One year after the pandemic: The path from darkness into light

This past week, we shared real world evidence on the efficacy of our vaccine from an observational study conducted in Israel. The results: 14 days after the administration of the second dose the vaccine effectiveness was at least 97% in preventing symptomatic COVID-19 disease, hospitalizations, severe and critical hospitalizations, and death. This study also demonstrated a vaccine effectiveness of 94% against asymptomatic SARS-CoV-2 infections. These findings are important in many ways. 

First, the strong efficacy against symptomatic #COVID19, which was observed in our phase 3 clinical trial, has been confirmed, and the vaccine effectiveness has been validated in a real world setting.

Second, the study extended evidence for the efficacy of our vaccine to the SARS-CoV-2 variant B.1.1.7 (which was first detected in the U.K.). At the time the data was generated, this variant was the dominant strain in Israel, and is currently the fastest spreading variant in many regions of the world, including Europe. The variant B.1.1.7 appears to also have a higher transmission rate, and seems to be associated with a higher hospitalization and death rate.

Third, the data show a reduction of asymptomatic infections indicating that our vaccine can prevent infections and transmissions of the virus. This could help prevent infected individuals from unknowingly passing the virus to uninfected individuals.

Finally, the real world data show that the vaccine is reducing hospitalization and is saving lives. Decreasing mortality rates reported from the U.K. and the U.S. corroborate these observations as well.

It is truly encouraging to see life in Israel slowly return to normalcy. It is our belief and hope that this will also happen in other countries by end of summer 2021 – especially with more vaccines becoming available upon regulatory approval. 

How were all of these milestones achieved just one year after the declaration of the pandemic by the WHO?

Our journey started on a Friday evening in late January 2020 when we realized that a virus outbreak – seemingly far away in China – would become a global pandemic and would place our world as we knew it at risk.

Against all odds, we decided to reallocate substantial company resources and start a COVID-19 vaccine development program, ‘Project Lightspeed’. With science as our compass, Project Lightspeed was built on our relentless efforts to minimize development times without taking any shortcuts. We trusted in the abilities of our outstanding team to solve challenges in real-time, and that science will guide us.

Tasks – usually done sequentially – were done in parallel. We eliminated idle periods. Experiments were not paused and teams worked day and night, thanks to 24/7 coordinated shifts which were part of an agile team set-up. We were in constant dialogue with regulators to enable fast review and response cycles. This allowed us to generate more than 20 mRNA vaccine candidates, compare them in a battery of preclinical studies, produce clinical trial materials, prepare reports and clinical trial applications, receive feedback from authorities, respond to requested changes, set up clinical trial sites, and start clinical testing of multiple vaccine candidates in less than three months.

Grand global challenges require great international partnerships based on complementary skills, trust and shared values – this is why we asked our colleagues from Pfizer to join us initiating the first US clinical trial in May. Ten months after the initiation of Project Lightspeed we had jointly selected BNT162b2 as candidate for phase 3 clinical trials and demonstrated its safety and strong efficacy in humans. BNT162b2 is the first authorized mRNA drug ever, and was the first with proven efficacy as a COVID-19 vaccine that has been authorized for human use across the globe. This was a victory for science, technology, innovation and our global collaborative effort.

Our goal from the very beginning was to enable a global supply of our COVID-19 vaccine

As of today, we’ve received approval or authorizations for our vaccine in more than 65 countries and regions, including the U.K., the U.S., the EU, and Japan. The WHO issued its first emergency use validation for our vaccine representing 92 low and lower middle income countries. With our partner Fosun we have also conducted clinical trials on our vaccine in China as well. And, we have now supplied more than 200 million doses to the world, including low-and lower middle income countries through COVAX. COVAX is one of three pillars of the Access to COVID-19 Tools (ACT) Accelerator, which was launched in April by the World Health Organization. 

Our original plan was to produce 1.3 billion doses in 2021. However, given the high global demand we left no stone unturned to increase our target. Consequently, we acquired the former Novartis manufacturing site in Marburg, Germany, and we are now able to manufacture 2 billion doses in this year alone. Once fully operational, it will have a yearly manufacturing capacity of 750 million doses. This makes Marburg one of the largest mRNA production sites in Europe. Next year, we might even be able to increase capacities to 3 billion doses. 

Creating the foundation today to achieve our goals tomorrow

We will not stop in our efforts to address the viral mutations, to evaluate booster doses, to conduct clinical studies to make the vaccine available to children, immunosuppressed people and pregnant women, and to tackle any challenges that await the global roll out of our vaccine across diverse nations and economies.

The ultimate goal is to achieve herd immunity, and the more vaccines are approved the better it is for the world.

We are not there yet. We all must continue to practice transmission prevention measures. It will take a few more months of patience, but – as heralded by emerging real world data – we will slowly return to normalcy. Each step, each vaccinated person is important on our way forward to return to our normal lives again. Providing the path from darkness into light. 

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the US FDA, but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to prevent COVID-19 for use in individuals 16 years and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet at www.cvdvaccine.com