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FDA Director General Eric Domingo says the United States and United Kingdom placed their vaccine orders early, which explains why they were immediately able to roll out the vaccines upon EUA approval.
Domingo: There's quite a big supply of Pfizer that has been pre-ordered by the richer countries, but maybe they weren't able to mobilize it as quickly as they anticipated. bit.ly/2MVx26u
Domingo: So there's this possibility that some stocks are being freed up, which makes it available for countries like us which already have regulatory approvals for their product.
Domingo on the incomplete documents submitted by Chinese drug maker Sinovac: I believe the interim reports of the Phase 3 trials are being consolidated. bit.ly/39yz83U
If the Sinovac vaccines arrive and the data is still incomplete, what happens next?
Domingo: They cannot roll it out. It cannot be used until we have a complete evaluation.
Domingo: They cannot roll it out. It cannot be used until we have a complete evaluation.
Philippine Genome Center Executive Director Dr. Cynthia Saloma on the first case of new COVID-19 variant in the country: We expected this...but it's good that we were able to detect it immediately.
Dr. Saloma: So far, the data suggests that it is highly infectious...but it's not any deadlier than the Sars-Cov2 virus.
Dr. Saloma: It's unrealistic to close borders.
Domingo says the FDA will be "more meticulous" when evaluating Sinovac's vaccine as the Chinese company has not secured EUA from stringent regulatory agencies.
Domingo says Sinovac is planning to hold clinical trials in the country. "I believe it might start quite soon, but I believe that is more of an expansion, like trying it on other age groups."
Domingo: AstraZeneca has complete requirements. But aside from that, it has an EUA from a stringent regulatory authority from UK, so that is quite reassuring and it helps us evaluate a little faster.
Domingo says the FDA could decide on AstraZeneca's application for emergency use in PH before the end of January.
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