Anvisa suspends import of four million Covaxin doses

HYDERABAD: After closing the emergency use authorisation (EUA) and Phase-3 clinical trials requests for Bharat Biotech’s Covaxin, Brazil’s health regulator Anvisa (Agencia Nacional de Vigilancia Sanitaria) has now decided to provisionally suspend authorisation for exceptional import of 4 million doses of the Indian Covid-19 vaccine.
“The Collegiate Board of Anvisa unanimously decided, on Tuesday (27/7), to provisionally suspend the exceptional and temporary authorization for import and distribution of the vaccine against Covid-19, Covaxin, requested by the Ministry of Health,” said a translated version of the notice put up on Anvisa’s website. “The measure prevails until there is new information that allows us to conclude that the legal and technical security of maintaining the decision that authorized the importation is maintained,” Anvisa said.
The decision follows Bharat Biotech’s termination of its partnership with Brazilian partner Precisa Medicamentos. On July 23, Bharat Biotech had informed Anvisa that Precisa Medicamentos was no longer authorised to represent it in Brazil.
According to Anvisa, director Alex Machado Campos, rapporteur of the matter, “Considered that the loss of the legitimacy of the company Precisa to act before Anvisa can influence the fulfilment of the requirements and conditions of importation.”
“The decision also took into account news that illegitimate documents may have been added to the import process, which could impact the conclusions regarding the aspects of quality, safety and efficacy of the vaccine to be used by the national population,” Anvisa said.
Pointing out that no doses of Covaxin were imported by Brazil so far, Anvisa said the exceptional import authorisation required compliance with obligations and conditions set forth in the terms of rapporteur’s vote for the purposes of distribution and use of the Covaxin vaccine under controlled conditions.
The exceptional and temporary importation of Covaxin for distribution and use under controlled conditions had been authorised on June 4, at the 9th extraordinary meeting of the collegiate board of Anvisa. In his vote, the rapporteur informed that he called the Agency’s legal attorney and is promoting actions with the vaccine developer Bharat Biotech and the ministry of health.
Bharat Biotech too, after terminating its deal with Precisa, had said that it would continue to work with Anvisa to complete the regulatory approval process for Covaxin. After the Hyderabad-based vaccine maker’s termination of its deal with Precisa ended the $324 million deal for supply of 20 million doses of Covaxin to Brazil, Anvisa first suspended the proposed Phase-3 clinical trials of Covaxin that were to be conducted on 4,500 Brazilians and then closed the EUA request.
After Bharat Biotech’s termination of its deal with Precisa ended the $324 million deal for supply of 20 million doses of Covaxin to Brazil, Anvisa first suspended the proposed Phase-3 clinical trials of Covaxin and then closed the EUA request