Following Russian President Vladimir Putin’s announcement last Tuesday that his country has granted regulatory approval for COVID-19 vaccine Sputnik V—the first in the world to do so—experts have expressed their apprehension over this development. This includes the World Health Organization, who says that it has not received enough information about Russia’s trials to evaluate it.
Meanwhile, mostly words of gratitude and optimism have been coming out of Malacañang, along with the added news that the Philippines will be participating in clinical trials for the vaccine, which was developed by Russia’s Gamaleya Research Institute. In a recent Inter-Agency Task Force (IATF) meeting for the Management of Emerging Infections Diseases, President Duterte reiterated that ties between the two countries have remained friendly. The President is confident with Russia’s capability—so much so that he says he is willing to be administered the vaccine in public, probably to allay fears and so that, in his own words, there will be no “satsat.” (According to his own government requirements, however, he’s not qualified to do so.)
What DOST believes
Department of Science and Technology (DOST) executive director Dr. Jaime Montoya expressed his confidence based on his team’s first meeting with Sputnik V’s manufacturers and scientists. “They have shown that it was effective. It produced sufficient antibodies in the people that were given the vaccine. It was safe, only minor adverse effects such as fever for a few days after the injection,” Montoya says in a CNN Philippines interview, adding that DOST believes it will be safe for trial participants. Around 1,000 healthy Filipinos will be administered with Sputnik V in these trials.
But local health experts want to temper this enthusiasm over the vaccine, manage expectations and these pronouncements more responsibly. Former Department of Health (DoH) Secretary Esperanza Cabral says that with regards these trials, nobody should be throwing around words like “safe.” By definition, she explains, this is what trials are supposed to determine in the first place.
“We cannot say it’s safe until it’s completed and the results show that it’s safe,” Cabral says. “DOST must not bias the public in favor of the vaccine by just their unfounded ‘confidence’ without actually knowing if it is ‘safe and effective.’” She emphasizes that at this point in the vaccine’s development, no one knows if it will be safe for the population.
Vaccine and drug development is a necessarily long and complicated journey, and the way that Russia has somehow rushed this and approved Sputnik V before completing trials is a valid cause for concern. Infectious Diseases and Clinical Pharmacology expert Dr. Benjamin Co, who breaks down DoH’s daily updates for ANCX, says that before clinical trials are even undertaken, an ethics review must be put in place.
“An accredited level III ethics board is required because this is an early phase clinical trial. In the conduct of research, the ethical principles are dictated and directed toward respect for the dignity of the human person,” says Dr. Co, adding that he speaks from his experiences as chair of the Research and Ethics Committee for Asian Hospital. “That is it’s overarching goal. All stages of the research must ensure safety, protect the rights and promote welfare of the participants, and ensure proper adherence to confidentiality.”
Our volunteers for these trials, Cabral says, must be prepared to know what they’re getting into, what the vaccine is and what it is for. “Because these are healthy volunteers, okay. They’re not sick at all. They must know what it is they’re receiving. They must know of the potential side effects—including death. And they must consent to this, it being a drug that can give them side effects,” she says.
Questions volunteers must ask
Co also says that every consent form that participants will sign should explain the study, its process, risks, and benefits. “What the patients will gain from the study, what the compensation will be, what the risks will be if the patients encounter problems during the study and who answers for those risks, who will cover for insurance in case the study turns bad or patients get sick, how many times will the patient need to return and what else will be done to the patient,” he lists. “If there is any level of deception in the recruitment, then that study is unethical from the onset and the results may end up being questionable.”
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We have suffered many battle scars and body counts in this months-long fight with the pandemic, but Cabral urges everyone to wait for all results to come in before declaring anything to be “safe” or “good.” These volunteer participants shouldn’t go into these trials with false expectations. “I think we are all desperate for something that will control COVID. But we must temper our desperation with reality,” Cabral says.