Shiela Crisostomo (The Philippine Star) – February 13, 2021 – 12:00am
MANILA, Philippines — The Food and Drug Administration (FDA) is investigating reports that a shipment containing COVID-19 vaccines by US firm Moderna arrived in the country last Thursday.
In an interview, FDA director general Eric Domingo said if Moderna vaccines have indeed arrived in the country, “it’s probably counterfeit.”
“I heard about it, but we don’t have any report from our Regulatory Enforcement Unit. I am sure there is no actual Moderna vaccines,” he noted.
Domingo said they had a meeting with Moderna last Tuesday and the vaccine manufacturer shared that it is planning to apply for an emergency use authorization (EUA) with the FDA.
“Hopefully next week. (They said) they cannot supply vaccines to the Philippines until June or July of this year,” he maintained.
Department of the Interior and Local Government spokesman Jonathan Malaya said they would investigate the reported arrival.
Domingo meanwhile said the government is setting up an indemnity fund for those who will be inoculated primarily because the COVID-19 vaccines are still underdeveloped.
“These COVID-19 vaccines are all for emergency use. They have not completed the Phase-3 trial but what happens is we are asking the companies for these vaccines although they are not ready,” he pointed out.
Domingo added that in exchange for this, the vaccine companies have asked to be free of responsibility for adverse reactions or side effects.
Yesterday, vaccine czar Carlito Galvez Jr. announced in a telephone interview that the arrival of the vaccines coming from the World Health Organization’s COVAX Facility might be delayed by one week because the government is still settling the indemnity agreement.
He gave assurance though that the Philippines would not lose its 44 million COVID-19 vaccines from the global initiative.
“I think the delay is only for one week. There was no mention of something like that,” he told ANC in reaction to Sen. Panfilo Lacson’s tweet that that the Philippines may be losing its free 44 million vaccines.
Galvez said the delay is not coming from the Philippine government, explaining that “we are only on the receiving end and we are finishing our documentation on time. But the indemnification clause, we’ve looked for that for a long time, but it was only given last week.”
The arrival of Pfizer’s vaccines from the COVAX facility was supposed to be by mid-February. However, an indemnity agreement is necessary as it would state that the responsibility of the manufacturer, in the event of any adverse effects on the vaccine recipients, would be shouldered by the government.
Aside from the Pfizer vaccine from the COVAX facility, the Philippines is also expecting to receive Sinovac shots within the month. The FDA has yet to issue an EUA for the Chinese drug.
Science Secretary Fortunato dela Peña said they are still waiting for advice from the World Health Organization on the conduct of the Solidarity Trials for candidate COVID-19 vaccines in the country. – Jose Rodel Clapano, Romina Cabrera, Rainier Allan Ronda
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