Pharmaceutical giant Pfizer has announced that a Phase 3, late-stage study found their potential COVID-19 vaccine showed more than 90% effectiveness. The two-dose vaccine still faces several challenges, including how to store and transport it, since it must be refrigerated at subzero temperatures. Pulitzer Prize-winning science journalist Laurie Garrett says the news is hopeful, but urges caution. “There’s been no scientific release. There’s no published data,” she says. “We don’t have anything to go with except what the lawyers at Pfizer massaged carefully into a single-page press release. So, we have to take that with a big caveat.”
AMY GOODMAN: As the number of coronavirus cases worldwide tops more than 51 million, the U.S. pharmaceutical company Pfizer announced Monday a Phase 3, late-stage study found their potential COVID-19 vaccine shows more than 90% effectiveness. This is Pfizer CEO Albert Bourla on CNN.
ALBERT BOURLA: Ninety percent is a game changer. Ninety percent, now you are hoping to have a tool in your war against this pandemic that could be significantly effective. How long this protection will last is something that we don’t know right now. … We believe that we are in a good situation to have up to 50 million doses this year globally. And I believe we are in a very, very good situation to have 1.3 billion doses globally.
AMY GOODMAN: The two-dose vaccine still faces several challenges, including how to store and transport it, since it must be refrigerated at subzero temperatures.
In response to the news, Vice President Mike Pence tweeted, ”HUGE NEWS: Thanks to the public-private partnership forged by President @realDonaldTrump, @pfizer announced its Coronavirus Vaccine trial is EFFECTIVE, preventing infection in 90% of its volunteers,” unquote. Pfizer immediately debunked the claim, which referenced Operation Warp Speed, the federal effort to rush a vaccine to market. Senior vice president and head of vaccine research, Kathrin Jansen, told The New York Times, quote, “We were never part of the Warp Speed. … We have never taken any money from the U.S. government, or from anyone,” she said.
Meanwhile, President-elect Joe Biden said Monday the coronavirus vaccine approval process must be guided by science, and warned a vaccine likely won’t be available for months. He spoke after meeting with the 12-member coronavirus task force that he has just appointed to advise him during the transition before his January 20th inauguration. It includes Dr. Rick Bright, the whistleblower from the Trump administration who said his early warnings about the pandemic were ignored.
PRESIDENT-ELECT JOE BIDEN: This group will advise on detailed plans built on a bedrock of science, and the key compassion, empathy and care for every American at its core, making rapid testing widely available — more widely available, much more widely available — and building a core of contact tracers who will track and curb this disease, while we prioritize getting vaccines first to the most at-risk populations.
AMY GOODMAN: President-elect Biden has also said he plans to repair the U.S. relationship with the World Health Organization. This comes as the U.S. passed 10 million COVID cases on Monday, with the most recent 1 million infections happening faster than any previous million — in just 10 days.
Well, for more, we’re joined by Laurie Garrett, Pulitzer Prize-winning science writer, former senior fellow for global health at the Council on Foreign Relations. She’s the author of a number of books, including Ebola: Story of an Outbreak and The Coming Plague: Newly Emerging Diseases in a World Out of Balance.
It’s great to have you with us, Laurie. Thanks so much for joining us. If you can first start off by responding to the Pfizer announcement yesterday?
LAURIE GARRETT: Well, on the front end, I have to say it’s great news. It’s always encouraging to see positive results in a vaccine trial, especially at this stage in an epidemic, very quickly. And, you know, it’s hopeful. But it is only a press release. There has been no scientific release. There’s no published data. We don’t have anything to go with except what the lawyers at Pfizer massaged carefully into a single-page press release. So, we have to take that with a big caveat.
And the other thing that has to be considered very carefully is that this president is in the process of carrying out retribution, vindictive firings all across his government, getting rid of people who have stood up to him in various agencies. I mean, the most astounding was yesterday, firing the secretary of defense. And Steve Hahn, the head of FDA, has been consistently on Trump’s hit list. He stood up to the president regarding hydroxychloroquine, regarding convalescent plasma therapy and other things that the president claimed would treat or cure or eliminate COVID, but they wouldn’t. And so, we could have a situation now where, in the coming days, Steve Hahn’s head would go on a platter, and the FDA would really not be able to take speedy steps to usher this vaccine through the next stage that could allow it to potentially get an emergency approval before the new year.
