Vaccine makers call for alternative study designs for COVID vaccines

Regulatory NewsRegulatory News | 04 March 2021 |  By 

Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive vice president of Sanofi Pasteur, testified at a joint meeting of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and the Committee on the Environment, Public Health and Food Safety (ENVI).
With over a dozen vaccines authorized or approved around the world, a significant number of adults will be vaccinated by the time developers of early-stage candidates, including oral and intranasal prospects from smaller companies, start planning their pivotal trials. Triomphe called on the European Medicines Agency (EMA) and its peers to provide routes to market for developers of vaccines that are yet to reach Phase 3. 
Sanofi Pasteur fell behind in the vaccine race last year when lackluster clinical data on its GlaxoSmithKline-partnered program forced a formulation change. Having suffered the setback, the company now finds itself gearing up to run a Phase 3 clinical trial at a time when millions are being vaccinated weekly.
“Our Phase 3 study will probably be the last one ethically possible with an efficacy study design. Therefore, we absolutely need international regulators to propose a path forward for developers to enable the use of alternative study design and/or so-called correlates of protection, so that we have more vaccines available in '22 and beyond with more producers,” Triomphe said.
Triomphe praised EMA and other regulators for establishing regulatory frameworks to support the development of vaccines that are effective against coronavirus variants. That said, the frameworks focus on already approved vaccines and, as such, leave a need for pathways designed for developers of shots that are yet to come to market, he noted.
Triomphe was joined at the meeting by the CEOs of AstraZeneca, CureVac, Moderna and Novavax, as well as senior executives from Johnson & Johnson and Pfizer.
MEPs questioned the industry leaders over the factors that have limited the supply of COVID-19 vaccines in the European Union so far, allowing the executives to share some of the problems that can arise when scaling up manufacturing of a new product in a highly regulated industry at an unprecedented pace.
Moderna CEO Stéphane Bancel described the specific example of a pump that broke on a weekend at a manufacturing facility earlier this year. Bancel said the team worked round the clock for several days to replace the pump and address the regulatory implications of the replacement.
“Regulators rightly ask us to document that the qualification of that equipment ... was in accordance to what the pump was designed for. And so then you have to do a lot of validation, qualification, and then you have to document everything. And so because we run nonstop, the days we lost to replace the pump and the days we lost for the documentation ... that time is lost forever,” Bancel said.
Indeed, the European Commission is contemplating a shift to issuing emergency use authorizations to bring additional COVID vaccines to the bloc, Stefan De Keersmaecke, an EC spokesperson said at a 3 March press briefing.  
“As far as an emergency authorization is concerned, we are ready to reflect with the member states on all possible avenues to indeed accelerate the approval of the vaccines. One such option or possibility could indeed be having the option of such an emergency authorization of vaccines at EU level with shared liability among member states,” De Kerrsmaecke said. “If member states are interested, we will start working on a proposal to present very quickly, but of course what remains very important is safety and effectiveness and that should remain at the core of the work.”
The potential for emergency authorizations is included in the proposal for creation of a European Health Emergency Preparedness and Response Authority (HERA) (RELATED: Euro Roundup: EC seeks input on health emergency authority, Regulatory Focus 04 February 2021).
Meeting Replay, Press Release


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