-- Company will focus on process development and improvements for manufacturing 
Baylor's Covid-19 vaccine candidates 

Merck, a leading science and technology company, and Baylor College of 
Medicine, Houston, Texas, USA, today announced an extension of their ongoing 
collaboration to advance a manufacturing platform to fight Covid-19, designed 
to accelerate transition to Phase 1 clinical trials.

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"Vaccine manufacturing is extremely complicated, so we are collaborating on a 
process development approach to accelerate manufacturing of Baylor's Covid-19 
vaccine candidates," said Udit Batra, member of the Merck Executive Board and 
CEO, Life Science. "To fight this pandemic, we will need to produce an 
unprecedented amount of vaccine in a very short period of time, and we need as 
many approaches as possible to be successful."

There are no standard manufacturing templates or processes due to the 
complexity and diversity of vaccine modalities, which makes production a 
challenge for every organization racing to develop a safe and effective 
Covid-19 vaccine. Using key learnings from their ongoing collaboration on a 
schistosomiasis vaccine, Merck, along with researchers at Baylor College of 
Medicine and the Texas Children's Hospital Center for Vaccine Development, is 
optimizing the production processes to advance two Covid-19 vaccine candidates, 
including the CoV RBD219-N1 vaccine candidate expected to enter clinical trials 
later this year. Merck will help to accelerate their sustainability for 
large-scale manufacturing. This collaboration will focus on improvements to 
production efficiency, yield, robustness, scalability and costs.

"Our initial collaboration with Merck built an important and critical framework 
for us to quickly validate and ready the production of our portfolio of 
neglected tropical disease vaccines for global access," said Dr. Peter Hotez, 
dean of the National School of Tropical Medicine at Baylor College of Medicine 
and co-director of the Texas Children's Hospital Center for Vaccine 
Development, alongside Dr. Maria Elena Bottazzi. 

"The expansion of our  collaboration to include diseases of pandemic importance 
will now allow us to accelerate the development of a scalable and affordable 
manufacturing process of our Covid-19 vaccine candidates and enable them to 
advance as quickly as possible to support vaccine production in low- and 
middle- income countries," said Bottazzi, who leads the product development 
activities and serves as associate dean of the National School of Tropical 
Medicine at Baylor. 

The Merck-Baylor teams will improve the manufacturing platform for the CoV 
RBD219-N1 vaccine candidate, which was originally developed to target SARS in 
2011-2016. Additionally, they will develop a new manufacturing platform for a 
second Covid-19 vaccine candidate to shorten the time to enter into Phase 1 
clinical trials. The goal for the partnership is to develop a suitable 
manufacturing process and steps that would lead to a scale-up approach suitable 
for pilot and later industrial production. 

Researchers from the Texas Children’s Center for Vaccine Development first 
formed a partnership with Merck's process development scientists and 
biomanufacturing engineers in 2018 to advance vaccine development and 
production and enhance the response to outbreaks, such as Covid-19. Because the 
initial groundwork is laid through their existing process development platform 
work, the team can quickly shorten the time to the clinic, realizing a key goal.

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Baylor College of Medicine and the Texas Children’s Hospital Center for Vaccine 
Development received funding from NAID for their earlier work in developing the 
CoV RBD219-N1 vaccine candidate and recently to initiate development of the 
second Covid-19 vaccine candidate. In addition, Baylor and Texas Children’s, 
through their alliance with PATH, expect to advance the Covid-19 candidates to 
support access to low- and middle-income countries.  

About Merck 
Merck, a leading science and technology company, operates across healthcare, 
life science and performance materials. Around 57,000 employees work to make a 
positive difference to millions of people's lives every day by creating more 
joyful and sustainable ways to live. From advancing gene editing technologies 
and discovering unique ways to treat the most challenging diseases to enabling 
the intelligence of devices - the company is everywhere. In 2019, Merck 
generated sales of EUR16.2 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to 
Merck's technological and scientific advances. This is how Merck has thrived 
since its founding in 1668. The founding family remains the majority owner of 
the publicly listed company. Merck holds the global rights to the Merck name 
and brand. The only exceptions are the United States and Canada, where the 
business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma 
in life science and EMD Performance Materials.

SOURCE:  Merck

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