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What We Need To Do To Ensure India’s COVID Vaccine Shortage Doesn’t Get Worse

What We Need To Do To Ensure India’s COVID Vaccine Shortage Doesn’t Get Worse

Union health minister Harsh Vardhan displays a Covishield vaccine vial, at AIIMS, New Delhi, January 16, 2021. Photo: PTI Photo/Vijay Verma

The current official and public narrative on vaccine shortage appears to treat it as a temporary affair that will be resolved as soon as some imports arrive or Serum Institute and/or Bharat Biotech increase their production capabilities. The details, including timing and quantity, of all these events also remain obfuscated.

The narrative rests on the mistaken belief that India is the largest manufacturer in the world and could somehow make up for lost time.

The enormity of the problem and the lack of urgency in addressing it are all too apparent.

This is in spite of the data having been staring us in the face. The pace of vaccinations plummeted in April thanks to shortages, before dropping further in May. According to the Co-Win dashboard, only 3.6 million doses have been administered in the first three days of May – an average of 1.2 million doses per day.

Given the gravity of the situation, it’s baffling that the crucial issue of vaccine procurement and supply still hasn’t received the attention it deserves. There is currently zero visibility of the Centre’s plans for vaccine procurement, even if it palmed off this responsibility to ill-equipped state governments.

The following list enumerates what we ought to do to ensure more Indians have access to more vaccines soon.

Vaccine procurement and supply

1. Change the vaccination policy

Foremost, the Centre needs to take charge of all procurement and negotiations with all vaccine suppliers, domestic and foreign, without exception. It needs to negotiate one price for all supplies from one manufacturer – irrespective of whether the people receive the shot at a government centre or at a private facility. The Supreme Court also issued similar directions recently to the Centre, from a constitutional perspective. It should also book supplies by issuing confirmed orders on companies.

2. Work with Serum Institute to increase supplies

2a. Covishield – Negotiate one price for all supplies. Currently, the company has quoted Rs 150 per dose to the Centre, Rs 300 per dose to states and Rs 600 per dose to private hospitals. Considering half of the production has been allotted for the Centre at the lowest price, it’s easy to see that a uniform price between Rs 225 and Rs 250 should work for all customers and for the company.

Ask Serum Institute to provide a weekly schedule of supplies for the next year. This should reflect increased capacities: 100 million doses per month from July according to recent reports. The Centre has said that the company will supply 200 million doses by July, implying that 100% of production at the current capacity will be handed over to the Centre.

New reports indicate that the Centre has placed a total order of 266 million doses of Covishield from Serum Institute. A previous order for 110 million doses was released on April 28, expected to last until July, even as 13 million doses are pending against an even older order. Taken together, they represent less than 200 million doses already expected up to July.

Serum Institute has an obligation to supply vaccines to many countries and has an order for 200 million doses from Covax. Covax has said that it expects the company to resume supplies in May – supplies that were stopped in March after the magnitude of India’s second wave became apparent. This will reduce the quantities available for India.

The Indian government needs to resolve this conflicting demand for stock with Serum Institute and Covax, and then place a confirmed order for supplies in the next 12 months for the maximum quantity that the company can deliver.

Once this is done and the Centre takes the responsibility to allocate stocks to the states and private facilities, the pressure that Serum Institute CEO Adar Poonawalla has said he is under will disappear. He could even come back to India, to his company, where his services are most required at this point.

2b. Covovax – This is the two dose vaccine developed by Novavax and which has shown 89.3% efficacy in a phase 3 trial in the UK. It is effective against the B.1.1.7 and B.1.351 strains. Approval from the country’s Medicines and Healthcare products Regulatory Agency (MHRA) is expected soon and the country has already ordered 60 million doses. Trials in the US and Mexico are still underway.

Donald Trump during a tour of the Fujifilm Diosynth Biotechnologies’ Innovation Centre in North Carolina, a pharmaceutical manufacturing plant where components for the Novavax vaccine are being developed. Photo: Reuters/Carlos Barria

Serum Institute had signed an agreement with Novavax to manufacture Covovax at its Pune plant. Serum Institute also applied for bridging trials in India in January 2021, and said it will begin stockpiling doses from April 2021. It is not clear if it has done so. Now, Serum Institute expects to start production in September, a delay of three months.

In February 2021, Serum Institute said it would supply 1.1 billion doses of Covovax to low and middle income countries under an arrangement with Covax. It is not clear if any supplies have been earmarked for India or if the government has even discussed this with Serum Institute.

2c. Consolidated schedule – The Centre should seek clarity from Serum Institute about the total quantities of the two vaccines that will be produced at the company’s plant in Pune, whether the manufacture of Covovax will affect the output of Covishield, what quantities of the two vaccines will be available for India, and a monthly delivery schedule for at least the next 12 months.

