Contents
- More than 30 potential C0VID-19 vaccines are already being tested in humans
- How vaccines are tested – the most important information
- Vaccine against COVID-19. The five most advanced designs
- Americans: Moderna company
- International cooperation: Pfizer, BioNTech and Fosun Pharma
- Chinese. CanSino Biologics
- s. National Center for Epidemiology and Microbiology of Nikolai Gamalei
- The British. Oxford University in collaboration with AstraZeneca
- Who will win the race for the COVID-19 vaccine?
The race for the COVID-19 vaccine continues. According to the World Health Organization, 176 potential vaccines are being developed worldwide, more than 30 of which are tested in humans. Who is closest to the vaccine release? We present five preparations on which the work is the most advanced.
- The invention of vaccines is considered to be the greatest medical achievement. One of the biggest challenges today is developing an effective and safe vaccine against the SARS-CoV-2 coronavirus
- According to WHO data, 176 potential vaccines are currently being developed all over the world. 34 are already being tested on humans (The New York Times writes on 37).
- Eight preparations are on the third – the most advanced stage. Among them there are devices developed by the following companies: Moderna (USA), BioNTech, Pfizer and Fosun Pharma cooperating with each other; CanSino Biologics (China); Gamaleya Research Institute (Our Country); AstraZeneca and the University of Oxford – Below we present the results of their research.
More than 30 potential C0VID-19 vaccines are already being tested in humans
The invention of vaccines is considered to be the greatest medical achievement. Thanks to them, it became possible to eliminate or reduce many diseases that have decimated humanity over the years. One of the biggest challenges today is developing an effective and safe vaccine against the SARS-CoV-2 coronavirus. How close are we to this achievement?
According to WHO data, 176 potential vaccines are currently being developed all over the world. 34 are already being tested on people (New York Times writes about 37). Eight is on the third – most advanced stage. Among them there are preparations developed by the following companies: Moderna (USA), BioNTech, Pfizer and Fosun Pharma cooperating with each other; CanSino Biologics (China); Gamaleya Research Institute (Our Country); AstraZeneca and the University of Oxford – Below we present the results of their research.
In addition to those mentioned, the third phase of tests also includes vaccines developed by, among others: Sinovac Biotech (China); Wuhan Institute of Biological Products – they are tested by the Chinese company Sinopharm, as is the vaccine developed by the Beijing Institute of Biological Products (also China).
- A Polish COVID-19 vaccine is being developed
How vaccines are tested – the most important information
We would like to remind you that vaccines are the most carefully controlled medicinal products available on the market (for vaccinations.pzh.gov.pl). Before these products are introduced to the market, they are subjected to rigorous testing. Briefly, after the stage of preclinical research, which includes, inter alia, animal testing, human testing begins, it covers three phases.
The first includes a group of 20 to 100 volunteers. In this phase, data on the safety of the vaccine are collected, with particular attention to possible side effects, the dose and the administration schedule of the vaccine. From 100 to 300 volunteers take part in the second phase. At this stage, information is gathered on the safety of the potential vaccine and its immunogenicity.
The most promising vaccines are qualified to the third phase. The study is designed with the participation of 10 thousand. or more volunteers. Through these studies, enough data can be gathered on the safety and efficacy of the vaccine for approval by registration and regulatory authorities. In the United States, for ethical reasons, the principle of testing the effectiveness of vaccines in animal models has been introduced by law. (source: badaniaklinicznewpolsce.pl)
- More on how vaccines are tested
Vaccine against COVID-19. The five most advanced designs
The summary of the research on potential vaccines to date was published on September 8 by The New York Times, considered one of the most important American newspapers.
It all started in January with deciphering the SARS-CoV-2 genome. The first safety testing of potential vaccines began in humans in March. After six months, the future still remains uncertain. “Some attempts will fail and others may fail without a clear result” The New York Times notes. Nevertheless, some research centers have reached the most advanced phase of testing. What do we know about their tests so far? You will know the details.
Americans: Moderna company
Moderna is an American company that is pioneering the development of a new class of mRNA-based vaccines. He has been testing a potential SARS-CoV-2 vaccine since March. It uses a fragment of the genetic material of the SARS-CoV-2 coronavirus that does not cause infection but can trigger an immune response.
Animal studies (in this case monkeys) have shown that the vaccine protects them against the coronavirus. It was tested on humans in May 2020. The first phase of testing showed that the vaccine produced adequate levels of antibodies without serious side effects.
In July, it was announced that the preparation entered the third phase of clinical trials. About 30 thousand people take part in it. healthy people from approximately 89 centers in the United States.
