Indonesia Awaits Assessment Results from BPOM

KOMPAS/COKORDA YUDISTIRA

President Joko Widodo monitors the implementation of the Covid-19 vaccine immunization at Puri Saren Agung Ubud, Gianyar, Bali, Tuesday (16/3/2021).

COVID-19 vaccines produced by AstraZeneca have been declared unrelated to blood clots reportedly suffered by some who received the vaccine. Regardless, Indonesia has decided to postpone mass vaccination using AstraZeneca vaccines until the Food and Drug Administration (BPOM) concludes its assessment of the vaccine.

GENEVA, TUESDAY — The World Health Organization and the European Medicines Agency (EMA) announced that the COVID-19 vaccine produced by AstraZeneca was safe to use. The vaccine has also been deemed unrelated to recent incidents in which several recipients of the vaccine in several countries suffered from post-vaccination blood clots.

“We do not want people to panic. We recommend countries to continue their mass vaccination programs using the AstraZeneca vaccine,” said the WHO’s chief scientist, Soumya Swaminathan, in Geneva, Switzerland, on Monday (15/3/2021).

“We did not find any connections between the [blood clot] incidents and the vaccine,” added Soumya.

Also read: Gearing up for Gotong Royong Vaccination Program

The WHO and the EMA hope COVID-19 vaccination will continue. It is feared that a delay in mass vaccination would weaken the world’s fight against the pandemic.

On Tuesday (16/3), WHO experts held a meeting to further discuss the safety of the AstraZeneca vaccine. The WHO and the EMA discussed data on the safety of AstraZeneca vaccine separately. Then, the EMA organized an extraordinary meeting to decide on further action.

The benefits of the AstraZeneca vaccine outweigh the risk of side effects. Regardless, a scientific evaluation is still needed.

On a separate occasion, the EMA declared that there was no indication that the AstraZeneca vaccine had caused blood clots. “The benefits of the AstraZeneca vaccine outweigh the risk of side effects. Regardless, a scientific evaluation is still needed,” said EMA executive director Emer Cooke during an online press conference from Amsterdam after a meeting that discussed the post-vaccination blood clot incidents.

Meanwhile, a spokesperson for United Kingdom Prime Minister Boris Johnson has issued a statement as well. “As stated by the Medicines and Healthcare products Regulatory Agency (MHRA), the incidents of blood clots occurred naturally after vaccination. Hence, there is no proof that the incidents were connected with the AstraZeneca vaccine.”

STEFAN ROUSSEAU/POOL PHOTO VIA AP

Britain\'s Prime Minister Boris Johnson watches a patient receiving a dose of the Oxford/Astrazeneca coronavirus vaccine, during a visit to Barnet FC\'s ground at the Hive, which is being used as a coronavirus vaccination centre, in London, Monday, Jan. 25, 2021.

Cases of blood clots following the use of AstraZeneca vaccine have prompted a number of European countries to suspend their use of the vaccine. With Sweden and Latvia recently announcing postponements, there are now more than 10 European Union member states that have delayed their mass vaccination programs.

The Indonesian situation

The AstraZeneca vaccine was developed by British-Swedish pharmaceutical company AstraZeneca with Oxford University. The vaccine is the cheapest of the available COVID-19 vaccines, making it a popular option for poor countries.

Yesterday, the Health Ministry’s spokesperson for national COVID-19 vaccination affairs, Siti Nadia Tarmizi, said the government had decided to delay the distribution of the AstraZeneca vaccine until after the BPOM concluded its assessment of the vaccine. The delay was deemed necessary to maintain cautiousness, as well as to ensure the vaccine’s quality and decide the target population that will receive the vaccine.

However, we decided to postpone the vaccine distribution nonetheless as we remain cautious.

The distribution of the AstraZeneca vaccine in Indonesia will be postponed until there is further information from the WHO and other medical regulatory authorities from European countries to ensure that the vaccine is indeed safe to use. “The EMA has indeed announced that the cases [of blood clots] were unrelated to the AstraZeneca vaccine. However, we decided to postpone the vaccine distribution nonetheless as we remain cautious,” said Nadia.

Also read: Limited Supply Main Challenge in RI’s Vaccination Drive

“We’re maintaining communication with the WHO. We have noticed as well that the batch number of the AstraZeneca vaccine that has been postponed in Europe is different from the batch number of AstraZeneca vaccine that Indonesia received,” added Nadia.

KOMPAS/AGUS SUSANTO

A medical worker administers a Covid-19 vaccine to an elderly person at a community health center (Puskesmas) in Duren Sawit, East Jakarta, on Tuesday (23/2/2021). Each day, the health center administers 20-50 doses of vaccines for elderly people. Health Ministry Covid-19 vaccination spokesperson Siti Nadia Tarmizi said the current second phase of the vaccination drive was for public service workers and elderly people. In the case of the elderly, the first and second shot of the vaccine are given with a 28-day interval. For people aged 18-59, the vaccines are given with a 14-day interval. According to Health Ministry data, an additional 16,297 people received their first vaccine shots on Monday, bringing the total to 1,244,215 people. With the limited global supply of vaccines, the government prioritizes the vaccination of high-risk people to lower the mortality rate.

Nadia explained that the BPOM and other experts were currently formulating criteria for recipients of the AstraZeneca vaccine. The criteria may differ from the previous criteria used to determine the recipients of the Sinovac vaccine. One of the main considerations is the interval of 9 to 12 weeks between the first and the second injection of AstraZeneca vaccine.

While the AstraZeneca vaccine’s expiration date falls in late May, Nadia remains optimistic that the vaccine can be used optimally in Indonesia. As Indonesia aims to vaccine 250,000-300,000 people a day, the 1.1 million doses of AstraZeneca vaccine that Indonesia received could be used within a week.

Also read: Vaccine Development Must Meet Standard

A Health Ministry report on March 16 recorded that some 4.4 million Indonesians had received a first dose of a COVID-19 vaccine. Meanwhile, 1.7 million people had received a second dose. The government’s target is to vaccinate 181.5 million people in total.

Remaining cautious

In Gianyar, Bali, President Joko “Jokowi” Widodo urged all regional leaders to remain cautious and to encourage their constituents to continue following health protocols so that the spread of COVID-19 infections could be halted. Through the national COVID-19 vaccination program, it is hoped that herd immunity can be achieved.

Kompas/Heru Sri Kumoro

A medical officer injects the Covid-19 vaccine at the ulama and management of the Indonesian Ulema Council at the MUI Office, Jakarta, Wednesday (3/3/2021).

During a press conference, the Indonesian Ulema Council (MUI) said the government might carry out mass vaccination during Ramadan while taking the condition of Muslims who were fasting during the month into consideration. “Muslims are obliged to participate in the COVID-19 vaccination program in order to achieve herd immunity,” said Asrorun Niam Sholeh, head of the MUI’s fatwa commission.

Indonesia has detected another case of the B117 variant of the virus in Bogor, West Java. The patient had reportedly traveled to Ghana. In total, seven cases of B117 infection have been detected in Indonesia.

(This article was translated by Astria Z. Nabila).