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Helping to vaccinate the world against COVID-19

Susan Rienow
Head of Vaccines, Pfizer UK

29th September 2021

 
When the WHO declared COVID-19 a global pandemic on 11th March 2020, we were quick to appreciate that vaccination would play an essential role in helping to protect public health.

 

Just six days later, we announced our collaboration with the German based company BioNTech, to co-develop a potential vaccine. In doing so, we started the process of combining our industry-leading vaccine development, manufacturing and distribution capabilities with BioNTech’s expertise in innovative mRNA technologies to quickly develop, manufacture and distribute large quantities of high-quality COVID-19 vaccine.

The challenge for Pfizer and BioNTech when the pandemic began was not just to conceptualise and develop a vaccine. We also had to work out how to manufacture and ship hundreds of millions of doses. This would normally take about five years and no mRNA vaccine had ever been authorised or manufactured to scale. However, we had over 172 years of experience to draw on and are one of the biggest suppliers of sterile injectables (medicines and vaccines) in the world.

Given the urgency of the situation, Pfizer self-funded more than $2 billion at risk in 2020 to run clinical development and manufacturing processes in parallel and at scale. Five hundred million dollars of this was spent on scaling up our manufacturing capabilities, before we knew the results of our clinical trials, and is the largest capacity extension in Pfizer’s history. Pfizer received no public funding, meaning that if the vaccine hadn’t worked, we would have borne the cost but we took the decision to self-fund to give us the freedom to make our own choices, act independently and ultimately move as quickly as possible.

Since then we have authorised spending an additional $600 million on COVID-19 research and development, which will bring our total spend across all R&D in 2021 to more than $10 billion. We continue to invest in the COVID-19 vaccination programme, including through developing alternative formulations of the existing vaccine and updating potential versions of the vaccine that target the full spike protein of variants, such as Delta. We are also investigating potential antiviral treatments (oral and IV).

Thanks to the ingenuity and hard work of our scientists, engineers and skilled workers, in addition to  billions of dollars of investment, we expect to manufacture up to 3 billion doses of our COVD-19 vaccine by the end of 2021, and we will continue to make investments and process improvements to enable more capacity in 2022. We’ve achieved this through making almost continuous process and site improvements. Among the many advancements, we have reduced our COVID-19 vaccine manufacturing timeline from approximately 110 days (from start to vial-ready) to an average of 60 days, representing an almost 50% improvement. To date, Pfizer and BioNTech have eight operational facilities supporting the global supply chain for our COVID-19 vaccine and more than 20 contract manufacturers across four continents that are, or will be, helping to manufacture it.

 

We continue to invest in the COVID-19 vaccination programme, including through developing alternative formulations of the existing vaccine and updating potential versions of the vaccine that target the full spike protein of variants, such as Delta. We are also investigating potential antiviral treatments."

Despite these achievements, we remain acutely aware that there is a dire need to vaccinate more people quickly, especially in low- and middle-income countries where the COVID-19 infection rate continues to climb. We are actively working with governments around the world, as well as with global health partners, on fair and equitable access to COVID-19 vaccines while also providing our expertise and resources for novel approaches that can help to strengthen healthcare systems where greater support may be needed. We began reaching out to governments across the globe in May and June last year. Today, we have direct supply agreements in place with over 120 countries and discussions are ongoing with many more.

With all government agreements, Pfizer and BioNTech are using a tiered pricing formula, based on factors including volume and delivery dates, which ensures agreements are bespoke to the needs of each vaccination programme that we support. High-income countries pay about the cost of a takeaway meal for each dose, middle-income countries pay roughly half that price and low- and lower middle-income countries pay a not-for-profit price.

When we developed our tiered vaccine pricing policy in 2020, we reached out to all nations asking them to place orders so we could allocate doses for them. Although some countries decided to place initial orders with other vaccine makers, several of these countries have subsequently reopened conversations with us and we have started signing supply agreements with them. As we work to ensure equitable distribution of the vaccine, we expect the balance of supply to weigh in favour of low- and lower-middle income countries in the second half of 2021.

In addition, we have pledged to provide 2 billion doses of our COVID-19 vaccine to low- and middle-income countries in 2021 and 2022 – at least 1 billion doses each year. As part of this pledge, Pfizer and BioNTech will provide 1 billion doses at the not-for-profit price to the US Government to support multilateral efforts to address the surge of infection in many parts of the world. The US Government will, in turn, donate the doses to the 92 COVAX Advanced Market Commitment (AMC) countries, as well as the member states of the African Union that are not already part of the AMC 92. Initial deliveries began in August 2021 and the total 1 billion doses are expected to be delivered by the end of September 2022. The 2 billion doses also includes direct supply agreements with individual country governments and a direct supply agreement with COVAX for 40 million doses in 2021.

To date, our COVID-19 vaccine has reached more than 130 countries and territories in every region of the globe. We believe that our commitment to helping address this devastating pandemic and any future ones, demonstrates our dedication to our purpose, that is creating and delivering breakthroughs that change patients’ lives.

 

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PP-CMR-GBR-0080 / Sept 2021