Day: April 6, 2022

The extension of the shelf life of COVID-19 vaccines has been carried out based on data from the results of vaccine stability tests by manufacturers holding emergency-use permits.

Head of the Food and Drug Supervisory Agency (BPOM), Penny K. Lukito, delivered the statement during a hearing meeting with Commission IX of the House of Representatives (DPR) on Wednesday.

“Pharmaceutical companies will provide data for the extension of the use of vaccines because the companies continue to test the stability of their products,” Lukito said.

The vaccine shelf life is the period of time during which a vaccine still meets the specifications and requirements for use. The shelf life of a vaccine is determined based on the results of product stability testing.

Meanwhile, the expiration period, which is usually shown on the vaccine packaging, indicates that the vaccine is still stable and meets the quality requirements specified under the storage conditions listed on the package.

“BPOM has determined the shelf life of vaccines according to international standards, which is based on real-time stability data on a commercial scale,” Lukito informed.

The process of determining the vaccine shelf life and its extension is being carried out according to the ASEAN Variation Guideline For Pharmaceutical Products and European, Australian, and World Health Organization (WHO) pharmaceutical product standards, she said.

The process of extending vaccine shelf life includes the submission of new data on the results of long-term stability tests conducted by vaccine manufacturers, she added.

“The determination of the extension of the vaccine expiration date is in accordance with the stability data with the results that meet the requirements,” she said.

The extension permit is given per facility but for the same vaccine brand, she revealed. Based on the stability test data, BPOM inspects production facilities and evaluates the extension of the expiration time.

Vaccine shelf life extension is commonly undertaken in several countries based on the latest data from stability test results submitted by pharmaceutical companies holding permits for emergency use or vaccine distribution permits, Lukito said.

Pharmaceutical companies holding permits for emergency vaccines are responsible for monitoring the shelf life of COVID-19 vaccines and relabeling the vaccine packaging that was circulated before the shelf life extension, she explained.

In Indonesia, COVID-19 vaccine products that have received approval for shelf life extension of 12 months include the vaccine made by Bio Farma, a vaccine made by Sinopharm in one-dose prefilled syringe packaging, and the one-dose CoronaVac vial.

They further include COVID-19 vaccines made by AstraZeneca, which are being produced by Catalent Anagni SRL, Italy, and Pfizer-BioNTech COVID 19 Vaccine (Comirnaty) produced at Pfizer Manufacturing Belgium, Puurs, Baxter, whose shelf life has been extended by nine months, and the COVID-19 vaccine of Sinopharm, packaged in two doses, with an extended shelf life of 11 months.

Source: Antara News

Around 1.53 million doses of COVID-19 vaccines potentially hit their expiration date in April this year, according to state-owned vaccine manufacturer PT Bio Farma (Persero).

During a virtual COVID-19 Vaccine Work Committee Meeting on Wednesday, Bio Farma president director Honesti Basyir informed that the potentially expired COVID-19 vaccines comprise 1.095 million AstraZeneca doses and 436,730 Moderna doses.

Meanwhile, the number of COVID-19 vaccines that reached their expiration date as of March 25, 2022, stood at 19.32 million doses, he added.

The vaccines comprised 18.68 million doses obtained through the GAVI scheme or donations and 0.64 million doses obtained through the B2B (business-to-business) procurement scheme, he said.

There are four aspects that must be examined to ensure that the quality of COVID-19 vaccines meets the applicable standards, he noted.

These four aspects are determined by quality, safety, efficacy, and stability trials.

“This is what we do as the license holder of COVID-19 vaccines,” Basyir remarked.

During the event, head of the National Agency of Drug and Food Control (BPOM), Penny K. Lukito, said that a vaccine’s expiration limit is part of the safety, benefit, and quality guarantees.

These guarantees are determined based on vaccine trial data, in accordance with the specified standards.

The minimum trial data requirement for medicines and vaccines’ emergency-use authorization (EUA) is three months, she added.

BPOM evaluates the quality and stability trial result data that encompasses identification, potential, sterility, and particulate parameters.

“If it remains stable for more than three months, there is a possibility that it can receive shelf life extension,” she informed.

BPOM determines the shelf life of vaccines in accordance with the international standards, namely based on commercial-scale real-time stability data, she added.

Source: Antara News

As many as 25.2 million Indonesian citizens have received the third or booster dose of the COVID-19 vaccine as of Wednesday, the COVID-19 Handling Task Force reported.

According to data from the task force, accessed by ANTARA here on Wednesday, the number of booster dose recipients rose by 1,250,477 on Wednesday, taking the total number of people who have received the booster to 25,296,816.

For the second dose vaccinations, the number of recipients increased by 634,177 to reach 160,741,389 on Wednesday, the task force’s data revealed.

