Russian vaccine maker seeking approval for emergency use in PH — DOST

MANILA, Philippines — Russia’s Gamaleya Institute is set to submit its application for emergency use authorization (EUA) for its COVID-19 vaccine in the Philippines, the Department of Science and Technology (DOST) said on Friday.

Gamaleya is expected to submit its application for EUA for its COVID-19 vaccine, Sputnik V, this weekend, DOST Undersecretary Rowena Guevarra said in an online briefing of the Department of Health.

DOST chairs the Task Group on Vaccine Evaluation and Selection, while DOH serves as its vice chair.

The task group performs oversight functions on the evaluation of applications and conduct of COVID-19 vaccine clinical trials in the country

With this development, Gamaleya told Philippine authorities it was withdrawing its application to conduct Phase 3 clinical trials of its vaccine in the country.

There are two other vaccine developers that have applied for EUA before the local Food and Drug Authority — Pfizer-BioNTech (USA and Germany) and AstraZeneca-Oxford University (United Kingdom).

Pfizer already has an EUA with the UK, USA, Kuwait, Mexico, Singapore, and Canada.

AstraZeneca has an EUA to use its vaccine in the UK, Mexico, Argentina, and India.

Gamaleya has an EUA issued by Russia, Argentina and Belarus.

In December, President Duterte allowed the FDA to grant EUA for COVID-19 vaccines, which will shorten the process of approving the vaccines from the usual six months to 21 days.

An EUA is a mechanism which aims to expedite the availability of a drug or vaccine to the public in times of a health emergency, such as the current pandemic.

Even if the vaccine development process is still ongoing, an EUA may be issued if there is already available and “convincing” safety and efficacy data.

This authorization, however, does not exempt the manufacturer from completing the development of its product and applying for prequalification once it is licensed.