The approval process for COVID-19 vaccines is going to look very different in the U.S. In a nutshell, Trump officials no longer want to approve annual COVID-19 boosters for healthy adults and children. This means that millions of Americans may lose access to updated COVID-19 boosters.
Going forward, the Trump administration only wants to offer the vaccines to those 65 and older or high-risk individuals.
“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, PBS reported. “The only thing that can come of this will make vaccines less insurable and less available.”
The U.S. Food and Drug Administration wants to hold new clinical trials proving that COVID-19 shots are still safe and effective for healthy adults and children.
“We simply don’t know whether a healthy 52-year-old woman with a normal BMI who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” the FDA officials wrote.
Why is the FDA planning to restrict access to COVID-19 vaccines?
The FDA’s announcement comes as vaccine skeptic Robert F. Kennedy Jr., who now leads the Department of Health and Human Services, raises more concerns over the COVID-19 vaccines.
FDA officials want to conduct clinical trials — which, in reality, could prove to be too costly for pharmaceutical companies — in order to prove that the COVID-19 vaccine is still safe and effective for healthy individuals. If the plan follows through, only 33 percent of Americans will be eligible to get the COVID-19 shot on an annual basis.
“We simply don’t know whether a healthy 52-year-old woman with a normal B.M.I. who has had COVID-19 three times and has received six previous doses of a COVID-19 vaccine will benefit from the seventh dose,” FDA officials wrote, per The New York Times.
What are experts saying about the possibility of COVID-19 vaccines being restricted?
“This is overly restrictive and will deny many people who want to be vaccinated a vaccine,” Dr. Anna Durbin, director of the Center for Immunization Research at Johns Hopkins University, said via email, according to The New York Times.
The changes do “not make sense from a public health perspective,” Durbin added.
Another expert argued that limiting access to the COVID-19 vaccine would only cause more distrust among Americans.
“Since the public trust in vaccines has declined, I would hope that we would be thoughtful about preserving vaccine choice for people who want to get vaccinated,” said Dr. Denise Jamieson, VP for medical affairs at the University of Iowa. Jamieson also serves as a Centers for Disease Control and Prevention adviser on immunizations.
From her perspective, the announcement “doesn’t preserve people’s choice to get vaccinated.”
