The Gam-COVID-Vac, the Russian vaccine, also Sputnik V, covered the headlines when it was announced early this month August 2020.
It was developed by Gamaleya Research Institute of Epidemiology and Microbiology and had limited registration in Russia on 11 August 2020 by the Russian Ministry of Health.
The vaccine’s announcement prompted the alarm of global health experts and scientific communities mainly because there has been no publication of clinical trial results. An article published on Nature, notes that there exists no definitive and final evidence for the safety, effective dose, biomarkers of an immune response, or efficacy against COVID-19 infection.
The World Health Organization’s standards on Vaccine and Immunization quality and safety states that vaccine candidates are not approved or licensed until safety and efficacy are reviewed internationally by regulators – something Sputnik V lacks.
Implications
An improperly tested vaccine is unethical, problems may arise when negative effects on health surface as sooner or later after it will be mobilized.
An indirect but equally drastic effect to the population after the probability of negative effects surfacing is when it would further set back the efforts of vaccine acceptance because of the years it was tainted by antivaxx / antiscience campaigns.
Vaccine / drug development takes more or less a decade and goes through meticulous processes and that is common knowledge.
While the hunt for the COVID-19 cure is a global effort and is a reason why vaccines had been fast-tracked to double / triple the time of turnovers, one reason why Sputnik V become infamous in its introduction is because the rest of the vaccines had their trials publicized worldwide – while Sputnik V, had not.
This concern draws closer to home when President Duterte expressed interest in “buying” the vaccine and stated that the Philippines will participate in the what may be the last leg of clinical trials – which is first and foremost, a false statement, since Most clinical trials for drugs and vaccines are supposedly free of charge and sponsored by the companies making them. Volunteers would even be compensated either through medical insurance, cash, etc.
Perhaps a good example would be the Clinical trials of the COVID-19 vaccine being developed by Saint Louis University Center for Vaccine Development – in which their website states that
“Participation in a vaccine study is voluntary and confidential. All study vaccines and tests are free of charge and volunteers receive compensation for time and travel. Participation involves completing a short online survey that includes some personal questions. Your participation is voluntary.”
The Philippines has yet to recover from the obviously politicized Dengvaxia controversy which is fresh as it was within the first 2 years of the Duterte presidency.
The country is embroiled in the current war against COVID-19, taking the lead in cases in South east Asia, and the fastest rise in cases in the Western pacific according to the World Health Organization. Controversies and issues with the government and its health authorities towards handling the crisis spark turmoil among its citizens, and Sputnik V will most likely only add fuel to this raging fire.
Any Silver Lining in the bottle?
Sputnik V’s website briefly details the “effectivity and safety” of their vaccine, including the methodology of how they made it. While the clinical trial study named “An Open Study of the Safety, Tolerability and Immunogenicity of “Gam-COVID-Vac Lyo” Vaccine Against COVID-19” published on ClinicalTrials.gov had no final results to date and had a United States Federal Government Warning and Disclaimer tag.
While the odds of the vaccine being a disastrous mess highly outweigh its probable benefits, the prospects of it working is not impossible. This is not planting false hope, but an author’s conclusion that no matter how we plot probabilities, we can never know the exact and definite thing to happen by tomorrow.
