Guinea pig nation
Russian President Vladimir Putin announced last Tuesday that Russia has registered the world’s first coronavirus vaccine. He claimed it had “passed all the necessary tests” and had been “proven efficient” (one of his daughters has reportedly been given a shot). Russia aims to start mass production by September and produce several millions of doses per month by next year.
However, results from the Phase 1 and 2 trials, which usually involve a few hundred people and should test whether the vaccine provokes an immune response without triggering dangerous short-term side effects, have not been made public. The state-run Gamaleya Research Institute started Phase 1 on June 17 with 38 participants and completed it on Aug. 10, but no data have been submitted by researchers for peer review. “In effect, Russia will be conducting its Phase 3 trials live, treating it more as a demonstrator group than a control group meant to ensure there is nothing dangerous awaiting the larger population,” American broadcaster NBC News reported.
Serious concerns have been raised over the process Russia has taken for its so-called Sputnik V vaccine—named after the world’s first satellite launched by the Soviet Union in 1957 during the Cold War. The World Health Organization reminded Russia to follow established protocols on vaccine development. “In general terms, there are a set of guidances and regulations, rules, how to deal with safe development of a vaccine,” said WHO spokesperson Christian Lindmeier. “These should be definitely followed in order to make sure that we know what the vaccine is working against, who it can help and, of course, also if it has any negative side effects.”
The Russian vaccine uses an adenovirus, which can cause cold-like symptoms, to deliver components of the pathogen that causes COVID-19, and is said to be similar to the technology used by Oxford University and AstraZeneca. But the lack of data, said Russian virologist Alexander Chepurnov, should raise red flags.
“Until I see studies and scientific publications that say how the vaccine was studied, what level of neutralization is formed, what doses of the virus it protects against and, most importantly, whether it is developing the ability to increase infection by antibodies, it is impossible to talk about the release of a vaccine,” said Chepurnov, who used to head the infectious diseases arm of biological research center Vektor, one of three laboratories developing Russia’s prototype vaccines. “The danger is there… in terms of the possibility of increasing the disease[‘s severity] with the wrong vaccine. With some diseases—and for the coronavirus, this is already known — the infection can intensify with the presence of certain antibodies.”
Russia’s Association of Clinical Trials Organizations has also joined the chorus against Sputnik V. “Fast-tracked approval will not make Russia the leader in the [vaccine] race, it will just expose consumers of the vaccine to unnecessary danger,” it said in a statement released last Aug. 11.
The skepticism over Sputnik V, including among Russia’s medical experts no less, should give anyone pause. But such reports appear not to have reached President Duterte, because last Monday he committed himself, and the Philippines, to be the virtual guinea pigs to the Phase 3 trials of Russia’s purported vaccine. Mr. Duterte, 75, who once said Putin was his “hero,” not only profusely welcomed Russia’s free vaccine offer, he also volunteered to be the first to get inoculated and be the subject of foreign experimentation: “… pagdating ng bakuna, in public, para walang satsat ’yan, in public, magpa-injection ako. Ako ’yung maunang ma-eksperimentuhan…”
Days later, however, his spokesperson clarified that the President is not likely to get the Russian vaccine until after May 1, 2021, when Phase 3 of the clinical trial in the Philippines ends. In addition, as local experts pointed out, Mr. Duterte, because of his age, cannot in fact receive the vaccine until it has been guaranteed safe by clinical trials.
The Philippines, together with the United Arab Emirates, Saudi Arabia, and possibly Brazil, is now set to be among the countries where the Phase 3 trials will be conducted. No wonder Russia offered the vaccine for free. And yet no trace of the slightest reservations about this monumental decision bound to affect the health and well-being of Filipino citizens seems evident in either Mr. Duterte’s statements or Malacañang’s explications. Where is the word of caution, at the very least, from the ineffectual health secretary? Shouldn’t it be that if a vaccine is still not good enough for the rest of the world, then it shouldn’t be good enough for Filipinos? The ignominy of an already-battered country ending up as a “demonstrator group” for testing an unproven drug, with all the danger that entails—because the President so happens to think the world of Vladimir Putin.
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