THE Supreme Court has junked a petition that sought to stop government from procuring and using the COVID-19 vaccine made by the private Chinese firm Sinovac Biotech.
The petition also asked the High Court to compel the Department of Health and the Food and Drug Administration to conduct trials for Sinovac and other COVID-19 vaccines before they are used.
The SC resolution said the petition failed in all aspects — on merits and on procedure.
The resolution was promulgated on May 11 but released only yesterday. The petition was filed by Pedrito Nepomuceno, former mayor of Boac town in Marinduque.
“In the absence of proof that the grant of an emergency use authorization or EUA was not made in accordance with law and prescribed procedure, this Court cannot issue an order that would stop the procurement and use of the Sinovac vaccine or require additional trials that are not mandated by law,” the decision penned by Associate Justice Jhosep Lopez said.
In his plea, Nepomuceno said their were doubts as to the efficacy of the Chinese-made vaccine and that the EUA issued by the FDA was made without results from completed clinical trials of the said vaccine.
Sinovac’s CoronaVac makes up almost half of the country’s current vaccine supply. The Philippines has so far received 25 million doses of vaccines of various brands, including 12 million doses of CoronaVac, since February this year. The country is set to receive 3.2 million doses of the one-dose vaccine made by Johnson & Johnson on July 19.
Last month, the World Health Organization approved the Sinovac vaccine for emergency use, saying it was 51% effective at preventing COVID-19 in late-stage trials. The effectivity rate is lower than that of seven other WHO-approved vaccines.
Questions about Sinovac’s effectivity were anew raised recently, after at least 350 doctors and medical workers in Indonesia, who have been vaccinated with Sinovac, were infected with COVID-19, with dozens hospitalized. On Sunday in Thailand, more than 600 medical workers were also infected despite having been fully vaccinated with the two-dose jab.
The incidents gave rise to suggestions that a booster shot be given to healthcare workers.
Vaccine-maker Pfizer is also asking US and European health regulators to authorize a third dose of its COVID-19 shot amid the fast-spreading Delta variant.
Yesterday, the GAVI alliance said it has signed two advance purchase agreements with Sinovac and another Chinese drugmaker, Sinopharm, to provide COVID-19 vaccines to the COVAX program immediately.
The Philippines is among recipients of vaccines from the WHO-backed global vaccine-sharing scheme COVAX Facility.
COVAX, which distributes vaccines to poorer countries, has struggled to meet its early commitments amid Indian export disruptions, forcing many countries like the Philippines to freeze their inoculation programs. However, its latest supply forecast shows that the program is on track to deliver more than 2 billion doses by early 2022.
The government targets to vaccinate 50 million to 70 million Filipinos this year, and to procure 148 million doses of vaccines..
As of July 11, some 13.2 million doses have been administered, 9.7 million given as first doses and 3.5 million as second dose.
DUTERTE’S 2ND SHOT
President Duterte completed his Sinopharm jab last night, some two months after he received his first jab, before his met with members of the Interagency Task Force for the Management of Emerging Infectious Diseases, said presidential spokesman Harry Roque.
Health Secretary Francisco Duque III administered the second dose.
The 76-year-old Duterte received the first dose of Sinopharm on May 3. The vaccine was sourced from a 1,000-dose Sinopharm donation by the Chinese government.
Malacañang has said the Sinopharm vaccine is covered by a compassionate use permit issued to the Presidential Security Group Hospital in February but the Department of Health in April applied for a separate compassionate use permit for the donation after the President ordered its return to China to appease critics for using a vaccine that is neither registered nor granted an EUA.
Last month, the FDA said it granted the DOH an EAU “to accept the donations of Sinopharm.”
‘BOOTLEG DOSES’
San Juan Rep. Ronaldo Zamora said he was inoculated using two shots of smuggled China-made Sinopharm vaccines last December.
“Noong December, na-vaccinate ako – ewan ko kung dapat kong sabihin ito, Sinopharm (Last December, I was vaccinated – I don’t know if I should say this, Sinopharm),” he told reporters at an event in the city, where it was announced that the city has met its target of vaccinating 85,000 of its residents.
Zamora said he and the President both received “bootleg doses” of Sinopharm shots.
Zamora further disclosed he recently got two shots of Pfizer-BioNTech COVID-19 vaccine as “boosters,” on the advise of his doctors because he is “immunodeficient.”
“Kaya si Congressman Zamora, di na masyadong nagma-mask (That’s why Congressman Zamora does not wear masks that often anymore),” he said.
His son, Mayor Francis Zamora, said the congressman was advised by his doctors to receive the Sinopharm vaccine because he had a quadruple bypass 16 years ago, a kidney transplant six years ago, and remains immuno-compromised.
“He is a person with comorbidity and he is 76 years old. So his doctor gave the order and directions,” he said in mixed English and Filipino.
Philippine Foundation for Vaccination executive director Lulu Bravo, during the “Laging Handa” public briefing, said the mix and match of vaccine brands is still undergoing studies abroad. A study in the country has yet to start.
Health Undersecretary Maria Rosario Vergeire, asked about booster shots, said, “Let us give the chance for everybody to get vaccinated first before we think of booster doses.”
“We want to have a larger portion of the population to get vaccinated before we go into the discussions of giving booster shots,” she added.
She also said there is no evidence showing a need for booster shots for COVID-19 vaccines.
NO LAW
The Supreme Court, in dismissing Nepomuceno’s petition, said there is no law that requires the mandatory conduct of clinical trials for the procurement of any COVID-19 vaccine, including that of Sinovac.
The SC said Republic Act No. 11494, the Bayanihan to Recover as One Act, even bestowed President Duterte the discretion as to how to address the COVID-19 pandemic, such as by exercising powers needed to implement the government’s response and recovery programs, including the purchase of vaccines.
“On the contrary, the requirement for the completion of clinical trials before a vaccine may be used in the Philippines as required by the Universal Healthcare Act was suspended for a period of three months,” the SC said, adding that RA 11525, or the COVID-19 Vaccination Program Act exempted the procurement of COVID-19 vaccines, including subsidiary supplies and services, from the general procurement requirement of public bidding and allowed its negotiated procurement under emergency cases.
The SC also said that granting Nepomuceno’s petition would render irrelevant Executive Order No. 121 signed in December 2020, which mandates the immediate availability and use of COVID-19 vaccines.
“The issuance of an EUA precludes the need for the completion of the conduct of clinical trials,” the SC further explained, adding that while there are doubts about the efficacy of the Sinovac vaccine, it is not within the authority of the Court to compel the government to conduct further testing before it can be distributed and used. — With Jocelyn Montemayor, Wendell Vigilia, Gerard Naval and Reuters
