### FDA Commissioner Declines Clear Guidance on Covid Vaccines, Urges Consulting Doctors

In a recent interview meant to elucidate the federal government's stance on Covid-19 vaccinations, Food and Drug Administration (FDA) Commissioner Marty Makary offered limited direct answers, instead advising Americans to consult with their healthcare providers. During his appearance on CBS News' "Face the Nation" on Sunday, Makary commented on the mixed data regarding Covid vaccinations in healthy children and pregnant individuals, advocating that vaccination decisions should be made in consultation with doctors.

Makary also criticized the Center for Disease Control and Prevention’s (CDC) independent vaccine advisory panel, labeling it a "kangaroo court" that routinely endorses every vaccine presented to it. This stance aligns with the Trump administration’s recent actions to limit Covid vaccine access. The FDA plans to restrict vaccine use to individuals aged 65 and older or those with risk factors. Concurrently, Health Secretary Robert F. Kennedy, Jr. revoked a CDC recommendation advocating Covid shots for healthy children and pregnant people. Although numerous European countries have ceased recommending Covid vaccines for healthy children, the U.S. decisions notably bypassed the usual regulatory processes involving public and expert input.

Public health experts have expressed particular concern over the withdrawal of vaccine recommendations for pregnant individuals. CDC data indicates that most babies hospitalized due to Covid were born to unvaccinated mothers. Furthermore, Covid infection during pregnancy poses a significant health risk to the mother. FDA Commissioner Makary and vaccine regulator Vinay Prasad highlighted in a New England Journal of Medicine commentary that pregnancy is a risk factor meriting vaccination.

During the interview, "Face the Nation" host Margaret Brennan asked Makary to address this contradiction, pointing out the inconsistency between listing pregnancy as a risk factor and rescinding vaccine recommendations for pregnant individuals. Makary stated he could not offer a definitive recommendation without data from a randomized controlled trial on the vaccine's use in pregnant people. He evaded questions about who would conduct these studies and their timeline, maintaining that individuals should rely on their doctors’ best judgment in the absence of data.

Makary extended the same advice to parents contemplating vaccination for their six-month-old children, who are at significant risk of disease but lack sufficient population-specific data. Brennan questioned why Makary and Kennedy preempted the CDC’s Advisory Committee for Immunization Practices (ACIP), which traditionally reviews vaccine recommendations. Makary disparaged the ACIP’s credibility, dismissing it as a "rubber-stamp" body.

Ironically, Makary later referenced the ACIP’s proposed shift to a risk-based vaccination strategy as a justification for recent policy changes. The ACIP panel, which evaluates vaccines approved by the FDA, does not always endorse as broad use as the FDA approval might allow. Citing cautious approaches in other instances, such as RSV and human papillomavirus (HPV) vaccines, Makary reinforced the recent changes despite external criticisms and regulatory uncertainties regarding some recommendations.

The debate over Covid-19 vaccines continues to evoke strong reactions, highlighting the complexities and challenges in balancing individual health choices with public health strategies during a pandemic.