Zydus Cadila’s two-dose Covid vaccine approved for phase 3 trials by Indian drug regulator
Emergency use authorisation was granted to the company’s three-dose vaccine on August 20.
Pharmaceutical company Zydus Cadila has received approval from the Drugs Controller General of India for the phase three trials of its two-dose Covid-19 vaccine, the firm said on Tuesday.
“...we hereby confirm that we have got the permission for conduct of phase III trials for two-dose Covid vaccine,” the company said in a regulatory filing.
India’s drug regulator had granted emergency use authorisation to ZyCov-D on August 20. This is India’s first vaccine for children aged above 12.
The ZyCov-D is the world’s first DNA vaccine against the coronavirus disease and is given in three doses. It makes use of a portion of the genetic code – deoxyribonucleic acid or ribonucleic acid – in the SARS-CoV-2 virus to stimulate an immune response against its spike protein, according to the Ahmedabad-headquartered company.
In recent weeks, discussions have been underway between the Centre and Zydus Cadila about the price of the company’s three-dose Covid-19 vaccine. The company has proposed a price of Rs 1,900 with taxes for its three-dose vaccine, reported PTI.
On September 30, Union Health Secretary Rajesh Bhushan had said that Zydus Cadila’s Covid-19 vaccine would be made a part of the countrywide immunisation programme soon.
Bhushan had then said that the vaccine would be priced differently than the ones being used currently. He added that this was because Zydus Cadila’s vaccine, ZyCov-D, is a three-dose needle-free vaccine.
In August, the company’s managing director Sharvil Patel had said it will supply one crore doses of its three-shot coronavirus vaccine by October. Patel said the company planned to supply about 30 lakh to 40 lakh doses of ZyCov-D vaccine by September. He added that they aimed to up the supply to 3 crore to 4 crore by December.
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Coronavirus: Zydus Cadila to supply 1 crore vaccine doses by October