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EU reviews Pfizer Covid pill for emergency use

The move would allow the European Medicines Agency to advise countries that wanted to use the US pharma giant's promising antiviral treatment ahead of formal approval across the EU.

November 19, 2021 / 21:05 IST
Reuters

The EU's drug watchdog on Friday started reviewing Pfizer's Covid pill for emergency use by member states as Europe grappled for ways to tackle a sudden spike in coronavirus cases.

The move would allow the European Medicines Agency to advise countries that wanted to use the US pharma giant's promising antiviral treatment ahead of formal approval across the EU.

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"EMA is reviewing currently available data on the use of Paxlovid, an oral treatment for Covid-19 developed by Pfizer," the Amsterdam-based European Medicines Agency (EMA) said.

"EMA is starting this review to support national authorities who may decide on its early use for Covid-19, for example in emergency use settings, prior to marketing authorisation," it said.

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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A full "rolling review" for formal approval is expected to start next week but the EMA said it wanted to be able to help national authorities "in the shortest possible timeframe".

AFP
first published: Nov 19, 2021 09:05 pm

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