The universal influenza vaccine may be the next big Moderna, Pfizer mRNA development

Workers in special suits are testing methods for preparing Covid-19 vaccine messenger RNA (mRNA) at BioNTech in Marburg, Germany on March 29, 2021.

Abdulhamid Hosbas Anadolu Agency | Getty Images

Research and development leading to Covid-19 vaccines has stepped up efforts to find a more effective, longer-lasting influenza vaccine, perhaps a step toward the virologists: a one-time, universal influenza vaccine.

Researchers at Pfizer and Moderna, the pharmaceutical companies that harnessed half a century of research into mRNA technology to create Covid vaccines, are using the same know-how to study ways to vaccinate the masses against the flu.

“As the COVID-19 vaccine has shown, mRNA vaccines offer … the potential to produce more effective influenza vaccines faster than current influenza vaccines,” Pirada Suphaphiphat, vice president of Pfizer’s viral vaccine research in New York, told CNBC. e-mail. “The pandemic allowed us to take advantage of the huge scientific potential of mRNA.”

In 2020, the number of flu cases fell sharply, mainly due to Covid restrictions. But with the onset of this winter, flu infections and hospitalizations will continue to increase, especially in the eastern and central states, according to a weekly Fluview report from the Centers for Disease Control and Prevention.

The CDC always recommends an annual influenza vaccine as the best way to protect against the virus and its potentially serious complications. However, there have been indications that influenza vaccinations are lower this season than last year, possibly due to a vaccine hesitation that erupted during the coronavirus pandemic.

Although North America is usually dominated by one influenza virus each year – A (H3N2) this season – tetravalent injections are designed to protect against three other types that can cause infections when the virus mutates on a monthly basis.

This shotgun approach recognizes the fact that influenza vaccines are only 40-60% effective in preventing infection and sometimes only 10% effective at the end of the flu season. Traditional influenza vaccines are grown in either eggs or mammalian cells, and it also takes 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, significantly accelerating production time. The flexibility of MRNA technology and its rapid manufacturing time, Pfizer reports, could potentially allow for better strain compatibility, better security of supply, and the potential to improve the efficacy of existing influenza vaccines.

“We believe mRNA is the ideal technology to take on this challenge,” Suphaphiphat adds.

Proliferation of mRNA technology

The technology behind messenger RNA, or mRNA, was developed since its discovery in 1960, but the Pfizer and Moderna Covid vaccines marked the first time it was approved for use in humans.

It is now being applied to the development of several different vaccines. Pfizer and German BioNTech said earlier this month that they are developing a potential mRNA-based vaccine to prevent shingles, while researchers have said they hope the technology could be a turning point in the development of an HIV vaccine.

“mRNA is the beginning,” Moderna CEO Stéphane Bancel said of broader vaccine targets at CNBC’s Squawk Box on Monday. “mRNA is an information molecule, so we now have forty-four null programs under development and, in fact, many more in the lab.”

Bancel said there are about 10 viruses that lead to hospitalization each year, focusing on respiratory diseases.

“The flu is well known, of course, but RSV and many other viruses that are not very well known to the public because the symptoms are similar to the flu, where we believe the world deserves one annual booster that includes all those different vaccines. One dose against the flu, RSV, Covid, properly adapted to the circulating populations here, and we are working towards that, “he said.

Moderna has an RSV program and a flu program in the trials, and “we’re working very fast to combine this,” Bancel said.

“I think you get an annual update for the product by adding more vaccine to the same vial. So you get an adjustment to the current strains for that year in your geographic area, US, Europe or Japan, because as we see many winters, the flu vaccine isn’t considered effective Stocks orbiting the world. “

In September, Pfizer announced the launch of a Phase 1 human trial of an adult mRNA influenza vaccine, marking the drug manufacturer’s first mRNA-based influenza program. It is a so-called tetravalent vaccine, like the vaccines given to the general public today, and is targeted at four different variants of the flu.

