Universal flu vaccine could be next big development for Moderna and Pfizer mRNA

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Employees in special suits test the manufacturing process of messenger RNA (mRNA) for the Covid-19 vaccine at the German company BioNTech on March 29, 2021 in Marburg, Germany.

Abdulhamid Khosbas | Anadolu Agency | Getty Images

The research and development that led to a Covid-19 vaccine has fueled the search for a stronger, longer-lasting flu vaccine, perhaps a step toward the holy grail of virologists: a single-use, universal flu shot.

Two pharmaceutical companies, Pfizer and Moderna, used half a century of mRNA technology research to create a Covid vaccine, and their scientists are using the same expertise to explore ways to vaccinate the masses against the flu.

Pirada Suphaphiphat, vice president of viral vaccine research at New York City-based Pfizer, told CNBC: “As demonstrated by the COVID-19 vaccine, mRNA vaccines offer … the potential to create a more potent flu vaccine faster than contemporary flu vaccines. .”e-mail. “The pandemic has allowed us to take advantage of the enormous scientific opportunity in mRNA.”

In 2020, the number of flu cases has dropped sharply, most likely due to Covid restrictions. But flu infections and hospitalizations continue to rise as the winter rolls around, especially in the eastern and central states, according to the Centers for Disease Control and Prevention’s Fluview weekly report.

The CDC always recommends getting an annual flu shot as the best way to prevent contracting the virus and its potentially serious complications. However, there are signs that flu vaccination rates are lower this season compared to the previous season, likely due to vaccine hesitancy during the coronavirus pandemic.

Although there is usually one flu virus in North America each year — this season’s influenza A H3N2 virus — the quadrivalent vaccine is designed to protect against three other strains that can cause infection because the virus mutates every month.

This shotgun approach admits that the flu vaccine is only 40 to 60 percent effective at preventing infection, and sometimes only 10 percent effective by the end of the flu season. Conventional flu vaccines, grown in eggs or mammalian cells, also take about six months to produce the millions of doses needed.

In contrast, mRNA-based influenza vaccine design requires only the genetic sequence of the dominant virus, which significantly speeds up production time. Pfizer reports that the flexibility of mRNA technology and its rapid manufacturing time could lead to better strain matching, greater supply reliability, and potential opportunities to improve the efficacy of current influenza vaccines.

“We think mRNA is the ideal technology to address this challenge,” Suphaphiphat added.

The popularity of mRNA technology

The technology behind messenger RNA, or mRNA, has been in development since it was discovered in 1960, but the Pfizer and Moderna Covid vaccine marks its first approval for use in humans.

It is now used to develop several different vaccines. Pfizer and Germany’s BioNTech said earlier this month they would develop a potential mRNA-based vaccine to prevent shingles, and scientists said they hoped the technology could be a turning point in the development of an HIV vaccine.

“mRNA is a platform,” Moderna CEO Stéphane Bancel said of the broader vaccine ambitions on CNBC’s Squawk Box on Monday. “mRNA is an information molecule, so we now have 44 zero programs in development, and there are actually many more in the lab.”

Bancel, who focuses on respiratory diseases, said about 10 viruses cause hospitalizations each year.

“Of course, the flu is well known, but RSV and many other viruses are not well known to the general public because their symptoms are similar to the flu, and we think the world should get an annual booster vaccine that contains all of these different vaccines. A single dose of anti-influenza, Anti-RSV, anti-Covid, and properly adapted to the strains that are prevalent here, that’s what we’re working towards,” he said.

Moderna has an RSV program and an influenza program in trials, “and we’re combining the two very quickly,” Bancel said.

“It seems to me a bit like you can get an annual upgrade of the product by adding more vaccines to the same vial. So, you’re adapting to the current strain for that year in your region, so in the U.S. or Europe or Japan, Because we see a lot of winters, the flu vaccine isn’t thought to work because we actually have different strains circulating around the world.”

In September, Pfizer announced the start of a Phase 1 human trial of an mRNA flu vaccine for adults, marking the drugmaker’s first mRNA-based flu program. It’s a so-called quadrivalent vaccine, like the one available to the public today, against four different flu variants.

