Don’t pin hopes on a Covid-19 vaccine. It may be a two-year wait

An effective vaccine may be the only real protection against Covid-19 as things stand, but don’t pin your hopes on getting it soon. As India’s death toll from Covid crosses one lakh, insights from the scientific community and government officials suggest it could take up to two years from now to get the much-awaited shot.

This is not only because the formidable task of delivering the vaccine to over 1.3 billion Indians, in a massive, never-done-before exercise, is one that will test the system at every step, but also because there are several imponderables involved in the process. Here’s a sampler: Once the vaccine gets the needed regulatory approvals by the first half of 2021 — this in itself is a very big ‘if’ — statutory agencies and manufacturing firms have to navigate the minefields of cost per dose, establishment of a cold chain, arranging adequate numbers of trained people to push the needle and ramping up production lines without compromising other vaccines needed for immunisation.

“From regulatory approval, it would take a minimum of one year before the vaccine is available to the common man,” K Srinath Reddy, President, Public Health Foundation, said.

The first of these steps, picking out the right vaccine for commercial roll out, is an extremely critical one. Any adverse medical reaction would not only give a body blow to people’s faith in the Covid-19 vaccine but would also be counter-productive to existing immunisation schemes. The good news is that there is enough information about potential challenges to the delivery of the vaccine that could alert authorities about what could go wrong and help fix the gap.

Crossing the cost hurdle

Globally there are more than 180 vaccines under various stages of development in the laboratories while nine have entered the third and most crucial parts of clinical trial. This is remarkable given that traditionally vaccine development takes nearly 15 years. With the pandemic killing more than a million worldwide, the process has been accelerated all over the globe resulting in Phase III clinical trials within 11 months of the disease being reported.

Three vaccines are in trial in India and regulatory approvals are being sought for a fourth one. But the first two that are likely to come through are the Oxford University-AstraZeneca-Serum Institute vaccine (ChAdOxnCoV-19) and the Sputnik-V developed by Russia. Assuming that they clear the clinical trials with flying colours, the first hurdle before the government will be to fix a price for the buyer.Last month, Serum Institute of India’s chief executive officer Adar Poonawalla asked whether the government has Rs 80,000 crore in its kitty to pay for the vaccination of all Indians. Back-of-the-envelope calculations show that for a population of 138 crore, this roughly translates into Rs 290 for one dose and Rs 580 for a two-dose regimen.

Govt faces hurdles of cost, storage and who to vaccinate first

Considering that the company had earlier spoken of delivering the vaccine at a cost of Rs 225 per dose, one would assume that other expenses are included in the Rs 290 price band. While this may be an acceptable price for those in the middle and upper-classes, it may not be a price acceptable to the government, which would have to procure the vaccine for public use.

“Rs 290 is not a feasible price for the government programme. Even with a price of (lets say) Rs 40 per dose, the (Indian) government would be needing close to one billion dollars,” said Ramanan Laxminarayan of the Centre for Disease Dynamics, Economics and Policy, Washington DC.

Union Health Secretary Rajesh Bhushan said he too didn’t agree with Poonawalla’s estimates. The government has created a committee on Covid-19 vaccines that has met five times so far to deliberate on issues related to vaccine procurement, distribution and costs. “We have calculated the amount required in the meetings and currently, that amount is available with the government,” Bhushan said.

The X-factor, however, is the chance of a foreign vaccine (like the ones being developed by Moderna or Pfizer) beating the others in the race. “It would be hard negotiations then and the terms and conditions of those negotiations would become important to decide the vaccine’s availability to common Indians,” Reddy said.

Planning the who & how of vaccination

Once the first challenge is overcome, the government would have to deal with an equally complicated and politically-loaded issue of whom to vaccinate, given that the stock is limited.

“The first priority would be doctors, nurses and healthcare workers. It may subsequently be given to older people and those with comorbidities. But with studies showing more than 65% of Covid-19 affected people having a comorbidity, the government needs to start an exercise to identify the people who would receive the vaccine,” said Shahid Jameel, a virologist and Director of the Trivedi School of Biosciences, Ashoka University. The policy needs to be transparent with all state governments coming on-board, Reddy added.

The third hurdle is a huge logistic challenge. While there is a cold chain in place for the polio vaccine, the Covid-19 vaccine simply can not ride piggyback on that for two reasons: First, much more storage space is needed and second the vaccine (depending on the clinical trial outcome obviously) may need a temperature beyond what is provided in a simple refrigerator.

Added to this complication is a rule that doesn’t permit ANM and ASHA workers to administer an injection (due to lack of proper training), leading to the key question on the availability of an adequate number of doctors and nurses to vaccinate a billion-plus population. “Its a logistical nightmare and needs a mammoth effort,” said Laxminarayan.

Battling unknowns of Covid-19

Even after these challenges are navigated successfully, there is no answer to the final question: How long will the protection last? Will this be an annual vaccine like the flu shots or will the protection remain for a longer period? Experts are divided on this.

“Scientific evidence so far suggests that Covid-19 vaccines are unlikely to be efficient for more than a year as the antibodies are not long-lasting enough. But since the T-cell remains, it is possible that in future an infected person may pick up the infection again, but that won’t lead to the disease. But nothing can be said definitely in the absence of a long term study,” Jameel of Ashoka University said.

“Since nobody has followed the virus for a long time, there is little data on how long the immunity lasts. It can be five months or five years; no one knows at the moment.”