FDA aims to reduce vaccine trial approval process to maximum of 43 days — DOH

Kristine Sabillo, ABS-CBN News

Posted at Sep 21 2020 08:35 PM

MANILA — As the Philippines continues to negotiate for COVID-19 vaccine allotment with other countries, the Food and Drug Administration (FDA) has promised to expedite the approval process for vaccine trials.

“Dati we are pegging na mga 55 days ang ating span of time from the vaccine experts panel review to ethical clearance to FDA’s review o evaluation…Pero the FDA has committed to shorten the process. So we are now looking at 43 days. Ito na yung maximum natin,” Health Undersecretary Maria Rosario said in a virtual briefing.

(We used to estimate 55 days from the time the vaccine experts panel reviews the documents to ethical clearance to FDA’s evaluation…But the FDA has committed to shorten the process. So we are now looking at 43 days. This would be the maximum.)

Vergeire said this as she discussed the government’s meeting with the Russian Embassy last week.

She said they discussed the regulatory process of the Philippines.

“Isa sa hinihingi natin sa kanila yung clinical trial protocol. Hanggang ngayon kasi, inaantay pa ng ating vaccine experts panel para maumpisahan nila ang pagaaral ng clinical trial na gagawin dito for the Sputnik V vaccine,” she said.

“Ito ay nagkaroon ng magandang response ang Russian Embassy (This got a good response from the Russian Embassy). They committed to us that they will follow up…so we can start the evaluation by our vaccine experts panel,” Vergeire added.

Last week, the DOH said the Philippine government has already signed and transmitted the required confidential disclosure agreement to access documents of the vaccine manufacturers from different countries.

Vergeire said the 43 days will definitely be feasible as long as the manufacturers provide complete documents upon application.

The health official said that besides arranging for COVID-19 vaccines to be trialed and distributed in the country, the government is also preparing for the necessary logistics.

This includes the warehousing and distribution of vaccines that might need to be maintained at a certain temperature.

“Ito ay kasama sa paguusapan. Merong na tayong mga plano ukol dito para po tayo ay magkaroon ng adequate at appropriate na logistic system when it comes to vaccines,” Vergeire said.

(This is included in the discussions. We already have a plan for this so we can have an adequate and appropriate logistic system when it comes to vaccines.)