3. Help Bharat Biotech enhance capacities for Covaxin

3a. Negotiate one price for Covaxin. According to the latest price revision, Covaxin costs Rs 150 per dose to the Centre, Rs 400 per dose to states and Rs 1,200 per dose to private hospitals. In this case as well, Bharat Biotech, Covaxin’s maker, has allocated half of its production to the Centre at the lowest price, so a uniform price of Rs 250-275 should be equally feasible.

3b. While Bharat Biotech has said it will increase production to 30 million doses per month and eventually to 70 million doses per month this year, the timelines are not clear. The Central government has said that the company will supply 90 million doses to it by July.

The Centre has also ordered 80 million doses of Covaxin from Bharat Biotech. But as with Serum Institute and Covishield, a previous order for 50 million doses was released on April 28, to last until July, while 11.2 million doses are pending against an older order.

If this hasn’t already been done, the government should release a purchase order for the company’s entire production so that it doesn’t export any stock. This is generally not good practice, but the times are desperate and India needs vaccines. For now, the company hasn’t exported any large quantities of Covaxin, although it has some agreements that it will have to honour.

3c. Times of India reported that Biovet Pvt. Ltd, an associate of Bharat Biotech, is expected to receive possession of a ready to use BSL-3 vaccine manufacturing facility near Pune, Maharashtra, as long as it’s used only to make Covaxin. This facility belonged to Intervet India Pvt. Ltd, a subsidiary of Merck & Co., and was taken over by Biovet.

However, the Deputy Conservator of Forests (Pune) put the transfer on hold in September 2020. Biovet filed a petition that is still pending in the Bombay high court. In April 2021, Biovet filed an interim application and is set to regain possession once it provides the undertaking. Bharat Biotech should ramp up production at this facility as soon as possible.

3d. Bharat Biotech has indicated that it has tied up with Indian Immunologicals Ltd. to manufacture Covaxin. It should provide visibility into when and how much stock we can expect from this facility.

3e. The Indian government has staked a claim in the intellectual property rights of Covaxin, since it enabled the development. It should then facilitate Covaxin manufacturing in the refurbished facilities of other vaccine manufacturers in India and which are currently lying idle. If not, Bharat Biotech should at least produce the bulk and allow multiple manufacturers to perform the fill and finish activity. This will increase the quantity of Covaxin available.

3f. Consolidated schedule – Finally, the government should ask Bharat Biotech to provide a detailed and consolidated schedule of deliveries, facility-wise, for the next year, to begin with.

4. Sign a deal with Pfizer

Pfizer chairman and CEO Albert Bourla has reiterated his company’s commitment to making the Pfizer vaccine available in India “through government channels”. The company has ample manufacturing capacity. Between Pfizer and BioNTech (which jointly own the vaccine), the capacity is expected to reach 2.5 billion doses a year by the end of 2021.

The two companies have added new sites in the US and Europe to make the vaccine, and have optimised production processes such that they can go from producing the DNA template to fill-and-finish, plus testing and release, in 6-8 weeks.

A healthcare worker of Asl Roma 1 holds a syringe after vaccinating a resident with a dose of the Pfizer-BioNTech COVID-19 vaccine at the Villa Verde elderly care home in Rome, January 2021. Photo: Reutrs/Guglielmo Mangiapane/File Photo

With confirmed orders for 1.4 billion doses this year – from the US (300 million), the EU (500 million), Japan (144 million), the UK (30 million) and others (450 million) – there are still a billion potential doses expected to be available with Pfizer.

Two formidable challenges remain: price and logistics.

While the price of the Pfizer vaccine has been around $20 (Rs 1,500) a dose in the US and the UK, the price for the EU isn’t well known. The Week stated it was $12 (Rs 900) a dose, while Economic Times said it was around $19 (Rs 1,425).

It is obvious that Pfizer is keen to strike a deal with India at the moment, and India needs the Pfizer vaccine too. The Centre should press ahead with a view to importing, say, 500 million doses in 2021 at the not-for-profit price that Pfizer has offered. The quantity should be decided based on logistics: this particular vaccine should be limited to the metropolitan and tier 1 cities.

On the logistics front: the Pfizer vaccine is transported in a thermal shipper that can preserve the doses for up to 30 days, provided the dry ice in the shipper is refilled every five days. The imports should be routed via Pfizer India, which should assume an active role, facilitated by the Central and state governments, including augmenting dry ice supplies and checking that freezers are available at local vaccination centres.

The government should also negotiate with, or persuade, Pfizer to explore manufacturing in India in the near future – or even to import the bulk and fill-and-finish in India. The company has used this strategy extensively in the US and Europe to increase its deliverable volumes.

5. Study Sputnik V agreements with Indian manufacturers

On May 1, the first consignment of the Sputnik V vaccine – 1.5 lakh doses – arrived in India, presumably to be followed by larger quantities, though the details aren’t public yet.

This quantity is to be sold and distributed via different channels, according to the prevailing vaccination policy, unless the government changes it. Dr Reddy’s is yet to disclose any details of confirmed orders and prices, though previous indications suggested a per-dose price of Rs 750.

