So far, the state of SP has signed a contract with Sinovac, a Chinese laboratory that produces the vaccine against Covid-19 together with the Butantan Institute, for the production of 46 million doses still in 2020. The other 55 million additional doses, foreseen for next year, have not yet been acquired. CoronaVac is in the testing phase, which needs to be completed before it is released for use in the population.
Asked if the government of São Paulo would guarantee the acquisition of additional doses, to total 100 million, Doria said that “the answer is yes”, but that he believes that the best option would be the distribution of the vaccine by the Ministry of Health.
“The answer is yes, and we will also make it available to all governors who wish. Of course, the ideal is that we do the rite of the last 50 years: national immunization system, vaccine distribution by the Ministry of Health, acquisition and distribution by the Ministry of Health “, he said at a press conference.
“Unfortunately, if there is a denial for actions of a political or ideological order, São Paulo, with the approval of Anvisa, will buy the vaccine, distribute the vaccine and make it available to all state governments that wish to acquire it for the immunization of its population”, he added. .
The purchase of the CoronaVac vaccine was announced by the Ministry of Health, but was suspended after declarations to the contrary by the president.
Although Bolsonaro has expressly stated that the “Chinese vaccine” will not be purchased, the State Department of Health said it has not been officially communicated about the withdrawal from the agreement.
CoronaVac vaccine, produced by Sinovac in partnership with Butantan – Photo: EPA / Wu Hong
At a press conference at Palácio dos Bandeirantes, Doria also states that he has already been contacted by governors from other states who are interested in the acquisition of CoronaVac, in case there is no agreement with the federal government.
“Our position is to try at the limit that the entire acquisition of vaccines and their distribution be made in the national immunization system. There was never a situation of interruption of the program for political, ideological, party reasons, not even during the 1964 coup. But, given the circumstances, we have an alternative plan shared by the governors, “said the governor.
The state of SP has already closed an agreement for the purchase of 46 million CoronaVac, which is in the third phase of testing among Brazilian health professionals. For it to be released for use in the population, its efficiency has yet to be proven.
Of these, 6 million will come ready from China and the other 40 million will be packaged and labeled at the Butantan Institute. As the agreement also provides for technology transfer for the production of the vaccine, Butantan will start to produce more doses on a large scale after the adaptation of a factory.
Butantan, which has a partnership with the Chinese laboratory Sinovac for the production of CoronaVac, said on Thursday (22) that it had waited for more than a month for the release of Anvisa to import inputs, and that this could “impact” the beginning of the vaccination in health professionals by the end of the year, if the effectiveness is proven in the last phase of testing.
On Friday (23), the director of the institute, Dimas Covas, said that the vaccination schedule would be maintained, despite Anvisa’s “delay”.
“The original schedule was to start production [envase] in the second half of October. Therefore, depending on this decision, we will have a delay of 10 to 15 days. And we are going to make up for this delay, we are going to put our production line receiving the raw material to recover the schedule. “
Aina on Friday, Anvisa stated that “there is no type of delay / delay / delay” by the agency. He also said that he dismembered the analysis of requests made by Butantan to speed up the process.
“In the same process as the inputs, there is the request for exceptional authorization to import vaccine in the form of a filled syringe and in the form of an intermediate product, not bottled. It is important to clarify that they are products in different sanitary conditions. […] In order to avoid wasting time, the process was dismembered and the packaged vaccines will have their analysis done within a maximum period of up to five working days, separately from the analysis of the input order “, he said in a note.
Later that same day, the agency announced the release of the import of the 6 million ready doses of the vaccine, but the order for the input for the other 40 million is still under analysis.
This Wednesday (28th), Dimas Covas again said that the vaccination schedule can be changed if the import of inputs takes too long. According to the director, Anvisa gave the maximum deadline until next Thursday (5) to analyze the order on the raw material for the 40 million doses.
“Until today, this authorization has not yet been issued. Therefore, this delay in issuing this authorization may indeed have an effect on the production of the vaccine. Each day that we wait for the authorization means one day less of the vaccine. We hope that Anvisa will pronounce itself as soon as possible, “he said.
