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Brazil Approves Limited Doses of Covaxin With Strict Conditions

The Brazilian health regulator says phase-3 trial of the Bharat Biotech vaccine is not concluded yet, and use depends on results of trial being conducted in Brazil.
A vial labelled with Bharat Biotech's 'Covaxin'. Photo: bharatbiotech.com

Sao Paulo: After a marathon meeting that lasted eight hours, the National Health Surveillance Agency (ANVISA) of Brazil approved on Friday night the import and use of Covaxin, manufactured by Bharat Biotech. But the approval came with strict conditions which limit the number of doses that can be imported and with restrictions on the use of vaccine in Brazil. The same conditions also apply to Sputnik V of Russia, which was also approved at the same meeting conducted online and broadcast live on the agency’s YouTube channel.

Though the federal Ministry of Health (MoH) has placed an order of 20 million doses with the Indian company, the collegiate board of ANVISA gave its approval, by four votes to one, for the import of four million doses, which can only be used under “specific conditions determined by the agency”. “I emphasise that the exceptional and temporary import of the quantity (four million) is authorised, corresponding to doses for immunisation of 1% of our population, within the schedule sent by the Ministry of Health,” said Alex Machado Campos, the director of ANVISA.

Speaking at the meeting, followed by thousands across the country, Campos said the approval is being recommended because of the improvements made by Bharat Biotech in its manufacturing process after an inspection of its plant by ANVISA technicians in April this year, in addition to the agency’s decision to conduct a phase-3 clinical trial of the vaccine in Brazil.

The Brazilian ministry had placed the order for the Indian vaccine with much fanfare last year. But on March 31 of this year, ANVISA rejected the application for importing the serum on the grounds of that the Indian company was not “following good manufacturing practices” and there were huge gaps in its data. On May 13, the Brazilian agency gave approval to the company to conduct the phase-3 trials in Brazil for analysis locally.

Also read: Realistically, How Can India Expand COVID Vaccine Production Quickly?

At the meeting on Friday, Gustavo Mendes, general manager of medicines and biological products at ANVISA, emphasised that the phase-3 trial of Covaxin was not yet concluded and the clinical study to be carried out in Brazil would contribute to fill the gaps in the clinical data. Mendes, who is a well-respected figure in the medicine field here, also pointed out that Bharat Biotech did not provide full reports of its trials but submitted only “summaries of the information needed to ensure the safety and effectiveness” of the Indian vaccine.

According to Mendes’ elaborate presentation at the meeting, the report sent by the Indian firm showed test results with only 45 days of follow-up after the vaccination. As per ANVISA manual, he said, that was inadequate. “At least two months after vaccination, with the second dose, are needed in order to have an adequate profile of the vaccine’s safety and efficacy,” said Mendes.

Given Brazil’s pandemic situation and faltering vaccination plan, ANVISA might have approved the Indian vaccine but it comes with severe conditions. As per a statement from the health agency, released on Friday night, the import of Covaxin into Brazil is subject to the following conditions: 1) that all batches destined for Brazil have been manufactured after the adaptations of Good Manufacturing Practices (GMP) implemented by the manufacturer Bharat Biotech; 2) presentation of power certificate for all batches; 3) delivery and evaluation by ANVISA of data referring to two months of safety follow-up of the phase-3 clinical trial; and 4) release of all batches regarding quality aspects by laboratory analysis by the National Institute for Quality Control in Health.

The statement also said that after using the four million authorised doses, the agency would analyse the data for monitoring the use of the vaccine “in order to assess the next quantities to be imported”. “The import and use of vaccines may be suspended if the request for emergency use under analysis by ANVISA or the World Health Organization (WHO) is denied or based on information from the control and monitoring of the use of the Covaxin vaccine in Brazil,” it added.

Both the vaccines, Russian and Indian, can’t be administered to any person at the risk of adverse reaction. “We understand that this vaccine should not be used by people with hypersensitivity to any of the components of the formula, pregnant women, nursing mothers, children under 18, women of childbearing age who want to become pregnant, serious or uncontrolled illnesses and a history of anaphylaxis,” said Mendes.

So far, ANVISA has granted definitive registration to vaccines made by Pfizer and AstraZeneca made by the Fiocruz institute in Rio de Janeiro. Three other vaccines Coronavac of Butanta Institute of Sao Paulo, Janssen of US and Covishield of Serum Institute of India have received only emergency use authorisation.

Shobhan Saxena is a journalist based in Sao Paulo, Brazil.

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