To ensure the timely development of vaccines to curb the spread of COVID-19, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) released the principles it will follow in evaluating a vaccine candidate.
Developed last month but released Oct. 12, the principles address the various stages of vaccine development from preclinical to postmarket and discuss the inclusion of specific populations, such as older people, pregnant women and nursing mothers. The document describes two pathways: one for vaccines first developed for the Japanese market and the other for vaccines initially developed in other countries. The document also discusses manufacturing requirements.
Even if a large-scale confirmatory trial is conducted overseas, the PMDA said there may be a “high need of evaluating the efficacy and safety of the vaccine in Japanese subjects,” given the possibility of viral mutations, ethnic differences, and the varying severity of the disease and pandemic by geographic location.
Since the demand for a COVID-19 vaccine is expected to be large, vaccines with smaller and fewer doses are preferred. If multiple doses will be needed, “it is preferable to have a shorter dosing interval for rapid acquisition of immunity,” the PMDA said, encouraging sponsors to consider such factors in the early stages of development.
To determine safety, the PMDA will require trial sponsors to collect adverse events (AEs) of solicited local and systemic reactions observed during at least the first seven days after administration, as well as all AEs observed during at least the first 28 days after administration. Trials also should assess the risk that a vaccine candidate may worsen the disease.
For long-term efficacy and safety, sponsors should follow subjects for at least one year after the trial; however, a longer follow-up may be required depending on the characteristics of the vaccine candidate. During the follow-up, sponsors will be required to collect data about the persistence of antibody titer and the incidence of COVID-19 and AEs, including assessment of the disease enhancement risk.
The PMDA doesn’t usually require pharmacokinetic studies for vaccines intended to prevent infectious diseases. But if a SARS-CoV-2 vaccine contains a novel substance, pharmacokinetic studies of that substance may be required, the agency said.
ICER cost models going global
The Institute for Clinical and Economic Review’s (ICER) cost-effectiveness models are going international via a cloud-based platform that allows health technology assessment agencies (HTA) across the world to customize the model assumptions and inputs.
ICER’s Interactive Modeler will launch in November for payers, life science companies, patient groups and other stakeholders. The first offering will be the COVID-19 model that ICER developed to evaluate the cost-effectiveness of Gilead Sciences Inc.’s Veklury (remdesivir) and other COVID-19 therapies. Going forward, ICER will make additional models from previous, ongoing and future cost-effectiveness reports available within the Interactive Modeler.
“Because many new drugs are launched first in the U.S., ICER is often the first HTA organization to perform a formal assessment – including independent economic modeling – of a new drug,” ICER President Steven Pearson said. He noted that ICER already has had extensive interest among HTA groups in utilizing its COVID model.
Making the cost-effectiveness models available to all international HTAs should improve the transparency of assessments and enable HTAs to inform governmental decisions about drug pricing and coverage with economic model results based on science and tailored to reflect diverse health systems, according to ICER.
Canada prepares for ICH Q12
To give regulators and stakeholders sufficient time to prepare, Health Canada plans to implement the International Conference on Harmonisation’s (ICH) Q12 guidance and annexes on technical and regulatory considerations of pharmaceutical lifestyle management in the third quarter of 2021.
ICH Q12 provides a “framework to facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes in a more predictable and efficient manner across the product lifecycle,” according to Health Canada.
The guideline is expected “to promote innovation and continual improvement in the biopharmaceutical sector and strengthen quality assurance and reliable supply of product, including proactive planning of supply chain adjustments,” the Canadian agency said.
Health Canada will launch a stakeholder consultation early next year to get feedback on the final elements of implementing the guidance in Canada.
HHS partners on Lyme innovation
The U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation announced the Lymex Innovation Accelerator, a $25 million public-private partnership aimed at advancing treatments for Lyme and other tickborne diseases by collaborating directly with Lyme patients, patient advocates, and stakeholders in academia, nonprofits, industry and government.
Unveiled Oct. 10, the partnership will include up to $25 million for Lyme innovation and competition prize awards, with diagnostics prize challenges a big priority, HHS said. The first Lymex diagnostics prize is to be launched next year. Open to U.S. universities, nonprofits, companies and domestic organizations, the challenge will focus on improving diagnostics at all stages of Lyme disease.