MOSCOW – Russia on Monday cleared a hurdle in the explosion of vaccines with the publication in the respected British medical journal The Lancet of the results of late stages of trials showing that the country’s Sputnik V vaccine is safe and extremely effective is.
The publication will certainly promote the Russian government’s promotion of the vaccine at home and around the world, which strengthens the Kremlin’s hand in vaccine diplomacy with a credible endorsement of the safety of the product.
Russia drew criticism from Western experts when it approved the vaccine for emergency use in August – even before the late stages of the trials – and began the month with vaccinations.
Moscow won the vaccine race, as it had decades earlier in the space race with the launch of the Sputnik satellite, although other vaccines were further tested at the time. Eventually, its politicized implementation deepened skepticism.
The peer-reviewed article published on Tuesday dispelled the doubts. It has been shown that the vaccine has an impressive 91.6 percent efficacy rate against the virus and that it is completely protective against severe forms of Covid-19.
“The development of the Sputnik V vaccine has been criticized for awkward haste, cutting corners and the absence of transparency,” said two independent researchers, Ian Jones of the University of Reading and Polly Roy, with the London School of Hygiene and Tropical Medicine, written. in a commentary published in The Lancet.
“But the results reported here,” they continued, “are clear and the scientific principle of vaccination is being demonstrated.”
Their comments did note that the design of the Russian vaccine, which is dependent on a genetically modified cold virus, is similar to half a dozen others, including those manufactured by Johnson & Johnson and AstraZeneca, which is difficult to produce.
Although Russia is quickly out of the gate with the adoption of the regulations, it has lagged behind in mass production and vaccinations, the process that protects people from disease and death.
The Russian financial company that promotes the vaccine said about two million people were vaccinated worldwide with Sputnik V, much less than with the Pfizer or Moderna vaccines.
The company, the Russian Direct Investment Fund, does not break the vaccinations by country. But of the two million vaccinations, at least hundreds of thousands were in countries outside Russia, indicating that the government has quietly prioritized exports.
While beneficial for accelerating global immunity to the disease, the policy has also drawn public relations and diplomatic benefits for the Russian government, even though residents of many provincial Russian cities still do not have access to shots. On Monday, for example, authorities in the Leningrad region in northwestern Russia said supplies were running out.
So far, 15 other countries, including Argentina, Hungary and Serbia, have approved the Sputnik V vaccine for emergency use.
Covid19 vaccines>
Answers to your vaccine questions
At present, more than 150 million people can be vaccinated – almost half of the population. But each state makes the final decision about who goes first. The country’s 21 million health workers and three million residents of long-term care facilities were the first to qualify. In mid-January, federal officials called on all states to be eligible for all ages 65 and older and for adults of any age with medical conditions at risk of becoming seriously ill or to Covid-19 to die. Adults in the general population are at the back of the queue. If federal and state health officials can clear up bottlenecks in the distribution of vaccines, everyone 16 years and older will be eligible as early as spring or early summer. The vaccine has not been approved in children, although studies are underway. It can take months for a vaccine to be available to anyone under the age of 16. Visit your health website for recent information on vaccination policies in your area.
You do not have to pay anything out of pocket to get the vaccine, although you will be asked for insurance information. If you do not have insurance, you should still receive the vaccine free of charge. Congress passed this spring legislation that prohibits insurers from applying any cost sharing, such as a co-payment or deductible. It was based on additional protection that pharmacies, doctors and hospitals prevented from patients, including those who were uninsured. Nevertheless, health experts are concerned that patients could end up in loopholes that make them vulnerable to surprising bills. This can happen to those who charge a doctor’s fee along with their vaccine, or Americans who have certain types of health coverage that do not fall under the new rules. If you get your vaccine at a doctor’s office or an urgent clinic, talk to them about possible hidden charges. To make sure you do not get a surprise bill, this is the best way to get your vaccine at a vaccination center or local pharmacy once the shots are more available.
It must be determined. It is possible that Covid-19 vaccinations will become an annual event, just like the flu shot. Or it could be that the benefits of the vaccine last longer than a year. We have to wait and see how durable the protection against the vaccines is. To determine this, vaccinated researchers are monitoring people to look for “breakthrough cases” – those who become ill with Covid-19 despite being vaccinated. This is a sign of weakening of protection and will give researchers clues as to how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of vaccines to determine if and when a booster shot is needed. It is possible that people need boosters every few months, once a year or only every few years. It’s just a matter of waiting for the data.
“Today’s publication in The Lancet really shows that Sputnik V is the vaccine for all mankind,” Kirill Dmitriev, director of the Russian Direct Investment Fund, said in a statement. “Today is a great victory.”
The vaccine is one of three that have completed late-stage trials, with an efficiency rate of more than 90 percent, coupled with the shots made by Pfizer and Moderna.
The version of the Russian vaccine tested in the trials must be shipped and stored at difficult-to-control temperatures below about zero degrees Fahrenheit. The Russian Ministry of Health has also approved a lyophilized version that can be stored in a refrigerator. Russia markets Sputnik V at a price of about $ 10 per dose for the two-shot vaccine.
The clinical trial, which was conducted in Moscow at the end of last year on about 20,000 volunteers, showed only side effects commonly associated with vaccinations, such as headaches or mild fever.
The researchers found that no so-called side effects, or serious medical problems among the participants in the trial, were related to the vaccine. In total, they found 70 serious medical episodes in 68 people in the trial, in both the placebo and vaccine group.
In particular, two people who administered the vaccine died from Covid-19 due to diseases that started days after the first injection. The researchers said both people were probably infected before the trial began, and that they became ill before the vaccine had time to generate antibodies against the coronavirus.
The ‘disease progressed before any immunity to the vaccine developed’, they wrote.
The Russian authors of the Lancet article also noted that the trial in Moscow lacks ethnic diversity to ensure the vaccine is safe among non-white recipients. A trial of Sputnik V now underway in the United Arab Emirates contains a more diverse study group, the researchers say.