Representative image of vaccines in vials. Photo: Sanofi Pasteur/Flickr, CC BY-NC-ND 2.0.
New Delhi: With Union health minister Harsh Vardhan saying India will have more than one COVID-19 vaccine available to distribute by early next year, experts have raised questions about whether the country has the requisite infrastructure to store the vaccines and the logistical capacity to distribute them.
India plans to immunise 200-250 million people – some one-sixth of its population – with 400-500 million COVID-19 vaccines by July 2021, the health minister said on October 4. In the first round, vulnerable population groups, including healthcare workers, will be prioritised.
In this mammoth exercise, India has two advantages if a vaccine were to become available: Indian companies already manufacture and supply the bulk of the world’s vaccines, and India has already experience in conducting one of the world’s largest immunisation programmes for children and mothers, as IndianSpend has reported.
Currently, India’s universal immunisation programme (UIP) targets 26.7 million newborns and 29 million pregnant women every year – together making up 4% of the total population. These people receive about 390 million doses of vaccines, over nine million sessions, every year.
In this scenario, to administer 400-500 million doses of a COVID-19 vaccine by the first two quarters of 2021, India needs to ramp up its existing infrastructure significantly. This capacity-building entails strengthening the vaccine cold-chain network, increasing the stock of ancillary items like syringes and glass vials, and training healthcare workers. Otherwise, a COVID-19 vaccine may not be made accessible to people who need it the most, according to IndiaSpend.
Although private players make most of India’s vaccines, the entire cold-chain is operated by the government (however, a few private players have forayed into the system of late with ‘Made in India’ contributions).
At the moment, the UIP has over 27,000 cold-chain points and 76,000 items of cold-chain equipment, with 95% located in primary health centres, community health centres and sub-centres. There are also 55,000 staff members, according to government data. By 2014, the government added five new vaccines to the basket of routine vaccines, and needed more cold-chain equipment. By 2017, 28,340 new items on this list were purchased.
The cold chain will be vital to the new COVID-19 vaccine too. “There is some spare capacity in the existing cold-chain network because India has been scaling back its polio vaccinations,” Gagandeep Kang, a member of the World Health Organisation’s (WHO) working group on COVID-19 vaccines, told IndiaSpend.
“But for the 500 million COVID-19 vaccines which the Indian government is talking about – we don’t even know yet whether there will be those many doses available to India, and who the priority groups are that will need it. Only when the government discloses this can we look into whether India’s existing cold-chain capacity is really enough,” Kang added.
Currently, vaccines under the UIP programme – except those for the poliovirus and rotavirus – are stored at 2-8º C. Some of the current COVID-19 vaccine candidates, such as those from AstraZeneca, Johnson & Johnson and Novavax, will also need to be stored in the same range. Others, including those by Moderna and Pfizer, will need to be stored at sub-zero temperatures. If such vaccine candidates prove successful, India’s cold-chain won’t be able to stock them without affecting existing vaccines, IndiaSpend pointed out.
At a press conference on Tuesday, ICMR director general Dr Balram Bhargava said a sub-group of the National Committee for Vaccine Administration has already mapped the available cold-chain infrastructure being utilised for the government’s immunisation programme and made projections for additional requirements. The group is engaged in mapping the private sector facilities that could serve the needs of supplementing the cold-chain equipment, he told the media in response to a question.
Syringes and vials
Commensurate with the millions of vaccine doses that the country expects to administer, India will also need syringes and vials in the same range. Manufactures of such equipment fear that as the government hasn’t yet floated any tenders or reached out to them for these products, it may be left scrambling later – just as it did with PPE earlier during the epidemic.
According to IndiaSpend, the managing director of Borosil Klasspack, which makes glass vials for vaccines, Prashant Amin, said that testing vials are also integral to the approval process for vaccines: “After a vaccine is placed in a glass vial, the complete package, including the rubber stopper, is studied for the vaccine’s stability. Only after this do companies prepare a full dossier to send to national drug regulators for approval.”
Experts on vaccination and immunisation believe that COVID-19 vaccine efforts could shift the focus away from immunisation of children and pregnant mothers.
Routine immunisation has already been stretched during the COVID-19 lockdown. Between January and August 2020, only 12 million children were vaccinated, a coverage of 68.5%, in eight months, according to data from the Union health ministry. But 17.8 million children should have been vaccinated in these months to meet the UIP’s 2019 goal of vaccinating 26.7 million infants every year. In fact, India’s routine vaccination programme has struggled to meet its goal of vaccinating 55.7 million people annually over the last five decades, according to the UIP’s five-year plan in 2018.
India does not have a universal adult vaccination programme, for example for flu shots, the human papillomavirus or pneumococcus. If a COVID-19 vaccine becomes available, and if it piggybacks on the existing children’s and mothers’ immunisation programme, it could burden the existing system as well as compromise the health of children and pregnant women.
Currently, two indigenously-developed vaccine candidates – one by Bharat Biotech in collaboration with Indian Council of Medical Research and the other by Zydus Cadila Ltd. – are in phase 2 of their human clinical trials. The Pune-based Serum Institute of India has partnered with AstraZeneca to manufacture the ‘Oxford’ COVID-19 vaccine candidate, and is also conducting its phase 2 and 3 human clinical trials in India.
Around the world, 42 vaccine candidates are in different stages of trials, and are being monitored by the WHO.
Note: This article was updated on October 14 at 11:28 am to include Balram Bhargava’s statement on cold chain infrastructure.