Sinovac vaccine against Covid-19 is approved for emergency use in China – 09/04/2020 – Balance and health



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In late August, China approved the coronavirus vaccine from manufacturer Sinovac for emergency use by healthcare professionals, subject to the increased risk of Covid-19 contamination.

Called CoronaVac, the Chinese vaccine is in phase 3 of clinical trials, including testing with about 9,000 volunteers in Brazil. The São Paulo government reached an agreement with the pharmaceutical company Sinovac to transfer technology and produce the vaccine together with the country’s Butantan Institute.

Information about the approval in China was released on August 28 by the Reuters news agency in Beijing, which heard from a source close to the pharmaceutical company.

The results of phases 1 and 2 of the vaccine have already shown good results, with a protection superior to 97% at 28 days. 148 people between 18 and 59 years old were evaluated in phase 1 and another 600 people in phase 2. The adverse effects reported were mild. There were no serious side effects that could indicate a possible lack of safety of the vaccine.

The randomized, double-blind study included two doses of the immunizer, one on the first day of the test and the other 14 days later. The amount of antibodies in the body was measured 14 days after each dose.

The good news is that the vaccine induced the production of neutralizing antibodies, whose function is precisely to prevent the virus from entering cells, which suggests that the vaccine may be effective in containing the infection, not just the development of the disease.

The authors, however, say that it is necessary to wait for the results of phase 3 to be sure of the effectiveness of the immunizer.

CoronaVac is made of inactivated viruses. The idea is to modify Sars-CoV-2 making it non-infectious. Scientists insert the coronavirus into Vero cells, cell lines commonly used in microbiological cultures, synthesized from cells isolated from the kidneys of a monkey species in the 1960s and used today, to multiply it in the laboratory. From there, the virus is inactivated and incorporated into the vaccine.

Total inactivated virus vaccine production is similar to that used for rabies vaccine production. However, this type of vaccine requires significant safety tests. Phase 3 that is ongoing in Brazil should continue for at least six months.

According to the director of the Butantan Institute Dimas Tadeu Covas, if the results of phase 3 are favorable, the intention is to start the vaccination from January.

Butantan, which plans to produce 120 million doses by 2021, will face a logistical hurdle: CoronaVac needs two doses for immunization. In other words, the total produced can serve 60 million people, less than 1/3 of the country’s population.

In addition to Sinovac, two other large Chinese pharmaceutical companies have already approved restricted-use vaccines. The first to receive approval was CanSino in July, whose vaccine, made from adenovirus, a technology similar to that of the Oxford vaccine and AstraZeneca, was approved for use by military personnel in the country.

The CanSino vaccine is currently undergoing phase 3 clinical trials in Saudi Arabia.

The state pharmaceutical giant Sinopharm, through the China National Biotechnology Group (CNBG), also announced that it had authorization for the emergency use of one of its candidates for the coronavirus vaccine under study, as revealed on social networks. last Sunday (30).

The CNBG has two vaccine candidates in phase 3 trials, but did not disclose which one had the approved use.

According to the Xinhua agency, the Chinese government has approved vaccines for emergency use as a measure to block possible new outbreaks of Covid-19 during the fall and winter. However, the government has not released more information on how these vaccinations will be carried out and the number of people who will be vaccinated.

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