By: Reuters | Sao Paulo | January 5, 2021 1:36:42 am
On Sunday, India's drugs regulator DCGI approved Covaxin and AstraZeneca's vaccine for emergency use, the first approvals of vaccines in India. (File)
Private Brazilian clinics plan to buy 5 million doses of a COVID-19 vaccine developed by Indian company Bharat Biotech, their association said on Monday, one day after India’s health regulator gave it emergency use approval.
Bharat Biotech has not yet applied for approval by Brazil’s health regulator Anvisa for its Covaxin vaccine, and the agency said it would have to undergo Phase III trials in the country. Geraldo Barbosa, head of the Brazilian Association of Vaccine Clinics (ABCVAC), who will lead a delegation to India departing on Monday, said a memorandum of understanding has already been signed with Bharat Biotech. “This should be the first vaccine available on the private market in Brazil,” he said.
The plan is for the 5 million doses of Covaxin to arrive in Brazil in mid-March, to be sold by private clinics after regulators there approve the vaccine.
Anvisa said in a statement on Sunday that Covaxin does not fit the continuous data submission process for vaccine registration and the vaccine would have to undergo late phase clinical trials in Brazil.On Sunday, India’s drugs regulator DCGI approved Covaxin and AstraZeneca’s vaccine for emergency use, the first approvals of vaccines in India.The fast-tracking of the home-grown vaccine faced questions from industry experts and opposition lawmakers because the company has not published efficacy data.Covaxin is currently undergoing late stage trials in the largest such trial in India.
A spokeswoman for Bharat Biotech said 24,000 volunteers have been recruited out of a target of 26,000 for the Phase III trial, which began in November.
The pharmaceutical company, based in Hyderabad in southern India, produces millions of doses of vaccines for hepatitis, Zika, Japanese encephalitis and others illnesses.In November, Bharat Biotech executives visited Brazil and offered the vaccine and a possible technology transfer partnership.
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