Philippines reviews 'accelerated' approval of Russia's coronavirus vaccine

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Metro Manila (CNN Philippines, August 12) — The Food and Drug Administration in the Philippines will conduct more studies on the approval process of the world's first coronavirus vaccine developed by Russia amid allegations it has skipped essential steps in its development.

Most parts of the world were surprised when President Vladimir Putin on Tuesday announced Russia has approved and registered a vaccine for COVID-19, which has now infected more than 20 million people and killed more than 730,000 globally.

FDA General Director Eric Domingo on Wednesday said the vaccine developed by the Moscow-based Gamaleya Institute was scheduled to start Phase 3 of its clinical trial this month. This stage is critical as it is where thousands of patients have to be vaccinated to test its safety and efficacy. There are no reports on how many patients have undergone the third stage of the trial in Russia, but Putin said his own daughter was injected with it.

"As far as we know this vaccine is in the second phase of the clinical trial. We want to know how accelerated the approval was and what the basis was for that," he told CNN Philippines.

He said the Philippines' FDA will only approve the use of vaccines if it has been tested on a large group of patients and it has proven to be safe and effective in building a patient's immunity against the virus.

The Philippines is in talks with the Russian manufacturer to join the Phase 3 of the clinical trial the vaccine named Sputnik-V, health and science officials said.

President Rodrigo Duterte has accepted Russia's offer to provide their vaccines for Filipinos, even volunteering himself a the first one to be "experimented" on. But his spokesman later said the vaccine has to first undergo FDA approval.

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Former United States FDA Associate Commissioner Peter Pitts warned the Russians are not transparent in sharing scientific data on how the vaccine was created. He pointed out that Russia’s vaccine program is not recognized by the World Health Organization and historically, the country has quality issues on the medicines they created.

“Using the Russian vaccine really is playing Russian roulette with people’s health,” Pitts told CNN Philippines on Tuesday.

Despite safety concerns, Russian officials said twenty countries around the world have requested more than a billion doses of "Sputnik-V" — a reference to the surprise 1957 launch of the world's first satellite by the Soviet Union.

The vaccine on Tuesday received a registration certificate from the Russian Ministry of Health despite skipping Phase 3 — the final stage before approval. Under Russia's emergency rules adopted during the COVID-19 pandemic, it can be used to vaccinate its population.

The Phase 1 and 2 were completed on August 1. Phase 3, which will involve at least 2,000 people from Russia, United Arab Emirates, Saudi Arabia, Brazil, and Mexico, will start on August 12, according to the company's website.

Kirill Dmitriev, the CEO of the fund that bankrolled the development of the Russia vaccine, told CNN International that the Sputnik-V will be available to other countries around November. He said the vaccine will initially be provided to their frontliners and high-risk groups before Russia conducts its mass immunization in October.

There are six potential vaccines under the third phase of clinical trials, with four of them coming from China. Domingo said it's possible that another vaccine will be available by the end of the year to early next year.