The EU Medicines Agency will decide on Monday whether the Pfizer BioNTech coronavirus vaccine should be approved. Desperate countries are hoping that the green light will come to vaccinate their citizens.
The Amsterdam-based European Medicines Agency dramatically pushed the decision on the sting from December 29, after Germany and other EU countries exerted pressure to speed up the process.
The demand for action grew as Britain and the United States began giving their citizens the vaccine that US giant Pfizer and German company BioNTech had developed under national emergency rules.
The EU will start vaccinations against Covid-19 on December 27, provided the EMA grants a one-year conditional marketing authorization, according to the European Commission.
The regulator said it worked around the clock to speed things up but needs to make sure the Pfizer BioNTech vaccine is safe and effective to avoid doubts that could affect uptake.
“We were able to revise the schedules for the Covid-19 vaccine evaluation due to the incredible efforts of everyone involved in these evaluations,” said EMA chief Emer Cooke last week.
“Infections are increasing across Europe and we recognize the great responsibility of getting a vaccine to market as quickly as possible while maintaining the robustness of our scientific review.”
The EMA said if a decision is not possible at Monday’s meeting, it will hold another meeting on the original December 29 to reconsider.
A decision on another vaccine from the US company Moderna is due by January 6th.
The Pfizer BioNTech vaccine has been shown to be 95 percent effective in global studies that inject two doses three weeks apart.
It has to be stored at -70 degrees Celsius, a temperature much lower than standard freezers and which has forced the company to develop special containers for transportation.
The EMA has been conducting what is known as an “rolling review” of the vaccine over the past few months, which includes laboratory tests and large-scale human trials to speed up a process that typically takes years.
The regulator can give medicines conditional approval to be placed on the EU market in public health emergencies. Further tests are then carried out to ensure that there are no problems later.
The EMA had originally announced that it would take a decision at a meeting of drug experts on December 29 at the latest.
But Britain – the pre-Brexit home of the EMA until last year – the United States and Canada have now enforced an emergency permit, which meant they could start vaccinating earlier.
The heads of state and government of the EU complained at an EU summit in early December, and Germany then weighed it last week.
Hours later, the EMA announced that it had received new data from Pfizer-BioNTech and would instead make its decision on December 21.
Meanwhile, the EMA also had to deal with a cyber attack in which data from the Pfizer-BioNTech and Moderna vaccines were stolen.
If the EMA gives the green light on Monday, the European Commission will stamp it within a few days so that vaccinations can start on December 27 in a block of 450 million people.