BPOM Allows The Use Of Sinopharm For Heterolog Booster
JAKARTA - The Indonesian Food and Drug Administration (BPOM) issued a permit to use the Sinopharm vaccine (Sars-CoV-2 Vero Cell, Inactivated) as a heterologous booster regimen or a different type from the primary vaccine.
"After previously being inaugurated as a homologous booster dose in early February 2022, now BPOM has released a heterologous booster regimen for Sinopharm," said Head of BPOM RI Penny K Lukito in a written statement received in Jakarta, Tuesday, March 22.
Penny said that the issuance of the regimen complements six types of booster vaccines, both as heterologous and homologous boosters with various regimens in Indonesia.
The six regimens include Sinovac, AstraZeneca, Pfizer, Moderna, Janssen (J&J) vaccines, and Sinopharm vaccines. The implementation of booster vaccination can be carried out in all districts/cities for the general public.
"One dose of the Sinopharm heterologous booster is intended for subjects aged 18 years and over who have received the complete primary dose of Sinovac vaccine six months earlier," she said.
Based on the consideration of the safety aspect, said Penny, the use of Sinopharm vaccine as a heterologous booster was generally well tolerated.
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The most frequently reported local reactions in clinical trials of this heterologous booster vaccine were pain at the injection site, pruritus/itching, redness, and swelling. The most commonly reported systemic side events were fatigue, muscle aches, headaches, and coughs.
"The profile of adverse events (adverse events / AEs) reported in this heterologous booster clinical trial is similar to that of the primary and homologous booster vaccine clinical trials, which are mild to moderate," she said.
From the immunogenicity aspect, the results of the analysis of giving 1 booster dose of Sinopharm Vaccine to the Sinovac primary vaccine subject group showed an increase in antibody response, said Penny.
This increase occurred on the 14th and 28th day measurements after giving a booster dose. Anti-sRBD IgG antibodies showed an increase of 8.19 times and 10.65 times compared to before giving the booster.
"The approval of the use of the Sinopharm vaccine has added an alternative to the heterologous booster vaccine for people who used the previous Sinovac primary vaccine," she said.
Therefore, the BPOM once again expressed its appreciation to the Expert Team of the National Committee for Assessing the COVID-19 Vaccine and the Indonesian Technical Advisory Group on Immunization (ITAGI) for their cooperation while evaluating the use of the second booster dose for the Sinopharm vaccine so that it can be immediately used by the public.
Penny appealed to the public to always apply health protocols and make vaccination a success as a key effort in breaking the chain of spread of COVID-19.
The public is also asked to be wise and careful in consuming medicines used in handling COVID-19, and not to be easily influenced by the promotion of medicinal products, traditional medicines, and health supplements with claims that they can prevent or treat COVID-19.