Russia’s Gamaleya Institute applies for COVID-19 vaccine emergency use but documents incomplete — FDA

Kristine Sabillo, ABS-CBN News

Posted at Jan 08 2021 07:51 PM | Updated as of Jan 08 2021 09:26 PM

MANILA — The Philippine Food and Drug Administration on Friday confirmed that Russia's Gamaleya Institute has filed for emergency use authorization (EUA) of its COVID-19 vaccine but would still need to file lacking documents.

“The EUA application for Sputnik V developed by Gamaleya National Central of Epidemiology and Microbiology - Ministry of Health Russia was received on 07 January 2021,” the FDA said in its advisory.

FDA Director General Eric Domingo said the state-funded research institute’s submission was “pre-assessed and the applicant was instructed to comply with the lacking documents.”

Domingo told ABS-CBN News that they already consider it officially filed but can only start reviewing once the documents are complete.

Department of Science and Technology Undersecretary Rowena Guevara said Gamaleya Institute also withdrew its application for clinical trials in the Philippines.

“Napakasimple ng rason nila. Mag-a-apply na sila for emergency use authorization kaya hindi na sila magki-clinical trial dito,” she explained during a virtual briefing on Friday.

(They have a simple reason for that - they are already applying for emergency use authorization that’s why they will no longer have clinical trials here.)

Because of Gamaleya’s submission, there are now 3 vaccine developers applying for emergency use in the Philippines.

“Evaluation of Pfizer-BioNTech COVID-19 Vaccine and AstraZeneca Pharmaceuticals-ChAdOx1-S (recombinant) COVID-19 Vaccine is ongoing,” FDA said.

Domingo said it would take around 21 days for the FDA to decide on the EUA applications. Normally, the FDA’s approval process is 6 months long but an EUA allows the government to consider the approval of other regulatory bodies.

Gamaleya already has an EUA with Russia, Argentina and Belarus. Pfizer has existing EUAs in the United Kingdom, United States, Kuwait, Mexico, Singapore, and Canada. Meanwhile, AstraZeneca has EUAs in the UK, Mexico, Argentina and India.

If granted an EUA, the said COVID-19 vaccines can then be imported, purchased, and administered by the national government for its immunization program.

Guevara said the Philippines continues to negotiate with several other companies.

She said they included even those that are still in earlier phases of their development.

“Maaari pa yung mga nahuling bakuna pwedeng mas magaling sila sa current vaccines. Merong potential ang iba dito masasama sa procurement natin pagdating ng 2022,” she said.

(The vaccines currently lagging behind might be more effective than current vaccines. There is a potential for them to be included in our procurement for 2022.)

Meanwhile, Health Undersecretary Maria Rosario Vergeire said there is no need for the Department of Health to apply for EUA in behalf of vaccine developers.

“Because almost all of these vaccines na advance stages na meron nang intensyon nakapagbigay sa gobyerno ng intent to apply for EUA here in the country,” she said.

(Almost all of these vaccines in the advance stages already have an intension or told the government their intent to apply for EUA here in the country.)


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