has been met with controversy, as it circumvents the usual process for evaluating vaccine recommendations and may limit access to vaccines for healthy individuals.
Under the new framework, healthy younger adults and children will not be automatically eligible for COVID-19 vaccines unless they meet specific risk criteria. The FDA requires manufacturers to conduct clinical trials to demonstrate vaccine benefits for low-risk groups.
Pregnancy is included as a risk factor, but some conditions, such as physical inactivity, are unclear. The list of conditions also omits caregivers and household members of high-risk individuals, leaving them more vulnerable to exposure.
The FDA’s new policy will likely delay the availability of COVID-19 vaccine boosters and slow public health decision-making. Low-risk individuals may face obstacles in accessing vaccines, including reduced insurance coverage.
While the FDA focuses on individual risks and benefits, some experts argue that this approach overlooks broader public health benefits, particularly in communities with high vaccination rates.
Source: https://theconversation.com/fda-will-approve-covid-19-vaccine-only-for-older-adults-and-high-risk-groups-a-public-health-expert-explains-the-new-rules-257226