JAKARTA - Head of the Food and Drug Supervisory Agency (BPOM) Penny K Lukito said AWcorna became the first trademark for a COVID-19 vaccine with an mRNA platform developed and produced in Indonesia.
"With the approval of an Emergency Use Permit (EUA) for this vaccine, it will increase the alternative vaccine that can be used in the COVID-19 Vaccination program for adults aged 18 years and over," said Penny K Lukito at a press conference at the BPOM Building, Friday, September 30.
AWcorna was registered by private pharmaceutical company PT Etana Biotechnology Indonesia (PT Etana) and developed through technology transfer and 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 vaccine (messanger RNA) is the latest type of vaccine that contains different ingredients from other types of vaccines.
If conventional vaccines contain viruses or germs that have been weakened or killed, the mRNA vaccine is a vaccine with the latest technology resulting from biotechnology development.
The number of computer-based vaccine manufacturers is also still limited in the world, including the Pfizer Vaccine and Moderna from the United States.
"An important thing that needs to be a concern, especially by the distribution facilities and health care facilities, is the AWcorna Vaccine storage process. Even though it includes an mRNA platform vaccine, this vaccine can be stored at a temperature of 2 to 8 degrees Celsius," he said.
AWcorna has advantages of similar platforms of vaccines because storage temperature standards are available in almost all regions.
Meanwhile, other vaccines require cold chain storage facilities at very low temperatures, namely minus 70 degrees Celsius or lower which is still limited in number in Indonesia.
Penny said AWcorna had met aspects of security, efficacy/immunogenicity, quality, and fulfillment of the principles of Good Manufacturing Practices (CPOB).
The AWcorna vaccine was approved to receive EUA for indications of preventing infection with the SARS CoV-2 virus in individuals aged 18 years and over.
The dose as primary vaccination is 15 'g/dose given in 2 doses of injection with an interval of 28 days.
As a heterologous booster vaccine, given in one dose as many as 15 doses/dose after 6 months of the second dose of primary vaccination using the inactivated vaccine (Sinovac or Sinopharm).
From the results of clinical trials, said Penny, the efficacy of the AWcorna Vaccine against the wild type (COVID-19 virus) which has not mutated) is 83.58 percent, while the efficacy of the AWcorna Vaccine against the Omicron variant is 71.17 percent in preventing moderate COVID-19 cases.
"AWcorna vaccine security in general can be properly tolerated and reported side effects are mild," he said.
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