Rosie Geier, PharmD, is a clinical manager at Enclara Pharmacia. Each Enclara hospice client is assigned their own clinical pharmacist manager who helps monitor utilization and provides educational and operational support to help hospices improve quality of care while managing costs.
Whether I’m watching the news, going through social media, or talking to my mother-in-law, it seems I can’t escape constant COVID-19 vaccine updates and discussions. With terms like “Operation Warp Speed” and “Emergency Use Authorization,” it can be hard to feel confident in the safety and efficacy of a COVID vaccine.
In my past life, I worked in pharmaceutical marketing and advertising. Often, the marketing process begins when medications are still in development, so I became very familiar with the FDA drug and vaccine approval process. The aspect that stood out the most was how long this process can take and how many setbacks researchers face along the way. Drug companies must go back and forth with the FDA many times to ensure their product is safe and effective.
High Stakes
I was curious as to how a vaccine could be approved in such a short amount of time. I used to wait weeks to receive comments from the FDA. I was used to clinical trial recruitments that lasted years. I felt unsure about a COVID-19 vaccine approval process that could move so quickly.
It is important for us as hospice professionals to feel confident in the COVID-19 vaccine. There is no one working in hospice that has not been impacted on a professional and/or personal level by this pandemic and healthcare professionals, including hospice and home care workers, will likely be among the first to have access to the new vaccines. With an effective vaccine, patients and their families will feel more comfortable letting us do in-person visits. We can increase long-term-care admissions. And maybe we can even enjoy Thanksgiving 2021 with our own families in person.
With all that in mind, I dove into the COVID-19 vaccine approval process. And I must say, I am feeling extremely confident that once the FDA approves a vaccine, it will be safe and effective, and I will be getting it as soon as I am eligible to do so.
How Do Vaccines Get Approved?
Every vaccine that is administered in the United States must undergo rigorous testing and analysis by the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER)1. The FDA follows a standard approval process to ensure the safety and efficacy of vaccines. This approval process is outlined below:
Research and Development (R&D)
R&D typically occurs in lab setting1. Researchers will analyze the organism in question and look for possible vaccine targets.
Pre-Clinical Trials
Prior to testing a vaccine in humans, researchers will administer the vaccine to animals1. In doing so, they will assess the safety and possible efficacy before administration to humans.
Investigational New Drug Application (NDA)
If R&D and pre-clinical trials show positive results and meet safety requirements, researchers will submit an NDA to the FDA1. The FDA will analyze the pre-clinical trials for product quality, safety and manufacturing requirements, while also ensuring the trials were conducted using Good Laboratory Practices (GLP).
Phase 1 Clinical Trials
The focus of a phase 1 clinical trial is safety1. In this phase, 20-100 healthy volunteers are administered the vaccine at increasing doses to assess adverse reactions and determine possible signs of efficacy (immune response).
Phase 2 Clinical Trials
The focus of phase 2 clinical trials remains on safety with an additional investigation into the dose versus immune response1 to determine the lowest effective dose. In this phase, hundreds of patients with varying medical histories and demographics are studied in a randomized-controlled fashion. Short-term side effects are monitored and documented.
Phase 3 Clinical Trials
The focus of phase 3 clinical trials is both safety and efficacy1. In this phase, thousands of patients are recruited using stringent inclusion and exclusion criteria. A test group will be compared to a control group to examine the incidence of disease occurrence in both groups. The longer duration and larger test group in phase 3 trials also allows for observation of less common side effects.
Biologics License Application (BLA) Submission
Once a company has completed phase 3 clinical trials, it will submit a BLA to the FDA1. The FDA will review all of the research for safety and efficacy of the vaccine. The FDA will also determine if the manufacturing techniques used will provide a quality and consistent product.
Phase 4 Clinical Trials
Even after a vaccine is approved by the FDA, safety and sometimes efficacy of the vaccine continues1. During this time, uncommon adverse effects and long-term complications are surveyed.
What is Operation Warp Speed?
Operation Warp Speed (OWS) is a partnership between government agencies and private firms to expedite the development, testing, manufacturing and distribution of a possible COVID-19 vaccine2. The goal of OWS is to deliver 300 million doses of COVID-19 vaccine with initial doses delivered by January 1 20213.
In OWS, each stage of vaccine development has been accelerated3. To ensure standards of safety and efficacy are maintained, OWS selected the most promising vaccine candidates and then provided coordinated support for these candidates2. Research and testing protocols are directly overseen by the government. This has allowed clinical trials to proceed more quickly.
In OWS, no stage of vaccine development is skipped or overlooked2. Instead, pharmaceutical companies are allowed to complete some steps in vaccine development concurrently. For example, OWS allows select drug manufacturers to begin manufacturing their vaccines prior to BLA submission. This makes initial doses available to the public shortly after FDA approval. Manufacturing vaccines prior to approval is a financial risk (largely borne by the government) but it does not increase the risks around safety, efficacy, or product issues.
Where can I get updates on Operation Warp Speed?
References:
- Center for Biologics Evaluation and Research. (2020, November 20). Vaccine Development – 101. Retrieved December 01, 2020, from https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-development-101
- Secretary, H., & Assistant Secretary for Public Affairs (ASPA). (2020, November 20). Fact Sheet: Explaining Operation Warp Speed. Retrieved December 01, 2020, from https://www.hhs.gov/coronavirus/explaining-operation-warp-speed/index.html
- U.S. Dept of Defense. (2020, November 27). Coronavirus: Operation Warp Speed. Retrieved December 01, 2020, from https://www.defense.gov/Explore/Spotlight/Coronavirus/Operation-Warp-Speed/
