AstraZeneca Vaccinations Halted Temporarily

Kompas

A nurse, left, prepares a shot of AstraZeneca COVID-19 vaccine, manufactured by the Serum Institute of India and provided through the global COVAX initiative, from a portable cold storage box, center, in Machakos, Kenya, Wednesday, March 24, 2021. AstraZeneca\'s repeated missteps in reporting vaccine data coupled with a blood clot scare could do lasting damage to the credibility of a shot that is the linchpin in the global strategy to stop the coronavirus pandemic, potentially even undermining vaccine confidence more broadly, experts say.

JAKARTA, KOMPAS — The government has temporarily halted the distribution and use of the CTMAV547 batch of COVID-19 vaccines made by AstraZeneca. The decision was made to improve testing at the Food and Drug Monitoring Agency (BPOM) and ensure the vaccine’s safety after reports of two fatal cases suspected of being related to AstraZeneca.

"This is a form of caution by the government to ensure the safety of this vaccine. The Health Ministry urges residents to be calm and not be consumed by hoaxes," Health Ministry’s vaccination spokesperson, Siti Nadia Tarmizi, said in a press statement in Jakarta on Sunday (16/5/2021).

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According to Nadia, not all the distribution and use of AstraZeneca vaccines received in Indonesia have been stopped. The temporary suspension was only carried out for vaccines in the CTMAV547 production batch totaling 448,480 doses and part of the 3.85 million doses of AstraZeneca vaccines that Indonesia received on April 26 through a multilateral scheme, namely the Covax facility of the World Health Organization (WHO).

Doses in this production group were distributed to the Indonesian Military (TNI) and partly to Jakarta and North Sulawesi. Outside this batch, said Nadia, "the use of AstraZeneca vaccines continues because vaccination brings greater benefits”.

Post-immunization incidents

In the BPOM letter to the Health Ministry on May 11, it was disclosed that the BPOM was further investigating two reports of fatal post-immunization incidents (KIPI) allegedly related to the AstraZeneca COVID-19 vaccine of the CTMAV547 batch.

"These two cases were from Jakarta," said Nadia.

KOMPAS/DEONISIA ARLINTA

Siti Nadia Tarmizi

In accordance with the recommendation of the National Commission on KIPI (Komnas KIPI), the BPOM was asked to test the sterility and toxicity of the vaccine for that group. During investigation and testing, the distribution and use of the AstraZeneca vaccine of this production group was halted.

When contacted separately, the chairperson of Komnas KIPI, Hindra Irawan Satari, explained that recipients of the COVID-19 vaccine made by AstraZeneca could receive a second dose. If someone has already used the Astra-Zeneca vaccine, they must wait for the next schedule to ensure its safety.

Previously, it was reported that Komnas KIPI was investigating the death of Trio Fauqi Virdaus, 22, who died on May 6 (6/5) after being injected with the AstraZeneca vaccine the day before (5/5). Hindra said Komnas KIPI recommended that a post mortem examination was carried out on Trio Fauqi Virdaus\'s body to determine the connection between his death and the vaccination.

“Komnas KIPI and a forensic team will carry out the examination," said Nadia.

Before the post-mortem examination is conducted, the cause of death of the victim could not be concluded.

Other countries

So far, a number of countries have stopped using the AstraZeneca vaccine, mainly because of the suspicion that it can trigger blood clots. For example, two Canadian provinces stopped using this vaccine last week because there were reports of 28 cases of blood clotting or vaccine-induced thrombotic thrombocytopenia (VITT) from 2.3 million doses of the AstraZeneca vaccine injected in Canada.

The study was published in the British Medical Journal (BMJ) on May 5.

Previously, Denmark and Norway also decided to stop using this vaccine. A study in the two countries found slightly increased rates of venous blood clotting among people who had received the first dose of AstraZeneca\'s COVID-19 vaccine, which included clots in the brain, compared to levels expected in the general population. The study was published in the British Medical Journal (BMJ) on May 5.

The BMJ study examined 280,000 people aged 18-65 in Denmark and Norway who received their first dose of the AstraZeneca vaccine between early February and March 11. By using national health data, the research team identified rates of heart attacks, stroke, deep vein blood clots and bleeding 28 days after receiving the first dose of the vaccine, then compared them to "normal" levels in the general population in Denmark and Norway.

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The results showed that there were 59 cases of blood clots in the vessels compared to the expected 30, which was equivalent to 11 incidents for every 100,000 vaccinations. The researchers said this included a higher-than-expected rate of cerebral blood clotting (which is rare), known as cerebral venous thrombosis, at 2.5 cases per 100,000 vaccinations.

AP PHOTO/BRIAN INGANGA

A vial of the AstraZeneca COVID-19 vaccine, manufactured by the Serum Institute of India and provided through the global COVAX initiative, is removed from a portable cold storage box in preparation for a vaccination, in Machakos, Kenya, Wednesday, March 24, 2021. AstraZeneca\'s repeated missteps in reporting vaccine data coupled with a blood clot scare could do lasting damage to the credibility of a shot that is the linchpin in the global strategy to stop the coronavirus pandemic, potentially even undermining vaccine confidence more broadly, experts say. (AP Photo/Brian Inganga)

However, Rafael Perera and John Fletcher, researchers who conducted the study, emphasized that such side effects were extremely rare and that the benefits of the vaccines still outweighed the risks in many situations.

"The absolute risk of venous thromboembolism described in this study is small and the findings should be interpreted in the context of the benefits of Covid-19 vaccination at the community and individual levels," they wrote in a summary of their findings.

Meanwhile, European and British drug regulators said the vaccine is safe and effective, and its benefits far outweigh the risk of side effects. However, several other countries recommended its use only for certain age groups. (EVY)

(This article was translated by Hyginus Hardoyo).