How Merck, a vaccine titan, lost the Covid-19 race

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,” Mayor Bill de Blasio 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 Pfizer and 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,” 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.”

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 drugmaker 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,” Frazier said in an interview with a Harvard Business School professor. 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.

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% 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 said more 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 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 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.”