President Duterte has ordered the pullout of 1,000 doses of donated Sinopharm Covid-19 vaccine to China.
During his public address late Wednesday, the President made the announcement apparently to fend off criticisms on why he availed of the Sinopharm vaccine, which has yet to be included in the government’s inoculation drive.
Currently, the vaccines being used by the government are only those from Sinovac Biotech, AstraZeneca and Gamaleya Research Institute of Epidemiology and Microbiology.
In an interview with PTV, however, Food and Drug Administration (FDA) Director General Eric Domingo said the President may have made the decision to avoid casting doubt on the efficacy and safety of the vaccines, which are currently being deployed by the government. Presidential spokesman Harry Roque, however, said Sinopharm may still be used in the country once it secures an emergency use authorization (EUA) from the FDA.
The President decided to get his first jab of the vaccine last Monday after he reportedly grew impatient over the slow processing of an EUA for Sinopharm, according to Roque.
President Duterte was still able to “legally” use the Sinopharm vaccine through compassionate special permit from FDA though.
Domingo explained that unlike the EUA, wherein the FDA will guarantee the efficacy of a vaccine, in the case of a CSP the burden of ensuring of the safety of the vaccine would shift to the doctor who recommended it.
As of Thursday, Domingo said they have yet to issue any EUA for Sinopharm.
‘Let’s abide by vaccination rules’
A civil-society network has expressed concern over the inoculation of President Duterte with an unregistered Covid-19 vaccine.
Covid-19 Action Network (CAN), a broad civil-society network consolidating policy gains in pandemic response, stressed that the inoculation of President Duterte with the Sinopharm vaccine, which has no EUA from the Food and Drug Administration (FDA), shows “blatant” disregard for the scientific standards and regulatory processes required to ensure public safety in Covid-19 vaccination.
After drawing criticisms for receiving an unregistered Covid-19 vaccine, President Duterte on Monday night said that he had asked Chinese Ambassador Huang Xilian to withdraw China’s donation of 1,000 Sinopharm vaccines to the country.
“President Duterte, as chief executive, should have a greater moral imperative to abide by vaccine protocols. How can we trust the President to lead us in fighting the Covid-19 crisis when he himself does not follow the rules? The rules and regulations enforced by our government become meaningless if they are subject to political accommodation, and can be so easily bent by those in power,” the group said.
“The process of acquiring an EUA from the FDA, supported by other expert groups, is critical, as it guarantees the safety and efficacy of vaccines. The compassionate use permit granted to the Presidential Security Group for Sinopharm is unnecessary because of the presence of several vaccines in the country, which already have an EUA and are endorsed by the FDA as safe and effective,” they added.
The President’s vaccination with the unregistered Sinopharm vaccine, they stressed, sends the “wrong message” to the already vaccine hesitant public.
“Transparency is essential to build vaccination trust among our citizens so we can reach herd immunity,” they added.