Sinovac applies for EUA of COVID-19 vaccine in Philippines, but docs incomplete - FDA

Kristine Sabillo, ABS-CBN News

Posted at Jan 14 2021 12:37 PM | Updated as of Jan 14 2021 03:24 PM

Video courtesy of Department of Health

MANILA (UPDATE 2) — China's Sinovac has applied for emergency use authorization (EUA) of its COVID-19 vaccine in the Philippines, but the documents submitted by the company were incomplete, the Food and Drug Administration said Thursday.

“And the last to submit to us yesterday afternoon, nag-submit ng application ang Sinovac. Ang EUA nito is from China, and they are undergoing pre-assessment now,” FDA Director General Eric Domingo said during a virtual briefing. 

(And the last to submit to us yesterday afternoon is Sinovac. Their EUA is from China, and they are undergoing pre-assessment now.)

Domingo said the Chinese firm’s documents were incomplete, as they only included Phase I and Phase II clinical trial data.
 
"So we will have to ask for the clinical trial Phase III report, which I think they are collating now kasi several countries yata ginawa ito. Until we see Phase 3 results, hindi naman natin talaga maa-assess,” he said.

(So we will have to ask for the clinical trial Phase III report, which I think they are collating now because they did it in several countries. Until we see Phase 3 results, we cannot assess.)

Domingo explained that Phase III trial results are crucial in deciding whether the vaccine’s benefits outweigh its risks, as required by the EUA.

An EUA would allow a vaccine to be imported, distributed and administered in the Philippines through a national immunization program even though it is still under development. It also allows the country to recognize the EUA issued by other countries and expedite the approval process from 6 months to just 21 days.

Domingo said the evaluation will only start once Sinovac submits their Phase 3 results. He said the approval of its EUA application will depend on how soon complete documents will be sent and how fast the company will respond to their questions. 

However, he pointed out that he cannot ensure if Sinovac's application will be approved within 21 days since its candidate vaccine has not yet received an EUA from a stringent regulatory authority (SRA).

Having an EUA from an SRA, which is recognized by the World Health Organization (reference: https://www.who.int/medicines/regulation/sras/en/), can bolster a company’s application. Domingo said the expedited 21-day processing of EUA applications in the country is only for vaccines approved by an SRA.

While Sinovac's vaccine has been granted EUA by China's regulatory body, the latter is not considered an SRA, under the WHO listing. Russia's regulatory body is also not an SRA.

It was previously announced that the Philippines will be receiving 25 million doses from Sinovac, with the first batch arriving in February.

The FDA announced Thursday it has granted its first OCVID-19 vaccine EUA to Pfizer.

ASTRAZENECA

Expected to be approved also this month is AstraZeneca’s EUA. The British company submitted its application on Jan. 6 after receiving an EUA from the United Kingdom, Argentina and India.

Domingo said only UK is considered an SRA.

The official said the FDA’s expert panel will be sending questions on Thursday to AstraZeneca for clarifications on its vaccine's clinical trial data.

“Pag na-complete naman ang trial data, they plan to make a conclusion soon and make recommendations,” he said.

(Once the trial data is completed, they plan to make a conclusion soon and make recommendations.)

GAMALEYA

Gamaleya Institute of the Russian government also applied for EUA last Jan. 7.

“Ito yung merong a few documents na needed that we asked them to complete. But we have also sent rin this week their preliminary data nila for evaluation,” Domingo said.

(There are a few documents needed that we asked them to complete. But we have also sent their preliminary data for evaluation.)

Once complete data from Gamaleya is received, questions will be sent to the company for clarifications.

The Philippines has recorded 492,700 confirmed COVID-19 cases, as of Wednesday, including 24,478 active infections, 9,699 that led to deaths, and 458,523 recoveries.

The government aims to inoculate up to 70 million Filipinos this year.

RELATED VIDEOS

Watch more in iWantTFC
Watch more in iWantTFC