Health experts testifying before the House Oversight Subcommittee on Economic and Consumer Policy expressed concerns that a Covid-19 vaccine would have to be distributed under a US Food and Drug Administration’s emergency use authorization.
Emergency use authorization from the FDA is not the same as approval, but when there is no available or accessible alternative, it’s a signal from regulators that the likely benefits of a product seem to outweigh the risks.
The experts testified at a Tuesday hearing and cautioned against rushing a vaccine before Phase 3 clinical trials are complete. They urged decision makers to balance the need for urgency with transparency.
Here’s what the experts said:
- Dr. Bruce Gellin, president of global immunization at the Sabin Vaccine Institute, said he “strongly recommends that any vaccine being considered for any type of approval by the FDA be reviewed in an open, public meeting of the FDA Vaccine and Related Biological Product Advisory Committee.” Gellin added that “if a vaccine used under an EUA turns out to be ineffective or raise safety concerns and users are unclear if the vaccine was unapproved, a crisis could occur undermining confidence in all vaccines.”
- Dr. Jesse Goodman, director of the Center on Medical Product Access, Safety and Stewardship a Georgetown University, said that while issuing an EUA to distribute a vaccine in an area with a severe Covid-19 outbreak could be appropriate, “experience has shown the public may interpret an EUA as the same as an approval.”
- Dr. Jason Schwartz, assistant professor of health policy at Yale University, echoed those concerns, saying he would also be worries that an EUA “would not be understood to be different from full approval” of a vaccine.
- Dr. Ruth Karron, director of the Center for Immunization Research at Johns Hopkins Bloomberg said “decisions may need to be made about issuing EUAs for one or more vaccines with data that are promising but incomplete,” which would raise questions about the risk and benefits to those in high-risk groups.
Source : CNN News