JAKARTA - The Food and Drug Supervisory Agency (BPOM) has allowed the use of the Sinopharm type of COVID-19 vaccine as a heterologous third dose (booster) vaccine.
Heterology is the administration of a booster dose by using a different type of vaccine from the full-dose primary vaccine that has been previously obtained.
In this case, BPOM stated that the Sinopharm vaccine could be a booster for primary vaccines (first and second doses) using Sinovac.
"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 6 months earlier," said Head of BPOM Penny Lukito in a statement, Tuesday, March 22.
Penny explained, from the safety aspect, the use of Sinopharm vaccine as a heterologous booster was generally well tolerated.
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 adverse event profile reported in this heterologous booster clinical trial is similar to that of the primary and homologous booster vaccine clinical trials, which is mild to moderate." said Penny.
From the aspect of immunogenicity, continued Penny, the results of the analysis of giving 1 booster dose of Sinopharm Vaccine to the primary Sinovac vaccine subject group, showed an increase in antibody response.
This increase occurred on the 14th and 28th day measurements after the booster dose was given. Anti-sRBD IgG antibodies showed an increase of 8.19 times and 10.65 times compared to before giving the booster (baseline).
"The approval of the use of the Sinopharm vaccine has added an alternative heterologous booster vaccine for people who used the previous Sinovac primary vaccine," he explained. So far, there are 6 COVID-19 vaccine regimens used in Infonesia, including Sinovac, AstraZeneca, Pfizer, Moderna, Janssen, and Sinopharm.
In the primary Sinovac vaccine, the booster vaccine can use 3 types of vaccines, including half-dose of AstraZeneca (0.25 ml), half-dose of Pfizer (0.15 ml), full-dose of Moderna (0.5 ml), and full-dose of Sinopharm (0 ,5 ml).
If the primary vaccine is AstraZeneca, the booster can use half dose of Moderna vaccine (0.25 ml), half dose of Pfizer vaccine (0.15 ml), and full dose of AstraZeneca vaccine (0.5 ml).
In the Pfizer primary vaccine, the booster can use the full dose of Pfizer (0.3 ml), half dose of Moderna (0.25 ml), and the full dose of AstraZeneca (0.5 ml).
Then in the Moderna primary vaccine, a booster using the same vaccine is half the dose (0.25 ml). Then the primary vaccine is Janssen (J&J), then for a booster, use a half dose of Moderna (0.25 ml).
While for the primary Sinopharm vaccine, the booster vaccine also uses the full dose (0.5 ml) of the Sinopharm vaccine.
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