After ending its own Covid-19 vaccine trials, the company said that it was actively discussing with governments how to help its competitors make their shots.
From Ebola to H.I.V. to river blindness, the American pharmaceutical giant Merck has been on the front lines of the biggest public health emergencies in recent history.
So when the company announced last May that it was a late entrant in the race to develop a Covid-19 vaccine, Merck was a popular pick to win. Even if the company wasn’t first, proponents argued, its expertise as the world’s second-largest vaccine maker gave it a good shot at developing the best product — and manufacturing it quickly.
But then, last month, Merck exited the vaccine race, abandoning its two candidates after early clinical trials flopped. Now, in addition to testing two experimental Covid-19 drugs, the company says that it’s looking for ways to help competitors supply the world with vaccines.
“We are in regular conversation with governments, we’re in regular conversations with the public health authorities, with the foremost experts on all this,” said Michael T. Nally, the chief marketing officer at Merck. The company, he said, is now asking: “With all that we know today, what is the best way for us to help?”
Merck did not provide details about which companies or governments it planned to work with, or how it would help. But as a major vaccine maker, it has factories that specialize in a range of vaccine technologies, as well as ones that fill the bulk product into ready-to-ship vials.
Mr. Nally’s statements follow weeks of speculation in which industry insiders and public figures have called on Merck to do more to help with the vaccine effort, as demand outstrips supply and contagious variants boom around the globe.
“Merck tried to make a vaccine, didn’t succeed,” Bill de Blasio, the mayor of New York City, said earlier this month. “And now they’re going to go off and do other types of drugs. Well, I disagree. I think the federal government should say, no, Merck, you’re producing the vaccines we have now because we have a massive shortage.”
Officials in both the Trump and Biden administrations have considered enlisting Merck’s help in manufacturing vaccines developed by Pfizerand Johnson & Johnson.
Merck is now considering a range of options, both in the United States and around the world, mindful that anything it chooses to do would take months to bring to fruition, given the complexity of the manufacturing process. For the United States, that could mean shoring up supply later in the year or supplying booster shots needed to fight emerging variants. For other countries that do not have enough vaccines to immunize their populations, Merck’s support could be even more significant.
Given the unknowns about how long current vaccines will work, as well as the spread of variants that may make them less effective, “I think there’s a broader recognition, certainly within the U.S. government, but governments around the world, that this is a bit more complicated than we had at one time thought,” Mr. Nally said. “If there’s a way that we can help think through that, and prepare the world for what we see on the horizon, that’s where we’re focused.”
Doses of the AstraZeneca vaccine in Rome. Early talks with the University of Oxford to develop a vaccine with Merck fell through, and university researchers later chose to work with AstraZeneca.Credit…Cecilia Fabiano/LaPresse, via Associated Press
The turn of events leaves Merck — which brought in $8.3 billion in revenue from vaccines in 2020, second only to GlaxoSmithKline in global vaccine sales — without a starring role in the biggest public health crisis in a century. The spotlight is instead on a major competitor, Pfizer, and an upstart, Moderna, which developed two highly effective vaccines in record time, using a new technology known as mRNA.
“It is really interesting to see what Merck will do next,” said Ronny Gal, a pharmaceutical analyst with the Wall Street firm Bernstein, noting that in abandoning its Covid-19 vaccines, the company has conceded that its technology could not compete with the newer mRNA methods. “And since they have a very large vaccine business, they kind of have to do something.”
Merck has lagged its competitors for a range of reasons, experts say. Early talks with the University of Oxford about a partnership to develop its vaccine fell through, with the university researchers later choosing AstraZeneca. And Moderna chose not to partner with a bigger drug maker on its Covid-19 shot, despite a collaboration with Merck on other vaccines. (Merck has profited from Moderna’s success, however: It sold its stock in Moderna late last year, after Moderna’s share price had skyrocketed.)
Merck may have also simply been a victim of bad luck, as vaccine development is notoriously unpredictable. Sanofi and GlaxoSmithKline, major vaccine makers that have partnered on a Covid-19 vaccine, experienced a major setback when their shot failed to work on older people.
“I was very encouraged when Merck announced their commitment, because I have a high degree of confidence that Merck has what it takes, from a capability perspective and from a corporate commitment to global health,” said Margaret McGlynn, the former president of global vaccines at Merck, who is now on the board of Novavax, a small Maryland company that is developing a Covid-19 vaccine. “But you can only tell what’s going to work by doing the trials.”
