Safety, shortage and scaling-up: How prepared is India for the arrival of the COVID-19 vaccine?

India has the world’s largest immunisation programme, annually covering 157 million newborn, young children and pregnant women. The Indian government plans to administer the COVID-19 vaccine to about 300 million high-risk category people by September 2021. Clearly, it won’t be easy.

Nidhi Jamwal
Deputy Managing Editor| Updated: November 30th, 2020

Photo: Pixabay

In the past couple of weeks, several companies across the globe have issued press statements announcing the efficacy of their COVID-19 vaccine candidates, giving hope the vaccine will be available soon. The Indian government, which already runs the world’s largest immunisation programme, is drawing up a special immunisation programme for the COVID-19 vaccine.

Union health minister Harsh Vardhan recently informed that India would get a COVID-19 vaccine within the first quarter of 2021 and about 250-300 million people would be vaccinated by September. This COVID-19 vaccine target is much higher than the 157 million newborn, young children and pregnant women covered annually under the government’s routine immunisation.

About 157 million beneficiaries, including mothers and children, are vaccinated under the universal immunisation programme in India every year.

As per the government’s COVID-19 vaccine strategy, to begin with, about 30 million frontline healthcare workers will be vaccinated on priority, as they face maximum risk. The second priority group is the elderly population, especially those with comorbidities. For a large country with 1.35 billion people, vaccinating the entire population will be a huge challenge as making available several million doses of vaccine in a short span of time and at an affordable price will be no less than a feat.

“The COVID-19 vaccine would be first distributed among the special groups. After health workers, priority must be given to police personnel, jawans [soldiers] and then to patients above fifty years of age and those suffering from acute illness,” K Suresh Kishanrao, a public health specialist associated with the Indian government’s universal immunisation programme for nearly five decades, told Gaon Connection.

“The vaccine may take a long time to reach the common people. It might be difficult for the government to provide the vaccine to them even by the next year,” he added.

Predictably, COVID-19 vaccine tourism has kicked off, with a Mumbai-based travel company offering a package, priced Rs 1,74,999 — this comprises Mumbai-New-York-Mumbai airfare, three night/four day stay along with a vaccine shot to ‘high networth individuals’ who wish to fly to the US.

This is just the beginning.

There are also concerns about the lack of transparency in clinical trials data and vaccine safety. Most companies have made efficacy claims by issuing press statements, but have not publicly shared the clinical trials’ data.

Based on interim analysis, Pfizer Inc. and BioNTech SE have claimed vaccine efficacy of 90 per cent; Moderna has declared vaccine efficacy of 94.5 per cent; and the Oxford/AstraZeneca COVID-19 vaccine candidate called AZ1222, being developed in partnership with Pune-based Serum Institute of India Ltd, has showed 70 per cent efficacy. Meanwhile Hyderabad-based Bharat Biotech’s COVAXIN, being developed in collaboration with the Indian Council of Medical Research and National Institute of Virology, is expected to have an efficacy of 60 per cent.

Serum Institute of India. Photo: Narendra Modi/Twitter

It is largely believed that the Indian government will not depend on international vaccines, and Covaxin or the Oxford/AstraZeneca COVID-19 vaccine may be the preferred choice depending on the trial results and related data.

Safety concerns

“There is a sense of anticipation in the public for a COVID-19 vaccine. But there is a lack of transparency regarding clinical trials data and the regulatory approval processes, which precludes independent scrutiny of data prior to approval of any vaccine candidate. In light of the preparations being made for rolling out vaccines to millions of people, it is essential that these vaccines are safe and rigorously tested,” Malini Aisola, co-convenor of All India Drug Action Network, told Gaon Connection.

“At present, Bharat Biotech is in Phase 3 of vaccine trials for COVAXIN. The protocol for the Phase 1/2 trials was amended before the Phase 2 trial began,” she said. For instance, the sample size for the Phase 2 trial was reduced from 750 to 380 because the placebo arm was dropped.

“Another change was in the dosing regimen — whereas in Phase 1 the vaccine doses were administered 14 days apart, the protocol was amended so that dosing would be 28 days apart in Phase 2. The rationale provided for these changes was ‘to expedite the phase 2 trial’, but there is nothing scientific about this,” she added. 

Image used for representational purpose. Photo: Pixabay

It has recently emerged that, during its phase one trials, COVAXIN experienced an adverse event in a volunteer that Bharat Biotech did not promptly admit to the public, but reported to the necessary committees and the regulatory body within 24 hours of the incident. 

Sheela Panicker, media representative for Bharat Biotech, told Gaon Connection that the company is moving towards the third stage in the development of the corona vaccine, wherein it will undertake testing on more than 26,000 volunteers across 25 different centres in 13 states of the country. “We are hoping that by June 2021, we will be able to launch the vaccine,” she added.

Meanwhile, a 40-year-old Chennai-based participant in the trial for the ‘Covishield’ vaccine developed by Serum Institute of India Ltd has sent a legal notice to the company seeking Rs 5 crore as compensation. The legal notice alleged that the man suffered serious neurological impairment after the under-trial vaccine was administered to him.

Vaccine Manufacturing. Photo: Serum Institute of India.

The company has, in turn, issued a statement calling the allegations “malicious and misconceived” and claimed the volunteer was specifically informed by the medical team that the complications were independent of the vaccine trial. The Serum Institute of India said it would “seek damages in excess of 100 crore for the same and will defend such malicious claims”.

Echoing Aisola’s concerns, Anant Bhan, an independent researcher on bioethics, global health and health policy, said we need good quality data on the safety, efficacy and cost effectiveness of the COVID-19 vaccine candidates, which will decide the vaccine we use in India. “Once a decision is made to use a particular COVID19 vaccine in the country, the next challenge will be to make it available to the entire population that is eagerly awaiting the shot,” he told Gaon Connection.

