The Food and Drug Administration looks to impose new standards on vaccine testing that could impede the development of novel immunizations, as they would require manufacturers to conduct longer and larger studies before approving updates to and indications for at least several vaccines. Director of the FDA’s Center for Drug Evaluation and Research, Vinay Prasad, suggested these changes in the wake of making a claim in an internal memorandum to staff that COVID-19 vaccines caused the deaths of ten children.
Prasad seeks more definitive data for vaccines administered during pregnancy. He noted specifically that COVID-19 vaccines have not been tested in randomized controlled trials in pregnant women. Experts have countered that pregnant women are almost never included in RCTs of vaccines, or drugs for that matter, due to potential risks to the fetus.
Also, apparently in reference to a childhood pneumonia vaccine, Prasad wants pharmaceutical manufacturers to demonstrate that their products reduce disease incidence—at least after the point at which they’re licensed—rather than provide indirect evidence of protection, such as detection of antibody levels. This would disrupt a longstanding convention for pneumococcal vaccines is to authorize their marketing based on antibody levels.
Similarly, Prasad plans to reform the way that annual influenza vaccines offered to adults and children are regulated, by requiring that large clinical trials on each year’s influenza vaccines be conducted. This runs counter to the current vaccine development process that relies on scientists making informed predictions about which of the constantly evolving strains to include in vaccines.
Flu viruses are constantly mutating. The influenza viruses that circulate and cause disease in people often change from one year to another, necessitating a new vaccine every year. Long before the new influenza season begins, the FDA convenes its vaccines advisory panel (not to be confused with the panel that advises the Centers for Disease Control and Prevention, the Advisory Committee on Immunization Practices) to review data about which flu viruses have caused disease worldwide in the past year and specifically, how the viruses are changing. This facilitates their recommendations regarding which specific virus strains to include in the vaccines. This advice must be given roughly six months before the start of flu season because manufacturing the vaccines takes that amount of time. And so, it’s infeasible to carry out the clinical trials that Prasad says will be required for each year’s influenza vaccines before the start of flu season.
Experts told reporter Liz Szabo that if the new proposals detailed in the memorandum are put into place, it could mean the inability to update certain shots in a timely manner and possibly the end of most vaccines for pregnant women.
Expressing worry about the direction of the agency, 12 former FDA commissioners wrote not to change the way the FDA regulates vaccines that are “safe and well-characterized.” What concerned the authors most was that policy changes would “disadvantage the people the FDA exists to protect, including millions of Americans at high risk from serious infections.”
Vaccine development is a lengthy and costly process. Technical, clinical, regulatory and manufacturing risks permeate the development cycle, perhaps to a greater degree than some other types of pharmaceuticals. And now, Dan Diamond of the Washington Post writes in his newsletter, the new approach will add time and money to the approval process.
Additionally, public health experts and bioethicists argue that there are major ethical problems associated with conducting RCTs of proven vaccines.
Prasad defends his plans. He states it’s part of “modernizing” FDA policy. According to STAT News, Prasad said at a closed meeting that included investors last week that the FDA needs to be very confident the agency is “doing something on average that has a net benefit.” Department of Health and Human Services officials, including Prasad, have said they want to rebuild trust, by having open, transparent debates about vaccines of all kinds. However, having a closed-door meeting with investors rather than public health experts, doesn’t seem consistent with an open discussion.
As a reminder of what vaccines do, they prime the immune system in different ways to respond to future infections. For many decades, they’ve led to global declines in morbidity and mortality from a wide range of infectious diseases, from smallpox to polio to measles to COVID-19. Vaccines have prevented an estimated 154 million deaths worldwide since 1974.
Yet childhood vaccines rates are declining in the U.S., the corollary being that vaccine hesitancy is on the rise.
Last week, ACIP voted 8-3 to overturn a 30-year-old vaccine policy that has contributed to a significant decline in cases of hepatitis B. The current ACIP panel is debating aluminum adjuvants in vaccines. Adjuvants are compounds that boost immune responses, improving the ability of vaccines to elicit long-lasting immunity against infectious diseases. Aluminum salts are widely used in inoculations against diphtheria, tetanus and hepatitis B, among others.
Prasad has said he supports the measles vaccine and the COVID-19 vaccines, too, early in the pandemic. Nevertheless, it’s obvious that throughout several of HHS’s agencies, including the Centers for Disease Control and Prevention and FDA, there is opposition to business as usual regarding vaccines.
It starts at the top. HHS Secretary Robert F. Kennedy Jr. has long falsely asserted that vaccines that contain aluminum salts as an adjuvant cause health problems. He has made similar erroneous claims regarding vaccines that include thimerosal as a preservative. In June, ACIP recommended against the use of thimerosal in influenza vaccines. Unlike thimerosal, which is only used in a small percentage of influenza vaccines, multiple types of vaccines contain aluminum. This implies that a possible decision to curb or ban its use could have far-reaching implications.
Misinformation about vaccines has become widespread on social media, amplified by politicization of vaccines and vaccine policies during the COVID-19 pandemic. Positions that the new chair of ACIP, Kirk Milhoan, holds exemplify a problematic turn in practice by a body formerly governed strictly by evidence rather than conjecture. Milhoan claimed in a YouTube video in October that COVID-19 vaccines cause cancer and myocarditis. He has also adamantly expressed opposition to the entire mRNA platform, on which two COVID-19 vaccines are based as well as a large number of products in development.
Oddly, anti-vaccine sentiment is often expressed as being opposed to Big Pharma profits. But contrary to popular belief, not a lot of money is made by pharmaceutical firms on vaccines. Even at its peak—at the end of 2021—vaccines accounted for less than 10% of overall revenue. Vaccines usually comprise a relatively small segment of the pharmaceutical industry’s sales of less than 4% of total revenue. Yet puzzlingly, vaccines receive outsize attention when it comes to criticism of the drug industry.
The entire vaccine ecosystem is under threat, prompted less by evidence than a seeming desire to upend a system that has worked well for the American population for decades.
