The expected early delivery of two vaccines for the coronavirus disease 2019 (Covid-19) to the Philippines has been delayed by paperwork.
The shipment of 600,000 doses of China’s Sinovac Biotech vaccine, due to arrive on February 23, might be postponed if the Food and Drug Administration (FDA) would not grant the manufacturer an Emergency Use Authorization (EUA) by February 18, which was yesterday, Thursday, according to Palace spokesman Harry Roque Jr.
The Pfizer Inc. and BioNTech SE vaccine must wait for an indemnification agreement to be signed before it can be shipped, according to the World Health Organization (WHO) Philippines Country Representative Dr. Rabindra Abeyasinghe.
The agreement has to be signed by the developers as part of the requirements of the Global Covax Facility, which will supply the vaccine.
The 117,000 doses of the Pfizer vaccine were supposed to arrive on February 15.
Roque said China’s Sinovac wanted to wait for an EUA before delivering the vaccine it is donating to the Philippines.
FDA Director General Eric Domingo had said the application of Sinovac had been hanging because it had not completed all the required documents.
Domingo said Sinovac promised to submit the documents within the week.
The Covax Facility said the delivery of the Pfizer vaccine could be delayed by transportation and logistical issues.
The vaccine must be kept in subzero temperature during transportation and distribution.
In the face of the delays, vaccine czar Carlito Galvez Jr. is still hoping the government can launch its nationwide vaccination program this February.
During a briefing on Thursday, Abeyasinghe said the Covax Facility’s proponent, Gavi Vaccine Alliance, has assured that the indemnification agreements that were signed by the Philippine government will be accepted by both manufacturers.
“The Pfizer lawyers need to have their own indemnification agreements which specific countries need to sign to,” Galvez said.
The shipment of the vaccines might be pushed back by two weeks, he added.
More doses of the Pfizer-BioNTech Tozinameran vaccine could arrive by late March or April.
The delivery of the first batch of the AstraZeneca-Oxford’s AZD1222 vaccine, manufactured by SKBio, also hinges on the signing of indemnification agreements.
“I was made to understand that the AstraZeneca plant has a consignment of vaccines and ready for shipment for the Philippines if we meet the requirements,” Abeyasinghe said.
Aside from Pfizer-BioNTech and AstraZeneca-Oxford, three more vaccine manufacturers — Moderna, Sinopharm Group and Sinovac — are having their brands evaluated for possible emergency use listing by the WHO.
“Moderna is in advance stage [of evaluation] for emergency use listing, and we were also made to understand that Sinopharm and Sinovac are also on the evaluation for emergency use listing. We believe that this is the next brand of vaccine that will be given EUL (Emergency Use Listing) with WHO provided they complete evaluation,”’ Abeyasinghe said.
Senate Minority Leader Franklin Drilon lamented the delay in vaccine shipments, saying six of the 10 countries in Southeast Asia have already begun vaccination programs.
Singapore, Indonesia, Cambodia, Vietnam, Laos and Myanmar have begun inoculations, leaving the Philippines, Brunei, Malaysia and Thailand behind, Drilon said.
“We are left behind in the procurement and administration of Covid-19 vaccines. It is very disappointing. I am worried for the future of our country,” Drilon said.
“Each day we fail to start the vaccination raises the risk of further spread of the virus and makes our economic recovery longer,” he said.
The country aims to inoculate at least 70 million of its population to achieve herd immunity, he noted.
The delay comes on the heels of reports that other pharmaceutical companies such as Moderna and AstraZeneca have stopped accepting orders.
“I cannot emphasize this enough: our survival as a nation largely depends on our ability to ensure immediate access and distribution of Covid-19 vaccines to our people. At the rate things are going, however, Filipinos have to wait longer,” Drilon said.
Even as the government waits for the vaccine shipments, President Rodrigo Duterte has allowed local government units (LGUs) to make advance payments to drug manufacturers for Covid-19 vaccines.
In a virtual press briefing, Galvez said Executive Secretary Salvador Medialdea told him the President signed on Thursday a memorandum order for the LGUs to procure and make advance payment for the vaccines it ordered.
“Ito po ay napakagandang balita lalong lalo na ngayon po ay malapit na po ang advance payment natin sa AstraZeneca (This is good news, especially with the deadline for the advance payment for AstraZeneca’s Covid-19 vaccines drawing near),” he said.
The League of Cities of the Philippines had asked Duterte to issue an executive order allowing LGUs to make advance payments for Covid-19 vaccines they contracted ahead of a February 24 deadline.
The Government Procurement Reform Act limits an advance payment to a maximum of 15 percent of the cost of government-financed projects.
In the same press briefing, Roque said local governments can now make a down payment of as high as 50 percent for vaccine orders.
A number of local governments have entered into deals with British-Swedish firm AstraZeneca and the national government to buy vaccines for their constituents.
AstraZeneca is asking for a 20-percent down payment, said San Juan Mayor Francis Zamora.
WITH JAVIER JOE ISMAEL AND CATHERINE S. VALENTE
(Source: The Manila Times)