Health and Science
On March 29, 2021 in Marburg, employees in special suits will test the processes for producing the messenger RNA (mRNA) for the Covid-19 vaccine in the German company BioNTech.
Abdulhamid Hosbas | Anadolu Agency | Getty Images
The research and development that led to the Covid-19 vaccines has stepped up efforts to find a stronger, longer-lasting flu vaccine and possibly taken steps toward the virologists’ Holy Grail: a one-off, universal flu shot.
Scientists from Pfizer and Moderna, the pharmaceutical companies who spent half a century researching mRNA technology to create Covid vaccines, are using the same expertise to look for ways to vaccinate the masses against the flu.
“As the COVID-19 vaccine demonstrated, mRNA vaccines offer… email. “The pandemic made it possible for us to take advantage of the immense scientific opportunity of mRNA.”
In 2020, the number of flu cases dropped sharply, likely due to Covid restrictions. But as winter sets in, flu infections and hospital admissions continue to rise, especially in eastern and central states, according to the Centers for Disease Control and Prevention’s weekly Fluview report.
The CDC always recommends annual flu vaccination as the best protection against contracting the virus and its potentially serious complications. However, there have been signs that flu vaccination rates are lower this season compared to last season, possibly due to vaccine refusals that broke out during the coronavirus pandemic.
Although one flu virus usually dominates each year in North America – the A (H3N2) this season – tetravalent vaccinations are designed to protect against three other strains that can cause infection if the virus mutates from month to month.
This shotgun approach recognizes the fact that flu vaccines are only 40 to 60% effective at preventing infection, and sometimes only 10% effective at the end of a flu season. Traditional flu vaccines are grown in either chicken eggs or mammalian cells and also take around six months to make the millions of doses needed.
Conversely, the mRNA-based design of influenza vaccines only requires the genetic sequence of the dominant virus, which significantly speeds up production time. The flexibility of mRNA technology and its fast manufacturing time could potentially enable better strain matching, greater delivery reliability, and the potential opportunity to improve the effectiveness of current flu vaccines, according to Pfizer.
“We believe that mRNA is the ideal technology to meet this challenge,” adds Suphaphiphat.
The spread of mRNA technology
The technology behind messenger RNA, or mRNA, has been in development since its discovery in 1960, but it was first approved for use in humans with the Pfizer and Moderna Covid vaccines.
It is now used in the development of several different vaccines. Pfizer and BioNTech of Germany announced earlier this month that they would develop a potential mRNA-based vaccine for the prevention of shingles, while scientists hope the technology could mark a turning point in the development of an HIV vaccine.
“MRNA is a platform,” said Moderna CEO Stéphane Bancel on Monday of broader vaccine ambitions on CNBC’s Squawk Box. “mRNA is an information molecule, so we now have forty-four null programs in development and, in fact, many more in the labs.”
With a focus on respiratory diseases, Bancel said there are around 10 viruses that lead to hospital admissions every year.
“Influenza is very well known, of course, but RSV and many other viruses that are not well known to the public because the symptoms are similar to the flu, which we believe the world deserves the only annual booster that contains all of these different vaccines a single dose against flu, against RSV, against Covid with the right adjustment to the circulating strains that are circulating here and that is what we are working towards, “he said.
Moderna has an RSV program and a flu program in trials and “we’re working very quickly to combine these,” said Bancel.
“The way I look at it, it’s a bit like getting an annual upgrade of a product by putting more vaccine in the same vial. So you get an adjustment based on the current strains of that year in your region. in the US or in Europe or in Japan because the flu vaccine is not considered effective in many winters because we are actually different strains circulating around the world. “
In September, Pfizer announced the start of a Phase 1 human study of an adult mRNA flu vaccine, marking the drugmaker’s first mRNA-based flu program. It is a so-called quadrivalent vaccine, as it is administered to the public today, and is directed against four different variants of the flu.
In December, Moderna announced the first positive interim data from a Phase 1 study of its tetravalent seasonal flu vaccine candidate, mRNA-1010, in older and younger adults. The company also announced that the Phase 2 study of mRNA-1010 is now fully initiated and preparations for the Phase 3 study are underway.