Merck, which was founded in 1891, has been in the vaccine business for more than 100 years, having developed some of the world’s most well-known vaccines, including those for mumps, hepatitis A and chickenpox. In 2019, it was the first company to win approval from the Food and Drug Administration for an Ebola vaccine.
When the coronavirus began spreading around the world, however, Merck was slow to announce plans for a vaccine. By the time it provided details about two vaccine candidates in late May, most of its major competitors had already announced deals, and Pfizer and Moderna had already begun early clinical trials.
But Merck didn’t have to be first to win. Executives decided to pursue two projects that they felt had advantages over competitors. One vaccine, developed in partnership with the International AIDS Vaccine Initiative, would rely on the same technology, based on a harmless livestock virus, that had yielded their successful Ebola vaccine. The other, acquired through a purchase of Themis Bioscience, was based on an existing measles vaccine.
Both of the experimental Covid vaccines, the company said, would be tested using a single dose, and Merck was also exploring whether the one using the livestock virus could be given orally — two big edges over potential competitors, especially in the developing world.
In July, Merck’s chief executive, Kenneth C. Frazier, warned against moving too quickly. “I think when people tell the public that there’s going to be a vaccine by the end of 2020, for example, I think they do a grave disservice to the public,” Mr. Frazier said in an interview with a Harvard Business School professor. Mr. Frazier recently announced that he would retire as chief executive later this year, a decision that had been long planned.
In an interview in August, Dr. Nicholas Kartsonis, Merck’s senior vice president of clinical research for vaccines and infectious diseases, said the company’s position as leading vaccine maker gave it the luxury of time. “We are a much larger company. We are not as beholden to having to be first,” he said.
From left, Kenneth Frazier, Merck’s C.E.O., Albert Bourla, Pfizer’s C.E.O., and Olivier Brandicourt, Sanofi’s C.E.O., speaking to a Senate committee in February 2019.Credit…Erin Schaff/The New York Times
As it turned out, Pfizer and Moderna — who were in a close race to complete their vaccines — not only achieved their goal of producing something by the end of the year, but the results also exceeded expectations. Whereas some thought that the first generation of vaccines would show modest efficacy, akin to a flu vaccine, the shots from Moderna and Pfizer were 95 percent effective in clinical trials.
That set a high bar for other vaccines, one that Merck concluded last month it could not meet. In its announcement two weeks ago, the company said that the vaccines appeared safe, but did not generate immune responses that were comparable to other Covid-19 vaccines.
Saad Omer, a vaccine expert at Yale University, said Merck should get credit for trying, even if it did not succeed this time. “This is not the last pandemic,” he said. “So the more entities we have developing these kinds of things, the better off we are.”
Merck is now redoubling its efforts to develop two drugs to treat Covid-19, both of which are in clinical trials with results expected soon. In December, the company reached a $356 million deal with the federal government to supply up to 100,000 doses of one of them, a drug known as MK-7110 that affects the immune system, if it is shown to work.
Public health experts have saidmore treatments are needed for Covid-19, because even if vaccines become widely available, they may not work on everyone, and people will still get sick.
Still, some politicians and public health experts have questioned whether Merck should do more to aid the vaccine effort, especially given its expertise. Novartis and Sanofi recently announced deals outside of the United States to pack and fill millions of doses of the vaccine developed by Pfizer and the German company BioNTech; the so-called fill and finish process is one of the biggest bottlenecks in manufacturing. On Wednesday, the chief executive of the pharmaceutical giant Teva said its company was also considering aiding the vaccine production effort.
“There’s always a chance to build more capacity, but it takes time,” said Ms. McGlynn, the former Merck executive. Still, she said, “until we know that we have ample vaccine to immunize everyone in the world, and not have the access issues that are being predicted by some, I think we have to keep looking under every rock to see where can we find additional capacity.”
Just under three years ago, Infowars anchor Alex Jones was tossed off Facebook, Apple, YouTube, and Spotify, marking the unofficial launch of the “content moderation” era. The censorship envelope has since widened dramatically via a series of high-profile incidents: Facebook and Twitter
This week’s decision by YouTube to demonetize podcaster Bret Weinstein belongs on that list, and has a case to be put at or near the top, representing a different and perhaps more unnerving speech conundrum than those other episodes.
