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Universal flu vaccine may be next big Moderna, Pfizer mRNA development

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In special-fitted suits, employees examine the processes for manufacturing the messenger RNA(mRNA) of Covid-19 vaccine at German company BioNTech. This was in Marburg Germany, on March 29, 20,21.

Abdulhamid Hosbas | Anadolu Agency | Getty Images

Research and development that resulted in the Covid-19 flu vaccines has boosted efforts for a stronger, more long-lasting vaccine. Perhaps this is the first step towards finding the universal, one-time flu shot.

Scientists PfizerAnd ModernaThe pharmaceutical giants that have used a 50-year-old research effort to develop Covid vaccines are now using the same knowledge to find ways to immunize the public against the flu.

“As demonstrated through the COVID-19 vaccine, mRNA vaccines offer…the potential to manufacture higher potency flu vaccines more rapidly than contemporary flu vaccines,” Pirada Suphaphiphat, vice president of viral vaccine research at New York City-based Pfizer, told CNBC by email. The pandemic gave us the opportunity to realize the scientific potential of mRNA.

The Covid restrictions likely contributed to a drop in flu cases for 2020. However, as the winter approaches, flu cases and hospitalizations are on the rise in central and eastern states. Centers for Disease Control and Prevention Fluview report.

The CDC recommends that you get the flu vaccine every year to prevent the possibility of contracting it and other serious complications. However, there have been some signs that the flu vaccine rates this year are less than last. This could be due to lower vaccination rates. vaccine hesitancy that has erupted during the coronavirus pandemic.

Although one flu virus usually dominates each year in North America — the A(H3N2) this season — quadrivalent jabs are designed to protect against three other strains that may cause infections as the virus mutates from month to month.

This shotgun approach recognizes the fact flu vaccines only 40-60% effective at preventing infection. Sometimes, flu seasons end with only 10% effectiveness. It takes six months for conventional flu vaccines to be produced. They are made in mammalian or chicken cells.

MRNA-based vaccines for influenza are much faster because they only require the genome of the dominant virus. Pfizer says that mRNA technology’s flexibility and rapid manufacturing could allow for better strain matching, increased reliability in supply and the possibility of improving the effectiveness of existing flu vaccines.

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

Spread of the mRNA technology

The technology that powers messenger RNA or mRNA has been under development since its discovery in 1960. However, it was only approved by Pfizer and Moderna Covid for human use.

The technology has been applied in the creation of multiple vaccines. Pfizer Germany’s BioNTech announced this month they are working together to develop vaccines. a potential mRNA-based vaccine for the prevention of shinglesScientists have expressed optimism that the technology might be possible, but they do not know how. a turning point in the development of a HIV vaccine.

“mRNA is a platform,” Moderna CEO Stéphane Bancel said of broader vaccine ambitions on CNBC’s Squawk Box on Monday. “mRNA can be described as an information molecule. There are currently forty-four zero programs and many more that are being developed.”

Bancel stated that there are approximately 10 respiratory diseases that can lead to hospitalizations each year.

He said that flu is well-known, but RSV and other viruses are less well known. “We believe that the world should have one annual booster against flu and RSV. We also think that Covid needs to be adapted to all the strains that circulate, so that we can provide the best possible vaccine,” he stated.

Moderna is currently testing a RSV and flu program. Bancel stated that they are working quickly to merge these programs.

The way that I see it is like you get an annual upgrade to your product. You add more vaccines in one vial. You’ll receive an adaptation to the current flu strains in that particular year, either in the U.S. or Europe or Japan. Because we have a lot more winters than we actually see, it is easy for influenza vaccines not to be effective.

Pfizer, the world’s leading drugmaker, announced in September that it had begun a human phase one trial for an mRNA flu vaccine. This was the first time Pfizer has launched an mRNA-based influenza program. The quadrivalent vaccine targets four variants of flu, similar to those that are administered to the public.

Moderna, a company that produces quadrivalent flu vaccine candidates, announced positive interim results from its phase 1 study. Moderna also revealed that the Phase 2 Study of mRNA-1010 has been completed and is in preparation for its phase 3.

