Health

India’s ‘other’ COVID vaccines: The status of under-trial, approved and unused jabs

Representational image

Representational image | Photo Credit: MURALI KUMAR K

As India nears the 200-crore COVID-19 vaccination mark, Serum Institute of India’s (SII) Covishield accounts for 80 per cent (154 crore) of the jabs, while Bharat Biotech’s Covaxin accounts for 16.75 per cent (32 crore) jabs. 

Of the 191 crore jabs administered till now, the remaining three vaccines used — Gamelaya’s Sputnik –V, Biological E’s Corbevax and Novovax-SII’s Covovax — account only for 3.25 per cent (6.25 crore) altogether.

As of date, India has granted emergency usage authorisation (EUA) to nine COVID-19 vaccine candidates in total – Covishield, Covaxin, Covovax, Corbevax, Zydus Cadila’s ZyCoV-D, Moderna’s Spikevax, Sputnik-V, Sputnik Light, and Johnson & Johnson’s (J&J) Ad26.COV2.S.

However, only five vaccines are in use and all are indigenously produced.

Vaccines in use in India

Vaccines in use in India | Photo Credit: -

The four COVID-19 vaccines approved but not in use in India

ZyCoV-D:

Produced by Ahmedabad-based Zydus Cadila in collaboration with the Centre’s National Biopharma Mission, ZyCoV-D is India’s first DNA COVID-19 vaccine. Using a plasmid DNA — a small, circular and extrachromosomal bacterial DNA — ZyCoV-D creates spike protein to develop anti-bodies to counter the COVID-19 virus. Injected in three doses with a disposable painless jet applicator at an interval of 28 days each, ZyCoV-D clocked a vaccine efficacy of 66.6 per cent.

While the Drug Controller General of India (DCGI) granted approval to ZyCoV-D on August 20, 2021, the manufacturer and the Centre could not agree on the price for each dose. Zydus Cadila had quoted a price of Rs 1900 for its three-dose regimen and its jet applicators used for each dose. After a series of negotiations, the company reduced its cost to Rs 265 per dose and Rs 93 for the applicator – tallying to Rs 358 per dose (Rs 1074 for three doses).

Finally, in February 2022, Zydus Cadila started supplying its COVID-19 vaccine to the Centre, which decided to introduce it in Bihar, Jharkhand, Maharashtra, Punjab, Tamil Nadu, Uttar Pradesh and West Bengal. These states have been asked to identify districts with a high number of people who have not taken the first dose of the COVID-19 vaccine. However, according to the CoWIN Portal, not a single dose of ZyCoV-D has been administered outside of clinical trials until now.

Pfizer:

Despite lengthy discussions, U.S. pharma giant Pfizer and the Central government could not agree on favourable terms for vaccine distribution in India. The Pfizer-BioNTech mRNA-based Covid-19 vaccine, sold under the brand name Comirnaty, is among the most predominantly used vaccines in Europe and the U.S.

While the Centre had fast-tracked clearances for importing foreign COVID-19 vaccines to India in June 2021, the U.S. pharma company had locked horns with the Centre over the indemnity clause. Pfizer insisted on an indemnity clause which would protect the company if its vaccine was perceived to have caused death or any lasting damage to a recipient. Under such a clause, any compensation claim would have to be paid by the government, not the company.

Hesitating to agree to this binding clause, Centre held several rounds of talks with Pfizer to negotiate prices and the volume of a potential vaccine order. Pfizer had also applied for EUA in India but later withdrew its application when there was no breakthrough in the indemnity negotiations.

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Moderna and J&J:

India did grant EUA to Moderna’s mRNA COVID-19 vaccine in June 2021, allowing Indian pharma company Cipla to import vaccines. However, in September, as domestic vaccine manufacturing picked up, the Centre decided not to import Moderna vaccines, according to Reuters. The two-dose vaccine also needs ultra-cold storage facilities which are not available in most Indian districts.

For the J&J vaccine, the Centre agreed to waive bridging clinical studies — studies used for vaccines for which clinical trials have not been conducted in India — and granted EUA in August 2021. J&J had agreed to produce the vaccine domestically with Biological E, during a severe vaccine shortage in September 2021. The Centre had been in talks to acquire as many as 43.5 million doses of the single-dose Janssen vaccine; however, it later dropped these plans as the domestic production of indigenous vaccines picked up.

The Centre has allowed private firms to acquire these foreign jabs on their own. However, firms have hesitated to place orders due to the availability of cheaper domestic vaccine options.

Which other vaccines are still in pipeline?

As of date, about 97 per cent of India’s eligible population over 18 years has received their first COVID-19 vaccine shot while 80 per cent has received two doses.

However, there are three vaccines still undergoing clinical trials in India which may be used either for export purposes or for vaccinating toddlers.

Bharat Biotech’s nasal vaccine (BBV154):

An intranasal adenoviral vaccine, BBV154 is currently in its third stage of human trials in four sites across India. This vaccine generates an immune response at the site of infection (in the nasal area) and essentially blocks both infection and transmission of COVID-19. The single-dose vaccine can be administered to children over the age of two with a non-invasive, needle-free technique. The Centre is aiming to inoculate young children with the intranasal vaccine, to reduce transmission of the virus.

Gennova Biopharmaceutical’s Gemcovac:

India’s first mRNA COVID-19 vaccine — Gemcovac1-19 — is currently seeking EUA from the Centre. Cleared to stockpile over 21 lakh doses from the Central Drugs Laboratory (CDL), Kasauli, the Pune-based pharma company has run into trouble over allegations of violating clinical trial protocol.

The Centre has alleged that the company did not comply with clinical trial protocol during Phase-2 and 3 of human trials. During these phases, the company had been cleared to study the neutralisation antibodies of the mRNA vaccine on volunteers on days 29, 43, 57, 119 and 209. However, during the trial, day 57 was cancelled without informing the Central Licencing Authority, the Centre says. The company has refuted these allegations and submitted all documents regarding the trials to the DGCI for approval.

Genique Lifesciences’ vaccine:

As per the Centre’s statement to the Parliament, Gurugram-based Genique Lifesciences had started advanced pre-clinical trials for its vaccine candidate in July 2021. However, the vaccine has not yet been recommended by ICMR for clinical trials.


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Printable version | Aug 14, 2022 2:34:37 am | https://www.thehindu.com/sci-tech/health/indias-other-covid-vaccines-status-of-under-trial-approved-but-unused-jabs/article65410283.ece