Proving the Pfizer-BioNTech and Moderna are not only vaccine makers with over 90% efficacy, the prestigious British Journal Lancet announce today the Russia’s Sputnik V vaccine was 92% effective against the novel coronavirus. Moscow Sovereign Wealth Fund said the Russia will move swiftly to make its Covid-19 available all over the planet, already getting order from the Czech Republic, even it it’s not approved by the European Union. Russia’s findings in Phase 3 trials were based on much smaller samples making the exact efficacy number more uncertain. Sputnik V’s analysis was on 20 participants infected with Covd-19, compared with 94 infections from Pfizer and BioNTech. “I assume there was political pressure after the press release from Prizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director o Mainz University Institute of Virology.
Whether admitted to or not, all vaccine makers compete with each other for worldwide distribution and market share. Russian Direct Investment Fund [RDIF] who backs the Sputnik V vaccine said the clinical trials and data analysis will continue for six more months, despite of the current emergency use authorization. Alexander Gintsburg, director of Gamaleya Institute that developed Sputnik V vaccine said it was safe and effective and would be widely dispensed all over Russia. Russia’s Rossiya-24 state TV said the 1.5 millions vaccinations would happen by year’s end, estimating that between 40,000 and 45,000 have already been vaccinated. China’s Sinopharm has also developed a Covid-19 vaccine, claiming at least 50% efficacy, not nearly as high as Russia’s Sputnik-V vaccine. Some scientists worry that the pace of pushing the Sputnik V to market compromises its safety and efficacy.
U.S. Food and Drug Administration [FDA] demands the most stringent Phase 3 double-blind clinical trials with extensive data analysis to determine safety and efficacy for U.S.-approved vaccines. Pfizer and Moderna satisfied regulators’ requirements, despite the fact the Moderna’s vaccine has three times the mRNA as the Pfizer vaccine to achieve about the same results in two shots. Sputnik V’s vaccine is also two-shot dosage to achieve the 92% efficacy promised by Gamaleya Institute. “This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for unbinding the trial data are adhered to avoid cherry picking the data,” said Eleanor Riley, professor of immunology and infectious disease University of Edinburgh. Riley knows that the rush to get vaccines to market can compromise integrity.
Rushing to get vaccines to market in record time created concerns in the U.S., EU and Russia regarding the safety and efficacy. While Riley thinks it’s not a competition, the fact is that vaccine makers get market share by being the first mover, the one to market first. Pfizer eclipsed all other vaccine makers getting their vaccine FDA emergency use authorization Dec. 11. Modern followed Dec. 18 but has caught up in its distribution channels largely because they can transport their product in normal freezers, not requiring the minus 70 degrees Celsius required by Pfizer. Unlike Pfizer and Moderna’s refrigeration requirements, Sputnik V vaccine can be freeze-dried and transported with normal refrigeration, making it easier to distribute the vaccine to third world countries where deep freeze requirements are not available. Russia should make a fortune off their Sputnik V vaccine.
Russian authorities insist they have a safe-and-effective vaccine, ready to go into mass use even without the scientific data. “We are showing, based on the data, that we have a very effective vaccine,” said FDIF head Kirill Dmitriev, confident that the vaccine would deliver the results needed to finally get a grip on the deadly Covid-19 global pandemic. When the Czech Republic is willing to bypass the EU to get Sputnik V vaccines for its people, you know there’s something to it. Yet Czech President Milos Zeman knows that that this is no time for the EU to demand the Russian President Vladimir Putin release dissident Alexi Navalny or face economic and travel sanctions. EU officials should do everything possible to work with Putin on getting out as many vaccines as possible to help reverse the Covid-19 global pandemic. Bickering over Navalny hurts everyone’s interests.
Sputnik V’s safety-and-efficacy data were peer reviewed in the British Journal Lancet Dmitriev confirmed that early data was reviewed and published in Lancet in Sept. 2020. “We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer and BioNTech’s numbers,” said Bodo Plachter of Mainz University. No one from Pfizer, Moderna or Sputnik V knows how long the vaccines give immunity to the novel coronavirirus or any of its more contagious variants coming from the U.K. or South Africa. Unlike the Pfizer and Moderna vaccines, Sputnik V uses viral vectors from the Ad5 and Ad26 common cold adenoviruses to trigger the immune response to the deadly coronavirus. Whatever the efficacy and side effects of the Sputnik V vaccines, now is not the time to pick a fight with Putin over what happens to Alexi Navalny.
