WHO to PH: Prepare regulatory processes to expedite COVID-19 vaccine when it becomes available
By Betheena Unite
While no vaccine has yet been developed against COVID-19, the World Health Organization (WHO) encouraged the Philippines to prepare its regulatory processes to expedite the assessment of the vaccine once it becomes available.
A logo is pictured on the headquarters of the World Health Orgnaization (WHO) ahead of a meeting of the Emergency Committee on the novel coronavirus (2019-nCoV) in Geneva, Switzerland, January 30, 2020. (REUTERS/Denis Balibouse/FILE PHOTO/MANILA BULLETIN)
Currently, there are six “vaccine candidates” that are being developed worldwide, WHO acting country representative for the Philippines Socorro Escalante said in a virtual presser with the Department of Health (DOH).
While these candidate vaccines are undergoing research and development, Escalante said the government can take advantage of the time to polish regulatory processes and formulate vaccine strategy.
“I think the country could take advantage of the vaccines that are now in the pipeline, but what is key for the country is to be able to prepare its regulatory processes… Because the vaccine development will really take time. For the meantime, we encourage the country to prepare its regulatory processes in terms of assessment and evaluation of the vaccine,” Escalante said.
This is to fast-track the process of receiving and registering the vaccines developed by other countries.
The WHO official also emphasized that the country should formulate strategies on the vaccine’s deployment “depending on how we are going to prioritize the vaccine to the more susceptible population."
“Dahil kapag nagawa na 'yung bakuna, hindi natin mababakunahan lahat ng tao at the same time, so 'yung gobyerno kailangan ding gumawa ng (because when the vaccine is already available, we won’t be able to vaccinated everybody at the same time, so the government needs to formulate) vaccine strategy particularly by prioritizing more healthcare workers or 'yung may comorbidities,” Escalante added.
The process to develop a vaccine to counter COVID-19 is “highly technical and tedious” as it may take a year to a year-and-a-half before it can be declared safe and effective.
“There are steps that scientists and experts must follow to be able to develop the vaccines,” Escalante said.
The first stage, which can last up to six months, is where the experts identify potential candidates for the vaccine. Clinical trials with three phases will then follow to test the vaccines on animals to determine their safety and efficacy.
“Then, the vaccine will be registered national regulation authority of a country for another evaluation. It will be given marketing authorization and could finally be used, but this period is actually the phase 4 of clinical trial where the vaccine needs to be monitored in terms of safety,” Escalante explained.
If the Philippines opts to develop a vaccine on its own in the future, the country must first prepare for local production capacity, particularly technology, the WHO official said.
“I think the Philippines has experts and scientists that are world-class, and we also have institutions to be able to undertake research and development, but the technology has to be really adapted to the vaccine development.
"The Research Institute for Tropical Medicine is capable but on a small scale. laboratory for testing quality and safety of the vaccine must also be developed,” Escalante said.
A logo is pictured on the headquarters of the World Health Orgnaization (WHO) ahead of a meeting of the Emergency Committee on the novel coronavirus (2019-nCoV) in Geneva, Switzerland, January 30, 2020. (REUTERS/Denis Balibouse/FILE PHOTO/MANILA BULLETIN)
Currently, there are six “vaccine candidates” that are being developed worldwide, WHO acting country representative for the Philippines Socorro Escalante said in a virtual presser with the Department of Health (DOH).
While these candidate vaccines are undergoing research and development, Escalante said the government can take advantage of the time to polish regulatory processes and formulate vaccine strategy.
“I think the country could take advantage of the vaccines that are now in the pipeline, but what is key for the country is to be able to prepare its regulatory processes… Because the vaccine development will really take time. For the meantime, we encourage the country to prepare its regulatory processes in terms of assessment and evaluation of the vaccine,” Escalante said.
This is to fast-track the process of receiving and registering the vaccines developed by other countries.
The WHO official also emphasized that the country should formulate strategies on the vaccine’s deployment “depending on how we are going to prioritize the vaccine to the more susceptible population."
“Dahil kapag nagawa na 'yung bakuna, hindi natin mababakunahan lahat ng tao at the same time, so 'yung gobyerno kailangan ding gumawa ng (because when the vaccine is already available, we won’t be able to vaccinated everybody at the same time, so the government needs to formulate) vaccine strategy particularly by prioritizing more healthcare workers or 'yung may comorbidities,” Escalante added.
The process to develop a vaccine to counter COVID-19 is “highly technical and tedious” as it may take a year to a year-and-a-half before it can be declared safe and effective.
“There are steps that scientists and experts must follow to be able to develop the vaccines,” Escalante said.
The first stage, which can last up to six months, is where the experts identify potential candidates for the vaccine. Clinical trials with three phases will then follow to test the vaccines on animals to determine their safety and efficacy.
“Then, the vaccine will be registered national regulation authority of a country for another evaluation. It will be given marketing authorization and could finally be used, but this period is actually the phase 4 of clinical trial where the vaccine needs to be monitored in terms of safety,” Escalante explained.
If the Philippines opts to develop a vaccine on its own in the future, the country must first prepare for local production capacity, particularly technology, the WHO official said.
“I think the Philippines has experts and scientists that are world-class, and we also have institutions to be able to undertake research and development, but the technology has to be really adapted to the vaccine development.
"The Research Institute for Tropical Medicine is capable but on a small scale. laboratory for testing quality and safety of the vaccine must also be developed,” Escalante said.