Sinovac Vaccine Emergency Permit Shows Bright Spot

JAKARTA - The process of preparing for the COVID-19 vaccination, which begins with the Sinovac brand vaccine, was tinged with concern some time ago. As many as 3 million Sinovac Vaccines have been distributed to all provinces.

Many regions have set a date to start vaccination, until President Joko Widodo (Jokowi) plans to be the first person to be injected on January 13.

In fact, when the plan was issued and the vaccines were distributed, an emergency use authorization (EUA) had not been issued by the Food and Drug Administration (BOPM).

Until finally, BPOM Penny K. Lukito confirmed that the EUA would come out before the government's target to start vaccination on January 13.

"Regarding the certainty of the EUA, the government has planned for January 13 to carry out the vaccination. We are quite confident that we will issue the EUA before that date," Penny said on Friday, January 8.

Although the date for the commencement of vaccination has been determined by the government, Penny claims that this does not mean that BPOM is urged to provide EUA before January 13.

Penny said BPOM's confidence in issuing the Sinovac vaccine emergency permit before January 13 was based on belief and safety aspects.

He said, the results of the efficacy or the ability to provide benefits for people undergoing clinical trials of injecting vaccines as the basis for granting emergency clearance will be delivered in the near future.

"We will convey the complete determination of the efficacy in Indonesia, when we issue the EUA. This is related to statistics (efficacy results) in Brazil and Turkey. So, we have no doubt associated with statistical methods and clinical trial methods that have been carried out in Indonesia. Bandung, "he explained.

Halal Sinovac vaccine

The Indonesian Ulema Council (MUI) Fatwa Commission completed a fatwa session regarding the Sinovac brand of COVID-19 vaccine products. In the results of the plenary session of the Fatwa Commission and auditors of the MUI's Institute for the Study of Food, Drugs and Cosmetics (LPPOM), it was stated that the COVID-19 vaccine produced by Sinovac was halal and sacred to be injected into the public.

"After a long discussion of the auditor's explanation, the Fatwa Commission meeting agreed that the COVID-19 vaccine produced by Sinovac Lifescience whose certification was submitted by Bio Farma was holy and halal," said the Head of MUI for Fatwa, Asrorun Niam Sholeh.

According to Asrorun, regarding the permissibility of its use, it is closely related to the discontinuation of the safety, quality, and efficacy aspects of the Food and Drug Supervisory Agency (BPOM).

Thus, the official fatwa of the Indonesian Ulema Council regarding vaccine products from Sinovac China will await the final results from the POM.

"The whole fatwa will be submitted after BPOM has conveyed the safety aspect to be used, whether it is safe or not, then the fatwa will see," he said.

Recognize emergency clearance

Emergency use authorization (EUA) is a permit used for certain medical methods provided that it is given in an emergency.

The party authorized to issue emergency permits is BPOM, supported by evidence of adequate safety, efficacy and quality. After EUA administration, strict monitoring of its efficacy and long-term safety must be carried out.

The requirements for granting a Sinovac vaccine emergency permit are that the vaccine must already have complete data on phase 1 and phase 2 clinical trials as well as interim analysis data for phase 3 clinical trials to show the efficacy and safety of the vaccine.

Vaccine efficacy was demonstrated based on vaccine efficacy data, measured by the percentage reduction in disease incidence in the group of people who received the vaccine compared to the group of people receiving placebo in the phase 3 clinical trial with monitoring for up to 6 months. WHO requires that the minimum efficacy of the COVID-19 vaccine is 50 percent from 3 months of interim analysis data.

Meanwhile, vaccine safety can be obtained from preclinical test data in animals and phase 1 clinical trials in humans. If it has been declared safe, it can be continued to clinical trials in phase 2 and 3. Safety data are monitored for up to 6 months after vaccine injection.

BPOM implements rolling submissions in accelerating evaluations to issue emergency permits. Data evaluation has been carried out since October 2020 and as of today, an intensive evaluation meeting is held with the National Commission on Drug Assessment team on the complete data obtained.

Currently, POM has entered the final stage of evaluating clinical trial results. There are three clinical trial locations monitored by BPOM, namely Brazil, Turkey, and Bandung with PT Bio Farma and Padjajaran University as implementers.

Clinical trials in Brazil provide a vaccine efficacy of 78% and in Turkey 91.25%. The difference in efficacy between different clinical trials of vaccines in each country is influenced, among others, by factors of differences in the number of subjects, the selection of the subject population, the characteristics of the subjects, and environmental conditions.

However, even though there are differences in the efficacy value, the BPOM does not make a problem because the regulatory requirements from WHO are greater than 50 percent are met.