Ramping up production capacities and meeting supply demands of new COVID-19 vaccines and therapeutics is likely to be the key focus for pharma companies in 2022.
Year 2021 witnessed major dynamism in terms of development and seeking approvals for coronavirus vaccines and therapeutics by drug makers. Hyderabad-based pharma company Bharat Biotech, that strived to obtain Emergency Use Listing (EUL) from the World Health Organization (WHO) in 2021, is now on a race to meet export demands alongside ramping up its capacity for domestic supply.
“Manufacturing scale up has been carried out in a stepwise manner across multiple, specially designed Bio-Safety Level-3 production facilities in Hyderabad in Telangana, Malur in Karnataka and Ankleshwar in Gujarat and Pune, Maharashtra, the productions are on track and on target, with an aim to touch an annualized 100 crores doses of covaxin,” Bharat Biotech told Business Today. Bharat Biotech has already commenced exports of Covaxin soon after it received the EUL.
“Long pending export orders will be executed in early 2022 to countries that have granted emergency use approvals for Covaxin and to those additional countries that are recently added to our export lists,” the company said, adding that more than 60 countries have already shown interest to use is Whole-Virion Inactivated Vero Cell derived platform technology vaccine against COVID-19.
There were major interruptions in exporting of COVID-19 vaccines manufactured in India in 2021. With India achieving desired vaccination percentage of Indian population, exports are likely to be smooth.
Last year the Indian government clarified that it had calibrated shipments keeping in mind domestic requirements and had not entirely banned the exports. However, COVAX, a WHO-led initiative to foster global access to COVID-19 vaccines, cut the forecast for the availability of doses for 2021 by 25 per cent citing the major reason as uncertainty around the resumption of exports by Serum Institute of India (SII), a key COVAX supplier. SII, the world's largest manufacturer of vaccines, in November resumed exports to the international vaccine sharing programme.
The resumption of exports is linked to SII surpassing its original target to produce 100 crores doses of Covishield by the end of this year.
The Pune-based pharma major said that it will bring into production other vaccines under licence. These include Covovax, from US-based company Novavax, which has received Emergency Use Authorisation (EUA) from regulators by WHO and approval in India as well. The central government has also permitted the export of 7 crore doses of Covovax to Netherlands, Australia and New Zealand for which SII will need to meet the demand.
Adar Poonawalla, CEO of SII, on Friday said that supplies of the Covishield vaccine in India have exceeded 1.25 billion doses and his company is seeking full market authorisation. This will mean further expansion of supplies in 2022.
“The government of India now has enough data for full market authorisation, the SII has approached the drug control general of India for the permission,” Poonawalla said via Twitter. Another new entrant in the COVID-19 vaccine category in 2021 was indigenously developed ZyCoV-D, by the Ahmadabad-based company Zydus Cadila.
The world’s first DNA-based vaccine for COVID-19 remained important for India in 2021 because it was for children above 12 years. The company is yet to provide the promised supply to the government for rolling out the vaccine under the national COVID-19 program. Sharvil Patel Managing Director at Zydus Cadila, recently said that the company is expected to produce 4-5 crores doses every month by January 2022 for which it is ramping up production.
The Russian Direct Investment Fund (RDIF), the global commercializing partner for the Sputnik V, is in partnership with Dr Reddy’s that is expected to supply 250 million doses by 2021 end. Further, RDIF has also partnered with five other domestic companies—Hetero Biopharma, Gland Pharma, Virchow Biotech, Stelis Biopharma and Panacea Biotec for manufacturing over 850 million doses for India and to meet export targets. Hetero Biopharma alone plans to manufacture over 100 million doses per year of Sputnik V.
As far as therapeutics against COVID-19 are concerned, pharma companies in India are racing to manufacture the antiviral drug Molnupiravir which recently received emergency use authorisation from Indian drug regulator, the Central Drugs Standard Control Organisation (CDSCO). The CDSCO said that it received total of 22 applications for manufacturing and marketing of the drug Molnupiravir in the country. At least 13 firms i.e. Dr Reddy’s, Natco, MSN, Hetero, Optimus, Aurobindo, Mylan, Strides, Emcure, Cipla, Sun Pharma, Torrent and BDR will now manufacture the drug in India.
Molnupiravir has been granted approval by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) as a safe and effective medication for patients with mild to moderate cases of COVID-19. The product also recently received the USFDA’s Emergency Use Authorization. The drug was invented by Emory University (Atlanta, USA) and was developed by Merck & Co in collaboration with Ridgeback Biotherapeutics. All companies manufacturing the drug are busy ramping up their capacities to fulfil their commitments in the year 2022.
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