The Food and Drug Administration on Monday approved a new round of COVID-19 vaccines, bringing them one step closer to public availability ahead of the looming respiratory virus season. However, some medical professionals are concerned with the potential cost of the new booster.
Pfizer and Moderna's updated vaccines and boosters were both approved Sept. 11. The FDA said in a media release that those vaccines have been updated to include a monovalent component that corresponds to the omicron variant XBB.1.5.
Dr. Melanie Golembiewski, chief medical officer of Neighborhood Family Practice, said she will urge her patients to get the booster. Neighborhood Family Practice largely serves Hispanic and Muslim communities on Cleveland’s West Side.
"I'm hoping that [the booster] will allow us to continue to keep hospitalizations and really severe outcomes from COVID-19 low," Golembiewski told Ideastream Public Media.
The approval comes at a time when case numbers are increasing in Ohio and across the country. The Ohio Department of Health reported 8,155 COVID-19 cases and 123 hospitalizations across the state last week. Cases increased 30% compared to the previous week, the ODH data show. Hospitalizations nationally are also up 15.7% in the last week, according to the Centers for Disease Control and Prevention.
The EG.5 variant, nicknamed Eris, remains the most prevalent in the United States, accounting for 21.5% of cases according to CDC data.
Early clinical trials of Moderna’s new vaccine were determined to be effective against the Eris variant and FL 1.5.1, nicknamed Fornax, according to the company.
“With this new trial data, Moderna has now confirmed an antibody response against current strains of concern,” the biotech company said in a news release.
A new variant, BA.2.86, nicknamed “Pirola," was confirmed in Lorain County Sept. 1. Health officials said the case was no cause for heightened concern, though the CDC added Pirola to its watchlist and noted it may pose a greater risk for breakthrough infections.
Now is not the time for most people to get the older shot, said Dr. Donald Dumford, director of infection prevention at Cleveland Clinic Akron General Hospital.
“For the average person, waiting for the new [COVID-19] booster is going to be better because it’s more tailored to what we see circulating right now,” he previously told Ideastream.
The FDA expressed confidence in the safety and effectiveness of the updated vaccines, in a media release.
"The agency’s benefit-risk assessment demonstrates that the benefits of these vaccines for individuals 6 months of age and older outweigh their risks," the release said.
Approval by the CDC is needed next. The FDA says the CDC will meet Tuesday to discuss its recommendations on who should get boosted, according to the release.
Pfizer and Moderna have both said their updated vaccines will be available this fall, though exact dates have not been announced. The FDA said in its release that it "anticipates that the updated vaccines will be available in the near future."
In 2022, the Biden administration announced plans to cease funding for future COVID-19 vaccines in order to transition them to a commercial market. The federal funding formally came to an end May 11, the day the federal public health emergency for COVID-19 ended.
This is a concern for Golembiewski as many of her patients are lower income, making cost a significant factor in whether they can get the booster. She said Neighborhood Family Practice is looking for ways to offset those costs.
“Many health centers are really looking at getting involved with any funding stream that we can to help support that effort," Golembiewski said. "Whether vaccination or COVID testing, we don't want our patients to get left out of access to that.”
She added Neighborhood Family Practice will be reaching out to the Health Resources and Services Administration for funding to offset costs. The HRSA is an agency within the U.S. Department of Health and Human Services focused on improving health access for uninsured, isolated or medically vulnerable individuals.
Golembiewski said she also anticipates partnering with local public health departments to obtain the booster shots for its patients.
Meanwhile, the Kaiser Family Foundation reports the boosters will likely be covered by private health insurance, Medicaid and Medicare.
Also, boosters will remain free at public health departments and community health centers for those without health insurance under the CDC's Bridge Access Program. Free boosters for the uninsured could also be available at some pharmacies if the CDC reaches an agreement with CVS, Walgreens and eTrueNorth, according to the agency.
But, the Bridge Access Program won't extend beyond 2023, according to the CDC website.
