Vaccine firms yet to apply for emergency use in PH, says FDA

Vaccine firms have yet to apply for emergency use in the Philippines, the Food and Drug Authority said as it urged Chinese drugmakers to register their COVID-19 vaccine in order for these to be distributed in three months.

The FDA published its guidelines for emergency use authorization last week, executive director Eric Domingo said.

He added, “So far we have not received any formal application yet…It takes time to prepare. In the Philippines, I’ll only accept the application if they already have an EUA in their home country.”

Domingo said China’s Sinovac or Sinopharm should now apply for an EUA in the country if they plan to roll out their vaccines by March.

The Philippines has no information yet on Sinopharm’s phase 3 clinical trials while Sinovac is expected to get their clinical trial phase 3 interim report by the end of the month.

He noted, “(The vaccines cannot enter the country until we have complete data on its safety and efficacy.)”

Source: : https://news.abs-cbn.com/news/12/16/20/vaccine-firms-yet-to-apply-for-emergency-use-in-ph-says-fda

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