In a surprising turn of events, Health Minister Robert F. Kennedy Jr. has taken a bold step by withdrawing the advice for healthy children and expectant parents to receive Covid-19 booster shots. This decision has taken the medical world by surprise, as it deviates from standard practice. Kennedy disclosed this decision on platform X, a social media network, where he was endorsed by Jay Bhattacharya, Head of the National Institutes of Health and Marty Makary, Commissioner of the Food and Drug Administration.
Bhattacharya, representing an agency not driving vaccine regulations, or deciding who is suitable for vaccinations, declared this move as based on ‘common sense’ and ‘good science’. However, one critical missing piece in this announcement was a representative from the Centers for Disease Control and Prevention (CDC), the agency responsible for designing policies regarding approved vaccine administration, under the advisory of its expert panel, the Advisory Committee on Immunization Practices (ACIP). Presently, the CDC is operating without an acting director.
The CDC’s official website continues to place Covid vaccines in the Pediatric Vaccination Schedule which disseminates the importance and schedule of vaccines for children and pregnant individuals. The removal of a vaccine recommendation from the CDC’s schedule by the Health Secretary, without any formal consultation, is an uncommon event. This situation further gains intricacy as there was no input from ACIP, according to Dorit Reiss, a law professor well-versed in vaccination policies.
Reiss accentuated the disregard of due processes involved in this decision. She proposed the absence of these protocol measures might lead the decision to be overturned if legally contested. In such cases, courts would ask for evidence to show a systematic deliberative process that led to a change in policy.
“Government decisions need to be based on tangible evidence or reasons, not solely led by the agency’s desires,” noted Reiss, expressing doubts about the lack of a thorough and comprehensive explanation preceding the abrupt policy change announced in a minute-long Twitter Video. Kathryn Edwards, an eminent vaccine expert and professor emeritus at Vanderbilt University, also found Kennedy’s step to be overreaching.
Reiss also illuminated on a New England Journal of Medicine article last week that details a fresh approach to Covid booster shots application. The piece, co-authored by Makary and Vinay Prasad, who heads FDA’s Center for Biologics Evaluation and Research, identifies pregnancy as a medical condition necessitating Covid vaccination. This acknowledgment makes Kennedy’s removal of booster shots from healthy children and expecting parents’ schedules even more contentious.
Potential consequences of this step could involve insurance companies discontinuing coverage for the vaccines, as indicated by Reiss. The reciprocation from insurance providers could result in a mix, with some maintaining the coverage while others withdraw. Furthermore, the sudden policy shift might cause perplexity among healthcare providers administering vaccines, over whether it’s permissible to vaccinate.
Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, remarked that Kennedy’s decision contradicts the commitment he made during his Senate affirmation— to not deny vaccines to people intending to get them. This resolution arises when ACIP is actively reevaluating the guidelines for receiving Covid vaccines.
An ACIP subcommittee, that specializes in Covid-19 vaccination policies, had signaled last month, its plans to replace the existing universal vaccination suggestion with one directed towards people vulnerable to severe Covid-19 health repercussions. But the American Association of Pediatrics, which usually has a voice in such decisions, was not consulted, marking another deviation from standard procedure.
Until now, the AAP’s recommendations have generally been in alignment with those of ACIP. But now, given HHS’s recent decision, the association may need to reassess its concurrence with the federal government. This decision entirely overlooks the data-driven evidence that typically forms the scaffold of the recommendation framework.
Although the final recommendations haven’t been revealed, indications are that the committee might lean towards urging people over the age of 65, those with a high-risk profile due to health conditions (inclusive of pregnant individuals), and very young children to continue with their vaccinations. Evidently, this new recommendation might give liberty to other groups to decide whether they wish to be vaccinated against Covid-19.