Source: Atlantic Health Partners
Facing the COVID-19 pandemic, scientists and manufacturers are working to develop a new vaccine that will protect against the virus. Though there is urgency surrounding the need for a coronavirus vaccine, there are many steps that go into the research, development, approval, and manufacturing of a new vaccine.
By understanding the vaccine development process, physicians and other health care providers can ensure that their patients are well-educated about vaccine development and properly prepare their practices for any new vaccines that become available.
Vaccine Research, Development, and Approval
Every vaccine that is recommended by the Centers for Disease Control and Prevention (CDC) goes through a rigorous research and development process, which can take several years from research to production. The process, as outlined by the CDC, begins with an exploratory research and development stage, before moving on to pre-clinical testing, followed by three to four phases of clinical trials.
Once a new vaccine has passed each of these stages, the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research External (CBER) begins its review process. In this phase, the vaccine undergoes a series of reviews of clinical trials, manufacturing facilities, and more. After FDA approval, the agency continues to monitor the vaccine and production activities for as long as the vaccine is in distribution.
When the FDA completes initial oversight, the Advisory Committee on Immunization Practices (ACIP) reviews the vaccine to make a potential recommendation for the national vaccination schedule. The ACIP considers the vaccine’s safety and effectiveness at different ages, as well as the severity and reach of the disease it prevents before making a recommendation.
Vaccine manufacturing differs from other pharmaceutical manufacturing, in that it is highly customized to each vaccine, with many tests to ensure the safety of the vaccine. According to a study published in the Expert Review of Vaccines, vaccines can take anywhere from several months to produce, as with the annual influenza vaccine, to three years, as with more complex combination vaccines.
Once a new vaccine becomes available, physicians and other health care providers can begin to introduce it to their practices and patients. The ordering process varies between different vaccines, but generally, physicians and other health care providers may go through the manufacturer or a vaccine distributor to place vaccine orders for their practice. There are a few questions providers may consider before and after submitting an order for a new vaccine to ensure they can best meet the needs of their patients.
- Does my patient population need the vaccine?
Before submitting an order for a new vaccine, physicians and other health care providers can consider the ACIP-recommended population for the vaccine and how many, if any, of their patients will fall into this category. For example, the ACIP recommends the serogroup B meningococcal vaccine (MenB) for adolescents and young adults. As a result, practices primarily serving seniors may not prioritize having a comprehensive stock of the MenB vaccine on hand.
- How will we incorporate the vaccine?
Reviewing vaccine administration guidelines, as well as the recommended immunization schedule and patient groups with staff will ensure that practices are prepared to recommend and properly administer the vaccine once the first shipment arrives.
- How will we inform and educate patients about the vaccine?
Once physicians and other health care providers have submitted an order for the new vaccine, they can establish a plan on how to inform relevant patients about the availability of the new vaccine, such as during a well-visit or through regular patient communication. Studies show that strong recommendations early on will encourage vaccine uptake amongst patients and ensure their added protection against disease.
Vaccine research and development is an arduous and important process. Even as the race for a COVID-19 vaccine continues, the careful and safe methods of vaccine development will be maintained. By staying up to date on these vaccine development processes, physicians and other health care providers can feel confident to make decisions around any new vaccines that best serve their practices and patients.