Vaccines

COVID-19 Vaccine Hesitancy An Opening For New Trial, US FDA’s Califf Says In Farewell

 

In his final days as commissioner, Robert Califf posted thoughts on the COVID-19 vaccine experience and the limited booster uptake, suggesting that a placebo-controlled trial of the next booster update be run to improve confidence and develop better evidence in subgroups.

Meiji Seika Pharma Files Lawsuit In Japan Over Kostaive Misinformation

 
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The Japanese pharma firm sued a politician, claiming defamatory actions on social media related to its novel COVID-19 vaccine.

European Pharmacopoeia Adopts New Standards To Accelerate mRNA Vaccine Development

 

New general texts to be published in the European Pharmacopoeia in July 2025 are intended to support the rapidly developing mRNA vaccine field, which has become an increasingly important technology in recent years.

Vaccine Manufacturers To Fight Disinformation With Transparency

 

At the J.P. Morgan Healthcare Conference, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA Commissioner Scott Gottlieb warned of threats to public safety.


Pharma’s ‘Middleman’ Message Still Resonates With Trump

 

Some pharma industry CEOs appear to have done well in their meeting with President-elect Donald Trump and his health care team.

US FDA Rethinking Requirements For Pediatric RSV Vax Studies After Indication-Wide Holds

 

The FDA wants to update 2017 requirements for the data needed before initiating RSV vaccine trials in infants and toddlers after vaccine-associated enhanced respiratory disease triggered an indication-wide research hold.

Tackling Mpox: Global Regulators Call For Larger Trials And Coordinated Pathways

 

International regulators want developers of new mpox vaccines to consider alternatives to placebo-controlled studies when these are not feasible, such as the use of animal models and immunobridging studies.

Pediatric COVID Shots, Still Under EUA, Would Be Vulnerable In Anti-Vax HHS

 

Pulling a product that was granted an emergency use authorization is easier than pulling a fully licensed vaccine, which could place Pfizer and Moderna’s COVID-19 vaccine pediatric indications at risk, along with Novavax’s vaccine in all age groups.


RSV Vaccines: ACIP Recommendations For Adults Younger Than Age 60 Await More Data

 
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GSK’s Arexvy and Pfizer’s Abrysvo are FDA-approved for individuals younger than 60 years old, but CDC’s Advisory Committee on Immunization Practices wants more data on Guillain-Barré syndrome cases in older adults and efficacy in severely immune-compromised persons before making a recommendation.

US FDA’s Drug Approval Norms Could Be Upended In Second Trump Term

 

Despite the recent anti-vaccine rhetoric in the final weeks of the Trump campaign, pulling an established safe and effective product off market would be difficult. But there’s little to stop political interference in approvals.

Pfizer, GSK Pentavalent Meningococcal Vaccine Recommendations Should Be Harmonized, ACIP Says

 
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The US CDC committee appears on track to recommend GSK’s five-in-one vaccine when use of both a quadrivalent vaccine and a separate meningitis B vaccine are indicated at the same visit, the approach adopted for Pfizer’s Penbraya.

Pneumococcal Vaccines: US CDC Panel Supports Universal Use In Adults Down To Age 50

 
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Advisory Committee on Immunization Practices wants to shift from a risk-based to an age-based recommendation for PCV-naïve adults between the ages of 50 and 64. The recommendation would put Merck’s recently approved Capvaxive and Pfizer’s market-leading Prevnar 20 on equal footing.


Vaccine Misinformation: Meiji Considers Legal Action Amid Japan Launch Of Kostaive

 
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Dispute around the first-in-world license for a self-amplifying mRNA COVID-19 vaccine castes light on Japan’s ongoing dilemma between a government trying to build its own capabilities to attract, develop and manufacture new modalities and the anti-vax movement in the country.

Novel Pertussis Vaccines: Challenge Models ‘Promising’ But Need More Work

 

A US FDA Advisory Committee responded enthusiastically to the potential use of challenge models to enable pivotal trials of novel pertussis vaccines, but most members suggested more refinements are needed before they are ready to use.

Pink Sheet Podcast: Inside Medicare Price Negotiations, New US FDA Vaccine Pathway

 
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Pink Sheet reporter and editors discuss experts’ experience helping drug sponsors negotiate prices with CMS and the FDA’s proposal for a new pathway to update vaccines before a pandemic is declared.

US FDA Advisors Urge Faster Movement, mRNA Consideration, In Updating Pandemic Flu Vaccines

 

The FDA’s vaccine advisory committee endorsed a new plan to update pandemic influenza vaccines “inter-pandemic,” but encouraged the agency to consider how to make the approach feasible for novel vaccine technologies.  


Europe Must Turn To Science Diplomacy With Developing Countries To Counter Tomorrow’s Health Threats

 

Public-private partnerships can help industry better understand neglected diseases and develop potential treatments.

US FDA Proposes New ‘Inter-Pandemic’ Pathway For Updating Flu Vaccines

 

The threat of a highly pathogenic avian influenza pandemic spurred the FDA to have its vaccine advisory committee comment on a new process to update licensed prototype pandemic flu vaccines.

Could US-Style Priority Review Vouchers Drive European Neglected Disease R&D?

 

Having its own priority review vouchers could serve as an important pull incentive for neglected disease R&D in Europe, although the unpredictable nature of the vouchers may deter some investors.

Flu Vaccine Nasal Spray Is Latest Prescription Drug Available Direct To US Consumers

 

The FDA approved MedImmune’s FluMist for home use to prevent flu caused by virus subtypes A and B in individuals age 2 through 49 years old.