Sinovac jab coming, permit to follow

LIGHT MOMENT Vaccine czar Carlito Galvez Jr. chats with Health Secretary Francisco Duque III before the opening on Monday of Senate committee of the whole’s inquiry into the government’s vaccination program on Monday. —SENATE PRIB

MANILA, Philippines — The first batch of COVID-19 vaccines to be administered to Filipinos will arrive on Feb. 20, but the Chinese manufacturer, Sinovac Biotech Ltd., has yet to apply for emergency use authorization (EUA) from the Philippine regulator, senators learned on Monday.

“Why did you conclude a contract for 25 million doses [of the Sinovac vaccine] when there’s no EUA yet [from the Food and Drug Administration or FDA]?” Sen. Panfilo Lacson asked officials during the inquiry of the Senate committee of the whole.

EUA is a requirement for the mass inoculation program that the government would launch next month.

In Malacañang, presidential spokesperson Harry Roque said on Monday that the Department of Health had confirmed that the country would be acquiring 25 million doses of the Sinovac vaccine, known as CoronaVac.

Roque said 50,000 doses would arrive next month for inoculation to priority sectors, like front-line health workers, the elderly, poor people and uniformed personnel.

Around 950,000 doses will follow in March, 1 million doses each in April and May, 2 million in June, and the final batch in December.

Priority areas for vaccination will be Metro Manila, Cordillera Administrative Region, Davao region and Calabarzon region.

Senate hearing

FDA Director General Eric Domingo admitted during the Senate hearing that Sinovac had not yet submitted an application for EUA, but added that the pharmaceutical company “might be applying next week or very soon.”

That prompted Lacson’s question why a contract with Sinovac had been completed even without EUA.

Secretary Carlito Galvez Jr., the chief implementer of the National Task Force Against COVID-19, explained that there were two “pathways” in vaccine procurement: financing and regulatory. He said it was not necessary to perform the latter before the former was finalized, adding that this process did not preclude a “very rigorous supply agreement” with the supplier.

But Lacson wondered why it seemed that priority was given to Sinovac, considering that other companies, like Pfizer of the United States and AstraZeneca of the United Kingdom, had already secured EUA.

At that point, Galvez started talking about Sinovac’s clinical trials in other countries, but Lacson interrupted him: “No, that is not my point.”

Competition among countries

The senator said it did not make sense to give priority to a company that had not even applied for authorization. But Galvez explained that the government could not afford to bargain only with manufacturers that had already secured FDA permit.

“If you only negotiate with makers of vaccines with EUA, you will be at the tail-end … because there is some sort of competition” among countries looking for vaccine supply, he said.

Galvez stressed that Sinovac would not be able to deliver to the Philippines if it failed to secure FDA approval. “We will not allow inoculation” of the Sinovac vaccine without EUA, he said.

The vaccine, which was given EUA in China last August, uses inactivated SARS-CoV-2, the virus that causes COVID-19. “It’s inactivated, meaning natural. It’s a weakened form of [the] virus which is the traditional vaccine that we have known for the past 300 years,” Roque said.

Aside from Sinovac vaccines, Roque said the Philippines had negotiated for 30 million doses from Novavax and 10 million from AstraZeneca.

The delivery of 30 million doses of India-manufactured Covovax will begin in the third quarter of the year and will be completed in five to six months, according to an official of Faberco Life Sciences Inc., the private company representing Serum Institute of India (SII) in the Philippines.

The Philippine government has signed a deal with SII to procure the Indian vaccine developed by American company Novovax. Faberco will coordinate efforts to deliver the vaccine in the country, according to its medical director, Ma. Luningning Villa.

Covovax is a recombinant vaccine that has a spike protein that helps in the development of antibodies that could fight the coronavirus, Villa said.

Private companies

It also has the Novovax adjuvant that increases immune response and stimulates high levels of neutralizing antibodies, she said. The adjuvant is organic and can lower the dose of antigens required to achieve the desired immune response, she said.

More private companies have joined the effort to acquire the AstraZeneca vaccine for their workers, according to presidential adviser for entrepreneurship Joey Concepcion.

Concepcion said the total number of doses that the private companies would acquire would reach 6 million doses, which would cover 3 million people.

The initial deal, signed last November, provided for 2.6 million doses.

Half of the doses that the private sector would acquire would be donated to the government. The doses would arrive by May or June.

The government will spend at least P140.5 billion to vaccinate at least 100 million Filipinos against COVID-19, with the bulk of the money coming from the national budget and borrowings, the Department of Finance (DOF) said on Monday.

The DOF said the health department had set aside P2.5 billion in its budget for mass vaccination this year, while P70 billion in unprogrammed appropriations would go to vaccine procurement and deployment.

National Treasurer Rosalia de Leon said the unprogrammed items in the budget would be funded by loans or new revenue.

—With reports from Jerome Aning, Leila B. Salaverria and Ben O. de Vera