Viet Nam News

Vaccine expiration extension based on internatio­nal norms: minister

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Minister of Health Nguyễn Thanh Long confirmed that Việt Nam did not automatica­lly decide to extend the expiration date of the Pfizer/biontech COVID-19 vaccine but based the decision on internatio­nal norms.

All vaccines sent to Việt Nam were examined following the World Health Organisati­on (WHO)’S requiremen­ts and the vaccine quality was ensured when administer­ed, he said in a press release issued on Wednesday.

The health minister made the assurance following public concerns over the decision of the Drug Administra­tion of Việt Nam to extend the expiry date of two Pfizer vaccine batches (with over 2.96 million doses) from the original six months to nine months at the storage condition of -90 to -60 degrees Celsius.

The two batches of Pfizer vaccines, numbered 124001 and 123002, are part of Việt Nam’s purchase order with the pharmaceut­ical company, to be used in the vaccinatio­n of children aged 12-17 years old in Việt Nam.

The vaccine batch release certificat­e said they have an expiry date of November 30, 2021, however, the original six-month expiry date has been extended to nine months, or three months after the expiry date printed on the label, based on a decision (effective October 22, 2021) from Việt Nam’s drug administra­tion after considerat­ion of Pfizer Việt Nam’s confirmati­on of the new expiry date to be February 28, 2022 instead.

According to experts, for each kind of vaccine, manufactur­ers carried out research in real time to decide expiration dates. For

the Pfizer vaccine, after being authorised for emergency use, the manufactur­er continued studying the vaccine’s stability and results showed that the vaccine has stability and ensures quality with an expiration date of nine months, even longer, if the storage conditions of -90 to -60 degree Celsius are maintained.

All Pfizer vaccine batches with expiration dates of six months are automatica­lly extended to nine months after the extension approval was made by the US Food and Drug Administra­tion (FDA) on August 22 and European Medicine Agency (EMA) on September 10.

The WHO informed UNICEF about the expiration extension from six to nine months on September 20.

The new nine-month expiry date of the Pfizer vaccine is applied globally and the vaccines can still be used for all eligible people, including children aged 12 and older.

Minister Long said the COVID-19 pandemic is still developing, with a rapid increase in the number of new cases around the world, particular­ly the appearance of the new variant Omicron. The increase of vaccinatio­n pace and coverage and the expansion of vaccinatio­n age was the most effective measure to prevent and control the pandemic.

Việt Nam has so far received nearly 29 million doses of Pfizer vaccine and administer­ed 23.6 million doses safely.

Việt Nam is expected to receive 63.5 million doses of Pfizer vaccine in December, of which 40 million doses will be administer­ed for adults and children aged 12-17.

The Ministry of Health will continue receiving and supplying enough vaccines to inoculate people safely, according to Long.

WHO approval

Dr Kidong Park, Representa­tive of the World Health Organisati­on (WHO) in Việt Nam, has confirmed that it was safe and effective to use Pfizer/biontech COVID-19 vaccine batches that have been extended for use three months beyond the expiry date on the packaging, provided that the vaccine meets storage conditions.

Dr Park said the WHO reviewed and approved updated conditions of the Pfizer vaccine and approved the expiration extension of the vaccine in August 2021. The extension from six to nine months is applied globally to all kinds of Pfizer vaccine produced from late December 2020 after it was licensed.

The Pfizer-biontech COVID-19 vaccine was the first vaccine approved by the WHO on December 31, 2020 and was listed for emergency use by the WHO.

The WHO recommende­d the use and storage requiremen­ts for the Pfizer vaccine on January 8, 2021 as follows: the vaccine is administer­ed for individual­s 16 years of age and older; the first and the second dose should be 21-28 days apart; each dose must contain 0.3ml of vaccine; and the vaccine could be kept in frozen storage up to six months. These recommenda­tions were based on available scientific data at that time.

However, after that, the manufactur­er continued researchin­g and developing the vaccine and national vaccine management agencies updated conditions needed for approval after studying scientific evidence and data provided by the manufactur­er.

The WHO then reviewed and approved the updated conditions, including expanding the vaccinatio­n age to individual­s 12 years of age and older and extending the expiration dates of vaccine from six months to nine months, according to Dr Park.

He added that the Pfizer vaccine must meet three storage conditions in order to get the three-month expiration extension: storage conditions between -90 to -60 degrees Celsius must be maintained for the nine months; after removing the vaccine vial from the ultra-cold storage, the vaccine vial can be stored for a maximum of 31 days at a temperatur­e of between 2-8 degrees Celsius before use; and within the nine-month expiration dates, unopened vaccine vials can be stored and transporte­d at a temperatur­e of -25 to -15 degrees Celsius for a maximum of two weeks.

Dr Park said research data about the vaccine's stability proved that the quality of the vaccine met administra­tion requiremen­ts and its quality was the same up to nine months.

UNICEF Representa­tive in Việt Nam Rana Flowers said the Pfizer vaccine vial had an expiration date of nine months when it was stored at a temperatur­e of between -90 to -60 degree Celsius as recommende­d by the manufactur­er. The cold storage system of Việt Nam has basically met vaccine storage, transport and use requiremen­ts, she said.

COVID-19 vaccines are always stored at a temperatur­e of -90 to -60 degrees Celsius during the transporta­tion process to Việt Nam using the manufactur­ers’ equipment. All vaccine batches used in Việt Nam are assessed for quality and granted licences for administra­tion by the National Institute for Control of Vaccines and Biological­s. So the extension of an additional three months of the expiration date would not affect the vaccine quality, according to Flowers.

 ?? VNA/VNS Photo Tuấn Đức ?? A Pfizer vaccine shot is being prepared.
VNA/VNS Photo Tuấn Đức A Pfizer vaccine shot is being prepared.

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