President Vladimir Putin announced on August 11 that a coronavirus vaccine manufactured by the Gamaleya Research Institute of Moscow had been granted regulatory approval. Mikhail Murashko, the Russian Minister of Health, stated in a later press release that early clinical trials showed no serious side effects and that the vaccine could provide two years of immunity based on similar Gamaleya products. Phase III trials will now begin enrolling two thousand frontline health workers and others at high-risk in Russia and elsewhere. Under normal circumstances, Phase III trials for efficacy and safety in humans would take up to four years and involve tens of thousands of carefully monitored vaccine recipients. Minister Murashko has stated that large-scale vaccinations would begin in October, far earlier than expected for an untried vaccine of this importance.
This is a significant move in what has become a geopolitical race for status and respect among the world’s powers, and it has been announced less than ninety days prior to the United States presidential election. If the goal is to confuse, upend, and disempower, Russia may have found an effective strategy.
By claiming this particular prize, Russia has succeeded in shifting the global conversation around the pandemic. Global news outlets have reacted predictably, and the doubt and hesitation in the professional communities is in stark contrast to the eagerness with which national leaders have embraced the news. Several sources have reported that this is the first SARS-CoV-2 vaccine to be approved for broad use, including the vaccine’s own website, but the certificate as written is just the next step in an ongoing clinical evaluation. Gamaleya has been moving at a breakneck speed understandably, but their documentation states that their vaccine is not intended to be publicly distributed until January 2021. If trial results can be independently evaluated, that might allow enough time to at least understand its short-term efficacy, but the language of Putin’s statement reads differently. He’s said that the vaccine has completed all necessary evaluations and that one of his daughters has received it. The vaccine is even named “Sputnik V,” a throwback to the Russian scientific triumph that startled the world when the United States and Russia were peer-competitors.
If this vaccine is indeed both safe and effective, it’s a significant achievement, but either way, it distracts from headlines that the pandemic has hit the United States disproportionately hard. It also fits President Trump’s timeline that a vaccine will be ready by January, far faster than believed possible by much of the medical community, based on the occasionally painful lessons of the past.
When evaluating such narratives, it’s valuable to look at the possible impact of the messaging as much as the message itself. While intent is difficult to assess, geopolitically, this could be a significant, if oblique, win for the US president in a re-election race that many reputable polls say he’s losing. For example, it could make the past four years of criticism of the Trump-Putin relationship seem foolish . Russia looks smart and globally well-intentioned, President Trump looks insightful and misjudged, and the US public health and scientific community appears to be failing him just as he said. This noise, appearing just as COVID-19 is setting records for infections and deaths across the geography of Trump’s base, may not actually be disinformation per se, but it certainly plays into his narrative that the experts are wrong and makes an argument that his relationship with Putin is prescient if it might now save American lives. The chance that the vaccine will be the first to successfully protect humanity from a scourge that has killed hundreds of thousands makes criticism from US politicians now risky. It would appear mean-spirited, partisan, and uncooperative at a time when the world should be united against the virus.
At least two basic questions about Gamaleya’s vaccine have not yet been addressed: First, does it actually work? Does it create persistent antibodies to SARS-CoV-2 that inhibit infection? And second, what else does it do? There has been no published evidence to support the Russian Ministry of Health’s statements that the vaccine generates useful antibodies and has limited side effects. Even if independent scientists began an assessment of the data today, the described sample size is unlikely to discern risks and benefits before the election on November 3. Meanwhile, several studies in SARS-CoV-2 patients have shown a steep decline in virus-specific antibodies as soon as three months after the onset of infection. Rolling out an untested vaccine to the broader population could provide a false sense of security, and if persistent immunity is not in fact achieved, we have historical evidence that it could lead to potentially more virulent outbreaks down the road.
The biological and social consequences of rushed vaccinations in the past have been severe. Respiratory Syncytial Virus (RSV) was a vaccine failure in the 1960s that led to a wave of fear and mistrust at a time when science was widely respected, and vaccines were considered all but miraculous. The Salk polio vaccine was at the time rapidly eradicating polio in the developed world, and smallpox eradication was becoming a possibility, but inadequate preparation of the RSV vaccine led to the creation of poorly functioning antibodies in children. That functional gap caused a more severe form of RSV infection upon exposure to the wild-type virus in the community and the consequences—to the children and to perceptions of vaccine safety and efficacy—were great. The RSV vaccine debacle occurred just ten years after the infamous Cutter incident, where a manufacturing design error led vaccines to cause active cases of polio and subsequent paralysis in children. These incidents, though vanishingly rare in the scale of vaccination exposure overall, have caused an understandable and deeply regrettable mistrust of vaccines and the people who develop them. To this day that hesitancy, helped by a very significant amount of misinformation, has contributed to outbreaks of diseases like measles, tetanus, and polio, which were once hoped eliminable.
The United States needs to be appropriately cautious in rolling out its own vaccine(s) prematurely as it heads into an election where mistrust, disinformation, inequity, and the politicization of science each play key roles. The US government has already prepared to capitalize on domestic science, awarding $1.525 billion to Moderna for an initial 100 million doses of an mRNA SARS-CoV-2 vaccine. The current plan is to provide the vaccine to the American public for free, but it’s not clear the public will accept it. A recent Gallup poll found that one in three Americans would not be willing to receive the coronavirus vaccine even after FDA approval, mirroring results from AP and Pew Research Center surveys. There is, unfortunately, good reason for the 2020 World Health Organization’s listing “vaccine hesitancy” as one of the top ten global health threats. If a US vaccine is rushed to market and does not provide the safety and efficacy expected, it will further worsen the cynicism and mistrust that plague the country and contribute to an increase in preventable disease outbreaks.
Sputnik was a remarkable achievement in October 1957 and led to a space race that placed Neil Armstrong on the moon twelve years later. A COVID-19 vaccine should be pursued with similar urgency, but with the recognition that it needs to be right more than it needs to be fast, and with caution given towards claims that seem too good to be true.
Claire Branley is a recent graduate of the University of Washington with a BS in Public Health/Global Health and experience studying heart disease, chronic diseases, community food systems, bioengineering, and epidemiology. She is a new program assistant with the GeoTech Center focusing on Future of Health and Food Security topics.
Esther Dyson (@edyson) is executive founder of Wellville.net (@WaytoWellville), a ten-year nonprofit project focused on health and equity working in five small US communities. In addition to this full-time role, she is also an active investor in a variety of tech and health startups.