Clover Biopharmaceuticals Touts Positive Phase 1 Data for COVID-19 Vaccine

China’s Clover Biopharmaceuticals has announced its COVID-19 S Trimer vaccine candidate delivered a “strong immune response” in 150 adult and elderly phase 1 trial participants, with pre-publication results to be released soon.

The randomized, placebo-controlled study evaluated the vaccine’s safety, reactogenicity and immunogenicity when combined with an adjuvant from either the UK’s GlaxoSmithKline or Emeryville, Calif.-based Dynavax Technologies to boost the vaccine’s efficacy. With the adjuvants tiered at two different vaccine dosages, antibodies were induced in 100 percent of participants, Clover says.

Early data indicate the vaccine can be stored using normal refrigeration at 35.6 to 46.4 degrees Fahrenheit (2 to 8 degrees Celsius), maintain its stability at room temperature and be stored at 104 degrees Fahrenheit (40 degrees Celsius) for a month, which means the vaccine can be shipped worldwide using existing global distribution networks.

Clover has planned a global phase 2/3 study evaluating the GlaxoSmithKline adjuvant system for this month, while preparing a separate pivotal trial evaluating the vaccine with Dynavax’s adjuvant to begin in the first half of next year.

Vaccine developers like Clover, who are behind Pfizer/BioNTech, Moderna and AstraZeneca in clinical trials and emergency use regulatory filings, have been betting on the fact that the world will need abundant vaccine supply to eradicate COVID-19.

The phase 1 trial received funding from the Coalition for Epidemic Preparedness Innovations (CEPI), which noted the vaccine’s storage requirements would make it easier to ship to “low-resource settings.” CEPI plans to ship “million of doses of this vaccine globally” via the World Health Organization-backed COVAX project, which aims to deliver 2 billion doses of COVID-19 vaccines to 92 lower-income nations by the end of 2021. ― Jason Scott