As of this writing, the world would have seen over a million deaths due to COVID-19. A vaccine is the best solution to effectively end the pandemic globally, but having one isn’t as simple as it sounds. It has to be effective, efficient, and, more importantly, safe for the population. We cannot rush the process so much that it will create vaccine hesitancy.
Eric Domingo, Food and Drug Administration (FDA) director-general, assured there will be “regulatory flexibility [once a vaccine has passed clinical trials] but without compromising safety because these are extraordinary times.” The FDA is the agency responsible for licensing, monitoring, and and regulating vaccine for safety, efficacy, and quality.
Domingo had been speaking at a forum titled “Understanding the Landscape of Cutting-Edge Vaccine Development” organized by the Pharmaceutical and Healthcare Association of the Philippines (PHAP) in partnership with the Philippine Foundation for Vaccination (PFV) and the Philippine Medical Association (PMA).
Vaccine development process in the Philippines
According to Domingo, a handful of leading manufacturers will hopefully start clinical trials by the end of October. “The forecast is to finish these trials by December or January2021, and that’s when we can start regulating.”
The FDA has set a shorter process for its approval from the usual 60 days to 40 days. Domingo assured that the process is still the same but faster because they have a whole team dedicated to the COVID-19 vaccine. “Napaiksi because unlike other vaccines, may vaccine expert panel na tayo,” he says.
If a manufacturer has passed all four phases required, it is possible to have an approved vaccine by April.
ADVERTISEMENT - CONTINUE READING BELOWIn the same forum, pediatric infectious disease specialist and clinical trialist, Dr. Josefina Carlos, said before certification of any vaccine, it has to pass through four phases:
- Phase I is tried on 20-100 subjects to test safety, reactions, and immunogenicity or a foreign substance’s ability, such as an antigen, to provoke an immune response.
- Phase 2 is tried on several hundreds of high-risk subjects to define the optimal dose needed (short term side effect)
- Phase 3 is tried on several thousand subjects to provide data on efficacy and safety (monitoring of any adverse reactions)
- Phase 4 is tried on an entire population to detect rarer or unexpected events.
FDA also needs to ensure that standard clinical practices were observed during the trial and that no one was harmed, exploited, or exposed to severe risk during the process.
The usual process for other vaccines involving approval, manufacturing, and vaccination usually takes 6-24 months, but for COVID-19, it will be reduced to six months, says Carlos.
Vaccine hesitancy
The forum brought to light the issue of vaccine hesitancy, another challenge the government has to work on once a vaccine has been approved. Dr. May Montellano, professor of Pediatrics at the Far Eastern University and a pediatric infectious disease expert, says vaccine hesitancy is the result of:
- Low levels of confidence in a vaccine, in health authorities, and in the delivery system
- Complacency or the mindset that a vaccine is not necessary
- The inconvenience brought about by inaccessibility or cost
It has often been mentioned that we can overcome the COVID-19 pandemic through herd immunity. Dr. Montellano explains a vaccine is one of two ways that a population may achieve herd immunity, the other being previous infection in a sufficient percentage of a population. According to the World Health Organization (WHO), however, the world is “nowhere close” to achieving herd immunity [via the previous infection] to stop the virus.
CONTINUE READING BELOWwatch nowIn the campaign to deal with vaccine hesitancy, Dr. Montellano says that “it is still the health workers who remain the most trusted advisor and influencer of vaccination decisions.”
No COVID-19 vaccine yet
To date, no vaccine has been endorsed at the level of the FDA, says Domingo. However, the country’s vaccine experts panel is reviewing vaccines being manufactured by Johnson & Johnson’s Janssen Pharmaceutical Companies and Russia’s Sputnik V developed by the Gamaleya Research Institute before allowing them to conduct Phase 3 of the clinical trial in the Philippines.
Domingo quickly added, “It doesn’t mean na pagkatapos na Phase 3, [okay na]. Di pa rin natin alam kung mabibigyan sila ng approval,”
In the end, Domingo stresses, the safety of the vaccine is the top priority of his agency. “In the same vein as any other drugs, we should always be on the side of caution. We cannot compromise safety [of a vaccine] for speed, as WHO reminds us. Remember, a bad vaccine is worse than no vaccine at all,” he concludes.
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