Moderna drops 25% as its MRNA flu vaccine’s phase 1 data

Moderna Inc. (NASDAQ: MRNA) is a biotech firm that focuses on mRNA vaccines and therapeutics. The company announced the results of the mRNA-1010 flu vaccine candidate. The study found that HAI (hemagglutination inhibition) works against all four strains in both kids and adults 29 days after doses are administered. 

Moderna also said that mRNA-1010’s phase 2 trial has also been fully enrolled, and the Phase 3 study is also in the works. Moderna also gave a brief update regarding its seasonal flu vaccine. 

What did top management say?

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Moderna’s Chief Executive Officer, Stephane Bancel, claims that even before the global pandemic, roughly 3 million people passed away every year because of different respiratory infections. He said that many more become ill or hospitalized because of the viruses. 

The CEO said, At Moderna, our goal is to limit this suffering with an annual pan-respiratory single-dose booster vaccine that is adapted to the circulating strains of SARS-CoV-2, seasonal influenza, and RSV.” Mr. Bancel continued to say:

The positive interim results from our Phase 1 quadrivalent flu vaccine candidate, mRNA-1010, are an essential milestone toward achieving that goal.

He claimed that It’s encouraging to see how participants who got the 50 µg dose, even the older adults, achieved substantial boosts in their geometric mean antibody titers that battle H1N1 and H3N2. 

The CEO said they believe their mRNA platform is well-placed to address the unmet needs in the seasonal flu space, as seen by their new beyond quadrivalent candidates. 

Update on phase II and phase III studies

The Phase II study was fully initiated in November. The enrollment confirmed the doses across 3 doses, including the lowest dosages from the phase I trials, which were 100 and 50 grams, and a 25-gram dose. 

The Phase II trials will also have a flu vaccine comparator. Phase III trials are underway, including manufacturing. However, the company is still looking for approval from different global regulatory agencies before they start running official clinical trials. Nevertheless, the company is confident it’ll succeed.