SP Government receives from China the first 120 thousand doses of CoronaVac, vaccine against Covid-19 | Saint Paul

Governor João Doria (PSDB) accompanied the arrival of the lots to the site.

Coronavac is one of four vaccine candidates against the new coronavirus (Sars-CoV-2) that are being tested in Brazil. The São Paulo government signed an agreement for the purchase of 46 million doses and the transfer of technology to the Butantan Institute.

The 120,000 doses are part of a 6 million batch scheduled to arrive in late December. They will be stored in a place that was not disclosed by the São Paulo government for security reasons.

Initially, the arrival was scheduled for November 20, according to the São Paulo government, but the material landed this morning in Guarulhos.

In addition to the vaccines that will already be ready, the Butantan Institute should receive part of the raw material this year to manufacture another 40 million doses, according to the São Paulo government.

• Vaccine effectiveness and 7 more topics: understanding the concepts
• CoronaVac: what the research shows, how many have already been vaccinated, and which countries develop the vaccine besides Brazil

In the early hours of Thursday (19), the general director of the Butantan Institute, Dimas Covas, celebrated the arrival of the Sinovac vaccine on national soil and said that Coronavac’s clinical tests are advanced. His expectation is to send the results of the last phase of studies on the vaccine to Anvisa in 2020.

“Therefore, we are only waiting for Anvisa’s registration. It is the first vaccine to reach national soil. This is important: Brazil already has its vaccine, which will be pending procedures with Anvisa and the Ministry of Health to be able to start the vaccination program. And we hope that there will begin in mid-January at the latest until February and we await the definitions of the Ministry of Health, “said Dimas Covas to Jornal da Globo.

A study of 743 patients showed that the CoronaVac vaccine, produced by the Chinese pharmaceutical company Sinovac against Covid-19, and which is being tested in Brazil, showed safety and a satisfactory immune response during phases 1 and 2 of the tests. (see study details below).

The article was published this Tuesday (17) in the scientific journal “The Lancet”. Phase 2 of testing a vaccine verifies the safety and ability to elicit a defense system response. It is usually done with hundreds of volunteers. Phase 1, on the other hand, is carried out by dozens of people and phase 3 by thousands. It is in phase 3 where the efficacy of the vaccine will be measured.

Participants were healthy adults 18 to 59 years old and were randomly chosen to receive two doses of the experimental vaccine: low dose 3 micrograms, high dose 6 micrograms, or placebo. According to the research, antibody responses were induced within 28 days after the first immunization.

• Study highlights:
• Phases 1 and 2 involved 743 healthy volunteers in China, ages 18 to 59. In phase 1, there were 143; in phase 2, 600.
• The vaccine has two doses and appears to be safe and well tolerated.
• The most common side effect reported was pain at the injection site.
• The main objective of this stage of the research was to evaluate the immune response and the safety of the vaccine.
• One study did not evaluate the effectiveness in preventing Covid-19 infection.
• More studies are needed to test the vaccine in other age groups, as well as in people who have pre-existing medical conditions.

“Our findings show that CoronaVac is able to induce a rapid antibody response within four weeks after immunization, delivering two doses of vaccine at a 14-day interval,” said Professor Fengcai Zhu, lead author of the study.

Import release

At the end of October, the National Health Surveillance Agency (Anvisa) authorized the importation of 6 million of the immunizer.

“The first doses of the Coronavac vaccine arrive in Brazil on November 20 and this date is confirmed. The National Health Surveillance Agency (Anvisa) had already authorized it, we had already discussed it with you, Anvisa itself had already issued a statement as well. , and now the Chinese health authorities, Anvisa Chinese has also given authorization to import, by the Butantan institute, batches of 6 million vaccines, the first 120 thousand doses arriving on November 20 at the Guarulhos international airport in São Paulo ” Doria said during a press conference this afternoon.

Also according to the governor, Butantan will receive the doses in batches and by December 30, the Institute will have the 6 million vaccines planned.

The director of the Institute, Dimas Covas, said that the place where the immunizer will be kept will be confidential for security reasons.

In late September, Doria even said that the first doses would arrive in October.

During the press conference, the construction of the factory in Butantan, which will be responsible for the production of the vaccine, was also announced. The forecast is that the work will be completed in September 2021.

For construction, in addition to the resources donated by the private sector, the São Paulo government expected to receive R $ 80 million from the federal government, as announced by João Doria in a press conference at the end of September.

However, according to the Secretary of State for Health, Jean Gorinchteyn, the transfer was not made by the Ministry of Health.

“We had one of the meetings we had at the Ministry [da Saúde], several weeks ago, the reference of R $ 84 million that would be offered to help the factory. So far these resources have not been made available. So until now, we don’t have that feature, “Gorinchteyn said.

CoronaVac is currently in the third phase of testing. Sinovac, the Chinese pharmacist responsible for the vaccine, has not yet obtained the registration for the application of the immunizer, which cannot be used in the population.

“I want to clarify here that we follow and will strictly follow the protocols of the National Health Surveillance Agency (Anvisa) for the application of the vaccine. The vaccine will only be brought to the public to people after final authorization from Anvisa, ”said Doria.

• Butantan Says Anvisa’s Delay ‘Affects’ CoronaVac Distribution and Calls for Reassessment of Import Deadlines
• Chinese vaccine: see 5 points to understand the conflict over the purchase of CoronaVac

So far, the São Paulo government has only presented partial data on the safety of the vaccine, but they have not been sent to the agency or published in scientific journals.

CoronaVac is the subject of a political dispute involving the Ministry of Health, President Jair Bolsonaro, and the Governor of São Paulo, João Doria.

At the end of October, the Minister of Health, Eduardo Pazuello, announced the negotiation to acquire the 46 million doses. Annoyed, Bolsonaro ordered the cancellation of the purchase, and the ministry, in turn, declared that “there is no intention to buy” and replaced the statement on the website.

• Maia visits Doria and says that ‘Brazilians need this vaccine and the others’

46 million doses expected

In total, the São Paulo government signed a contract with the Chinese company Sinovac to purchase 46 million doses of CoronaVac. These first 6 million will come ready from China, and the other 40 million will be packaged and labeled at the Butantan Institute with material that will be imported.

According to the director of Butantan, Dimas Covas, the schedule established by the São Paulo government is being maintained, regardless of what the São Paulo authorities point to as a delay by Anvisa in freeing the import of raw materials from China.

CoronaVac is in the third phase of testing. The group of volunteers is made up exclusively of health professionals. So far, 15,000 vaccinations have been given to 9,000 volunteers. Each volunteer receives two doses. With the opening of the new centers, the objective is to expand the survey for a total of 13,000 volunteers.

In this final phase of the research, half of the participants are inoculated with the vaccine and the other half receive a placebo. To determine the effectiveness of CoronaVac, at least 61 participants must be infected with the coronavirus.

If the immunizing agent reaches the necessary levels of efficacy and safety, it can be sent to Anvisa (National Health Surveillance Agency) for registration and subsequent use in the population.

To streamline the process for testing potential coronavirus immunizers, Anvisa reduced the initial documentation requirement and simplified the registration process so that study data is submitted during work, and not just at the end.

Videos: Vaccine News