One such partnership is already underway. Pfizer has joined forces with German biotech company BioNTech to develop a potential RNA vaccine to prevent the spread of COVID-19. As we have already been working with the German partners since 2018 to develop an RNA influenza vaccine, we are well poised to quickly bring together our expertise to combat COVID-19.
Developing any type of vaccine is known to be a costly, time consuming, and risky endeavor, but given the rapidly evolving situation, we are working at unprecedented speed and levels of collaboration to address the crisis. While we are still working through terms of an agreement, we have already begun accelerated development work on the vaccine candidate. “This is not how it’s normally done,” says Phil Dormitzer, Vice President and Chief Scientific Officer for Viral Vaccines based at Pfizer’s Pearl River, New York, research site. “Our rapid response really exceeds my expectations. It's coming from the top — the attitude that we will make our resources available to do as much as we can to help in this public health crisis. We are able to make decisions so that things can happen quickly.”
Dormitzer is no stranger to global outbreaks, having been involved in responses to the 2009 H1N1 pandemic, as well as the 2013 H7N9 avian influenza in Shanghai prior to working at Pfizer. But the recent COVID-19 crisis is different, he says. “This crisis has reached pandemic level, impacting numerous countries around the globe, and it’s going to require an industry-wide effort to address this crisis.”
A faster formula
Unlike conventional vaccines — which take months to produce by growing weakened forms of the virus — RNA vaccines can be constructed quickly using only the pathogen’s genetic code. Scientists in China released the genetic sequence of SARS-CoV-2 (the virus that causes COVID-19) in January, which kicked off research around the globe for a potential vaccine. “One reason why this technology is so useful is that you don't need the virus, all you need is the genetic sequence of the virus,” says Dormitzer. But having access to global data has been critical, says Dormitzer, who credits partners such as the Global Initiative on Sharing All Influenza Data (GISAID), which has expanded its data sharing to include coronavirus data.
RNA vaccines work by introducing a type of RNA, which is produced without growing the virus, into the body. The cells then use this information to build a protein, called an antigen, which is specific to the virus. The immune system then recognizes the antigen and builds up immunity against it.
Addressing the crisis first
BioNTech has already synthesized a set of potential RNA vaccines and expects to begin testing in human subjects in a small study in Germany in April. Meanwhile, we will be contributing our expertise in specialized research, manufacturing, pre-clinical testing, and clinical testing, as well as serologic testing, which measures how the immune system responds to a vaccine. We already have a well-established rapport with BioNTech. “We have teams that have been working very closely together on the existing flu collaboration,” says Dormitzer. “And that is what is really enabling us to start so fast — it’s a natural extension to work together on the COVID-19 vaccine.”
In the weeks and months ahead, we plan to work with regulatory officials in hopes of fast tracking the vaccine’s testing, as well as to scale-up manufacturing, testing facilities and storage. “Our partners are turning to us for our experience in development of preventive vaccines and our relationships with U.S. regulatory and public health organizations. Addressing this crisis is our priority,” he says.
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