The Food and Drug Administration is gearing up for significant changes in how Covid vaccines are distributed and who can receive them this fall.  The FDA is pushing for new clinical trials that include placebo groups. This means some participants will receive the actual vaccine, while others get a harmless substance like saline.  The goal is to compare the results and ensure the vaccines are effective.

The FDA's vaccine advisory committee is set to meet and advise drugmakers on which virus strains to target for the new shots.  This new requirement won't affect the fall rollout for older adults and those at high risk for severe illness.  These groups are exempt from additional testing.  The FDA's new vaccine chief and the FDA Commissioner have suggested that annual shots for healthy children and adults might not be routinely approved.  They argue that the virus doesn't follow a calendar, so the vaccine strategy shouldn't either.  The FDA has previously cleared updated Covid vaccines in a way similar to flu vaccines.  The original Covid shots from Pfizer and Moderna underwent placebo-controlled trials.  Later, drugmakers used smaller studies to test the updated shots against current variants.

The FDA officials have questioned the flu vaccine model, noting that only a quarter of Americans get the updated shots each year.  In contrast, about 75% of healthcare workers get seasonal flu shots.  The officials have rejected the idea that Americans can't understand age- and risk-based recommendations.  They believe people can make informed decisions about their health risks.

The FDA's new guidance requires drugmakers to run new trials tracking participants for at least six months.  The main goal is to show that the shots prevent symptomatic Covid, with at least 30% effectiveness.  People who've had Covid in the past should still be included in the trials to reflect the general population.  Drugmakers can use smaller studies for adults 65 and up, as well as children and adults with high-risk conditions.

The FDA considers many people at high risk, including pregnant women and those with obesity or mental health conditions.  Other high-risk conditions include diabetes, heart disease, and asthma.  The FDA's mandate comes ahead of a vaccine advisory committee meeting, where experts will discuss which strains should be in the next round of Covid shots.  The change means it will be challenging for Pfizer and Moderna to complete the new trials in time for the fall season.  The data would then need to be analyzed and approved by the FDA.

It's unclear what the change means for healthy children and adults who want the updated shots.  Some experts argue that even low-risk individuals can be harmed by the virus.  The FDA's move has raised questions about why the change was made instead of involving the CDC's independent vaccine advisory committee.  The FDA's decision comes after a mandate from the Health and Human Services Secretary that all new vaccines must undergo placebo-controlled clinical trials.

Fall Vaccine Shifts: Who Gets the Shot?

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