Generic influenza vaccine could be the next big mRNA development Moderna, Pfizer

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

Abdulhamid Khosbas | Anadolu Agency | Getty Images

The research and development that led to the Covid-19 vaccine has stepped up efforts to find a more potent, longer-lasting influenza vaccine, possibly taking steps towards the Holy Grail of virologists: a one-time, universal flu shot.

Scientists at Pfizer and Moderna, pharmaceutical companies that have used half a century of research on mRNA technology to create vaccines against Covid, are using the same know-how to study how to get the flu shot on a mass scale.

“As the COVID-19 vaccine has shown, mRNA vaccines offer … the potential to produce influenza vaccines more quickly with better efficacy than current influenza vaccines,” Pirada Sufafifat, vice president of viral vaccine research at New York-based company Pfizer. email. “The pandemic has enabled us to realize the enormous scientific potential of mRNA.”

In 2020, the number of flu cases has dropped sharply, mostly likely due to Covid restrictions. But with the onset of this winter, the number of flu cases and hospitalizations continues to rise, especially in the eastern and central states, according to a weekly report. Centers for Disease Control and Prevention Fluview report

The CDC always recommends getting an annual flu vaccine as the best way to protect against contracting the virus and its potentially serious complications. However, there are indications that influenza vaccination rates are lower this season than in the past, which may be due to vaccine hesitancy during the coronavirus pandemic

Although North America is usually dominated by one influenza virus each year – A (H3N2) this season – tetravalent vaccines are designed to protect against three other strains that can cause infections as the virus mutates from month to month.

This blind approach recognizes that influenza vaccines are only 40-60% effective in preventing infection, and sometimes only 10% effective by the end of the influenza season. Conventional influenza vaccines are grown in either chicken eggs or mammalian cells, and it also takes about six months to produce the millions of doses needed.

Conversely, the development of an mRNA-based influenza vaccine requires only the genetic sequence of the dominant virus, significantly speeding up production times. The flexibility of mRNA technology and its fast production time, Pfizer says, has the potential to provide better strain matching, greater reliability of supply, and the potential to improve the effectiveness of existing influenza vaccines.

“We believe that mRNA is the ideal technology to meet this challenge,” adds Sufafifat.

Diffusion of mRNA technology

The technology behind messenger RNA, or mRNA, has been in development since its discovery in 1960, but the Pfizer and Moderna Covid vaccines are the first time they have been approved for use in humans.

It is currently being used to develop several different vaccines. Earlier this month, Pfizer and Germany’s BioNTech said they would be developing a potential mRNA vaccine to prevent shingles, while scientists hope the technology could be a turning point in the development of an HIV vaccine.

“MRNA is the platform,” Moderna CEO Stefan Bansel said Monday of broader vaccine ambitions on CNBC’s Squawk Box program. “MRNA is an information molecule, so we now have forty-four zero programs in development and many more in laboratories.”

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

“Influenza is, of course, very well known, but RSV and many other viruses are not very well known to the general public because the symptoms are similar to the flu, in which we believe the world deserves an annual revaccination containing all these different vaccines in a single dose of influenza. , RSV, against Covid with the right adaptation to circulating strains and this is what we are working on, ”he said.

Moderna is testing the RSV program and the influenza program, and “we’re working very quickly to bring that together,” Bansel said.

“I think of it this way: you get an annual product update by adding more vaccine to the same bottle. So you get an adaptation to the current strains of that year in your geography, so in the US, or in Europe, or in Japan, because we see many winters, it is believed that the flu vaccine does not work because we are actually different. strains circulating around the world. “

In September, Pfizer announced Phase 1 clinical trials for an adult mRNA influenza vaccine, the first mRNA drug manufacturer’s program for influenza. This is a so-called quadrivalent vaccine, similar to those given to the general public today, targeting four different types of influenza.

