New Delhi: The Brazilian health regulator Anvisa – short for Agência Nacional de Vigilância Sanitári – has said Bharati Biotech’s COVID-19 vaccine has been authorised for a clinical trial in the country, and can be used in the country depending on the results.
“The authorized study is a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, immunogenicity and consistency between batches of BBV152, a whole virus vaccine inactivated against Sars-CoV-2 , in adults 18 years of age or older,” an Anvisa press release says (translated from Portugese by The Wire).
“The study foresees the application of two doses, with 28 days of interval. It is expected that 4,500 volunteers will be involved in Brazil, in the following states: São Paulo (3,000), Rio de Janeiro (500), Bahia (500) and Mato Grosso (500). The vaccine study is also being conducted in India with another 26,300 volunteers, totaling 30,800 volunteers in the global study,” the release continues.
All the other vaccines permitted in Brazil so far – Sinovac, AstraZeneca and Pfizer – were also tested in Brazil before being put into use.
This news is significant because on April 1, Anvisa had denied a request to important doses of Covaxin, made in India by Hyderabad-based pharma company Bharat Biotech, for use in Brazil’s COVID-19 vaccination drive. This was despite the fact that India’s Union health ministry had appealed to Anvisa to authorise the application to import 20 million doses of Covaxin into Brazil.
This move by Brazil’s regulator came after it had also denied a certificate of good manufacturing practices to Bharat Biotech on March 30. Bharat Biotech had failed to comply to manufacturing standards, including not adhering to demands for documentation and maintaining the integrity of containers and methods of analysis.
As The Wire has reported before, one of the principal factors that contributed to Anivsa’s decision to push back on the application is reportedly that Bharat Biotech has allegedly failed to check the method it uses to inactivate the novel coronavirus.
Unlike the Pfizer and Moderna vaccine candidates, Covaxin delivers a relatively small number of viral particles to the body. These particles are first modified to keep them from replicating within the human body.
As a result, any concerns over the method by which Bharat Biotech inactivates the viral particles before using them in the vaccine doses are likely to affect perceptions of the vaccine’s safety and vaccine hesitancy.