The government's plan to carry out the Covid-19 vaccination, which was previously planned for December 2020, is confirmed to be delayed. Head of the Food and Drug Supervisory Agency (BPOM), Penny K. Lukito, stated the conditions for using vaccines in an emergency or emergency use authorization (EUA) in Indonesia has not been fulfilled.
"Vaccination must adhere to scientific principles," said Penny when giving a press statement at the BPOM office, Thursday, November 19, 2020.
EUA is a vaccine license that is temporary and not a distribution permit. BPOM can issue it in an emergency, such as during the Covid-19 disaster. However, to do this, BPOM must refer to the procedures established by the World Health Organization (WHO), US Food and Drug Administration, and European Medicines Agency / EMA. Some of them are completing comprehensive report files related to clinical trials of phase I and II vaccines, as well as phase III interim analysis.
"BPOM is still waiting because the one analyzing is the research team," he said.
In this series of clinical trials, according to Penny, it is only possible to know the extent of the efficacy of the Covid-19 vaccine. The standard of efficacy or the ability of the vaccine to provide benefits for individuals recommended by WHO, touching the figure of 70 percent. However, during a pandemic the value was reduced to only 50 percent. This means that at least 50 people are immune from 100 people who have been vaccinated.
“It's not a matter of fast and slow. This is a matter of whether the data is sufficient and valid, and is available with a good analysis, "he said.
BPOM hopes that the clinical trial of the vaccine will be completed quickly so that the EUA can be published in January 2021. "We can get the third and fourth week (clinical trial report-ed)," he added.
Penny assured that the vaccines produced by pharmaceutical companies from China had met the quality requirements. BPOM became aware of this after conducting inspections at Sinovac Biotech Ltd together with the Ministry of Health, PT Bio Farma (Persero), and the Indonesian Ulema Council (MUI) Food and Cosmetic Assessment Institute (MUI) on Thursday, October 15, 2020. BPOM assessed the standard mechanism for making vaccines by Sinovac is GMP compliant or good manufacture practice.
"We guarantee good quality. We see the process, from raw materials to production, "he said.
As is known, medical personnel, members of the Indonesian National Army (TNI), Polri, and volunteers will be prioritized to get the Covid-19 vaccine. The process will be supervised and accompanied by BPOM. Because vaccines are products that are sensitive to temperature changes (cold chain product). The Sinovac vaccine, said Penny, requires storage with a constant temperature of 2-8 degrees Celsius.
"Efforts and strict control along the distribution channel are needed so that the quality and stability of vaccines are maintained until later used by end user (patient), "explained Penny.
BPOM will also monitor side effects and clinical symptoms that can appear after vaccination is carried out. "If the effect is significant, BPOM will make a decision. We cooperate with many parties based on their respective expertise, "he concluded.
Apart from Sinovac, pharmaceutical companies Pfizer, AstraZeneca, and Sputnik V have also requested permission for clinical trials in Indonesia. Based on the results of phase III clinical trials, the Pfizer vaccine is claimed to be able to fight the Covid-19 virus by up to 95 percent. Meanwhile, the Sputnik vaccine claims 92 percent potency. Even so, BPOM has not been able to open the door for the three vaccine producers.
"I think they will look for pharmaceutical industry partners in Indonesia first," said Penny.
Meanwhile, a Chinese company, Sinovac Biotech, has collaborated with PT Bio Farma (Persero) to conduct clinical trials. "We hope that Biofarma and Sinovac Biotech China are committed to fulfilling these data so that the issuance of permits can be carried out immediately by BPOM as planned," he said.
President Director of PT Bio Farma, Honesti Basyir, stated that the phase I, II and III clinical trial reports are still in process. In the final phase of clinical trials in Bandung, a team of researchers from the Faculty of Medicine, Padjadjaran University had vaccinated around 1,620 subjects. Of these, 1,603 subjects had received a second injection that was administered on day 14 after the first injection of the vaccine.
"We cannot reveal the results yet because it is still in process. Around January 2021, the first week, we submit the report to BPOM and we can find out the results in the 3rd week of January 2021, "said Basyir when conveying vaccine developments at a press conference at the BPOM Building, Thursday, November 19, 2020.
Even though it has not yet obtained EUA, Bio Farma has started producing Sinovac Biotech vaccines. This was done after the government and BPOM reviewed and audited the Covid-19 vaccine production process.
"We hope this will meet vaccine production," he said.
Research conducted by the Ministry of Health and Indonesia Technical Advisory Group on Immunization (ITAGI) on September 19-30, 2020, showed that around 64.8 percent of 155 thousand respondents in 34 provinces were willing to receive Covid-19 vaccinations. Meanwhile 27.8 percent were doubtful and 7.6 percent of other respondents refused.
The chairman of ITAGI, Sri Rezeki Hadinegoro stated that West Papua and East Nusa Tenggara had the highest level of enthusiasm. Respectively pocketed the figures of 74 percent and 70 percent. Meanwhile, most of the rejection of vaccination came from Nangroe Aceh Darussalam (46 percent) and West Sumatra (47 percent).
Respondents who refused vaccination had a number of reasons, such as the safety of the vaccine (30 percent), unsure of the effectiveness of the vaccine (22 percent), distrust of the vaccine (13 percent), fear of side effects (12 percent), religious belief (8 percent), and other reasons (15 percent). Therefore, Sri warned the government not to mess around in fulfilling all the procedures for making and distributing vaccines. He said, the fulfillment of the requirements from WHO is useful for ensuring vaccine safety.
"This is not a trick from BPOM. This is in a state of emergency, ”said Sri Rezeki Hadinegoro when delivering a press statement at BPOM, Thursday, November 19, 2020.
Until November 19, 2020, positive cases of Covid-19 reached 483,518 people. Of that number, around 406,612 people were declared cured, while 15,600 others died. For this reason, the Chairman of the Indonesian Doctors Association (IDI), Daeng Faqih supports the emergency curation process that is currently being carried out by BPOM.
"We believe what BPOM is doing," said Daeng at BPOM, Thursday, November 19, 2020.
According to him, mass vaccination procedures need to be carried out to prevent the Covid-19 pandemic from getting worse. "This is a health service modality to prevent disease," he added.
Meanwhile, President Joko Widodo in a simulation of giving the Covid-19 vaccine at the Tanah Sareal Community Health Center, Bogor City, West Java, warned the safety and security of the public. The President requested that the vaccine production process follow the procedures of the world health organization.
"I have said that these scientific principles must be followed," said Jokowi on Wednesday, November 18, 2020, as quoted by Jaring.id from the official website of the State Secretariat of the Republic of Indonesia.
The president is targeting mass vaccination to be carried out at the end of this year or January 2021. "Because the preparation process does not only involve receiving vaccines, then direct injection. But they also have to prepare distribution throughout the country, "he said. (Abdus Somad)