India’s vaccine stats: How many is too many

India’s vaccine stats:  How many is too many

The Indian government has come out with detailed projections for vaccine availability for the period of August to December. As per the list published in mid-May, the break-up of individual vaccine contribution is: Covishield – 75 cr, Covaxin – 55 cr, Bio E Subunit vaccine – 30 cr, Zydus Cadila DNA vaccine – 0.5 cr, SII-Novavax- 20 cr, BB Nasal vaccine-10 cr, Gennova mRNA vaccine – 0.6 cr and Sputnik vaccine – 15.6 cr. The total number works out to around 216 cr, or over 2 billion.

In addition, other foreign vaccines are likely to become available, claimed the government.

However, critics point out that if one looks at the actual available and projected doses of each of the shots, one will come to the conclusion that almost all the projections are off-target and unrealistic.

For instance, take the case of Serum Institute of India (SII). India banks on this Pune-based firm, which is currently the world’s largest vaccine manufacturer, as the chief source of vaccine for what it describes as the “world’s biggest” mass immunisation programme.

It aims to purchase 75 crore doses of the Covishield vaccine between August and December from SII. The figure translates to 15 crore doses per month or 50 lakh doses per day.

As per a production plan submitted in May by SII for the next four months to the government, the company promised 10 crore doses per month by August, reports said.

“We confirm that the quantities mentioned will be fulfilled under all circumstances. Also, we are trying our best by utilising all our resources to increase our production capacity of Covishield. In view of this, the production during June and July may also increase by some quantity,” Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India, has been reported to have said in a communique to the health ministry.

10 crore doses per month in August and September is equal to 33.33 lakh doses per day, and is way below the government’s estimate of 50 lakh per day for August-December. Furthermore, SII has to fulfill other supply obligations with many countries and organisations, including the COVAX network set up by Gavi — The Vaccine Alliance and WHO for equitable distribution of COVID-19 vaccines to middle- and low-income economies.

Covishield is the brand name given by SII to the Oxford-AstraZeneca vaccine. The vaccine is made from a weakened version of a common cold adenovirus from chimpanzees. The overall efficacy of Covishield was found to be 70.4%.

Similarly, Bharat Biotech would have to produce 11-12 crores of doses per month to meet the target of 55 crore doses the government has projected to deliver in the time period of August and December.

As per the central government’s own admission in the Supreme Court in May, the company was producing Covaxin at the rate of only 1 crore doses a month. The affidavit said that the company will take another 8-10 months to scale up to 11 crore doses a month.  

Bharat Bio recently stated it can ramp up the production to the tune of 100 crore/year by the last quarter of 2021.

The company has already deployed multiple production lines at its Hyderabad and Bengaluru campuses, Bharat Bio said, while announcing its decision to augment the capacity further by adding the facility of Chiron Behring Vaccines, Ankleshwar, Gujarat, one of the company’s wholly-owned subsidiaries.

If the company can achieve this target, the augmented capacity will be nearly 40-50% more than the existing 50-70 million doses per annum.

However, in a statement issued towards the end of May, the company said: “There is a four-month lag for Covaxin to translate into actual vaccination. The manufacturing, testing, release and distribution of vaccines are complex and multi-factorial processes with hundreds of steps, requiring a diverse pool of human resources.”

According to a health ministry statement, India has placed a total order of 7 crore vaccines with Bharat Biotech. Of this, the order for 5 crore Covaxin doses was placed on April 28. To meet this order, the company will take time till July.

A whole virion inactivated SARS-CoV-2 vaccine, Covaxin has been developed under technical collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

Bharat Bio submitted the phase 3 data of the vaccine — showing 77.8% efficacy — to India’s drug regulator in the fourth week of June after administering the shot to millions of people. The drug had secured emergency use authorisation from India’s drug regulator in January. The indigenously developed vaccine is yet to be recognized by WHO.

Russia’s Sputnik V is the third coronavirus vaccine to receive emergency use authorization in India. The vaccine has an efficacy of over 91%.

The Russian Direct Investment Fund (RDIF), which is marketing the vaccine, has signed manufacturing deals with over half a dozen domestic vaccine makers in India to produce more than 850 million doses of Sputnik V in the country.

Hyderabad-based pharmaceutical firm Dr Reddy’s Laboratories will be importing the first batch of 125 million Sputnik V doses to India during this quarter.

Supplies will be ramped up only next quarter (July-September) when the six Indian firms begin making the vaccine under the supervision of Dr Reddy’s.

Pipe dreams

Apart from Covishield, Covaxin and Sputnik V, all the other vaccines mentioned in the government list are yet to get EUAs and are still in the clinical trials pipeline.

For instance, the list shows the government has factored in 30 crore doses of Bio E subunit vaccine Corbevax developed by Biological E with financial aid from the government, between August and December this year.

But the candidate vaccine secured approval for the phase 3 studies only at the end of April.   

The Hyderabad-based company plans to produce 75 to 80 million doses a month from August, its managing director said on May 7, 2021. Government officials have said the vaccine could be rolled out in the country from August. Biological E would apply for emergency use authorisation (EUA) for the drug based on government advice, according to its MD.

BE’s vaccine candidate contains an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicines integrated commercialization team, along with Dynavax Technologies Corporation’s advanced adjuvant CpG 1018. The vaccine candidate consists of the Receptor Binding Domain of the spike protein of SARS-CoV-2 at a three-dose level adjuvanted with CpG 1018 plus alum.

Covovax, another vaccine candidate developed by SII in partnership with Novavax, is currently in the phase 2 stage. According to filings with the clinical trial registry on May 5, SII started a phase-2/3 observer-blinded, randomised, active-controlled trial in May with 1,600 participants over the age of 18 across 15 centres.

The company had announced plans to launch Covovax in India by September 2021.

However, SII’s launch of its Novavax version is likely to happen after the global launch, as its trial is based on comparing immunogenicity and safety data with the Novavax candidate. On the other hand, US-based vaccine maker Novavax said that its worldwide launch of the COVID-19 shot will get pushed beyond Q3 2021 (July to September).

India’s Cadila Healthcare, which is expecting to get the regulatory nod for its ZyCoV-D vaccine soon, is also planning to boost the production of the plasmid DNA vaccine to 240 million annual doses. The Ahmedabad-based company started phase 3 trials in December with about 28,000 volunteers.

PSU backups

In the affidavit, the government informed Supreme Court that apart from Bharat Bio, a private enterprise, the government is supporting three public sector manufacturing facilities to augment vaccine production over the next 6-8 months in its endeavour to ensure sufficient doses under Mission COVID Suraksha.

Indian Immunologicals, Hyderabad; Haffkine Biopharmaceuticals, Mumbai and Bharat Immunologicals and Biologicals, Bulandshar are the three PSUs.

For Haffkines, a BSL-3 lab has to be made ready before starting the production process for Covaxin.

The establishment of such facilities is usually a long-hauled process, experts said. In an interview given to the media in June, Haffkines’ managing director said the BSL-3 facility will be ready in 8 months. Obviously, production is unlikely to commence in 2021, and

Haffkine will be able to supply 22 crore vaccines annually once the lab for the production of Covaxin is ready..

Similar upgrades will be required at other PSUs as well before vaccines can be made there.   

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