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New COVID-19 Vaccines Shipping Soon, After Rapid Pivot To Address New Strain

 
• By Alaric DeArment

Pfizer/BioNTech and Moderna rapidly adapted Comirnaty and Spikevax for the 2024-2025 season to address the KP.2 variant after the US FDA had advised them to target JN.1 in June.

• Source: Shutterstock

The rapid change to the latest versions of Pfizer Inc./BioNTech SE’s Comirnaty and Moderna, Inc.’s Spikevax vaccines against SARS-CoV-2 illustrates the likelihood that they will maintain their leading market positions for vaccines to prevent COVID-19, given the “plug-and-play” properties of messenger RNA vaccines that allow much more rapid development than their traditional counterparts.

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Pipeline Watch: Eight Approvals And Three Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

In Brief: US FDA Rejects Regeneron’s Bid to Extend Eylea HD Dosing

 
• By Sushmita Panda

Regeneron is disappointed by the knock-back for longer dosing intervals for its high-dose version of Eylea, but its supplemental application for a more commercially important shorter four-week regimen has received a priority review.

Seven Up For Sanofi and Regeneron With Dupixent CSU Approval

 
• By Kevin Grogan

The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

Leqembi Launch Set For Germany And Austria As EU Approval Finally Comes

 
• By Neena Brizmohun

Eisai is working on securing reimbursement across the EU for Leqembi now that the Alzheimer’s disease treatment has secured marketing approval from the European Commission.

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Genentech To Try Repertoire’s Immune Synapse Technology In Autoimmune Disease

 
• By Joseph Haas

Deal snapshot: The Flagship portfolio firm will use its Decode platform to seek novel targets for an unspecified autoimmune disease, with Genentech holding license rights.

Sebela’s Tegoprazan Poised For GERD Market

 
• By Jessica Merrill

Two Phase III trials testing tegoprazan read out positively, but the potassium-competitive acid blocker will compete with Phathom’s Voquezna (vonoprazan).

Veraxa Takes SPAC Route To Develop Bispecific ADCs and T-Cell Engagers

 
• By Andrew McConaghie

The Swiss biotech firm could go public on the NASDAQ later this year, and points to other preclinical dealmaking in the space to back its strategy.