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In China, tens of thousands of people have already received a dose of experimental vaccines against the coronavirus under development in the country. At least 3-4 different vaccines have been administered to healthcare workers, the military, government officials and even employees of pharmaceutical companies despite the fact that large-scale trials have not ended. An approach that has some risk because at this time there are no known potential adverse reactions. The Russian Spuntik V has also obtained approval from regulatory authorities. before the clinical phase ended, but its use among the population still seems limited compared to what is happening in China. Certainly that Russian and Chinese vaccines, which have to cover a population of 1.5 billion people, will be among the most widespread in the world.. Information about these products is not always transparent. But what do we know? You are safe? At what stage is the investigation?
The Chinese CanSino vaccine
The Chinese company CanSino Biologics has developed a vaccine (Ad5-nCoV) based on a adenovirus called Ad5 in collaboration with the Institute of Biology of the Academy of Military Medical Sciences of the country. The vaccine to non-replicating viral vector ed only one dose is needed. In this case, the viral vector consists of a virus (Ad5), which is a weakened version of a common cold virus (adenovirus), which has been genetically modified in such a way that it cannot replicate in humans. To also make it “recombinant” with the adenovirus, the genetic code was added to provide instructions for the production of the coronavirus Spike protein, so that, once injected into the body, the adenovirus begins to produce this protein. This results in the formation of antibodies against the Spike protein, the same protein found on the surface of coronaviruses. It is the same platform as vaccines against influenza, tuberculosis, chikungunya, Zika, menB, and plague.
Russia: Spuntik V
The Gamaleya Research Institute, which depends on the Russian Ministry of Health, has created a vaccine, also with a non-replicating viral vector such as the Chinese CanSio. Two doses are needed 21 days apart. Preliminary results announced in November indicate that the vaccine has a high efficacy rate in phase 3 studies. Scientists began clinical trials in June. On August 11, President Vladimir Putin announced that the Russian regulatory body had approved the vaccine, dubbed Spuntik V, even before phase 3, large-scale trials began. Experts from around the world have called the measure very dangerous. Russia withdrew the announcement, arguing that the approval was a conditional registration certificate and that everything will depend on the results of phase 3. The trials, initially planned on 2,000 volunteers, have been expanded to 40,000. Volunteers were recruited as well as in Russia in Belarus, United Arab Emirates, Venezuela. On September 4, the Gamaleya researchers published the results of phase 1-2. In a small study, they found that Sputnik produced antibodies against the coronavirus and mild side effects. On November 11, the Russian Investment Fund announced that preliminary results from phase 3 indicate that the vaccine is effective. Based on just 20 cases of Covid-19 among study participants, Russian scientists estimated that the vaccine was 92% effective. On November 24, the researchers, after analyzing 39 other cases, reported a 95% efficacy rate 42 days after the first dose. However, the latest findings have not been published in scientific journals.. Russia has negotiated agreements to supply the vaccine to countries such as Argentina, Brazil, India, Mexico and Venezuela. Today, December 2, the presentation of the vaccine at the UN is scheduled.
Russia: EpiVacCorona
On August 26, the Vector Institute, a Russian biological research center, registered a phase 1/2 study for a coronavirus vaccine they call EpiVacCorona. The vaccine contains small portions of viral proteins, known as peptides. On October 14, Vladimir Putin announced that Russia granted EpiVacCorona approval, making it the second vaccine to receive that designation after Sputnik V. from the Gamaleya Institute. Like the Sputnik vaccine, EpiVacCorona received approval before a phase 3 trial to prove it was safe and effective. Testing is expected to begin at the end of the year.
China: Sinopharm’s two vaccines
Chinese state enterprise Sinopharm is currently testing two vaccines (BBIBP-CorV and New Crown Covid-19) based on inactivated coronavirus, which use viruses that are killed and mixed with an adjuvant (aluminum hydroxide) before injecting into patients. In this way, the immune response is achieved, but no infection occurs. Inactivated virus vaccines use the technology and mechanisms used by many existing vaccines, including vaccines against measles and polio. Both vaccines need two doses 21 days apart. One of these two vaccines was created by the Wuhan Institute of Biological Products. The phase 1-2 study showed that the vaccine produced antibodies in volunteers, some of whom experienced fever and other side effects. Phase 3 started in the United Arab Emirates, Morocco and Peru. On September 14, the United Arab Emirates gave emergency approval for the Sinopharm vaccine to be used in healthcare workers. Over the summer, Sinopharm announced that the Chinese government had approved the administration of both candidate vaccines to government officials, healthcare professionals and other select categories. According to the president of Sinopharm, almost a million Chinese had been vaccinated in November. On November 25, Sinopharm announced that it had submitted an application to market its vaccines in China, despite the fact that phase 3 trials that should demonstrate the safety and efficacy of the serum have not yet been completed.
China: CoronaVac
Sinovac Biotech, a privately owned Chinese company in collaboration with the Butantan Institute of São Paulo in Brazil, has developed an inactivated virus vaccine called CoronaVac. In June, the company announced that phase 1/2 studies of 743 volunteers found no serious adverse effects and produced an immune response. Sinovac published the details of the trial in the Lancet Infectious Diseases in November, showing relatively modest antibody production. Only a phase 3 study would show if those antibodies are enough to protect people from Covid-19. In July, Sinovac launched a phase 3 study in Brazil, followed by others in Indonesia and Turkey. In August 2020, the vaccine received advance approval for emergency use in China, even though trials were not completed. In October, authorities in eastern China’s Jiaxing city announced that they were administering CoronVac to people in high-risk jobs, including health workers, port inspectors and public service personnel. On November 9, the Brazilian government announced that it had suspended Sinovac trials in the country in October due to the death of a volunteer (it appears to be unrelated to the vaccine), but the details have never been clarified. The trials resumed two days after the announcement.
December 2, 2020 (change December 2, 2020 | 14:01)
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