While generally encouraging, the results nonetheless indicated that Moderna’s mRNA-based flu vaccine was no more effective than previously-approved vaccines on the market, particularly Sanofi’s Fluzone HD, in older adults. After the results were presented by Moderna investors, shares fell 10%. “We cannot make a direct comparison. We have only presented (Fluzone data) as a guide,” said a company director on a conference call with investors, telling them to wait for more data before selling shares.
Typically, big pharma companies like Pfizer and Moderna shy away from early-stage flu vaccine research and development because of their modest past revenues. The global influenza vaccine market was estimated at $ 6.59 billion in 2021 by Fortune Business Insights and is expected to grow to $ 10.73 billion in 2028 at a CAGR of 7.2 percent. According to Statista, global sales for the entire pharmaceutical industry in 2020 were $ 1.27 trillion.
Covid vaccines, however, are a whole different story.
In November, when Pfizer announced third quarter results, Pfizer expected its coronavirus vaccine to reach $ 36 billion in sales in 2021, up from an earlier estimate of $ 20 billion, in part due to manufacturing issues.
With Covid-related deaths in the US of more than 832,000 and more than 5.4 million worldwide, the public has lost sight of seasonal flu, which lasts from October through May. Still, it has its own fatal history, with four pandemic flu in the last century (1918, 1957, 1968, 2009), each claiming at least a million lives.
From 2010 to 2020, the CDC estimates that the flu caused between 12,000 and 52,000 deaths annually in the US, from nine million to 41 million infections. According to estimates by the World Health Organization (WHO), 290,000 to 650,000 people worldwide die from the flu every year.
Increase in research and development spending
Despite these terrible statistics, research and development into improved flu vaccines and funding has been relatively low, largely confined to colleges, biotech startups, and the National Institutes of Health (NIH).
The NIH’s National Institute of Allergy and Infectious Diseases (NIAID) unit has an annual budget of approximately $ 220 million for the universal flu vaccine, part of which is a grant to the Collaborative Influenza Vaccine Innovation Centers (CIVICs) launched in 2019 By comparison, the NIH allocated nearly $ 7 billion to research into cancer, which killed 606,520 people in 2020.
Last November, Connecticut MP Rosa DeLauro and Massachusetts Senator Ed Markey reintroduced the Influenza Vaccine Bill, a bill that calls for a $ 1 billion investment in the NIH’s flu research projects, including outside collaborations.
Dozens of other flu vaccine research and development projects are ongoing in the US, some of which look for so-called overseason vaccines that could prevent recipients from becoming infected for several years. A promising program is underway at the University of Washington’s Medicine Institute for Protein Design in Seattle by a team led by Neil King, an assistant professor of biochemistry at the university’s School of Medicine, to use computers to create new, self-assembling protein nanoparticles develops a vaccine.
“The vaccine is in a small phase 1 study at the NIH,” said King. “Volunteers have been dosed and we’re starting the analysis.” He expects the results to be in a few months and, after the Phase 2 and 3 studies, will receive FDA approval “within the next five years.”
NIAID is involved in several Phase 1 studies of universal flu vaccines, said Dr. Jennifer Gordon, influenza vaccine development program officer. One was launched in 2019 and one last June, each using different scientific approaches.
Without setting a timeframe, Dr. Gordon does not overlook the fact that one day a truly one-off flu vaccine will become a reality, but does not overlook the fact that better ones are developed in the meantime. “We’re not saying that we only care about vaccines that last forever,” she said. “There are approaches that are significant improvements over what we have now and that are great achievements, even if they are not universal.”
Albert Bourla, CEO of Pfizer, said Monday that his latest research collaborations will allow him to fight the flu through DNA technology in particular, which will enable the time to manufacture a substantial part of the entire RNA vaccine manufacturing process from almost 10 months to a couple of days.
“That could dramatically reduce our ability to offer new vaccine variants when needed, and possibly even further, instead of going from three months to two months. That will have dramatic benefits for our fight against Covid and other diseases like the flu, for example, because we will allow you to be very, very close when the new variants are released, “said Bourla.
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