Vials with Covid-19 vaccine stickers and syringes with the logo of the American biotechnology company Novavax, November 17, 2020. (Credit: Justin Tallis.)
United States set to tighten access to COVID-19 vaccines, limiting recommendations to individuals aged 65 and older or to those considered at risk, according to an announcement made by two senior officials on Tuesday.
This policy shift coincides with Donald Trump's Health Secretary, vaccine skeptic Robert Kennedy Jr., aiming to reform the nation's vaccination policies.
The modifications aim to align U.S. guidelines with other major developed countries, including those in the European Union, as justified by high-ranking officials of the U.S. Food and Drug Administration (FDA), Marty Makary and Vinayak Prasad, in an editorial.
"While other wealthy nations limit vaccine recommendations to older adults or those at high risk of severe COVID-19 symptoms, the U.S. has maintained a uniform approach across age groups," they noted in an article published in the New England Journal of Medicine.
The FDA will now recommend COVID-19 vaccination only for those aged 65 and older or for individuals aged 6 months to 64 years who have at least one risk factor for developing severe illness, they announced.
The list of risk factors is broad, including conditions such as asthma, HIV, diabetes, obesity, schizophrenia, smoking, or lack of physical activity.
According to U.S. health authorities, approximately 74% of American adults have at least one of these risk factors.
New Studies
Another significant change: Authorities will request that pharmaceutical companies conduct clinical trials on the benefits of vaccines for healthy individuals under 65, according to the officials—despite previous large-scale studies on these vaccines.
The aim is to assess the benefits and risks of annual COVID-19 vaccination for people not at risk, following "the FDA's study model," as they explained.
This model includes a control group receiving a saline solution as a placebo, a method that has been debated within the medical community given the existence of a "standard" vaccine but is strongly supported by U.S. Health Secretary RFK Jr.
RFK Jr. recently expressed a desire to change the way vaccines are tested, raising concerns among experts who fear such changes could limit access to these treatments in a country known for its rigorous standards.
Trust and Misinformation
This policy shift is intended to rebuild public trust in health authorities, which was shaken during the COVID-19 pandemic, the officials emphasized. They highlighted growing public reluctance to get vaccinated, even against measles, despite the "clearly established safety and efficacy" of the vaccine.
The Health Secretary himself is accused of fueling this skepticism by repeatedly spreading misinformation about COVID-19 and measles vaccines.
RFK Jr. notably described the COVID-19 vaccines as "the deadliest ever made" during the pandemic and implied the virus was "ethnically targeted" to harm Black and White individuals while sparing "Ashkenazi Jews and Chinese" people.
The U.S. was hit hardest during the COVID-19 pandemic, with 1.2 million deaths according to the WHO.
This announcement of policy change follows new restrictions on one of the COVID-19 vaccines.
In a notable delay, the FDA granted full approval to the Nuvaxovid vaccine—already authorized in the U.S.—but imposed strict usage restrictions, as announced Monday by Novavax, the pharmaceutical company developing it.