What You Need to Know About the COVID-19 Vaccine
November 05, 2020 | Emma Lange
Many pharmaceutical companies urgently began developing a COVID-19 vaccine earlier this year to reduce the spread of the virus as the threat of a pandemic loomed. Fast forward several months and millions of COVID-19 cases later, states and territories are preparing to distribute a potential vaccine with preliminary plans for distributing a COVID-19 vaccine due to the CDC in October.
The federal government has made significant investments to support the development of a COVID-19 vaccine, or vaccines, at an unprecedented speed while maintaining strict safety requirements. Concurrently, the CDC, FDA, and Operation Warp Speed (OWS) have begun to coordinate activities to ensure a vaccine will transition seamlessly from development through mass production, review, and deployment.
OWS was created to accelerate the development, production, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. For the six vaccine candidates supported by OWS, the federal government is investing in mass production of vaccine candidates at the same time they are being studied for safety and efficacy. This ensures there are doses on hand for deployment as soon as approval is given. If any of the vaccine candidates are found to not be safe or effective, the mass-produced doses will be destroyed.
With significant investment from OWS, mass production of vaccine candidates ensures that any candidate who completes phase three of its study is immediately available for distribution to state and territorial departments of health as soon as it receives FDA approval. Four of these six candidates are currently in the final stages of clinical trials, Moderna, Pfizer, AstraZeneca, and Johnson & Johnson. Per FDA guidance, these vaccines must have two full months of follow-up data after the second dose of the two-dose vaccinations have been administered to phase three clinical trial participants.
What’s to Come
The FDA signaled that a COVID-19 vaccine will likely be approved through a Biologic License Application (BLA) or an Emergency Use Authorization (EUA). The BLA is a common vehicle through which a vaccine is approved for use in the U.S. The process to submit a BLA to the FDA is time consuming and requires lengthy pre-clinical studies and data analysis. To provide timely medical counter measures, in the instance of an emerging chemical, biological, radiological, and nuclear threat, the FDA established the EUA authority. Under an EUA, the FDA may allow unapproved medical products to be used in specific populations where risk of severe outcomes is high.
It’s expected that a COVID-19 vaccine will likely receive EUA licensure as a first step. A vaccine that successfully clears an EUA application will only be approved for use within specific, pre-determined populations based on their demographic’s unique risk and benefit equation. A patient at risk of severe outcomes from COVID-19 would benefit most greatly from a successful vaccine, as the risk of receiving a vaccine approved through EUA will be much lower than the benefit of said patient potentially avoiding a positive COVID-19 diagnosis.
The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) will independently review clinical trial data to make a recommendation on the safety, effectiveness, and appropriate use of a vaccine candidate. Members of this committee are selected by the FDA Commissioner and have expertise in immunology, epidemiology or biostatics, and vaccine policy, to name a few. If a vaccine is determined by VRBPAC to “cause more benefit than harm,” FDA will announce a decision to grant EUA or BLA status.
Next Steps After (Some Sort) of Approval
Once a vaccine candidate has cleared the FDA, the Advisory Committee on Immunization Practices (ACIP) will then hold an emergency meeting and vote on recommendations for vaccine and prioritization of vaccine within populations. ACIP’s recommendations will be submitted to the CDC Director. ACIP and its role in the use of vaccines in the country can be traced back to its original appointment in 1964 by the Surgeon General of the United States. Its scope has always been to develop recommendations on how to effectively and safely use vaccines to control disease in the country to the CDC and the Department of Health and Human Services.
While a vaccine may receive approval through an EUA for use within a specific population, experts hope and expect that the manufacturer will continue monitoring phase 3 trials, providing and analyzing data. This expanded data set will be submitted to the FDA as a BLA for coverage of broader demographic groups.
In order for the entire COVID-19 vaccine infrastructure and distribution process to be successful ASTHO and the Association of Immunization Managers estimated at least $8.4 billion is needed in federal funding to support this endeavor. Without this funding, states and territories will not have the ability to expand and strengthen capacity for a timely, comprehensive, and equitable vaccine distribution. For additional information please check out our ASTHO brief that provides an overview of the COVID-19 vaccine approval process. ASTHO will continue to monitor the status of COVID-19 vaccine development.