Since then, the results of phase 1/2 have been published in The Lancet. The vaccine elicited a strong immune response in all 76 participants. Presumably, these results were available to the Russian Ministry of Health. For regulatory agencies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency, however, data on the immune response alone would generally not provide an adequate basis for the approval of a. vaccine. “The immune response may not be directly proportional to the degree of protection – you can only find this in large-scale trials,” explains Peter Openshaw, professor of experimental medicine at Imperial College London (London, UK ).
The Russian vaccine is named Sputnik V, after the Soviet-era space program. One person who received it is the president’s daughter. “She feels good and the antibody level is high,” Putin said. “The main thing is to ensure the unconditional safety and efficacy of this vaccine in the future.” Mass production is expected to begin in September 2020. Russia, which has recorded nearly one million cases of COVID-19, said it would be able to supply 500 million doses of Sputnik V per year.
“We don’t know if this vaccine is safe or if it works,” warns Ashish Jha, dean of the Brown University School of Public Health (Providence, RI, USA). “It’s really worrying when people start to bypass the standard process we have for vaccine development.” The authors of the Russian vaccine offered a combative response to these criticisms. The official website was created with the stated aim of “providing accurate and up-to-date information on Sputnik V and combating the disinformation campaign launched against him in the international media”.
The vaccine is funded by the Russian Direct Investment Fund (RDIF), the country’s sovereign wealth fund. Kirill Dmitriev, chief executive of RDIF, complained that instead of delving into the science behind the proven adenoviral vector vaccine platform that Russia has developed, some international politicians and media have chosen to go along with it. focus on politics and try to undermine the credibility of the Russian vaccine ”. Large-scale clinical trials of the vaccine, involving more than 40,000 people, were due to start in Russia during the last week of August. “A number of countries, such as the United Arab Emirates, Saudi Arabia, the Philippines, and possibly India or Brazil, will locally join clinical trials of Sputnik V,” the official website said.
Dmitriev confirmed that Russia has received international requests for 1 billion doses of its vaccine. On August 26, 2020, the Russian news agency TASS announced that the country would provide more than 2 million doses of Sputnik V to Kazakhstan. Openshaw points out that places that have expressed an interest in the vaccine are unlikely to begin mass administration until they are satisfied that it is safe and effective. “There is a huge difference between Russia registering a vaccine within its own borders, which it has the right to do, and international approval or WHO prequalification,” he said. -he declares.
Countries around the world have pre-ordered millions of doses of other potential COVID-19 vaccines, with deployment contingent on the results of Phase 3 studies. For example, the United States has purchased 100 million doses of the candidate- Moderna mRNA vaccine and 300 million doses of Astrazeneca adenovirus vector vaccine. Other countries may choose to enter into similar arrangements with the Gamaleya Center. Press reports quoted the Azerbaijani Foreign Minister as saying that the country was “ready to consider the possibility of purchasing a Russian vaccine against the coronavirus after the completion of recognition procedures by the WHO.”
According to the WHO, as of August 28, 2020, nine vaccine candidates were in the late testing phase. These included separate adenovirus vector vaccines, a few mRNA vaccines, and several inactivated virus vaccines. There are many vaccine candidates in the early stages of evaluation. The experts are convinced that at least one of the candidates will succeed. COVAX, a joint initiative of Gavi, the Coalition for Epidemic Preparedness Innovations, and WHO, aims to ensure that any possible vaccine is distributed fairly and equitably. 92 low-income and middle-income countries are eligible for assistance. The initiative supports a range of vaccine candidates, including seven in clinical trials.
Given the pace at which applicants move through the development stages, Jha wonders why Russia felt it was necessary to move directly to approval. “I don’t think that makes sense; the difference between doing it right and not doing it right is a matter of a few months, ”he said. “It seems like a very small gain, and the middle of a pandemic is not the time to cut corners.” There has been speculation that the approval was motivated by nationalism. Most countries would welcome the positive publicity generated by being the first to market a vaccine against SARS-CoV-2. The United States has also invoked the space age in its fight against COVID-19; he named his desire to secure 300 million doses of vaccine by January 2021, Operation Warp Speed.
If Sputnik V does not work or results in some kind of unexpected adverse event in the Phase 3 trial, it could affect public perception of the vaccination process. Plus, an ineffective product could actually make the pandemic worse – those who received the vaccine could stop taking SARS-CoV-2 precautions. “There is a huge risk that confidence in vaccines will be damaged by a vaccine that has received approval and is subsequently found to be harmful,” Openshaw said. A large group of vaccine-reluctant people are already laying the groundwork on social media to discredit any potential COVID-19 vaccine. “We really don’t want to make life easier for those who are trying to undermine science,” Jha said.
On the other hand, it is entirely possible that Russia will delay vaccination of its general population until it has obtained favorable results from the phase 3 trial. In this case, the announcement of approving Sputnik V could be a political move, rather than a serious attempt to circumvent the standard vaccine development process. The FDA has stipulated that a vaccine against COVID-19 should be at least 50% effective. Sputnik V could well meet this criterion. But until the Phase 3 trial is complete and the results are available, it won’t be possible to make a judgment. “It is certainly not advisable to use a vaccine in an uncontrolled manner until it has been subjected to appropriate tests to determine whether the immune response it produces is truly protective and that there is no unexpected adverse events, ”said Openshaw.
Posted: September 4, 2020
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