COVID Cases Increase, BPOM Approves Inavac Vaccine as a Booster

VIVA – After three years in Indonesia, COVID-19 cases have increased again along with reports of the entry of the Sub Omicron XBB variant. Based on reports as of November 22, 2022, the total death cases of new COVID-19 in Indonesia reached 51 people. 

Therefore, this is a reminder for the government and the public not to forget about the pandemic situation in Indonesia.

The implementation of health protocols and vaccination is one of the ways to prevent the spread of COVID-19. Then, the Food and Drug Administration (BPOM) approves an Emergency Use Authorization (EUA) for the Inavac Vaccine to be used as a booster vaccine.

The Inavac vaccine is one of the COVID-19 vaccines developed domestically using the inactivated virus vaccine platform. This vaccine was developed by Airlangga University researchers in collaboration with PT Biotis Pharmaceuticals Indonesia.

The issuance of EUA for the Inavac Vaccine as a booster vaccine has been carried out by the requirements, namely by first going through an evaluation process on the efficacy and safety aspects of the Inavac Vaccine for heterologous booster administration. The evaluation conducted by BPOM refers to the internationally accepted COVID-19 vaccine evaluation standards.

As information, the approved use of the Inavac Vaccine booster is as a heterologous booster vaccine with the primary Sinovac Vaccine in adults aged 18 years and over, which is given in 1 injection dose (5 mcg/0.5 mL) with an interval of at least 6 months after the complete primary dose using Sinovac Vaccine.

"Previously on November 1, 2022, BPOM had issued a EUA for Inavac Vaccine as a 2-dose primary vaccine for adults aged 18 years and over. With the approval of the Inavac Vaccine EUA for use as a booster vaccine, it adds to the booster vaccine alternatives for adults aged 18 years and over who have received primary vaccination using Sinovac Vaccine," Head of BPOM Indonesia, Penny K Lukito said.

Meanwhile, the efficacy and safety of the Inavac Vaccine as a heterologous booster refers to a clinical study using a vaccine comparator from an inactivated virus platform that has been approved as a booster vaccine.

The results of this study showed non-inferior neutralizing antibody and Immunoglobulin G (IgG) antibody responses compared to the approved booster vaccine.

The neutralizing antibody seroconversion rate at 28 days after booster administration was 74 percent (Inavac vaccine) vs 78 percent (comparison vaccine).

The Geometric Mean Titer (GMT) value of the neutralization antibody ratio of the Inavac Vaccine with the comparison vaccine was 0.86 with a 95 percent confidence interval (CI) value range between 0.82 to 0.90 and a seroresponse difference of -4 percent with a 95 percent confidence interval (CI) value range between -0.019 to -0.061 which met WHO requirements. The IgG seroconversion rate at 28 days after the booster dose was 19 percent vs 21 percent.

According to Penny K. Lukito, the safety profile of the Inavac Vaccine heterology booster is similar to the primary vaccination, and there are no new types of side effects.

"The safety profile of Inavac Vaccine heterologous booster administration is similar to the safety profile of primary vaccination. There are no new side effects reported in the administration of the Inavac Vaccine booster compared to the administration of the primary dose of Inavac Vaccine," the Head of BPOM explained.

This safety profile is also evident from the side effects reported from the clinical trial process of the Inavac Vaccine as a heterologous booster, which are generally mild to moderate in nature.

The most commonly reported side effects are pain at the injection site and headache, with the incidence of side effects tending to be lower in the administration of the Inavac Vaccine booster compared to the comparison vaccine.