Profiled in this space two weeks ago, Weinstein and his wife Heather Heying — both biologists — host the podcast DarkHorse, which by any measure is among the more successful independent media operations in the country.They have two YouTube channels, a main channel featuring whole episodes and livestreams, and a “clips” channel featuring excerpts from those shows.
Between the two channels, they’ve been flagged 11 times in the last month or so. Specifically, YouTube has honed in on two areas of discussion it believes promote “medical misinformation.” The first is the potential efficacy of the repurposed drug ivermectin as a Covid-19 treatment. The second is the third rail of third rails, i.e. the possible shortcomings of the mRNA vaccines produced by companies like Moderna and Pfizer.
Weinstein, who was also criticized for arguing the lab-leak theory before conventional wisdom shifted on that topic, says YouTube’s decision will result in the loss of “half” of his and Heying’s income. However, he says, YouTube told him he can reapply after a month.
YouTube’s notice put it as follows: “Edit your channel and reapply for monetization… Make changes to your channel based on our feedback. Changes can include editing or deleting videos and updating video details.”
“They want me to self-censor,” he says. “Unless I stop broadcasting information that runs afoul of their CDC-approved talking points, I’ll remain demonetized.”
Weinstein’s travails with YouTube sound like something out of a Star Trek episode, in which the Enterprise crew tries and fails to communicate with a malevolent AI attacking the ship. In the last two weeks, he emailed back and forth with the firm, at one point receiving an email from someone who identified himself only as “Christopher,” indicating a desire to set up a discussion between Weinstein and various parties at YouTube.
Over the course of these communications, Weinstein asked if he could nail down the name and contact number of the person with whom he was interacting. “I said, ‘Look, I need to know who you are first, whether you’re real, what your real first and last names are, what your phone number is, and so on,” Weinstein recounts. “But on asking what ‘Christopher’s’ real name and email was, they wouldn’t even go that far.” After this demand of his, instead of giving him an actual contact, YouTube sent him a pair of less personalized demonetization notices.
As has been noted in this space multiple times, this is a common theme in nearly all of these stories, but Weinstein’s tale is at once weirder and more involved, as most people in these dilemmas never get past the form-letter response stage. YouTube has responded throughout to media queries about Weinstein’s case, suggesting they take it seriously.
YouTube’s decision with regard to Weinstein and Heying seems part of an overall butterfly effect, as numerous other figures either connected to the topic or to DarkHorse have been censured by various platforms. Weinstein guest Dr. Robert Malone, a former Salk Institute researcher often credited with helping develop mRNA vaccine technology, has been suspended from LinkedIn, and Weinstein guest Dr. Pierre Kory of the Front Line COVID-19 Critical Care Alliance (FLCCC) has had his appearances removed by YouTube. Even Satoshi Ōmura, who won the Nobel Prize in 2015 for his work on ivermectin, reportedly had a video removed by YouTube this week.
There are several factors that make the DarkHorse incident different from other major Silicon Valley moderation decisions, including the fact that the content in question doesn’t involve electoral politics, foreign intervention, or incitement. The main issue is the possible blurring of lines between public and private censorship.
When I contacted YouTube about Weinstein two weeks ago, I was told, “In general, we rely on guidance from local and global health authorities (FDA, CDC, WHO, NHS, etc) in developing our COVID-19 misinformation policies.”
The question is, how active is that “guidance”? Is YouTube acting in consultation with those bodies in developing those moderation policies? As Weinstein notes, an answer in the affirmative would likely make theirs a true First Amendment problem, with an agency like the CDC not only setting public health policy but also effectively setting guidelines for private discussion about those policies. “If it is in consultation with the government,” he says, “it’s an entirely different issue.”
Asked specifically after Weinstein’s demonetization if the “guidance” included consultation with authorities, YouTube essentially said yes, pointing to previous announcements that they consult other authorities, and adding, “When we develop our policies we consult outside experts and YouTube creators. In the case of our COVID-19 misinformation policies, it would be guidance from local and global health authorities.”
Weinstein and Heying might be the most prominent non-conservative media operation to fall this far afoul of a platform like YouTube. Unlike the case of, say, Alex Jones, the moves against the show’s content have not been roundly cheered. In fact, they’ve inspired blowback from across the media spectrum, with everyone from Bill Maher to Joe Rogan to Tucker Carlson taking notice.
“They threw Bret Weinstein off YouTube, or almost,” Maher said on Real Time last week. “YouTube should not be telling me what I can see about ivermectin. Ivermectin isn’t a registered Republican. It’s a drug!”
