With pharmaceutical giants racing over the COVID-19 vaccine, Russia seems to have won the war. Last week, the world’s biggest country announced its first COVID-19 vaccine. Is the Sputnik V vaccine the answer to the menacing COVID-19 crisis?
Russia is the first country to approve the COVID-19 vaccine last August 11, 2020. The vaccine name originated from Sputnik V, the world’s first satellite launched by the Soviet Union in 1957.
President Vladimir Putin stated that the vaccine guarantees “sustainable immunity” against the coronavirus. In an announcement made on August 11, 2020, the Russian President announced that one of his daughters has already been inoculated. He assured the public about the efficacy of Sputnik V. The news about the “cure” against the COVID-19 pandemic received mixed reactions globally.
The “Sputnik V” is the COVID-19 vaccine made by the Gamaleya Research Institute, together with the Russian Defence Ministry. The Sputnik V, a kind of adenoviral vector-based vaccine, is certain to be safe and effective against COVID-19.
The vaccine guarantees to give immunity from SARs-COV-2, the COVID-19 causing virus, for up to two years. The vaccine works by employing another virus to carry the DNA encoding of the needed immune response into cells. The administration of the vaccine will be in two doses. The dose is consists of two serotypes of human adenovirus which carry an S-antigen of the new coronavirus. This S-antigen enters human cells and produces an immune response.
Though Kremlin just published a few documents regarding the vaccine trials, the government assures the world of the vaccine’s effectiveness. On August 12, the Russian government announced that a Phase 3 trial involving over 2,000 people in Russia and several Middle Eastern and Latin American countries had begun.
The safest answer could be “We don’t know.” Despite Russia’s first global approval on the vaccine, we are still unsure unless they have already tested the millions. While leading laboratories in the US and the UK have regularly released scientific data about the vaccine, the Gamaleya Research Institute gave fewer details.
The surprising announcement of Russia raised eyebrows to some specialists in the West questioning the safety of the vaccine.
Russia has released no scientific data on its vaccine testing, and CNN cannot verify claims about its safety or effectiveness. But Russia says the vaccine has passed through Phase 1 and Phase 2 trials upon completion on August 1.
“We do not have any information on whether this is safe,” Keith Neal, Emeritus Professor of the Epidemiology of Infectious Diseases, University of Nottingham, told CNN.
Russia also claims that volunteers in Phase 1 and 2 trials felt well after taking the vaccine. The participants exhibited no unforeseen or unwanted side effects.
Skeptical about the vaccine, Keith Neal asserted that the side effects of the vaccine will only be known through widespread testing. “You won’t know about side effects without [widespread] testing if they’re rare. That’s the point of a Phase 3 study,” he said.
Dr. Scott Gottlieb, the former commissioner of the US Foods and Drug Administration (FDA), expressed concerns on the safety of the Sputnik V. He said that the number of people the vaccine who have taken the trial on so far was the equivalent of a Phase 1 trial. This means that the test just typically involves a small group and claim the safety of the vaccine.
With less data being presented, the world will continue to question one thin in mind – Is the Sputnik V Vaccine effective?
During an interview with CNN, Keith Neal is keen on the Sputnik V effectiveness yet. Though the makers stated that the vaccine-induced a “strong antibody and cellular immune response,” the professor is more than concerned.
“I would think it at least produces antibodies. What we don’t know is if it protects people against infection,” Neal told CNN.
Russia has said that its vaccine is an adenoviral vector one. Adenoviruses cause the common cold, but in Covid-19 vaccines, they’re weakened. They are changed to deliver genetic material that codes for a protein from the novel coronavirus. The Sputnik V vaccine official website stated that “Not a single participant of the current clinical trials got infected with Covid-19 after being administered with the vaccine.” However, Gottlieb said that the efficiency of the virus will not be clear. He pointed out that not all people will not have the same prior immunity to the adenovirus they’re using to deliver the coronavirus gene sequence.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, showed the same concerns.
“I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they’ve done that,” Fauci told Deborah Roberts of ABC News last August 13, 2020.
The platform they use for the Sputnik V vaccine development took over two decades by Russian scientists to complete. These groups of scientists have also formed the basis for several vaccines in the past, including those against Ebola.
In April, Russia signed a law that eliminated the need for a Phase 3 vaccine trial before approval. This means it is legal to distribute the COVID-19 vaccine while Phase 3 is still ongoing.
On the contrary, Russia’s quick approval on Sputnik V does not fully follow the health protocols and standards on vaccine approval by the WHO. As per WHO, the legal distribution of vaccines to the public must only be after Phase 3. Pharmaceutical giants like Moderna and Oxford’s vaccine have already started their Phase 3 trials.
But critics argued that Russia’s shocking announcement about Sputnik’s V is partly because of Russia’s political pressure, striving to portray Kremlin as a global scientific and medical force.
Yet in July, the US, the UK, and Canada threw allegations of cyber hacking over the world’s biggest country. The report, which Moscow right away dismissed, alleged that Russian cyber actors were targeting organizations involved in coronavirus vaccine development.
According to Health Minister, Mikhail Murashko, health professionals and teachers will get the first vaccination within two weeks. He also added that the vaccination will be voluntary.
In a recent CNN Interview, Kirill Dmitriev, CEO of the RDIF said that massive vaccinations among Russians will start in October. Dmitriev also said during the telecast that the Sputnik V vaccine will be available worldwide come November.
While several leaders and scientists condemn Putin for releasing the vaccine without finishing the required trials, the Philippine and Serbian leaders vowed to receive the Sputnik V vaccine first.
Philippines Duterte announced Tuesday to vaccinate himself first to minimize fears over the new vaccine. “I will tell President (Vladimir) Putin that I have huge trust in your studies in combating COVID. I believe that the vaccine that you have produced is great for humanity. I can be the first they can experiment on,” he said in a public address on August 11.
Serbian President Aleksandar Vucic joined Duterte in congratulating Russia for developing an ‘effective’ vaccine so quickly. Just like Duterte, the Serbian leader announced that he would also be happy to be the first person to have the vaccine, as long as the Serbian scientists will give it a green signal.
“Our specialists must just confirm to us it is safe. The vaccine must appear as soon as possible because it will save our economy,” President Vucic iterated during a press briefing.
While some trusted the safety and efficacy of the Sputnik V vaccine, a lot were also skeptical of the vaccine. At a press conference last August 11, Dmitriev said that Russia had “received preliminary applications for over 1 billion doses of the vaccine. Majority of which coming from Latin America, the Middle East, and Asia.”
The Russian vaccine is unlikely to be meet approval regulations for European Union countries and in the US, will need the FDA’s approval.
Duncan Matthews, Professor of IP Law at Queen Mary University of London is truly uncertain of the vaccine.“The US Foods and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use. And we also need to see evidence that Russia is adopting an equally prudent approach,” he stated.
US Health and Human Services Secretary Alex Azar said on ABC Tuesday that the point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective for the American people. It must also be safe for people all over the world.
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