The US government has introduced new standards for updated COVID-19 shots, limiting access to vaccines for healthy adults and children pending more data on their effectiveness.
Top officials at the Food and Drug Administration (FDA) have proposed a revised framework that requires companies to conduct large studies before tweaked vaccines can be approved for healthier people. This approach marks a significant change from the previous federal policy recommending an annual COVID-19 vaccine for all Americans six months and older.
The new guidelines aim to generate more data on whether updated vaccines still offer benefits for people who don’t have high-risk health conditions. Dr. Vinay Prasad, FDA’s top vaccine official, described this approach as a “reasonable compromise” that allows vaccinations in high-risk groups to continue while gathering information on the effectiveness of vaccines in healthier individuals.
However, this new policy has raised concerns among experts and parents about limited access to COVID-19 vaccines for people who want one. Many argue that the policy will limit options for families who wish to protect their children from COVID-19.
The Centers for Disease Control and Prevention (CDC) reported 47,000 American deaths related to COVID-19 in 2022, with most of those being attributed to underlying causes rather than direct virus-related deaths.
The new guidelines mirror restrictions on the use of Novavax’s COVID-19 vaccine granted last week by the FDA, which is only approved for people with high-risk health conditions. Pfizer and Moderna, makers of the commonly used COVID shots, have stated they will continue working with the agency to develop updated vaccines.
As experts debate the benefits and limitations of yearly COVID vaccinations, a panel of advisers at the CDC is set to discuss vaccine recommendations for specific groups in June.
Source: https://apnews.com/article/vaccines-fda-kennedy-covid-shots-rfk-trump-bb4de15b6ff955d6cd0b406aaec3cdc5