Two homegrown Covid-19 Vaccines Receives the Go-Ahead

KOMPAS/HERU SRI KUMORO

Medical personnel inject the third dose of Covid-19 vaccine (booster) to workers at the Kompas Tower, Jakarta, on Tuesday (25/1/2022).

JAKARTA, KOMPAS - The Food and Drug Monitoring Agency (BPOM) issued emergency use authorizations (EUA) for two locally developed Covid-19 vaccines, namely the Indovac vaccine and the AWcorna vaccine. The granting of the EUAs also reflects Indonesia’s increasing independence in vaccine production.

The Indovac Covid-19 vaccine was developed by state-owned pharmaceutical firm PT Bio Farma, while the AWcorna Covid-19 vaccine was developed by PT Etana Biotechnologies Indonesia. The EUAs guarantee both vaccines’ efficacy and safety.

“The development and production of homegrown vaccines are the pride of Indonesians as it serves as a stepping stone toward strengthening the country’s independence in drugs and vaccines,” said BPOM head Penny K. Lukito at a press conference in Jakarta on Friday (30/9/2022).Also read:

> Welcoming Booster Vaccine for Children

> Regions at Greater Risk, Accelerate Vaccinations

He said the issuance of the EUAs for the two vaccines was expected to encourage other national pharmaceutical businesses to continue to innovate and produce vaccines using the latest technology. That way, Indonesia’s pharmaceutical industry can increasingly be able to compete at the global level.

The Indovac vaccine was developed by PT Bio Farma along with Baylor College of Medicine in the United States. This vaccine was developed using a recombinant protein subunit platform containing the active substance recombinant receptor-binding domain (RBD) of the SARS-CoV-2 virus’ S protein.

In the meantime, the Indovac vaccine will be used for primary vaccinations for ages 18 years and over. The vaccine is administered in two shots of 25 micrograms, with a 28-day interval. Based on the results of the third phase of the clinical trials, the vaccine’s efficacy was reflected by the presence of the non-inferior vaccine neutralizing antibodies and compared against the control protein subunit vaccine.

The efficacy rate is 92.5 percent compared with 87.09 percent. “This means that the Indovac vaccine’s [efficacy rate] is higher than the protein subunit vaccine,” said Penny.

The results of immunogenicity testing also showed that the vaccine provided an increase in immune response, meaning that the antibodies were comparable to the control vaccine.

Additionally, side effects of the Indovac vaccine observed during the clinical trials were generally mild, such as local pain and muscle aches. The results of immunogenicity testing also showed that the vaccine provided an increase in immune response, meaning that the antibodies were comparable to the control vaccine.

“Based on a quality evaluation, it can be concluded that the Indovac vaccine has met international vaccine quality standards,” said Penny.

NUT

BPOM head Penny K Lukito

An EUA was also issued for the AWcorna vaccine. The vaccine developed by PT Etana Biotechnologies Indonesia, along with China’s Abogen-Yuxi Walvax, is a Covid-19 vaccine with an mRNA platform. This vaccine was given the go-ahead for emergency use for primary doses for ages 18 years and over. The vaccine is administered in two shots of 15 micrograms per dose, including a 28-day interval.

In addition to primary vaccination, the AWcorna vaccine has also been permitted to be used as a heterologous booster shot, administered in one dose of 15 micrograms given six months after the second shot of the primary vaccination.

As a booster, the AWcorna vaccine can be administered to those whose primary doses used virus inactivation platforms, namely Sinovac and Sinopharm.

Penny said that the AWcorna vaccine was different from other mRNA vaccines. This vaccine can be stored at 2-8 degrees Celsius, while other mRNA Covid-19 vaccines, such as Pfizer, must be stored at around minus 70 degrees Celsius.

“The AWcorna vaccine gives Indonesia an opportunity to produce its own mRNA vaccine through a technology transfer process that is already up and running. This can support Indonesia’s goal to become independent in Covid-19 vaccine production,” he said.

In this way, both vaccines can serve as an alternative Covid-19 vaccine.

Penny added that the Indovac vaccine and the AWcorna vaccine were deemed halal by the Indonesian Ulema Council (MUI) and are halal-certified, according to the Halal Certification Agency (BPJPH). In this way, both vaccines can serve as an alternative Covid-19 vaccine.

PT Bio Farma operations director M. Rahman Roestan said that it is estimated that as many as 20 million doses of the Indovac vaccine can be produced each year. However, this figure may increase in accordance with demand.

“If later we need to make global contributions, we will gradually try to produce 100 million doses per year. Indonesia’s vaccines are not only for domestic use but also for other regions, such as countries in the OIC [Organization of Islamic Cooperation] as they have been monitored for its halal-certification,” he said.

Vaccine supply

Covid-19 vaccine supplies in certain areas are beginning to run out. The Health Ministry is attempting to distribute more vaccines from the center, while also reallocating vaccines from regions with larger supplies.

Health Ministry pharmaceutical management and services director Dina Sintia Pamela said in Jakarta on Friday that Indonesia currently had around 5 million doses of vaccine supply. Most have already been distributed across the country.

KOMPAS/PRIYOMBODO (PRI)

Vaccinator officers prepare the first dose of the Covid-19 vaccine at the precision vaccine booth by the National Police in front of the Ramayana shopping center, Ciledug, Tangerang City, Banten, on Tuesday (3/8/2021).

Now, several regions have reported dwindling supply, especially in areas with high vaccination rates and high mobility of people for travel and business, such as Yogyakarta and Bali.

On the other hand, there are regions with large vaccine supplies, such as North Maluku and East Nusa Tenggara, but with slowing vaccination rates. (TAN)

(This article was translated by Kesya Adhalia)