The US Food and Drug Administration is changing the way Americans approve COVID-19 vaccines. This is a move to limit future vaccines to older Americans and those at high risk of serious COVID-19 infections.
The agency is changing the standard of evidence required to approve the Covid-19 vaccine in the United States. Dr. Vinay Prasad, the new director of the FDA’s Center for Biological Evaluation and Research, and Dr. Marty McCurry, FDA Commissioner, said in an editorial published in the New England Journal of Medicine of Medicine, published Tuesday.
This change means that Covid-19 shots are likely to be available in adults over 65 years old and in the fall, where there is a higher risk of Covid-19 infection, but not for everyone who has qualified for previously updated shots. According to the US Centers for Disease Control and Prevention, almost three-quarters of Americans over six months have a underlying medical condition, which means they are more fundamentally ill and at higher risk.
This change has already been studied by experts advising the CDC on vaccine recommendations, but will more closely coordinate the US with Covid-19 vaccine recommendations in the UK, Canada and Australia.
Millions of healthy adults and children may lose access to updated vaccines under new standards. Prasad and Makary say there is not enough evidence that healthy children and adults are gaining clinically meaningful benefits from regular Covid-19 shots. They want to see a placebo-controlled trial, especially in adults aged 50-64, before recommending shots from other groups.
Dr. Noel Brewer, professor of public health and health behavior at the University of North Carolina, Chapel Hill, said he supports the change.
“The proposed policy moves the United States along other countries. This global view on public health is a welcome development,” he said, a member of the CDC’s advisory committee on vaccination practices and was part of a working group pondering changes to Covid vaccine recommendations.
However, he and other experts say they are still worried about children under the age of 2, who have a high hospitalization rate since Covid-19.
Dr. Paul Offit, director of the Center for Vaccine Education at the Children’s Hospital of Philadelphia and a member of the FDA’s Independent Advisory Group on Vaccines, says he is opposed to the premises underlying the new framework.
“We have been using evidence-based approaches to Covid-19 vaccination, but we believe that they are kind of swooping and getting ‘gold standard’ data for the first time, robust data.
“That’s why we made a good decision about the vaccine. That’s why it’s so safe. In other words, mRNA vaccines are very safe.”
The editors say the Covid-19 vaccine for people over 65 years old and the Covid-19 vaccine for people over six months, which underlie health conditions at higher risk from COVID-19 infection, will be approved as able to demonstrate that drug companies produce protective antibody levels in people.
These types of studies are called immunobridging studies. They are usually done in a small number of people, and, importantly, they can be done quickly, so vaccine production is up in time and ready for the waves of disease that are normally expected over fall and winter.
This is primarily how seasonal influenza vaccinations are approved annually in the United States, and is how the FDA has approved the Covid-19 vaccine for the past few years.
For everyone else, the FDA only approves the vaccine after studies that prove that shots can better prevent symptomatic Covid-19 than placebo. The FDA considers several secondary outcomes, including severe illness, hospitalization, and death.
The new plan does not consider other effects of Covid-19 infections, such as the long Covid. Research shows that vaccinations may reduce the risk of developing long covids between 25% and 60%.
Prasad and Makary say the new policy needs to balance the need to quickly approve vaccines by fall for the most vulnerable adults and children and provide more evidence before they can be provided to others.
Additionally, millions of Americans under the age of 65 say they are eligible to win the covid-19 vaccine if they have a wide range of health conditions identified by the CDC as being at high risk for severe illness from COVID-19.
“Estimates suggest that between 100 million and 200 million Americans have access to the vaccine this way,” FDA officials wrote.
Prasad and Makary say the goal of asking other groups for more evidence is to restore public confidence in the vaccine.
They point out that over the past two seasons, under 25% of Americans have been receiving Covid-19 shots. This includes less than 10% of children over the age of 75 and less than 50% of adults.
They say the widespread Covid-19 vaccine recommendations and mandate during the pandemic have erod public trust and have also caused a drop in the proportion of other types of vaccines, including measles, mumps and rubella vaccines.
This is a broken news article and will be updated.