COVID-19

With order from Duterte, FDA says COVID-19 vaccine can arrive in PH before April 2021

Bonz Magsambol

This is AI generated summarization, which may have errors. For context, always refer to the full article.

With order from Duterte, FDA says COVID-19 vaccine can arrive in PH before April 2021

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'Once we have an emergency use authorization mechanism in place, the process will be faster,' says FDA Director General Eric Domingo

With President Rodrigo Duterte set to issue an emergency use authorization or EUA, coronavirus vaccines could arrive in the country before the second quarter of 2021.

Food and Drug Administration (FDA) Director General Eric Domingo said during a virtual press briefing on Friday, November 20, that the EUA would hasten the government vaccine procurement plan.

With order from Duterte, FDA says COVID-19 vaccine can arrive in PH before April 2021

In his reply to queries about the effect of an EUA, Doming said: “Once we have an EUA mechanism in place. Once nakakuha na sila ng (they have the) EUA , for example in the US FDA, mas mapapabilis talaga ang proseso (the process will quicken). We’re able to look at the evaluation that are done by these mature and advanced regulatory agencies,” Domingo said.

Malacañang said on Thursday, November 19, that Duterte already approved “in principle” the request of the health department for an EUA.

An EUA would speed up the processing time for approval of COVID-19 vaccines that would enter the country – from 6 months to 21 days.

It would be an order from the President to create an express lane that would skip the usual red tape and load of paperwork which bog down vaccine purchases.

Earlier, DOH assured the public that fast-tracking would not mean compromising on quality studies.

“We have the vaccine expert panel at the start, and the FDA would continuously monitor this technology kahit nabigyan na nila ng rehistro sa ating bansa (even though they are already registered in our country),” said Health Undersecretary Maria Rosario Vergeire in a previous briefing.

In September, the FDA said that in a “best case scenario,” the earliest possible availability of a coronavirus vaccine in the Philippines would be by April 2021.

On Tuesday, November 17, Pfizer’s Albert Bourla said that they were “very close” to applying for an emergency use approval for its COVID-19 vaccine after collecting safety data to submit to US regulators.

Moderna has previously said it expects to apply for an EUA by November 25.

The Philippines is currently looking at 17 possible sources of vaccines from various countries. Out of the 17, 9 are now undergoing the 3rd phase of trials, with Pfizer and Moderna reporting promising results, both with 95% efficacy in their phase 3 clinical trials results.

Malacañang announced that Duterte would allow the government to provide an advance payment to pharmaceutical companies developing a COVID-19 vaccine, reversing his previous rejection of the proposal. – Rappler.com

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Bonz Magsambol

Bonz Magsambol covers the Philippine Senate for Rappler.