Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (BPOM) has issued a permit to use the Sinopharm vaccine (Sars-CoV-2 Vero Cell, Inactivated) as a heterologous booster vaccine or a different type from the primary one.
“After being inaugurated as a homologous booster dose in early February 2022, the BPOM has now issued a permit for Sinopharm as heterologous booster vaccine,” the BPOM’s head Penny K Lukito said in a written statement received here on Tuesday (March 21).
Penny said that Sinopharm has been included in the list of booster vaccines, both as heterologous and homologous boosters with various brands in the country.
The six brands now are Sinovac, AstraZeneca, Pfizer, Moderna, Janssen (J&J), and Sinopharm.
“One dose of the Sinopharm heterologous booster is provided for a subject aged 18 years old and over who has received a complete primary dose of Sinovac vaccine six months earlier,” Penny explained.
Based on the safety aspect, she added that the use of the Sinopharm vaccine as a heterologous booster is generally well tolerated.
The most frequently reported reactions in clinical trials of this heterologous booster vaccine were pain at the injection site, pruritus/itching, skin redness and swelling. Meanwhile, the most reported systemic side events were fatigue, muscle aches, headaches, and coughs.
“The adverse events (AEs) reported in this heterologous booster clinical trial are similar to those of the primary and homologous booster vaccine clinical trials, which are mild to moderate,” Penny said.
In terms of the immunogenicity aspect, the analysis results of giving one booster dose of Sinopharm vaccine to a subject group that have received primary Sinovac vaccine showed an increase in antibody response, she noted.
This increase was recorded on day 14 and 28 after they received a booster dose of anti-sRBD IgG antibodies with an increase of 8.19 times and 10.65 times respectively.
Reporting by Indonesia Window