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

Although the findings were generally encouraging, they showed that Moderna’s mRNA-based influenza vaccine was not more effective in elderly adults than vaccines already approved in the market, particularly Sanofin Fluzone HD. Following a modern investor presentation, its shares fell 10%. “We cannot make a direct comparison. We presented (Fluzone data) for guidance only,” the company executive said in a conference call with investors, urging them to wait for more information before selling the shares.

Typically, large pharmaceutical companies such as Pfizer and Moderna avoid early-stage research and development of influenza vaccines because historically they generate modest revenues. Fortune Business Insights estimates the global influenza vaccine market to be $ 6.59 billion in 2021 and is projected to grow to $ 10.73 billion in 2028, with a CAGR of 7.2 percent over that forecast period. The global turnover of the entire pharmaceutical industry was $ 1.27 trillion in 2020, according to Statistics.

However, Covid vaccines are a whole other story.

Reporting its third-quarter results in November, Pfizer said it expects the coronavirus vaccine to bring in $ 36 billion in revenue in 2021. At the same time, Moderna lowered its 2021 Covid vaccine return forecast to $ 15-18 billion. from an earlier estimate of $ 20 billion, due in part to production problems.

With more than 832,000 Covid-related deaths in the U.S. and more than 5.4 million worldwide, the public has turned their attention to the ongoing seasonal flu from October to May. Yet it has its own deadly history, with four influenza pandemics (1918, 1957, 1968, 2009) during the past century, claiming at least a million people each.

From 2010 to 2020, the CDC estimates that the flu caused 12,000 to 52,000 deaths in the United States each year, from nine million to 41 million infections. The World Health Organization (WHO) estimates that the flu kills 290,000 to 650,000 people each year.

Increasing research and development spending

Despite these appalling statistics, research and development and funding for improved influenza vaccines have been relatively limited and largely limited to academia, biotechnology startups, and the National Institutes of Health (NIH).

The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) has an annual budget of approximately $ 220 million for a global influenza vaccine, part of which will be awarded to the Collaborative Influenza Vaccine Innovation Center, or CIVIC, launched in 2019. By comparison, the NIH earmarked nearly $ 7 billion for cancer research that claimed 606,520 lives in 2020.

Last November, Connecticut Republican Rosa DeLauro and Massachusetts Senator Ed Markey re-enacted the Influenza Vaccine Act, a bill proposing a $ 1 billion investment in NIH flu research projects, including external collaboration.

There are dozens of other influenza vaccine R&D projects in the United States, some of which are looking for so-called over-seasonal vaccines that could prevent recipients from becoming infected for several years. The University of Washington’s Institute for Medical Protein Design in Seattle is running a promising program led by Neil King, an assistant professor of biochemistry at the University School of Medicine, who is using computers to design new, self-assembled protein nanoparticles. vaccine.

“The vaccine is in a small phase 1 trial at the NIH,” King said. “The volunteers have been dosed and we’re starting the analysis.” He expects to receive results in a couple of months and, after Phase 2 and 3 trials, to receive FDA approval “within the next five years.”

NIAID is involved in several general influenza vaccine Phase 1 studies, said Dr. Jennifer Gordon, program director responsible for influenza vaccine development. One was launched in 2019 and the other last June, and each uses a different scientific approach.

Without setting a timetable, Dr. Gordon hopes that a truly one-time flu vaccine will sometimes become a reality, but he won’t ignore creating better ones in the meantime. “We don’t want to say we only care about vaccinations that last forever,” he said. “There are approaches that are significant improvements over the current one and have huge gains, although they are not common.”

Albert Bourla, CEO of Pfizer, said Monday that its recent research collaboration will allow it to target the flu, particularly through DNA technology, which could reduce the time it takes to produce an essential part of the overall RNA vaccine manufacturing process from nearly a month to a couple of days.

“It could dramatically reduce, possibly even further, our ability to get new vaccines if needed for two months instead of three. It says dramatic benefits in our fight against Covid and other diseases like the flu because it allows you to be very, very close to the time the new versions will be disseminated, “Bourla said.

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