Russia Claims Largely Untested Vaccine Candidate Is 2% More Effective than Pfizer’s

KEY BISCAYNE, FLORIDA - SEPTEMBER 03: Enbal Sabag, a Nurse Practitioner, prepares a flu vaccination for a patient at the CVS Pharmacy and MinuteClinic on September 03, 2020 in Key Biscayne, Florida. Flu shots are available at the nearly 10,000 CVS pharmacies and approximately 100 MinuteClinic locations across the country. …
Joe Raedle/Getty Images

Russia claims its Sputnik V coronavirus vaccine candidate, which has only been tested with a tiny group of trial volunteers, is at least two percent more effective than the vaccine announced by American pharmaceutical company Pfizer and its German partner BioNTech on Monday.

The Russian Direct Investment Fund (RDIF), the sovereign wealth fund backing development of Sputnik V at the Gamaleya Institute in Moscow, claimed on Wednesday that the vaccine is 92 percent effective at protecting patients from the Wuhan coronavirus. 

Pfizer said on Monday that late-stage testing shows its vaccine candidate is 90 percent effective, substantially exceeding the predictions of researchers who expected it to be 70 percent effective at best. The U.S. Food and Drug Administration (FDA) stipulated over the summer that a vaccine must be at least 50 percent effective to be considered for approval.

Reuters reported skepticism of the Russian claims, which were based on a shorter, smaller, and less rigorous trial than Pfizer’s:

While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19 [Chinese coronavirus].

The analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That is significantly lower than the 94 infections in the trial of the vaccine being developed by Pfizer and BioNTech.

“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University. “What is missing for now is an analysis of statistical significance.”

RDIF claimed there were no unexpected adverse side effects among its trial participants. Both the Gamelaya Institute and Pfizer reported expected side effects, including pain at the injection site and fevers, that were slightly more pronounced than common reactions to pneumonia and flu vaccinations. 

Gamelaya Institute director Alexander Gintsburg said he expected to begin rolling out mass vaccinations in Russia within the next few weeks. Russia has encountered technical issues and equipment malfunctions that make it unlikely for more than 10 million doses of Sputnik V to be shipped this year. About 10,000 “high-risk individuals” have been inoculated with experimental Russian vaccines.

“Sputnik V vaccine will soon be available for a wider population. This will break the current trend and lead to an eventual decrease in Covid-19 infection rates, first in Russia, then globally,” Gintsburg said on Wednesday.

Pfizer has said it hopes to make some 50 million doses of its vaccine candidate available worldwide by the end of the year, with over a billion to follow in 2021. Russian researchers claim Sputnik V has an advantage over the Pfizer product because the latter must be stored at extremely low temperatures, making it more difficult to distribute.

One of the prospective customers for Russia’s vaccine candidate is Israel, which has already begun the process of registering Sputnik V and signed a memorandum of understanding to purchase 1.5 million doses.

“We know that the chances of Israel enjoying vaccines from different countries are unclear. Different governments could decide to vaccinate their people first and only then send vaccines to other countries. We came to the agency early so we could get on the list,” Professor Zeev Rotstein of Hadassah University Medical Center explained to the Jerusalem Post on Wednesday. Hadassah has a branch in Moscow that has been collaborating on the Sputnik V trial.

Rotstein said he hoped Hadassah could help convince the Israeli government to make a larger purchase of the Russian vaccine candidate. He also hoped trials in the U.S. and other countries would prove successful so “the people of Israel could enjoy more than one vaccine.”

“We are serving as a pilot to show the Health Ministry the right way and we are hoping that, over time, the government of Israel will realize that this vaccine is safe and efficient. Then, we will be ready to pass everything necessary over to the government so that people can get vaccinated through the health funds and not Hadassah,” he said.

An hour after Rotstein gave his interview to the Jerusalem Post, Israeli Prime Minister Benjamin Netanyahu announced he has spoke with CEO Albert Bourla of Pfizer about buying the U.S. vaccine. Israel also signed an agreement with Moderna, Inc. to buy its product if trials are successful. 

The Wall Street Journal noted Russia is banking heavily on developing one of the first widely-accepted coronavirus vaccines:

Russia in August became the first country to approve a Covid-19 vaccine, despite skepticism in the West over the speed at which it was developed and the fact that trials were still ongoing. Moscow has since registered a second vaccine and authorities say a third could be approved next month.

Russia has also begun to sell Sputnik V to other countries, including Brazil, India, Mexico and Egypt, in what analysts have said is an effort to use the vaccine as a way to exert soft power.

At home, with the economy battered by a combination of quarantine measures and low oil prices, Russian President Vladimir Putin has ruled out a new national lockdown and authorities have instead pinned their hopes on a vaccine.

“The use of the vaccine and the results of clinical trials demonstrate that it is an efficient solution to stop the spread of coronavirus infection, [a] preventative health care tool, and this is the most successful path to defeat the pandemic,” the Wall Street Journal quoted Russian Health Minister Mikhail Murashko declaring.

The BBC noted on Wednesday that “questions still need answering for both vaccines,” such as whether they provide adequate protection for older people who are at the greatest risk of dying from the coronavirus, how long the protection lasts, and if the vaccines will help prevent asymptomatic carriers from spreading the disease.

“This is not a competition. We need all trials to be carried out to the highest possible standards,” Professor Eleanor Riley of the University of Edinburgh told the BBC.

Newsweek reported on Wednesday that three healthcare workers in Siberia tested positive for Chinese coronavirus after receiving Sputnik V. Russian officials suggested the three might have contracted the disease before they were inoculated, although they reportedly tested negative the day before receiving the shots. 

Russia declared “victory” over the coronavirus over the summer, only to be hit with a surge of cases so massive that huge sports stadiums have been converted to field hospitals to deal with it. 

The government is resisting calls for a national lockdown, although the city of Moscow has imposed some tightened restrictions due to the “unstable” situation. A nationwide mask mandate has been imposed, to little apparent effect, so clearly the Russians are counting on vaccinations to control the pandemic. If the game-changing vaccine is not of Russian origin, Putin could have a major political crisis on his hands.

.

Please let us know if you're having issues with commenting.