Walvax and Abogen Granted Indonesian Emergency Use Authorization for the SARS-CoV-2 mRNA Vaccine (AWcorna)
- EUA is granted based on safety, efficacy, immunogenicity, quality, and compliance with Good Manufacturing Practice (GMP).
- Protective efficacy of AWcorna against symptomatic wild-type SARS-CoV-2 infection was 83.58%, and the efficacy against the Omicron variant was 71.17% in preventing moderate COVID-19 disease
- Adults aged 18 years and above in Indonesia are now eligible to receive: a primary series with two doses (0.5 mL each) at an interval of 28 days between doses administered intramuscularly into the deltoid muscle of the upper arm; or, a heterologous booster dose (0.5 mL) administered intramuscularly into the deltoid muscle of the upper arm at least 6 months after the completion of a 2-dose primary series with CoronaVac®.
(September 30, 2022, Kunming) Walvax Biotechnology Co., Ltd. (“Walvax”, together with its subsidiaries, the “Group”, stock code: 300142.SZ) and Suzhou Abogen Biosciences Co., Ltd. (“Abogen”), are pleased to announce that the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, “Badan POM”) authorized Walvax-Abogen SARS-CoV-2 mRNA vaccine (Brand name: AWcorna, previously referred to as ARCoV or ARCoVax) for emergency use in individuals 18 years of age or above, as either primary or booster dose. This announcement was made on the morning of September 30, 2022, at the press conference for publishing EUA of Indovac vaccine and AWcorna vaccine, delivered in the speech given by Dr. Ir. Penny K. Lukito, Head of Badan POM.
“We are delighted to share the good news with everyone, that obtaining the Indonesian EUA is a remarkable achievement in the commercialization stage of this product. As a proprietary mRNA vaccine independently developed in China, it is indeed a proof for the effectiveness of our mRNA technology platform,” commented by Mr. Li Yunchun, Chairman, Walvax Biotechnology Co., Ltd. “Indonesia is the country with the fourth largest population and most Muslim in the world, so we believe the certified halal vaccine will be a safe, effective option for Indonesian people, which is also in alignment with their culture. This is the first step, and we are hoping to see more families across the country and the rest of the globe are protected, which is a shared goal for us all.”
By considering aspects of safety, efficacy, immunogenicity, quality, and compliance with Good Manufacturing Practice (GMP), AWcorna is approved under EUA for indications of preventing SARS CoV-2 virus infection in individuals aged 18 years and above either by dosing as a primary series with 2 doses (15 μg/dose) of injections at an interval of 28 days, or by vaccination as a heterologous booster dose, given as a single dose (15 μg/dose) at least 6 months after the second dose of primary vaccination of an inactivated vaccine.
According to the results of clinical trials, the efficacy of AWcorna against symptomatic wild-type SARS-CoV-2 infection was 83.58%, and the efficacy against the Omicron variant was 71.17% in preventing moderate COVID-19 diseases. The administration of AWcorna in general population showed good safety and tolerability, the most commonly reported symptoms of side effects were fever, pain at injection site, fatigue, muscle pain (myalgia), headache, chills, swelling, and itching (pruritus).
ISSUANCE OF THE EUA
Indonesian Government has declared an emergency situation as a result of pandemic outbreak of COVID-19 that justifies the emergency need of using AWcorna as an option in this situation. In response to that situation, the Badan POM has issued an Emergency Use Authorization (EUA) for the use of AWcorna, which is indicated for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and above. This EUA for AWcorna will end when the Badan POM determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
AUTHORIZED USE IN INDONESIA:
The Walvax-Abogen SARS-CoV-2 mRNA vaccine is authorized under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older. The Walvax-Abogen SARS-CoV-2 mRNA vaccine is authorized as:
- A primary series with two doses (0.5 mL each) at an interval of 28 days between doses administered intramuscularly into the deltoid muscle of the upper arm for individuals 18 years of age and older;
- A heterologous booster dose (0.5 mL) administered intramuscularly into the deltoid muscle of the upper arm in individuals 18 years of age and older who have completed the 2-dose primary series with CoronaVac® vaccines at least 6 months ago.
About the Global Phase 3 Efficacy Study (ARCoV-005)
The phase 3 clinical study ARCoV-005, registered at https://clinicaltrials.gov (NCT04847102), was a global, multi-center, randomized, double-blind, placebo-controlled, phase 3 clinical study to evaluate the protective efficacy, safety and immunogenicity of AWcorna in population aged 18 years and older. Primary objectives for ARCoV-005 included to evaluate the protective efficacy of AWcorna in the prevention of COVID-19 of any severity starting from at least 14 days (>D42) after the two-dose primary series (with an interval of 28 days); and to evaluate the safety and reactogenicity of AWcorna after the two-dose primary series (with an interval of 28 days). Subjects were randomized to receive either 2 doses of AWcorna or placebo, and COVID-19 cases of different outcomes were collected at different time points post the two-dose primary series, for the measurement of vaccine efficacy, with the safety profile observed at the same time.
About the Heterologous Booster Studies (AWcorna-006 and AWcorna-007)
Two phase 3(b) clinical trials, AWcorna-006 and AWcorna-007, registered at https://www.chictr.org.cn (ChiCTR2100053551 and ChiCTR2100053701), designed as single-center, randomized, double-blind, positive-controlled clinical trials, have so far been initiated to evaluate the safety and immunogenicity of AWcorna as a heterologous booster following the completion (at least 6 months before) of the 2-dose primary series with inactivated COVID-19 vaccines (CoronaVac® or Covilo®) in subjects aged 18 years and above, with 1400 and 300 subjects enrolled, respectively. At about 6-month post-priming, subjects were randomly assigned to either the AWcorna or inactivated booster group, to evaluate the neutralizing and IgG antibody titers against wild-type (WT) SARS-CoV-2 and VOCs at pre-booster, 14- and 28-day post booster, with the safety profile of AWcorna as a heterologous booster observed at the same time.
AWcorna, previously referred to as ARCoV or ARCoVax, is a SARS-CoV-2 mRNA vaccine developed by Suzhou Abogen Biosciences Co., Ltd. with the participation of Yuxi Walvax Biotechnology Co., Ltd. The vaccine is presented in 0.5 mL prefilled syringe, with mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2 as the active substance. AWcorna can be stored and transported at 2℃ to 8℃ with protection from light.
Founded in 2001, Walvax Biotechnology Co., Ltd. (Walvax) is a leading vaccine producer, engaged in research and development, manufacturing and distribution of safe and efficacious vaccines. Headquartered in China’s southwestern city Kunming in Yunnan Province, Walvax went to IPO in 2010 (300142.SZ) and started business expansion from traditional vaccines to innovative vaccines since then. As of September 2022, Walvax has successfully developed 9 licensed vaccines (13 presentations), including SARS-CoV-2 mRNA vaccine, 13-valent Pneumococcal Polysaccharide Conjugate Vaccine (PCV13) and Recombinant Human Papillomavirus Bivalent (Types 16,18) Vaccine (HPV-2).
Abogen is a clinical-stage biotechnology company focused on advancing mRNA-based therapeutics for the treatment of cancer and other infectious diseases. Since its establishment in January 2019, Abogen has developed its own mRNA technology platform and proprietary delivery system which empowers the development of a series of drug product candidates including vaccines for infectious diseases and therapies for cancer.