From YouTube’s perspective, the argument for “medical misinformation” in the DarkHorse videos probably comes down to a few themes in Weinstein’s shows. Take, for example, an exchange between Weinstein and Malone in a video about the mRNA vaccines produced by companies like Moderna and Pfizer:
Weinstein: The other problem is that what these vaccines do is they encode spike protein… but the spike protein itself we now know is very dangerous, it’s cytotoxic, is that a fair description?
Malone: More than fair, and I alerted the FDA about this risk months and months and months ago.
In another moment, entrepreneur and funder of fluvoxamine studies Steve Kirsch mentioned that his carpet cleaner had a heart attack minutes after taking the Pfizer vaccine, and cited Canadian viral immunologist Byram Bridle in saying that that the COVID-19 vaccine doesn’t stay localized at point of injection, but “goes throughout your entire body, it goes to your brain to your heart.”
Politifactrated the claim that spike protein is cytotoxic “false,” citing the CDC to describe the spike protein as “harmless.” As to the idea that the protein does damage to other parts of the body, including the heart, they quoted an FDA spokesperson who said there’s no evidence the spike protein “lingers at any toxic level in the body.”
Would many doctors argue that the 226 identified cases of myocarditis so far is tiny in the context of 130 million vaccine doses administered, and overall the danger of myocarditis associated with vaccine is far lower than the dangers of myocarditis in Covid-19 patients?
Absolutely. It’s also true that the CDC itself had a meeting on June 18th to discuss cases of heart inflammation reported among people who’d received the vaccine. The CDC, in other words, is simultaneously telling news outlets like Politifact that spike protein is “harmless,” and also having ad-hoc meetings to discuss the possibility, however remote from their point of view, that it is not harmless. Are only CDC officials allowed to discuss these matters?
The larger problem with YouTube’s action is that it relies upon those government guidelines, which in turn are significantly dependent upon information provided to them by pharmaceutical companies, which have long track records of being less than forthright with the public.
In the last decade, for instance, the U.S. government spent over $1.5 billion to stockpile Tamiflu, a drug produced by the Swiss pharma firm Roche. It later came out — thanks to the efforts of a Japanese pediatrician who left a comment on an online forum — that Roche had withheld crucial testing information from British and American buyers, leading to a massive fraud suit. Similar controversies involving the arthritis drug Vioxx and the diabetes drug Avandia were prompted by investigations by independent doctors and academics.
As with financial services, military contracting, environmental protection, and other fields, the phenomenon of regulatory capture is demonstrably real in the pharmaceutical world. This makes basing any moderation policy on official guidelines problematic. If the proper vaccine policy is X, but the actual policy ends up being X plus unknown commercial consideration Y, a policy like YouTube’s more or less automatically preempts discussion of Y.
Some of Weinstein’s broadcasts involve exactly such questions about whether or not it’s necessary to give Covid-19 vaccines to children, to pregnant women, and to people who’ve already had Covid-19, and whether or not the official stance on those matters is colored by profit considerations. Other issues, like whether or not boosters are going to be necessary, need a hard look in light of the commercial incentives.
These are legitimate discussions, as the WHOs own behavior shows. On April 8th, the WHO website said flatly: “Children should not be vaccinated for the moment.” A month and a half later, the WHO issued a new guidance, saying the Pfizer vaccine was “suitable for use by people aged 12 years and above.”
The WHO was clear that its early recommendation was based on a lack of data, and on uncertainty about whether or not children with a low likelihood of infection should be a “priority,” and not on any definite conviction that the vaccine was unsafe. And, again, a Politifact check on the notion that the WHO “reversed its stance” on children rated the claim false, saying that the WHO merely “updated” its guidance on children. Still, the whole drama over the WHO recommendation suggested it should at least be an allowable topic of discussion.
Certainly there are critics of Weinstein’s who blanch at the use of sci-fi terms like “red pill” (derived from worldview-altering truth pill in The Matrix), employing language like “very dangerous” to describe the mRNA vaccines, and descriptions of ivermectin as a drug that would “almost certainly make you better.”
Even to those critics, however, the larger issue Weinstein’s case highlights should be clear. If platforms like YouTube are basing speech regulation policies on government guidelines, and government agencies demonstrably can be captured by industry, the potential exists for a new brand of capture — intellectual capture, where corporate money can theoretically buy not just regulatory relief but the broader preemption of public criticism. It’s vaccines today, and that issue is important enough, but what if in the future the questions involve the performance of an expensive weapons program, or a finance company contracted to administer bailout funds, or health risks posed by a private polluter?
