Lancet: RFK Jr vaccine statement overturns decision-making conventions

6 June, 2025

Dear HIFA colleagues,

The US Health Secretary Kennedy has withdrawn COVID-19 vaccine recommendation for pregnant women and children, creating an "unheard of situation in which the science shows pregnant women should be vaccinated, yet the health secretary says — with no evidence — that they should not be."

Extracts from a paper in this week's Lancet below and a comment from me.

US Health Secretary Kennedy's withdrawal of COVID-19 vaccine recommendation for pregnant women and children surprised officials and bypassed key committees...

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01180-8/fulltext?dgcid=raven_jbs_etoc_email

The reaction from vaccine experts, doctors and medical societies—including, but not limited to, the American Lung Association, The Infectious Diseases Society of America, and the American College of Obstetricians and Gynecologists—was swift and damning. Most highlighted that pregnant women and children, particularly infants aged 6 months and younger, are among the highest risk groups for serious complications from COVID-19 infection—indeed, children younger than 6 months have the highest rate of hospitalisation after adults aged 75 years and older.

But there is also deeper concern over the policy change in how it tramples over long-practised conventions for making such decisions and announcements. Normally, vaccine recommendations are made by the Advisory Committee on Immunization Practices (ACIP), an expert panel convened by the US Centers for Disease Control and Prevention (CDC) specifically for this purpose. Although the ultimate authority rests with the CDC and the Health Secretary, they almost always follow the committee's recommendations. “In this case, the committee was completely left out of the decision-making process, and indeed I have heard many in the CDC were completely taken by surprise by this announcement”, says Paul Offit, paediatrician and vaccine expert based at the Children's Hospital of Philadelphia, PA, USA. “Added to this, a few days before Kennedy's announcement, FDA leaders published a piece in NEJM [New England Journal of Medicine] stating that people in high-risk groups would continue to be eligible for COVID vaccination, and that pregnancy is a high-risk condition… We now have this unheard of situation in which the science shows pregnant women should be vaccinated, yet the health secretary says—with no evidence—that they should not be.”...

COMMENT (NPW): It can be argued that policymakers who deliberately enact policy that is contrary to the evidence, and which ignores established checks and balances, should be held accountable for their actions. I am reminded of South African President Thabo Mbeki, where he 'criticized the scientific consensus that HIV is the cause of AIDS... and instituted policies denying antiretroviral drugs to AIDS patients.' https://en.wikipedia.org/wiki/HIV/AIDS_denialism_in_South_Africa Such policymakers are rarely, if ever, held to account for the consequences of their actions. In my view policymakers should be held accountable for anti-evidence public health measures that cause avoidable deaths and harm.

HIFA profile: Neil Pakenham-Walsh is coordinator of HIFA (Healthcare Information For All), a global health community that brings all stakeholders together around the shared goal of universal access to reliable healthcare information. HIFA has 20,000 members in 180 countries, interacting in four languages and representing all parts of the global evidence ecosystem. HIFA is administered by Global Healthcare Information Network, a UK-based nonprofit in official relations with the World Health Organization. Email: neil@hifa.org