The Department of Health and Human Services under Health Secretary Robert F. Kennedy Jr. revoked emergency authorization for COVID-19 vaccines.
“The emergency use authorizations for Covid vaccines, once used to justify broad mandates on the general public during the Biden administration, are now rescinded,” Kennedy posted to X on Wednesday.
The news comes as the FDA, which is part of HHS, announced the approval of the Pfizer-BioNTech COVID-19 vaccine for older adults and children as young as 5-years-old who have at least one condition that puts them at higher risk of severe COVID-19 outcomes, Pfizer said in a Wednesday statement.
Regulators have issued similar approvals for COVID-19 jabs from Novavax and Moderna.
HHS revoking emergency approval means that FDA clearance is no longer in place for some 240 million Americans, however “These vaccines are available for all patients who choose them after consulting with their doctors,” Kennedy sai.
As the Epoch Times notes further, per federal law, the FDA approves products it determines are “safe, pure, and potent.” Emergency authorizations, in contrast, can only be offered under certain circumstances, such as during a public health emergency, and are for products that officials believe “may be effective” in treating or preventing a life-threatening disease or condition.
Updated Approvals
Dr. Marty Makary, the FDA’s commissioner, and Dr. Vinay Prasad, its top vaccine official at the time, signaled the change in May, when they said that the FDA would stop approving COVID-19 vaccines for many Americans absent clinical trial data.
“The FDA can only approve products if it concludes, based on scientific evidence, that the benefit-to-harm balance is favorable. And we simply need more data to have that confidence for younger individuals at low-risk of severe disease,” Prasad said at the time.
In the United States, regulators in recent years have been authorizing updated COVID-19 vaccines annually in a bid to counter waning effectiveness and better match circulating variants. The model is based on the historical approach to influenza vaccines.
Regulators in 2024 cleared updated shots from Moderna, Pfizer, and Novavax without human data, citing animal tests and data from trials for previous versions.
Hellbound and Down 