ATLANTA (WATE) — Over the last year, vaccines have become a more prominent topic of conversation and policy talks as the COVID-19 pandemic continues and vaccines developed by American pharmaceutical companies were approved by the U.S. Food and Drug Administration (FDA). The advisory committee responsible for making vaccine recommendations at the U.S. Centers for Disease Control and Prevention (CDC) meets three times a year in Atlanta before the director of the CDC signs off on the recommendations.
Keep in mind that the FDA approves, regulates and gives licensure to new vaccines in the U.S., while the CDC gives its stamp of approval by making recommendations for the use of the FDA-approved vaccine along with additional considerations and data.
What is the ACIP? What were its latest recommendations to the CDC?
The Advisory Committee on Immunization Practices (ACIP) is the advisory committee for the CDC. It provides advice and guidance to the director of the CDC regarding the use of vaccines and related agents for control of vaccine-preventable diseases in the civilian population of the United States. Then, the recommendations made by the ACIP are reviewed by the CDC director and, if adopted, are published as official CDC/HHS recommendations in the Morbidity and Mortality Weekly Report (MMWR).
According to the CDC’s website, the ACIP includes 15 voting members responsible for making vaccine recommendations. The Secretary of the U.S. Department of Health and Human Services (DHHS) selects these members following an application and nomination process. Fourteen of the members have expertise in vaccinology, immunology, pediatrics, internal medicine, nursing, family medicine, virology, public health, infectious diseases, and/or preventive medicine; one member is a consumer representative who provides perspectives on the social and community aspects of vaccination.
In its final meeting of 2021, ACIP met to review and make recommendations for vaccinations including that of Pfizer’s COVID-19 vaccine for children ages 5-11 as well as for a hepatitis B vaccine for adults. The group also discussed immunization schedules, orthopoxvirus vaccines, and the Ebola vaccine.
The Associated Press reported this week that the ACIP voted unanimously to approve the recommendation that all U.S. adults younger than 60 be vaccinated against hepatitis B Wednesday. The CDC’s director, Dr. Rochelle Walensky, must sign off on it before it becomes public policy, but it’s not clear when she will decide. The hepatitis B virus is spread through contact with blood or other bodily fluids and many recent cases have been linked to the opioid epidemic.
The ACIP holds three meetings each year at the CDC in Atlanta, Ga. in order to review scientific data and vote on vaccine recommendations. Meetings are open to the public and are also made accessible online via live webcasts. For 2022, the posted, scheduled meetings will take place in February, June and October.
In addition to the 15 voting members, ACIP includes 8 ex officio members who represent other federal agencies with responsibility for immunization programs in the United States, and 30 non-voting representatives of liaison organizations that bring related immunization expertise. Members and representatives serve on the committee voluntarily.
Which group approves vaccines in the U.S.?
Clinical development of new vaccines and the product approval process are both multitiered and involve FDA’s Center for Biologics Evaluation and Research (CBER), which is responsible for regulating vaccines in the United States.
Although the CDC’s ACIP makes its recommendations based on scientific data, that committee is part of the CDC, which is a separate agency from the FDA. Usually, the agencies separately approve a new vaccine as part of the overall process of new vaccine rollouts in the U.S.
So, what happens when a new vaccine is developed?
The general stages of the development cycle of a vaccine are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccines in the United States.
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes:
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- A Biologics License Application (BLA)
- Inspection of the manufacturing facility
- Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC)
- Usability testing of product labeling
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
What happens after a vaccine is administered?
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the CDC.
VAERS collects and analyzes information from reports of adverse events (side effects) that occur after the administration of US licensed vaccines. Reports are welcome from all concerned individuals: patients, parents, healthcare providers, pharmacists, and vaccine manufacturers. To submit a report, use VAERS’ reporting page.
For more information on VAERS, consult VAERS website.
The Associated Press contributed to this report. Additional details about agency and vaccine information were obtained through the CDC and FDA’s websites.