Homework To Be Done Once A COVID-19 Vaccine Emergency Permit Is Issued

Illustration (Photo: Antara)

JAKARTA - The Food and Drug Administration (BPOM) has issued an emergency use authorization (EUA) for the COVID-19 vaccine produced by Sinovac. Although the COVID-19 vaccine can be injected immediately, epidemiologists assess that the government still has a lot of homework to do.

In an online press conference on Monday, January 11, BPOM Head Penny K Lukito said the COVID-19 vaccine produced by Sinovac has met the requirements for an emergency use permit.

"Today, the Food and Drug Supervisory Agency (BPOM) has approved the first use of authorization for the COVID-19 vaccine for the Coronavax vaccine produced by Sinova Biotech Incorporated in collaboration with PT Bio Farma," said Pennny. .

In deciding to grant the emergency permit, his party considers the results of clinical trials in Indonesia and a number of other countries such as Brazil and Turkey. As a result, the vaccine against COVID-19 has safety and efficacy or what is known as efficacy.

Not only that, this vaccine has met the standards of the World Health Organization (WHO) for obtaining EUA approval with a safety and efficacy level of at least 50 percent. Because, from the results of clinical trials conducted in Bandung by Bio Farma and Sinovac, the efficacy reached 65.3 percent while the results from clinical trials in Turkey reached 91 percent and Brazil 78 percent.

In addition, the provision of EUA from BPOM also considers the results of cross-sectoral joint meetings such as the National Committee for Drug Assessment, ITAGI, epidemic experts and other related elements. According to Penny, BPOM and related stakeholders continue to monitor the vaccination process, especially the side effects of the Sinovac vaccine preventing the occurrence of post-immunization follow-up events.

So, with a number of these analyzes, the BPOM ensures that the vaccine from Sinovac is safe to use.

"Overall, it shows that the Coronavax vaccine is safe with the incidence of side effects being mild to moderate," he said.

Still on the same day, Health Minister Budi Gunadi Sadikin confirmed that the government would carry out the COVID-19 vaccination on Wednesday, January 13. President Joko Widodo (Jokowi) will receive the first vaccine.

"Regarding vaccination, God willing, our ladies and gentlemen will start on Wednesday and will be started by the President," Budi said as quoted from a press statement broadcast on the YouTube account of the Presidential Secretariat.

Apart from the matter of implementing the initial vaccination, Budi also explained that the government will receive millions of vaccine raw materials from Sinovac. This raw material will come on Tuesday, January 12 or today.

"This raw material will be processed by Bio Farma within a month so that in early February we already have a finished vaccine and 15 million vaccine ingredients," he said.

Not only that, Budi also explained that Indonesia would receive free vaccines from Gavi. "At least 54 million doses, maximum 108 million and the good news can come sooner. Either, at the end of February or in early March," he explained.

"And the vaccines from Gavi are Pfizer, AstraZeneca, and Moderna which have obtained approval from their home country and another one from Novavax. We are currently discussing what type we want to take because this vaccine can be given over the age of 60," he added. this former Deputy Minister of BUMN.

There is still some homework to do

The news about the issuance of an emergency permit for use of the Sinovac vaccine by BPOM was then responded to by an epidemiologist from Australia's Griffith University, Dicky Budiman. He said that the granting of this permit had been given in the right stages because clinical trials began and the results had met WHO standards.

In addition, the granting of this permit is also considered to be an adequate and strong basis that the Sinovac vaccine which will be injected is safe, has adequate efficacy, and is lawful based on the decision of the Indonesian Ulema Council (MUI). However, he still reminded the government that it still has a long way to go and must be done immediately to perfect the vaccine.

"The long homework that still needs to be known is that there are many unanswered questions, such as the efficacy of preventing transmission, then how long it will take you do not know yet cannot be answered because in my opinion this is fast track research. Including all other COVID-19 vaccines there is not yet. the certainty of how long the vaccine will last, "said Dicky when contacted by VOI.

This is what makes future vaccinations still need to be closely monitored to find out the effectiveness of this vaccine when it is injected.

Furthermore, Dicky also reminded that the vaccination that will start for the first time on January 13 is only one part of the effort to resolve this pandemic. However, because there is no certainty what percentage of the capacity of each vaccine is available, the public is still required to carry out health protocols and the government still has to strengthen 3T, namely testing, tracing, and treatment.

"And over time, monitoring of this vaccine will really need to be included in the data. Because this data will become the basis for better understanding the potential of the vaccine and its performance. Full data is vital so that we can finally assess and determine future strategies. "he concluded.