FDA Approves Updated COVID-19 Vaccines from Pfizer and Moderna, Commercialization Begins
In exciting news, the U.S. Food and Drug Administration (FDA) has granted approval and authorization for the updated COVID-19 vaccines developed by Pfizer and Moderna. The announcement was made on September 11, 2023, and is seen as a significant milestone in the fight against the ongoing pandemic.
Following the FDA’s decision, the Advisory Committee on Immunization Practices (ACIP) wasted no time in recommending these vaccines for everyone aged 6 months and older. On September 12, the recommendation was adopted by the Director of the Centers for Disease Control and Prevention (CDC).
What sets this development apart from previous vaccine rollouts is that it marks the first time COVID-19 vaccines will be commercialized. This means that the responsibility for manufacturing, procurement, and pricing will now shift to the commercial market. However, this transition has raised some concerns regarding the affordability and accessibility of the vaccines.
Both Pfizer and Moderna have set the commercial price for their vaccines at a staggering $115 to $128 per dose. This is approximately 3-4 times higher than the price previously paid by the federal government. In the past, the government offered these vaccines free of charge to anyone, regardless of insurance coverage or ability to pay.
With the commercialization of these vaccines, how individuals will pay for them and whether they will be covered by insurance will now be determined by insurance market rules and regulations. Thankfully, under the Affordable Care Act (ACA) and laws passed during the pandemic, COVID-19 vaccines will continue to be provided free of charge for most people with private and public insurance coverage.
However, uninsured adults are not guaranteed free access to these vaccines. While private insurers are required to cover any ACIP-recommended vaccine within one year of CDC Director adoption under the ACA, those without insurance may face challenges in accessing the vaccines without incurring significant costs.
Medicare and Medicaid have their own requirements for covering ACIP-recommended vaccines with no cost-sharing, ensuring that vulnerable populations are not left behind. Additionally, the American Rescue Plan Act (ARPA) mandates Medicaid coverage of these vaccines for adults with no cost-sharing through September 2024.
Unfortunately, there is currently no federal guarantee for free vaccines for uninsured adults and children. However, in response to this issue, the Biden administration has proposed the creation of a mandatory Vaccines for Adults Program, akin to the existing Vaccines for Children Program, to support the immunization efforts of uninsured individuals.
It is important to note that various legal acts and regulations serve as the foundation for insurance coverage of COVID-19 vaccines. Individuals seeking information on vaccine coverage rules based on insurance type or for uninsured individuals can find sources providing this information.
As the commercialization of COVID-19 vaccines unfolds, it is crucial to ensure that access to these life-saving immunizations remains affordable and equitable for all, regardless of their insurance status.