Passing Clinical Trials In The UK And India, BPOM Claims Covovax Efficacy Reaches 88.9 Percent For The Elderly

Illustration - COVID-19 Vaccine (ANTARA/Andi Firdaus).

JAKARTA - The Indonesian Food and Drug Administration (BPOM) claims that the complete dose of Covovax vaccine has an efficacy of up to 88.9 percent for the elderly (elderly) group based on phase 3 clinical trials in the UK.

"The vaccine efficacy in the elderly group based on the phase 3 clinical trial in the UK was 88.9 percent. In addition, the results of the phase 2/3 clinical trial in India showed a good immune response from the measurement 14 days after administration of the second dose of Covovax vaccine," said Head of BPOM RI Penny K. Lukito in a press release received in Jakarta, Antara, Thursday, November 18.

From observations for a week on the aspect of efficacy or efficacy of Covovax complete doses of adults aged 18 years or older with negative (seronegative) immune status ranging from 89.7-90.4 percent in all cases of COVID-19 with various levels of severity. Meanwhile, cases with moderate to severe severity ranged from 86.9-100 percent.

From the safety aspect, said Penny, the incidence of side effects reported was generally mild to moderate. The most frequently reported side effects included local pain (23.9-32 percent), tenderness (9.9-11.4 percent), headache (15.5-19.9 percent), fatigue (8 ,7-17.9 percent), muscle pain/myalgia (8.5-15.5 percent), and fever (3.5-14.4 percent).

Penny said the quality aspect and the fulfillment of production standards have met the requirements according to the quality evaluation standards that apply internationally, ranging from starting materials, bulk antigens, to vaccine products, including evaluation of quality.

These standards include standards from the World Health Organization (WHO), the United States Food and Drug Administration (US-FDA) and the European Medicines Agency (EMA).

The Covovax vaccine is the 11th COVID-19 vaccine that can be used in Indonesia after officially obtaining an Emergency Use Authorization (EUA) from BPOM.

Vaccines made by Serum Institute of India Pvt. Ltd., India (SII) is a vaccine with a recombinant glycoprotein spike protein subunit platform technology using the Matrix-M1 adjuvant vaccine.

"In accordance with EUA requirements, BPOM has evaluated the safety, efficacy, and quality aspects that refer to the COVID-19 vaccine evaluation standard, both national and international standards as well as an evaluation of the fulfillment of Good Manufacturing Practices (GMP) at the Covovax Vaccine production facility in Indonesia. India," he said.

From the evaluation results, said Penny, Covovax vaccine can be used for adults aged 18 years and over at a dose of 5 g / dose, given twice with an interval of 21 days.