The Food and Drug Administration on Thursday green-lit updated coronavirus vaccines for higher-risk Americans, such as older adults and people with at least one underlying health condition, vaccine manufacturers announced.
The approved shots from vaccine manufacturers Pfizer-BioNTech and Moderna, which make mRNA-based vaccines, have an updated formulation aimed at better targeting the coronavirus variants circulating around the country. The FDA also cleared an updated vaccine from Sanofi, which doesn't use mRNA-based technology and was originally licensed by Novavax, a Sanofi spokesperson confirmed. The companies said the vaccines are expected to be available in the coming days.
But questions remain over formal federal recommendations for which Americans should get a vaccine, which could complicate availability of the shots in a handful of states. A federal vaccine panel charged with making immunization recommendations has been thrown into legal limbo after a federal judge ruled Health Secretary Robert F. Kennedy Jr. improperly reconstituted it last year after firing all of its members.
However, public health experts and others involved in vaccination efforts aren't anticipating last year's widespread confusion. The coronavirus shots weren't initially available in pharmacies in 16 states because federal vaccine experts and federal officials had not yet issued formal recommendations for which Americans should get a shot.
"A lot of the solutions already got put in place," said Stephen Hoge, Moderna's president. "As it stands right now, we believe everybody -- most states and certainly any clinicians or pharmacies or others -- have already planned to deal with this challenge."
Kennedy, the founder of a prominent anti-vaccine group, has sought to bypass the traditional process for some of his department's changes regarding who should get a coronavirus shot. Kennedy has criticized the shots, which President Donald Trump hailed as a "modern-day miracle" during the pandemic.
Medical experts say the vaccines are effective at preventing serious illness, hospitalization and death, but uptake of the shots updated annually remains low, according to Centers for Disease Control and Prevention data. Coronavirus infections are increasing or likely to be growing in 47 states, according to Aug. 19 CDC data. COVID-19 has typically had a summer wave the last several years, but infectious-disease experts note that the spread of the virus still remains low, particularly compared with last summer.
Specifically, the FDA signed off on updated vaccines for adults 65 and over, as well as those with at least one health condition putting them at risk of severe disease, according to the companies.
Last year, this included a wide range of conditions, such as diabetes, obesity, chronic kidney disease, physical inactivity and more.
Specific vaccines for higher-risk children depend on their age: A Moderna vaccine was approved for ages 6 months and older, Pfizer for those 5 years old and older, and Sanofi for those 12 years old and older.
The FDA last year narrowed approval of the shots to high-risk groups, a significant shift for the vaccine once routinely provided to nearly all Americans. Then-FDA Commissioner Marty Makary and top vaccine regulator Vinay Prasad, both of whom departed the agency earlier this year, laid out the new approach requiring vaccine manufacturers to conduct a randomized controlled trial before the agency signs off on shots for healthy people between the ages of 6 months and 64 years.
However, most Americans can still get the shots off-label, which essentially means doctors and other healthcare providers can administer medications to populations the FDA did not approve them for. Doctors generally weigh various factors, including the advice of major medical societies, government recommendations and a patient's individual health.
That is a complicated question -- and it's not clear whether there will be new federal recommendations this year.
Typically, an expert vaccine advisory panel, known as the Advisory Committee on Immunization Practices, votes annually on which people they believe should receive the updated coronavirus vaccine. Then the CDC makes an official recommendation.
But a meeting to discuss coronavirus vaccines has not been scheduled. That's because a federal judge in March blocked many of the Trump administration's changes to vaccine policy, including temporarily suspending the appointment of the vast majority of Kennedy's handpicked members, some of whom had histories of criticizing the use of mRNA coronavirus vaccines.
Last year, the panel replaced a universal recommendation that everyone 6 months and older receive the vaccine with a more restrictive approach. It sought for everyone to consult a health care provider before getting a shot -- a recommendation that has been placed on hold by a federal judge.
Yet two changes made under Kennedy's leadership are still in effect: revisions regarding healthy children and pregnant women. There is currently no recommendation for pregnant women to receive the shots, and the vaccine is recommended for healthy children through shared decision-making, meaning parents and children should talk with health providers and decide what makes sense for them.
"This is really uncharted," said Jennifer Kates, a senior vice president at KFF, a health policy research and news organization. "We have not had this situation ever before."
Medical societies are planning to put out their recommendations on who should get the updated shots in early September.
Here's what major associations recently recommended:
Children: The American Academy of Pediatrics last year recommended all children ages 6 months through 23 months receive a coronavirus immunization, as well as those who are at high risk of severe disease. For healthy children ages 2 to 18, the group said they can get an updated shot if their parents or guardians want them to have protection.
Adults: The American Academy of Family Physicians last year recommended all adults 19 years and older receive the vaccine. The medical society said doing so was "especially important" for those 65 and older, at increased risk of severe disease or who have never received a coronavirus shot.
Pregnant women: The American College of Obstetricians and Gynecologists this spring said it continues to recommend routine updated shots for pregnant women, those considering getting pregnant and those who are breastfeeding.
Most Americans typically get vaccinated against the coronavirus at retail pharmacies.
Pharmacies are actively preparing to receive the updated shots, so they can begin vaccinations as soon as they receive shipments and all state requirements are met, according to Brigid Groves, a vice president at the American Pharmacists Association.
Amy Thibault, a CVS spokeswoman, said pharmacies and MinuteClinics are expected to start receiving supplies of the shots within a few days and "will be offering them to eligible patients in all states as permitted by law."
She added, "Once the vaccine arrives, patients will be able to see which CVS Pharmacy and MinuteClinic location has which vaccine, as well as appointment availability."
In a statement, Walgreens said the updated COVID-19 shots will be available for "eligible patients in the coming days."
It was not immediately clear in which states the shots would be offered. Yet, public health and pharmacy experts believe access will be quicker in most states than it was last year.
Some states tie the authority of pharmacists to offer vaccines to federal immunization recommendations. That led to a scenario last year in which the availability of vaccines at pharmacies in some states was initially delayed as federal vaccine advisers had not yet made a formal recommendation.
Since last year, there has been "substantial state-level work to preserve pharmacy access," Groves said. That includes modifying pharmacy practice laws, updating regulations,