At a press conference on the provision of domestically produced vaccine EUA at the BPOM RI Building, Jakarta, Friday (30/9), Head of the Indonesian Food and Drug Administration (BPOM) Penny K Lukito said, “With the approval of the Emergency Use Permit (EUA) for this vaccine, increasingly adding alternative vaccines that can be used in the COVID-19 Vaccination program for adults aged 18 years and over.”
AWcorna is registered by the private pharmaceutical company PT Etana Biotechnologies Indonesia (PT Etana) and was developed through technology transfer and joint research with Abogen-Yuxi Walvax, China.
The development of the mRNA platform was carried out at the production facility of PT Etana, which is domiciled in the Pulogadung area, East Jakarta.
The mRNA (messenger RNA) vaccine is a new type of vaccine whose content is different from other types of vaccines. If conventional vaccines contain viruses or disease-causing germs that have been weakened or killed, mRNA vaccines are vaccines with the latest technology developed by biotechnology.
The number of vaccine producers based on computerized platforms is also still limited in the world, including the Pfizer and Moderna vaccines from the United States.
“An important thing that needs attention, especially by distribution facilities and health care facilities, is the storage process for the AWcorna vaccine. Even though it is an mRNA platform vaccine, this vaccine can be stored at a temperature of 2 to 8 degrees Celsius,” he said.
AWcorna has advantages over similar platform vaccines because standard storage temperatures are available in almost all regions.
While other vaccines require cold chain storage facilities at very low temperatures, namely minus 70 degrees Celsius or lower which are still limited in number in Indonesia.
Penny said that AWcorna has met the aspects of safety, efficacy/immunogenicity, quality, and compliance with the principles of Good Manufacturing Practices (GMP).
The AWcorna vaccine is approved by the EUA for the indication of preventing infection with the SARS-CoV-2 virus in individuals aged 18 years and over.
The dose for primary vaccination is 15 g/dose given in 2 injection doses with an interval of 28 days.
As a heterologous booster vaccine, it is given in a single dose of 15 g/dose after 6 months of the second dose of primary vaccination using an inactivated vaccine (Sinovac or Sinopharm).
From the results of clinical trials, said Penny, the efficacy of the AWcorna vaccine against wild-type (unmutated COVID-19 virus) was 83.58 percent, while the AWcorna vaccine’s efficacy against the Omicron variant was 71.17 percent in preventing moderate cases of COVID-19. ).
“The safety of the AWcorna vaccine is generally well tolerated and the reported side effects are mild,” he said.