Pfizer applies for first Covid vaccine approval in US

Pfizer applies for first approval in US
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Daily US Times: Giant pharmaceutical corporation Pfizer and its partner BioNTech are on Friday filing for emergency authorisation in the United States of their Covid-19 vaccine.

It will be the responsibility of the US Food and Drug Administration (FDA) to decide if the vaccine is safe to roll out.

It is not clear how long the FDA will take to study the data about the vaccine, but the US government expects to approve the vaccine in the first half of December.

Data from an advanced trial suggested the vaccine protects 94% of adults over 65.

The trial involved 41,000 people around the world. Half were given a placebo and half were given the vaccine.

The United Kingdom has pre-ordered 40 million doses and should get 10 million by the end of the year.

If FDA authorisation does come in the first half of December, Pfizer and BioNTech both said they will “be ready to distribute the vaccine candidate within hours”.

This would be remarkably quick for vaccine development – within 10 months of detailing the genetic code. The average wait for approval for a vaccine in the US is nearer eight years.

Albert Bourla, the CEO of Pfizer, said on Thursday that the filing for emergency use was a “milestone in our journey to deliver a Covid-19 vaccine to the world”.

Initial vaccine doses would be scarce, though, and the Centers for Disease Control and Prevention (CDCP) will decide who will get the first shots.

Ursula von der Leyen, European Commission president, said the EU could move quickly too – by the end of the year.

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