But scaling up and delivery, especially in the hinterland, will be a huge challenge. “Our health system has never done anything like immunising the entire population. Our universal immunisation programme is mostly targeted towards pregnant women, newborns and young children, and, even then, the coverage is not hundred per cent,” he said.

A child being vaccinated by a polio vaccination team. Photo: We the Solution/flickr

62% coverage under UIP

India’s universal immunisation programme (UIP) is the world’s biggest such programme. Under it, the Indian government provides vaccination free of cost against 12 vaccine-preventable diseases.

According to a Union health and family welfare ministry document, every year, 27 million newborns are vaccinated with all primary doses, and 100 million children between one and five years of age with booster doses of UIP vaccines. In addition, 30 million pregnant mothers are targeted for tetanus vaccination each year. Thus, about 157 million beneficiaries are vaccinated under the universal immunisation programme.

However, even in this limited target population, the vaccine coverage is only 62 per cent, as documented in the National Family Health Survey (2015-16). “The slow progress in full immunization coverage in India during 2005-06 to 2015-16 needs attention, particularly when new vaccines are being introduced in immunization programme, and lessons learned should inform our way forward,” reads the Union health ministry’s ‘Comprehensive Multi-Year Plan 2018-2022: Universal Immunization Programme.  

Source: https://nhm.gov.in/New_Updates_2018/NHM_Components/Immunization/Guildelines_for_immunization/cMYP_2018-22_final_pdf

Additionally, this year, vaccination coverage has been affected due to the COVID-19 pandemic. Both the World Health Organization and UNICEF have been warning member countries against the decline in vaccinations due to the pandemic. “In such a scenario, immunising the entire population, even in a phased manner, will be a big challenge,” said Bhan.

Priority basis

The Indian government isn’t unaware of the COVID-19 vaccination challenge. This is why it has decided to follow a priority list to vaccinate people. The Centre has directed all states to prepare their own priority list of people in the high-risk category.

“At present, this listing is going on in Jharkhand,” Nitin Madan Kulkarni, secretary at the department of health in Jharkhand, told Gaon Connection.

In Haryana. the list of all the healthcare workers is being made. “Data has also been sought from all government departments. The final list will be forwarded to the headquarters as soon as it is ready,” informed Sant Lal Verma, chief medical officer in Panipat district of Haryana.

According to Vikasendu Agarwal, state surveillance officer, Uttar Pradesh, the state’s list of high-risk category healthcare workers, who are directly working in COVID-19 hospitals and who will be vaccinated first, has already been prepared and a social portal on the same is ready. Second on the priority list are pregnant women and the elderly. 

“As soon as the vaccine is made available, we will ship it to the districts, who will store the vaccine doses in the revamped old chain system and start vaccination,” he told Gaon Connection.

Photo: Aisanet

Last-mile challenge

Vaccinating the population against COVID-19 is expected to face the last-mile challenge, including cold chain management. The Central government needs to ramp up its cold chain under the Universal Immunisation Programme, which, at present, consists of a network of 27,000 cold chain points created across the country where vaccines are stored at recommended temperatures.

It is claimed that the Pfizer vaccine will need to be maintained at minus 70 degree Celsius. The Moderna vaccine candidate can be shipped in minus 20 degrees Celsius and held at 2-4 degrees for seven days.

“At present, India has a cold storage facility with a minimum storing temperature of only upto minus twenty five degree Celsius and that too at only one or two places in each state,” informed Kishanrao. “As far as Pfizer’s Corona vaccine is concerned, it would be difficult for us even to reach minus forty degree Celsius. Not just  India, even many developed countries do not have the facilities to store at the extreme temperatures required for the Pfizer vaccine,” he added.

And so, delivering the COVID-19 vaccine to various towns and villages will be a challenge. “That is why we need to develop a vaccine that can be stored between zero and minus twenty five degrees celsius,” said Kishanrao.

Renu Singh, along with 25 more ASHA (accredited social health activist) workers, is working on the vaccination programme at 13 gram panchayats in Itaunja area of Lucknow district in Uttar Pradesh. Talking about the last-mile connectivity challenge, she told Gaon Connection: “The cold storage of vaccines is at present done at the community health centres, from where we carry polio and measles vaccines in ice bags to the villages. Although such vaccines require a temperature of only between zero and minus two to minus six degrees Celsius, we still have to be very careful.” 

Frontline health workers ensuring the polio vaccine reaches the remotest parts of the country. Photo: Ministry of Health, India, twitter.

There are other issues too. “If we open the vaccine bag more than six times, there is a risk of the vaccine going bad. If the COVID vaccine needs a temperature lower than this, the government will have to make some other arrangements to provide such facilities to the villages,” she added.

State governments claim they are already working on revamping their cold chain systems. “Because of the Pulse Polio campaign and intensified vaccination campaigns, we have a good cold chain system in the state. We can easily maintain the cold chain in block-level hospitals till minus twenty degree Celsius,” informed Agarwal.

According to Aisola, we need millions of doses of COVID-19 vaccine, because of which the government is looking at multiple vaccine candidates and considering different sources to bring vaccines to India. “We also need millions of syringes, vials, etc. Logistically, it will be quite a feat to roll out vaccination against COVID-19 and also ensure there is no disruption to existing vaccine programmes. Adequate financial resources are, of course, a prerequisite,” she said. 

Above all, she added, we need to ensure the vaccines eventually distributed have been assessed rigorously through transparent mechanisms. This is critical not only for public confidence, but also because the government cannot afford to expend limited public resources on unproven vaccines and which, in future, are suboptimal on safety and effectiveness.

With inputs from Kushal Mishra.