The findings were encouraging but not conclusive. They showed Moderna’s flu vaccine based on mRNA was not more effective in elderly adults than other approved shots, such as Sanofi Fluzone HD. Moderna lost 10% after its investor presentation. It is impossible to make any direct comparison. “We presented (Fluzone information) only as guidance,” an executive from the company said to investors on a conference phone call. He urged them not to sell shares until they have more data.

Typically, Big Pharma companies such as Pfizer and Moderna shy away from early-stage R&D on flu vaccines, because historically they generate modest revenues. In 2021, the global market for influenza vaccines was $6.59 million. Fortune Business Insights and is projected to grow to $10.73 billion in 2028 at a CAGR of 7.2% during that forecast period. Global revenues from the pharmaceutical industry totaled $1.27 trillion by 2020 according to Statista.

Covid vaccines, however, are a different story.

Pfizer reported its third quarter earnings in November. It said that its coronavirus vaccine will bring in $36 million in revenues in 2021. Moderna made a similar announcement, lowering its 2021 Covid vaccine earnings estimates to between $15 billion – $18 billion. The reduction was partially due to problems with production.

The number of Covid-related death in America at over 832,000 is staggering, and the global figure at more than 5.4 million. This has led to the public ignoring the seasonal flu which occurs from October through May. It has a tragic history with at least one million deaths from flu pandemics that occurred in the last century (in 1918, 1957, 1968 and 2009).

Between 2010 and 2020, the CDC estimated that flu has caused 12,000-52,000 deaths annually in the United States. The number of infections ranges from nine million to 41 millions. According to WHO, flu deaths worldwide range from 290,000 up 650,000 per year.

Research and Development spending should be increased

Despite those horrific statistics, R&D toward improved flu vaccines, as well as funding, has been relatively paltry and largely confined to academia, biotech startups, and the National Institutes of Health (NIH).

The NIH’s National Institute of Allergy and Infectious Diseases unit (NIAID), has an annual budget of approximately $220 million to fund the universal flu vaccine. A portion of this money is distributed as grants to Collaborative Influenza Vaccine Innovative Centers (CIVICs) which were launched in 2019. Comparatively, nearly $7B was allocated by the NIH for cancer research. 606,520 deaths were recorded in 2020.

The Flu Vaccine Act was reintroduced by Senator Ed Markey of Massachusetts and Connecticut Rep. Rosa DeLauro in November 2017. This bill proposes an investment of $1Billion for the NIH’s influenza research projects.

There are dozens of other flu vaccine R&D projects underway in the U.S., some in search of what are known as supra-seasonal shots that could prevent recipients from becoming infected for several years. The University of Washington’s Medicine Institute for Protein Design is home to a promising research program. It was led by Neil King (assistant professor of biochemistry) and uses computers to create self-assembling proteins nanoparticles that will be used to make a vaccine.

King explained that “the vaccine is currently in a small, phase 1 trial at NIH.” The volunteers were dosed, and the analysis is underway. His expectation is that he will have results within a few months and, following the phase 2/3 trials, FDA approval in “within five years.”

Dr. Jennifer Gordon is the program officer responsible for influenza vaccine design. One launched in 2019 and another last June, each employing different scientific approaches.

Although Dr. Gordon doesn’t have a timeline in mind, she is optimistic that one-time influenza vaccines will become reality. However, it won’t be long before better options are available. She said, “We don’t want to claim that we care only about vaccines which last forever.” There are many approaches to improve on what we have now and they are big wins even though not all of them are universal. 

Albert Bourla, CEO of Pfizer, stated Monday that the company’s recent collaborations with researchers will allow it to fight the flu through DNA technology. This allows the company to cut down on the manufacturing time for RNA vaccines, which can take up to a month, and reduces the production process from almost a full month to a few days.

This could reduce dramatically and potentially even further our capacity to obtain new variant vaccines, if necessary, in three months instead of two. Bourla explained that it will bring about dramatic improvements in our fight against Covid and other illnesses like flu.

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