Covaxin manufacturer Bharat Biotech on June 30 asserted that it had followed a routine ‘step-by-step approach’ towards getting contracts and regulatory approvals for supply of the vaccine in Brazil and added that it had neither received any advance payments nor supplied any vaccines to the South American country’s Health Ministry.
Reacting to media reports, including a Rio De Janeiro-datelined news report in which Reuters cited Brazil’s Health Minister Marcelo Queiroga announcing the suspension of a $324-million Indian vaccine contract in the wake of allegations of irregularity, the Hyderabad-based company laid out the timeline of developments related to its efforts to supply the vaccine to Brazil.
Stating that discussions with the Brazilian Ministry had begun in November 2020, Bharat Biotech said that over the course of eight months, a step-by-step approach, similar to what was observed in other countries where the company sought approvals, had been followed. Subsequently, Covaxin received emergency use authorisation in Brazil on June 4.
On the issue of pricing, Bharat Biotech said it had been clearly established that the vaccine would be priced between $15 and $20 per dose for supplies to governments outside India. The pricing for Brazil had also been indicated at $15 per dose.
Also, while advance payments had been received from several countries at the same price points, with supplies in process, pending approvals, “as of June 29, Bharat Biotech has not received any advance payments or supplied any vaccines to MOH Brazil,” the company said.
Elaborating on the procurement process in Brazil and other countries, Bharat Biotech said a common approach, widely accepted and established in the industry, was followed for COVID-19 vaccines and several vaccines for routine immunisation.
The vaccine maker said it had partnered with Brazil’s Precisa Medicamentos for assistance, guidance and support with regulatory submissions, distribution, insurance and conduct of phase III clinical trials. The trials, approved recently by Brazil’s health regulator ANVISA, are to be conducted on 5,000 participants.
“Dr. Ella and his wife Mrs. Ella founded Bharat Biotech in 1996 with a mission to drive innovation and large-scale manufacturing in the field of human vaccines,” the company said, referring to its founder Chairman Krishna Ella.
“Since then, Dr. Ella has also founded or acquired 13 other organisations. This includes Madison Biotech, which he founded in 2020 for the purpose of external R&D and sales and marketing of vaccines... We wish to dispel any notion or implication of any wrongdoing whatsoever, as all these are affiliate companies founded/acquired and operated by Dr. Krishna Ella,” the company asserted.
