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1248. Pfizer Head of Anti-Viral Has Good News on COVID-19 By Maurine Proctor, in Meridian Magazine

This is very interesting, and encouraging!


Richard Hutchins is not speaking officially for Pfizer nor any other organization in this article, but merely sharing the latest information about vaccine development.
The more we are stuck under masks in public gatherings and stay in when we want to go out, questions multiply about COVID-19. News reports give us mixed messages, cases spike when states open up, and people talk about the “new normal” as if we will spend a lifetime looking at each other mainly as carriers.
The question that haunts us most is “When will this ever end?” Or will this virus just mutate into new and more contagious forms, so we are isolated indefinitely? We took some of our questions to someone we knew could give us authoritative answers and what he told us was the most optimistic news we’ve heard yet in this fight to defeat COVID-19. Look to November for the vaccine to begin to be available to the public.
Richard S. Hutchins is an executive director for pharmaceutical sciences for Pfizer, responsible for oncology and anti-viral development. As such, he’s been one of those pioneers on the frontlines of vaccine development.
Before he answered our COVID-19 questions, he said, “Can I speak as a Latter-day Saint for just a second? I think God knows all things. He knew this was coming. I’m sure there are lots of valuable lessons we can take from it collectively and individually, institutionally and in the church, but also there needs to be a solution eventually. He has provided a way out.” New technology has been in place for two years that has allowed companies to do the unthinkable—provide a vaccine in record time. To Hutchins, this is no accident.
In the interview that follows, Hutchins answers the questions that we have all wanted to know.
Tell us a little bit about what to anticipate with this vaccine development? Are we are all going to be stuck home for months and months more?
That’s a question I want to give a caveat to. I don’t have detailed information on vaccine development at other places. There are over 100 different companies that have vaccines for the COVID-19 illness at some stage of development. There’s about 10 to 12 that are in clinical studies and Pfizer has just issued a conference to update the press on the status of our vaccine in the phase one and two trials. Moderna was the first to share some clinical data. They did that earlier in June. And there’s other companies that are coming behind, but probably eight to ten are at the forefront. Several have hopes of delivering vaccines for use before the end of this year.
What size of a group have you been doing your clinical trials on?
In the phase 1 and 2 trials, there are several hundred patients that are involved in those trials. Pfizer is actually evaluating five different constructs of vaccines in that phase 1 and 2 trial and the data we shared was on the very first one of those. The data is in the process of being read, but we’re manufacturing all of them at risk for the larger stage trials that will begin later this month for approximately 30,000 volunteers.
How long do you do a trial? How can you tell if you’ve been successful? What amount of time has to pass before you say, this is really working and we don’t see negative side-effects?
Traditionally or now? Things are different now. Obviously there are concerns about safety and side-effects from the regulatory agencies. They want to make sure it is safe. It is given to healthy people, not sick people, so you don’t want to make them sick with the vaccine. There’s animal work that has to happen. That’s been done. There’s evaluation of different dose levels. That’s what happens in the phase 1-2. There’s low dose, medium dose and high dose. You look at young population. You look at old population.
Based on those factors you make a decision and you take that information into your larger trial.
The 30,000 volunteer trial will have the best facts based on all that data we’ve been gathering from hundreds of patients in the earlier studies. The data that Pfizer shared involved patients who were given a dose on day one and a booster on day 21 and at day 28, they measured their antibodies.
In the first of five constructs of the vaccine we are looking at, patients did very, very well. They have averaged between two or three times the amount of antibodies that are being seen in people who have had COVID-19. They have measured their blood samples to see about their future immunity to infection. We don’t know how long that immunity will last. We don’t know if that’s a year or a lifetime. It’s too new of a disease.
What we do know is that the early stages of our vaccines show that we are double or triple the level of antibodies already after 28 days.
Your understanding is that one cannot get it again, or that they are less inclined to get it again? What your sense about that?
That’s what the larger trials will prove out to some extent. But the anticipation is that would be protective for some extensive period going forward. As you think about it, different diseases have required that over time you get a booster, but some you just get once, and so we really don’t know if once is enough or down the road people may need a booster. We feel like it will certainly give short-term protection for a period of a year or more. That all has to be proved out. Nobody knows.
It is so interesting to be dealing with something that nobody knows. I’ve said “God is the only one who knows any answers here, and the rest of us are just in the dark.
That’s right, and you see this played out in so many ways in the media. Questions about wearing masks. Or how does it get transmitted. Does it get transmitted by touch? Now we think it doesn’t. All these things they go back and forth on because we are all just learning about it. It’s brand new so it takes some time to get the answers.