In December, Moderna announced the first positive interim data from a Phase 1 study of its quadrivalent seasonal influenza vaccine candidate mRNA-1010 in older adults and younger adults. The company also announced that the Phase 2 study of mRNA-1010 is now fully enrolled and preparations for the Phase 3 study are underway.

While encouraging overall, the findings suggest that Moderna’s mRNA-based flu vaccine is no more effective in older adults than already-approved vaccines on the market, especially Sanofi’s Fluzone HD. Moderna’s shares fell 10% after investors in Moderna presented the findings. “We cannot make direct comparisons. We provide (Fluzone data) as a guide only,” a company executive said on a conference call with investors, urging them to wait for further data before selling shares.

Typically, big pharma companies like Pfizer and Moderna shy away from early-stage development of flu vaccines because, historically, they don’t make a lot of money. Fortune Business Insights estimated the global flu vaccine market at USD 6.59 billion in 2021 and is expected to grow to USD 10.73 billion by 2028, at a CAGR of 7.2% during the forecast period. According to Statista, the global revenue of the entire pharmaceutical industry in 2020 was $1.27 trillion.

A Covid-19 vaccine, however, is another matter entirely.

In November, when reporting its third-quarter earnings, Pfizer said it expected its coronavirus vaccine to bring in $36 billion in 2021. Around the same time, Moderna lowered its 2021 Covid vaccine earnings forecast to between $15 billion and $18 billion, down from an earlier estimate of $20 billion, partly due to production issues.

With the death toll from the coronavirus surpassing 832,000 in the U.S. and more than 5.4 million globally, the public has turned the attention off the seasonal flu from October to May. However, it also has a deadly history, with four influenza pandemics over the past century (1918, 1957, 1968, 2009), each claiming at least a million lives.

The CDC estimates that from 2010 to 2020, influenza killed 12,000 to 52,000 people in the United States each year and infected anywhere from 9 million to 41 million. Globally, the World Health Organization (WHO) estimates that influenza kills 290,000 to 650,000 people each year.

Increase R&D spending

Despite these dire statistics, R&D and funding for improved flu vaccines have been relatively insignificant and largely confined to academia, biotech startups and the National Institutes of Health (NIH).

NIH’s National Institute of Allergy and Infectious Diseases (NIAID) division provides an annual budget of approximately $220 million for universal influenza vaccines, part of which is dispersed as a grant to the Collaborative Influenza Vaccine Innovation Center (CIVIC), launched in 2019. By comparison, the National Institutes of Health has allocated nearly $7 billion to research cancer, which has claimed 606,520 lives by 2020.

In November, Rep. Rosa DeLauro of Connecticut and Sen. Ed Markey of Massachusetts reintroduced the Flu Vaccine Act, which was proposed as NIH’s influenza research program $1 billion investment, including external partnerships.

There are dozens of other flu vaccine development programs underway in the U.S., some of which are looking for so-called hyperseasonal vaccines to prevent recipients from becoming infected for several years. A team led by Neil King, assistant professor of biochemistry at the University of Washington School of Medicine, is working on a promising project at the University of Washington’s Institute for Medicine in Protein Design in Seattle, using computers to design new, self-assembling protein nanoparticles for vaccine production.

“The vaccine is in a small Phase 1 trial at the NIH,” King said. “Volunteers have already received the doses and we are starting the analysis.” He expects results within a few months and FDA approval “within the next five years” after Phase 2 and Phase 3 trials.

NIAID has participated in several Phase 1 trials of the universal influenza vaccine, said Dr. Jennifer Gordon, program officer for influenza vaccine development. One launched in 2019 and the other in June last year, each with a different scientific approach.

With no clear timetable, Dr Gordon hopes that a true one-off flu vaccine will one day be a reality, but at the same time won’t overlook creating better vaccines. “We don’t want to say that we only care about a permanent vaccine,” she said. “Some methods are a dramatic improvement over what we have now, and are huge wins, even if they’re not universal.”

Pfizer Chief Executive Albert Bourla said Monday that its recent research collaboration will allow it to target the flu, particularly through DNA technology, allowing it to reduce the number of infections from almost a month to a few days. .

“If needed, this could be significantly reduced, and possibly even further increased our ability to get a new variant of the vaccine, instead of three months. This would be a huge benefit for us in the fight against Covid and other diseases like the flu, for example, because it would Allows you to get very, very close to the release time of a new variant,” Bourla said.

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