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: Moderna ‘firmly’ thinks another COVID-19 booster will be necessary this fall

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Moderna
MRNA,
+13.82%

CEO Stéphane Bancel predicts that the next phase of the pandemic is here, and what we’ll need going forward is a booster shot every fall that can protect us from COVID-19 and other respiratory viruses.

“We do believe that we are transitioning into an endemic phase marked by a period of stability [in] case counts, hospitalizations, and deaths, at least in the Northern Hemisphere,” Bancel told investors, according to a FactSet transcript of Thursday’s earnings call.

Bancel and other Moderna executives on Thursday outlined a range of commercial and development plans that speak to the future of a company that has only one approved or authorized therapy: SpikeVax, its COVID-19 shot.

SpikeVax is a blockbuster many times over. It generated $6.9 billion in sales in the fourth quarter of 2021 and a total of $17.7 billion for the year; Moderna’s stock soared 11.8% in trading on Thursday afternoon after beating earnings and revenue expectations for the fourth quarter of the year.

At the same time, the company is trying to communicate to investors that its pipeline is robust enough to withstand the next phase of the pandemic.

Moderna’s strategy appears to fall into two buckets: what’s next for the COVID-19 vaccine and booster market, and what other health conditions can be addressed with its technology.

This includes furthering development of a bivalent COVID-19 booster; inking 10-year agreements with governments like Australia and Canada for annual “pan-respiratory” boosters; possibly upping the price of a COVID-19 booster in the U.S.; and pushing forward with late-stage clinical trials assessing RSV and herpes vaccine candidates. 

“The company continues to expand at a rapid pace,” Bancel said.

It’s uncertain if another COVID-19 vaccine or booster will be necessary in the future. However, Moderna said that Canada, Kuwait, Taiwan, and the U.K. have already put in SpikeVax orders for 2023, and executives say they “firmly” believe that people in the Northern Hemisphere will need a booster in the second half of the year that can help protect them against both the delta and omicron variants, citing waning immunity at the six-month mark. (This is the bivalent booster in development.)

“The fall 2022 booster should reflect the diversity of circulating mutations that are out there…and seek to achieve greater than six months of neutralizing titer durability,” Moderna President Stephen Hoge said, “to increase the potential for protection throughout the entire full season, in this case, we think September through February.”

The company has slightly different expectations for people in the Southern Hemisphere, where the primary vaccine series are still being rolled out. It instead predicts that those populations will need a combination of the primary series of shots and boosters in the first half of this year.

That geographic shift is already reflected on Moderna’s balance sheet. SpikeVax brought in $6.9 billion in revenue in the fourth quarter of 2021, and only about $700 million of that came from doses sold to the U.S. during the final three months of the year. The COVID-19 vaccination campaign in the U.S. has largely stalled in recent months.

Wall Street analysts have mixed views on the company’s plan.

“Will doubling down on spend in the internal pipeline provide relevant novel products to backfill declining COVID sales?” SVB Leerink’s Mani Foroohar wrote in a note to investors on Thursday.

Moderna’s stock is up 2.8% over the past year, while the broader S&P 500
SPX,
+0.63%

has climbed 8.8%.

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