The world ravaged by the COVID19 pandemic is looking to India for the large-scale development and supply of coronavirus vaccines as it enters 2021 with the vaccine rollout beginning in some countries. As the pandemic hit the world in 2020, the Indian pharmaceutical industry rose to the challenge and was able to generate and sustain supply chains even during the lockout era, and exported medicines such as HCQ
The world is again looking at India as a beacon of hope that the enormous number of vaccines needed to tackle the pandemic will be developed and supplied.
“India contributes 60 percent of the vaccine production to the world. India is going to play a vital role inequitable distribution of vaccines around the world,” Secretary-General Sudarshan Jain of the Indian Pharmaceutical Alliance (IPA) said.
Though indigenous vaccines are being produced by Indian companies such as Zydus, Bharat Biotech, and Gennova, other domestic companies are working with global companies such as Serum Institute with AstraZeneca, Dr. Reddys with Sputnik, and Biological E with J&J, he added.
“India will also be a benchmark in vaccine distribution and will be using technology to ensure targeted and phase distribution. India has always believed that global cooperation and coordination is fundamental to meet the COVID situation,” Jain said.
Three COVID-19 vaccine candidates from Bharat Biotech, the Serum Institute of India, and Pfizer are currently under active consideration by India’s drug regulator and, according to the Ministry of Health of the Union, there is hope that early licensing is possible for all or some of them.
Ashok Kumar Madan, Executive Director of the Indian Drug Manufacturers’ Association (IDMA), said, “We are sure with all the attention given by the government, vaccines will too be available for use from January 2021 onwards. These vaccines are being approved by our Drugs Controller as per the stringent international norms. We take pride that almost 70 percent of the WHO vaccine procurements are from India”
In order to manufacture vaccines, Indian companies have used various platforms. Scientists in these companies have the potential to manufacture the vaccine in a short time to fight the mutated forms, he said.
On the availability of the AstraZeneca-Oxford vaccine, Serum Institute of India (SII) CEO Adar Poonawalla told PTI that “then we can expect the vaccine to be available in India by January 2021 (only if it is proven immunogenic and efficacious)” on the basis of the trial results in India and the UK and if approvals from regulatory bodies are in place on time.
SII will hold aside 50 percent of whatever quantity of the vaccine candidates are developed for India as part of various alliances and collaborations for vaccine candidates, and the remaining quantity will go to low and middle-income countries, he noted.
“So far, under at-risk manufacturing, we have already stockpiled 50 million doses. Currently, our capacity is 60-70 million doses per month, which will increase further up to 100 million doses of the vaccine per month by February 2021. However, we will progress to mass production only after it is proven efficacious and immunogenic for mass use,” Poonawalla said.
He said about the vaccine price, “We want the vaccine to be affordable and accessible to all. The Government of India will receive it at a far more affordable price of USD 3-4 since they will be buying in a larger volume. The priority is going to be India and the GAVI countries, after which only, the private market will open up where the pricing would be USD 6-8 per dose”
Poonawalla said its effectiveness in terms of affordability and composition makes it easier to transport and store at 2-8 ° C, i.e. normal refrigerator temperatures, for long periods, stating that Covishield is an extremely viable and essential vaccine for India and other low-and-middle-income countries. This will help to ensure fair distribution and sustainable affordability for countries with warm climates.
“Add to that, we have a long-standing relationship with the Jenner Institute at the University of Oxford for our various other vaccine initiatives and are hopeful that it will be an efficacious and immunogenic vaccine viable for mass use,” he added.
Zydus Group Chairman Pankaj R. Patel said, “we are committed to offering a safe and efficacious vaccine to fight the pandemic and our researchers have been working tirelessly to make this happen”.
The findings of the Phase I/II clinical trials of the ZyCoV-D vaccine have been submitted to the DCGI (Drugs Controller General of India) and the company hopes to begin Phase III trials, which will be conducted across the country for 30,000 volunteers, he added.
“We have the capabilities to manufacture over 120 million doses to start with and shall ramp up depending on the demand. Our focus right through the year has been to support patients with access to critical medicines, diagnostics and other medical essentials in an affordable way to fight COVID-19 and this will continue to be a key factor in our vaccine launch as well,” Patel said.
In September, billionaire philanthropist Bill Gates said that the ability of India to play a ‘huge role’ in the production and supply of COVID-19 vaccine to other developing countries would play a critical role in the global containment of the pandemic.
Recently, Krishna Ella, Chairman and Managing Director of Bharat Biotech, said that individuals who are infected should also take a vaccine, and India is well equipped for vaccine delivery logistics as it has a very robust immunization system.
By entering into an exclusive license agreement with US-based COVAXX, another domestic pharmaceutical firm, Aurobindo Pharma, has entered into the vaccine fray to produce, market, and manufacture a vaccine for India and UNICEF to combat COVID-19.
Wockhardt, in early December, joining hands in efforts to assist with the availability of the vaccine, said it is in negotiations with a number of global developers of COVID-19 vaccines to sell them drug substances as well as fill and finish development facilities.
“2021 will be a year of transformative measures that have been set into motion across the industry. Resilience-strengthening efforts through aspects like digital transformation, securing manufacturing and supply chains, will continue,” Cipla President and Global CFO Kedar Upadhye said.
The first human cases of COVID-19, the disease caused by the novel coronavirus, subsequently called SARS-CoV-2, were first recorded by officials in Wuhan City, China, in December 2019, according to the World Health Organization (WHO).