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Precis Medicamentos, representative of Bharat Biotech in Brazil, said today that it presented the documentation to try to obtain approval for the emergency use of the Covaxin vaccine in the country. Anvisa (National Health Surveillance Agency), in charge of analyzing the request, however, denies having received it.
Precis Medicamentos submitted to Anvisa the documentation for the request for release for emergency use of the Covaxin vaccine, produced by the Indian laboratory Bharat Biotech, of which Precis is the exclusive representative and distributor in the country, the laboratory said in a note.
Also according to the statement, “Phase 3 studies show that the vaccine is 81% effective, and the antibodies induced by the application can neutralize variant strains.”
Anvisa, for its part, reported that it had received a request for a preliminary presentation meeting with Precis Medicamentos, which would be a first step in the process, but denied that the laboratory had sent a request for approval for the emergency use of Covaxin.
“The pre-presentation meeting is provided in the Emergency Use Guide,” the agency explained, “[e] it must be done before ordering the use of the emergency vaccine. The pre-presentation meeting is for Anvisa’s technical team to evaluate whether there is already enough data for the laboratory to make an emergency use request. “
According to the Twitter, that meeting should take place tomorrow.
In February, the Ministry of Health announced the signing of a contract with Precis Medicamentos for the delivery of 20 million doses of the vaccine against covid-19 between March and May. The use of the immunizer in the country can only occur, however, with the authorization of Anvisa.
Previously, the Minister of Health, Eduardo Pazuello, announced a reduction in the expectation of vaccines against covid-19 distributed to the states at the end of March. Now, according to the general, there will be 28 million doses of CoronaVac, manufactured by the Butantan Institute, and AstraZeneca / Oxford, of Fiocruz (Oswaldo Cruz Foundation), 18 million less than the amount reported in February (46 million).
On the last day 4, Pazuello had already reduced the forecast to approximately 38 million vaccines and, two days later, he affirmed that the states would have a maximum of 30 million doses. Today, the minister said that this number should be between 25 and 28 million immunizers.
However, it did not detail why this reduction in the final number of vaccines available is due.
(With Reuters)
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