Shelf life of Covid-19 vaccine may be extended up to 12-24 months
Pfizer is continuing its research and if it finds the vaccine quality to be stable, it may submit dossiers to appropriate agencies to apply for a shelf-life extension to 12, 18 or even 24 months.
Deputy Minister of Health Tran Van Thuan
At a Government press conference on December 2, 2021, VietNamNet raised a question about the extension of the shelf life of the two Pfizer vaccine batches to nine months.
“The Ministry of Health (MOH) explained that on September 30, 2021, the Advisory Council for the Grant of Drug Registration Numbers approved the extension of the shelf life of Pfizer vaccine to nine from the previous six months. However, people cannot understand why MOH announced the expiry date extension some days ago, when the two batches of vaccines were near the expiry date. And when announcing the extension, MOH did not give detailed explanations. Only when newspapers began reporting the public’s complaints about this did the ministry raise its voice explaining the extension. Could you please tell us if there are any other countries which have also extended the expiry dates as Vietnam has done?”
In reply, MOH Deputy Minister Tran Van Thuan said the expiry date extension has been applied everywhere to Pfizer vaccines used for people aged 12 and above, not only in Vietnam.
The decision about the extension was made after the manufacturer proved that vaccine quality remains stable and unchanged when the shelf life is extended. The vaccines produced at the time when FDA (Food and Drug Administration) and EMA (European Medicines Agency) gave authorization had shelf life of six months and they will be automatically extended to nine months.
Thuan said that other countries have not changed the labels with expiry dates and they have only made private announcements about the extension of the shelf life.
The manufacturer is continuing its research and if it finds that the quality of vaccines is stable, it may ask for permission to extend the shelf life to 12, 18 or even 24 months.
Thuan quoted Kidong Park, Chief Representative of World Health Organization (WHO) in Vietnam, as saying that the Pfizer vaccine was the first vaccine approved by WHO on December 31, 2020 for emergency use.
On January 8, WHO gave recommendations about the use and required preservation of Pfizer vaccines. The manufacturer then continued to conduct research on the vaccine and develop it. National vaccine administration agencies updated approval conditions after thoroughly considering new proofs and scientific data provided by the manufacturer, including the extension for immunization to people aged 12 and above; and extension of the shelf life to nine months.
All the batches of vaccines are inspected by the National Institute for Control of Vaccine and Biologicals before use in Vietnam. The extension of the expiry date by three months absolutely doesn’t affect the quality of vaccines,”
Deputy Minister of Health Tran Van Thuan
In August, WHO approved the updated approval conditions, including the extension of the shelf life to nine months applied to all Pfizer vaccines, including ones produced before August 2021.
During the transport of vaccines from the manufacturer to Vietnam, the vaccines are stored at minus 90 degrees C to minus 60 degrees C in specialized equipment from the manufacturer. This kind of vaccine can be preserved at 2-8 degrees C for one month at maximum.
“All the batches of vaccines are inspected by the National Institute for Control of Vaccine and Biologicals before use in Vietnam. The extension of the expiry date by three months absolutely doesn’t affect the quality of vaccines,” Thuan said.
He repeated Minister of Health Nguyen Thanh Long’s statement, stressing that the expiry date extension in Vietnam is implemented in accordance with international practice, and that Vietnam has not done this independently. All vaccines are inspected as per WHO request to ensure their quality before use.
When asked about pandemic developments and the measures taken to reduce the death rate, Thuan said the number of infections and deaths are on the rise. Most of the deaths are people aged over 50.
MOH has applied measures to cope with the problem, including the re-activation of centers giving support from a distance and the establishment of a center for surveillance of deaths and their causes. The ministry has asked experts to coordinate the treatment so that appropriate treatment is given to patients. Vietnam is applying a three-level treatment model, with the third level reserved for severe cases.
“If patients are taken to the third level too soon, this will cause overloading, and if too late, this will lead to a higher risk of death. Therefore, it’s necessary to give suitable treatment level in accordance with MOH’s instructions on patient classification,” Huan explained.
Vietnam has given 125 million immunization doses to people aged 18 and over, and children aged 12 and above. At least 94 percent of people aged 18 and over have received the first jab and nearly 80 percent have had two. In many cities and provinces, 80-90 percent of people aged 18 and over have been fully vaccinated.
Regarding booster shots, Thuan said Vietnam will have enough vaccines for booster shots. The country is expected to have 200 million doses by the end of the year under signed contracts.
The news about one more death in Binh Phuoc after a Covid-19 vaccination and the extension of expiry dates for two batches of Pfizer vaccines has caused concern among Hanoi parents.
The Hanoi Department of Health confirmed on December 1 that it has suspended COVID-19 vaccinations for two batches of shelf-life Pfizer vaccines that had already expired on November 30 for consultations.