India’s Bharat Biotech is aiming to have a production capacity of about 700 million doses of its COVID-19 vaccine this year, according to a top executive of the biotechnology company.
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The vaccine candidate, COVAXIN, received emergency use approval from India’s drugs regulator on Sunday, a move that faced questions from industry experts and opposition lawmakers due to lack of efficacy data.
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Efficacy data from the company’s ongoing late-stage trial should be available by March, Krishna Ella, chairman and managing director of Hyderabad-based Bharat Biotech, said in an online address to the media on Monday.
“We have four facilities coming up and we are planning (to make) around 200 million doses in Hyderabad, 500 million doses in other cities,” Ella said. The company has 20 million doses available so far, he added.
The approval for COVAXIN, jointly developed with a government institute, was hailed by Prime Minister Narendra Modi and his ministers as a success in India’s self-reliance push.
Ella defended the approval, citing multiple examples of emergency authorization approvals given in the past based only on immunogenicity data, and said he believes in COVAXIN’s efficacy.
Health Minister Harsh Vardhan clarified on Twitter on Sunday that the emergency use approval for COVAXIN was “in clinical trial mode”, wherein all recipients of the vaccine would be tracked and monitored as if they are in trial.
India has the second-highest number of coronavirus infections in the world, though cases have been steadily falling since a peak in September.
Private Brazilian clinics to buy Bharat Biotech’s vaccine
Private Brazilian clinics plan to buy 5 million doses of a COVID-19 vaccine developed by India’s Bharat Biotech, their association said on Monday in a
Bharat Biotech has not yet applied for approval by Brazil’s health regulator Anvisa for its Covaxin vaccine.
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.
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 clinical trial in Brazil.
Bharat Biotech is a pharmaceutical company based in Hyderabad in southern India that 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.
Covaxin is a whole-virion inactivated vaccine that could be licensed by the second quarter of 2021 in India, an executive told Reuters.
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