Covid Shots Could Run as High as $225 as FDA Limits Approval (1)

Millions of Americans may struggle to find Covid-19 vaccines this fall, and the shots they do find are likely to be more expensive after the Food and Drug Administration this week narrowed their approvals.

The FDA on Wednesday approved Covid-19 boosters from Moderna Inc., Pfizer Inc., and Novavax for individuals with qualifying conditions that put them at greater risk for the virus. The shots are also approved for seniors age 65 and older, while age limits for children vary by manufacturer.

The Centers for Disease Control and Prevention is expected to follow suit, meaning health plans, which follow CDC recommendations, will no longer have to cover the costs of the vaccines for many policy holders.

Anyone under 65 without an underlying condition would technically be seeking the vaccine “off label,” potentially exposing them to high out-of-pocket costs if their health plans don’t choose to cover the shots more broadly.

Moderna and Pfizer vaccines cost $225 at CVS pharmacies without insurance, a spokesperson for the retailer said. Sanofi SA, which partnered with Novavax to roll out its Covid vaccine, said the list price for its shot, which starts lower than the retail price, will likely be similar to the others.

The uncertainty is the latest to surface under the tenure of Health and Human Services Secretary Robert F. Kennedy, Jr., a prominent vaccine skeptic who is radically overhauling longstanding policy related to immunizations. But the vaccines’ narrowed eligibility also largely aligns with the World Health Organization’s recommendations, which several European countries are already following.

Questions around how the CDC will recommend the shots’ use also sharpened after Kennedy ousted recently confirmed Director Susan Monarez, prompting a trio of senior CDC leaders to resign in protest.

Insurance Coverage

Insurers and employers will have to decide whether to cover the shots for everyone.

“We’re working closely with our members to review yesterday’s FDA announcement and will be monitoring the forthcoming meetings and recommendations from ACIP and CDC on considerations around coverage,” AHIP spokesperson Tina Stow said in a statement.

“Individual health plans and plan sponsors will be prepared to make coverage decisions informed by science, the latest medical evidence and data. This process will be evidence-based, evaluate multiple sources of data, including but not limited to ACIP, and will be informed by customer needs.”

Aetna said in a statement that it plans to continue covering the shots for its fully insured plans, but noted that self-insured employers make their own coverage decisions.

“All members of insured plans voluntarily choosing to vaccinate against COVID-19 may do so with no cost sharing,” spokesperson Phillip Blando said.

“As with all coverage decisions, self-funded employers determine their own insurance coverage as allowed under various federal and state laws,” he added.

Shawn Gremminger, president and CEO of employer group the National Alliance of Healthcare Purchaser Coalitions, said he expects most employers to continue covering the vaccines at no cost for the time being, considering how inexpensive they are relative to the cost of treating Covid.

Employers are also interested in staying out of the limelight following the backlash they weathered from all sides during the pandemic, he said.

“There is very much a sort of hunker down approach, right?” he said. “I don’t want to get too far in one direction, saying you have to use these things. I also don’t want to be too far in the other direction.”

Access Hurdles

Still, people might find it more difficult to access the shots if their doctor or pharmacist isn’t comfortable prescribing it off label, said Jennifer Kates, senior vice president at health-care think tank KFF. A recent KFF poll found that four in 10 respondents planned to get a booster this fall.

State pharmacy laws also often adhere to CDC recommendations, preventing pharmacists from administering a shot off label, she added.

“It’s not what the FDA approved,” she said. “Who is going to give it to you?”

Doctors are often asked to prescribe vaccines for people caring for family members with high-risk conditions, said William Schaffner, an infectious disease professor at Vanderbilt University who works with ACIP as a liaison for professional medical groups.

“We’ve gotten those kinds of request from patients all the time,” he said. “It’s not unusual.”

The American Pharmacists Association is hoping the CDC will include a caveat for “shared clinical decisionmaking” in its recommendations for the broader population, said Vice President for Professional Affairs Brigid Groves. The group is also urging governors to issue executive orders broadening pharmacists’ authority to evaluate patients and administer shots.

“Pharmacists are trained to review a patient’s history and talk to them and ascertain that they might have conditions that put them at higher risk for certain diseases,” she said.

Kennedy posted on social media site X Wednesday that the vaccines “are available for all patients who choose them after consulting with their doctors.”

The questions also come as Covid infections are increasing. National test positivity reached nearly 10% nationally last week, according to the CDC, double the 5% benchmark epidemiologists used during the pandemic to determine whether communities were testing enough to track cases.

Kennedy previously threw health plans into limbo when he pulled Covid shots from the CDC’s recommended immunization list for pregnant women—conflicting with WHO recommendations—and children who aren’t high-risk. He also installed vaccine skeptics on CDC’s Advisory Committee on Immunization Practices, whose recommendations set coverage requirements under the Affordable Care Act.

In general, focusing vaccines on high-risk populations is a good tactic, Schaffner said, adding that previous ACIP members were already headed in that direction. The US takes a more expansive view of vaccines than many other countries, he added. But he pointed to data showing that roughly half of the 2,073 children recently hospitalized for flu had no underlying conditions as one example of why the US is more liberal.

Kennedy is set to testify before the Senate Finance Committee Sept. 4, where he’ll likely face backlash from Democrats, and possibly Republicans. Senate Health, Education, Labor and Pensions Committee Chairman Bill Cassidy (R-La.), who also sits on the Finance panel, called for Kennedy to delay ACIP’s Sept. 18 meeting.

“If the meeting proceeds, any recommendations made should be rejected as lacking legitimacy given the seriousness of the allegations and the current turmoil in CDC leadership,” he said in a statement.