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

Overall, the encouraging results, however, showed that the mRNA-based Moderna influenza vaccine was no more effective in the elderly than already approved vaccines on the market, notably Sanofi’s Fluzone HD. After Moderna presented the results to investors, its shares fell 10%. “We cannot make a direct comparison. We have presented (Fluzone data) as a guideline only, ”the company executive said in a conference call with investors, urging them to wait for further data before selling the stock.

Typically, large pharmaceutical companies such as Pfizer and Moderna avoid early-stage influenza vaccine research and development because they have historically generated modest revenues. The global influenza vaccine market in 2021 was estimated at US $ 6.59 billion. Fortune Business Intelligence and is projected to grow to $ 10.73 billion in 2028 at a 7.2% CAGR during this forecast period. According to Statistics

Coronavirus vaccines are a different story, however.

In November, reporting third-quarter revenue, Pfizer said it expects its coronavirus vaccine to generate $ 36 billion in revenue in 2021. Around the same time, Moderna downgraded its 2021 Covid vaccine revenue projections to $ 15 billion to $ 18 billion, lower. up from an earlier estimate of $ 20 billion, in part due to manufacturing problems.

With more than 832,000 deaths from coronavirus in the United States and more than 5.4 million worldwide, the public is oblivious to the seasonal flu that runs from October to May. Nevertheless, it has its own deadly history: in the last century, there were four influenza pandemics (1918, 1957, 1968, 2009), each of which claimed at least a million lives.

The CDC estimates that between 2010 and 2020, the flu killed 12,000 to 52,000 deaths in the United States each year, from nine to 41 million infections. The World Health Organization (WHO) estimates that between 290,000 and 650,000 people die from influenza worldwide each year.

Increased research and development costs

Despite these horrific statistics, research and development to improve influenza vaccines, as well as funding, were relatively scanty and largely confined to academia, biotech startups, and the National Institutes of Health (NIH).

The National Institutes of Allergy and Infectious Diseases (NIAID) division of the National Institutes of Health has an annual budget of approximately $ 220 million for a universal influenza vaccine, some of which is distributed in grants to the Collaborative Influenza Innovation Centers, or CIVIC, launched in 2019. In comparison, the NIH committed nearly $ 7 billion to research on cancer that claimed 606,520 lives in 2020.

Last November, Connecticut Rep. Rosa DeLauro and Massachusetts Senator Ed Markey resubmitted the Influenza Vaccines Act, a bill proposing $ 1 billion investment in NIH research projects on influenza, including outside collaboration.

Dozens of other influenza vaccine research and development projects are underway in the United States, some of which are looking for so-called over-season vaccinations that could prevent infection in recipients for several years. A promising program is underway at the University of Washington’s Protein Design Institute of Medicine in Seattle by a team led by Neil King, assistant professor of biochemistry at the University School of Medicine, using computers to develop new, self-assembling protein nanoparticles for production. vaccine.

“The vaccine is in Phase I trials at the National Institutes of Health,” King said. “The volunteers received their doses and we are starting the analysis.” He expects to receive results in a couple of months, and after Phase 2 and 3 trials, receive FDA approval “within the next five years.”

NIAID is participating in several Phase 1 trials of a universal influenza vaccine, said Dr Jennifer Gordon, influenza vaccine program manager. One launched in 2019 and Other last June, each taking a different scientific approach.

Without specifying a timeline, Dr. Gordon hopes that a truly disposable influenza vaccine will someday become a reality, but in the meantime, he is not overlooking the development of more effective vaccines. “We don’t want to say that we are only interested in vaccines that last forever,” she said. “There are approaches that greatly improve what we have now and are huge wins, even if they are not universal.”

Pfizer CEO Albert Burla said on Monday that his recent research collaboration will enable him to fight the flu, in part through DNA technology, which will shorten the time it takes to produce an important part of the overall manufacturing process for RNA vaccines. months to a couple of days.

“This could drastically, potentially even further reduce our ability to create new vaccine variants, if needed, by two instead of three months. This will bring, shall we say, tremendous benefits to our fight against Covid and other diseases such as the flu, for example, because it will allow you to be very, very close to the time when new options are circulating, ”Burla said.

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