Phase 3 clinical trials of Russian vaccine in PH set Oct

Phase 3 clinical trials of Russian vaccine in PH set Oct

CLINICAL TRIALS. Presidential Spokesperson Harry Roque announces schedule of Phase 3 clinical trials of Russia’s coronavirus disease 2019 vaccine during a virtual presser on Thursday (Aug. 13, 2020). Roque said Phase 3 clinical trials of the vaccine in the Philippines will be held from October 2020 to March 2021. (Screenshot)

MANILA – Malacañang on Thursday laid down the timeline on the Philippines’ participation on clinical trials of the coronavirus disease 2019 (Covid-19) vaccine developed by Moscow-based Gamaleya Institute of Epidemiology and Microbiology.

In a virtual Palace briefing, Presidential Spokesperson Harry Roque announced that the Philippines will begin Phase 3 of the Russia-funded clinical trials of the vaccine from October 2020 to March 2021.

Phase 3 of clinical trials will be done in the Philippines simultaneously with Russia after a vaccine expert panel review on the results of clinical trials for Phase 1 and Phase 2 is conducted in the month September.

Roque said registration with the Food and Drug Administration (FDA) can take place in April 2021.

Should the process move as scheduled, Roque said President Rodrigo Duterte can be vaccinated by May 1, 2021.

“Iyong aking target date po na May 1, ito po’y sang-ayon nga pala sa DOH at sa DOST po, Department of Science and Technology (My May 1 target date, this is according to the Department of Health and DOST),” Roque said.

Roque said the Philippines’ participation in Russia’s clinical trials are expected to erase doubts on concerns over the Russian vaccine, named Sputnik V.

Duterte, in a public address on Monday, accepted Russia’s offer to supply the Philippines with a vaccine and even volunteered to be the first person to be injected in the country.

He also expressed hope that the world would be Covid-free by December.

The Presidential Security Group (PSG) said they will allow the President to be inoculated with the Russian vaccine as long as it has received approval from the FDA.

Roque said that a Covid-free Christmas may still be possible since vaccines being developed by other countries are also undergoing Phase 3 of clinical trials.

“Sabihin nalang natin na ito naman pong Gamaleya vaccine is only one. Marami na pong mga vaccine na nasa third phase na of clinical trials. So baka meron naman pong mauna pa. Dahil itong Gamaleya sisimulan pa lang ang third phase (Let’s just say Gamaleya is not the only one. There are many vaccines on the third phase of clinical trials. Gamaleya is just starting its third phase),” he said.

Despite Duterte’s vote of confidence on Russia’s vaccine, Roque said it will have no bearing on the expert review.

“This is conducted by scientists, not politicians so I think they will be following strict scientific protocols,” he said.

On Wednesday, Russia announced that initial batches of Sputnik V are expected to roll out within two weeks.

However, there is mounting skepticism over its safety and effectiveness as it has yet to go through crucial Phase 3 or the final phase of clinical trials.

The World Health Organization (WHO) said there are six vaccine candidates that are already on the final phase.

Three of the six vaccine candidates are being developed by China-based pharmaceutical companies — one from Sinovac, and the two are from the Wuhan Institute of Biological Products, and Beijing Institute of Biological Products which are both under Sinopharm.

Also in the final phase of trials are vaccines developed by AstraZeneca and University of Oxford (UK); Moderna and the National Institute of Allergy and Infectious Diseases (US); and BioNTech (Germany), Fosun Pharma (China) and Pfizer (US), according to the WHO. (PNA)

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