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The first coronavirus vaccine is on track for international rollout in a few weeks, and health officials on both sides of the Atlantic are confident that inoculations will begin before the end of the year.
The UK is expected to become the first country to approve a vaccine jointly developed by Pfizer and BioNTech, aiming to kick-start as early as December 7.
US approval could be granted shortly after a Food and Drug Administration advisory meeting on Dec. 10.
Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, told NBC on Sunday: “It is likely, almost certainly, that we will vaccinate a portion of the people on the first priority before the end of December. “.
German officials said over the weekend that preparations had been made to ensure that people could start receiving vaccines next month, once European regulators give the green light.
“From today we are waiting for you [the Pfizer/BioNTech vaccine] to be approved in mid-December, ”Jens Spahn, Germany’s health minister, told Bavarian radio.
The European Medicines Agency, which licenses medicines across the EU, is scheduled to consider next month whether to approve the Pfizer / BioNTech vaccine and a rival candidate developed by Moderna, according to confidential documents seen by the Financial Times. Approval next month would pave the way for the bloc’s 27 member states to start vaccines before the end of the year.
However, there are many hurdles to cross on the timeline and failure in just one could significantly delay it, people with knowledge of the EMA process have warned.
The UK is technically within the regulatory purview of the EMA until January 1, when the Brexit transition period ends. However, the UK drug watchdog may break out of the EU regulatory orbit in the event of an urgent public health need under a 2012 regulatory change.
The EMA said it would announce when the vaccine authorization requests were submitted and provide detailed timetables for the approval process thereafter.
Depending on how the evaluations progress, the agency could complete its evaluation of the more advanced vaccine candidates by the end of this year or early next, he told the FT.
Regulators face the difficult task of balancing the overwhelming need for public health with the imperative of ensuring trust in the approval process, which has become a contentious health issue in some countries. Public hesitancy to receive the vaccine could hamper attempts by medical authorities to stop the spread of the pandemic.
The EMA has been under pressure to speed up the process because the UK and US are likely to approve a vaccine sooner, people familiar with the agency’s process said.
But in a statement, the EMA said it “had not experienced political pressure.”
“The recommendation will be based on the strength of scientific evidence about the safety, quality and efficacy of a vaccine, and nothing else,” he said. “Authorization will be granted when the evidence convincingly shows that the benefits of the vaccination outweigh the risks of the vaccine.”
Around the world, frontline healthcare workers and vulnerable patients will be first in line for any available vaccine, and the vaccine supply is expected to meet demand only by the end of next year. Any implementation of the vaccines would depend on the amount of product available, the people said, making large-scale campaigns unlikely until the end of next year.
Additional reporting by Hannah Kuchler in New York and Sebastian Payne in London