Weinstein believes capture plays a role in his case at some level. “It’s the only thing that makes sense,” he says. He hopes the pressure from the public and from the media will push platforms like YouTube to reveal exactly how, and with whom, they settle upon their speech guidelines. “There’s something industrial strength about the censorship,” he says, adding. “There needs to be a public campaign to reject it.”
I watched Weinstein’s Youtube discussion of the mRNA vaccine with Robert Malone. As a physician, I didn’t find his discussion particularly convincing, nor that of Dr. Malone. Three or four hundred million people have now been vaccinated and we are not seeing a lot of serious side effects, which we would almost have certainly seen by now if there really was a problem. The issue, as I see it, is that Weinstein is making a living with his Youtube channel and obviously, he is motivated to increase his income by generating controversy. There’s a heck of a lot of content on Youtube and careful, well-reasoned discussion probably would generate less income than outlandish claims. As a physician, I’m used to reading medical journals and I have enough statistical training to evaluate the evidence. That’s not true for the majority of people exposed to this kind of programming. I’d have found Weinstein’s program a lot more interesting if he had brought on an active mRNA researcher to debate Dr. Malone. (I don’t think Dr. Malone is “in his dotage” at age 60, but he’s clearly not involved with this kind of work anymore.) Weinstein is a smart guy, but he’s not a physician, and not a virologist. His show needs to be a little more balanced if he wants to be taken seriously.
Check out Dr John Campbell , https://youtube.com/c/Campbellteaching he has over 1 million subs, talks about ivermectin all the time and is not demonetized. Why? Because of how he frames it, he is also a believer in vaccines.
Bret on the other hand has gone full Alex Jones with a messiah complex to boot! He has lost the fucking plot completely. Nothing he says makes sense anymore, it’s full on global conspiracy shit. He takes ivermectin live on air.. says he is not getting vaccinated but using ivermectin prophylacticly?.. it’s just totally over the top for a public channel and asking to be demonetized.
I think the reason there’s very little effort going into figuring out if ivermectin works is because we have vaccines that work so well and the fact that so many people got burned promoting early alternative treatments that turned out to be bullshit like hydroxychloroquine…. But I’m sure I’m wrong and Bret is the savior of humanity battling against big tech and the globalists behind the great reset! Maybe he should try and build back betterer his channel.
I watched Weinstein’s Youtube discussion of the mRNA vaccine with Robert Malone. As a physician, I didn’t find his discussion particularly convincing, nor that of Dr. Malone. Three or four hundred million people have now been vaccinated and we are not seeing a lot of serious side effects, which we would almost have certainly seen by now if there really was a problem. The issue, as I see it, is that Weinstein is making a living with his Youtube channel and obviously, he is motivated to increase his income by generating controversy. There’s a heck of a lot of content on Youtube and careful, well-reasoned discussion probably would generate less income than outlandish claims. As a physician, I’m used to reading medical journals and I have enough statistical training to evaluate the evidence. That’s not true for the majority of people exposed to this kind of programming. I’d have found Weinstein’s program a lot more interesting if he had brought on an active mRNA researcher to debate Dr. Malone. (I don’t think Dr. Malone is “in his dotage” at age 60, but he’s clearly not involved with this kind of work anymore.) Weinstein is a smart guy, but he’s not a physician, and not a virologist. His show needs to be a little more balanced if he wants to be taken seriously.
Check out Dr John Campbell , https://youtube.com/c/Campbellteaching he has over 1 million subs, talks about ivermectin all the time and is not demonetized. Why? Because of how he frames it, he is also a believer in vaccines.
Bret on the other hand has gone full Alex Jones with a messiah complex to boot! He has lost the fucking plot completely. Nothing he says makes sense anymore, it’s full on global conspiracy shit. He takes ivermectin live on air.. says he is not getting vaccinated but using ivermectin prophylacticly?.. it’s just totally over the top for a public channel and asking to be demonetized.
I think the reason there’s very little effort going into figuring out if ivermectin works is because we have vaccines that work so well and the fact that so many people got burned promoting early alternative treatments that turned out to be bullshit like hydroxychloroquine…. But I’m sure I’m wrong and Bret is the savior of humanity battling against big tech and the globalists behind the great reset! Maybe he should try and build back betterer his channel.