As Covid rages, India lands in a vaccine mess of its own making
As Maharashtra, India’s worst Covid-19-affected state, stopped vaccinating people in the 18-44 age group due to paucity in vaccine supply — a trend that may be picked up by Karnataka and Delhi in the next few days — medical and public health experts have squarely blamed the Centre for its abject failure in arranging adequate number of doses. This, despite knowing the size of the target population and production capacities of the two big domestic vaccine manufacturers, the first responders to the crisis, well in advance.
The present crisis had its genesis in the early months of the pandemic when Prime Minister Narendra Modi first announced vaccines for all but soon moved the goalposts by announcing that only 30 crore people needed to be vaccinated as a critical mass, that would be enough to break the virus’ chain of transmission. However, there was barely any attempt to ensure timely supply of 60 crore doses either from global players or Indian manufacturers like the Serum Institute of Institute (SII) or Bharat Biotech International Limited (BBIL) even as the requirement gradually kept on increasing over the next few months.
“The supply would have been more liberal had advance purchase orders been given very early, or at least the volume that the government would desire on a timescale was given in September 2020 to Bharat Biotech, when phase-3 trial approval was given. In September 2020, the phase-2 trial had given clear clues to a good vaccine,” said T Jacob John, eminent virologist and a former professor at the Christian Medical College, Vellore.
Also read: When will US send Covid-19 vaccines to India?
Experts pointed out that the Centre should have made a risk investment in local vaccine manufacturing firms to ramp up production and pre-book some of the capacities of global giants like Pfizer, Moderna and Johnson and Johnson (J&J). “We could have also placed global orders early. It’s a mistake that we made,” a top government official, who did not wish to be identified, told DH.
Several countries pre-booked for eventual supply of vaccine candidates that had not been shown to work as yet, leave alone approved for usage. Many, including the USA, also pumped billions of dollars into the vaccine industry to augment production. India did not opt for either of the two routes.
“India should have relied on the two Indian companies but they should have been given some assurances of how much vaccine would be picked and at what pace. That was left to the companies to decide — which is not the way the government should have planned. As a result, when the dire need for huge volumes of vaccine became apparent, India could only get the amount the companies had made and is making at their own pace,” said John.
Also read: Steroids, diabetes main causes of black fungal infections in Covid patients
In addition, the government also did not mediate licensing deals early on between Indian vaccine manufacturers and global vaccine developers, without which these capacities would not be of much use anyway, pointed out biologist Satyajit Rath, formerly associated with the National Institute of Immunology, Delhi.
The SII invested Rs 2,012 crore of its money and Rs 2,236 crore from the Bill and Melinda Gates Foundation in building production capacity for its vaccines, while BBIL relied almost entirely on its internal resources. The Centre only covered the cost involved in research and clinical trial. Even in November, when the government approved a Rs 900 crore for Covid-19, the money went to the development of new vaccines in laboratories rather than ramping up manufacturing capacities.
With more than 2.5 lakh daily new cases, the Centre, in the third week of April, announced it would give Rs 3,100 crore to SII and Rs 1,500 crore to BBIL for capacity boosting. The Finance Ministry on April 21 said the government cleared an advance payment of Rs 4,600 crore to SII and BBIL to help ramp up capacities, but there is no clarity on whether the money has been released even after three weeks.
Also read: Overall Covid-19 situation stabilising in India: Centre
The two companies have only been paid in advance for the vaccine that the Centre would buy — Rs 1,732.50 crore to SII for 11 crore doses of Covishield to be supplied in May, June and July, and Rs 787.5 crore to BBIL to supply 5 crore doses of Covaxin in the same period. The only additional money promised by the Centre to BBIL is over Rs 130 crore, which would be used to increase supply at four new sites, three of which are public sector units. SII says it will raise its capacity up to 10 crore by August while BBIL plans an increase up to 5.5 crore doses per month by July.
Wrong calculations
Did the government err in the maths? The size of the initial target population was known, production capacities of the companies (60-70 million for SII and 10 million for BBIL last year) were known as well as the SII’s international obligation to supply 50% of its vaccine to the WHO-Covax channel. So, why not do the arithmetic and look for options to build the stockpile?
