Dear Colleagues,
One of my hopes over the next two years as your society
President is to have sit-down conversations with some of the leading experts in
cancer immunotherapy, and even potentially, the greater global scientific
field. These “fireside chats” will seek to celebrate the work accomplished by
the individual (and his/her team) in cancer research, and discuss the ornate
hurdles that remain present to any number of challenges in their line of work.
This month, I am extremely pleased to welcome SITC
member, Ugur Sahin, MD. CEO of BioNTech SE, Dr. Sahin and his company
collaborated with Pfizer Inc., to produce and receive emergency use
authorization for a SARS-CoV-2 vaccine in record time. I spoke to Dr. Sahin
this month, in my first fireside chat, to discuss his background as an academic
professor and researcher, the obstacles his company has had to overcome to develop
an extremely effective vaccine and his expectations for the months ahead as a
billion or more humans seek to receive protection from this virus.
I’m featuring a portion of the Q&A below for this
month’s President’s Message, but please visit SITC’s COVID-19
Resources page on SITC CONNECT to watch the entire discussion.
Question: How did you get this vaccine to U.S. FDA (emergency use
authorization) in less than a year? Even the experts everywhere were saying it
would take three to five years to get a vaccine initially, and here you did it
in 11 months. How did you get that done?
Dr. Sahin: When we started our project, we expected this would
really become a global pandemic. Our goal from the very beginning was to develop
a vaccine and make it available in less than one year. We named our project
Lightspeed, and the idea behind this designation was that we should not lose
any time, so we did not have time to waste.
We implemented a 24/7 research
program. When we started, we did not know what the best vaccine candidate was,
so we started with 20 vaccine candidates. We did the full pre-clinical testing
immunogenicity operation of these candidates. We even GMP toxicology study,
because this was a pre-requisite from the Paul-Ehrlich Institute to evaluate
that. We did the GMP manufacturing, and then we started the program just a few
days later.
We submitted our documents on
April 20 and three days later we had the approval to start the clinical trial
in Germany. We did a partnership with Pfizer. Our plan was to have a serious
approach to get all of the immunogenicity data from Phase 1. We understood that
two vaccines provided really strong antibody and T-cell responses. We made the
decision on July 24 for one of the candidates, and on July 27 the Phase 3
clinical trial started.
Question: What’s the future hold for RNA vaccines and infectious
disease? Do you see that this technology is going to start to take over, and
how many different epitopes can you put in there? Do you think you’re going to
one day make a COVID-flu combination vaccine for example?
Dr. Sahin: The technology has extremely broad versatility, so you
can combine. In our cancer trials, we are already combining four antigens, or
six antigens. And this is of course possible in the same way for infectious
disease vaccines. You can combine several antigens for one virus or combine
antigens for different viruses.
Another key advantage of mRNA is
to be able to make faster vaccines, so the manufacturing itself takes less than
two weeks, then we have about two additional weeks for quality control and
sterility testing, so that means you can in principle deliver a vaccine, from
scratch, within four to six weeks. This is of course important advantages
compared to the viral vector vaccines or the recombinant protein vaccines.
Question: How long do you think people will be immune for after
having taken an RNA-based vaccine? Do you know from your cancer studies, can
you predict with the COVID vaccine, is it going to be years?
Dr. Sahin: In principle we have to ask the question in different
ways. The first lesson is what is needed to avoid infection at all? The
prediction here is to avoid infection, you would need higher neutralizing
antibodies, which are the key to avoiding infection. If you ask the question
how long is protection for avoiding severe disease, this will be much longer.
Avoiding severe disease can already be happening by having sufficient number of
memory cells so that the immune response can kick on early, and even if you get
infected, it’s not as severe disease because the immune system can catch up and
control the virus infection in a few days. I think this is the way how vaccines
work – if the immune response is quick, it can prevent severe disease; if the immune
responses is very strong it can prevent infection.
Here at the moment in the
pandemic situation, we are of course interested in both. First of all we would
like to prevent infection, because if we prevent infection we will also prevent
transmissions. But the second best thing we can do is prevent severe disease
and thereby avoiding people dying from the infection. The latter could be
accomplished, if the goal is the latter, then I believe such vaccines could
have a memory effect for years. If we really want to avoid infection, then
every year a booster might be useful.
It was a very enjoyable and thought-provoking
conversation, and I am very thankful for Dr. Sahin for his eagerness to share
his experiences and lessons learned thus far from developing the coronavirus
vaccine. I hope you enjoy listening to the
entire discussion on the SITC website, and I look forward to other engaging
fireside chats with cancer leaders in the future!
Sincerely,
Patrick Hwu, MD
SITC President