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Many scientists have questioned the legitimacy of the data, claiming to have noticed inconsistencies in the facts and figures that are part of the vaccine study.
The Russian vaccine against COVID-19, Sputnik V, produced antibodies in volunteers injected with it, without causing any adverse effect. The findings from the phase 1 and 2 human trials of the vaccine were published in the journal The lancet September 4.
On August 11, Russian President Vladimir Putin announced that his country was the first to approve a vaccine offering “sustainable immunity” against the new coronavirus, leaving experts clamoring for the results of the vaccine trials. While most of the reserves of health experts They came from the United States and the United Kingdom, there were voices of mistrust within Russia.
On August 12, the World Health Organization (WHO) said it will review data from the studies before giving its seal of approval for human use of the vaccine. Recently, 32 researchers who participated in clinical trials published the results of the first human trials to test its safety.
Two vectors, two shots
the Satellite vaccine V is being developed by the Gamaleya Scientific Research Institute of Epidemiology and Microbiology together with the Russian Defense Ministry and the Russian Direct Investment Fund (RDIF) has funded the project.
Sputnik V uses a combination of two viral vectors adapted from the common cold-causing adenovirus for pharmaceutical use: the adenovirus type 26 vector (rAd26) and a recombinant adenovirus type 5 vector (rAd5). The vector carries the genetic code for the “spike” protein, which spreads across the surface of the SARS-CoV-2 virus that causes COVID-19. This code acts as a label for the immune system to recognize the virus if a genuine coronavirus infection appears.
In Phase 1 of each trial, individual components of the two-part vaccine (rAd26-S and rAd5-S) were tested for safety.
Phase 2 tested whether the vaccine elicited an immune response by administering the full two-part vaccine: rAd26-S was given first, then rAd5-S was given 21 days later (4/8)
– The Lancet (@TheLancet) September 4, 2020
According to a RDIF statement, the use of two different vectors in two separate shots achieves a more effective immune response, compared to using the same vector in two shots. By using the same vector twice, the immune system launches a defense mechanism against the virus and begins to reject the drug on the second injection.
The vaccine can be given to a person in two ways: frozen or lyophilized – It is the freeze-drying process of a vaccine to facilitate its transfer and increase its useful life. It is administered through a intramuscular injection – which is a technique used to deliver the vaccine deep into the muscles, allowing it to be rapidly absorbed into the bloodstream.
Sputnik vaccine from Russia. Image Credit: RDIF
Phase 1 and 2 completed
As of August 1, Phase 1 and 2 clinical trials of Gam-COVID-Vac Lyo were completed, according to a TASS report, in adult male and female volunteers ages 18 to 60.
The first trials of the vaccine began on June 18 in a group of 18 volunteers. In this phase 1 study, nine volunteers received one dose of rAd26-S and the other nine received one dose of rAd5-S. This was done to determine that both adenovirus vector constructs were safe to use in people.
This was soon followed by second stage trials in 20 volunteers, who received injections of a ‘primary booster vaccine’ with rAd26-S on day 0 (June 23) and rAd5-S 21 days later.
The research team, led by Denis Y Logunov, who is the principal investigator of the study, found that the vaccine provides immunity to antibodies (stable cellular and humoral immune response) and had no adverse reactions in any of the volunteers who were tested. administered.
The most common adverse events reported in the study were injection site pain, hyperthermia, headache, asthenia, and muscle and joint pain. That said, the majority of these adverse events were mild and no serious adverse events were reported, which is an encouraging sign.
According to a RDIF statement, the antibody level in the vaccinated volunteers was 1.4 to 1.5 times higher than in the patients who had recovered from COVID-19. By contrast, AstraZeneca-Oxford found that volunteers who participated in its clinical trials had nearly the same antibodies as those who had recovered from infection.
Had concerns that using the common cold virus, the resulting vaccine would not be as effective and people would have pre-existing immunity against adenoviruses. The institute researchers through this study have shown otherwise. the RDIF statement He said the study has also determined the optimal dose that is safe and will allow “an effective immune response in 100 percent of those vaccinated, even those who have recently had a common cold.”
Volunteers given the Russian vaccine are assumed to have antibodies between 1.4 and 1.5 times higher than those of patients who had recovered from COVID-19. Image Credit: Pixabay
What are the critics saying
According to a recent New York Times report, even if the vaccine was modestly effective, there is no research to show whether people who received the vaccine were less likely to become infected than those who did not. This is an observation that is commonly made in phase 3 trials.
Naor Bar-Zeev and Tom Inglesby of the Johns Hopkins Bloomberg School of Public Health criticized, in a comment on The lancet, that the vaccine was administered to “young military personnel” who are probably “fitter and healthier than the general population.” They also point to the ethnicity of the people who participated in the trials, implying a lack of diversity for the vaccine to be considered safe to test in a larger population.
In a comment, @naorbz AND @T_Inglesby describe the studies as “promising but small. Immunogenicity bodes well, although nothing can be inferred about immunogenicity in older age groups and clinical efficacy for any # COVID-19 the vaccine has not been shown yet “https://t.co/nYQ6QfqccD pic.twitter.com/0RttILQVF9
– The Lancet (@TheLancet) September 4, 2020
However, Bar-Zeev also said The New York Times“It seems like the science was done impeccably well,” but larger trials need to be completed before knowing if it is effective.
Enrico Bucci, an expert in biochemistry and microbiology at Temple University, USA, has written a open letter to the editor of The lancet alleging inconsistencies in the facts and figures that are part of the Russian vaccine study. At the last count, 26 other scientists have also signed the letter of agreement with Bucci. They believe that “various data patterns” appear repeatedly in experiments.
“The data appears to have been Photoshopped … it is too similar and too unlikely from a statistical point of view,” Andrea Cossarizza, professor of pathology and immunology at the University of Modena and one of the signatories of the letter said as she spoke. with The Moscow Times.
According to a report by The impression, The Lancet said in an emailed statement that they are aware of the letter and “encourage scientific debate on the articles we have published … We have shared the letter directly with the authors and encourage them to participate in the scientific discussion. “.
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