Pfizer to apply for Clearance in US

Pfizer and its partner BioNTech have said they will apply for emergency clearance in the US for their Covid-19 vaccine on Friday.

It will be the job 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.

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However, the US government expects to approve the vaccine in the first half of December.

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

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

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

Furthermore,

Last week, Pfizer and BioNTech published introductory data suggesting the vaccine offered 90% protection against Covid-19 and said there were no safety concerns. Subsequent data released on Wednesday suggested 95% effectiveness.

This was followed by data on a vaccine made by US company Moderna 

If FDA authorisation does come in the first half of next month, Pfizer and BioNTech will “be ready to distribute the vaccine candidate within hours”, the two companies said.

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

In conclusion

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

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