MANILA, Philippines — President Rodrigo Duterte boldly declared on Monday night that he would immediately try out the vaccine against the new coronavirus being developed by Russia, but the government’s own requirements for people who would be allowed to take part in the clinical trials disqualify him outright.
According to the guidelines set by the country’s vaccine expert panel for the conduct here of the Phase 3 clinical trials, priority will be given to people aged 18 to 59 and are at high risk of coronavirus infection. These people include health workers and contacts of COVID-19 patients.
While the elderly and immunocompromised people, like Duterte, may be included later on, their participation would “depend on the results” of the priority group.
Criteria for participation
“There will be inclusion and exclusion criteria on who can participate in the clinical trials. This will be strictly implemented,” Dr. Nina Gloriani, chair of the country’s vaccine expert panel, said in July as she explained how the trials for the candidate COVID-19 vaccine would be done, likely starting in October.
In a televised address on Monday night, Duterte said Russian President Vladimir Putin had committed to provide the Philippines with the COVID-19 vaccine that Russia was developing.
To show his confidence in Russia’s candidate vaccine, Duterte offered to be the first to be inoculated when it arrives and said: “I can be the first they can experiment on.”
“Let us see if it’s safe for me, safe for all. If not, that would be the problem since this will be given for free,” Duterte said.
Like in his previous addresses, Duterte again raised the possibility of a vaccine becoming available by December, a timeline the World Health Organization (WHO) had already said was unlikely.
“We’re speeding up as much as possible but we’re not in any way going to cut corners on safety. We have to be able to look ourselves in the eye and be able to look at our communities and assure them that we have taken every precaution to make sure these vaccines are safe and effective before we go giving them to the general population,” WHO health emergencies program executive director Mike Ryan said earlier.
“In order to make that happen, we can shorten that time but realistically it’s going to be the first part of next year before we start seeing people getting vaccinated,” he added.
In a statement, the Department of Health (DOH) said the Russian Direct Investment Fund proposed to not only conduct clinical trials in the Philippines, but also supply the country with vaccines and set up local manufacturing.
“The Department of Science and Technology, as the lead vaccine development portfolio, will handle the conduct of clinical trials in accordance with the requirements of the Food and Drug Administration,” the DOH said.
Primary results
If the trials in the country begin by October, Gloriani said, the primary outcomes will only be known six months after the first immunization.
“Monitoring for those who will be vaccinated will be up to 12 months,” Gloriani said.
Earlier, the Inter-Agency Task Force for the Management of Emerging Infectious Diseases approved clinical trials in the country of vaccines being developed by five pharmaceutical groups from China and Taiwan.
The China groups are the Chinese Academy of Science-Guangzhou Institute of Biomedicine and Health, Sinovac Biotech Ltd. and Sinopharm, which collaborated with the Wuhan Institute and Beijing Biologicals Institute for the development of its candidate vaccine.
The Taiwan groups are Adimmune Corp. and Academia Sinica.
Eight candidate vaccines are in the third phase of clinical trials. At this stage, the vaccine’s safety and efficacy are tested on thousands of patients.
To ensure that the Philippines gets a vaccine once one becomes available, the DOH has allocated an initial P2.4 billion in its 2021 budget for the purchase, Health Undersecretary Maria Rosario Vergeire said.
—With a report from Reuters