FDA Approves Pfizer and Moderna COVID-19 Vaccines for Commercial Use
On September 11, 2023, the U.S. Food and Drug Administration (FDA) granted approval and authorization to updated COVID-19 vaccines from Pfizer and Moderna. This landmark decision paves the way for the commercialization of these vaccines, marking a significant shift in their manufacturing, procurement, and pricing.
Up until this point, the federal government had exclusively purchased and distributed COVID-19 vaccines, providing them free of charge to individuals regardless of insurance coverage or ability to pay. However, with commercialization, Pfizer and Moderna will now charge a commercial price for their vaccines.
According to reports, Pfizer’s vaccine will be priced at $115 per dose, while Moderna’s vaccine will be priced at $128 per dose. These prices are approximately three to four times higher than what the federal government has been paying for the vaccines.
In addition to the cost of the vaccine itself, there may be additional charges associated with administering the vaccine and provider visits. The specifics of these costs are yet to be determined.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) swiftly recommended Pfizer and Moderna’s COVID-19 vaccines for individuals aged 6 months and older on September 12. The CDC Director, on the same day, adopted this recommendation.
Despite the commercialization of the vaccines, coverage and payment for them will continue to be guided by insurance market rules and regulations. Thanks to the Affordable Care Act (ACA) and legislation passed during the COVID-19 pandemic, COVID-19 vaccines will remain free for most individuals with private and public insurance coverage.
However, uninsured adults will not have a guarantee of free vaccines. While a discretionary program created under Section 317 of the Public Health Services Act provides limited support for recommended vaccines, the Biden administration has proposed establishing a mandatory Vaccines for Adults Program, inspired by the successful Vaccines for Children Program.
Medicaid will cover ACIP-recommended vaccines for adults without cost-sharing permanently under the Improved Health Care Access Act (IRA). Furthermore, Medicaid covers ACIP-recommended vaccines for children at no cost through the Vaccines for Children (VFC) Program.
For Medicare beneficiaries, the CARES Act ensures that COVID-19 vaccines will be covered without any cost-sharing.
The FDA’s approval and authorization of Pfizer and Moderna’s updated COVID-19 vaccines for commercial use signify a major step in the fight against the ongoing pandemic. As these vaccines enter the commercial market, the public can expect changes in the way vaccines are acquired and paid for, particularly for uninsured individuals.
Sources:
– Affordable Care Act, March 23, 2010, Section 300gg–13
– CARES Act, March 27, 2030, Section 3203 and Section 3713
– Department of Labor FAQ, October 4, 2021
– Department of Labor FAQ, March 29, 2023
– American Rescue Plan Act (ARPA), March 11, 2021, Section 9811
– Vaccines for Children Program
– HHS Bridge Access Program and KFF
– Vaccines for Adults Program proposal