RIO DE JANEIRO, BRAZIL – The immunizer is in Phase 3 trials in India and is dependent on ANVISA approval to be administered in Brazil. The agency finds no obstacle in the private network application.
The most optimistic scenario estimates that the vaccine will be available in the Brazilian private network in March.
The Brazilian Association of Vaccination Clinics (ABCVAC) reported on Sunday, January 3rd, that it is negotiating with India’s Bharat Biotech laboratory the purchase of five million doses of a vaccine against Covid-19.
The immunizer, called Covaxin, had its emergency use in India approved by the country’s authorities on Sunday and is still subject to authorization by the National Health Regulatory Agency (ANVISA) to be administered in Brazil.
The vaccine is in Phase 3 trials in India, a stage in which efficacy is examined. The first clinical trials showed that the immunizer does not cause serious side effects and produces antibodies for Covid-19.
According to ABCVAC chairman Geraldo Barbosa, the results of Phase 3 trials are expected to come out later this month. Should this be the case, the laboratory is expected to submit a request for final registration with ANVISA in February.
According to him, in an optimistic scenario, the vaccine should be available in private clinics in Brazil in the second half of March.
ANVISA reported that the emergency use authorization is temporary and prioritizes the public network. However, it stated that there is no impediment for a laboratory to also apply for emergency use to sell the vaccine to the private network. Nevertheless, this particular authorization must be requested.
In cases where a final registration is granted, use is approved in Brazil in general and the authorization will automatically apply to both the public and private networks.
Although the laboratory intends to apply for the final direct registration, Barbosa explained that the association has sent a letter to ANVISA regarding the option of extending the emergency registration, if granted, to the private network.
“If we secure this extension, we will be able to assist with vaccination coverage faster because the government must comply with the priority list it has defined. Because we understand that the vaccine is the same, the safety is the same. It would only be a bureaucratic matter, but we understand and respect the legislation,” he said.
Barbosa explained that the sale of vaccines to the private market will not impact the immunizer’s supply to the public network, given that the doses are part of an additional production by the laboratory.
“We have been looking for solutions for the private market and the option of this Indian vaccine has emerged, which is very promising. As the whole market was already committed to the government’s demands – and rightly so, because I believe it must be a priority – we tried an alternative solution. And this Indian company made itself available to offer part of its production to the Brazilian private market. So, it is an additional sale that will not interfere on the quantity that the government requested”, said the association’s chairman.
He stated that a memorandum of intent has already been signed between ABCVAC and the laboratory expressing interest in the purchase of vaccines. On Monday, January 4th, association representatives will fly to India to visit the laboratory, to check production capacity, and to proceed with the purchase negotiations.
“We are taking all precautions to overcome all health obstacles that are mandatory. Therefore, we don’t want to raise expectations, but we will have a vaccine for the private market in line with our prospects,” he said.
Still according to the chairman, data on the Covaxin have been in the process of ongoing submission to ANVISA for approximately 40 days.
Typically, all data on an immunizer are submitted and analyzed jointly, at the end of the process. However, faced with the Covid pandemic, ANVISA has implemented a new process in which data are submitted as soon as available in order to speed up its evaluation.