The Jakarta Post
Indonesia is on track to roll out its COVID-19 vaccination campaign next week, just as the country extends its record-breaking streak of highest new daily confirmed cases for a third consecutive day.
The highly anticipated vaccination drive, which President Joko “Jokowi” Widodo has ordered to commence after he takes the first jab of the CoronaVac vaccine on Jan. 13, looks likely to proceed after the Food and Drug Monitoring Agency (BPOM) indicated it would keep to the agreed timetable to authorize use of the vaccine.
BPOM head Penny Lukito expressed optimism on Friday that her agency would be able to issue emergency use authorization (EUA) for Chinese firm Sinovac Biotech’s candidate vaccine before Wednesday.
She was also quick to dismiss allegations that Jokowi’s announcement would “bind BPOM to issuing the EUA on a certain date”, saying that the plan did in fact line up with BPOM’s own timeline and that it was waiting for the full set of interim data to be compiled and analyzed.
"We're grateful that we have growing conviction up to this day so that [...] it can be confirmed that the [EUA] will be issued before Jan. 13," she told a virtual press briefing.
Penny explained that the agency had employed a rolling submission of interim data from ongoing late-stage clinical trials of the candidate vaccine in Bandung, West Java, rejecting any claim that it was a “sudden” forced decision.
BPOM had received half of the trial’s data by Thursday and was expected to acquire the complete dataset on Friday.
"We'll analyze it internally first before we conduct final deliberations with the national committee on drug evaluation specifically on COVID-19 vaccines, which also involves ITAGI [Indonesian Technical Advisory Group on Immunization], clinicians on a wider scale and epidemiologists – all so that we can issue [the EUA] in the next few days," she said.
In addition to the Bandung data, Penny said the agency would also consider interim data from the larger phase three trials of the same candidate vaccine in Turkey and Brazil.
Turkey revealed last month that CoronaVac’s efficacy from the trials was 91.25 percent, based on data from 1,322 of the 7,000 participants, Reuters reported.
Meanwhile, Brazilian officials announced on Thursday that its trials showed an efficacy of at least 78 percent from a pool of 13,000 participants, although the lack of detailed data has prompted calls for transparency.
Reuters reported that from Brazil’s interim data, as many as 218 participants had contracted the virus, with over 160 of those cases occurring among participants who received a placebo instead of the vaccine.
The efficacy figures are below those reported by the vaccines from United States firms Pfizer and Moderna, but they are also above the minimum efficacy rate of 50 percent set by the World Health Organization, which BPOM uses as a guideline for authorizing use.
The trials in Indonesia are being carried out by Padjadjaran University researchers and state-owned pharmaceuticals company Bio Farma and involve 1,620 participants, a figure experts fear is too small to determine efficacy. They have suggested that BPOM also consider trial data from other countries as a precaution.
Biotechnology researcher Wien Kusharyoto, for instance, has said that interim reports of other vaccines required data from around 150 subjects who have contracted COVID-19 to be able to draw accurate conclusions on efficacy, after comparing their results with those of healthy subjects in a placebo test.
Pfizer announced on Nov. 18 that its interim analysis, with 170 confirmed cases among the trial participants, showed an efficacy rate of 95 percent. The United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine for emergency use on Dec. 2, 2020, followed by the US Food and Drug Agency (FDA) on Dec. 11.
Penny, however, brushed off such concerns, claiming that her agency was already following statistical methodology recommended by the WHO and other countries’ agencies.
She did not disclose any exact figures, saying they would be released upon the EUA’s announcement.
The implicit nod by BPOM comes as Indonesia saw its daily tally of new confirmed COVID-19 cases reach new heights for three days in a row. Friday saw the cases reaching five digits for the first time with 10,617 new cases, surpassing Wednesday’s 8,854 new cases and Thursday’s 9,321 cases.
According to the government's tally, the accuracy of which has been questioned by many, the country now has over 117,000 active cases with a total of 23,753 deaths.
The surge in COVID-19 cases stands in stark contrast to the government’s eagerness to carry out the immunization of some 181 million people within a year, which has been touted as overly ambitious by experts.
Hospitals across regions in the country have also reported rising bed occupancy rates, with the government announcing that it would reimpose a tweaked version of large-scale social restrictions (PSBB) on Jan. 11.
Experts have called on the government not to rely only on vaccines, as the outbreak may take a turn for the worse if supplies remain limited and the country continues to forgo strict mobility curbs and sufficient efforts to test, trace and isolate new cases.
Indonesia has received 3 million doses of CoronaVac ready-to-use vaccines, which have been distributed to regions across the country. Statements from the Home Ministry have revealed that Jokowi will be the first to be inoculated on Jan. 13. The following day and over the next few months, around 1.3 million medical workers will begin to get vaccinated for free.
In addition to BPOM’s authorization, the vaccination also requires a seal of approval from the Indonesian Ulema Council (MUI) to appease the nation’s Muslim majority.
The head of MUI’s fatwa commission, Asrorun Niam Sholeh, told The Jakarta Post on Friday that the council had deemed the Sinovac vaccine “halal and holy”.