MOSCOW – Russia overcame a hurdle in launching the vaccine on Monday with the publication in the respected British medical journal The Lancet of final stage test results, showing that the country’s Sputnik V vaccine is safe and highly effective.
The publication will certainly boost the vaccine’s promotion by the Russian government at home and around the world, strengthening the Kremlin’s hand in vaccine diplomacy with a credible endorsement of product safety.
Russia drew criticism from Western experts when it approved the vaccine for emergency use in August – even before the final stage tests began – and started vaccination that month.
Moscow won the vaccine race victory, just as it had decades ago in the space race with the launch of the Sputnik satellite, although at the time other vaccines were in the testing phase. In the end, its politicized implementation only served to deepen skepticism.
The peer-reviewed article published Tuesday clarified those doubts. He showed that the vaccine had an impressive 91.6% efficacy rate against the virus and was fully protective against the severe forms of Covid-19.
“The development of the Sputnik V vaccine has been criticized for improper haste, cutting corners and the lack of transparency,” wrote two independent researchers, Ian Jones, from the University of Reading and Polly Roy, from the London School of Hygiene and Tropical Medicine. in a comment published in The Lancet.
“But the result reported here,” they continued, “is clear and the scientific principle of vaccination is demonstrated.”
Their comment noted that the Russian vaccine project, which relies on a genetically modified cold virus and is similar to half a dozen others, including those produced by Johnson & Johnson and AstraZeneca, is difficult to mass produce.
Although it was quick about regulatory approval, Russia lagged behind in mass production and actual vaccination, the process that actually protects people from illness and death.
The Russian financial company that promotes the vaccine said that about two million people were vaccinated with Sputnik V worldwide, much less than with the Pfizer or Moderna vaccines.
The company, the Russian Direct Investment Fund, does not divide vaccines by country. But of the two million vaccinations, at least hundreds of thousands have been in countries outside Russia, suggesting that the government has quietly prioritized exports.
While beneficial for accelerating global immunity to the disease, the policy has also reaped diplomatic and public relations benefits for the Russian government, even though residents of many provincial cities in Russia do not yet have access to vaccines. On Monday, for example, officials in northwestern Russia’s Leningrad region said supplies had run out.
So far, 15 other countries, including Argentina, Hungary and Serbia, have approved the Sputnik V vaccine for emergency use.
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Currently, more than 150 million people – almost half the population – can be vaccinated. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents in long-term care facilities were the first to qualify. In mid-January, federal authorities urged all states to open eligibility for all people aged 65 and over and adults of any age with medical conditions that put them at high risk of becoming seriously ill or dying from Covid-19. . Adults in the general population are at the rear of the line. If federal and state health officials can resolve bottlenecks in vaccine delivery, all 16 years and older will be eligible as early as this spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It may take months before a vaccine is available to anyone under the age of 16. Go to your state’s health website for up-to-date information on vaccination policies in your area
You should not have to pay anything out of your pocket to get the vaccine, although insurance information is requested. Even if you are not insured, you should receive the vaccine free of charge. Congress passed legislation this spring that prohibits insurers from applying any cost sharing, such as copayment or deductibles. He imposed additional protections, preventing pharmacies, doctors and hospitals from charging patients, including those without insurance. Even so, health experts fear that patients may run into gaps that leave them vulnerable to unexpected bills. This can happen for those who pay a medical consultation fee with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get the vaccine at a doctor’s office or urgent care clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise bill, the best bet is to get your vaccine at a vaccination post in the health department or at a local pharmacy as soon as the vaccines are more widely available.
This must be determined. It is possible that Covid-19 vaccines will become an annual event, as well as the flu vaccine. Or it may be that the benefits of the vaccine last for more than a year. We have to wait to see how durable vaccine protection is. To determine this, the researchers will screen vaccinated people for “innovative cases” – those who fall ill with Covid-19 despite the vaccination. This is a sign of weakened protection and will give researchers clues as to how long the vaccine lasts. They will also monitor the levels of antibodies and T cells in the blood of vaccinated people to determine if and when a booster injection may be needed. It is conceivable that people need reinforcements every few months, once a year or just every few years. It is just a matter of waiting for the data.
“The publication in The Lancet today really shows that Sputnik V is the vaccine for all of humanity,” said Kirill Dmitriev, director of the Russian Direct Investment Fund, in a statement. “Today is a great victory.”
The vaccine is one of three that completed final-stage tests showing an efficacy rate above 90 percent, along with vaccines made by Pfizer and Moderna.
The version of the Russian vaccine tested in the tests must be shipped and stored at temperatures that are difficult to handle below zero degrees Fahrenheit. The Russian health ministry has also approved a lyophilized version that can be stored in a refrigerator. Russia is marketing Sputnik V at a price of about $ 10 per dose for the double vaccine.
The clinical trial conducted in Moscow last year with some 20,000 volunteers showed only side effects commonly associated with vaccines, such as headaches or mild fevers.
The researchers determined that none of the so-called adverse events or serious medical problems among trial participants were associated with the vaccine. In total, they found 70 serious medical episodes in 68 people in the study, both in the placebo and vaccine groups.
Notably, two people who received the vaccine died of Covid-19 after illnesses that started days after the first injection. The researchers said the two people were probably infected before the test started and fell ill before the vaccine had time to generate antibodies to the coronavirus.
The “disease progressed before any immunity from the vaccine developed,” they wrote.
Russian authors of the Lancet article also noted that the Moscow trial lacked ethnic diversity to ensure that the vaccine was safe in non-white recipients. A Sputnik V trial now underway in the UAE includes a more diverse study group, the researchers say.