The US Food and Drug Administration has a plan for what COVID-19 vaccination campaign will look like this year and beyond, as the country exits the emergency phase of the pandemic.
Moving ahead, boosters and vaccines will probably work similarly to how annual flu shots roll out, the FDA decided in late January. The US Centers for Disease Control and Prevention has also updated its vaccine schedule guidance to include COVID-19 shots, likewise signaling a shift toward a more routine series.
While details still need to be determined, the focus will remain on mRNA vaccines made by Pfizer-BioNTech and Moderna. A group of FDA advisers voted last month to endorse replacing all vaccines currently on the market with the bivalent vaccines tweaked to better neutralize omicron variants. This is meant to simplify vaccines in general, so everyone will get the same formula, whether it's their first shot or fourth.
A final decision has yet to be made, though, and there are still many details the FDA, the CDC and the vaccine makers themselves must 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 -- with most people getting one shot per year and 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 need to overcome in this next phase.
"Public awareness, public acceptance -- how do we simplify that for people?" Limaye said to CNET after the FDA's proposal was first published.
In addition to public health awareness, details on who will pay and how much they'll pay for vaccines once the government is no longer footing the bill must still be be determined. Moderna's CEO was called to testify at a Senate hearing in March by Sen. Bernie Sanders, an independent of Vermont, after the vaccine company proposed a vaccine price hike.
Here's what we know now about the future of COVID-19 vaccines.
What's going on with the vaccine price hikes?
Moderna was criticized for planning to raise its vaccine price to up to $130, roughly four times the price the federal government currently pays, once the public health emergency ends in May and the federal government will no longer cover the cost for all vaccines. Pfizer's adult vaccine price-per-dose will also cost $110 to $130. However, Pfizer didn't receive the same federal money or assistance for its research, according to a CNN fact check. The taxpayer-funded element is Sanders' main argument against Modernas price increase.
On Feb. 15, the same day Sanders announced that Moderna's CEO will testify in front of a Senate committee in March, the vaccine company announced that its COVID vaccine will "continue to be available at no cost" for people in the US, whether they're insured or uninsured. For the uninsured, Moderna has a patient assistance program that will go into effect this spring. Moderna didn't immediately respond to a request for additional comment.
Pfizer also said earlier that it will have a patient assistance program to keep shots free for people without health insurance and that the company expects most people with insurance will continue to pay nothing out of pocket.
However, the details on both vaccine companies' assistance programs for the uninsured remain unclear, and insurance companies were likely to pay for vaccines regardless of price changes. For more about health care after the COVID-19 public health emergency ends, read how treatments could be affected starting this spring.
COVID vaccines will probably work like flu shots going forward, but nothing's final
The FDA's proposal is for COVID-19 vaccines to 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 will 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 a member of the FDA's advisory committee, said during the advisory meeting.
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 of the mRNA vaccines 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 with children in older age groups, according to a presentation from the CDC. Children under 6 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.
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 January'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.
Getting there requires bodies of data supporting the use of such vaccines 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 said.
"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.