COVID-19: Pfizer/BioNTech and Moderna vaccines Europe decision dates revealed

·2-min read

The Pfizer/BioNTech and Moderna COVID-19 vaccines are neck-and-neck to become the first to be rolled out in Europe after they both submitted their approval applications.

Pfizer and BioNTech submitted its emergency application on Monday to the European Medicines Agency (EMA), while Moderna submitted its on Tuesday, the agency said.

If everything goes to plan, the Pfizer/BioNTech COVID-19 vaccine will get approval to be used in Europe first.

The EMA said if there is enough data, it will complete its assessment of the Pfizer vaccine by 29 December, and the Moderna jab two weeks later by 12 January.

It will hold a public hearing on 11 December on the approval request by Pfizer/BioNTech.

BioNTech said it stands ready to ship stockpiles of vaccines where they are needed within hours of approval.

EU Commission President Ursula von der Leyen said around two billion doses of potential COVID-19 vaccines have been secured for its 27 nations. The UK is not included in that.

Vaccine approval normally takes a long time but both vaccines have been part of a rolling review process in which each phase of the trials are reviewed when they are finished, as opposed to doing it all at the end.

Pfizer and BioNTech said its candidate, BNT162b2, could be launched in the EU this month.

"If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID-19, it will recommend granting a CMA (conditional marketing authorisation) that could potentially enable use of BNT162b2 in Europe before the end of 2020," they said in a joint statement.

The EMA will now assess data on how well the vaccines trigger an immune response and whether it is safe enough for broad use across Europe.

Moderna submitted its emergency application to US regulators on Monday, while Pfizer and BioNTech filed theirs on 20 November.

The Pfizer/BioNTech vaccine could be rolled out in the UK first, possibly on 7 December, after the government said last week it had submitted its data for approval.

The highly respected Medicines and Healthcare Products Regulatory Agency (MHRA) is also evaluating whether the Oxford University/AstraZeneca vaccine is safe to roll-out.

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An effective vaccine is seen as the main weapon in fighting the pandemic, which has claimed more than 1.4 million lives worldwide.

Pfizer and BioNTech reported final trial results on 18 November that showed its vaccine was 95% effective in preventing COVID-19, with no major safety concerns.

Moderna's results indicated 94.5% effectiveness.

The Oxford trial found with two doses its vaccine was 62% effective, but when people were given a half dose followed by a full dose at least a month later its efficacy rose to 90% - giving an average of 70%.

As the half dose was a mistake, it is carrying out further trials.