About the 6 million ready-made doses, already authorized by Anvisa, Dimas Covas said that he now awaits the release of the Chinese authorities so that they can be sent to Brazil in the next few days.
The government of São Paulo announced on Friday (23) the creation of six new centers for the testing of CoronaVac in volunteers. As a result, the total of places where research is carried out in the country increases to 22.
So far, 15,000 vaccinations have been applied to 9,000 volunteers. Each volunteer receives two doses. With the opening of the new centers, the goal is to expand the research to a total of 13 thousand volunteers.
In this final phase of the research, half of the participants are inoculated with the vaccine and the other half are given 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 submitted to the evaluation of Anvisa (National Health Surveillance Agency) for registration and later use in the population.
To speed up the process of analyzing potential immunizers against the coronavirus, Anvisa reduced the requirement for the initial documentation and simplified the registration process so that the data from the studies are sent during the work, and not just at the end. Since the beginning of October, the state government has been sharing data about CoronaVac with the agency.
To date, only partial data regarding vaccine safety have been presented by the state government, but these have not yet been published in scientific journals.
According to Dimas Covas, now, with the mark of 15 thousand vaccinations in volunteers, it will be possible to send safety data.
“Yesterday, we reached 15 thousand vaccinations and therefore we reached the first milestone in relation to the FDA itself, which is ‘Anvisa americana’. ‘Anvisa americana’ requires that in at least 3 thousand vaccinations of a candidate vaccine not be monitor serious adverse effects. We reached that number and we are preparing a report to be sent to our Anvisa, therefore closing the issue of security there “, he said on Friday.
According to the director of Butantan, the opening of new research centers will also speed up the process of demonstrating the vaccine’s effectiveness to Anvisa.
“With the opening of these centers, we will gain speed so that the demonstration of effectiveness can appear as soon as possible. We hope this will happen in November, mid-December,” said the director of Butantan.
Withdrawal from the federal government
Last Tuesday (20), Health Minister Eduardo Pazuello announced his intention to purchase 46 million doses of CoronaVac and the inclusion in the National Immunization Plan (PNI), after it was released by Anvisa. With this, the federal government would issue a new Provisional Measure to make R $ 2.6 billion available to CoronaVac.
However, on Wednesday (21), President Jair Bolsonaro (without party) disapproved of the minister stating that he “would not buy vaccine from China” and said he ordered the deal to be canceled. After the repercussion of the disapproval, Pazuello said in a live broadcast alongside the president on Thursday that “it is as simple as that: one commands and the other obeys”.
On Thursday (23), the Secretary of Health of the State of São Paulo, Jean Gorinchteyn, said that he has not yet been officially notified by the Ministry of Health about the suspension of the purchase. In a note sent to the press on Wednesday (21), the State Health Secretariat of São Paulo stated that it expects the ministry to honor “a commitment it has made publicly” to negotiate the purchase of CoronaVac.
The secretariat cited an official letter on Monday (19), in which the Ministry expressed its intention to purchase, in addition to the speech of the minister himself during the meeting with the governors on Tuesday, in which he stated that “The Butantan vaccine will be the Brazilian vaccine “.
The government of São Paulo closed on September 30 the contract with the Chinese laboratory for the acquisition of these 46 million doses of CoronaVac with a state budget of 90 million dollars. But the João Doria management (PSDB) seeks to negotiate with the federal government so that they are financed and distributed via the Unified Health System (SUS).
Despite this, the governor has already stated that, if there is no agreement with the Ministry of Health, the state government would guarantee vaccination for “Brazilians from São Paulo”.
The state government also announced a forecast to acquire an additional 15 million doses by February 2021, reaching a total of 61 million with its own funds. The expectation was that, with the federal government’s money, another 40 million would be acquired, reaching 100 million by May 2021.
However, the agreement canceled by the federal government did not include the 55 million additional doses that the government of the state of SP announced until May 2021, only the 46 million doses that were already guaranteed.
The governor of São Paulo, João Doria, shows a CoronaVac package during a press conference in September 2020 – Photo: Bruno Escolastico / Photopress / Estadão Content
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