Instituto Butantan And Sinovac Biotech Organized The First Vaccine Against Covid-19 in Brazil
The Butantan Institute and the Chinese laboratory Sinovac Biotech should formalize on Wednesday (23) the first application for registration of a vaccine against covid-19 in Brazil.
The final documentation will be delivered to Anvisa (National Health Surveillance Agency) and also to the equivalent regulatory body in China.
In Brazil, CoronaVac will be subjected to two processes: health registration – normal route for authorization of a drug, which allows a more comprehensive application; and and authorization for emergency use – a modality that allows the vaccine to be released to selected groups only during the pandemic.
The latter has a period of ten days to have an answer from Anvisa. The health registration takes longer.
The conclusions of phase 3 of CoronaVac clinical studies, such as the rate of effectiveness and incidence of side effects, should also be known today.
The tests were carried out with about 11 thousand volunteers in the health area in Sao Paulo, Federal District, Rio de Janeiro, Minas Gerais, Paraná and Rio Grande do Sul.
On Monday (21), Anvisa anticipated the publication of Sinovac’s Good Manufacturing Practice certificate, days after the inspection of the company’s plant in China. This is one of the prerequisites for the release of a vaccine.
Butantan expects to have a total of 10.8 million doses of the vaccine on Brazilian soil by December 31. The Sao Paulo government, on the other hand, maintains the forecast to start vaccinating on January 25, depending, obviously, on Anvisa’s decision.
An alternative, in case the agency does not take a stand, is to use law 14.006 / 2020, approved at the beginning of the year, which allows the use of vaccines authorized by regulatory agencies in the United States, the European Union, Japan or China.
Thus, if the regular registration is approved earlier in China, this would allow vaccine developers to request analysis from Anvisa, which legally has a 72-hour deadline to respond.
The Ministry of Health, after a setback, decided to purchase doses of CoronaVac for use in the PNI (National Immunization Program). Even so, the governor of Sao Paulo, João Doria (PSDB), maintains individual agreements with states.
CoronaVac is a vaccine that uses an inactivated version of the coronavirus SARS-CoV-2, which causes covid-19. The product was developed by the private laboratory Sinovac Biotech, based in Beijing, China.
The company was already a partner of the Butantan Institute, linked to the government of Sao Paulo, in other projects. The partnership in relation to CoronaVac was signed on June 10.
Inactivated virus technology has been widely used by Butantan for decades.
There is also the advantage of the storage temperature (from 2 ° C to 8 ° C), which allows distribution in Brazil without additional investments in the so-called cold chain.
Sinovac started in 2004 the first studies for a vaccine against the first SARS-CoV-1 coronavirus, which caused an epidemic in Asia a year earlier.
As soon as SARS-CoV-2 emerged, the laboratory directed the research line towards this virus, whose genome is 80% similar to SARS-CoV-2.
The Chinese laboratory has orders from CoronaVac to governments in Saudi Arabia, Hong Kong, Indonesia, the Philippines, Turkey and Chile.
In addition, the Sinovac vaccine is also used in China in an emergency manner for risk groups of covid-19 and health workers.
Instituto Butantan And Sinovac Biotech Organized The First Vaccine Against Covid-19 in Brazi - /10