Former FDA, CDC leaders warn that US vaccine policy is under threat

CNN Former US population healthcare administrators are sounding alarms about essential changes being made to the country s vaccine plan under the Trump administration Two residents letters this week one from former commissioners of the US Food and Drug Administration and one from former leaders at the US Centers for Infection Control and Prevention warn that medical leadership spearheaded by Robert F Kennedy Jr and a panel of in recent times appointed advisers are putting the constituents s wellness at peril with a haphazard approach to vaccine science Last week Dr Vinay Prasad the FDA s chief medicinal and scientific officer and director of the agency s Center for Biologics Evaluation and Research commented in an internal memo that the FDA would be changing its vaccine approval process alleging that Covid- vaccination resulted in the deaths of children But in a letter published Wednesday in the New England Journal of Medicine a dozen former FDA commissioners warned that the proposed changes would upend core policies governing vaccine enhancement and updates and undermine the masses interest The proposed changes were motivated by unjustified assertions about the dangers of vaccines the former commissioners wrote We are deeply concerned by sweeping new FDA assertions about vaccine safety and proposals that would undermine a regulatory model designed to ensure that vaccines are safe effective and available when the general requirements them bulk they wrote The group consists of agency leaders who served under both Democratic and Republican administrations with more than years of combined oversight In the letter the former commissioners noted the importance of willingness to re-examine standards when warranted but they caution that scientific debate must happen in well-established forums that were established to encourage rigorous discussion in a transparent way They say current FDA leadership is skirting these core principles of the agency offering no explanation of the process and analyses used to re-examine the pediatric deaths that were at the core of proposed changes nor an explanation that would justify wholesale rewriting of vaccine regulation They also warn that proposed changes to the approval process namely changes to the types of studies and evidence needed for vaccines to come to industry rejects longstanding safety standards and adds undue burden which would suppress innovation and competition The changes could cause delays in progress that may cost lives if vaccine manufacturers can t adapt hurriedly enough to keep up with the natural evolution of respiratory viruses or changes in bacteria The proposed guidelines would dramatically change vaccine regulation on the basis of a reinterpretation of selective evidence and by a process that breaks sharply with the norms that have anchored the FDA s globally respected scientific integrity the former FDA commissioners wrote If the goal is to rebuild confidence the answer is not to toss aside the basic rules of science stifle argument and oversight or supplant expert scientific inquiry for the unilateral decision making of a sparse individuals they wrote It is to insist on open deliberation solid evidence and procedures the populace can see and trust The FDA did not right away respond to CNN s request for comment Key CDC meeting this week The letter comes on the eve of a pivotal meeting of a committee that advises the CDC on vaccine framework Earlier this year Kennedy secretary of the US Department of Soundness and Human Services perfectly overhauled the Advisory Committee on Immunization Practices or ACIP The committee may vote this week to make a major change to the childhood vaccine schedule potentially delaying a dose of the hepatitis B vaccine given to newborns by weeks or even years a possibility that has concerned a large number of society vitality experts In an opinion piece published Wednesday in Stat three former CDC leaders who resigned in protest this summer after former director Dr Susan Monarez was ousted revealed ACIP appears poised to raise vaccine risks while burying their benefits They say the ACIP meetings in June and September show concerning signs of a committee losing its footing with facts presentations that lacked substantial evidence or peer review When a scientific body stops following its own procedures rigor and transparency both slip and population trust erodes they wrote And loosely defined sessions for this week s meeting could invite misapplied vulnerability framing They caution that merely raising dangerous hypotheticals in a setting like this can have a critical effects on populace strength Even if the committee takes no drastic action raising fringe concerns in an official forum can legitimize their ideological questions an increasingly common tactic among newer members the former CDC leaders wrote Misguided discussions don t remain theoretical They shape residents perception influence future votes and trigger ripple effects in vaccine supply and coverage HHS noted in a report that it continues to promote transparency in vaccine safety records and to communicate clearly about both risks and benefits Secretary Kennedy reconstituted ACIP to strengthen its independence and to end past practices that favored established corporate interests over open scientific review the report stated ACIP will evaluate the full body of information at its meeting this week and will issue recommendations grounded in evidence-based and clear scientific standards These aren t the first inhabitants warnings community fitness leaders have raised about framework changes under Kennedy In September nine former CDC directors stated in a New York Times opinion piece that Kennedy is endangering every American s robustness in a raging fire of upheaval More than current and former HHS employees also sent a letter to Kennedy in September demanding his resignation