Vaccines

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

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.  

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

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.

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.

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.

The World Health Organization has also prequalified the Bavarian Nordic vaccine to enable broader and timely access.

The Democratic Republic of Congo, the country worst hit by the mpox crisis, has now received the first batch of vaccines for the disease. Meanwhile, the World Health Organization is expected to complete its review for emergency use listing of mpox vaccines soon.

South Korea is set to provide an additional $18m in support to CEPI amid heighted global worries over mpox. The coalition's CEO and Korea's foreign minister met to discuss strengthened collaboration to prevent and respond to any future pandemics.

The launch of Pfizer's new direct-to-consumer program for vaccines and migraine drugs follows the introduction of Eli Lilly's LillyDirect in January. Company-branded initiatives are careful to partner with third-party vendors and allow the use of treatments marketed by other companies to avoid compliance pitfalls.