EU awaits watchdog decision on coronavirus vaccine

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La Haye (AFP)

The European medicines regulator will decide on Monday whether or not to authorize the Pfizer-BioNTech coronavirus vaccine, with desperate countries hoping the green light will finally begin to vaccinate their citizens.

The Amsterdam-based European Medicines Agency drastically brought the decision forward immediately from December 29, following pressure to speed up the process from Germany and other EU states.

Demand for action has grown as Britain and the US have already started giving their citizens the vaccine developed by US giant Pfizer and German company BioNTech under national emergency rules .

The EU will start Covid-19 inoculations on December 27 provided the EMA grants a one-year conditional marketing authorization, the European Commission has said.

The regulator said it had been working around the clock to speed things up, but needed to make sure the Pfizer-BioNTech vaccine was safe and effective, to avoid any doubts that could affect its adoption.

“We have been able to revise the Covid-19 vaccine assessment schedules thanks to the incredible efforts of everyone involved in these assessments,” EMA chief Emer Cooke said last week.

“The number of infections is increasing across Europe and we recognize the enormous responsibility we have to bring a vaccine to market as quickly as possible, while maintaining the robustness of our scientific journal. ”

The EMA said that if a decision is not possible at Monday’s meeting, it will hold another meeting on the initial date of December 29 to rethink.

A decision on another vaccine produced by the American company Moderna is expected on January 6.

– German pressure –

The Pfizer-BioNTech vaccine has been shown to be 95% effective in global trials where two doses are injected three weeks apart.

It must be stored at -70 degrees Celsius (-94 degrees Fahrenheit), a temperature much lower than that of standard freezers and which has forced the company to develop special containers for transportation.

The EMA has been carrying out a so-called “continuous review” of the vaccine in recent months involving large-scale laboratory and human trials, speeding up a process that normally takes years.

The regulator can grant drugs conditional marketing authorization for the EU in the event of a public health emergency. It then performs further tests to make sure there aren’t any issues down the line.

The EMA had originally announced that it would decide at a meeting of drug experts to be held no later than December 29.

But Britain – the pre-Brexit homeland of the EMA until last year – the United States and Canada meanwhile imposed an emergency clearance, which allowed them to start vaccinating more. early.

EU leaders complained at an EU summit earlier in December, and Germany then weighed in last week.

Hours later, the EMA announced that it had received new data from Pfizer-BioNTech and would make its decision on December 21 instead.

Meanwhile, the EMA also faced a cyberattack in which data from the Pfizer-BioNTech and Moderna vaccines was stolen.

If the EMA gives the green light on Monday, the European Commission will call it automatically within days so that vaccinations can start on December 27 in the bloc of 450 million people.

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