What’s happening: The US FDA (Food and Drug Administration) late Friday issued an EUA (emergency use authorisation) for BNT162b2, the covid-19 vaccine candidate developed by Pfizer and its German partner BioNTech.
What happened: With the latest move by the FDA, the US becomes the fifth country after the UK, Bahrain, Canada, and Saudi Arabia to authorise the emergency use of a coronavirus vaccine.
The vaccine was approved for individuals 16 years and above despite some apprehensions. The EUA lasts as long as the pandemic emergency continues, following which Pfizer will need to apply again for a full approval by submitting safety data from participants of its Phase III trials.
Why it matters: Pfizer’s vaccine candidate showed 95% efficacy in preventing covid-19 during the late-stage trial. Healthcare workers and older people are likely to be the first to receive vaccine shots in the first round of 2.9 million doses during December.
The US health authorities and various shipping services have been readying an inoculation campaign to deliver the vaccine doses. Pfizer is expected to roll out the first doses of the vaccine immediately, reaching 50 million doses by yearend. The US had earlier signed a deal with the pharmaceutical giant to provide 100 million doses for $1.95 billion, which is enough for 50 million people. The deal also provides the US government the option to purchase another 500 million doses thereafter.
Pfizer and BioNTech plan to supply around 1.3 billion doses worldwide by 2021.
Despite this positive news, investor sentiment is likely to remain muted, with reports of severe allergic reactions to the vaccine coming in from the UK, the first country to approve Pfizer’s covid-19 vaccine on December 2. The US FDA has also warned people with a history of “significant” allergic reactions to avoid taking the vaccine developed by Pfizer.
What to watch: Pfizer and BioNTech are collecting additional data for their vaccine candidate to file a BLA (biologics license application) for gaining full approval in 2021.
The companies expect to obtain EUAs for the vaccine in other regions, including Europe, where the European Medicines Agency's scientific committee for human medicines is expected to announce its decision after a special meeting on December 29.
Markets will also keep an eye on news around Moderna's covid-19 vaccine, which is currently being reviewed by the FDA. The US government has the option to purchase 100 million doses this vaccine after the FDA grants an EUA