Vaccines

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. 

US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.

To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.

The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

The vaccines alliance says its First Response Fund could be used to cover the cost of doses and has outlined plans for a vaccine stockpile. Some experts have criticized the slow rate of response to mpox and called for more solidarity on vaccine provision at global level.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

An emergency use listing means the vaccines can be approved for use in lower-income countries where they are not licensed, and will allow international organizations like Gavi and UNICEF to procure them for wider distribution.

HPV vaccine shipments to China are expected to fall after a government crackdown on bribery and corruption caused scientific communication with health care providers to decline. Gardasil also may be hurt by budgetary pressures on distribution of the government-reimbursed vaccine.

The effort and expense to maintain the committee, which met only 10 days in the past 15 years, can no longer be justified, the FDA said. The terminated panel’s responsibilities will be integrated into the Vaccines and Related Biological Products Advisory Committee.

The CDC’s ACIP again punted a decision on whether to make a pneumococcal vaccine available to all adults 50 and older amid concerns over cost and equity tradeoffs, as well as unknowns about the length of vaccine protection.