Patient safety is at the heart of COVID‑19 vaccine development

In a previous column, we talked about the four types of COVID-19 vaccines and how they work (“No one is safe unless everyone is safe,” BusinessWorld, Feb. 24, 2021). In today’s column, we will discuss how vaccine manufacturers and regulatory agencies work together to make these all-important vaccines safe and effective.

Patient safety is central to the research and development of every vaccine. Vaccine makers must follow very strict scientific and health authority processes to bring a new vaccine to the public, even during the current pandemic. With vaccine development moving so quickly, it is understandable why some people are asking whether a vaccine for coronavirus disease 2019 (COVID-19) will be safe and effective.

Like all vaccines, the COVID-19 vaccines go through many stages of approval, including exploratory “proof of concept” stage, pre-clinical stage, clinical development (which include human clinical trial phases 1 to 3), health authority review, authorization or approval, and finally, manufacturing and quality control.

COVID-19 vaccines are only authorized or approved for use with the general public after a rigorous process. Clinical trials thoroughly test candidate vaccines on tens of thousands of people. An independent group of experts work with health authorities to carefully review all the scientific and clinical trial data results. They will only authorize said vaccine for use with the general public if the benefits of the vaccine far outweigh the known and possible risks of getting a COVID-19 infection.

Clinical trials also help find adverse events that may happen shortly after getting a vaccine. The health authorities also check for very rare side effects, or side-effects that may become apparent only after long-term use. This is why researchers and health authorities will continually monitor that use to check that no safety concerns surface and the vaccines continue to work well in different groups of people over time.

Health authorities review all the scientific and clinical trial data and decide if the vaccines can be authorized or approved for use in their region or countries. They review all the preclinical, clinical, and manufacturing process data, including the safety and efficacy (i.e., how well it works) data. These health authorities include regional regulatory authorities like the European Medicines Agency (EMA) in the European Union, and national regulatory authorities such as the Food and Drug Administration (FDA) in the US and the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. In the Philippines, scientific and clinical data are reviewed by the Food and Drug Administration and expert panels convened by the government.

COVID-19 vaccines follow international standards for vaccine development and approval. Like all new medicines or treatments, vaccines must pass a thorough set of tests that show their quality, safety, and efficacy in tens of thousands of volunteers before being approved or authorized by independent, scientific experts who work for health authorities.

Due to the public health emergency, the authorization and manufacturing of COVID-19 vaccines have been quicker than with previous vaccines. There has been a unique level of preparation and collaboration among researchers, vaccine makers, governments, and health authorities, as well as unprecedented funding for vaccine development and manufacturing. These partnerships accelerated the safe and effective development and authorization of COVID-19 vaccines, without compromising on any of the safety or authorization processes.

There were other factors as well that shortened the development timeline. Vaccine makers carried out clinical trials and making vaccines in parallel instead of doing one after the other. This avoided long wait times between trials. Given the high spread of the virus, it has been easier to have clinical trial volunteers and easier to test the efficacy of vaccines. Vaccine makers gave health authorities access to the clinical trial results throughout the process (“a rolling review”), rather than waiting until the end, to help them carry out ongoing reviews of results. Even before final authorization, vaccine makers started manufacturing preparations to shorten the time it would take to distribute vaccines.

Vaccine makers have worked around the clock to update facilities and hire and train more staff to make the huge number of vaccines needed. Suppliers making vials, syringes, and stoppers are working overtime and in close partnership with the vaccine makers. Health authorities set up dedicated task forces made up of independent experts and rapid review processes to evaluate high-quality applications from vaccine makers. This allows the shortest possible timeframes while ensuring robust scientific opinions.

Teodoro B. Padilla is the executive director of the Pharmaceutical and Healthcare Association of the Philippines (PHAP). PHAP and its member companies represent the research-based pharmaceutical and healthcare industry. For more information about vaccine development, please go to teamvaccines.ifpma.org. #TeamVaccines