The nation's top disease and vaccine experts are trying to figure out their next move against COVID-19 before it's too late.
On Wednesday, an independent advisory committee to the US Food and Drug Administration met to discuss the future of CO. It was a departure from the previous meetings of the committee, which focused more on OKing specific COVID-19 vaccine candidates for different age groups, as well as booster shots.
The committee had a discussion.
There is a worry that protection against severe illness won't hold up forever, according to the FDA.
The FDA and its advisers are under a lot of pressure to make sure that new shots can be used as early as this fall. The Center for Biologics Evaluation and Research is the arm of the FDA that is in charge of regulating all vaccines.
He said at the meeting that the FDA's decision in late March to authorize second booster doses for people over 50 years old was a stopgap.
Moderna and Pfizer are two of the successful vaccine makers who have not received any direction from the federal government.
They are working on new vaccines that might target the Omicron variant. Other vaccine makers are trying out different approaches to fighting this disease, in both early and late-stage clinical trials.
The FDA committee members said that a national strategy for new vaccines is needed. Vaccine makers will miss the boat if they Tailoring vaccines too tightly to circulating variants is a futile strategy.
Nelson suggested, instead, making changes only when we feel confident that it will lead to a longer duration of protection.
Professor Drew Weissman at the University of Pennsylvania is working on that task. Large-scale human trials of those pan-corona vaccines are likely months away.
Marks said that they have to do tremendous work in researching more advanced vaccines.
The vaccines authorized and approved for use in the US are still very protective against infections that can lead to hospitalization or death.
The chief medical officer at the National Center for Immunizations and Respiratory Diseases of the Centers for Disease Control and Prevention asked what was enough at the meeting.
There was no evidence of vaccine effectiveness waning during the recent Omicron wave, according to data presented by the CDC. Even in highly vulnerable populations, such as older adults and those with comorbidities, vaccine effectiveness against hospitalization remains well above 80%.
I think we may have to accept that level of protection, and then use other alternative ways to protect individuals.
If we are going to create a new vaccine, experts on the committee urged the FDA to find a better way to measure COVID-19.
Marks said during the meeting that measuring antibody levels is a poor indicator of immunity against COVID.
There is no way to know if someone really needs a booster or a new shot because experts know it's imprecise.
The director of the precision vaccines program division of infectious diseases at Boston Children's Hospital suggested that the US government should create a repository where the best immunology studies from around the world could be consulted. He said that it could help drive the conversation about what the next vaccines need to do for our immune systems, and how we will know when they work well.
The FDA advisory committee is expected to meet again some time this summer, hopefully with more data from pharmaceutical companies about next-generation vaccine candidates they are working on. The hope is that the committee can make some informed decisions about what should happen this fall and beyond, assessing whether additional shots will be needed, and what kind.
The committee chair Dr. Arnold Monto said that the task was difficult.
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