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Pfizer/BioNTech, Moderna Vaccines Take Baby Steps Into Booster Shots

 
• By Alaric DeArment

Moderna may benefit from data indicating strong efficacy against the Delta strain, though an analyst pointed out that they come with some important caveats.

Adolescent covid vaccination US
The FDA expanded the EUAs for Pfizer/BioNTech and Moderna's COVID-19 vaccines to include third shots for severely immunocompromised individuals • Source: Shutterstock

While the commercial position of Pfizer Inc./BioNTech SE’s and Moderna, Inc.’s COVID-19 vaccines would strengthen if it is recommended that people who received the initial two-dose vaccination series of BNT162b2 or mRNA-1273 get boosters, the US Food and Drug Administration’s expansion of the vaccines’ emergency use authorizations to include third shots for certain vulnerable people accounts for only a very small number of patients. But as variants of concern continue spreading, Moderna may have an upper hand, with data showing strong efficacy against the Delta strain, though those results come with certain caveats.

The FDA said late on 12 August that it amended the EUAs for the two vaccines to allow for additional...

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Sanofi Bid For Second COPD Approval Hurt By Mixed Itepekimab Data

 
• By Kevin Grogan

One Phase III trial hits but a second study misses by a mile.

New Vaccine Framework Avoided Worst-Case Scenario, Analysts Say

 
• By Joseph Haas

The new US FDA vaccine guidelines introduced on 20 May might cause financial woes for Moderna, but overall vaccine makers should not be as impacted as feared.

Arcturus and CSL Take on Pfizer With Longer-Lasting COVID Vaccine

 
• By Kevin Grogan

Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.

Under-Pressure Moderna Banks $590m To Speed Up Bird Flu Vaccine

 
• By Kevin Grogan

A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.

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Syncona Looks To Go Private As Market Decline Deepens

 
• By Andrew McConaghie

While some are calling for Syncona to be wound up, the UK-based company believes many existing and new investors will back the creation of new private fund.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

ASCO: Pushing The Frontiers Of ADCs

 
• By Mary Jo Laffler

Antibody-drug conjugates are a major part of the oncology pipeline, and data presented at the American Society of Clinical Oncology meeting highlight the emergence of new technologies.