Editor’s Note: This story has been updated to reflect changes to the US disease control and preventive vaccination schedule.
The U.S. Department of Health and Human Services has recently made major changes to how they are approved for the Covid-19 vaccine and the group they are recommended.
Over the past few years, the federal government has been widely approved and recommends updated Covid-19 shots for everyone from six months ago.
However, last week, US Food and Drug Administration leaders outlined a new framework for the Covid-19 vaccine approval process that can limit shots to older people and people at high risk of severe Covid-19 infections. On Tuesday, Kennedy announced that the vaccine will no longer be one of the recommended vaccines for pregnant women and healthy children at the U.S. Center for Disease Control and Prevention Vaccination Schedule.
However, the schedule currently classifies children’s Covid-19 shots as “recommended vaccinations based on shared clinical decisions.”
These changes, made in unconventional ways, will likely affect access and availability of millions of Covid-19 vaccine shots.
Under the framework outlined by FDA Commissioner Dr. Marty McCurry and Dr. Vinai Prasad, the new director of the FDA’s Center for Biological Evaluation and Research, renewing the Covid-19 vaccine is approved for people over the age of 65 and above with at least significant conditions.
The CDC lists a number of conditions that can increase your risk of Covid-19, including asthma, cancer, diabetes, obesity and the history of smoking. These underlying conditions are estimated by FDA leaders that between 100 million and 200 million people in the United States will be eligible for the Covid-19 vaccine under the new framework.
The CDC list of factors states that it presents a “conclusive increase in risk” for at least one severe COVID-19 outcome. Kennedy did not provide any specific reason behind the decision to change Covid-19 recommendations for pregnant people, but the move appears to be directly inconsistent with the new FDA framework outlined a week ago.
Many of the CDC information pages continue to recommend the Covid-19 vaccine for pregnant women, but adult vaccination schedules have been changed, specifying that the recommendations apply only to non-pregnant adults.
For children and adults under the age of 65 who do not have a fundamental condition, the FDA says detailed clinical trials will be required before licensing new vaccines.
The CDC’s independent advisor group (Advisory Committee on Vaccination Practices, or ACIP) is expected to meet at the end of June on Covid-19 vaccine recommendations, and had already evaluated the options for more targeted risk-based recommendations than the general guidelines issued the previous year.
Maybe, but it may be even more difficult – and expensive.
“In theory, you can find someone who is willing to offer the vaccine, and while you may have to pay out of your pocket to get it, there are a lot of things you need to line up to get it.”
Healthcare providers may be able to offer the Covid-19 vaccine “off-label” but they must stock the vaccine.
The majority of Covid-19 vaccinations occur at pharmacies. Pharmacists generally do not have the tools to check their medical history. Many people can take patients in their own words to see if an individual has a risk-increasing condition. However, recent announcements from the federal government could have a calm impact on what providers are willing to do, experts say.
Those who are eligible for public insurance such as Medicare and Medicaid and meet new FDA eligibility requirements are likely to continue to cover the Covid-19 vaccine, experts say.
There is more uncertainty about how private insurers choose to adjust their coverage. Some of the conditions that the CDC lists Covid-19 risks as risks such as “physical inertness” are loosely defined and may be left to the individual plan to interpret.
According to the CDC, “It should be covered by insurance without cost sharing, based on shared clinical decisions, based on shared clinical decisions, based on shared clinical decisions, without cost sharing.
Insurers should cover adult vaccines if ACIP is recommended under the Affordable Care Act. The committee will also vote on whether the vaccine should be added to the federal vaccine for Children program.
However, there is a gray area as to what happens when ACIP recommendations differ from CDC recommendations, experts say.
In a video posted on social media on Tuesday, Kennedy said changes to recommendations for children and pregnant people came into effect that day.
An editorial from Makary and Prasad last week said that the new framework for vaccine approval would be adopted “advanced.” FDA officials say the new policy balances the need to quickly approve vaccines against the need to require more evidence before providing them to others to prepare them by the fall respiratory virus season for the most vulnerable adults and children.
Under this newly proposed framework, the FDA says additional evidence from vaccine manufacturers will be needed before approving the latest COVID-19 shots for healthy children and adults. Officials said these studies should last for a minimum of six months, but this would eliminate findings from affecting approval this fall.
The CDC’s independent vaccine advisors will meet at the end of June and will vote for recommendations for Covid-19 vaccine this fall. Their decision has guided vaccine policies in the United States for decades, but it is unclear how much of the impact it will have on newly announced changes. HHS has yet to sign off to two of the three recommendations made at the group’s final meeting in April.
The Covid-19 vaccine currently available in the US has been approved by the FDA after rigorous analysis and is considered safe.
Editorially outlines a new framework for approval of the Covid-19 vaccine, FDA’s Makary and Prasad said “the benefits of repeated administration are uncertain,” but there was no evidence that the Covid-19 vaccine itself is unsafe.
The agency says it will only approve a vaccine for healthy children and adults after a study that proves that shots can better prevent symptomatic covid-19 than placebo. However, the new plan does not take into account other effects of Covid-19 infections.
These changes to the Covid-19 vaccine policy limit opportunities to protect high-risk people, including young children and pregnant people, experts say
“We have vaccines that we know are important in saving lives during the pandemic and we continue to see morbidity and mortality from Covid-19,” Fiscus said. “It’s very concerning that people who choose to protect themselves and their children with vaccines may be deprived of that choice.”
CNN’s Brenda Goodman contributed to this report.