AMY GOODMAN: Laurie Garrett, just very quickly, explain what you mean by Esper — the significance of him in relation to the vaccine. He is in charge of Operation Warp Speed? He’s the secretary of defense.
LAURIE GARRETT: No, my reason for raising that is that it’s very clear the president has now offed, by my count, 10 people in the government, from USAID, from the Energy Commission, from all sorts of different agencies and departments around the government. If he targets Steve Hahn, as he has threatened to do many times — he has threatened Steve Hahn, the FDA commissioner, with firing on multiple occasions. If he offs him, it would be very hard to imagine how the FDA could proceed for a rapid approval of this vaccine.
Meanwhile, I mean, there are issues about the vaccine. Because of the nature of how the Operation Warp Speed trial designs were set up, it is possible to claim victory based on seven days of data. And that’s what this study did. They had two arms of volunteers — one were placebo recipients, one were vaccine recipients. The two arms are blinded, so none of the people executing the study know who is getting what. And that’s good, and that’s how it should be. And one arm had eight cases, and the other arm had 80 cases. And that looks like, since the arm with the eight cases was the vaccine recipient arm, then that gives it what they call 90% effectiveness in protecting against infection. But the window of looking at these people to see did they get coronavirus infected was seven days, seven days after their booster shot. Well, you know, that’s a pretty short-term durability of immune response. And if eight people got infected in just seven days, I wonder what the infection rate and the protection rate of this vaccine would be if you were looking out over two months.
JUAN GONZÁLEZ: And, Laurie, what do we know about the trial participants? There was supposedly, I think, 44,000 of them. Do we know anything about the breakdown in terms of vulnerable populations or not, or different nationalities? What do we know?
LAURIE GARRETT: Actually, we know a great deal, and all of this was in the press release detailed — far more detail about that than the outcome of the research. And, yes, it’s very, very racially diverse, age diverse. There are healthcare workers that are very directly exposed. It actually, you know, on the face of it, looks like an excellent study panel.
JUAN GONZÁLEZ: And in terms of the capacity of Pfizer and BioNTech to produce 50 million doses of the vaccine this year and 1.3 billion, as they claim, in 2021, has the U.S. already purchased some of these in advance? What’s the situation in terms of the rollout, if it is approved, especially to vulnerable populations? Do we have any idea about that?
LAURIE GARRETT: One of the key features of Operation Warp Speed on the U.S. side, and its equivalent efforts all over the world in wealthy countries, and in WHO’s hands, is to try and encourage drug companies to go ahead and gear up for manufacturing even before the trial results are in, so that we don’t — precisely to your point, we didn’t want to feet dragging, waiting for production capacity to rev up. Instead, everybody has been encouraged to gamble — and it’s a big financial gamble — to gamble that their vaccine will indeed work and to build up production capacity right away.
And so, Pfizer claims that they already have production capacity to make tens of millions of doses and that they will be revved up to make billions of doses sometime in late 2021. But at the front end, keep in mind, when you hear a figure like 50 million doses available, everybody has to take two. So that’s actually 25 million human beings vaccinated, not 50 million. And that means that there has to be determination of who gets in the front of the line and who gets in the second tier of the line. And the National Academy of Medicine has held numerous hearings on this topic to try and come up with equitable, smart ways to decide, essentially, who goes first. And obviously, frontline healthcare workers are at the front of that line.
AMY GOODMAN: And can you talk about the significance not only of the two-shot vaccine, but of it having to be kept at subfreezing temperature — states across the country are asking how exactly are they going to be dealing with this — not only what this means in the United States, but around the world, especially in poorer countries?
LAURIE GARRETT: Well, I’ve detailed a lot of this in a piece that’s published today by Foreign Policy, so people can look at that and see some of the — more references to things I’m going to say now. The first thing I really want to underscore is, the Pfizer vaccine may be the first one we’re hearing about, but there are a lot of other ones, more than 200 in the pipeline. And many of them will in fact be better vaccines, will have even better results and will be easier to transport, easier to store, easier — perhaps require only one dose, and so on. So, you know, let’s not put all of our eggs in this particular basket.