“There seems to have been an assumption that vaccine doses would be available when needed based on India’s historically strong position with vaccine manufacturing. There may have also been overcommitment by manufacturers, especially SII, for domestic and global needs,” said Krishna Udaykumar, professor of global health medicine at the Duke University, USA. “The companies promised more and faster. But now that’s water under the bridge,” noted the top government official.
“My guess is no maths was ever applied. Production is a function of time when capacity is fixed. Creating additional capacity costs money, which firms would not do on their own without knowing how much the government would ask for. Was there any guarantee that any vaccine would be purchased from Indian companies at all? Did the government reveal its intention regarding vaccine use on a huge scale,” asked John.
Also read: Home isolation discontinued in rural Karnataka to prevent spread of Covid-19
Notwithstanding the strained supply, the Centre did exactly that, further shrinking the availability. It first opened vaccination for everyone above 45, arguing they are the most vulnerable. Within weeks, the 18-44 category was added. The target population is now 95 crore, which means more than 200 crore doses would be required. But till July, only 51.6 crore are assured, suggesting that people’s struggle with vaccines would continue for the time being.
“The poor timing of expanding eligibility increased demand significantly without increasing supply. This model risks worsening inequities in access within India, making it harder for the most vulnerable to access vaccines,” said Udaykumar.
Government principal advisor and Niti Aayog member Vinod Paul claimed 216 crore doses of vaccines would be made available between August and December, of which 145 crore would be the three approved ones — Covishield (75 crore), Covaxin (55 crore) and Sputnik-V (15 crore). The remaining 71 crore are vaccines that are still undergoing trials and have not received regulatory approvals.
Importing vaccines
To make matters worse, Pfizer, Moderna and J&J said they would not be able to chip in till the third quarter of 2021. Importing vaccines isn’t a credible option in the next few months as there are few stockpiles or excess capacity right now.
Also read: The curious case of gaps between Covid-19 vaccine doses in India, UK
“We will be well into 2022 before India has enough vaccine supply. Even with supply, there will be distribution and vaccination challenges. India will have to rely on other public health measures to gain and maintain control over the pandemic,” observed Udaykumar.
Concurred John, “The only way out is social vaccine. Universal mask-wearing and non-crowding are key behaviours. This is inexpensive, yet highly effective to reduce infections. But for the leaders, these may look not sensational enough.”
As Maharashtra, India’s worst Covid-19-affected state, stopped vaccinating people in the 18-44 age group due to paucity in vaccine supply — a trend that may be picked up by Karnataka and Delhi in the next few days — medical and public health experts have squarely blamed the Centre for its abject failure in arranging adequate number of doses. This, despite knowing the size of the target population and production capacities of the two big domestic vaccine manufacturers, the first responders to the crisis, well in advance.
The present crisis had its genesis in the early months of the pandemic when Prime Minister Narendra Modi first announced vaccines for all but soon moved the goalposts by announcing that only 30 crore people needed to be vaccinated as a critical mass, that would be enough to break the virus’ chain of transmission. However, there was barely any attempt to ensure timely supply of 60 crore doses either from global players or Indian manufacturers like the Serum Institute of Institute (SII) or Bharat Biotech International Limited (BBIL) even as the requirement gradually kept on increasing over the next few months.
“The supply would have been more liberal had advance purchase orders been given very early, or at least the volume that the government would desire on a timescale was given in September 2020 to Bharat Biotech, when phase-3 trial approval was given. In September 2020, the phase-2 trial had given clear clues to a good vaccine,” said T Jacob John, eminent virologist and a former professor at the Christian Medical College, Vellore.
Also read: When will US send Covid-19 vaccines to India?
Experts pointed out that the Centre should have made a risk investment in local vaccine manufacturing firms to ramp up production and pre-book some of the capacities of global giants like Pfizer, Moderna and Johnson and Johnson (J&J). “We could have also placed global orders early. It’s a mistake that we made,” a top government official, who did not wish to be identified, told DH.
Several countries pre-booked for eventual supply of vaccine candidates that had not been shown to work as yet, leave alone approved for usage. Many, including the USA, also pumped billions of dollars into the vaccine industry to augment production. India did not opt for either of the two routes.
“India should have relied on the two Indian companies but they should have been given some assurances of how much vaccine would be picked and at what pace. That was left to the companies to decide — which is not the way the government should have planned. As a result, when the dire need for huge volumes of vaccine became apparent, India could only get the amount the companies had made and is making at their own pace,” said John.
