Health Secretary Robert F. Kennedy Jr. was not supposed to be apprised ahead of time of the Food and Drug Administration’s decision to expand its approval of Moderna’s COVID-19 vaccine, the Department of Health and Human Services (HHS) said in response to reports that officials approved the vaccine without Kennedy’s knowledge.
“For legal and scientific integrity purposes, all FDA product decisions are made at the FDA level. The HHS Secretary and his immediate office are not briefed on product decisions before they are announced,” a spokesperson for HHS told The Epoch Times in an email on July 21.
The FDA on July 10 approved Spikevax, the vaccine, for children ages 6 months through 11 years with at least one risk factor.
Following the approval, an HHS spokesperson said top officials with the agency had been fired, although one of those officials said she had resigned.
A fake X account purporting to belong to Kennedy stated on Monday that the officials were fired for “acting on their own” and greenlighting Moderna’s vaccine, while the Gateway Pundit said in a July 21 post that Kennedy reportedly fired the officials because they approved the vaccine while he was on vacation. The latter has since updated its story to remove the claim.
Kennedy was outside the country when the new approval was announced, a source familiar with the situation told The Epoch Times on condition of anonymity.
HHS was subsequently flooded with calls and messages expressing concern over the approval, the source said.
Dr. Robert Malone, who was appointed to a federal vaccine advisory panel by Kennedy, wrote in a blog post on Monday that Kennedy was on a working vacation at the time of the approval announcement, taking calls, participating in briefings, and mulling over critical matters.
Heather Flick Melanson, who had been the HHS chief of staff, told The Epoch Times via email that she was on a flight on July 10 without working internet.
Were Officials Involved?
The FDA approved the Spikevax license through its normal process, Melanson said.
“The front office had nothing to do with it.” She added later, “I would never have the power to approve a biologic or drug—never—nor … while the Secretary was on vacation.”
Melanson says she is a supporter of President Donald Trump and that she was not fired, but resigned.
Hannah Anderson, who had been the HHS deputy chief of staff before recently being ousted, could not be reached for comment. HHS has not specified why Melanson and Anderson are no longer with the agency.
Malone said that he was not sure whether the terminations were related to the failure to inform Kennedy ahead of time of the Spikevax approval. He said that he and others “insisted that there be consequences for failing to brief the chain of command,” that “there is solace in knowing that there were prompt consequences,” and that “the federal bureaucracy must recognize that there will be consequences for failing to brief their command chain on politically sensitive decisions.”
What the FDA Decision Means
Spikevax has been approved by the FDA since 2022, but only for certain ages. Before the new approval, the vaccine was approved for individuals who were at least 12 years of age. It was also available under emergency authorization for children from 6 months of age to 11 years old.
The decision broadened the approval down to 6 months of age.
It also limited the approval. While the new approval is for all people aged at least 65, it is only for those under the age of 65 with at least one risk factor that the Centers for Disease Control and Prevention says places people at higher risk of severe COVID-19 outcomes.
Those factors include asthma, cancer, pregnancy, and tuberculosis.
Prasad Overruled Reviewers
FDA staffers who reviewed Moderna’s application for a license, which sought approval for all children 6 months and older, reached a different conclusion than Dr. Vinay Prasad, the agency’s top vaccine official, Prasad said in a memorandum made public on July 11.
Prasad said that there is not sufficient evidence to be certain that the benefits of Spikevax outweigh the harms for healthy children. He also said the evidence shows the benefits outweigh the harms for children with one or more risk factors.
Prasad also overruled FDA reviewers in the two other decisions on COVID-19 vaccines made since Kennedy took office in February.
The reviewers favored making a new Moderna COVID-19 vaccine, mNEXSPIKE, and Novavax’s COVID-19 vaccine available to all people who are at least 12 years old, regardless of health.
Prasad said the evidence only supported approving the vaccines for those aged 12 to 64 with at least one risk factor in addition to all people 65 years of age and older.
Makary Addresses Criticism
Dr. Marty Makary, the FDA’s commissioner, told The Epoch Times in a recent interview that the FDA granted the approvals in part to convince companies to run clinical trials.
“We have a situation whereby we would love these companies to run a proper randomized, controlled trial. And so if you do nothing—if you reject the COVID vaccines as they come to you for approval—then you have no leverage to be able to ask the company to do that, and those studies may never be done,” he said.
Makary and Prasad had earlier in the year outlined how the FDA’s new leaders would no longer approve COVID-19 vaccines absent clinical data for many Americans, but they also said that data from antibody testing would be enough to secure approval for the elderly and younger people with underlying conditions.
“We are going to be OK with the COVID vaccines in high-risk Americans, which is a much more limited indication,” Makary told The Epoch Times.