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 is 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 will 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.
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.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
Taking the matter forward, 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 needs 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 a "need of the hour" to provide access to quality vaccine booster to bolster India's fight against COVID-19 and that it is 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 immunize 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. 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 can 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 appreciates 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 will be waived off altogether for well-established vaccines, manufactured in other countries. The company has 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 will 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.