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Coronavirus Notebook: Bivalent Spikevax OKd For Filing In Australia, Pfizer & Moderna Under Growing Pressure To Share mRNA Knowhow

 
• By Ian Schofield

The World Health Organization and UNICEF say that disruptions caused by COVID-19 and actions taken to tackle the pandemic have left many children without protection against measles and other diseases. Austria’s Apeiron has given an update on the development of its candidate therapeutic, APN01.

New Coronavirus variant outbreak and covid-19 virus cell mutation spread
Moderna's bivalent vaccine targets the Omicron variant • Source: Alamy

The Australian regulator, the Therapeutic Goods Administration, has given Moderna the go-ahead to seek marketing approval of Spikevax Bivalent Zero/Omicron, a bivalent version of its COVID-19 vaccine Spikevax.

The new version, which is also known as mRNA-1273.211 and is not yet authorized anywhere, includes the mRNA sequence encoding...

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‘Clean Sweep’ Of US CDC Vaccine Committee Puts Kennedy In Driver’s Seat

 
• By Bridget Silverman

With a 25-27 June meeting looming, HHS Secretary Robert F. Kennedy Jr. can fill all 17 spots on the CDC's Advisory Committee on Immunization Practices with people he says will "exercise independent judgment."

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

What Information Does US FDA Need For Stealth’s Elamipretide After CRL?

 
• By Sue Sutter

The agency said it will consider knee extensor muscle strength as a potential intermediate clinical endpoint to support accelerated approval, but Stealth CEO Reenie McCarthy said announcing it via complete response letter is confusing and inefficient.

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ACIP Upheaval Leaves Merck & Co. In A Lurch

 
• By Jessica Merrill and Bridget Silverman

Merck’s newly approved Enflonsia for RSV is one of the products expected to be recommended for use by the CDC Advisory Committee on Immunization Practices later this month.

‘Sex Pill For Women’: Sprout CEO’s Addyi Instagram Post Draws US FDA Warning Letter

 
• By Sue Sutter

Cindy Eckert’s social media post with a People.com story failed to include any risk information, made misleading representations about benefits and omitted material information about the indication, said the agency, which flagged similar concerns about an Addyi radio ad five years ago.

US FDA Chief Counsel Position Awaits HHS General Counsel Confirmation

 
• By Sue Sutter

Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.