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EU Drugs Regulator Recommends Authorizing Pfizer/BioNTech Covid-19 Vaccine

Strategic Insights

— 2 min read

The European Medicines Agency (EMA) has granted the Pfizer/BioNTech Covid-19 vaccine a conditional marketing authorization, clearing the way for the first phase of the European Union's mass vaccination program to begin later this week. This decision comes after the European Commission President, Ursula von der Leyen, emphasized the need for swift action, stating that the EU will act fast and expecting a final approval decision by the evening of the same day.

Key Takeaways:

  • The European Medicines Agency (EMA) has recommended authorizing the Pfizer/BioNTech Covid-19 vaccine for use in the European Union, paving the way for the first phase of the bloc's mass vaccination program.
  • The vaccine has been granted a conditional marketing authorization, which is a type of approval that allows the drug to be distributed while further studies are conducted to confirm its safety and efficacy.
  • The European Commission must give its final approval for the vaccine to be rolled out across the EU, which is expected to happen later on Monday.
  • The EU has secured over 2 billion doses of potential vaccines, including 300 million doses of the Pfizer/BioNTech vaccine, which is enough to vaccinate 150 million of the EU's 448 million citizens.
  • Member states will have to buy the vaccines on their own, as the agreement serves as a down-payment, and will have to determine how to distribute the vaccine to their citizens, with guidance from the EU on prioritizing the elderly, healthcare workers, and vulnerable populations.
  • Eight countries in the EU have coordinated their strategies around the rollout, including Belgium, France, Germany, Italy, the Netherlands, Spain, and Luxembourg, with plans to prioritize cross-border workers and streamline travel guidelines.
  • The biggest challenge for the EU will be the actual rollout of the vaccine, particularly due to the specific storage needs of the Pfizer/BioNTech shot, which must be stored at around -70C (-94F) and lasts just five days in a refrigerator.

Statistics:

  • The EU has secured over 2 billion doses of potential vaccines, including 300 million doses of the Pfizer/BioNTech vaccine.
  • The Pfizer/BioNTech vaccine can be stored at around -70C (-94F) and lasts just five days in a refrigerator.
  • 150 million EU citizens can be vaccinated with 300 million doses of the Pfizer/BioNTech vaccine.
  • The EU's population is 448 million people.
  • The EU vaccine agreement also includes the purchase of up to 160 million doses from US biotech company Moderna.

Sources:

  • CNN - Kara Fox
  • European Commission - Ursula von der Leyen
  • European Medicines Agency (EMA) - Marie-Agnes Heine

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