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Seeking fast-track approvals to bring Moderna’s single-dose COVID-19 booster vaccine in India expeditiously, Cipla has requested the government for indemnification and exemptions from price capping, bridging trials, and basic customs duty, while stating that it was close to committing over $1 billion as advance to the US major, sources said on Monday.

Commending the government for its efforts to increase the vaccine availability in the country for achieving effective protection against COVID-19, the Indian pharma giant has said its discussions with Moderna on the COVID-19 booster vaccine are nearing finalisation and for that, they are seeking the “partnership and support of the government to make this programme successful“.

Requesting the government to provide confirmation on four critical points — exemption from price restriction, indemnification, bridging trial waiver, and basic customs duty exemption, Cipla has said such an assurance would help make this significant financial commitment of more than $1 billion (over Rs 7,250 crore) advance to Moderna for its booster vaccine in India, sources privy to the development said.

‘Need of the hour’

Cipla’s latest communication to the government, dated May 29, follows a high-level meeting held recently during which it was discussed that Moderna has proposed to launch a single-dose vaccine for the Indian market, for which, they were in discussion with Cipla and other Indian companies.

It was also discussed in that meeting that orders for supply of the vaccine in 2022 may be placed with Moderna expeditiously and that Cipla has evinced interest to procure 50 million doses from Moderna for 2022.

It was also suggested that Cipla may be asked to submit their specific requests to the government on their request for a “confirmation from the Government of India in respect of stability in regulatory requirements/policy regime” and a decision on that can be taken thereafter expeditiously.

Cipla has now written to the government: “It is imperative Cipla brings Moderna booster vaccines to India urgently, having immediately made available the largest portfolio of COVID-19 drugs amongst Indian pharmaceutical companies, including the state-of-the-art antibody cocktail of Casirivimab and Imdevimab.”

Stating that Moderna’s COVID-19 vaccine has been rated at the highest efficacy with least side effects and that the US company was also leading the development of boosters and vaccines for adolescents and paediatrics, Cipla has told the government that it needed assurance from the government to include Moderna booster vaccine under the Liberalised Pricing and Accelerated National COVID-19 Vaccination Strategy, announced in April and made effective from May 1.

The company has said it is the “need of the hour” to provide access to quality vaccine booster to bolster India’s fight against COVID-19 and that it was looking forward to the government’s assurance to help it expeditiously close its supply arrangement with Moderna.

Seeking exemption from price restriction, Cipla said, “Given the size of the population we need to immunise with boosters, it is our avid belief that the government and private players can work together to deliver the vaccination programme, best serving the public interest.”

“Any restriction brought on pricing may dissuade the mRNA players from providing their vaccines in India, considering the serious competing demand by other countries chasing the limited supply of vaccines,” a source quoted Cipla as having communicated to the Indian government.

Request for indemnity, exemption

The company has further requested for the government’s assurance that no price capping would apply for imported vaccines to be provided through private hospitals and that the booster vaccine could be covered under the liberalised pricing policy and kept exempt from any price capping.

Cipla has also sought indemnity in case of any adverse effects or complications caused by the Moderna vaccine and cited instances of the US Countermeasures Injury Compensation Program (CICP) and similar programmes in the UK, Canada, EU, Singapore and even the WHO-led Covax, that protect vaccine manufacturers/distributors from claims and underwrite the compensation burden.

On basic custom duty exemption, Cipla said it appreciated the government’s intent on exempting basic customs duty on import of COVID-19 vaccines and urged it to be extended to the whole of 2022.

It also lauded NITI Aayog’s recent statement on “Myths and Facts on India’s Vaccination Process” where it had said that bridging trial requirement for vaccines approved by the US FDA, EMA and others would be waived off altogether for well-established vaccines manufactured in other countries.

The company sought confirmation that the Moderna booster vaccine, having received the USFDA’s Emergency Use Authorisation (EUA), will not require a bridging trial in India.

However, Cipla stated that as Moderna’s India partner, it would comply with post-marketing surveillance requirements.

Similar requests for indemnity and exemption from bridging trials have been made by another US major Pfizer as well.