Imported Covid-19 Vaccine Must Be with WHO Recommendations

Jakarta, Beritasatu.com – The Indonesian government continues to strive to provide safe and efficacious vaccines. The plan is for the Covid-19 vaccination program to use vaccines that are currently in clinical trials in Indonesia, as well as imported finished vaccines.

Apart from permission emergency use authorization (EUA) from the Food and Drug Administration (BPOM), vaccines taken from other countries also need to obtain permission or a recommendation from the World Health Organization (WHO).

Chairman of the Indonesian Technical Advisory Group on Immunization (ITAGI), Prof. Sri Rezeki Hadinegoro, said vaccines that need permission from WHO are vaccines that are exported or imported. For example, the Sinovac vaccine from China which is planned to provide around 3 million doses for Indonesia on a two-dose platform (dual dose).

Meanwhile, for domestically-made vaccines, for example Sinovac, which is currently undergoing a phase 3 clinical trial by Biofarma and Padjajaran University in Bandung, it is sufficient only to obtain a distribution permit from BPOM for domestic use only. If the Biofarma vaccine is later used by other countries, WHO must have permission.

“So if later the Sinovac vaccine, which is currently in phase 3 clinical trial in Bandung, will also be used by other countries, then WHO will come to Biofarma to check how it is made,” Sri told Suara Pembaruan, Monday (9/11/2020).

Likewise, for the Covid-19 vaccine from other countries entering Indonesia, according to Sri, it must go through WHO permission. However, this recommendation is not complicated. So far, according to Sri, the foreign vaccine manufacturer that has sent the documents is Sinovac from China. Meanwhile, others, such as Sinopharm or Cansino, have yet to send documents.

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This document includes, among other things, the development process, clinical trials and production, as well as vaccine components. What is clear, according to Sri, is that to import vaccines especially in large quantities, the precautionary factor is very important. That is why BPOM is not easy to issue permits.

Dead Vaccine
According to Sri, the Sinovac vaccine actually has low side effects because it is a type of dead vaccine or inactivated. This vaccine contains a virus that has been killed or inactivated so there is no risk of causing disease because it does not contain live components of the virus.

However, these vaccines have components that can trigger the immune system, thereby providing immunity to the injected person’s body. The resulting immunity is low so that this vaccine is added with adjuvants to stimulate the formation of antibodies against the antigen in the vaccine more effectively. Thus, the immune system is higher.

However, according to Sri, because it is a dead vaccine, the antibodies produced are not too high. Until now, from the results of the phase 3 clinical trial, it is not known how long the Covid-19 vaccine will provide immunity. For inactivated vaccines, he said, usually up to one year.

Sri reiterated that vaccines would not eliminate Covid-19 from Indonesia’s soil. Vaccines only prevent people from getting sick from this virus. One day this pandemic will turn into endemic, namely a common disease that lives with humans.

This is the same with measles, which, although it has been eliminated and there is already a vaccine, the case is still being found today. Therefore, health protocols still have to become people’s daily habits to prevent Covid-19 infection.

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Source: Voice of Update

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