FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people

The US Food and Drug Administration (FDA) on Tuesday announced a new framework for licensing COVID-19 vaccine boosters that would move away from the agency’s more universal approach to boosters to specifically target vaccine development for people 65 and older and individuals with certain underlying medical conditions that are at higher risk from the disease.

On 20 May, Vinay Prasad, the newly appointed director of FDA’s Center for Biologics Evaluation and Research (CBER), announced a major shift in the agency’s approach to approving annual updates to the COVID-19 vaccine. During a streamed presentation, he outlined the agency’s new policy would be to evaluate the COVID-19 vaccines for people 65 and older, or those between 6 months and 65 who have one or more risk factors such as asthma, cancer, diabetes, obesity, or a history of smoking. Under the new framework, COVID-19 vaccines for individuals without one of the listed risk factors, would have to undergo randomized, controlled trials (RCT) to ensure they provide the necessary level of benefit.

"FDA's thinking has evolved on this topic,” said Prasad. “With changing evidence, we have a changing regulatory framework."

"We must develop randomized evidence, we owe it to the American people,” he added. “We have launched down this multi-year campaign of booster after booster after booster and distrust of the American public and we do not have gold standard science to support this for average risk, low risk Americans."

To support their requirement for RCT, Prasad evoked former FDA Commissioner Rob Califf who wrote in a Journal of the American Medical Association (JAMA) earlier this year that COVID-19 vaccine uptake was now low enough for it to be feasible to conduct RCTs for updated boosters.

Just prior to his presentation, Prasad and FDA Commissioner Martin Makary published an article in the New England Journal of Medicine (NEJM) detailing the new framework and their rationale for it. They note that the US COVID-19 vaccination policy has been the most aggressive when compared to that of European nations.

“While all other high-income nations confine vaccine recommendations to older adults (typically those older than 65 years of age), or those at high risk for severe Covid-19, the United States has adopted a one-size-fits-all regulatory framework and has granted broad marketing authorization to all Americans over the age of 6 months,” wrote Prasad and Makary, “The U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations. We reject this view.”

During his presentation, Prasad said Americans are very divided on the COVID-19 vaccines. He noted that some are opposed to the vaccines arguing that FDA has not fully evaluated the products and their long-term safety while others are desperate for additional protection and want the vaccines.

Prasad also addressed concerns that by changing the vaccine requirements, it was stepping into the role of the Centers for Disease Control and Prevention (CDC) which provides public health recommendations. While he acknowledged that CDC issues recommendations on who receives FDA approved vaccines, the agency can only approve products that have proven they work, especially when it comes to young people at low risk of severe disease.

"We have to do our duty too here at FDA,” said Prasad. “We are committed to ensuring companies generate that evidence and we strongly suggest they complete any agreed upon post-marketing studies.”

After his presentation, Prasad sat down for an interview with Makary where the commissioner asked him about the need to change the current COVID-19 vaccine approval framework.

"Change in medicine isn't always easy,” he answered. “You know there are a lot of advances in medicine that aren't always easy and I think there are some people out there who are going to be concerned about various aspects of our framework but ultimately I do think this is a step forward and a lot of these questions will be answered by next calendar year when we start to get the interim results of some of these studies back."

Paul Offit, a pediatrician at the division of infectious diseases at Children's Hospital of Philadelphia and a member of FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) spoke to Focus about the new framework.

“There’s certain hubris to this that I think is a little presumptive,” he said. “The title [of the NEJM article] is, ‘An Evidence-Based Approach to Covid-19 Vaccination.’ We have been using evidence based COVID-19 vaccines, that’s why we’ve been successful and saved peoples lives.”

When asked about the different between US and European vaccine requirements, he said the US faced a messaging difficulty. He noted that during the pandemic he discussed the requirements with Anthony Fauci, then director of the National Institute of Allergy and Infectious Diseases, and they agreed that asking everyone to be vaccinated improved vaccine adoption in high-risk populations as well.

Offit said the biggest difference between how COVID-19 vaccines were regulated and how they will be regulated now, is that it seems FDA is now usurping the CDC’s role as a recommending body. He is also concerned that if the vaccine is only licensed for high-risk groups, insurance providers won’t cover it for health individuals without risk factors who may still want to get vaccinated to ensure they don’t suffer mild or moderate bouts of COVID-19. He also questioned whether people who have not been vaccinated or gotten natural immunity through previous infections would qualify for the updated vaccine.

Offit also raised concerns about the ethics of asking health people to participate in COVID-19 RCTs with placebos.

“The virus is still out there, and a low-risk person is not a no risk person,” he said. “I think it's unethical to give a placebo knowing there’s a vaccine out there.

“Imagine doing the trial and someone in the placebo group dying in a hospital,” he added.

FDA unveils new COVID-19 framework, restricting shots to elderly and high-risk people

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