UK Grants EUA to Pfizer/ BioNTech Covid Vaccine

03.12.2020 - In a move that was not on the world’s radar, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has become the first Western regulatory body to issue an Emergency Use Authorization EUA) for a Covid-19 vaccine, Pfizer-BioNTech’s BNT162b2 candidate.

The British approval is not only the first-ever of a coronavirus vaccine outside Russia and China, but also the first EUA for the American-German partnership’s candidate and the first-ever approval of a vaccine based on mRNA. What’s more, the Pfizer-BioNTech vaccine is the fastest to ever be developed, taking 10 months as opposed to the normal span of 10 years.

Russia and China already have begun vaccinations with their own Covid vaccines, without providing clinical data on safety and efficacy, however. The FDA, which was widely expected to be first, has not yet approved a vaccine candidate. Even before the UK announcement, US president Donald Trump was already restless about what he saw as a sluggish rollout process. Early this week, his chief of staff, Mark Meadows, leaned on the FDA to speed up its approval of the Pfizer BioNTech vaccine.

A spokesperson for the agency, however, told the Axios news service there are “thousands of pages” of data and details that must be divided up and reviewed by experts from different disciplines before the program can enter an overall review. The FDA’s advisory panel of expert sciences is due to discuss the EUA applications of Pfizer-BioNTech and Moderna at its meetings on Dec. 10 and Dec. 17 respectively.

In the UK, as initial vaccine supply will be limited, priority will be given to high-need individuals selected by the Joint Committee on Vaccinations and Immunisations, with the first recipients likely to include long-term care facility residents and healthcare staff. As part of a deal signed in July and expanded in October, London ordered 40 million doses of the Pfizer-BioNTech candidate, enough to vaccinate 20 million people on the basis of a two-dose regimen. The vaccine developers will make around 800,000 doses available in the UK next week, said health secretary Matt Hancock

Calling the British nod a “historic moment,” Pfizer CEO Albert Bourla said the partnership is “focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world,” and BioNTech CEO Ugur Sahin said in a US interview that “this is really the start of the end of the pandemic.”

Pfizer has chosen three locations in the US and one in Belgium as manufacturing sites, while BioNTech can tap facilities in Mainz and Idar-Oberstein , Germany, where doses for clinical trials have been produced. Additionally, the biotech has acquired a Novartis plant in Marburg, Germany, to accelerate commercial manufacturing. The duo expects to be able to produce up to 50 million doses in 2020 and up to 1.3 billion doses in 2021. 

Data from a Phase 3 trial published in November showed BNT162b2 to 95% effective for the average recipient; in adults age 65 and above, the figure was above 94%, the companies said.  Due to the need to store the vials at around minus 70°Celsius, Pfizer is providing specially designed boxes to help keep the vaccine cold during temporary storage at deployment sites.

According to Bernstein analysts, the top five vaccine makers will share about $38.5 billion in sales in 2021, led by Pfizer-BioNTech with $14.3 billion, followed by $10.9 billion for Moderna, $6.4 billion for AstraZeneca, $3.9 billion for Novavax and $3 billion for Johnson & Johnson. Only the first two have completed Phase 3 trials and applied for an EUA. The revenue wins may be fairly short-lived, however, as the analysts predict the market will dwindle to around $6 billion altogether in 2025, based on the assumption that vaccine recipients will need a booster every three years.

Author: Dede Williams, Freelance Journalist