In a post on X, Kennedy expressed his intention to “address those of you who have anxieties” regarding the Food and Drug Administration’s limited endorsement of Moderna’s vaccine, which was approved for a narrower demographic compared to previous shots.
Moderna opted not to provide comments. As a stipulation for the approval of the new vaccine, the FDA mandated a subsequent placebo-controlled study targeting adults aged 50 to 64 without high-risk conditions, as per agency documents.
Kennedy stated that “the FDA will monitor and collect data throughout the trial for every adverse outcome” and will “scrutinize every aspect of the trial.”
Under Kennedy’s guidance, US health agencies have implemented measures to restrict who can receive Covid vaccines, citing insufficient evidence for repeated doses. The FDA indicated last month that it would cease approval of Covid booster shots for healthy adults and children without new studies.
Moderna’s second-generation vaccine received approval for all adults aged 65 and older, as well as individuals 12 and over with at least one risk factor for severe illness. Previously, the company’s earlier Covid vaccine was approved for individuals aged 12 and above, irrespective of their underlying health.
Requiring vaccine manufacturers to evaluate their products against a placebo group is uncommon and raises ethical questions. Administering an inert substance to individuals when an effective vaccine is available may expose them to preventable disease. Moderna’s new Covid vaccine, branded as mNexspike, underwent testing against its older version, known as Spikevax.
