FDA Officials Unwisely Limit COVID-19 Vaccine Availability
WASHINGTON, D.C. — The FDA is set to sharply restrict vaccine availability to millions of Americans without a persuasive justification based in science.
In a medical journal commentary, Dr. Vinay Prasad, the director of the Center for Biologics Evaluation and Research at the Food and Drug Administration (FDA) and Dr. Martin Makary, the FDA Commissioner, announced that the agency will move to limit the approval of COVID-19 vaccines to adults over the age of 65 years and “all persons above the age of 6 months with one or more risk factors that put them at high risk for severe Covid-19 outcomes.” The risk factors include many chronic and infectious diseases, obesity, pregnancy and smoking. “Estimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,” according to the article.
Public Citizen Health Research Group Director Dr. Robert Steinbrook issued the following statement:
“Evolving scientific evidence has already suggested that the United States could move from a universal recommendation for COVID-19 vaccination and boosters to a recommendation considering individual risk.
“The unilateral FDA announcement has two big problems. First, the announcement entirely bypasses discussion by the FDA’s Vaccines and Related Biological Products Advisory Committee and the Advisory Committee on Immunization Practices at the Centers for Disease Control and Prevention. Public discussion by both committees is the time-tested approach to federal decision-making about vaccines based on the best scientific evidence.
“Second, the FDA announcement does not make a convincing public health case for why COVID-19 vaccines should become unavailable for healthy persons under 65. People should be able to look at the information, discuss it with their clinicians, and be vaccinated if that’s what they decide.
“The FDA advisory committee is set to meet on Thursday May 22, for the first time under the Trump Administration, and will discuss COVID vaccines. The CDC advisory committee will meet in June. Bypassing advisory committee discussion when both groups are about to meet is a missed opportunity to seek broad consensus about revised recommendations. It makes no sense.”