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Sinovac vaccine factory in Beijing, China. (REUTERS / Thomas Peter)
SÃO PAULO – Dimas Covas, director of the Butantan Institute (São Paulo), released today the preliminary results on CoronaVac’s safety. The vaccine is developed by the institute, in partnership with the Chinese pharmaceutical company Sinovac.
According to the data presented by the director, the results of the clinical tests carried out on 9 thousand volunteers in Brazil are similar to the studies presented in China, in which 94.7% of the 50 thousand volunteers did not present adverse effects.
The analysis of the results of the Brazilian clinical tests showed that, of the 9 thousand volunteers between 18 and 59 years old, only 35% had mild adverse reactions after application, such as pain at the application site.
The most common reactions among study participants after the first dose were application site pain (19%) and headache (15%). At the second dose, the most frequent adverse reactions were application site pain (19%), headache (10%), and fatigue (4%). Low fever was registered in only 0.1% of the participants. So far, there have been no reports of serious adverse reactions to the vaccine.
Covas says the Butantan vaccine worked better than the other three tested in the country on average for mild, moderate or severe side effects. “It is the safest in terms of side effects at the moment not only in Brazil, but in the world,” Covas said.
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Governor João Doria (PSDB) supported the speech of the director of the Butantan Institute during a press conference at the Palácio dos Bandeirantes, also in São Paulo.
“The first results of the clinical study carried out in Brazil show that, among all the vaccines tested in the country, CoronaVac is the one with the best and most promising rates in Brazil. In fact, it is the most advanced vaccine of the moment ”.
The vaccine is safe, but its effectiveness has not been proven
It is necessary to clarify, however, that these results do not prove that the Butantan vaccine is really effective against Covid-19. The results presented by the institute refer only to the safety of the vaccine in relation to possible side effects in the human body.
“These data show the success of the drug from the point of view of safety and this can accelerate the process of including the vaccine in the National Immunization Program. [PNI]”Said João Gabbardo, executive secretary of the Coronavirus Contingency Center in São Paulo.
The secretary explained that, although this first test is very important, it does not define the approval or not of the vaccine per se. It is necessary to analyze whether the drug is triggering a response in the immune system of the volunteers.
Definitive conclusions about the efficacy of a vaccine depend directly on a minimum number of cases of the disease in question among vaccinated volunteers. “We have to wait for a natural transmissibility of the disease to be able to conclude efficacy results,” Gabbardo said.
This infection rate is necessary for researchers to compare how many of those infected were in the vaccinated group and how many were in the group that received the placebo. Among the scientific community, this is a method considered standard in the development of new drugs and checks whether the vaccine really managed to protect those who were exposed to the virus.
In the case of CoronaVac, the minimum required is 61 contaminants. Gabbardo said that the state of São Paulo enters a downward curve in the number of new cases and hospitalizations, which shows that the virus is losing its transmission force. This can make it harder to reach the number of infections. “We are increasing the number of volunteers. We need people with symptoms and confirmation of the disease, “said the secretary.
Covas called on the population to volunteer. According to the director of the Butantan Institute, the tests should reach the control number in December, but it is not possible “to give a more precise date.” “Until we have these data, Anvisa’s file is not complete. The registration process for the non-vaccine is carried out ”, explained the director of the institute.
Anvisa’s analysis depends on the effectiveness result
Anvisa created a new analysis flow, which allows researchers to continually submit research data so that the agency can approve a drug for national use. But that flow depends on a study that tests the efficacy of the vaccine.
Due to the pandemic, the agency also revised its rules regarding the minimum effectiveness required to grant the vaccine registration. Immunizers are generally only approved if they demonstrate 70% protection. For vaccines against covid-19, Anvisa already admits that it can license with 50%.
According to Doria, the talks between the state government, the Butantan Institute, Anvisa and the Ministry of Health are taking place in “harmony.” “We want to monitor nationally and not something isolated in São Paulo, offering the vaccine to more Brazilians than the 46 million who live in the state,” added the governor.
It should be remembered that, on Wednesday (21), the governor must meet at 10 am with Eduardo Pazuello, Minister of Health. The objective is to reach a conclusion about the participation of the vaccine sponsored by the state of São Paulo in the federal program. Immediately after that first meeting, a meeting with Antônio Barra Torres, president of the National Health Surveillance Agency (Anvisa), is scheduled for 1:00 p.m.
CoronaVac doses promised by the government
The São Paulo government has said that the state will receive 6 million doses imported from China ready for application in October. Another 40 million, to be processed in São Paulo, should arrive at the end of this year. The 46 million initial doses will cost US $ 90 million, which also includes the transfer of technology from Sinovac to produce the Butantan vaccine. Another 15 million doses to be processed will arrive in February 2021.
The government also announced that it raised R $ 97 million with the private initiative of the Butantan Institute to start the construction of a new factory, with the capacity to manufacture 100 million doses of CoronaVac per year.
The government hopes to begin vaccination in the state in the second half of December, but the campaign guidelines have yet to be approved by the Health Ministry.
The world reaches 40 million infected
After practically a year of pandemic, the world reaches the mark of 40 million infected. The death toll from Covid-19 exceeds 1.1 million. The US, India and Brazil account for more than half of the cases in the world and lead in the number of contaminated and fatalities.
The daily registry of new cases was registered at the end of last week, with the global mark of new infections by the disease exceeding 400 thousand for the first time. Last week, an average of 347,000 new cases per day were recorded worldwide, up from an average of 292,000 in the first week of October.
The American continent is by far the most affected by the disease. North, Central and South America represent around 47.27% of the total world cases, an index extracted by the figures of countries such as the United States, Brazil, Argentina and Mexico. But new cases in Europe continue to exceed 150,000 a day. Countries such as Italy, the Netherlands, Germany, Austria, Poland, Ukraine, Cyprus, and the Czech Republic recorded daily infection records.
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