The Russian Direct Investment Fund has entered into agreements with many vaccine manufacturers in India and aims to produce over 850 million doses – sufficient for more than 425 million people around the world.

The government should step in to prohibit the use of Indian vaccine manufacturing capacity to manufacture vaccines to be exported.

6. Get a plan for the Johnson & Johnson vaccine

This is a single dose vaccine and hence of much interest. It has demonstrated an efficacy of 67%. There have been sporadic concerns about adverse events following immunisation but, as with Covishield, they remain rare.

In February, Biological Evans, the company that has an agreement with Johnson & Johnson to make the vaccine, said its target is to produce 600 million doses a year. The vaccine is expected to be imported for fill-and-finish by June or July at Biological Evans. Details of the quantity expected and the price at which it will be available are not known yet. The company has supplied doses to the US government at $10 (Rs 750) per dose.

Here, again, the government should step in and obtain commitments on quantity and price for the Indian market from both Johnson & Johnson and Biological Evans.

7. Explore the Moderna vaccine

A person receives the Moderna COVID-19 vaccine at a hospital in New York, December 2020. Photo: Reuters/Eduardo Munoz/Pool/File Photo

At around $35 (Rs 2,625) a dose and a two-dose regime, the Moderna vaccine is the most expensive COVID-19 vaccine in the world at the moment. As such, it should probably be the last resort for India. Moreover, unlike Pfizer, Moderna hasn’t been inclined towards entering India.

However, Covax recently contracted Moderna to supply 500 million doses – 90% of them in 2022. The price was not disclosed. Moderna has also increased its manufacturing capacity from a targeted 800 million to a billion doses in 2021 to 3 billion doses in 2022.

Considering these factors, the Indian government should explore this option carefully. Recall that the Moderna vaccine also poses a logistical challenge, even if the temperature at which it needs to be stored isn’t as low as that for Pfizer’s shot.

8. Monitor progress of domestic and foreign vaccines under development

A number of candidates, both in India and abroad, are in various stages of trials and development. The government should keep a close watch over all of them and be prepared to act on inviting and/or approving them for use in India at the most opportune moment.

9. Track adverse events

This is critical – especially since all vaccines currently in play have received only emergency-use authorisation. Experts in India and the EU have already raised concerns about rare side-effects following vaccination by the AstraZeneca shot (Covishield), and experts in the US of the Johnson & Johnson shot. Regulators should keep a track of adverse events reported in India and abroad, and regularly share reports about them, government scientists’ assessments and the basis of their assessments with the public.

In case of any serious adverse events, the government should weigh the risks and benefits carefully and take appropriate action, and be transparent about its decisions. It should also consider phasing out a vaccine should it be confronted with a worst-case scenario.

10. Consolidate, share and review performance

It’s hard to overstate the benefits of a clear and detailed plan supported by an effective review mechanism. The government should help consolidate all the expected supplies, under various arrangements, from all indigenous and imported companies, in one place. The supply plan should be split by time interval: daily for the first month, weekly for the next two months, and monthly for the next nine months, adding up to an annual plan. The supply plan should also have the explicit agreement of the vaccine manufacturers.

Next, the Centre should craft a longer-term plan, for up to 2023, once it has overcome the demands of the current crisis. It should also set up a review mechanism that reports to the highest levels, and use the plan to manage expectations and to allocate supplies to the states in a fair and transparent manner.

Managing demand and expectations

It’s unlikely that any action now could dramatically increase the supply of vaccines in India. The results – depending on actual efforts made – may show up only in the third quarter of 2021. But we should be able to reap substantial benefits in 2022.

A best-case scenario, based on the government going all out to procure vaccines, would be the availability of 800-1,000 million doses in 2021. Together with the under-160 million doses administered thus far should suffice to fully vaccinate 35-40% of the Indian population.

And since the government has already expanded the vaccination drive to all adults in the country, it must mindfully reset expectations and reorient its vaccination policy. Epidemiologists, doctors and state governments should be allowed a say in the decision-making process.

The Centre should determine the actual allocation of stocks to state governments on a daily/weekly basis. This should be on the basis of a predetermined template that anticipates logistical challenges, in addition to the parameters used by the vaccination policy. States should have confirmed supply schedules for at least one month at a time and visibility for at least the subsequent two months – so that they can plan and communicate with the people effectively.

While private hospitals should get their stock at the uniform price for all parties, negotiated by the Central government, the state governments should have a say in the allocations between them. Indeed, logistics within the state should be the responsibility of the state governments, in consultation with the manufacturers.

Finally, there should be a dashboard that shows the planned v. actual supplies and planned v. actual vaccinations.

COVID-19 has brought India down to its knees. The country needs vaccines and help from the Centre to stand up again. Will the Centre rise to the occasion? It must.

The author has no affiliations at the moment with, nor has she worked in the past for, any of the companies named in this article. All statements about vaccines in this article are based on current information in the public domain, to the best of her knowledge.

Neeta Sanghi has over three decades’ experience in managing pharmaceutical supply chains. She is currently working on a book about the industry.

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