American drugmaker Pfizer and its German collaborator BioNTech have said that the United Kingdom’s regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), have granted a temporary authorisation for emergency use for their Covid-19 mRNA vaccine (BNT162b2), against Covid-19.

“This is the first Emergency Use Authorisation (EUA) following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorisations or approvals. The distribution of the vaccine in the UK will be prioritised according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI),” a note from Pfizer said.

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The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfilment expected in 2021.

India, out of bounds?

Pfizer and fellow-American company Moderna had also approached the regulator in the United States, the Food and Drug Administration, for an EUA. Pfizer’s vaccine may, however, be out of bounds for India as it poses storage and distribution challenges, requiring as it does a temperature of -70 degrees Celsius. But Pfizer had indicated to BusinessLine that the Pfizer Covid-19 vaccine had the potential to be part of India’s bouquet of vaccines against the coronavirus.

“Today’s Emergency Use Authorisation in the UK marks a historic moment in the fight against Covid-19,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “As we anticipate further authorisations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic,” he said.

“The Emergency Use Authorisation in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against Covid-19,” said Ugur Sahin, Chief Executive and Co-founder of BioNTech. “We believe that the roll-out of the vaccination program in the UK will reduce the number of people in the high-risk population being hospitalised. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program.”

The MHRA’s decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95 per cent in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose. And, the efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94 per cent, it noted. In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date, it added.

In July 2020, Pfizer and BioNTech has announced an agreement with the UK to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorised for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts, it said.

Distribution plans

Further, the companies said, their combined manufacturing network had the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorisation). On the distribution challenges, it explained, “Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company’s distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need. So, this will minimise the need for long-term storage anywhere. Vaccination in a pandemic situation is expected to be rapid, with high demand, and we do not expect that the product will need to be stored at any location for more than 30 days.”

 

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