The number of COVID-19 cases in the United States has now exceeded 6 million and the total has exceeded 27 million.
As winter approaches, hopes for an effective COVID-19 vaccine increase.
A vaccine developed at the Gamaleya Epidemiology and Microbiology Research Institute in Moscow has gained a lot of attention, not everything has been positive.
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Some scientists have been skeptical of the vaccine, which was provisionally approved through the Russian government before any protection data was released.
Legitimizing its development, an article now appearing in The Lancet points to the effects of two early-phase clinical trials of the vaccine, dubbed Sputnik V after the area program of the 1950s.
The report concludes that the vaccine is safe and generated an immune reaction in everyone who won it. Vaccine scientists are now planning a much larger trial of 40,000 people.
The vaccine is based on an adenovirus, from a circle of relatives of viruses that cause colds.
The researchers weakened the virus so it could cause disease and changed it to spell out the complex protein of SARS-CoV-2, the virus that causes COVID-19.
“When adenovirus vaccines introduce human cells, they deliver the genetic code for the complex protein SARS-CoV-2, which causes cells to produce the complex protein. This is helping to teach the immune formula how to recognize and attack SARS- CoV-2, “explains Denis Logunov, the first to examine and head of the laboratory at the Gamaleya Research Institute.
The vaccine is broken down into two parts, adding a secondary injection of “reinforcement”, based on two adenoviral vectors. “We are two other vectors of adenovirus to prevent the immune formula from adapting to the immune vector,” Logunov explains.
Researchers also evaluated other formulations of the vaccine. One was frozen, which is the way vaccines are delivered, and the other was freeze-dried, making it stronger and allowing storage at refrigerator temperature, which would make it less difficult to deliver to more remote locations.
The team tested the two formulations in a small 42-day phase 1/2 trial.
The trials were conducted in two hospitals in Russia, involving 38 healthy adults between the ages of 18 and 60.
The researchers had designed the trials to assess the protection and immunogenicity of the vaccine, not to assess its clinical efficacy – in other words, whether it can save you COVID-19.
The trials showed that any of the vaccine formulations was safe, and the participants reported no serious side effects. Those that occurred are not unusual after vaccination and included pain at the injection site, headache, and fever.
The Lancet article also reports that all other people who won the vaccine produced antibodies opposed to the new coronavirus. On average, participants who won the frozen formulas produced more than those who won the freeze-dried version.
Researchers have also discovered evidence of more complex immune responses, adding the formation of T cells, which identify and kill inflamed cells.
The Russian government has already approved the new vaccine, allowing scientists to make a larger one that will come with vaccination from many more participants, in a phase 3 clinical trial.
“The phase 3 clinical trial of our vaccine was approved on August 26, 2020. It is planned to come with 40,000 volunteers of other ages and threat teams and will be carried out with constant follow-up of volunteers through a request online. “
– Professor Alexander Gintsburg, exam leader and director of Gamaleya’s Institute of Epidemiology and Microbiology Research
While this is very promising news, there are some limitations to be aware of.
Among them was the brief follow-up era of the initial trial, meaning that potential headaches that arose after 42 days would not have been evaluated. Other limitations come with a lack of organization and the fact that most participants were young and healthy.
The authors of a related observation in The Lancet, none of whom were involved in the study, point out:
“As in previous studies, the studies by Logunov and colleagues are encouraging but modest. Immunogenicity bodes well, nothing can be inferred from immunogenicity in older age groups, and clinical efficacy has not yet been demonstrated. of any COVID-19 vaccine. [. . . ] The protective effects so far are reassuring, however the studies to date are too small to treat less frequent or infrequent serious adverse events.
The authors of the comment, either from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD, also note that any effective vaccine should not only alleviate disease, but also prevent infection.
“A vaccine that reduces disease but does not save you from infection can also make things worse. This can also simply falsely reassure recipients of their private invulnerability, thereby reducing transmission mitigation behaviors. In turn, this can also lead to higher exposure in older adults, in whom efficacy is likely to be lower, or in other high-risk teams who would potentially have less acceptance and use of the vaccine.
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