As several late-stage trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust. Pharma Manufacturing editors Karen Langhauser and Meagan Parrish discuss.
Meagan Parrish: The date was September 8th, and like many moments in the coronavirus pandemic, a group pharma companies were taking unprecedented action: fearing that the rhetoric around vaccines was becoming too politicized, which could hurt public trust, they came together and released a joint pledge to continue to make safety the top priority in the development of the first COVID-19 vaccines/
[Audio clip]: However with increasing public concerns about the processes that we are using to develop this vaccine and even more importantly the processes that will be used to evaluate these vaccines, we saw it as critical to come out and reiterate our commitment: That we will develop out products our vaccines using the highest ethical standards, and the most scientific processes.
MP: That’s Pfizer CEO Albert Bourla speaking on the Today show following the release of the historic pledge. Bourla has led the charge for transparency from within the pharma industry, but as several late-stage vaccine trials edge towards the finish line, skepticism surrounding vaccines continues to spread at a rate faster than the coronavirus itself — and drugmakers and health officials are scrambling to restore public trust.
I’m Meagan Parrish, senior editor of Pharma Manufacturing magazine, and you’re listening to Off Script — Pharma Manufacturing’s podcast featuring conversations that run beyond the pages of our publication and focus on what’s trending in the drug industry.
This week we’re diving into the central question behind the cover story from our October issue — How did we get in a situation where vaccine confidence is so low, and what can the pharma industry do to build trust before it's too late?
The world is battling a pandemic that has now killed more than one million people. A return to some semblance of normalcy rests on safe and effective vaccines — but, more specifically, people willing to take these vaccines. And yet countless polls continue to reflect dwindling confidence, with some finding that as many as 50 percent of Americans say they will not get a vaccine when one is available. If pharma is ever going to claim victory over the pandemic, this problem with trust could be a massive hurdle. So what can the industry do?
This week I’m joined by our chief content director, Karen Langhauser who wrote this month’s cover story, “One shot: With vaccine skepticism threatening to shatter pandemic progress, pharma can’t afford to falter.” Thanks for joining us, Karen.
Karen Langhauser: Thanks for having me.
MP: So, I want to start by asking about what led you to decide to tackle this topic for our October issue?
KL: Well, as you and I both know and everybody does who’s been covering the pandemic so extensively, the pharma industry is putting forth this extraordinary effort towards the development, the testing, the manufacturing of these potential COVID vaccines, and they’ve managed to safely take a process that typically could take a decade and pare it down to, in some cases, a matter of months. And the U.S. government has invested billions of dollars in support of these efforts.
But all of this is happening amid this dumpster fire of extreme political divide, a serious crisis of misinformation made worse by social media, distrust in government agencies, distrust in science in general. It’s the perfect recipe for disaster when it comes to public confidence in vaccines.
As a result these polls are coming out saying that half of America doesn’t trust hypothetical COVID vaccines. We don’t even have all the data and already people don’t trust it. And yes, there is only so much value in polls – people’s intentions and actions don’t always line up – so these numbers aren’t set in stone. But nevertheless, the country, and the pharma industry, has a real problem when it comes to vaccine confidence.
MP: But the pharma industry has always faced opposition from anti-vaxxers, so how is this situation any different?
KL: Yeah, I mean, you’re right in that vaccine opposition is certainly not a new issue. It dates all the way back to smallpox outbreaks in the late 19th century and the associated vaccination campaigns across the U.S. Believe it or not people did disagree sharply on things before Twitter existed.
But the pharma industry is up against something different right now. And honestly that’s part of the reason why this story appealed to me so much. The traditional anti-vax argument is basically the social media apple that I can’t resist biting. I find it reckless and irresponsible it’s the ultimate misinformation campaign that has had deadly consequences. So imagine my surprise when my own family members, people who believe in science and vaccinations and who vaccinate their kids, expressed hesitation about getting COVID vaccines — and I understood that hesitation.
This new coronavirus vaccine skepticism has even permeated the circles of health professionals and scientists -- its totally different from the unfounded concerns conjured up by fringe conspiracy theorists watching Plandemic on repeat. And that makes the situation even more precarious for pharma — because they run the risk of losing their own supporters down the rabbit hole of anti-vaccination.
MP: But of course clearly, we’re all eager to get back to life as we knew it. So why are they hesitant?
KL: Well as one of the experts I interviewed for our cover story stated, “there are now many flavors of vaccine skepticism.”
The most obvious one is the politicization of vaccines. When you have the president constantly promising a vaccine before Election Day, despite health officials and the pharma companies themselves saying that likely isn’t happening, then the vaccine issue gets dragged into political debate. Kamala Harris responds by saying she won’t trust a “Trump vaccine” and then Trump turns around and accuses Democrats of “anti-vaccine rhetoric.” It’s a mess no matter what your political leanings are…and it’s causing a lot of people to lose confidence in the safety of hypothetical COVID vaccines.
Hand in hand with that comes the politicizing of the FDA. For 100+ years the U.S. FDA has represented the gold standard in assuring the safety of food and drugs. Agencies around the world have modelled their drug regulatory systems after that of the FDA. And now we are in this situation where the FDA’s judgment is being questioned by politicians, the president is on Twitter accusing the agency of being part of the “deep state,” the FDA commissioner is having to apologize for publicly misrepresenting data about potential COVID treatments, and if Americans can’t trust the FDA, they can’t trust vaccines approved by the FDA.
And yet another issue is simply speed itself. You take a process that typically takes a decade to complete, slap a warp speed label on it and cut it down to a matter of months, and the general public are going to start raising concerns about what steps are being skipped.