Is your thought that because everything has been sped up that there could be vaccines as soon as early next year?
Vaccine development historically was five or more years minimum until you would have something that could be made available to the public.
The technology that Moderna, that Pfizer and other companies are using is new. It has not been around for more than a couple of years and so there are not any commercially-manufactured vaccines using the type of technology we are using to develop this.
We began collaboration with a company in Germany, Biontech, two years ago to develop this new technology because you get a flu shot every year because that virus changes, but the problem is you are getting last year’s flu shot so the effectiveness is marginal. The reason you are getting an old one is that the technology to develop the vaccine isn’t fast enough to give you the current flu vaccine that you need.
The technology that we are developing is something called messenger RNA vaccine which can be developed much quicker. It doesn’t require that you work with a live virus. You can just work with a piece of it and so the speed at which you can develop this is much faster. And so my Area Seventy hat and my personal feeling is that the Lord has also prepared a way forward for a vaccine to be developed very quickly comparatively. I am sure to the world this doesn’t sound quick, but if you are in the science field, this is really quick.
I see great and promising data both inside and outside of Pfizer that we’ll have vaccines available soon. At our press conference, Pfizer said that we are going into the Phase 3 study, with 30,000 volunteers starting later in July, and then we’ll be manufacturing at risk, assuming it is positive, to have 200 million doses available in November of this year. That will be 100 million in the U.S. and 100 million ex-US, and in 2021, we are gearing up to make available 1.2 billion doses.
How will those get administered to all of us in a timely manner?
Pfizer has been in the vaccine business, as one of the major companies in the world. They are one of the few companies that have manufacturing capacity that can scale to this volume. There are very, very few companies in the world with this capacity—two or three. But in this case we are doing things differently to get to that level of dosing more quickly.
For example, rather than having every vial manufactured being an individual dose, we’re using a larger vial and 7 doses can be pulled from a single vial. It is pandemic dosing. You line up. They pull from a single vial, obviously different syringe, but they are able to vaccinate 7 people from a single vial. Things like that are enabling us to get to a larger number of doses quicker.
What is the technology of the messenger RNA? Usually you are dealing with live viruses and this is just a piece of the virus. A person’s anti-bodies will affect that piece of the virus and render it impotent.
In the Pfizer vaccines, we have five different constructs with different messenger RNAs and we’ve got two different options among the five different candidate vaccines. One of them is for the spike protein, which is the business end of the virus to get into the cells. That’s what allows the virus to get in and to replicate. It attaches to your cells and then the cell pulls it in, using the spike protein.
The other piece is just the tip of the spike protein, the head of it. It has this piece on it called the receptor binding domain and that is what actually attaches to the cell, so that little piece is what one of our candidates affects, and then the entire spike protein is the other candidate.  
The body develops anti-bodies to the spike protein which would prevent the virus from entering the cells of the body or with the other construct it develops anti-bodies that affect the receptor binding domains.
It is much faster than having to work with live vaccines which is much trickier, much more dangerous and has more testing required. This new technology is much safer for people.
We always hear about the coronavirus mutating and then if we get a vaccine, it will not be adequate for a new strain. What’s your response to that?
The part that allows this virus to be successful and to be spread is the spike protein. You can imagine if that mutates in any significant way, it probably becomes ineffective and unable to replicate. We feel like we are attacking the right piece of the virus to be able to be effective against it.
Separately, we are also developing therapeutics. What would happen if someone got infected and needed some treatment. Right now, there are no really effective treatments available.
We have a drug that is about to go into human testing in August which is a protease inhibitor. This virus, the SARS-2 virus, protease enzyme is inhibited by this drug. It was actually designed in 2004 to inhibit the SARS-1 enzyme. You remember, SARS in 2003, 2004, it went away very quickly. It was a different virus. People got very sick right away so they were able to contain it and basically it just died out. They were able to contain it and it’s gone. We developed a protease inhibitor back then that we put on the shelf, but now we’ve pulled it off the shelf. Remarkably, even though there’s been significant change from SARS-1 to SARS-2 the protease enzyme itself is largely unchanged.
This would have been effective against SARS-1. We believe in testing, it will be effective against SARS-2. It would have been effective against the MERS virus. Back to your question if it mutates, also on the therapeutic front, we believe that effective therapeutics are coming for this and for future mutations, because there are pieces of the virus that don’t seem to change from one strand to the next in any significant way.
