Safety and efficacy of vaccines is paramount
September 30, 2020by Alvin Manalansan, originally published in BusinessWorld
Over the years, vaccination has made an enormous contribution to global health. Many of the world’s deadliest and most infectious diseases have been eradicated due to the development of vaccines. Every year, millions of lives are saved in the country, much more all over the world, through vaccination.
Many did not realize the importance of this routine practice until this Wuhan virus shocked the whole world. The world has been paralyzed, waiting for a vaccine to cure COVID-19 and rebuild to a new normal. The extreme measures that we are having to live with at this moment show us that a world without a vaccine to fight just one contagion can be an existential threat to all humans.
Vaccine development is a long, complex process that often lasts around 10-15 years. However, in this time of pandemic, procedures have been compressed — but not to the extent of sacrificing the quality, safety, and efficacy of the potential vaccine.
The development of a particular vaccine starts with basic laboratory research. Followed by pre-clinical studies that use tissue-culture or cell-culture systems and animal testing to assess the safety of the candidate vaccine.
After attaining positive results, the next procedure is to conduct human trials which will require clearance from the Regulatory Authority where the pharmaceutical developer is situated. Once the approval for an investigational new drug has been attained, this is the only time that the potential vaccine will be subject to three phases of testing with human subjects.
The initial phase will assess the candidate vaccine in a small group, between 20 to 80 subjects, usually adults. The goal of the first phase is to assess the safety of the vaccine and to determine the type and extent of immune response it provokes.
Upon acquiring positive results, the second phase will require the participation of a larger group, usually composed of several hundred individuals. The goals of the second phase are to study the vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations, and method of delivery.
Once successful results are obtained, the next step is to proceed to larger trials (Phase III) which involve thousands to tens of thousands of participants. The goal in the third phase is to assess vaccine safety and efficacy in a large group of people.
After successful trials, vaccine developers will need to comply with the regulatory processes imposed by the Regulatory Agency in the country, such as, but not limited to, licensing of the manufacturing facility and registration of the vaccine. In addition, authorities may also require post monitoring information to be released to the public.
As recently stated by the Philippine Food and Drug Administration, the earliest possible availability of a vaccine in the country would be by April 2021. This is the best-case scenario to ensure the integrity of the trials and for all regulatory requirements to be completed. Returning to our pre-pandemic routines will not happen until a vaccine has been approved for general use and deployed among the majority of the population.
Currently there are 11 potential COVID-19 vaccines that have reached the phase 3 clinical trials. Some of these are part of the World Health Organization’s Solidarity Trial in which the country has participated. According to the country’s Vaccine Expert Panel, a group of technical experts tasked to identify, evaluate, and recommend possible vaccine candidates, the list of vaccines and protocols for the trial may be released by this October.
The Department of Health allocated P2.5 billion for the procurement of COVID-19 vaccines under the proposed budget for 2021. This amount will prioritize those who were identified as the most at-risk population and frontline workers in the country.
The Philippines, as a lower-middle-income country, is eligible to access the COVAX facility, a platform that aims to accelerate the development and manufacture of COVID-19 vaccines and to ensure that every country in the world is able to access the successful vaccines.
In the selection of a potential vaccine, the country’s decision makers must choose a vaccine based on sufficient evidence of quality, safety, and efficacy. Given the political and economic pressures, there must be no compromise in the safety of the vaccine that our limited resources will be investing in to defeat this pandemic crisis. There must be transparency and accountability of the government’s procurement and distribution operations.
As the head of the family, I must be convinced and absolutely trust the source, and be impressed by the track record of the developers of the vaccine to be injected into the bodies of my loved ones. The leaders of our country should have an even higher standard. This is not a game of who comes first or who I like wins the prize, but a matter of life and death.