Lapis Lazuli – Vaccine Approval: There IS a Process

by Marketouch BACK TO BLOG.

It seems like lately we have been inundated with news and information about COVID boosters, many of them conflicting, making it difficult for pharmacies to effectively plan. The good news is that there is a process of checks and balances from both a regulatory and scientific standpoint for the approval of any vaccine (and needed booster) and the associated vaccination schedule. Understanding this process, and timing of it will help you in your strategic vaccine and pharmacy operations planning. Today, I outline the various levels of the process, steps that different vaccine players must take, gates that must be cleared and the rules associated with them.

Step 1 – Ensuring Safety and Efficacy

The Food and Drug Administration (FDA) Reviews completed studies and other related information for the safety and effectiveness of a potential drug/biologic for a New Drug Application (NDA) This is a scientific review, first by an FDA subcommittee which provides their recommendation to the FDA. After the FDA reviews that recommendation, and all available study data, they have the regulatory authority to issue a full vaccine approval or an emergency use authorization (EUA). For example, Pfizer-BioNTech is completing its review of study data to submit and request for an EUA for its COVID vaccine (Comirnaty) for immunizing children 5-11 years old. Additionally, last week Pfizer-BioNTech submitted a request to change the 2 series Comirnaty shot to a three-dose series, requesting approval for a “booster” dose for the general public, 16 and older who received their first and second doses. The FDA subcommittee voted not to endorse that that request, however, they did provide a recommendation that modified those eligible for a ‘booster’ shot to those 65 and older and those with a high risk of exposure. On September 22, the FDA endorsed under an EUA, the use of booster Comirnaty doses for those >65 and those individuals >18 at high risk of severe COVID-19; and individuals >18 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19.

Step 2 – Determining Who, How, and When

After the FDA determines that a vaccine is safe and effectiveness of a vaccine, the Centers for Disease Control (CDC) gets their chance to review the scientific evidence available. The CDC’s Advisory Committee on Immunization Practices (ACIP) reviews all studies, adverse events, and supporting data to determine a recommendation regarding the appropriate vaccine dosages and administration schedule. ACIP is actually meeting on September 23 regarding FDA’s authorization for Comirnaty.

Step 3 – Final Approval Processes

Following ACIP recommendations on a vaccine dose and immunization schedule, the vaccine approval request, with the accompanying recommendation, is sent to the Director of the CDC and the Department of Health and Human Services (HHS) for review. If CDC and HHS concur with the ACIP recommendation, then all related vaccine guidance is published in the CDC’s Morbidity and Mortality Weekly Report (MMWR). The MMWR publication represents the final and official CDC recommendations for immunization approved for the U.S. population.

Using just the example of the Pfizer-BioNTech COVID-19 vaccine, the FDA first determined that it was safe and effective, and then based on the guidance provided by the CDC, established that it would be administered as an intramuscular injection given as a series of two doses (0.3 mL each) 3 weeks apart, initially under an Emergency Use Authorization. In August, the FDA (based on their work and that of the CDC) granted full approval of Comirnaty in individuals >12 . Not long after, Comirnaty was authorized to be administered as a third (0.3 mL IM) dose administered at least 28 days following the second dose, but only for individuals >12 who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to be immunocompromised.

Step 4 – Time To Administer

Once published in MMRW, providers can give the vaccine to patients. With good reason, much of this process has been fast- tracked for the COVID-19 vaccines. As you read this, both the scientific and regulatory agencies are reviewing the need for COVID-19 boosters and the opportunity to immunize those under the age of 12 years old.

Summary – Get Ready, Stay Tuned

The fall and winter seasons of 2021-22 is certainly going to be an extremely busy one for pharmacies; the peak of flu vaccinations, Medicare Open Enrollment, ongoing COVID vaccinations, the evolving need for COVID boosters, and the eventual COVID vaccination expansion to younger patients. All of these have the potential to stretch thin your pharmacy staff.

Please know that MarkeTouch is here to help lessen your burden, improve clinical outcomes and assist you in providing world-class customer experience. We offer turn-key patient communication, engagement and clinical solutions designed to reach patients with actionable messages designed to improve your pharmacy workflow, your patient experience and enhance your operational efficiency.

Until next time, take care.


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