The things you are saying are very optimistic. We are always hearing about the “new normal” as if we will never be going back to a world where we were before, where we traveled and didn’t have masks on etc. You don’t seem to see it that way. It sounds like you think we will be returning at some point to a more settled existence.
It’s not if, it is when. I am sure there will be great learnings that come from this about how we can use technology and do things smarter and more efficiently, but gatherings of people will take place and gatherings in safe ways will happen without having to wear masks and so forth.
So the new normal may be more like the old normal?
Yes.
When these billions of vaccinations are available, how do you see that they will be administered so that our society can move quickly back into something that’s a little more normal?
When there’s a billion vaccines made, I don’t know how that distribution will take place. Pfizer as a company has been impressive to me in terms of solving this challenge for humanity. We’ve partnered with a lot of companies to evaluate their pitches and proposals because we’ve got a bit more muscle to manufacture and Pfizer’s committed to make sure that everybody gets an opportunity to be vaccinated. One way or the other, they’ll make it available.
Meanwhile, do you think that the precautions that are being taken are necessary or are important? Do we just need to hang on for a few months being cautious and then it will be OK?
I think until we have the vaccine that there is not safe way to get a large group of people together in a confined space. If you are all wearing masks, that is going to be much safer, but not risk free. There was a great article that just came out signed by two hundred different health authorities, written to the CDC, talking about their beliefs that this virus can be aerosolized by someone who has it.
The six-foot rule that we’ve been talking about may not be enough. If someone spits or sneezes you get these particles that fly through the air that you can breathe in and get the virus, but if it is aerosolized, it is a smaller droplet that can remain aloft in the air and spread 30-feet across a room. So some of these super-spreader events that have happened at churches or at bars or other confined spaces, are believed to have happened because the virus was aerosolized and stayed aloft.
I don’t know that there’s any return to a sense of normalcy until we have vaccines and are able to be vaccinated, but certainly the masks are pivotal in protecting ourselves and protecting others from us if we happen to be a carrier of the virus.
When we first got news of this virus and we began to lock ourselves down in March, could you have anticipated where it would go or could you see that already you had things in place that would be helpful in creating a vaccine for this?
Personally, I didn’t start paying attention until March, but the World Health Organization was aware in December about what was happening in China. By mid-January, China had made available the genome sequence of this SARS-2 and then by February, Pfizer and Biontech had agreed to go into partnership to develop a vaccine. Think about that. It was an idea in February and by late April we had a vaccine in people being tested. That has never happened. It is a testament to the technology that has just become available in the last couple of years.
Back to your Latter-day Saint hat, it is such a testimony toward the Lord being prepared in all things, just as the same way the Church having gone to Come Follow Me studies at home.
Exactly.
What else should our readers know?
My personal thoughts are that until we have vaccine there is going to be a need to be cautious, to be considerate, to wear masks in public. I don’t think it means we need to isolate ourselves away from the world, but if you are in a high-risk category, you are certainly going to have to be even more cautious.
In terms of the vaccine, I am very optimistic that not only Pfizer but other companies will have successful options that will be available at the end of this calendar year. We’ve seen data already from multiple companies in phase one. The larger trials are about to get underway. They will have to prove out, but based on what we’ve seen, we’re optimistic that this will work out. We have the manufacturing clout so we will be able to deliver it. We’re just waiting for the clinical trials to prove that these are safe and effective and will do the job.
I would say, the medical profession, doctors and health staff, they are learning as they go, and though you see some infection rates rising in various places, you are not seeing the same death rates. This is not just because it is a younger crowd getting the virus but because hospitals are better equipped and better understand how to help patients, how to ventilate them. There are some therapies that are becoming available for patients who have respiratory problems beyond the viral load problem, and then down the road, later this year, we will have anti-virals that will be available even for patients to take earlier during the course of their diagnosis.
This is optimistic news. So our lives aren’t changed forever by this experience?
I was reading this morning in the Doctrine & Covenants a passage that talked about the Lord being in the earthquake, being in the tempest, being in the pestilence and I wrote in my scriptures there “and being in COVID-19.” There are lessons that we needed to learn. There are things that we’ll benefit from and progress from, and at the same, time, knowing that it would come, I believe that the Lord has provided a way out of it as well and that we will see that happen beginning at the end of the year.

Comments

Anonymous said…
What do you have to say now in November of 2021? Seeing that there are 17 000+ deaths caused by this "vaccine"?

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