As vaccinations begin elsewhere - and with Europeans eager to get started - the European Medicines Agency (EMA) on Tuesday said it will try to pull forward its decision on the Pfizer/BioNTech coronavirus vaccine to 21 December.
Previously, the EMA had set 29 December as its deadline. According to a release, it now hopes to be able to conclude its consideration by 21 December, but left open the possibility that the decision might not come until the later date.
"The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation," read the statement.
It noted that its human medicines committee had received new information from Pfizer and BioNTech on Monday, which it now hopes to evaluate in the next week.
"EMA's human medicines committee (CHMP) and its experts have been working intensively over the past weeks," it noted.
"The CHMP will conclude its assessment at the earliest possible time point and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks."
The European Commission would have to give final approval to any EMA recommendation, though that is generally considered a formality.
Last month's announcement by the two firms that they had developed a vaccine for the coronavirus with an effectiveness rate of around 95% buoyed hopes that some form of normal might soon return to the world after months of lockdowns and hygiene restrictions, even as hundreds of thousands died worldwide.
But, although the vaccine was partially developed in Germany, it has not been approved for use within the EU, even as it has been rolled out in countries such as Britain, Canada and the US.
Frustration in Europe
That has prompted some frustration in Europe. German Health Minister Jens Spahn told media on Tuesday that he expected an EMA decision by 23 December.
He was not the only one.
"My hope is that the EMA, in compliance with all safety procedures, will be able to approve the Pfizer/BioNTech vaccine earlier than expected and that vaccinations can also begin in European Union countries as soon as possible," Italian Health Minister Roberto Speranza said on Tuesday, before the EMA announcement.
Despite the comparatively slow approval process - albeit for a disease most scientists had never even heard of a year ago - many European countries have already secured doses of the vaccine and are laying down vaccination protocols.
Two other vaccines, one from US firm Moderna, the other by Oxford University and AstraZeneca, are still being reviewed. The Moderna and Pfizer/BioNTech vaccines rely on a new virus-fighting approach, drawing on the virus' genetic code to train the body's immune system to create antibodies against it.
But they also require new and special handling. The Pfizer/BioNTech version, for example, requires extreme refrigeration. Some people have also displayed allergic reactions.
The Oxford/AstraZeneca relies on more traditional anti-virus treatments, but seems to have a lower rate of effectiveness, around 70%.
