BPOM: Red And White Vaccine Needs Additional Clinical Trials As Booster

Head of the Food and Drug Administration (BPOM) Penny K Lukito/PHOTO VIA ANTARA

JAKARTA - Head of the Food and Drug Monitoring Agency (BPOM) Penny K Lukito said the Merah Putih vaccine still requires further clinical trials to be used as a booster vaccine amid the emergence of a new variant of COVID-19.

"It is being prepared, there may be a revision to the protocol (clinical trials). So after the premier vaccine, the test for the booster vaccine will be continued," said Penny K Lukito, quoted by Antara, Thursday, December 2.

Penny said that currently the development of the Red and White vaccine had reached the phase two clinical trials conducted on humans before being granted an emergency use permit by BPOM.

However, if used as a booster vaccine, said Penny, the vaccine by researchers from Airlangga University (Unair) still requires advanced clinical trials.

"Development and clinical trials are currently underway to produce a primary vaccine, so there will be possible changes to the clinical trial protocol," he said.

Penny believes that the development of boosters and effectiveness of new variants will not take a long time, as long as all stages of the primary vaccine have been carried out.

Penny added that the development of domestic vaccines is a new breakthrough, so it is necessary to increase the production capacity of vaccines in the country, in addition to those produced by PT Bio Farma.

Therefore, BPOM encourages various other pharmaceutical industries to support the expansion of production capacity, one of which is PT Biotis Pharmaceutical Indonesia, which is a partner of Airlangga University (Unair) in the development of the Red and White vaccine.

"BPOM is assisting the development of the Merah Putih vaccine with PT Biotis to immediately obtain a method of making good drugs (CPOB) and fill and finish," he said.