CIKARANG, WARTA-APOTEKER.com, Pusat Pengendalian dan Pencegahan Penyakit Amerika Serikat (CDC) pada 30 Agustus 2021, memberikan informasi tambahan dan kejelasan tentang perpanjangan kedaluwarsa vaksin Pfizer-BioNTech COVID-19. Pembaruan ini termasuk skenario bermanfaat yang kemungkinan akan kita temui pada praktik spesifik tentang Beyond Use Date. The FDA has approved an amendment to the EUA for Pfizer-BioNTech extending the expiration dates of COVID-19 Vaccine from six to nine months. Sementara di tanah air pada 1 April 2021, BPOM sendiri pernah mengeluarkan penjelasan tentang batas kedaluwarsa Vaksin COVID-19.
Juru Bicara Satuan Tugas (Satgas) Penanganan Covid-19, Wiku Adisasmito mengatakan pemerintah memutuskan untuk memperpanjang masa kedaluwarsa 18 juta vaksin Covid-19. 18 juta vaksin itu merupakan stok vaksin yang seharusnya disuntikkan pada Februari 2022.
“Di bulan Februari lalu sekitar 4 juta dosis berhasil digunakan sebelum mencapai tenggat kedaluwarsa. Sementara, sisa dosis yang belum disuntikkan berhasil diurus perpanjangan kedaluwarsanya,” kata Wiku secara daring dikutip Jumat (11/3).
Indonesia has extended the shelf life of AstraZeneca’s (AZN.L) COVID-19 vaccine to nine months, as nearly six million doses it received in donations approached their expiration dates, a health ministry spokesperson told Reuters on Tuesday. Siti Nadia Tarmizi, a health ministry spokesperson, told Reuters it had six million doses of vaccines set to expire at the end of February, but only 200,000 of them had expired after it extended the shelf life of the AstraZeneca shot to nine months from six.
RESPON ANGGOTA KOMISI IX DPR RI
Anggota Komisi IX DPR RI Rahmad Handoyo merespon kebijakan pemerintah memperpanjang masa kedaluwarsa 18 juta dosis vaksin Covid-19. Dia mengatakan perpanjangan masa kedaluwarsa vaksin itu bisa dipahami selama telah melakukan penelitian melibatkan ahli.
Politikus PDIP itu juga menyinggung soal penelitian tentang kemungkinan risiko yang mungkin ditimbulkan. “Kalau masih diterima dalam ambang batas kesehatan, tidak ada masalah,” kata Rahmad Handoyo kepada wartawan, Jumat (11/3). Dia menegaskan pemerintah juga harus memperhatikan risiko yang menyangkut tubuh penerima vaksin itu.
VAKSIN COVID-19 YANG DIPERPANJANG MASA KEDALUWARSA
Berdasarkan penelusuran WARTA-APOTEKER.com, beberapa vaksin yang mengalami perpanjangan masa kedaluwarsa dan beredar di dunia, tidak semuanya beredar di Indonesia.
The Pfizer-BioNTech COMIRNATY vaccine originally had a 6 month shelf life. That was extended by 3 months, to 9 months on 22 August 2021.
On 16 December 2021, the US FDA also extended shelf life for the COMIRNATY vaccine that uses the Tris buffer to 9 months.
So all existing vaccine doses can be used for an additional 3 months beyond their printed expiry dates, as long as they are stored between -90ºC to -60ºC.
The Moderna COVID-19 vaccine originally had a 7 month shelf life.
On 23 December 2021, both UK MHRA and Health Canada extended its shelf life by 2 months, to 9 months, as long as it is stored between -25ºC to -15ºC.
The US FDA also extended the shelf life of certain lots by 2 months, to 9 months, as long as they are stored between -50ºC to -15ºC.
J&J Janssen COVID-19 Vaccine
The Janssen COVID-19 vaccine from Johnson & Johnson originally has a 3 month (90-day) shelf life.
The US FDA extended its shelf life to 4.5 months (135 days) on 10 June 2021, and then 6 months (180 days) on 28 July 2021.
All existing vaccine doses can now be used for an additional 1.5 to 3 months (45 to 60 days) beyond their printed expiry dates, as long as they are stored at 2-8ºC.
In May 2021, Health Canada extended the shelf life of about 45,000 AstraZeneca doses by a month, following review of stability data.
It allowed the use of doses with an original expiry date of 31 May 2021, until 1 July 2021.
Otherwise, all AstraZeneca vaccine doses remain with their original shelf life of six months.
The CoronaVac inactivated virus vaccine from Sinovac originally had a 6-month shelf life, which was later extended to 12 months, when it was approved by the WHO.
However, Sinovac appears to give the CoronaVac different shelf lives depending on who’s purchasing their vaccine – 1 year in Malaysia, 2 years in Singapore, and 3 years in Indonesia and Thailand.
The Sinopharm BIBP vaccine has a 24-month shelf life, as registered with the WHO. With such a long shelf life, there is no real need for an extension.
The CanSino Convidecia vaccine has a 24-month shelf life, and remains stable for 60 days at room temperature.
With such a long shelf life, there is no real need for an extension.
Covishield is a rebranded AstraZeneca vaccine manufactured by the Serum Institute of India, and has the same original 6 month shelf life.
In March 2021, the Drugs Controller General of India (DCGI) extended its shelf life by 3 additional months, to 9 months.
Covaxin originally had a shelf life of 6 months, but that was extended to 12 months by the Indian Central Drugs Standard Control Organisation on 3 November 2021.
All existing vaccine doses can now be used for an additional 6 months beyond their printed expiry dates, as long as they are stored at 2-8ºC.
The Russian vaccine – Sputnik V originally had an incredibly short 2-month shelf life at -18ºC.
The Russian Healthcare Ministry then allowed it to be stored for 2 months at 2-8ºC, before later extending it to 6 months when stored at -18ºC to -22ºC.