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India’s Biological E to make Johnson & Johnson’s Covid vaccine

Biological E Ltd plans to manufacture Johnson and Johnson’s COVID-19 vaccine

Indian pharmaceutical major Biological E Ltd is looking to manufacture around 600 million doses a year of Johnson and Johnson’s COVID-19 vaccine, Mahima Datla, managing director of the Hyderabad-based company told Reuters on Wednesday.

Biological E is also looking at producing about 100 crore doses a year of its own Covid vaccine. Biological E's own covid vaccine is under clinical trials and interim data is expected this quarter.

The 600 million doses for J&J will be in addition to this, Datla said.

In August, Biological E had entered into an agreement with Janssen Pharmaceutica NV, a subsidiary of Johnson & Johnson, for the creation and enhancement of manufacturing capacities for Johnson & Johnson’s COVID-19 vaccine candidate.

 J&J applied this month for emergency use authorization in the US. It expects to have some vaccine ready for distribution as soon as it is authorized. However, the Indian rules require that the vaccine has to undergo local trials as well.

The vaccine is one-shot, as opposed to Pfizer's and Moderna Inc's two-dose vaccines, and can be stored in at normal refrigerator temperatures.

The drugmaker's application to the U.S. Food and Drug Administration (FDA) follows its Jan. 29 report in which it said the vaccine had a 66% rate of preventing infections in its large global trial.

The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on Feb. 26, to discuss the company's request for emergency use authorization.

The J&J vaccine uses a common cold virus, adenovirus 26, to  trigger an immune response.

The Pfizer-BioNTech and Moderna vaccines are based on messenger RNA (mRNA), which requires them to be stored in a deep freezer at temperatures of -80 degrees.