As India begins ramping up its Covid-19 vaccine production to meet the rising Covid-19 cases daily, indigenous vaccine maker Bharat Biotech is struggling to procure the key ingredient in its vaccine.
Hyderabad-based Bharat Biotech is facing acute shortage of the component adjuvant used in the Covid-19 vaccine, according to a Business Standard report.
The adjuvant identifies the antigenic component of the vaccine, instructing the immune system to defend against that antigen.
The shortage of this sourcing the adjuvant from the United States is what is holding up the pace of Covaxin production, sources in the know told the publication.
Bharat Biotech uses Kansas-based ViroVax’s adjuvant Alhydroxiquim-II to improve Covaxin's immune response.
Covaxin is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the National Institute of Virology (NIV), Pune, an Indian virology research institute.
The inactivated virus is formulated with ViroVax's adjuvant to produce the vaccine candidate.
"In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible. The vaccine, which is tested on volunteers and gets approved, is made with this adjuvant. Therefore, any change to this would lead to fresh clinical trials and fresh approvals,” one of the people aware of the development explained to the publication.
Addressing the gathering, Krishna Ella talked about the dependence on imports for some of the raw materials and the need to address the issue.
"When you want to leapfrog the vaccine field, we need other ancillary industries to come up, other technologies to come up along with it. Otherwise,I don't think, biotechnology field, we will go (far ahead). We will be importing lot of stuff from other place..," he said.
Recently, Bharat Biotech signed a collaborative research agreement with CSIR-Indian Institute of Chemical Technology (IICT) to collaborate on development of novel platform technologies for bio-therapeutics and vaccines to support affordable healthcare solutions for humans and animals.
Bharat Biotech chief, Krishna Ella Noting that some raw materials could not be obtained from the US due to certain restrictions imposed by that country, said such problems needed to be anticipated in the future.
However, Union Health Secretary Rajesh Bhushan denied claims of shortages and said that the problem is not of vaccine shortage but of better planning.
Currently, two vaccines -- Covaxin by Bharat Biotech and Oxford-AstraZeneca Covishield manufactured by Serum Institute of India (SII) -- are being used for inoculation in India.
India's drug regulator has also granted permission for the restricted emergency use of the Russian Covid-19 vaccine Sputnik V with certain conditions on Monday.
(With agency inputs)