What are the steps and who is involved in the process of vaccine development and approval?
Vaccine development and the process of a vaccine becoming authorized or approved and then recommended for use is a group effort involving many people and organizations. There are multiple layers of regulatory, medical, and scientific oversight. The process of vaccine regulation starts before human trials begin. A company with a promising vaccine based on non-human trials files an application for an Investigational New Drug (IND) with the U.S. Food and Drug Administration. The company describes the manufacturing and testing processes, summarizes the laboratory reports, and describes the proposed study.
Once the FDA allows human trials to begin the trials are monitored by the Data and Safety Monitoring Board. The DSMB is an independent group of experts that serve in an individual capacity and provide their expertise and recommendations. The responsibilities of the DSMB are to periodically review and evaluate the accumulated study data for safety, study conduct, and efficacy. The DSMB makes recommendations concerning the continuation, modification, or termination of the trial. It is this group of experts that notify the pharmaceutical or biotech company when the vaccine has met the statistical criteria for efficacy.
Often the company developing the vaccine will work with other organizations as well to set up and conduct clinical trials. For example, Moderna worked in collaboration with investigators at the NIAID Vaccine Research Center (VRC). Funding and support for developing and manufacturing of the vaccine for the early clinical trials was came from the Coalition for Epidemic Preparedness Innovations. CEPI is a global partnership between public, private, philanthropic, and civil society organizations. CEPI; launched in 2017, not only helps fund vaccine development but has scientists and researchers that can support biotech and pharmaceutical companies.
When the Data and Safety Monitoring Board has determined that the study data has shown the vaccine to be effective and there have been no significant safety concerns the company can then go to the FDA and ask for authorization or approval. The application to the FDA contains detailed data from the studies as well as product development and manufacturing information. Scientists at the FDA who have already been monitoring and reviewing data from the studies on a rolling basis review the application.
An independent advisory committee also looks at the data and makes recommendations to the FDA. Members of this committee are not government employees or associated with the study or company that has developed the vaccine. The Vaccines and Related Biological Products Advisory Committee is composed of representatives from various fields such as immunology, molecular biology, virology, epidemiology, biostatistics, infectious diseases, pediatrics, microbiology, and biochemistry. They conduct a public meeting - that you can view live online, vote and advise the FDA. The FDA then makes the decision on authorization or approval.
Next another independent group takes a look at the data from the studies and considers other information. The Advisory Committee on Immunization Practices (ACIP) is a group of medical and public health experts that develop recommendations on how to use vaccines to control diseases in the United States. The CDC then uses the ACIP guidance to make their recommendations and policy decisions. Anyone can watch live the proceedings of the ACIP meetings online.
The regulatory and oversight process does not stop once a vaccine is approved or authorized. Through various systems the safety of the vaccines are continuously and actively monitored by the FDA.
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