FDA aims to ‘simplify’ vaccination with tweaks to long-term COVID-19 strategy

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February 1, 2023 -

The FDA has recognized it needs to make its vaccination messaging simple and clear moving forward.

The COVID-19 pandemic has plagued America for nearly three years but the end might be in sight.

Last year, President Biden casually declared the pandemic over, but now it’s official: The White House announced this week that the national and public health emergency will end on May 11. The announcement came less than a week after an advisory panel at the Food and Drug Administration gathered to discuss the move to a long-term strategy for COVID-19, including how to administer vaccines going forward.

Both moves indicate a distinct shift in the federal government’s pandemic approach — from an acute, urgent and often confusing response to a more streamlined, simplified outlook that goes along with an endemic state of the virus. It also marks the FDA’s first step in figuring out a long-term strategy for providing annual COVID-19 shots, similar to yearly flu ones.

Experts voted unanimously last week to replace the original vaccine with a single shot of the updated bivalent vaccine. In other words, people getting any shot, first or booster, should get the Omicron- specific one. The decision is a reflection of the realization that the public has often been confused — and may continue to be confused – over COVID-19 messaging from public health agencies.

Following several instances of bungled communication throughout the pandemic — including flip- flopping on mask guidance and isolation periods — public health experts have called on agencies like the Centers for Disease Control and Prevention and FDA to improve their messaging. Well-meaning people across the U.S. have found themselves uncertain over whether booster shots in 2022 were necessary, leading to a much lower uptake in vaccinations than the original vaccine in 2021.

Part of that could be chalked up to COVID-19 fatigue. However, experts on the FDA advisory panel agreed that vaccination guidelines need to be simplified in order for them to be effective.

“We think that simplification of the vaccination regimen would contribute to easier vaccine deployment, better communication and improved vaccine coverage,” said Jerry Weir, director of the division of viral products at the FDA, according to The New York Times.

The advisory panel also discussed the FDA’s plans for updating vaccines every year to prepare for fall and winter surges. One option included updating vaccines based on the most prevalent COVID-19 variants of that year, a similar process that flu vaccines currently undergo. Still, no proposals have been set in stone yet. Experts at the panel noted that the FDA will need safety, immunogenicity, and efficacy data before making decisions about rolling out future vaccine versions.

For example, would all fully vaccinated people need annual shots? Will immunocompromised people, older or younger children be needing them most? How can vaccine makers like Pfizer, Moderna, Johnson & Johnson and Novavax coordinate to develop vaccines for the same variant each year? Those critical details still need to be sorted out.

But for now, the message is clear: Americans will just need the one-shot dose of the updated booster. “We heard loud and clear that we need to use a data-driven approach to get to the simplest possible scheme that we can for vaccination,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said, according to POLITICO. “It should be as simple as possible, but not over-simplified, a little bit like they say about Mozart’s music.”

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