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View all search resultsThe Food and Drug Monitoring Agency (BPOM) cleared a batch of the vaccine on Thursday, ending a suspension of its use after reports linking the vaccine with rare blood clots.
The government has resumed COVID-19 vaccinations using the suspended batch of AstraZeneca vaccine after investigating reports that it may have caused blood clot among some recipients.
The Health Ministry welcomed on Thursday the findings of the Food and Drug Monitoring Agency (BPOM), according to which the vaccine batch was “safe to use” and the suspension would be lifted.
“Batch CTMAV547 of the AstraZeneca COVID-19 vaccine can continue to be used in the national vaccination program,” ministry spokeswoman Siti Nadia Tarmizi said in a press statement.
Earlier this month, the ministry had halted the distribution of almost half a million doses of the vaccine for investigation purposes, following reports of three deaths allegedly linked to the vaccine.
Investigations on the toxicity and sterility of the batch were carried out by the BPOM, the state body responsible for authorizing the nationwide use of the vaccine in March.
In its findings released on Thursday, the agency concluded that the batch "meets quality requirements” in quality consistency during both the distribution and storage.
“According to the test results, it can be concluded that there was no relation between the quality of COVID-19 vaccine batch CTMAV547 and the reported post-immunization events,” said the BPOM.
The batch, comprising 448,480 doses, is part of 3.8 million doses Indonesia received in April through the COVAX facility, a multilateral effort seeking to ensure equitable global access to COVID-19 vaccination that is backed by the World Health Organization (WHO).
Some of the doses had been distributed to Jakarta and North Sulawesi, as well as to the military, the agency said.
Even so, the National Commission on Post-Immunization Accidents (Komnas KIPI), which is tasked with keeping track of adverse post-immunization events in the country, is still looking into one of three reported deaths that occurred after inoculation with the AstraZeneca vaccine.
Trio Fauqi Virdaus, 22, died on May 6, a day after participating in a vaccination program at the Gelora Bung Karno stadium, as Jakarta authorities expanded its list of eligible vaccine recipients to include anyone above the age of 18, kompas.com reported.
According to his family, he had suffered from fever, fatigue and severe headache before his condition worsened. Trio was pronounced dead at the hospital he was brought to in Jakarta before the doctors even had a chance to conduct emergency medical procedures, local media reported.
Komnas KIPI said they are still awaiting examination results from Cipto Mangunkusumo General Hospital’s (RSCM) forensics department to determine whether there was a link between the vaccine and Trio's death.
“The autopsy report will be available in one to two weeks,” Komnas KIPI head Hindra Irawan told The Jakarta Post on Friday.
The other two cases, the commission added, was of a 45-year-old man from Ambon, Maluku, who had shown COVID-19 symptoms, and a 60-year-old man from Jakarta, who had died of pneumonia.
Hindra insisted that the two deaths were not the result of the vaccination and that the deaths of people who had been vaccinated against COVID-19 could be linked to other causes.
Komnas KIPI finds that adverse events usually occur within 24 hours after the vaccination, unlike reports in the UK that claim it takes two weeks to show any symptoms.
The WHO has repeatedly said that the AstraZeneca vaccine is safe and effective and that the protection it offers against COVID-19 outweighs the small risk of rare blood clots. The Health Ministry repeated this message on Thursday, with Nadia urging the general public to refrain from having preferences for certain vaccine brands.
"Vaccines, regardless of the brand, have the same benefits," she said in the press statement.
Indonesia was the latest Asian country to halt the use of AstraZeneca vaccines, after several European countries suspended its use following reports of serious blood clots among people inoculated with the vaccine.
Malaysia made the AstraZeneca vaccine optional after around 8,000 people cancelled their online vaccination registration, following its government's announcement that the jab would be part of the nationwide rollout, Reuters reported.
As of Thursday, Indonesia has fully inoculated at least 10.3 million of its 187 million eligible citizens under a nationwide vaccination drive that started in mid-January.
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