3 experts okay with Sputnik

CEBU, Philippines — At least three medical experts in Cebu City agree to the possibility of the city participating in the third stage of clinical trial for Russia’s “Sputnik V,” a vaccine against COVID-19.

“Supposedly vaccine trials are long term but considering the circumstances, the benefits out-weigh the risks, so we just have to be hopeful nga walay long term consequences,” said Dr. Peter Mancao, medical director of the NOAH Complex and public information officer of the Cebu Medical Society.

Dr. Shawn Espina who shares Mancao’s passion in the fight against COVID-19, also said it is safe for Cebuanos to participate in the advanced trial but cautioned that Cebu City should make sure that the first two levels of testing were carried our properly.

“Yes, why not? Mao bitaw nang trial. The stage 3 is supposed to be on humans na,” he said.

Espina said rules on bio-ethics are strict in the third level of trial.

“When level 3 trials are made, strict and rules on bioethics. All test individuals are informed and made to sign an agreement,” Espina said.

Dr. Potentiano Larrazabal III, president and chairman of the Cebu Doctor’s Group of Hospitals, said any help is welcome as long as it is safe and approved by the country’s designated authorities.

Larrazabal said that like any vaccine, Sputnik V must demonstrate strong evidence of effectivity first through a thorough and medically acceptable validation process.

“To simply put it, any scientific endeavor, including this trial, should and will always be evidence-based,” Larrazabal said.

For his part, Dr. Jeffrey Ibones, the newly-named officer-in-charge of the Cebu City Health Department, said the city will have to look into the specifics of the vaccine before making a decision.

He said it is better to be cautious than sorry.

“Wala pa mi details or kung unsaon ni nila ang procedure sa trial nor any details gyud sa vaccine itself, so lisod pa gyud i-comment on this if okay ra ba for the Cebuanos to participate in this or not,” Ibones said.

Cebu is expected to participate in the clinical trial with its 9,257 total confirmed cases of COVID-19.

As of yesterday, Cebu City has 1,700 active cases; Mandaue City has 911 active cases; Lapu-Lapu City has 745; while Cebu Province has 713. Talisay City, Minglanilla, and Consolacion, which are under Cebu Province, have 76, 95, and 93 active cases, respectively.

Safety

The Department of Health (DOH) assured yesterday that safety and efficacy will not be compromised should the country use Sputnik V.

In a press briefing, DOH Undersecretary Maria Rosario Vergeire said that Sputnik V will have to undergo the regulatory processes, just like other medical products being used in the country.

“All clinicial trials that will be done for COVID-19 in the Philippines will go through the regulatory processes of the Food and Drug Administration and the Ethics Board,” she noted.

Vergeire added there will also be “inclusion and exclusion criteria” that will be based the capacity and characteristics of the vaccine.

On Tuesday, Russian president Vladimir Putin that the country has approved the first experimental vaccine on COVID-19 and that is own daughter where given a dose.

This, however, raised concerns across the globe as Sputnik V, developed by Gamelya Institute in Moscow, had skipped phase 3 of clinical trials, claiming it would have scientifically proved the efficacy of the vaccine.

In phase 3, hundreds to thousands people shall receive the candidate vaccine and then compare it to standard treatment

According to Vergeire, the Department of Science and Technology (DOST) was scheduled to meet with Gamaleya yesterday to discuss the new vaccine, being the head of the sub-Technical Working Group of the Inter-Agency Task Force for COVID-19 vaccines.

She said the DOST will determine how the clinical trial can be done in the Philippines and how many vaccines can the manufacturer be provided to the country, among others.

“We have this vaccine expert panel, which provides recommendations to the national government on vaccines.  We can assure the public that we are going to study this very critically,” she added. /JMO (FREEMAN)