Also read: Steroids, diabetes main causes of black fungal infections in Covid patients
In addition, the government also did not mediate licensing deals early on between Indian vaccine manufacturers and global vaccine developers, without which these capacities would not be of much use anyway, pointed out biologist Satyajit Rath, formerly associated with the National Institute of Immunology, Delhi.
The SII invested Rs 2,012 crore of its money and Rs 2,236 crore from the Bill and Melinda Gates Foundation in building production capacity for its vaccines, while BBIL relied almost entirely on its internal resources. The Centre only covered the cost involved in research and clinical trial. Even in November, when the government approved a Rs 900 crore for Covid-19, the money went to the development of new vaccines in laboratories rather than ramping up manufacturing capacities.
With more than 2.5 lakh daily new cases, the Centre, in the third week of April, announced it would give Rs 3,100 crore to SII and Rs 1,500 crore to BBIL for capacity boosting. The Finance Ministry on April 21 said the government cleared an advance payment of Rs 4,600 crore to SII and BBIL to help ramp up capacities, but there is no clarity on whether the money has been released even after three weeks.
Also read: Overall Covid-19 situation stabilising in India: Centre
The two companies have only been paid in advance for the vaccine that the Centre would buy — Rs 1,732.50 crore to SII for 11 crore doses of Covishield to be supplied in May, June and July, and Rs 787.5 crore to BBIL to supply 5 crore doses of Covaxin in the same period. The only additional money promised by the Centre to BBIL is over Rs 130 crore, which would be used to increase supply at four new sites, three of which are public sector units. SII says it will raise its capacity up to 10 crore by August while BBIL plans an increase up to 5.5 crore doses per month by July.
Wrong calculations
Did the government err in the maths? The size of the initial target population was known, production capacities of the companies (60-70 million for SII and 10 million for BBIL last year) were known as well as the SII’s international obligation to supply 50% of its vaccine to the WHO-Covax channel. So, why not do the arithmetic and look for options to build the stockpile?
“There seems to have been an assumption that vaccine doses would be available when needed based on India’s historically strong position with vaccine manufacturing. There may have also been overcommitment by manufacturers, especially SII, for domestic and global needs,” said Krishna Udaykumar, professor of global health medicine at the Duke University, USA. “The companies promised more and faster. But now that’s water under the bridge,” noted the top government official.
“My guess is no maths was ever applied. Production is a function of time when capacity is fixed. Creating additional capacity costs money, which firms would not do on their own without knowing how much the government would ask for. Was there any guarantee that any vaccine would be purchased from Indian companies at all? Did the government reveal its intention regarding vaccine use on a huge scale,” asked John.
Also read: Home isolation discontinued in rural Karnataka to prevent spread of Covid-19
Notwithstanding the strained supply, the Centre did exactly that, further shrinking the availability. It first opened vaccination for everyone above 45, arguing they are the most vulnerable. Within weeks, the 18-44 category was added. The target population is now 95 crore, which means more than 200 crore doses would be required. But till July, only 51.6 crore are assured, suggesting that people’s struggle with vaccines would continue for the time being.
“The poor timing of expanding eligibility increased demand significantly without increasing supply. This model risks worsening inequities in access within India, making it harder for the most vulnerable to access vaccines,” said Udaykumar.
Government principal advisor and Niti Aayog member Vinod Paul claimed 216 crore doses of vaccines would be made available between August and December, of which 145 crore would be the three approved ones — Covishield (75 crore), Covaxin (55 crore) and Sputnik-V (15 crore). The remaining 71 crore are vaccines that are still undergoing trials and have not received regulatory approvals.
Importing vaccines
To make matters worse, Pfizer, Moderna and J&J said they would not be able to chip in till the third quarter of 2021. Importing vaccines isn’t a credible option in the next few months as there are few stockpiles or excess capacity right now.
Also read: The curious case of gaps between Covid-19 vaccine doses in India, UK
“We will be well into 2022 before India has enough vaccine supply. Even with supply, there will be distribution and vaccination challenges. India will have to rely on other public health measures to gain and maintain control over the pandemic,” observed Udaykumar.
Concurred John, “The only way out is social vaccine. Universal mask-wearing and non-crowding are key behaviours. This is inexpensive, yet highly effective to reduce infections. But for the leaders, these may look not sensational enough.”
