Clover Biopharmaceuticals, Ltd. announced that Clover's contract development and manufacturing organization (CDMO) has received a European Union Good Manufacturing Practice (EU GMP) certificate for the production of Clover's lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum). The EU GMP certificate is in connection with Clover's regulatory submission to the European Medicines Agency (EMA) and follows a successful inspection of the CDMO site by the Ireland Health Products Regulatory Authority. It signifies that the production of SCB-2019 meets the EU's standards for quality and safety.

Clover is working towards completing regulatory submissions to the China National Medical Products Administration (NMPA), the EMA, and the World Health Organization (WHO) for SCB-2019 in the second half of 2022, while concurrently preparing for its commercialization in China and globally upon receiving regulatory approvals. About SCB-2019 (CpG 1018/Alum) Employing the Trimer-Tag(TM) technology platform, Clover developed the SCB-2019 antigen, a stabilized trimeric form of the S-protein (referred to as S-Trimer(TM)) based on the original strain of the SARS-CoV-2 virus. Clover created its COVID-19 vaccine candidate by combining SCB-2019 with Dynavax's CpG 1018 advanced adjuvant and aluminum hydroxide (alum).