The health secretary said he was addressing people with concerns about the new shot.
Moderna will carry out a placebo-controlled trial of its new COVID-19 vaccine, and U.S. regulators will keep tabs on the trial, Health Secretary Robert F. Kennedy Jr. said on June 3.
“I want to address those of you who have anxieties about [the Food and Drug Administration’s] limited approval of a new mRNA COVID vaccine for high-risk populations,” Kennedy wrote on social media platform X. “Moderna has agreed to a true placebo-controlled trial of the new vaccine.”
Moderna already has a COVID-19 vaccine, called Spikevax, on the market. The new vaccine, approved by health officials on May 31, is known as mNEXSPIKE. A Moderna spokesman confirmed to The Epoch Times that mNEXSPIKE utilizes messenger ribonucleic acid (mRNA) technology, just like Spikevax, but did not answer additional questions.
The Department of Health and Human Services (HHS), Kennedy’s agency, had announced in April that “under the Secretary’s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure.”
A spokesperson for the HHS told The Epoch Times in an email on Wednesday: “This approval was for high-risk individuals. Approvals for healthy people will still have to go through placebo-based trials.”
Top officials with the FDA, which is part of HHS, said in May that they would approve COVID-19 vaccines for the elderly and young people with one of the risk conditions based on immunogenicity data, but that they would require trial data to approve the vaccines for others. The officials said such trials could include saline placebos.
The Centers for Disease Control and Prevention, under orders from Kennedy, then stopped recommending COVID-19 vaccines to healthy children and pregnant women.
Approval Based on Trial
The FDA licensed mNEXSPIKE for previously vaccinated adults aged 65 and older. People aged 12 to 64 who have at least one condition, such as obesity, that authorities say places them at higher risk for severe COVID-19, and who received a COVID-19 vaccine before, can also take the shot, which Moderna says will be available later in the year.