Moderna says it may be able to deliver at least 2021 million doses of the vaccine annually as of 500.
International cooperation: Pfizer, BioNTech and Fosun Pharma
Pfizer, one of the world’s largest pharmaceutical companies based in New York, along with the German biotechnology company BioNTech and the Chinese drug manufacturer Fosun Pharma are also working on a genetic vaccine against COVID-19.
On July 1, companies announced that all volunteers participating in the Phase I / II study had developed antibodies to SARS-CoV-2. Some of the test subjects experienced moderate side effects such as sleep disturbance and shoulder pain. At the end of July, tests combining the second and third phases began. The effect of the vaccine is tested at 30 thousand. people from 39 US states, Brazil, Argentina and Germany.
Chinese. CanSino Biologics
The Chinese biotechnology company CanSino Biologics, in collaboration with the Institute of Biotechnology of the Academy of Military Medical Sciences, has developed an adenovirus-based vaccine called Ad5. Adenoviruses are pathogens that are responsible for upper respiratory tract infections and enter the body like SARS-CoV-2 – by droplets.
- Adenovirus – what is it and what kind of ailments does it cause?
Promising results of the first phase of clinical trials were published in May, it was reported in July that Phase XNUMX trials showed that the vaccine elicited a strong immune response. Also, no serious side effects have been documented.
On June 25, CanSino received limited approval for the use of the vaccine in humans. The Chinese government has approved the preparation for military use only for a period of one year.
On August 9, information was released that the third phase of the research would be conducted in Saudi Arabia. According to the NYT, the tests are also conducted in Pakistan.
s. National Center for Epidemiology and Microbiology of Nikolai Gamalei
On August 11, Our Country registered the world’s first SARS-CoV-2 coronavirus vaccine – Sputnik V. It was created at the epidemiology and microbiology center named after Nikolai Gamalei, who is part of the Ministry of Health. Like the Chinese vaccine, it is based on adenoviruses, and on a combination of two appropriately modified adenoviruses: Ad5 and Ad26. The vaccine must be given in two separate doses, each containing a different type of adenovirus.
The problem with the vaccine is that it was approved before the third phase of testing began. Our Country was accused of taking shortcuts to the “vaccine race”. This, in turn, has raised concerns about the effectiveness of the vaccine.
Meanwhile, in early September, scientists revealed more data about the tests related to the effects of the vaccine. On September 4, the prestigious medical journal “Lancet” published a report prepared by the s presenting the results of the first and second phase clinical trials. The COVID-19 vaccine produced antibodies in volunteers undergoing the study, it was reported. There were also mild side effects, such as headaches and joint pains.
Phase 2 testing has recently begun. According to the NYT, initially they were to be carried out on just 40. volunteers, eventually they were expanded to XNUMX thousand.
- More on the vaccine and related controversy
The British. Oxford University in collaboration with AstraZeneca
Back in June, WHO recognized the COVID-19 vaccine being developed by the British AstraZeneca as the world’s leading project and the most advanced in terms of development.
Indeed, the studies showed promising results, and the tests showed that the vaccine was safe to use and appeared to elicit an immune response. In early September, we wrote about the commencement of the third phase of research on the British vaccine, in which 50 participated. people around the world, including 30 thousand. from the USA.
On September 8, AstraZeneca announced that it had suspended clinical trials after detecting serious side effects in one of the people participating in these tests. According to a company spokesman, “The standardized review process prompted a break in vaccination to investigate safety features.” He described the move as “routine”.
More details have not been disclosed. However, according to the medical website Stat News, the victim should recover.
It is estimated that the interruption may delay the end of the vaccine trial phase. Initially, it was expected to happen by the end of the year, or the beginning of the next.
- More about the British vaccine
Who will win the race for the COVID-19 vaccine?
Let the comment of the virologist Dr. hab. n. med. Tomasz Dzieśćtkowski:
– We cannot say which country is closest to introducing the COVID-19 vaccine to the market. Why? It has happened more than once that a vaccine (or drug) stormed through the first and second phase of clinical trials, but it was stuck in phase three and was never approved for sale. It may turn out that both AstraZeneca and Pfizer, which are the leading companies in this work, will fail in this field, and other centers will succeed, he told Medonet.
I am a fan of each of the 200 research teams that are working on the SARS-CoV-2 vaccine around the world – ideally they all succeed, although I know it will not be possible. However, we should remember that the more suppliers and types of vaccines we have, the easier it will be for us to meet the world’s demand for a vaccine, and to choose the best one among them. This is a healthy competition, which is also a guarantee of safety – emphasizes the scientist.
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