Will Moderna’s mRNA Flu Vaccine Walk a Golden Road?

Moderna_Maddie Meyer/Getty Images

Maddie Meyer/Getty Images

From its launch in 2010, Moderna has worked feverishly to harness the power of messenger RNA for the treatment of diseases. While flush with investment dollars, the company had no approved products to call its own until a global pandemic hit and gave Moderna its chance to shine.

With the second emergency use approval granted in the U.S., Moderna’s mRNA vaccine against COVID-19 gave the company its first big breakthrough. Taking the company from relative obscurity to what is now a household name, the mRNA technology has finally been cracked. And there’s nowhere to go but up from here.

Next on Moderna’s list for transformation is our approach to the flu vaccine. Traditional flu vaccines have typically touted a 40-60% efficacy. The formula is decided half a year or more before the start of flu season, meaning the strains targeted by the vaccine are well-educated guesses of what we’ll be hit with.

Moderna plans to change that hit-or-miss approach with a quadrivalent seasonal flu vaccine, using its now-proven mRNA vaccine approach. Today, the company dosed its first participants in its Phase I/II study.

The vaccine, mRNA-1010, targets lineages recommended by the World Health Organization. This includes seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria. Approximately 180 healthy adults will get the jab to test for safety, reactogenicity and immunogenicity.

The key to this highly effective type of messenger RNA is that it's like software. Now that they’ve cracked the code with the COVID-19 mRNA vaccine, it’s a matter of reprogramming the sequencing to target and treat more diseases. In essence, if it works in one disease, it should work for thousands.

“We expect that our seasonal influenza vaccine candidates will be an important component of our future combination respiratory vaccines,” said Stéphane Bancel, Moderna’s CEO.

“Respiratory combination vaccines are an important pillar of our overall mRNA vaccine strategy. We believe that the advantages of mRNA vaccines include the ability to combine different antigens to protect against multiple viruses and the ability to rapidly respond to the evolution of respiratory viruses, such as influenza, SARS-CoV-2 and RSV. Our vision is to develop an mRNA combination vaccine so that people can get one shot each fall for high efficacy protection against the most problematic respiratory viruses.”

Moderna’s COVID-19 vaccine received emergency use approval shortly after Pfizer-BioNTech’s candidate at record-breaking speed due to the severity of the pandemic and incredible efficacy rates. The approval was granted in December with just two months of safety data. A full BLA approval requires at least six months of data, which is now available. 

Data from the vaccine’s Phase III study is being submitted to the FDA for a full approval in the US. While approval is likely to take months, it’s likely to carry a slew of implications from direct marketing to consumers to vaccine mandates imposed by employers and schools.

Lawrence Gostin, director of WHO’s Collaborating Center on National and Global Health Law, believes it is “highly likely” the vaccine will be fully approved by the FDA before the end of the year. 

Once Moderna’s mRNA vaccine aimed at SARS-CoV-2 is fully approved, it’s likely the company’s next mRNA vaccines will have somewhat of a golden road to approval. Having been there before, they’ll know the way. As long as the emergency use approved vaccines continue to prove safety and efficacy over the next months, the road to approval should be smooth.

The Massachusetts-based company won’t be the only one on the path though. Translate Bio has launched a Phase I trial with Sanofi’s vaccine business to evaluate an mRNA vaccine for the flu last month. 

Moderna’s mRNA technology doesn’t stop at respiratory viruses either. Included in their long pipeline list are programs for HIV, autoimmune disorders, cancer, and more. The COVID-19 pandemic vaccines are just the beginning for mRNA technology. 

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