Recently, Russian president Vladimir Putin declared the country’s vaccine candidate, developed by the Gamaleya Research Institute for Epidemiology and Microbiology, the “world’s first” vaccine for the coronavirus disease 2019 (COVID-19). Named Gam-COVID-Vac or “Sputnik V”, after the first artificial Earth satellite (Sputnik 1), the candidate quickly drew flak as the research team provided insufficient data to the public, even if Putin had demonstrated his daughter was vaccinated and is safe.

But his “biggest fan”, Philippine president Rodrigo Duterte, would not be moved by such insufficiency. Digong brought news to the nation that Russia would provide the Philippines the vaccine, and he volunteered to be the first Filipino to get vaccinated, only to retract his willingness after ineligibility. Serbian counterpart Aleksandar  also expressed willingness to be the first Serbian to be vaccinated.

Putin’s announcement was made as the candidate had just finished the 2nd phase of clinical trials, yet three vaccine candidates (by AstraZeneca-Univiersity of Oxford, Moderna-NIAID-BARDA and BioNTech-Fosun Pharma-Pfizer teams) are already in the 3rd phase or combined phase II-III; this is the major reason for the scepticism on Sputnik V, as it has been approved so quickly. To address the international communitiy’s doubts, the research team planned to conduct the next phase: in the Philippines, simultaneous with Russia. Duterte’s followers then wanted to be volunteers for the third trial, but I beg to differ and refuse from participating, because even medical experts such as in the Philippines and Russia themselves question the veracity of claims on Sputnik V’s effectiveness.

Former Philippine health secretary (minister) and now-congressperson Janette Garín expressed doubts over the candidate. “This is difficult because Sputnik V’s [research team] has no transparency on their scientific data”, she said in a radio interview; “if you see, the information they release is very limited”. Garín, a vaccinologist, opposed plans for the phase III to be conducted in the Philippines, “simply because we don’t have a copy of their protocol”.

Even Russian professionals in the field of medicine shared the same sentiments over the vaccine. The Association of Clinical Research Organisations (AOKI/ACRO), a local pharmaceutical organisation, sent an appeal earlier to the country’s Ministry of Health. “Accelerated registration will no longer make Russia a leader in this race, it will only expose the end users of the vaccine, the citizens of the Russian Federation, to unnecessary danger”, the appeal stated. News outlet RBC also obtained the results of a survey conducted by Doctor’s Handbook with more than 3 000 participating doctors; 66% of which noticed insufficient data, 48% were baffled for the swift creation and approval, and 52% refused vaccination, against 24,5% of respondents who are willing to volunteer.

So what would actually be the danger of taking this half-baked vaccine candidate? With Sputnik V approved, if an end-user patient had himself/herself injected and obtains serious adverse effects, the damages will not be shouldered by Gamaleya, and the patient would not be under the protection of the World Medical Association’s Helsinki Declaration on Ethical Principles for Medical Research Involving Human Subjects, since the use of the candidate is now outside a clinical trial. This is however answered by Gamaleya continuing the clinical trials, despite approval by Putin.

Then why did the Russian president made this step? This is just politics; Putin tries to regain influence after his counterpart from PR China, Xi Jinping, is able to overpower him through COVID-19, which came from China, and his aid efforts to affected countries. Since Russia is lagging in the vaccine race, Putin could just cheat his way to the finish line with the unfinished vaccine, and his reward is doubts from the scientific community and even commoners like me.

Honestly, I have nothing against the Gam-COVID-Vac itself; I am not an anti-vaxxer (I encourage vaccinations). My major reason for scepticism and hesitancy is that Gamaleya failed to provide us the full report of its candidate’s phase I, so I do not know its mechanism of action and I am not certain how effective and safe it is. Then it receives Putin’s blessing, which adds to my suspicions (this is the unwanted bias in me); given his murderous behaviour like in Ukraine, Syria and towards his oppositors, I fear at least for my life, if not for everyone’s lives, and I do not know Putin’s plans to us specifically. PRC is also searching for a vaccine for COVID-19, but it did not behave the way Putin did, that’s why my distrust for its candidates is much less against the Russian one.

So as certain fellow countrymen of mine follow Duterte and want to get doses of Sputnik V, I strongly refuse. If I were offered to participate in phase III trials, I would gladly take invitations from AstraZeneca, Moderna or Pfizer, if I were eligible. Putin’s hasty approval ruined the labour of Gamaleya.

 

Article posted on 14 August 2019, 21:22 (UTC +08:00).

Featured image: Gam-COVID-Vac, nicknamed “Sputnik V”, produced by the Gamaleya Research Institute for Epidemiology and Microbiology. © Dmitry Kurakin/ Press service of the Russian Health Ministry/ TASS.