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FDA Approves New COVID-19 Vaccines Amid Rising Cases: Affordability Concerns Amid Shift to Commercial Market

The Food and Drug Administration (FDA) has greenlit new COVID-19 vaccines by Pfizer and Moderna, heralding an advancement in the fight against the pandemic, particularly in light of the upcoming respiratory virus season. This comes at a time when infection rates in Ohio and nationwide are on an upward trend, thereby accentuating the significance of these boosters.

Both Pfizer’s and Moderna’s revised vaccines got the nod from the FDA on September 11, with the updated vaccines incorporating a mono component targeting the omicron variant XBB.1.5. This development has been met with enthusiasm by healthcare professionals like Dr. Melanie Golembiewski, Chief Medical Officer of Neighborhood Family Practice, who believes the booster will help in managing severe COVID-19 outcomes and hospitalizations.

The approval is timely as Ohio last week reported a 30% spike in COVID-19 cases compared to the previous week, with 8,155 cases and 123 hospitalizations, as per the Ohio Department of Health data. Nationally, hospitalizations saw an upswing of 15.7% in a week, says the Centers for Disease Control and Prevention (CDC).

At present, the EG.5 variant, also known as Eris, constitutes 21.5% of the cases in the US, according to CDC reports. Preliminary clinical trials indicate Moderna’s new vaccine is effective against the Eris variant and another variant, FL 1.5.1 (Fornax). Thus, Moderna now confirms an antibody response against the current strains of concern, as per their official statement.

Adding to the epidemiological landscape, a new variant, BA.2.86 (Pirola), was identified in Lorain County on September 1, though health officials have downplayed any cause for major concern. However, the new variant has made it to the CDC’s watchlist due to its potential for breakthrough infections.

Despite these developments, Dr. Donald Dumford, Director of Infection Prevention at Cleveland Clinic Akron General Hospital, advises most people against receiving the older shot and suggests waiting for the newer booster, which offers better protection against the currently circulating variants.

In an official statement, the FDA conveyed its faith in the safety and efficacy of these updated vaccines, stating that the benefits for individuals aged 6 months and up far outweigh their risks. However, the CDC’s approval is pending, with a meeting scheduled for Tuesday to discuss recommendations for the booster rollout. Pfizer and Moderna have announced a fall release for their vaccines, but the exact dates haven’t been mentioned.

However, there is a certain air of apprehension as the Biden administration ceased funding for future COVID-19 vaccines as of May 11—ending the federal public health emergency for COVID-19. This move towards transitioning vaccines to a commercial market stokes worries of affordability, especially among lower-income populations served by healthcare providers like Neighborhood Family Practice. Dr. Golembiewski highlights concerns about financial resources being a barrier in getting the booster shot. In response, the Practice is considering different funding options to support the cost of vaccination or testing, ensuring that their patients don’t miss out on care access.

To offset the costs, Dr. Golembiewski plans on reaching out to the Health Resources and Services Administration (HRSA). She also anticipates partnerships with local public health departments to procure the booster shots. Furthermore, the Kaiser Family Foundation reports that private health insurance, Medicaid, and Medicare will likely cover the cost of the boosters. Those without health insurance can avail free boosters at public health departments and community health centers under the CDC’s Bridge Access Program. The CDC is also in talks with CVS, Walgreen, and eTrueNorth to provide free vaccines for uninsured individuals at their outlets. However, this service may terminate after 2023 as per the CDC.


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