As if it were the ‘new space race’, the international community is immersed in a sprint to achieve an effective vaccine against COVID-19, the pandemic that is shaking the planet, already exceeding the two million infected at the level world. Poetically named Sputnik V (in homage to the Russian achievement of Sputnik I, the first orbiting artifact in history in 1957), the vaccine is already registered and ready for mass application to the population, as announced yesterday by Russian President Vladimir Putin .
However, this announcement has caused mistrust among the scientific community. And no wonder. The main reason is that a vaccine needs to ensure that its processes are safe and effective, in a series of phases that Sputnik V has not completed to this day . For all intents and purposes, as much as the Russian government assures it, for the scientific community there is evidence that only the first phase of these trials has been completed. There have been no published results of phase 2 that, according to the laboratory, they have performed; and phase 3 hasn’t even been launched yet.
The Science Media Center portal has collected the statements of several experts regarding the news, which focus on several problems.
In essence, the concern of scientists revolves around the speed of launching this vaccine, and gaining the worldwide prestige that this entails, could jeopardize the safety that vaccination requires. To begin with, it is important to emphasize that this vaccine has not been approved, or even fully tested . Despite the optimistic announcement by the Russian government, Russian health authorities are still discussing the process for a possible WHO prequalification as an approved vaccine.
The dangers of skipping phase 3
Making a vaccine is not just about designing it. Above all, it consists of subjecting it to a series of clinical trials to ensure its effectiveness, and especially its safety. Once a vaccine is manufactured in the laboratory, before it can be approved, it must determine its ability to generate antibodies in a large enough group of the population.
These clinical trials are done with different groups of people. As Professor Jonathan Ball, Professor of Molecular Virology at the University of Nottingham explains: “A major challenge for any COVID vaccine will be the need to protect the most vulnerable groups , for example the elderly with other health conditions such as diabetes. The only sensible way to get this information is through very large, well-designed phase 3 trials. “
The problem is that the details about these trials have not been published about the Sputnik V vaccine: as we mentioned, only the results of the clinical trials corresponding to phase 1 have been published . “Therefore, it does not seem very sensible to me to implement the vaccine in a massive way,” concludes Professor Ball.
So far, what we know is that the Russian vaccine has undergone less than two months of human testing on a total of 38 people. In the opinion of Peter Openshaw, Professor of Experimental Medicine at the National Heart and Lung Institute, Imperial College London: “It appears to be in Phase 1 or 2. According to the information we have, a phase 3 trial of 1600 is planned. people. That is not a very large number for a vaccine trial and it would mean a high rate of infection in the volunteers. “
Dr Ohid Yaqub, Senior Lecturer in the Science Policy Research Unit at the University of Sussex, has also raised concerns about the Sputnik V vaccine: “In terms of safety, skipping phase 3 means that confidence in this vaccine , and vaccines in general, could be undermined and could also give people a false sense of security, if it turns out that the vaccine is not really effective. Another important implication is that, if there is a wide diffusion of this vaccine, it may interfere with the tests of future vaccines that are potentially better. “
The risks of ‘a bad vaccine’
Sputnik V is a recombinant vaccine based on fragments of adenovirus (a family of viruses that often cause common colds). It is administered as an intramuscular injection and induces antibody responses with an ‘acceptable’ level of adverse effects: fever, malaise, and headache.
Its combination of ‘ingredients’, according to the professor of virology at the University of Reading, Ian Jones, is a good sign, since other vaccines with similar composition also gave good results, which suggests that “the vaccine itself will be safe in the usual doses ”. The greatest risk, however, is that “the immunity generated is not sufficient to provide protection, leading to continued spread of the virus even among immunized individuals.” That is, we would be facing apparently vaccinated people, with a false sense of security, who could become infected with the virus again and even continue to spread it without being aware of it. “In that sense, a bad vaccine is worse than no vaccine. Therefore, any early release must be accompanied by careful monitoring of the viruses ”, explains the virologist.
For his part, Francois Balloux, professor of computational systems biology at University College London and director of the UCL Genetics Institute, goes one step further, and questions even the ethical implications of applying a vaccine like this: “It is unethical to vaccinate massively with a vaccine that has not been properly tested ”.
As the professor explains, the application of a vaccine that has not completed all three phases is exceptional; but it can happen, in situations of extreme need. For example, in people with serious complications. “Sometimes treatments (and possibly vaccines) can be given for ‘compassionate’ reasons, but only in very limited circumstances. The use of this vaccine in people who are not at very high risk of exposure to SARS-CoV-2 or death from COVID-19 raises significant concerns. “
So what’s the rush?
This is not the first time they have tried to get vaccinated in a hurry. But this has always been done when the disease to be treated had a high mortality. As Eleanor Riley, Professor of Immunology and Infectious Diseases at the University of Edinburgh reminds us, the launch of experimental Ebola vaccines during the recent West Africa outbreak is a good example: “Importantly, the rollout is underway. in a discreet, high-risk environment with sufficient resources to monitor adverse events and efficacy, and under the oversight of an independent safety and data board. In the case of Ebola, this was justified by the very high transmission and fatality rates and the very high risks posed by the health and sanitation workers involved in controlling the outbreak. In essence, the risk of receiving an experimental vaccine was considered to be less than the risk of contracting and dying from the Ebola virus.
So can the same apply in the case of COVID-19? Would ‘skipping’ phase 3 be justified to stop the global pandemic? For Riley, there is no reason to apply an experimental vaccine en masse: “It could be said that the justifications that were used to apply experimental vaccines against Ebola do not correspond (or, at least, no longer) in the case of the COVID-19 pandemic. . The individual risk of dying from COVID-19 is low , in many countries it is decreasing, and we have effective public health measures to sustain it in the short and medium term ”.
In this regard, Michael Head, senior researcher in global health at the University of Southampton has also opined: “We have already learned the lesson in terms of previous vaccine launches, which were usurped by anti-vaccination activists, and the health of the population has suffered a lot. Examples include the HPV (Human Papillomavirus) vaccine in Denmark or Japan, where acceptance plummeted after anti-vaccine campaigns and irresponsible comments from some scientists. Health promotion and clear explanations to the general public are the minimum in terms of communication ”.
“It is vital that any vaccine launch is trusted by the general public and that there is good communication about the level of efficacy and possible side effects. And, at this time, there is not enough data on the vaccine led by Russia for the world scientific community to analyze it, ”he says.
