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Moscow – At least four Russian healthcare workers who received the country’s first COVID-19 vaccine have contracted the coronavirus, as its developers claim that human trials show their formula to be 92% effective. The efficacy claim of the government-run laboratory that developed the vaccine came immediately after the US pharmaceutical giant The Pfizer ad of data showing that their vaccine, developed in conjunction with a German company, is 90% effective.
The Russian vaccine it was registered as a safe and effective drug by the country’s regulatory body in August under the name Sputnik V, even as it continued to undergo phase 3 human trials.
Pharmaceutical companies have worked with government agencies in many countries, in unprecedented public-private initiatives, to accelerate what is typically a 10-year process for effective vaccines to be approved and released.
Many companies, including Pfizer, have large-scale manufacturing began even with ongoing trials, for example, but they have not yet received permission from any regulatory body in western nations to administer their vaccines to people who are not enrolled in clinical trials.
In Russia, however, authorities have been giving Sputnik V to doctors and teachers across the country since the summer, separately and apart from clinical trials. The head of the laboratory behind the Sputnik vaccine said this week that up to 50,000 people, again not participants in clinical trials, have received the vaccine.
Officials in the Siberian region of Altai reported Tuesday that three of the 42 local doctors who received the two-dose Sputnik V vaccine had become infected with the coronavirus after receiving their first injection, but said it was because the drug had no chance of work, not because it was ineffective.
“The immunity of sick doctors probably did not have time to form when they found the COVID-19 pathogen,” the region’s Health Ministry said. “That alone could have caused the infection of the doctors.”
On Thursday, the Health Ministry of another region of Siberia, Kuzbass, said that a doctor who had also received only the first of his two Sputnik V injections had tested positive for COVID-19. The ministry also blamed the infection on exposure that occurred before the drug had a chance to build immunity in the patient, according to the Russian state news agency RIA Novosti.
TATYANA MAKEYEVA / REUTERS
According to the government-run Gamaleya Research Institute of Epidemiology and Microbiology, which developed Sputnik V, complete immunity would not be expected until three weeks after administration of the second dose. Doctors in Altai received their first vaccine injection between September 25 and 30, and became ill seven to 10 days after that, before receiving the second injection, the Health Ministry said in a statement on Wednesday.
There have been a few cases of confirmed coronavirus infections among volunteers in the Sputnik vaccine trial. The Gamaleya center has downplayed those reports, suggesting that the infected volunteers were given the placebo instead of the actual vaccine.
“The efficacy of the Sputnik V vaccine was 92%,” the laboratory said Wednesday on its official Twitter page. He said the efficacy rating was based on results showing that about 20 people who took part in the trial, both those who received the vaccine and the placebo, had contracted the disease.
The figures were released two days after Pfizer announced its own test data showing more than 90% efficacy for its formula; news that doctors, epidemiologists and politicians consider the most optimistic development to date, as the world competes for a proven vaccine to turn the tide into the pandemic.
Many doctors and scientists in Russia and around the world have been skeptical about the country’s unusual move to register the vaccine for use before completing trials, but the Russian government has dismissed the criticism, insisting that the early trials showed that Sputnik V is safe and effective. President Vladimir Putin said one of his daughters received the vaccine even before it was officially registered.
As of Thursday, authorities said more than 20,000 people had received a first dose of the vaccine as part of the phase 3 human trial, and more than 16,000 had received both injections. Finally, some 40,000 people are expected to participate in the Sputnik trial.
By comparison, the Phase 3 trial for the Pfizer vaccine had seen nearly 39,000 people inoculated with the two required injections when the company announced preliminary data from the trial earlier this week.
Russia has seen a record number of deaths and new infections from COVID in recent days. Authorities have gradually re-imposed restrictions to try to curb the spread of the virus, while vowing not to regain a full national lockdown. Mass vaccination is a key part of the government’s pandemic response plan.
TATYANA MAKEYEVA / REUTERS
The director of the Gamaleya center, Aleksander Gintsburg, said on Wednesday that post-registration tests on Sputnik V would be completed around May or June, according to RIA. But he also said that the interim results should be sufficient to allow the start of mass vaccinations of the Russian population in the coming weeks.
Russia has already registered a second vaccine and the government says a third could be approved next month.
However, producing doses of vaccine has been a slower process than Russian officials anticipated.
On Wednesday, Deputy Prime Minister Tatyana Golikova said Russia planned to produce 2 million doses of Sputnik V by the end of the year and release up to 6 million doses per month starting in April 2021.
Pfizer said this week that it expected to “globally produce up to 50 million doses of vaccines” this year alone. Britain’s AstraZeneca has also manufactured millions of doses of its vaccine, which it hopes to have data showing its effectiveness in a few weeks.
Pfizer said it would likely have enough Phase 3 trial data to apply to the US Food and Drug Administration for emergency use authorization for its vaccine by the end of this month.
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