Russia was the first country to allow a COVID-19 vaccine, but it did so before completing appropriate clinical studies to show that it is effective.
Now, with questions about the whirlwind of the Russian vaccine, experts interviewed through ABC News expressed fear of the country’s immediate action to spread the unproven vaccine in low- and middle-income countries, noting that if the vaccine fails, it can lead to skepticism. vaccines.
Russian scientists from gamaleya’s National Research Center published the effects of an initial examination in the prestigious medical journal The Lancet on September 4, in which they appeared to be safe.
But molecular biologist Dr. Enrico Bucci said he temporarily developed “several concerns” when examining the data. Bucci, who runs a clinical integrity company called Resis in Italy, has published an open letter on his blog about vaccines in Russia. temporarily obtained more signatories, and on September 7, scientists filed their formal complaint with The Lancet.
The letter highlighted irregularities in knowledge that appear to be duplicated and has now been signed by a total of 38 experts.
“We are pleading guilt, we only need them to provide more data,” said Dr. Konstantin Andreev, one of the signatories and microbiologist and biophysicist affiliated with Howard Hughes Medical Institute and Northwestern University.
Another researcher who signed the open letter, Dr. Donald Thea, Director of the Center for Global Health
Gamaleya’s National Center for Epidemiology and Microbiology Research responded to ABC News’ request for comment.
Sputnik V has also not completed the gigantic phase 3 randomized controlled trials required in the United States and many other countries prior to vaccine approval. These studies historically compare the vaccine with placebo in thousands of others to determine whether it works in disease prevention and to further assess its protection profile.
“The fact is that they are looking to start distributing the vaccine before they have even completed Phase 3 clinical trials, and the Phase 1 and Phase 2 trials described involve only a very, very small number of patients, only 76 patients, [an] [quantity] incredibly small for such a vital topic,” Andreev said. First, Russia was able to skip Phase 3 clinical trials due to differences between foreign regulatory agencies.
As Russia prepares for mass production of Sputnik V, there are vital implications of global fitness to consider. Although foreign scientists have warned that no one yet knows if the vaccine is working, Russia already agrees to purchase orders from low- and middle-income countries seeking a coronavirus vaccine.
In a recent article in The Lancet, Kirill Dmitreiv, executive director of the Russian Direct Investment Fund, showed that Russia had earned one billion-dose applications for its vaccine.
Russia is talking to at least 20 countries about exporting the vaccine, adding Brazil, Cuba, the Philippines and Arabia Saudita. Si the vaccine is given to others before being tested well, the consequences can be simply catastrophic.
“If we end up with other people from poor countries who are getting unproven vaccines, first, ethically, it’s a disaster,” said Dr. Ashish Jha, dean of Brown University’s School of Public Health.
“Second, this will have long-term implications for the fitness of these other people and their confidence in vaccines. So I think it’s incredibly vital that we don’t do it anywhere, but in particular we don’t do it in low-income countries. “. . “
Other experts have warned that the overall distribution of a useless vaccine can simply inspire reluctance to vaccinate and create a false sense of security that can simply spread COVID-19 transmission.
“I hope it works, but if it doesn’t, it will send massive combined signals to the global community,” Jha said. “People will be very hesit about taking the COVID vaccine,” he said, “if the Russian vaccine ends up working.
“If we’re lucky, it will be, you know, 70% to 80% effective,” Jha said.
“They’ll think they’re protected and they’re very likely to be in poor health and die because of it,” he added. “So it’s probably imperative to discover its effectiveness and then talk to people. But the challenge is that if you haven’t tried it, you don’t know how effective it is, and if you don’t know, you know how effective it is, you don’t know what to tell people, and you’re going to create this massive false sense of accepting how true that can be very, very dangerous. “
Alexandra Lambert, D. O. , MPH, is the Head of Emergency Medicine Residents at VCU Health and a contributor to the ABC News Medical Unit.
Politics 24/7 of the latest news and events.