Approval of Russia-made COVID-19 vaccine ‘good news,’ but local use depends on laws, clinical trials — Palace

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The approval of the Russia-made COVID-19 vaccine is a welcome development for the Philippines, but its local use and rollout will still hinge on results of clinical trials as well as its compliance with local laws, Malacañang says. (FILE PHOTO)

Metro Manila (CNN Philippines, August 12)— The approval of the Russia-made COVID-19 vaccine is a welcome development for the Philippines, but its local use and rollout will still hinge on results of clinical trials as well as its compliance with local laws, Malacañang said Wednesday.

Speaking to CNN Philippines, Presidential Spokesperson Harry Roque stressed the “Sputnik V”— the vaccine claimed by Russia as the “world’s first” for the mysterious coronavirus— would have to earn the nod of the Philippines’ Food and Drug Administration as the country “cannot do away” with the local processes.

“Whether or not we could actually use it will depend on compliance with our existing laws, because we have a statute which penalizes the use of any drug without prior approval of the FDA,” Roque said in an interview with The Source. “And before the FDA could approve it, the universities will have to conduct clinical studies to prove that it has no adverse effects.”

“So it is good news, but it still has to go through our local processes, because we can’t do away with them,” he added, noting the procedure holds true for any other internationally-developed vaccine that will reach Philippine shores.

Russian President Vladimir Putin on Tuesday claimed a breakthrough in the global race for a coronavirus vaccine, as the transcontinental country unveiled the Sputnik V, a reference to the surprise 1957 launch of the world's first satellite by the Soviet Union.

Experts from the research and medical field, however, were quick to question Russia’s announcement as the product was hounded by safety concerns.

The vaccine— developed by the Moscow-based Gamaleya Institute— has yet to pass the crucial Phase 3 testing stage, where the product is typically administered to thousands of participants, CNN reported.

Concerns on Russia’s data transparency and track record in locally-developed medicine quality have also prompted the scientific community to issue warnings on the vaccine’s efficacy.

Russian Ambassador to the Philippines Igor Khovaev, however, said last week that the doses are deemed "safe and effective.”

Kirill Dmitriev, CEO of the Russia Direct Investment Fund that bankrolled the development of Russia's vaccine, in an interview with CNN International also allayed concerns on the incomplete clinical trials, saying the late stage trials would take place abroad, including the Philippines. Philippine health and science officials, however said the country was still in talks with Russian authorities about joining the Phase 3 clinical trials.

According to Sputnik-V's website, Phase 3 clinical trial involving more than 2,000 people in Russia and the United Arab Emirates, Saudi Arabia, Brazil, and Mexico will start on August 12.

Dmitriev added 20 countries are already requesting for over a billion doses of the product.

While the government welcomed Moscow authorities’ offer to provide Sputnik-V to Filipinos, Roque stressed the Philippines continues to work with the World Health Organization for the global clinical studies for vaccines being developed by other nations.

Duterte a guinea pig? ‘He doesn’t mind’

Roque meanwhile said that President Rodrigo Duterte doesn’t mind being a “guinea pig” for Russia’s vaccine project, after the chief executive volunteered himself to be the first person to try an injection.

“I think it was perfectly fine for him to offer it, because that’s his way of telling the people that I want us to have a vaccine, and if I have to be the guinea pig for it, I don’t mind. That’s the attitude of the President… he can sacrifice his life for the Filipino people,” Roque said, adding he himself considered to volunteer as the second person to go on the vaccine trial.

Addressing concerns on Duterte’s safety, Roque said the FDA will do “everything it can” to ensure the vaccine will be administered safely, with the agency seen to also fasttrack studies on the product.

Still little information

Health Secretary Francisco Duque III, on the other hand, assured his agency will be working closely with both the FDA and the Science and Technology Department to ensure the safety of the product prior to possible market rollout.

He underscored the need for experts of the regulatory agencies to gather more data about the vaccine.

“There is very little information about the vaccine… the duty of the government is to ensure it is safe to use and it is of quality,” Duque told reporters in an event in Antipolo City.

Countries have been in a race for a global vaccine for the deadly virus, which has infected over 20 million people in 188 different countries including China, the first epicenter of the outbreak.

Candidate vaccines from China, the United States, and the United Kingdom have likewise entered late-stage trials, but developers stressed the timeline for their rollout will still depend on data.

CNN Philippines' Melissa Lopez contributed to this report.