MOSCOW – Russia cleared a hurdle in introducing vaccines on Monday. The publication of the results of late-stage trials in the prestigious British medical journal The Lancet shows that the country’s Sputnik V vaccine is safe and highly effective.
The publication is sure to boost the promotion of the vaccine by the Russian government at home and abroad, and strengthen the Kremlin’s hand in vaccine diplomacy with a credible endorsement of product safety.
Russia has been criticized by Western experts for approving the emergency vaccine in August – before late-stage studies began – and starting vaccinations that month.
Moscow clinched victory in the vaccine race, as it did decades earlier in the space race with the launch of the Sputnik satellite, although other vaccines continued to be tested at the time. In the end, the politicized introduction only helped to deepen skepticism.
The peer-reviewed article published on Tuesday dispelled those doubts. The vaccine was shown to have an impressive 91.6 percent effectiveness rate against the virus and provided complete protection against severe forms of Covid-19.
“The development of the Sputnik V vaccine has been criticized for inappropriateness, corner cutting and lack of transparency,” wrote two independent researchers, Ian Jones of the University of Reading and Polly Roy of the London School of Hygiene and Tropical Medicine, in an published in The Lancet Comment.
“But the result reported here,” she continued, “is clear and the scientific principle of vaccination is demonstrated.”
In her comment, it was noted that the design of the Russian vaccine, based on a genetically engineered cold virus and similar to half a dozen others, including those made by Johnson & Johnson and AstraZeneca, is difficult to mass-produce.
Although Russia has quickly gotten out of hand with regulatory approval, it has lagged behind in mass production and actual vaccinations. This process actually protects people from illness and death.
The Russian financial firm promoting the vaccine has stated that around two million people worldwide have been vaccinated with Sputnik V, far fewer than with either Pfizer or Moderna vaccines.
The company, the Russian Direct Investment Fund, does not break down vaccinations by country. But of the two million vaccinations, at least hundreds of thousands were in countries outside Russia, suggesting the government has tacitly made exports a priority.
While the policy is beneficial in accelerating global immunity to the disease, it has also brought public relations and diplomatic benefits to the Russian government, even if residents of many Russian provincial cities still do not have access to gunfire. On Monday, for example, authorities in the Leningrad region in northwestern Russia said supplies had run out.
So far, 15 other countries, including Argentina, Hungary and Serbia, have approved the Sputnik V vaccine for emergency use.
Answers to your vaccine questions
Am I eligible for the Covid vaccine in my state?
Currently more than 150 million people – almost half of the population – can be vaccinated. But each state makes the final decision on who goes first. The country’s 21 million healthcare workers and three million long-term care residents were the first to qualify. In mid-January, federal officials asked all states to open eligibility to anyone over 65 and adults of any age with medical conditions that are at high risk of becoming seriously ill or dying of Covid-19. Adults in the general population are at the end of the line. If federal and state health authorities can remove bottlenecks in the distribution of vaccines, everyone over the age of 16 is eligible as early as spring or early summer. The vaccine has not been approved in children, although studies are ongoing. It can take months before a vaccine is available to anyone under the age of 16. For the latest information on vaccination guidelines in your area, see your state health website
Is the Vaccine Free?
You shouldn’t have to pay anything out of pocket to get the vaccine, despite being asked for insurance information. If you don’t have insurance, you should still get the vaccine for free. Congress passed law this spring banning insurers from applying cost-sharing such as a co-payment or deductible. It consisted of additional safeguards prohibiting pharmacies, doctors, and hospitals from charging patients, including uninsured patients. Even so, health experts fear that patients will end up in loopholes that make them prone to surprise bills. This may be the case for people who are charged a doctor’s visit fee with their vaccine, or for Americans who have certain types of health insurance that are not covered by the new regulations. When you get your vaccine from a doctor’s office or emergency clinic, talk to them about possible hidden costs. To make sure you don’t get a surprise invoice, it is best to get your vaccine at a Department of Health vaccination center or local pharmacy as soon as the shots become more widely available.
Can I choose which vaccine to get?How long does the vaccine last? Do I need another next year?
That is to be determined. It is possible that Covid-19 vaccinations will become an annual event just like the flu vaccination. Or the vaccine may last longer than a year. We’ll have to wait and see how durable the protection from the vaccines is. To determine this, researchers will track down vaccinated people to look for “breakthrough cases” – those people who get Covid-19 despite being vaccinated. This is a sign of a weakening of protection and gives researchers an indication of how long the vaccine will last. They will also monitor the levels of antibodies and T cells in the blood of people who have been vaccinated to see if and when a booster shot might be needed. It is conceivable that people might need boosters every few months, once a year, or just every few years. It’s just a matter of waiting for the data.
Does my employer need vaccinations?Where can I find out more?
“Today’s publication in The Lancet really shows that Sputnik V is the vaccine for all humanity,” Kirill Dmitriev, the director of the Russian Direct Investment Fund, said in a statement. “Today is a great victory.”
The vaccine is one of three vaccines that have completed late-stage studies and have an efficacy rate of over 90 percent, along with shots from Pfizer and Moderna.
The version of the Russian vaccine tested in the studies must be shipped and stored in difficult-to-manage temperatures below about zero degrees Fahrenheit. The Russian Ministry of Health has also approved a freeze-dried version that can be stored in the refrigerator. Russia is marketing Sputnik V at a price of around $ 10 per dose for the two-shot vaccine.
The clinical study carried out in Moscow late last year with around 20,000 volunteers only showed side effects commonly associated with vaccines, such as headache or a mild fever.
The researchers found that the vaccine did not have any so-called adverse events or serious medical problems associated with the study participants. In total, they found 70 serious medical episodes in 68 people in the study, in both the placebo and vaccine groups.
Notably, two people given the vaccine died of Covid-19 after illness that started days after the first injection. The researchers said both people were likely infected before the study began and got sick before the vaccine had time to make antibodies to the coronavirus.
The “disease was advanced before immunity to the vaccine developed,” they wrote.
The Russian authors of The Lancet also noted that the Moscow study lacked ethnic diversity to ensure that the vaccine is safe in non-white recipients. An ongoing lawsuit against Sputnik V in the United Arab Emirates includes a more diverse study group, the researcher said.