Moderna bets on booster demand, advancing new 'bivalent' COVID-19 shot

 

• Moderna will begin testing a COVID-19 vaccine that targets both the original coronavirus strain and the omicron variant, announcing Thursday trials in the U.S. and U.K. that will assess its efficacy in people who have already received boosters.
• Company executives, speaking on an earnings call Thursday, said additional protection will be necessary as they expect immunity from boosters to wane over time and the virus to continue to circulate. While new variants may emerge, a vaccine that stimulates antibodies to omicron could help broaden protection against a wider spectrum of coronavirus strains, they said.
• Moderna expects sales of its existing coronavirus vaccine to rise in the second half of 2022 as COVID-19 becomes endemic. Late last year, the company cut its sales and delivery expectations for 2021 following shipping delays and production setbacks.
• Public health authorities and vaccine makers have debated whether an omicron-specific booster or additional shots will be necessary to protect those already immunized as the COVID-19 pandemic continues. While data have pointed to enduring protection against severe disease, even in those who have received two shots, declining antibody levels and the emergence of variants remain risks.

Moderna has now placed its bet, contending that waning immunity in the midst of the coronavirus' continued spread will necessitate a new round of booster shots by fall 2022.

The company on Thursday announced a so-called bivalent vaccine will enter a U.S. Phase 2 trial in 750 volunteers and a U.K. Phase 3 trial in 3,000 where it will be tested alongside an omicron-specific shot. The volunteers will receive at least three shots, and in the U.K. trial both will be measured against a booster using the company's Spikevax vaccine as a control arm.

The expected demand for booster doses is driving Moderna executives' forecast for rising sales through 2022. The company outlined $19 billion worth of advance purchase agreements already signed — a number that has risen by $500 million since executives last disclosed totals to investors in January — and up to $3 billion in sales that could be driven by opt-in contracts. That latter number is $500 million lower than in January.

Presenting fourth quarter and full-year earnings Thursday, Moderna executives also confirmed that Spikevax delivery and sales fell behind earlier forecasts. The company delivered 807 million vaccine doses in 2021, resulting in full-year revenue of $18.5 billion, product sales of $17.7 billion and profit of more than $12 billion.

Earlier in 2021, the company had said it expected to generate $20 billion in sales and deliver 1 billion doses, but cut those numbers when it reported third quarter earnings.

Alongside Thursday's earnings, Moderna also announced a plan to repurchase up to $3 billion worth of shares, following up a $1 billion repurchase program that it completed at the end of January.

https://www.biopharmadive.com/news/moderna-covid-vaccine-omicron-2021-sales/619368/