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The EU says it will start Covid-19 inoculations on December 27 as long as the EMA grants a one-year conditional marketing authorization.
THE HAGUE – The EU drug regulator authorized the Pfizer-BioNTech coronavirus vaccine on Monday, saying there was no evidence that it would not work against a new strain found primarily in Britain.
The European Medicines Agency said the “historic” step paved the way for vaccines to finally start in a few days in the 27 EU countries where cases of the disease are increasing.
The Amsterdam-based regulator advanced the decision from December 29 under pressure from EU governments, after Britain and the United States gave the green light weeks earlier.
“It is a significant step forward in the fight against this pandemic that is causing suffering and hardship,” EMA Director Emer Cooke said at an online press conference announcing the decision.
“This is really a historic scientific achievement, in less than a year a vaccine against this disease will have been developed and licensed.”
The EMA approved a one-year “conditional marketing authorization” for the vaccine developed by US giant Pfizer and German company BioNTech, and the European Commission set out to formally approve it within hours.
“This is a watershed moment in our efforts to provide safe and effective vaccines to Europeans!” The head of the European Commission, Ursula von der Leyen, said on Twitter.
“Now we will act fast. I await a decision from the European Commission by tonight.”
The EU has said it will begin coordinated Covid-19 inoculations on December 27.
– ‘New variant’ –
The urgency surrounding the virus has heightened with news that a rapidly spreading variant is sweeping Britain, prompting a growing number of countries around the world to suspend flights from the UK.
Cooke said it looked like the Pfizer-BioNTech jab would work against the new strain.
“At this time there is no evidence to suggest that this vaccine will not work against the new variant,” he added.
The EMA has been under enormous pressure to speed up the process, and German-led governments are wondering why Britain and the United States were able to authorize the vaccine earlier.
He said the delay was because a conditional marketing authorization is more comprehensive and lasts longer than the emergency authorization used by London and Washington.
Cooke said the agency had “worked 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 uptake.
The decision on another vaccine produced by the American firm Moderna is scheduled for January 6.
The Pfizer-BioNTech vaccine has been shown to be 95 percent effective in global trials in which two doses are injected three weeks apart.
It must be stored at -70 degrees Celsius (-94 degrees Fahrenheit), a temperature much lower than standard freezers and one that forced the company to develop special shipping containers.
The EMA has been conducting a so-called “continuous review” of the vaccine, including laboratory tests and large-scale human trials for the past few months, speeding up a process that normally takes years.
The regulator can grant medicines a conditional marketing authorization for the EU in public health emergencies. Then follow up with more tests to make sure there are no problems in the future.
Meanwhile, the EMA has also had to deal with a cyber attack in which data was stolen from the Pfizer-BioNTech and Moderna vaccines.
