The US Food and Drug Administration wants to simplify COVID-19 vaccinations in the US, moving away from the rolling booster authorizations and recommendations to a more consistent pattern, similar to how flu vaccines are administered annually.
A panel of health experts that serve as the FDA’s advisory committee on Thursday made a step toward that goal, voting 21-0 to replace the COVID-19 vaccines on the US market with bivalent formulas. This means that — once the panel’s vote is officially accepted by health agencies — the “original” vaccine formulas we all received for the first two doses will be phased out and children and adults who haven’t been vaccinated yet will get the bivalent, omicron-specific formulas instead.
The bivalent vaccines currently on the market are Moderna’s and Pfizer-BioNTech’s formulas, and they’re already available to everyone six months and older as booster doses.
Before Thursday’s meeting with the FDA’s advisory committee, the health agency laid out a tentative plan for COVID-19 vaccines when the COVID-19 pandemic is no longer considered a public health emergency. This includes updating COVID-19 vaccines annually and giving them out in one dose (two doses for people at higher risk of severe illness), similar to how the flu vaccine campaign work each year.
But a decision on that hasn’t been formally made yet, and there are still many details the FDA, the US Centers for Disease Control and Prevention and the vaccine makers themselves have to iron out. Part of those considerations may include reflecting on the latest booster recommendation for everyone to get the bivalent vaccine — uptake on which has been “dismal,” according to Rupali J. Limaye, an associate professor of international health at the Johns Hopkins Bloomberg School of Public Health.
A more blanket approach to COVID-19 vaccines (most people getting one shot per year, people at higher risk of illness getting two shots) is what the FDA is aiming for. But past public messaging problems, including a sometimes confusing booster recommendation that marked earlier parts of the pandemic, are just a couple of the hurdles the FDA will have to overcome in this next phase of vaccines.
“Public awareness, public acceptance — how do we simplify that for people?” Limaye told CNET after the FDA’s proposal was first published.
Here’s what we know so far.
What’s different right now?
Nothing much right now, especially because the FDA committee’s vote isn’t official yet. It simply means health officials are on track to phase out the original vaccines on the market (older formulas from Moderna and Pfizer-BioNTech, as well as Novavax’s and Johnson & Johnson’s formulas). So people going in for their first or second primary series shot will get the bivalent formula that fully vaccinated people have been receiving as their booster dose.
If you’ve been fully vaccinated, nothing in the immediate future is changing for you.
Do I need another booster?
If you’re an adult who’s due for a booster, but hasn’t gotten it yet, you’ll still get either mRNA vaccine currently on the market. No changes or new recommendations have been made for booster doses. So if you were up-to-date on your shots last week, you’re up-to-date this week.
Everyone age 6 months and older can get a vaccine. Older adults in their 60s and up and younger adults with medical conditions are more likely to get severely sick with COVID-19 and would especially benefit from added protection.
Very young children and infants also had more reported deaths from COVID-19 last year compared to children in older age groups, according to a presentation from the CDC on Thursday. Children under six months aren’t eligible to be vaccinated against COVID-19, but the majority of kids under age 5 remain unvaccinated despite being eligible, according to information shared at the meeting.
Screenshot of a CDC presentation at the FDA advisory meeting.
US Centers for Disease Control and PreventionCOVID vaccines will probably work like flu shots going forward, but nothing’s final
The FDA’s proposal was the COVID-19 vaccines roll out each year similarly to annual flu shots, where a strain is selected for optimal protection prior to the fall and winter season. This likely means that the FDA and CDC have more discussions and age-specific guidelines ahead of them if the FDA wants to have the next round of shots ready for September.
The FDA advisers haven’t voted on annual shots yet, however. And there’s not total agreement on using the same vaccine path for both COVID-19 and the flu.
“COVID is not flu as an infection or a disease,” Dr. Pamela McInnes, past director of the National Center for Advancing Translational Sciences at the National Institutes of Health and member of the FDA’s advisory committee, said during Thursday’s meeting.
What about the nasal vaccines?
Some scientists have been pushing for more vaccine development in mucosal vaccines (including nasal vaccines), because new vaccine technologies may have the potential to offer better infection protection against COVID-19. Aside from a presentation at last week’s meeting by the National Institute of Allergy and Infectious Diseases on next-generation vaccines, which touched on the benefit of mucosal vaccines, the FDA’s plan right doesn’t appear to address new vaccine technologies.
But getting there requires bodies of data supporting their use in the US, which requires funding and demand. As the government moves away from paying for everyone’s shots, “there’s just not as much incentive” to create and test new vaccines, including nasal and inhaled vaccines, Limaye says.
“It’s gonna be a little bit of an uphill battle to get a product like that on the market, unfortunately,” she said.
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.