An increase was also recorded in the number of first dose recipients. Based on the data, the number of people who have received the first shot swelled by 227,752 to 197,107,907 as of Wednesday.

As part of efforts to boost community immunity against COVID-19, the Indonesian government launched a nationwide vaccination program on January 13, 2021, targeting as many as 208,265,720 citizens across the country.

Earlier, the COVID-19 Handling Task Force had reminded people seeking to join the 2022 Eid homecoming exodus to get the booster dose as soon as possible to maintain public health and safety.

“Whoever who has not received the booster (dose), immediately get the booster. Whoever who has not completed (the primary) vaccination, immediately complete it to receive the booster,” spokesperson for the COVID-19 handling task force, Wiku Adisasmito, said.

The government will not ban people from joining the exodus, but they must get the booster shot first, he added.

They must also make sure that the relatives whom they visit have completed primary vaccinations and have received a booster shot.

The first case of COVID-19 was confirmed in Indonesia in March 2020. According to data from the COVID-19 Handling Task Force, as of April 6, 2022, Indonesia has recorded a total of 6,026,324 COVID-19 cases, 5,788,714 recoveries, and 155,464 deaths.

Source: Antara News

President Joko Widodo (Jokowi) has declared April 29 and May 4, 5, 6, 2022, as collective leave days for the Eid al-Fitr period, which will fall on May 2–3.

“The government has decided that Eid al-Fitr 1443 H days will be on May 2–3, 2022, and collective leave days for the Eid al-Fitr period will be on April 29, and May 4, 5, 6, 2022,” the President said in an online press statement, issued from the Bogor Palace, West Java, on Wednesday.

A detailed regulation on collective leave will be issued by the relevant ministries, he added.

He said that residents can utilize the collective leave period to go home and meet parents, families, and relatives in their hometowns.

The President also reminded residents that the COVID-19 pandemic is not over yet and asked them to remain vigilant against COVID-19 by maintaining discipline in following the health protocols.

“We need to remain vigilant (against COVID-19). Take your COVID-19 booster vaccine right away, remain disciplined in observing the health protocols, and continue wearing masks in public places and while in crowds,” Widodo said.

The government has projected that up to 85 million residents will leave for their hometowns during the Eid al-Fitr homecoming period on the collective leave days, and 47 percent of all trips will be undertaken using private vehicles, he noted.

Up to 14 million residents are also projected to leave the Greater Jakarta area, the President added.

“The government will exert their effort in providing optimized services to ensure travelers can travel safely and comfortably (during the homecoming period),” he said.

Earlier, the government had announced that a booster vaccine will be required for homecoming trips during Eid al-Fitr, with residents who have received the vaccine booster free to travel without COVID-19 test certificates.

“Those who have received their COVID-19 booster vaccine are free to travel without further COVID-19 testing,” Health Minister Budi Gunadi Sadikin said.

Residents who have received only their first vaccine dose will be required to provide a COVID-19 PCR test certificate obtained at least three days before travel, while residents who have received their second vaccine dose will need to provide the results of either a COVID-19 PCR test or a COVID-19 antigen test performed one day before travel.

Source: Antara News

People’s Consultative Assembly (MPR) Deputy Speaker Lestari Moerdijat has urged the government and all elements of society to cooperate in handling the issue of fulfilling children’s nutrition and preventing stunting to realize Golden Indonesia 2045.

“We plan to produce smart generations to realize Golden Indonesia 2045, but the basic problem of fulfilling children’s nutrition has not been resolved,” she noted in a statement issued on Wednesday.

“There must be consistent and measured efforts to handle nutritional adequacy for the nation’s future generation,” she said during an online discussion on ‘Anticipating Lost Generation due to Stunting,’ held by Denpasar Discussion Forum 12.

Preparing the nation’s resilient future generation through resolving the problem of nutrition and stunting must be consistent and measured. A collective effort has to be made to realize it, she said.

Data from the National Population and Family Planning Agency (BKKBN) shows that currently, Indonesia has a high stunting prevalence of 24.4 percent.

This means that one out of four children in the nation experience stunting, and the figure is above the threshold set by the World Health Organization (WHO), which is below 20 percent.

“With this condition, we must prepare the younger generations so that they are capable of managing this nation well in the future,” Moerdijat remarked.

Thus, the target to reduce stunting cannot be achieved just by setting numbers. It has to be realized through several steps, she opined.

“The problem of stunting is not just about health, but more than that: it affects the nation’s resilience. How can future generations that lack nutrition maintain this nation’s sovereignty?” she asked.

The involvement of all parties is necessary to immediately handle the problem of stunting within the nation, she remarked.

“Especially since our Constitution has determined that the purpose of the nation is to protect every Indonesian, advance general prosperity, and to make the people smart,” she highlighted.

Source: Antara News