India to Make 216 Crore Vaccines By Dec? Data Shows Big Challenges

The stretched production capacities of vaccine manufacturers might pose a big challenge to the Centre’s goal.

Amid the Centre facing severe criticism over the shortage of vaccines and healthcare infrastructure to mitigate the pandemic, Niti Ayog’s VK Paul said that India will manufacture 216 crore doses of COVID-19 vaccines between August and December in a bid to vaccinate all citizens by December 2021.

Paul on Thursday said that “there should be no doubt that vaccine will be available for all as we move forward.”

While the goal of 216 crore vaccines being produced in India, other than the number of vaccines that India plans to import, seems optimistic, it is also extremely difficult to achieve in several ways if the manufacturing capacity of several companies and India’s overall production capacity is taken into consideration in detail.

While most of the vaccines are still in trials and have not begun mass production yet, Bharat Biotech’s Covaxin and Serum Institute’s Covishield, too, are currently struggling to ramp up production and meet the demands of the Centre and the states.

Why the Centre’s Goal Seems Unattainable as of Now

As per the announcement, India plans to produce 75 crore doses of Covishield, 55 crore doses of Covaxin, 30 crore doses of Bio E Sub vaccine, 20 crore SII- NOVAVAX, 10 crore BB Nasal vaccine, and 0.6 crore of Genova mNRA vaccine.

The possibility of India getting 216 crore doses between August-December 2021 can be analysed by merely looking at Bharat Biotech and Serum Institute of India’s current production capacities, the vaccines that have already been rolled out.

According to the Centre, 55 crore doses of Bharat Biotech’s Covaxin will be produced between August-December, which means 11 crore doses per month and approximately 36.6 lakh doses per day.

As of 20 April, Bharat Biotech’s production capacity is 70 crore doses per year, which amounts to 19.4 lakh doses per day.

So, in order to produce 55 crore doses between August and December, Bharat Biotech will have to ramp up production from 19.4 lakh doses per day to 36.6 lakh doses per day.

In a recent affidavit to the Supreme Court, the Centre reportedly said that Bharat Biotech is expected to increase production further up to 5.5 crore doses a month (18.3 lakh doses/day) by July 2021. Bharat Biotech CEO Krishna Ella in an event recently said that the company will be able to produce 7 crore doses (23.33 lakh per day) by July-August.

All these figures are still way less than the figure of 36.6 lakh doses per day for August-December estimated by the Centre.

Will the Figure Be Achieved With More Manufacturers Producing Covaxin?

Now, one may argue that Bharat Biotech is willing to share the code to produce Covaxin with other companies to ramp up production.

So far, the Centre has given permission only to two Central Government PSUs, namely, Indian Immunologicals Ltd (IIL) and BIBCOL, along with Mumbai’s Haffkine Bio Pharmaceuticals Corporation Limited, to produce Covaxin. This move, as per the Centre, has also been granted financial assistance.

According to Haffkine's Managing Director Sandip Rathod, the company has the capacity to manufacture only 22.8 crore doses annually, which is 6.33 lakh per day.

But, here comes the catch – Rathod said that Haffkine will begin the rollout of vaccines only in the next 8-10 months, IIL will be in a position to start production only from September 2021 and BIBCOL will start production only from November 2021, pushing the availability of these doses to the last quarter of the year.

So, unless the Centre starts giving permissions to more manufacturers other than Haffkine, IIL and BIBCOL that have the capacity to start production of Covaxin immediately, how it plans to achieve the goal to produce 55 crore doses of Covaxin in 5 months remains uncertain.

How Does the Math look for SII’s Covishield?

Coming to Serum Institute of India’s (SII) Covishield – the Centre aims to produce 75 crore doses between August and December, which means 15 crore doses per month and 50 lakh doses per day.

However, the government in a recent affidavit to the SC revealed that SII has currently ramped up production to 6.5 crore doses per month (21.66 lakh doses/day), and is expected to further ramp it up by July 2021.

However, SII has reportedly told the Centre that it can ramp up the production of Covishield to 10 crore doses per month in August and September, which is 33.33 lakh doses per day, way lesser than the Centre’s 50 lakh per day estimate for August-December.

Current Status of the Availability/Trials of Other Vaccines in the List

When one looks at the status of availability/trials of other vaccines on the list, most of them are in the trial phase and have not begun mass production yet.

In the case of the Russia-imported vaccine Sputnik V, the government said the production (by Dr Reddy’s Laboratories) is expected to increase from 30 lakh to 1.2 crore doses a month by July 2021.

After the completion of Phase I/II trials that began in November 2020, Hyderabad-based pharmaceutical company Biological E Limited (BE) received the approval to start the Phase III clinical trial for the Bio E Sub vaccine from the Central Drugs Standard Control Organisation-Subject Expert Committee late last month.

As of 5 May, SII started a Phase II/III observer-blinded, randomised, active-controlled trial of Novavax with 1,600 participants over the age of 18 across 15 centres, the launch of which has been delayed due to the issue of export of raw material from the US. It will be called Covavax in India.

All the current aspects and statuses of each vaccine manufacturer cast a major shadow of doubt on the Centre’s goal to achieve the 216-crore production mark.

Tall Claims and Mighty Statistics: Centre in the Soup?

Union health minister Dr Harsh Vardhan said on 13 May that India’s vaccine production is likely to reach 8 crore doses in May (26.6 lakh doses/day) and 9 crore doses in June (30 lakh doses/day).

If the Centre aims to produce 216 crore doses between August and December 2021, India as a country will have to produce 43.2 crore doses a month and 1.44 crore doses per day beginning August. This means that India will have to ramp up daily vaccine production in August to almost 4.8x of the manufacturing capacity in June.

How and in what ways the Centre aims to achieve this feat is still unclear.

The Centre told the Supreme Court on 9 May that the COVID-19 vaccine manufacturing capacity of India for three vaccines – Covishield, Covaxin and Sputnik V – could cumulatively cross 14 crore doses a month by July 2021.