Suspended AstraZaneca Vaccine, BPOM: We Evaluate Other Vaccines

JAKARTA - The Food and Drug Administration (BPOM) decided to postpone the use of the Astrazeneca vaccine following the emergence of cases of patient blood clots in several countries.

BPOM said the decision to delay this time was waiting for confirmation from the World Health Organization (WHO) and The Strategic Advisory Group of Experts on Immunization (SAGE) regarding the safety of the vaccine from the UK.

"Hopefully in the not too long time," said Head of BPOM Penny K Lukito in a working meeting with Commission IX DPR, Monday 15 March.

He revealed that his party already has a dossier (file) from the WHO regarding the Astrazeneca vaccine, so that they can find out about the safety issues of the vaccine.

Penny also emphasized that the Astrazeneca batch number which was suspended in a number of European Union (EU) countries was different from the Astrazeneca batch number that entered Indonesia via the multilateral route.

"However, for the sake of caution, we are still in the process of communicating with WHO and SAGE. The results of the communication will be discussed by the cross-sector team and the Ministry of Health to make decisions about using Astrazeneca in the national vaccination program, "said Penny.

The BPOM has conducted a comprehensive evaluation of the Astrazeneca vaccine. He said that the Astrazeneca vaccine entered Indonesia through two channels, namely the multilateral GAVI / Covax Facility scheme and the bilateral scheme.

For the multilateral route, said Penny, the Astrazeneca vaccine received by Indonesia has received an emergency use listing (EUL) followed by emergency use authorization (EUA) from WHO.

Penny explained, WHO initially gave EUL, but BPOM did not immediately accept it and urged the UN health agency to continue to provide EUO.

BPOM, he continued, had communicated and urged to provide the UAE so that they finally got a confidentiality agreement regarding the vaccine file.

"With the confidentiality agreement, we conduct a thorough evaluation like other vaccines, only then will we give an emergency use authorization on February 22, 2021," said Penny.

Earlier in the same meeting, Health Minister Budi Gunadi Sadikin stated that he was postponing the use of the AstraZeneca COVID-19 vaccine in Indonesia while awaiting the results of research by the World Health Organization (WHO).

Currently, said Budi, WHO together with the Medicines and Healthcare products Regulatory Agency (UK) and the European Medical Authority are examining a number of side effects such as blood clots in the case of using the Oxford vaccine.

"Until now, WHO is still researching, we have also received from the MHRA, the UK BPOM, and the EMA from the European Medical Authority. They have not confirmed whether there is a correlation due to vaccines or not," said Budi Gunadi.

So far, said Minister of Health Budi, information on several cases of blood clots was not caused by the AstraZeneca vaccine but by other incidents. However, the Ministry of Health together with the Food and Drug Supervisory Agency (BPOM) agreed to state a temporary suspension of use of AstraZeneca.

"For its conservatism, BPOM has postponed the implementation of AstraZeneca while waiting for WHO's confirmation, hopefully it can come out in a short time, because there is an expiration period at the end of May," he said.