JAKARTA
The Indonesian Food and Drug Supervisory Agency (BPOM) has officially issued a permit for the emergency use of the Covovax Covid-19 vaccine from the pharmaceutical company Novavax.
In his statement on Friday, Head of BPOM Penny K Lukito said the green light was given after the evaluation results of the Covovax vaccine had met the requirements.
The evaluation, he said, was related to aspects of safety, efficacy and quality that referred to national and international standards, as well as an evaluation of the fulfillment of Good Manufacturing Practices (GMP) at Covovax vaccine production facilities in India.
“Covovax vaccine can be used for adults aged 18 years and over at a dose of 5 micrograms per dose, given 2 times with an interval of 21 days,” said Penny.
Penny said the Covovax vaccine was produced by the Serum Institute of India Pvt. Ltd., India (SII).
Penny explained that the incidence of side effects reported from clinical trials of the Covovax vaccine was generally mild to moderate.
With an emergency permit for the Covovax vaccine, so far BPOM has given EUA approval to 11 vaccine brands.
Minister of Health Budi Gunadi Sadikin last October said that Indonesia failed to get access to 50 million doses of the vaccine from the Novavax company, according to the initial agreement and only got 20 million doses.
To meet the need for a Covid-19 vaccine, Budi said that Indonesia might return a vaccine produced by China, Sinovac.
Indonesia has so far recorded 4.2 million cases of Covid-19 with 143,000 deaths and nearly 4.1 million recovered patients.
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