But it is based on nucleic acid. It’s made from mRNA, messenger RNA. And this is the molecule that carries the blueprint from the DNA — right? — to the machinery inside the cell that manufactures proteins. And so, what it’s doing is turning your cells, your human cells, into little factories to make the protein that’s on the outside, that sticks up on the outside, in multiple copies surrounding the virus. And that way, making just that protein, which is harmless, your immune system will see it and make antibodies against it. So it’s programming your immune system to recognize the enemy.
The problem is that that mRNA is very unstable. It is so unstable that it has to be stored at minus-100 degrees Fahrenheit. Some reports say -110 degrees Fahrenheit, which is well below anybody’s freezer capacities. And so, you either have to have very, very, very powerful freezers or a lot of dry ice. And there we get to the second part of the problem. It’s been pointed out repeatedly that we have a global shortage of dry ice. Dry ice has to be made from pure CO2, and the primary source of pure CO2 in the whole sort of manufacturing chain for dry ice is burning ethanol. And since the epidemic has resulted in a huge decrease in the burning of fossil fuels, it’s also, fortunately, resulted in a decrease in the emission of CO2, including into this pure form to make dry ice.
So, all sorts of steps in the chain of transport and use of this vaccine will be challenging. And this was pointed out by the National Governors Association in a very blistering letter that they sent formally to Robert Redfield, the head of the CDC, and to the White House, saying, “You’re asking us, as governors, to be prepared to do mass immunization of our populations without telling us details about the likely vaccine. But we understand that at the front of the line are vaccines that require deep, deep, deep, deep, deep ultra freezing. We don’t have deep, deep, deep, deep ultra freezers. Our health departments are woefully underfunded. We don’t have the capacity to do this. Where will the money come from? Where will the equipment come from? Who’s in charge of all of this? And how are we going to do this?” And the response from the White House so far was simply to say, “Hey, you know, you should have been at this meeting, because we talked about that at this meeting. And Governor Cuomo, the head of the National Governors Association, didn’t show up for the meeting.”
JUAN GONZÁLEZ: And, Laurie, what do you make of the timing of this announcement coming just a couple of days after Joe Biden was declared the winner of the presidential debates? There’s, rightfully, some questions asked as to whether Pfizer and BioNTech could have made this announcement one or two days earlier or a week earlier? What’s your sense?
LAURIE GARRETT: The CEO of Pfizer made it very clear, in multiple public appearances and in writing, more than three weeks ago, that he was not going to see his vaccine be a political football, that he wasn’t making guarantees to have it available by any deadline date that was set by the White House or by anybody else, but that the science would determine, he said, what date the information, the results would be released. And we just have to take his word for it.
AMY GOODMAN: I wanted to ask you about Public Citizen saying that Pfizer should not have released this by press release without being able to provide further data, the questions, Laurie, about who this was tested on. Health Research Group’s Michael Carome released this statement saying, quote — that statement said, quote — I’m going to go to it right now — “The release of preliminary and incomplete clinical trial data by press release to the public is bad science. Until the trial results are independently reviewed and scrutinized by staff at the U.S. Food and Drug Administration and the independent experts on the agency’s Vaccines and Related Biological Products Advisory Committee, enthusiasm for the apparently promising interim results announced by Pfizer and BioNTech must be tempered. Crucial information absent from the companies’ announcement is any evidence that the vaccine prevents serious COVID-19 cases or reduces hospitalizations and deaths due to the disease. More importantly, critical safety data from the phase 3 trial of the … vaccine is not yet available.” But who has been tested so far, I mean, who the trials have been conducted on, the concerns raised — in the United States, communities of color, Latinx and African American populations underrepresented in a lot of these vaccine trials, and Oxfam raising the concern the vaccine would be committed — Oxfam has said the vaccine would be, quote, “0% effective to the people who can’t access or afford it.”
