MANILA—A public health expert with 20-year experience in the pharmaceutical industry sees the earliest possible time the vaccine against COVID-19 to be available in the Philippine is in the first quarter of 2021.
Dr. Tony Leachon, a public health expert and former member of the Inter-Agency Task Force on Emerging Infectious Diseases (IATF-EID), in an interview in the DZRH Special On Saturday (SOS) program, Aug. 8, said the development of the vaccine usually pass through four phases.
Leachon said the process of developing a vaccine against COVID-19 starts with the genome of the virus that China provided to the World
Health Organization (WHO) that led to the ongoing development of vaccines by several pharmaceutical companies all over the world.
He said the development of the vaccine against COVID-19 is faster now because its scientific development had been done earlier.
Leachon said the pharmaceutical companies all over the world helped each other while some merged.
“Why do we need a vaccine? In order to introduce to the body antigen so that an antibody will be developed to protect yourself and lessen your capability to acquire COVID. At the same time, if many people will be inoculated with a vaccine, herd immunity will set in when as much as 70 percent of the population have been infected,” he explained.
Leachon said upon the development of the vaccine there will be medical trials that involve animals in phase one while phase two involved 100 persons to determine dose ranging and if it’s effective and safe.
He said phase three study of the vaccine involved 3,000 individuals to a minimum but the case of the present study of the COVID-19 involves 30,000 individuals in different countries like the United States, Mexico and Germany, done simultaneously.
“Last week, Pfizer announced the start of their enrollment which is two months. The duration of the clinical trial is four months,” Leachon said.
He explained that enrollment involves the recruitment of patients who will undergo the clinical trial in which the bigger the sample size the better to know if the vaccine is effective and safe.
Leachon said when the clinical trial ended the principal investigators together with the sub-investigators are to collect the data to determine the effectiveness, safety, side effects, ages that must be given attention and need of multiple doses of the vaccine.
The results of the clinical trial will be submitted to the Food and Drugs Administration (FDA) of the United States which will approve the vaccine in two weeks to one month when everything goes right, he said.
Leachon said that upon approval by the US FDA, a certificate of product registration (CPR) will be issued as the basis of launching the vaccine.
He said when it reaches the Philippines it will take about three months to get approval from the Philippine FDA based on the dossier from the US FDA.
Leachon said that after the launching of the vaccine the phase four or the post marketing surveillance commences, wherein all of the people to be inoculated with the vaccine will be recorded and their consent solicited.
At the end of the phase four the results will be submitted again to the US FDA in anticipation of additional order of the vaccines, he said.
Earlier in the interview, Leachon lauded the government for coming up with the National Action Plan for COVID-19 and assessed the Philippines to be better than the US.
“May National Action Plan ang Pilipinas at may nakikita na talagang ginagawa. I think dapat kunin natin in a different angle, yon na nag-i-improve tayo. Syempre, hindi perfect system pero nag-i-improve tayo,” he said.
(The Philippines has National Action Plan and we can see something is actually being done. I think we go in a different angle, that we are improving. Of course, it is not perfect system but we are improving.)
Leachon said the Philippines should compare its performance from its baseline in the fight against the pandemic.