What struck me the most as I researched this is how fundamentally reasonable all of these concerns are — I get it. And Pharma gets it too.
MP: And of course, this isn’t entirely the pharma industry’s fault. Whether or not the industry likes it, there is a lot of political rhetoric around vaccines that is making this debate even harder for Americans to figure out — and, of course, being in an election year when everything is being politicized isn’t help. So, what is pharma’s role in building vaccine confidence and how has the industry responded to this challenge so far?
KL: No, I think pharma has really stepped up here. First of all you have to keep in mind that vaccine education is typically the responsibility of the government. But due to the uniqueness of this pandemic situation I think the pharma industry has recognized that their voices need to be part of the conversation.
The public in general does not have intimate knowledge the clinical trial process or the FDA approval process or the difference between a BLA and an EUA
So here is this historic chance for the industry to provide some transparency and visibility into their processes. And they’ve done that – the 9 vaccine maker pledge we referenced at the start of this conversation was a big step. And having the leaders in the vaccine race make public their phase three clinical trial protocols -- that’s not something you normally see happen. And we also seeing pharma CEOs – like Pfizer’s Alfred Bourla addressing the public directly and candidly – sometimes from their own living rooms.
It’s a fine line for pharma companies to walk when it comes to being vocal and transparent about vaccines in development, without overtly marketing them — especially when the general public perceives much of pharma’s actions as profit-driven — but I think they’ve done a really good job of finding that balance.
MP: Yeah Karen, and of course now we’re getting to the point where several drugmakers are getting very close to seeking FDA approval for their vaccines, whether it’s a full approval or an EUA, it seems like every day there something new is being reported in relation to vaccines. What has happened since the article was published? Or, sort of, what’s the latest from the wild world of COVID-19 vaccine development?
KL: Well, not to trivialize it but at times it’s become a bit of a vaccine soap opera. You know, I can barely keep track of who is attacking who on social media. And of course as we get closer and closer to the election, the political arguing over everything related to COVID, vaccines included, is intensifying and so is the misinformation.
But if we push that stuff aside, we now have four candidate vaccines selected by Operation Warp Speed in active phase 3 trials – with AstraZeneca and J&J both recently restarting their trials after they were paused due to adverse events.
On Oct 16 the Pfizer CEO – who has openly voiced his displeasure about vaccines being dragged into political discourse — posted an open letter on the Pfizer website clarifying the development timelines for the Pfizer, University of Oxford vaccine — that’s the vaccine that most are seeing as the frontrunner in the so called “vaccine race.” In this letter, Dr. Bourla clearly says that that assuming positive data from the phase 3 trial, Pfizer will apply for an EAU in the U.S. soon after the safety milestone is achieved in the third week of November, which definitively means that the controversy of a pre-election vaccine is now a moot point.
Also of note, on October 22,the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) held its long-awaited first COVID vaccine meeting. As planned, the panel did not weigh in on any particular vaccine. Instead the 9, almost 9-hour virtual meeting focused on the FDA’s approach to evaluating safety and efficacy data, including an in-depth discussion about Emergency Use Authorization designations. The entire event was open to the public — its on the FDA’s YouTube channel and all the briefing materials are posted on the FDA site.
While there’s a distinct possibility that I’m the only one who listened to the entire meeting, I think having that committee discussion in a public forum was critical to build trust and confidence in upcoming vaccines.
Aside from that, just a few days ago, Dr. Marks who is essentially the FDA point person for vaccine safety – actually I think he is long-time Star Trek fan and is also credited with coming up with the name “operation warp speed” (not overly relevant but a fun fact nonetheless) So Dr. Marks published what I thought was a very thoughtful opinion piece explaining what the agency is doing to make certain these vaccines are safe before getting approved.
So overall I’m hopeful that we as a country as in a slightly better place in terms of vaccine confidence, especially as COVID cases have begun to surge again all around the country.
MP: OK so let’s take a step back and look at this from a big picture point of view. Is there more at stake beyond just COVID vaccines? Why is this situation so high pressure?
KL: There’s a reason why we chose a vaccine vial bomb as our cover art for this story. In my column I wrote about the familiar movie scene where the hero is racing the clock to defuse the ticking bomb, right? He’s sweating, his hands are shaking, the ominous music is playing in the background, and he’s holding these wire cutters trying to decide which color wire to cut.
While that entire scenario is probably completely inaccurate in terms of the bomb defusing process, as I was writing this, I could help but think of the pharma industry as the one holding the wire cutters.
We have this completely perilous situation – a pandemic that has killed over a million people and shows no sign of going away without a vaccine while at the same time public trust is hanging by a thread. Any misstep by pharma – a vaccine that proves ineffective, a vaccine that proves unsafe — could not only undermine public trust in a COVID vaccine but it could destroy trust in vaccines general. What’s going to happen if people stop getting flu shots, stop vaccinating their kids against measles?
There’s a lot at risk here – efficacy matters, safety matters, even words matter – what’s at risk is really trust in the pharma industry in general. But on the flip side, this could be pharma’s greatest success story – they could be the hero who cuts the wire and saves the world — and we are all rooting for that b/c so many lives depend on it.
MP: Well, I’m sure this is an issue we will of course be hearing lots more about in the very near future. And of course, we here at Pharma Manufacturing Magazine will be following this very closely. So, thanks for taking the time to chat with me today, Karen, and keeping us all updated about the current situation.
This is Meagan Parrish and you’ve been listening to Off Script: A Pharma Manufacturing Podcast. Stay healthy, everyone, and stay informed.