LAURIE GARRETT: Well, there’s a lot of truth and untruth in that mix of comments that you just put out. First of all, Pfizer put out a very detailed list, as I already said to Juan, of the racial breakdown, age breakdown and susceptibility to COVID disease breakdown of the participants in their study. And it is a very diverse group. And I just — I don’t know who’s making claims otherwise, but they should look at the breakdown. It’s been published and known for quite some time.
But the larger question: What does this vaccine, or anything of its nature similar, like the Moderna vaccine, which is also based on mRNA and will require deep freezing, and some of the other vaccines in the pipeline that have difficult either production issues or logistic issues associated with the nature of the vaccine — what does this mean for the rest of the world? And that’s a very legitimate question and a very troubling one, but one that the community has been confronting from the very beginning. I mean, all the way back in February, there has been discussion of this.
COVAX was set up, which is a cooperative for vaccines, COVAX, set up by WHO in conjunction with several lead countries. Almost every country in the world is now a member — notably not the United States, because Trump refused to be involved in anything that WHO had its fingerprints on. But COVAX is a consortia of all the nations’ both producers of vaccines and likely recipients committing to lowering their patent thresholds, making vaccines affordable and available for the whole world, and trying to rush them into some form of generic manufacturing so that we’re not reliant on a single patent-based manufacturing site.
So, we’re learning from past experiences that we have to take innovative approaches to vaccine production, because, otherwise, it’s not available for the whole world. Nevertheless, if a vaccine as difficult to make and to maintain in stable form as this one, the Pfizer vaccine, is becomes something that we try to execute worldwide, there will be very, very significant hurdles to overcome, both in the distribution part and in the manufacturing side on a mass scale. So, I think a lot of us are really hoping that some of the more traditional types of vaccines, which are in the pipeline, which would be usable through systems already in existence for mass vaccination of children, will turn out to be successful and will eventually come forward for mass production.
JUAN GONZÁLEZ: And, Laurie, we’re in the midst now of the second surge, if in some places the third surge, in the numbers of coronavirus cases, and now President-elect Biden has named his coronavirus task force. How do you assess the task force that Biden has named? And what do you see as what should be the first, the key steps that that task force has to take?
LAURIE GARRETT: Yeah, Juan, I argue in today’s piece in Foreign Policy that, you know, it’s a fine task force — good names, smart people. And notably, exceptional differences compared to the current COVID task force in the White House, there are no relatives of the president-elect on the task force; there are no financial interests associated with the president-elect or his family or close associates represented on the task force. It is a public health and scientific task force. And I’m confident that they will make decisions based on the seven principles of fighting COVID, which the president-elect published on his website on Monday morning. And those clearly lay out a strategic scheme that’s in line with the kinds of things that Tony Fauci has been advocating and that most of the public health community has supported from the very beginning of this epidemic, that were never fully implement at any time, in any state, by any political leader in the United States of America, certainly not the president.
But let’s all be very clear. And this is the key point I really lead with in my Foreign Policy piece, is we are in very dire times in the United States right now. This surge that we’re in right now is going to surpass what we went through in the spring. We are looking very likely, because the administration will take no actions, to speak of, to control the spread of COVID for the next 70-plus days that Donald Trump is in charge of the country — we are looking very likely at 400,000 deaths cumulatively by Christmas. We will go to the inauguration with an out-of-control epidemic in all 50 states. It’s already out of control in 43 states. We will have surges that require actions by governors and mayors that exceed what most of them have ever done so far in fighting COVID. They’ll be very much like what we went through in New York in March, April and May. And the euphoria that we saw yesterday on the stock markets around the world in response to the Pfizer vaccine announcement will turn to a downturn as lockdowns are put in place, and we’ll feel more economic pain.
So, while I am optimistic that this COVID task force put together by President-elect Biden will take promising steps and certainly take this epidemic very, very, very seriously, both internationally, in the role of the United States as a world leader, and nationally, domestically, but there are 71 days left for this current president to screw up this epidemic further. He is a vindictive individual. He seems to be out of control right now in the White House. And I just — I’m terrified for what things he will and will not do between now and January 20th.