United States President Donald Trump's administration unveiled a new policy changing the annual routine approval of COVID-19 vaccines for healthy young adults and children.
The new requirements regarding access to yearly COVID-19 vaccines were laid out by top officials of the Food and Drug Administration (FDA). They said they would still continue to make use of a streamlined approach to offer the shots to adults aged 65 years and older and children and young adults who have at least one health issue.
New FDA Policy With COVID-19 Vaccine
The FDA framework also urges companies to conduct large, lengthy studies before they can approve tweaked vaccines for healthier people. Agency officials noted in a framework published on Tuesday that the approach could still keep annual shots available for roughly 100 million and 200 million individuals.
The planned changes also raised questions for individuals who may not want to get a fall COVID-19 vaccine but do not fit into one of the categories. Dr. Paul Offit, a vaccine expert at Children's Hospital in Philadelphia, asked if the pharmacist will be responsible for determining if a person is in a high-risk group, according to ABC News.
The new framework is a result of recent scrutiny regarding the use of COVID-19 vaccines. It raises major questions about the shots' broader availability under President Trump. The policy changes were released two days ahead of the first meeting of FDA's outside vaccine experts.
The FDA granted full approval of Novavax's COVID-19 shot last week but with major restrictions on which individuals can get it. The development came after Trump appointees overruled FDA scientists' earlier plans to approve the vaccine without any restrictions.
Restricting Vaccine Availability
Dr. Vinay Prasad defended the new policy, saying it is a "reasonable compromise" that would provide vaccinations to individuals in high-risk groups while gathering data about its benefits for healthy people, MSN reported.
The medical professional added that they do not know the answer to the question of whether or not healthy people should be getting their eighth, ninth, or tenth vaccine. Prasad made efforts to repeatedly criticize the FDA's handling of drug and vaccine approvals before joining the agency earlier this month.
On the other hand, the leading pediatrics group in the United States said that the FDA's new approach would only limit options for parents and their children. Dr. Sean O'Leary of the American Academy of Pediatrics said taking the vaccine away from being covered by insurance would remove parents' choice to protect their kids from COVID-19, as per the Associated Press.
