EDITOR’S NOTE: This story has been updated to reflect changes to US Centers for Disease Control and Prevention immunization schedules.
The US Department of Health and Human Services, under Secretary Robert F. Kennedy Jr., has recently made significant changes to how Covid-19 vaccines are approved and the groups they are recommended for.
For the past few years, the federal government has broadly approved and recommended an updated Covid-19 shot for everyone ages 6 months and up each fall.
But last week, leaders from the US Food and Drug Administration outlined a new framework for the approval process for Covid-19 vaccines that could limit shots to older Americans and people at higher risk of serious Covid-19 infection. On Tuesday, Kennedy announced that the vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention’s immunization schedule.
However, the schedule now categorizes Covid-19 shots for children as “recommended vaccination based on shared clinical decision-making,” meaning kids can get the shots after consulting with a health care provider such as a doctor, nurse or pharmacist.
These changes, made in unconventional ways, will probably affect access to and availability of Covid-19 vaccine shots for millions.
Who will be eligible for the Covid-19 vaccine?
Under the framework outlined by FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA’s Center for Biologics Evaluation and Research, updated Covid-19 vaccines will probably be approved for everyone 65 and older and for people 6 months and older who have at least one underlying condition that puts them at “high risk for severe Covid-19 outcomes.”
The CDC lists dozens of conditions that may contribute to higher Covid-19 risk, including asthma, cancer, diabetes, obesity and a history of smoking. These underlying conditions will make between 100 million and 200 million people in the US eligible for a Covid-19 vaccine under the new framework, the FDA leaders estimate.
Pregnancy is included on the list of factors that the CDC says have shown “a conclusive increase in risk” for at least one severe Covid-19 outcome. Kennedy did not offer a specific reason behind the decision to change recommendations for the Covid-19 for pregnant people, but the move appears to directly contradict the new FDA framework outlined a week earlier.
Many of the CDC’s information pages continue to recommend the Covid-19 vaccine for pregnant women, but the adult immunization schedule has been changed to specify that the recommendation applies only to adults who aren’t pregnant.
For kids and adults younger than 65 who do not have an underlying condition, the FDA says it will require in-depth clinical trials before licensing new vaccines.
An independent group of advisers to the CDC – the Advisory Committee on Immunization Practices, or ACIP – is expected meet at the end of June about Covid-19 vaccine recommendations, and it had already been weighing options for more targeted risk-based recommendations than the general guidelines issued in previous years.
Can people who do not meet the new eligibility criteria still get a Covid-19 shot for themselves or their kids?
Maybe, but it may be more difficult – and expensive.
“Theoretically, one could find someone who would be willing to provide them the vaccine – and they may have to pay out of pocket to get it – but there’s a lot of things that have to align for that to happen,” said Dr. Michelle Fiscus, a pediatrician and chief medical officer of the Association of Immunization Managers.
Health care providers may be able to provide the Covid-19 vaccine “off-label” – but they’d need to have the vaccine in stock, which has become increasingly uncommon.
The vast majority of Covid-19 vaccinations happen at pharmacies. Pharmacists generally don’t have the tools to verify medical history and whether an individual has a condition that makes them high-risk, so many of them could take patients at their word. But the recent announcements from the federal government may have a chilling effect on what providers are willing to do, experts say.
Will insurance cover Covid-19 shots?
It’s likely that people who are covered by public insurance such as Medicare and Medicaid and who meet the new FDA eligibility requirements will continue to have Covid-19 vaccines covered, experts say.
There’s more uncertainty around how private insurance companies will choose to adjust coverage. Some of the conditions that the CDC lists as high-risk for Covid-19 – such as “physical inactivity” – are loosely defined and may be left up to individual plans to interpret.
Vaccines listed on the immunization schedule as recommended “based on shared clinical decision-making – as the Covid shot is for healthy children – are required to be covered by insurance with no cost-sharing, meaning no co-pays for patients, according to the CDC.
Under the Affordable Care Act, insurance companies are required to cover vaccines for adults if they’ve been recommended by ACIP. The committee also votes on whether vaccines should be added to the federal Vaccines for Children program, which provides vaccines to children who would not otherwise be able to afford them.
However, there’s a gray area around what will happen if ACIP recommendations differ from CDC recommendations, experts say.
When do the changes take effect?
In a video posted on social media on Tuesday, Kennedy said that changes to the recommendations for children and pregnant people took effect that day.
Last week’s editorial from Makary and Prasad said that the new framework for vaccine approval would be adopted “moving forward.” The FDA officials say the new policy balances the need to swiftly approve vaccines – to have them ready by the fall respiratory virus season for the most vulnerable adults and children – against the need for more evidence before offering them to others.
Under this newly proposed framework, the FDA says, it will require additional evidence from vaccine manufacturers before approving updated Covid-19 shots for healthy kids and adults. The officials said those studies should last a minimum of six months, which would preclude any findings from influencing approvals in time for this fall.
The CDC’s independent vaccine advisers meet at the end of June and are expected to vote on this fall’s Covid-19 vaccine recommendations. Their decisions have guided vaccine policy in the US for decades, but it’s unclear how much influence it will have over the newly announced changes. HHS still hasn’t signed off on two of the three recommendations that were made at the group’s last meeting, in April.
Are Covid-19 vaccines still considered safe?
The Covid-19 vaccines that are currently available in the US have been approved by the FDA after rigorous analysis and are considered safe.
In their editorial outlining the new framework for Covid-19 vaccine approval, the FDA’s Makary and Prasad said that “the benefit of repeat dosing … is uncertain,” but they did not present evidence that Covid-19 vaccines themselves are unsafe.
The agency says it will approve vaccines for healthy kids and adults only after studies that prove that the shots can prevent symptomatic Covid-19 better than a placebo. However, the new plan doesn’t take into account other effects of Covid-19 infections, such as long Covid.
These changes to Covid-19 vaccine policy limit opportunities to protect people who are at high risk, including young children and pregnant people, experts say
“We have vaccines that we know were critical in saving lives during the pandemic and we continue to see the morbidity and mortality from Covid-19,” Fiscus said. “It’s very concerning that people who would choose to protect themselves or their children with a vaccine may have that choice taken away.”