Clover Biopharmaceuticals, Ltd., a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, announced that the launch of its COVID-19 vaccine, a recombinant SARS-CoV-2 subunit vaccine, in the People’s Republic of China has begun with the first doses delivered and administered in Changxing, Zhejiang as part of China’s national second booster dose (fourth vaccination dose) campaign targeting older adults, immunocompromised individuals and individuals with comorbidities.
“We are very proud to be delivering on our commitment to help protect the elderly and other vulnerable populations with our premium COVID-19 booster vaccine, and commencing the launch in Zhejiang province where our vaccine is manufactured,” said Joshua Liang, Chief Executive Officer and Executive Director of Clover. “I would like to sincerely thank everyone who contributed to making today’s launch possible, including our employees, clinical trial investigators and participants, health authorities in China and around the world, and our CEPI partners who provided instrumental technical and funding support.”
Clover’s COVID-19 vaccine was authorized for emergency use in China in December 2022. Subsequently, the China National Health Commission formally announced its national immunization plan for a second booster dose campaign and recommended prioritizing specified vaccines that demonstrate broad neutralization against Omicron, including Clover’s, for use.
“CEPI’s significant early investments in Clover’s COVID-19 vaccine have accelerated the clinical development and manufacturing of the vaccine and will enable equitable access to doses to millions of vulnerable people in China and the rest of the world,” said Dr. Melanie Saville, Executive Director of Vaccine R&D at CEPI. “As a result of CEPI’s partnership with Clover, this vaccine is poised to play a significant role in protecting those most at risk from COVID-19 as part of the international community’s ongoing management of SARS-CoV-2.”
In a global Phase 2/3 clinical trial with over 30,000 participants across five countries, Clover’s COVID-19 vaccine achieved 100% efficacy against severe COVID-19 and hospitalization caused by all strains of SARS-CoV-2 circulating during the trial (LINK). In addition, a study embedded within this Phase 2/3 trial demonstrated that a household contact was 84% less likely to get a SARS-CoV-2 infection when the infected household member had received Clover’s vaccine, compared to households where the infected household member was not vaccinated (LINK). Finally, in a separate Phase 3 study, Clover’s COVID-19 vaccine demonstrated broad and robust cross-neutralization of multiple Omicron subvariants, including Omicron BA.1, BA.2, and BA.5, when it was administered as a third dose heterologous booster after two doses of inactivated vaccine—a response that was superior to a third dose of inactivated vaccine (LINK) (LINK). Analysis of the booster vaccine’s cross-neutralization of more recently circulating subvariants including Omicron BF.7, BQ.1.1 and BA.2.75 is consistent with prior data.
In addition to Zhejiang province, Clover has started launch preparation activities in multiple strategically prioritized provinces and municipalities where it expects additional launches in Q1 2023. Further expansion within China will continue through 2023 based on production capacity and market dynamics. Outside of China, Clover is also prioritizing additional regulatory submissions directly in select countries, primarily in Asia Pacific and Latin America, based on the potential to generate significant near-term revenue and impact via bilateral supply agreements.