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Post MHRA nod, Pfizer-BioNTech expect US FDA, EU EMA decisions this month too

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First doses expected to arrive in the UK in days, companies had agreed to supply 40 million doses to the UK with delivery in 2020 and 2021

Pfizer and BioNTech have received UK’s Medicines & Healthcare Products Regulatory Agency’s temporary authorisation for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19.

Post this first Emergency Use Authorisation (EUA) following a worldwide Phase 3 trial of a vaccine to help fight the pandemic, the companies have communicated that they 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).

Albert Bourla, Chairman and CEO, Pfizer applauded the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK while said Ugur Sahin, M.D., CEO and Co-founder of BioNTech remarked that this EUA in the UK will mark the first time citizens outside of the trials will have the opportunity to be immunised against COVID-19and believed that the roll-out of the vaccination programme in the UK will reduce the number of people in the high-risk population being hospitalised.

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 (p<0.0001) 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. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol.

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. In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today’s decision also is based on a review of Pfizer’s and BioNTech’s Chemistry, Manufacturing and Control (CMC) data for BNT162b2.

In July 2020, Pfizer and BioNTech 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. Now that the vaccine is authorised in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the UK in the coming days, with complete delivery fulfilment expected in 2021.

The companies have reportedly filed a request for EUA with the US Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorisation Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world.

As  per the release, based on current projections, Pfizer’s and BioNTech’s combined manufacturing network has 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).

To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time without any additional equipment but dry ice. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally.

Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions (-70°C ±10°C) up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions.

Pfizer and BioNTech have supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the US, as well as Europe, Latin America and South Africa reaching approximately 44,000 participants. BioNTech will hold the regulatory authorisation in the UK, and, if granted, in the US, the EU, Canada and other countries while Pfizer will have the commercialisation right worldwide with the exception of China, Germany and Turkey.

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