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The vaccination plan would be similar to the way annual flu shots are given out, says a document shared ahead of a meeting with the FDA’s advisors.
The US Food and Drug Administration is starting to redesign the current COVID-19 vaccination and booster strategy in the US, but the focus still remains on variant-specific vaccines, according to an FDA document released Monday.
Ahead of a Thursday meeting with scientific advisors and experts that issue recommendations to the FDA, the agency released meeting material that proposes future COVID-19 vaccines should be updated annually based on the circulating strain of COVID-19, similar to how the flu vaccines roll out each year.
Most people will need one shot, and others with a higher risk of severe illness may get two, according to the proposal, which isn’t official yet.
The document also supports limiting all COVID-19 vaccinations to the bivalent formulas that, compared with the original vaccines, offer better protection against the current subvariants responsible for cases of COVID-19.
The FDA said a plan for “simplification” of COVID-19 vaccine composition, updates and messaging may lead to “improved vaccine coverage rates and, ultimately, to enhanced public health.”
Thursday’s meeting will offer more insight into health officials’ plans, support and concerns over the proposed strategy. While some health experts have welcomed the FDA’s proposal document as a simple way to get people vaccinated, some experts have criticized the blanket approach to boosters and vaccinations.
Thursday’s meeting will be an important one because it’ll help shape the vaccine campaign as the country attempts to reorganize itself before the COVID-19 pandemic is no longer considered a public health emergency. It also follows disagreements between the FDA and some of its advisory committee members, including over earlier COVID-19 booster decisions and even the recent Alzheimer’s drug recommendation, as STAT reports.
The FDA doesn’t necessarily have to follow its advisory committee’s recommendations or vote, but the precedent has been that it does.
According to the meeting document, the FDA is asking its committee to vote on whether all current vaccines should be bivalent (meaning that the original vaccines might be phased out in the US). The agency is also asking advisors to weigh in on how to “simplify” the vaccine schedule, with one-dose recommendations for many people, and two-dose recommendations for people at higher risk of severe disease, and to discuss updates to the COVID-19 vaccine compositions.
The scientific advisors will also go over safety and effectiveness data on the current COVID-19 vaccines, according to the meeting agenda. We can also expect Thursday’s meeting to address questions that have been raised at earlier discussions about vaccines: who needs one the most, what are the benefits and risks, and what’s the best time for everyone to get one.
The FDA’s meeting material appears to leave out discussions on other types of vaccines not currently authorized in the US, including nasal and mucosal vaccines. Some scientists have been pushing for more vaccine development going forward, some of which may offer better infection-protection against COVID-19.
The FDA advisory meetings are open to the public, so anyone who wants to can tune in for the daylong meeting on Thursday, Jan. 26 at 8:30 ET/5:30 PT by visiting the YouTube link on the FDA’s website. The meeting is scheduled to run until 5:30 ET/2:30 PT, but it could end earlier.
Following FDA authorization or approval of a vaccine, the US Centers for Disease Control and Prevention often holds a similar public meeting with its committee of independent experts to make recommendations and discuss any safety or effectiveness concerns.
The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.
