‘Pharmacy of the world’ flexes its vaccine manufacturing muscle
In less than a year since the vaccine development process began, India started manufacturing two shots — Serum Institute of India’s (SII) Covishield and Bharat Biotech’s Covaxin — not only for inoculation within the country but also for shipping to countries abroad, a feat that underlined India’s superlative vaccine manufacturing capacity. The country, the world’s largest vaccine maker by volume, supplies at least 60% of all shots sold around the world.
“It is one of the great achievements indeed, as it has become one of the qualifiers to be called a developed nation these days,” said Dr Balram Bhargava, director general, Indian Council of Medical Research (ICMR). Covaxin was completely made in India and co-developed by Bharat Biotech International Ltd and ICMR. Last week, Bharat Biotech announced a deal to supply 20 million doses to Brazil.
Covishield was developed by Oxford University and drug firm AstraZeneca, and locally manufactured by SII. A million doses of Covishield were shipped to Africa last week under the Covid-19 Vaccines Global Access, or Covax facility — created to ensure global equity in Covid-19 vaccines.
India-made vaccines suit the needs of developing nations because of its cost-effectiveness and ease of use, experts say.
Under the Vaccine Maitri (Vaccine friendship) initiative launched in January, India has gifted vaccines to Bhutan, Maldives, Bangladesh, Nepal, Myanmar, Seychelles, Mauritius and others.
Last week, foreign ministry spokesperson Anurag Srivastava said India sent a total of 36.1 million doses to various countries. This included 6.7 million doses supplied under grant assistance and 29.4 million under various commercial contracts.
“India contributes to Covax facility because their vaccine manufacturing base is solid and very appropriate for use in lower and middle income countries. It suits the settings of these countries in terms of cold chain management, training of workers etc,” said Anuradha Gupta, deputy chief executive officer, Gavi- the vaccine alliance, which leads Covax.
Another Covid-19 vaccine being locally manufactured, and undergoing phase 3 clinical trials in India, is Russian-developed Sputnik V with a known efficacy of 91.6%.
The vaccine’s local manufacturer, Dr Reddy’s Laboratories, has applied for emergency use authorisation to the national drugs controller and will submit more data soon. “More vaccine approvals will depend on manufacturers applying for emergency use authorization based on their safety, immunogenicity and efficacy data. Two of the three Covid-19 vaccine manufacturers that applied for emergency use approval were granted approvals based on the data they produced. There were marathon subject expert committee meetings conducted back to back under accelerated approval process so that absolutely no time was wasted. Another vaccine application, Sputnik V, is under process,” said a senior government official, requesting not to be identified.
A fourth vaccine candidate, Zydus Cadila’s ZyCov-D, is currently undergoing phase 3 clinical trials in India. Biological E. Limited’s candidate is also in phase 1/2 trials.
“As and when manufactures apply for emergency approval, drug controller’s subject expert committee members act on it,” the official quoted above added.
Globally, close to 200 Covid-19 vaccine candidates are at different stages of development. In India, apart from two approved for use, three more candidates are currently undergoing advanced trials. There are at least a dozen other Covid-19 vaccines under various stages of development. “The last one year has proved that India has top quality research and development, and manufacturing capacity. The experiences of last one year will be leveraged in future to strengthen country’s vaccine development process,” said Dr VK Paul, member (health), Niti Aayog.