Here we go again
The federal government has committed an additional $590 million to push Moderna ’s messenger RNA-based pandemic flu vaccine towards approval, as the Biden administration, in its waning hours, ramps up preparations for a potential H5N1 avian influenza pandemic.
The award is a large sum for the U.S. Department of Health and Human Services division known as BARDA, which last year gave Moderna $176 million to fund development of the shot, and which rarely announces contracts worth more than $150 million.
Shares of Moderna were up 4% in after-hours trading Friday.
The government’s recent funding for Moderna’s mRNA bird flu shot now totals $766 million, approaching the $995 million spent on the company’s Covid-19 shot in early 2020. It’s a sign of the seriousness with which HHS appears to be taking the pandemic threat.
HHS said the funding would speed up development of an mRNA-based H5N1 vaccine that would be “well matched” to the strains currently infecting cows and birds in the U.S. It said Moderna would also test versions of the shot targeting other flu strains that pose a potential pandemic threat.
An early-stage trial of Moderna’s shot has been completed since mid-July, according to a government database of clinical trials. The company has yet to publicly disclose the results, but said Friday that it had “positive preliminary data” from the trial and would share more at an upcoming scientific meeting.
Moderna said it was “preparing to advance” the pandemic influenza shot into a Phase 3 trial, though it didn’t provide a timeline.
The federal government already has a stockpile of five million doses of pandemic flu vaccine based on an older technology, and expects to have another five million doses in that stockpile by the end of this quarter. It has also recently increased its funding to Sanofi , GSK , and CSL Seqirus to help them quickly ramp up production of traditional pandemic flu vaccines if needed.
But experts have long worried that these older vaccines vaccines could be difficult to make during an avian flu pandemic, because the manufacturing process relies on chicken eggs, and H5N1 infections have been decimating U.S. poultry flocks since 2022.t
The federal government has aimed for years to advance mRNA-based pandemic influenza vaccines. At least four companies other than Moderna are currently running clinical trials of mRNA pandemic flu vaccines, including GSK, Sanofi, Pfizer , and Arcturus Therapeutics .
While Moderna appears to be in pole position to deliver an mRNA-based H5N1 vaccine if an emergency were to arise, the company no longer has the same manufacturing capacity it developed to deliver its Covid-19 vaccine.
Moderna sales have plummeted since 2022, as the Covid-19 vaccine market dried up, and the company has announced significant cost cuts, as it tries to preserve its cash hoard and avoid the need to raise new capital.
Many of the cuts have come at the expense of its manufacturing capacity. On Monday, the company’s Chief Financial Officer Jamey Mock told Barron’s that Moderna could still respond to a pandemic emergency.
“We still have most of the drug substance [manufacturing] capacity to be able to respond quite quickly to a potential pandemic,” Mock said.
Mock said that in a pandemic the company could swap how it packages shots to vastly increase its manufacturing capacity.
The federal government has committed an additional $590 million to push Moderna ’s messenger RNA-based pandemic flu vaccine towards approval, as the Biden administration, in its waning hours, ramps up preparations for a potential H5N1 avian influenza pandemic.
The award is a large sum for the U.S. Department of Health and Human Services division known as BARDA, which last year gave Moderna $176 million to fund development of the shot, and which rarely announces contracts worth more than $150 million.
Shares of Moderna were up 4% in after-hours trading Friday.
The government’s recent funding for Moderna’s mRNA bird flu shot now totals $766 million, approaching the $995 million spent on the company’s Covid-19 shot in early 2020. It’s a sign of the seriousness with which HHS appears to be taking the pandemic threat.
HHS said the funding would speed up development of an mRNA-based H5N1 vaccine that would be “well matched” to the strains currently infecting cows and birds in the U.S. It said Moderna would also test versions of the shot targeting other flu strains that pose a potential pandemic threat.
An early-stage trial of Moderna’s shot has been completed since mid-July, according to a government database of clinical trials. The company has yet to publicly disclose the results, but said Friday that it had “positive preliminary data” from the trial and would share more at an upcoming scientific meeting.
Moderna said it was “preparing to advance” the pandemic influenza shot into a Phase 3 trial, though it didn’t provide a timeline.
The federal government already has a stockpile of five million doses of pandemic flu vaccine based on an older technology, and expects to have another five million doses in that stockpile by the end of this quarter. It has also recently increased its funding to Sanofi , GSK , and CSL Seqirus to help them quickly ramp up production of traditional pandemic flu vaccines if needed.
But experts have long worried that these older vaccines vaccines could be difficult to make during an avian flu pandemic, because the manufacturing process relies on chicken eggs, and H5N1 infections have been decimating U.S. poultry flocks since 2022.t
The federal government has aimed for years to advance mRNA-based pandemic influenza vaccines. At least four companies other than Moderna are currently running clinical trials of mRNA pandemic flu vaccines, including GSK, Sanofi, Pfizer , and Arcturus Therapeutics .
While Moderna appears to be in pole position to deliver an mRNA-based H5N1 vaccine if an emergency were to arise, the company no longer has the same manufacturing capacity it developed to deliver its Covid-19 vaccine.
Moderna sales have plummeted since 2022, as the Covid-19 vaccine market dried up, and the company has announced significant cost cuts, as it tries to preserve its cash hoard and avoid the need to raise new capital.
Many of the cuts have come at the expense of its manufacturing capacity. On Monday, the company’s Chief Financial Officer Jamey Mock told Barron’s that Moderna could still respond to a pandemic emergency.
“We still have most of the drug substance [manufacturing] capacity to be able to respond quite quickly to a potential pandemic,” Mock said.
Mock said that in a pandemic the company could swap how it packages shots to vastly increase its manufacturing capacity.
