Q&A: Pfizer exec talks COVID-19 vaccine timetable, distribution
Swapna Venugopal Ramaswamy
Rockland/Westchester Journal News
WHITE PLAINS, N.Y. – On Monday, pharmaceutical giant Pfizer and its German partner BioNTech announced it had developed a coronavirus vaccine candidate shown to be 90% effective in preventing the disease, according to initial results.
Half the participants in a trial received a placebo and the other half the vaccine, so the new data show that more people who received the placebo than the vaccine came down with COVID-19. Each participant in the 43,538-person study receives two doses of the vaccine or the placebo, 21 days apart.
The company said it will soon be filing for an emergency use-authorization with the Food and Drug Administration to expedite the normal vetting process for vaccine approval.
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The Rockland/Westchester Journal News, part of the USA TODAY Network, spoke to Phil Dormitzer, Pfizer's Chief Scientific Officer for Viral Vaccine R&D – a virus expert who is responsible for research and development.
Q: Monday was a big day. What's the mood like at Pfizer?
A: It was a big day. The first thing is, of course, the relief because when you're in a blinded study you really don't know until the end of the study or until the first interim analysis, how things are going, how the execution's going. You really don't know of any information, whether the vaccine is working or not. So there's always some tension leading up to that first unveiling. And, obviously we were very, very pleased.
More on the vaccine candidate:Pfizer's COVID-19 vaccine candidate shown to be 90% effective in early findings
Q: Pfizer will soon seek emergency use authorization from the FDA. When will that happen?
A: We have more steps to complete before we do that. We also have a safety hurdle – that is they (the FDA) want us to observe the subjects for two months after the second dose and we must demonstrate a manufacturing consistency. We'll also have a public meeting with the FDA before that. So we have a couple of steps left to go. We anticipate it would be within the month.
Q: Do you expect the vaccine to be out by the end of the year?
A: We are hopeful that will be the case. It is, of course, not entirely in our hands. There are more results to come, particularly around safety. The FDA vets the file. So, many things still have to happen. Although there are no guarantees, we are hopeful that we can get this out before the end of the year.
Q: Do you know how long the vaccine would remain effective, meaning how often would somebody have to get the vaccine?
A: Yes, so that's a great question. And we know that with this current vaccine, you get two doses initially, which are three weeks apart. Whether after you've had those two doses (protection) lasts for a very long time or not, that is something that only time will tell.
Q: How many doses will be available by the end of the year?
A: Based on current projections, we expect to produce up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.
Q: How will it be distributed?
A: So right now, we have contracts with a number of transportation and other logistics companies to get this actually distributed. It tends to require specialized distribution. (The vaccine requires a storage temperature of minus 94 degrees Fahrenheit during shipment and storage)
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Q: Who gets it first?
A: We are committed to working collaboratively with governments to support the public health need, but believe that front line health care workers, essential workers, immunocompromised individuals, nursing homes, and public safety officials should be prioritized consistent with global public health guidelines.
Q: This is a global crisis, so is there a plan around which countries get it and how?
A: If our vaccine candidate is successful, we would allocate the available 2020 doses proportionally across the countries where we have fully executed supply agreements that include delivery of a portion of doses in 2020.
Q: Where is it being manufactured?
A: There are three sites in the U.S. One is in St. Louis, one is in Kalamazoo, Michigan, and one is in Andover, Massachusetts. There's also a site in Belgium.
Q: What is the most exciting part about this for you?
We didn't know whether COVID-19 was going to be a disease we can immunize against, or is this going to be like HIV or hepatitis C against which people struggled to develop a vaccine for many years? So we now know that it is broadly possible to immunize against COVID-19 and receive protection. That's a major step forward. And for the RNA platform, this is the first time an RNA vaccine has been shown to protect the human being against disease.
Q: When was the last time that there was such a frenzy around a vaccine?
A: It's been extraordinary. I participated in the response in 2009 during the H1N1 pandemic. But the impact on society and health was not nearly this great. I think you have to go all the way back to 1918 to see an event that really surpasses the COVID-19 pandemic and its impact. So it has been really more than a hundred years since we faced something of this magnitude.
Follow reporter Swapna Venugopal Ramaswamy on Twitter: @SwapnaVenugopal
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