Fall Covid vaccine rollout for healthy kids, adults is likely not going to happen

The Food and Drug Administration is preparing significant changes for the rollout of Covid vaccines this fall, as well as adjusting who will be eligible to receive the updated shots.

In a publication on Tuesday in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the FDA’s new vaccine chief, outlined that any new Covid vaccine must now undergo placebo-controlled clinical trials. This method involves some individuals receiving the actual vaccine while others receive an inactive substance, such as a saline shot, to compare the outcomes.

During an upcoming FDA vaccine panel meeting on Thursday, advisors are expected to recommend to vaccine manufacturers which strains to target for the new shots. The updated clinical trial requirement is not anticipated to impact the fall rollout for older adults and other high-risk populations, as drugmakers are exempt from further testing for these groups.

Makary and Prasad indicated in a subsequent Q&A session on Tuesday that routine approval for annual shots for healthy children and adults would no longer be granted. They also suggested that the vaccines may not need to be updated every year.

Prasad remarked, “Instead of having a Covid strategy that’s year to year, why don’t we let the science tell us when we should change? The virus doesn’t have a calendar.”

Previously, updated Covid vaccines were approved by the FDA in a similar manner to flu vaccines. The original Covid shots from Pfizer and Moderna, which were approved in late 2020, went through placebo-controlled trials. Subsequently, the drug manufacturers transitioned to smaller studies to assess the effectiveness of the updated shots against the current variants in the U.S.

In their article, Makary and Prasad expressed skepticism about the flu vaccine model, noting that only a quarter of people in the U.S. receive the updated shots each year, including less than a third of healthcare workers. In contrast, around 75% of healthcare workers receive seasonal flu shots based on data from the Centers for Disease Control and Prevention.

The FDA officials criticized the Covid shot policy, stating that it has sometimes been justified by the assumption that the American public may not comprehend age- and risk-based recommendations. They rejected this perspective.

Dr. Jesse Goodman, a professor of medicine and infectious disease at Georgetown University and a former chief scientist at the FDA, agreed that individuals can comprehend their own health risks but was skeptical of the agency’s new approach, suggesting that it restricts people’s ability to choose.

The FDA’s new guidance specifies that drugmakers must conduct new trials tracking participants for at least six months. The primary aim of these trials should be to demonstrate that the shots aid in preventing symptomatic Covid, with a minimum effectiveness rate of 30%. Individuals who previously had Covid should still be included in the trials to better represent the general population.

Drugmakers can continue to conduct smaller studies, known as immunogenicity studies, to seek approval for adults aged 65 and above, as well as children and adults with at least one medical condition that elevates their risk for severe Covid.

The FDA highlighted that many individuals are considered at high risk, including pregnant women, those with obesity, and individuals with mental health conditions like depression. Other conditions linked to severe Covid illness include diabetes, heart disease, and asthma.

The FDA’s directive precedes an upcoming vaccine advisory committee meeting on Thursday, where external experts will discuss which strains should be included in the next round of Covid shots. FDA staff mentioned in briefing documents published earlier on Tuesday that aligning the vaccines more closely with current strains may offer additional benefits in anticipation of a rise in cases during the fall and winter.

The alteration implies that Pfizer and Moderna may struggle to complete the new trials in time for the fall season. In addition to conducting the trials, the drug manufacturers must also design and enroll participants, processes that can take several weeks or months. Subsequently, the data must be analyzed and approved by the FDA.

The impact of the change on healthy children and adults seeking the updated shots remains uncertain. Dr. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the FDA’s vaccine advisory committee, emphasized that individuals considered at low risk can still be affected by the virus.

Formerly, Health and Human Services Secretary Robert F. Kennedy Jr. mandated that all new vaccines undergo placebo-controlled clinical trials. Until Tuesday, it was unclear whether HHS classified Pfizer’s and Moderna’s updated shots as new vaccines necessitating new clinical trials.

The FDA recently approved Novovax’s vaccine after a delay, limiting its use to individuals aged 65 and above and teenagers and adults with at least one medical condition putting them at risk of severe illness. Typically, the CDC provides recommendations regarding vaccine recipients.

Makary had forewarned about changes to the way vaccines are tested and approved, indicating that the FDA would soon introduce a comprehensive framework. Kennedy has long been critical of vaccines, including the Covid shot, and in 2021, he submitted a petition asking the FDA to revoke the authorization of the Covid vaccines.

During a Senate Health, Education, Labor and Pensions Committee hearing last week, Kennedy inaccurately claimed that only Covid shots were tested against a placebo. This assertion prompted Committee Chair Bill Cassidy, R-La., to pause the hearing and correct the health secretary.

Apart from Kennedy, other health officials such as Dr. Tracy Beth Hoeg, a special advisor to Makary, and Dr. Jay Bhattacharya, the head of the National Institutes of Health, have also expressed skepticism toward Covid vaccines.