FDA limits access to updated COVID-19 shots: What we know
COVID shots no longer recommended by CDC for kids
Health Secretary Robert F. Kennedy Jr. says CDC no longer recommends COVID-19 vaccines for healthy children or pregnant women. The move was announced via a video on X without CDC officials present. A CDC advisory panel was set to vote in June on updated vaccine guidance.
The Food and Drug Administration approved updated COVID-19 vaccines Wednesday, but limited their use to seniors and those with high-risk health conditions.
The new restrictions — previewed by FDA officials in May — are a break from the previous U.S. policy, which recommended an annual COVID-19 shot for all Americans 6 months and up. They reflect heightened skepticism about the ongoing risks of COVID-19 and the need for yearly booster shots from Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, who were both outspoken critics of wide-scale vaccinations.
The revamped vaccines target a newer version of the continuously evolving virus and are set to begin shipping immediately. But it could be days or weeks before many Americans know if they’ll be able to get one, with access dependent on decisions by federal health advisers, private health insurers, pharmacies and state authorities.
READ MORE: Hundreds of HHS staff sign letter urging RFK Jr. to stop spreading misinformation
The FDA has also removed one of the two shots available to young children.
Who can get an updated COVID-19 shot?
What we know:
The new shots from Pfizer, Moderna and Novavax are approved for all seniors. But the FDA narrowed their use for younger adults and children to those with at least one high-risk health condition, such as asthma or obesity.
FILE - A child receives a Pfizer-BioNTech Covid-19 Vaccine from a pharmacist at the Jewish Federation/JARC's offices in Bloomfield Hills, Michigan, on May 13, 2021. (Photo by JEFF KOWALSKY/AFP via Getty Images)
Novavax's shot is only open to people 12 or older, not younger children – and under the same risk-based restrictions as are now in place for the Moderna and Pfizer options. It's the nation's only traditional, protein-based COVID-19 vaccine.
Why you should care:
The new policy presents new barriers to access for millions of Americans who would have to prove their risk. Access could also be complicated for healthy adults and children who are interested in getting a shot for extra protection.
RELATED: Pediatricians’ group breaks with CDC, still urging COVID-19 shots for young children
If the latest vaccines aren’t covered by their insurance, those patients could be required to pay $150 or more out of pocket if they want one. If they aren't considered high-risk, they also might also have to find a doctor or other health professional willing to give the shot "off label."
What they're saying:
"The American people demanded science, safety, and common sense. This framework delivers all three," Kennedy wrote on social media.
What we don't know:
In his post Wednesday, Kennedy said the shots will be "available for all patients who choose them after consulting with their doctors," but Americans are likely to confront a number of logistical hurdles.
Insurers typically base their vaccine coverage decisions on the recommendations of a panel of advisers to Centers for Disease Control and Prevention.
RELATED: RFK Jr. ousts entire CDC vaccine panel
Earlier this year, Kennedy dissolved the CDC panel and replaced its members with a number of doctors and researchers who have repeatedly questioned the safety of commonly used vaccines and ingredients. The panel is expected to meet in September, but no specific date has been set and no agenda released.
Depending on the panel’s advice, Americans under age 65 could be expected to provide documentation of a serious medical condition before they can get a shot. Complicating the rollout is the fact that pharmacists — who administer most COVID-19 shots — typically aren’t expected to collect that kind of information. And laws governing their ability to administer routine vaccinations vary by state, where pharmacists are licensed.
Many states limit vaccinations by pharmacists to those recommended by the CDC panel.
What do doctors say?
The other side:
Some medical groups, including the American Academy of Pediatrics, have objected to the new limits, saying they may block vaccine access for families who want to protect their children. Last week, the group offered its own recommendations for kids, saying annual shots are strongly recommended for children ages 6 months to 2 years and advised for older children.
That differs from the latest guidance under Kennedy, which doesn’t recommend the shots for healthy children of any age, but says kids may get the shots in consultation with physicians.
COVID-19 vaccines do a good job preventing severe disease, hospitalization and death, which remain a bigger risk for seniors and people with underlying health factors, including heart disease, lung disease and cancer.
By the numbers:
Preliminary data from the CDC estimates 47,500 Americans died from COVID-related causes last year. In at least two-thirds of those cases, COVID-19 was listed as the underlying cause of death. For the rest, COVID-19 was a contributing factor.
Pfizer vaccine revoked for children under 5
Dig deeper:
Additionally, Pfizer’s vaccine will no longer be available for any child under 5, because the FDA said it was revoking the shot’s emergency authorization for that age group.
Parents will still be able to seek out shots from rival drugmaker Moderna, the other maker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem.
The Source: This report includes information from The Associated Press and previous LiveNow from FOX reporting.