Playing politics with human lives in middle of Covid-19 global pandemic, the European Union’s Amsterdam-based European Medicines Agency [EMA] said there wasn’t enough date to approve Russia’s Sputnik V vaccine, the first Covid-19 vaccine to hit the market Nov. 11, 2020. Authorizing three vaccines including Pfizer-BioNTech, Moderna and AstraZeneca-Oxford. Sputnik V beat Pfizer’s vaccine by a month, when it was approved the U.S. Food and Drug Administration [FDA] Dec. 11, 2020, followed a week later by Moderna. EMA board Chief Christa Wirthumer-Hoche told an Austrian radio talk show that she would urge the EMA to reject Sputnik V pending more review of its safety and effectiveness. Moscow reacted harshly to Wirthumer-Hoche’s public statement. Wirthhumer-Hoche knows that Sputnik V was reviewed by the British Medical Journal Lancet.
Lancet completed its review of Sputnik V, evaluating the vaccine’s efficacy at 92% and verified its safety protocol for the two shot vaccine. Unlike the Pfizer and Moderna mRNA vaccines, Sputnik V was DNA adenovirus vaccine the same type created to treat the deadly hemorrhagic fever Elola virus successfully. While the FDA and Centers for Disease Control Prevention [CDC] would have liked more Phase 3 data, Russia’s Gamaleya Institute has a track record making safe and effective vaccines, something they did again with Sputnik V for Covid-19. “We demand a public apology from EMA’s Crista Wirthumer-Hoche for her negative comments . . .. (which) raise serious question about possible political interference in the ongoing EMA review,” Tweeted the developers of Sputnik-V. After approved by Lancet, there’s no excuse to doubt the vaccine’s safety and effectiveness.
] If there’s any question about the safety or efficacy of vaccines, it’s with Pfizer Moderna’s new mRNA technology, never used before, creating unusual side effects in many people taking the vaccines. Sputnik V, like the Astra Zeneca-Oxford and Johnson & Johnson vaccines, makes use of old, tried-and-true vaccine technology to create an immune response to the novel coronavirus spike-proteins, that penetrates human cells. Sputnik V is unique among other adenovirus vaccines because its uses two different vaccine vectors, one in the first dose and another in the second dose to provide maximum immunity. At a time when the world suffers with 118,630,045 Covid-19 cases and 2,631,996 deaths, world heath agencies should do everything possible to get safe-and-effective vaccines to market. Hungary, Slovakia and Czech Republic already approved Sputnik V.
Kremlin spokesman Dmitry Peskov called Wirthumer-Hoche’s statement “regrettable and inappropriate,” saying Sputnik V was already in the EU and in 46 other countries, having been reviewed by the British Medical Journal Lancet. Peskov said Gamaleya Pharmaceuticals was in the process of licensing Sputnik V to Swiss Pharmaceutical company Adienne for manufacture in Italy, Brazil and Argentna. Peskov smells a rat with the EMA’s refusal to approve Sputnik V for emergency use authorization. Peskov noted that the EU has sanctioned Kremlin officials for treatment of 44-year-old Russian dissident Alexi Navalny who was recently sent to prison on a parole violation. Delaying approval of Sputnik V for political reasons violates every known principle of global health, where adversaries put aside their differenced for the betterment of civilization and humanity.
EMA noted in response to Russia’s request for approval of Sputnik V that EU countries have “access to effectively evaluate medicines at the same time and ensures centralized safety monitoring across their life cycle,” something already afforded to the EMA by Lancet. Sputnik V has been widely demanded by countries around the planet not only because it costs one-half of other vaccines because its 92% effective and completely safe. Whatever the issues and EMA, it’s looking more political that based on science. Sputnik V has been used successfully in numerous countries attesting to its safety and effectiveness. German Chancellor Angela Merkel said Feb. 26 she would not take AstraZenea-Oxford’s vaccine because it lacked enough safety data infuriating British Prime Minister Boris Johnson. Merkel knows that AstraZeneca-Oxford’s vaccine has been proven safe and effective.
Contradicting EMA about Sputnik V, Thomas Mertens, head o a German expert panel evaluating vaccines gave his approval to Sputnik V. “This is a good vaccine, which looks like it will be approved in the EU at some point. The Russian researchers are very experienced in vaccines,” Mertens said, who heads STIKO, Germany’s panel for approving vaccines. Mertens statements on Sputnik V puts added pressure on EMA to grant emergency use authorization, especially given that vaccine shortages have delayed the global effort to combat the Covid-19 pandemic. Moscow’s head of its RDIF sovereign wealth fund confirmed its in negotiations with Spain, France and Germany to develop agreements to start manufacturing Sputnik V under Switzerland’s Adienne Pharmaceuticals. EMA needs to stop playing politics and approve Sputnik V for emergency use.
