The first coronavirus vaccine is to be used internationally within a few weeks. Health officials on both sides of the Atlantic are confident that vaccinations will start before the end of the year.
The UK is expected to be the first country to approve a vaccine jointly developed by Pfizer and BioNTech, with the goal of delivering the first bursts by December 7th.
US approval could be granted shortly after a consultation with the Food and Drug Administration on December 10th.
Anthony Fauci, director of the US National Institute on Allergies and Infectious Diseases, told NBC on Sunday, "We'll almost certainly vaccinate some of the first priority people before the end of December."
German officials said over the weekend that preparations had been made to ensure people could start vaccinating next month as soon as European regulators give the go-ahead.
"From today we expect that it [the Pfizer / BioNTech vaccine] will be approved by mid-December," said the German health minister Jens Spahn to Bayerischer Rundfunk.
The recommendation is based on the strength of scientific knowledge about the safety, quality and effectiveness of a vaccine and nothing else
The European Medicines Agency, which licenses medicines across the EU, is expected to consider next month whether to approve the Pfizer / BioNTech vaccine and a competitive candidate developed by Moderna, according to confidential documents from the Financial Times. Approval next month would pave the way for the bloc's 27 member states to start vaccinating before the end of the year.
However, there are many hurdles to overcome in the timeline, and failure at just one could push them back significantly, warned those familiar with the EMA process.
The UK will technically fall under the EMA's regulatory remit until January 1, when the Brexit transition period ends. However, the UK drug watchdog can break out of the EU regulatory cycle in the event of an urgent public health need under a 2012 regulatory change.
The EMA announced that it will announce when vaccine applications have been submitted and provide detailed timetables for the subsequent approval process.
Depending on how the evaluations progress, the agency could finalize its evaluation of the most advanced vaccine candidates later this year or early next year, it told the FT.
Regulators are faced with the difficult task of balancing the overwhelming public health need with the need to ensure confidence in the approval process, which has become a controversial health issue in some countries. Public reluctance to receive the vaccine could hamper attempts by medical authorities to contain the spread of the pandemic.
The EMA has been under pressure to speed up the process as the UK and US are likely to approve a vaccine sooner, according to people familiar with the agency's process.
In a statement, however, the EMA said it had "experienced no political pressure".
"The recommendation is based on the strength of science about the safety, quality and effectiveness of a vaccine and nothing else," it says. "Approval will be granted when the evidence convincingly shows that the benefits of vaccination outweigh any risks of the vaccine."
Around the world, frontline healthcare workers and vulnerable patients will come first for every available shot. The vaccine supply is unlikely to meet demand until next year. Any introduction of vaccinations would depend on the amount of product available, making a large-scale campaign unlikely by the end of next year.
Additional reporting from Hannah Kuchler in New York and Sebastian Payne in London