THE Philippines is not the only country experiencing delays in acquiring COVID-19 vaccines from the COVAX Facility, a global initiative aimed at ensuring equitable access to the vaccines, an official of the World Health Organization said yesterday.
“This is not a problem unique to the Philippines,” said Dr. Rabindra Abeyasinghe, WHO Representative to the Philippines, in a virtual press briefing. “This is a common problem to all 18 countries that were earmarked for the early vaccine rollout.”
Abeyasinghe said not even the requirement of vaccine makers for an indemnification clause is unique to the Philippines.
Vaccine czar Carlito Galvez Jr. has said manufacturers are concerned about suffering the same fate as Sanofi Pasteur, which was slapped with faced lawsuits for deaths being linked to its anti-dengue vaccine Dengvaxia.
“The requirements and agreements are common to all countries, not specific to the Philippines, not related to any issue such as Dengvaxia or anything else. It is a common agreement sent to all recipient countries,” said Abeyasinghe.
Another factor for the delays, Abeyasinghe said, is the insufficiency of vaccine supplies. Add to this, he said, is that 80 percent of the global vaccine output has been reserved by high-income countries.
“There is limited manufacturing capacity that manufacturers have. Manufacturing outputs have not been as high as expected,” he said.
The Philippines was originally set to receive 117,000 doses of Pfizer-BioNTech vaccines sometime in the middle of February.
Abeyasinghe said he expects the “impasse” between Pfizer and the Philippines to be resolved soon. He said minor clauses proposed by Pfizer in the indemnification agreement have been received by government.
“We believe that, within today or tomorrow or when documents are cleared by the legal team, we will see a resolution of that impasse and we will be able to hear when the deliveries can happen,” said Abeyasinghe.
On AstraZeneca vaccines, which the Philippines is also expecting under the COVAX Facility which WHO co-leads, Abeyasinghe said the country has met the manufacturer’s requirements, including an indemnification agreement.
“My understanding is that there is no further requirement by AstraZeneca for exchange of letters. We are optimistic that before the end of this week, we will hear from the COVAX Facility on the delivery date for AstraZeneca vaccines,” said Abeyasinghe.
The Philippines is expecting 5.5 million to 9.2 million doses of vaccines from AstraZeneca in the first quarter of the year.
As for the vaccine from Sinovac Biotech, a private Chinese firm, Abeyasinghe said the WHO is still evaluating if it could be included in its emergency use listing (EUL).
“That process may be completed within the month of March. However, we are not privy to all information shared by the manufacturer,” he said.
The vaccines from Pfizer and AstraZeneca are in the WHO’s EUL. Inclusion in the list is a prerequisite for COVAX Facility vaccine supply.
The Philippines’ Food and Drug Administration has issued emergency use authorizations to Pfizer, AstraZeneca and Sinovac.
The Philippines is expected some 600,000 doses from Sinovac this month, which is a donation from China and not from the COVAX Facility.
Cabinet Secretary Karlo Nograles, concurrent co-chairman of the Interagency Task Force for the Management of Emerging Infectious Diseases, said vaccines would be used and administered based on what vaccine arrives first and regardless of brand.
Nograles said the important thing is an emergency use authorization has been issued by the FDA to enable the use of the vaccine.
Nograles also said President Duterte is not holding anyone accountable for the delay in the procurement of vaccines as he believes all government officials involved in negotiations are doing all they can to secure the vaccines.
“Si Pangulo also understands na we are at the receiving end of these vaccines. Ginagawa naman natin ang lahat ng kinakailangan natin based on the requirements being asked of us. But at the end of the day, it’s the vaccine manufacturers’ obligation and responsibility to ship it to us at the time that it has promised (The President understands that we are at the receiving end of these vaccines. We are doing all we can based on the requirements being asked of us. But at the end of the day, it’s the vaccine manufacturers’ obligation and responsibility to ship it to us at the time that it has promised),” he said.
COMPENSATION
Abeyasinghe said compensation of vaccine recipients who will experience adverse effects will be shouldered by receiving countries.
He said this is because indemnification agreements are strictly between the receiving countries and the vaccine manufacturers.
“The WHO will not be providing compensation. The compensation agreement will be between the recipient country and manufacturers,” he said.
“It is purely an internal agreement, where the countries are required to have an indemnification fund to manage indemnification issues,” he added.
The most that the WHO can do, Abeyasinghe said, is to facilitate the indemnification process, if it becomes necessary.
A Reuters report said WHO has agreed to a no-fault compensation plan for claims of serious side effects in people in 92 poorer countries due to get vaccines via COVAX, resolving a big concern among recipient governments.
The program, which the WHO said was the first and only vaccine injury compensation mechanism operating on an international scale, will offer eligible people “a fast, fair, robust and transparent process.”
“By providing a no-fault lump-sum compensation in full and final settlement of any claims, the COVAX programme aims to significantly reduce the need for recourse to the law courts, a potentially lengthy and costly process,” the WHO statement said.
Questions of how compensation claims would be handled in the event of any serious COVID-19 vaccine side effects, which are likely to be very rare, had been a worry for countries due to get COVID-19 shots via the COVAX plan.
Countries funding their own COVID-19 vaccine procurement also plan their own liability programs.
The WHO-agreed plan, which has been under discussion for several months, is designed to cover serious side effects linked to any COVAX-distributed vaccines until June 30, 2022, to COVAX’s Advance Market Commitment-eligible economies – a group of 92 poorer states which includes most African and Southeast Asian countries.
The program will be financed initially from donor funding to the AMC as an extra charge on all doses of COVID-19 vaccines distributed through COVAX. Applications can be made via a portal at www.covaxclaims.com from March 31, 2021, the WHO said.
Seth Berkley, chief executive of the GAVI vaccine alliance which co-leads COVAX, said the agreement on the compensation fund was “a massive boost” for COVAX, which aims to secure equitable global access to COVID-19 vaccines. — With Jocelyn Montemayor and Reuters
