Pfizer/BioNTech vaccine: what you need to know about UK approval

Britain has become the first developed country to approve a Covid-19 vaccine when its regulator, the Medicines and Healthcare Products Regulatory Agency, on Wednesday gave the green light to the treatment offered by Pfizer and German group BioNTech.

That sounds very quick. Didn’t the company only apply earlier this week?

European regulators have been operating rolling reviews of various late stage vaccine candidates as part of an effort to fast-track approval for effective vaccines. That means they have had access to the company’s data for some time.

So how soon will people in the UK get the vaccine?

Pfizer said doses of the vaccine would be delivered to the UK “in the coming days” after the UK’s Medicines and Healthcare products Regulatory Agency announced the approval on Wednesday morning.

UK health secretary Matt Hancock said 800,000 doses will arrive next week.

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Will Northern Ireland receive some of that?

Reports on Wednesday morning says that the vaccine will be distributed pro-rata across the four regions of the UK. Northern Ireland health minister Robin Swann said on Wednesday that, under the UK shared allocation of the vaccine, Northern Ireland will be entitled to 25,000 doses of vaccine. He said that, as it is a two-jab inoculation, that will entitle about 12,000 of the most vulnerable to get the vaccine before Christmas.

However, with a three week gap between the two doses it is possible a wider number of people could receive their first dose before Christmas.

And how are they going to administer it?

That’s also unclear but, given that this vaccine needs to be kept at extraordinarily low temperatures, it seems likely that vaccination will, initially at least, take place in hospitals.

How fast will the vaccine be rolled out?

Britain was the first country to reach an agreement with BioNTech/Pfizer for the supply of vaccines, ordering 30 million doses back in July. It has since signed a deal for a further 10 million doses. It is expected that 4 million doses will arrive before the end of December.

And where are UK batches of the vaccine coming from?

Much of the UK's supply will be produced at Pfizer's facilities in Puurs, Belgium. There will also be some production at BioNTech's sites in Germany.

None of Ireland’s Pfizer plants will be involved then, will they?

Oh, they will. The US group's biotech plant at Grange Castle in west Dublin is conducting quality tests on all batches of the Pfizer/BioNTech vaccine that will be used in Europe.

Has the UK decided who will be first in the queue for the jab?

The British government decided last month that it will first be made available to care home residents and staff, before being administered to those aged over 80 and to frontline health workers.

In Northern Ireland, it is expected that frontline healthcare workers will be the first to receive the jabs.

Last month? Has Ireland lost out then because our vaccine task force only got up and running more recently?

No. Irish access to the vaccine has, from the start, been dependent on clearance for the inoculation from the European Medicines Agency. Like Britain, it has been conducting a rolling of the progress by Pfizer/BioNTech – as well as other vaccines from Moderna, Oxford University/AstraZeneca and, from this week, Johnson & Johnson.

But the UK is still part of the EU. How come it got to make this call earlier?

Although the UK is not due to leave the EU’s regulatory framework until January 1st when the Brexit transition period ends, it was able to avail of a longstanding regulatory provision that allows it to diverge from the EMA in the case of urgent public need.

So why is the European regulator so far behind?

They’re not really. Pfizer (and Moderna) only formally applied for approval in Europe (and the US) earlier this week. The European Medicines Agency has said it will decide on that “conditional marketing approval” by December 29th for Pfizer and by January 12th on the Moderna alternative. It could be earlier.

Additional reporting: The Financial Times Limited 2020