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Pfizer-BioNTech COVID-19 vaccines can be stored in fridge for 31 days, says EMA

The Pfizer-BioNTech COVID-19 vaccine's storage time at normal fridge temperatures was extended by the European Medicines Agency (EMA) to 31 days from five days, easing logistical challenges during rollouts in the region.

May 18, 2021 / 08:17 AM IST
Pfizer’s vaccine is based on genetic material or mRNA.

Pfizer’s vaccine is based on genetic material or mRNA.

Europe's drug regulator on May 17 recommended extending the storage time for the Pfizer-BioNTech (PFE.N), (22UAy.DE) COVID-19 vaccine at normal fridge temperatures to 31 days from five days, easing logistical challenges during rollouts in the region.

The change is applicable to unopened vials, the European Medicines Agency (EMA) said, adding that the advice by its human medicines committee came after assessing additional stability study data submitted by Pfizer and BioNTech.

“EMA is in continuous dialogue with the marketing authorisation holders of COVID-19 vaccines as they seek to make manufacturing improvements to enhance vaccine distribution in the EU,” the watchdog said.

The European Union has allowed for ramped-up production of the Pfizer-BioNTech vaccine in the region and is eyeing a new deal to secure more doses of the shot after the bloc was hit by cuts in the supply of AstraZeneca's (AZN.L) vaccine.

Vaccine deliveries were also slower initially under the EU's centralised procurement strategy.

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COVID-19 Vaccine

Frequently Asked Questions

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How does a vaccine work?

A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.

How many types of vaccines are there?

There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.

What does it take to develop a vaccine of this kind?

Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.

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US authorities in February had approved storage and transport of the Pfizer-BioNTech vaccine at standard freezer temperatures of -15 to -25 degrees Celsius for up to two weeks instead of the ultra-cold temperatures between -80 to -60 degrees Celsius it usually requires.

The EU storage change also comes as the United States and German drugmakers are seeking approval of the vaccine for inoculating adolescents aged 12 to 15 years. The United States and Canada have started vaccinating this group with the shot, which uses the brand name Comirnaty.

The two-dose vaccine, similar to the one developed by Moderna (MRNA.O), uses new mRNA technology to deliver instructions to the human body to build immunity against COVID-19.

With 200 million vaccine doses delivered overall, the EU is on track to achieve its goal of inoculating 70 percent of its adult population by summer, European Commission President Ursula von der Leyen tweeted on May 9.
Reuters

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