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Pfizer and BioNTech coronavirus vaccine approved by UK regulators to roll out in days

James Smith


Pfizer’s coronavirus vaccine has been APPROVED by regulators for use in the UK and can be rolled out nationwide NEXT WEEK

  • The Ministry of Health announced the news just after 7am this morning
  • It came when England came out of its second national lockdown today
  • The Pfizer vaccine will reportedly be staffed first due to its short shelf life

By Dan Sales for Mailonline

Published: 2:10 AM EST, Dec 2, 2020 | Updated: 2:33 AM EST, Dec 2, 2020

A Pfizer / BioNTech Covid-19 vaccine has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in the UK – paving the way for mass vaccination to start in days.

Officials said the vaccine will be available “from next week” as health secretary Matt Hancock declared “Help is coming.”

A spokesman for the Department of Health and Social Care made the announcement just after 7am this morning as England exited its second national lockdown.

Pfizer / BioNTech's Covid-19 vaccine has been approved by the Regulatory Agency

Pfizer / BioNTech’s Covid-19 vaccine has been approved by the Regulatory Agency

An employee of the Pfizer laboratories where they conduct research and development

An employee of the Pfizer laboratories where they conduct research and development

An employee of the Pfizer laboratories where they conduct research and development

Vials of the life-saving shot are seen as a worker working on the Covid-19 vaccine

Vials of the life-saving shot are seen as a worker working on the Covid-19 vaccine

Vials of the life-saving shot are seen as a worker working on the Covid-19 vaccine

A priority list of who should get the vaccine first was prepared earlier this year by the influential Joint Committee on Vaccination and Immunization (JCVI)

A priority list of who should get the vaccine first was prepared earlier this year by the influential Joint Committee on Vaccination and Immunization (JCVI)

A priority list of who should get the vaccine first was prepared earlier this year by the influential Joint Committee on Vaccination and Immunization (JCVI)

He said, “The government today accepted the recommendation of the independent Medicines and Healthcare products Regulatory Agency (MHRA) to approve Pfizer / BioNTech’s Covid-19 vaccine for use.

This follows months of rigorous clinical trials and an in-depth analysis of the data by experts at the MHRA who have concluded that the vaccine meets strict standards of safety, quality and effectiveness.

The Joint Committee on Vaccination and Immunization (JCVI) will also soon publish its latest advice for the priority groups receiving the vaccine, including nursing home residents, health and care workers, the elderly and the clinically extremely frail.

“The vaccine will be available across the UK from next week.”

A chart of vaccine orders from the EU, US, Canada, UK, Japan and Australia

A chart of vaccine orders from the EU, US, Canada, UK, Japan and Australia

A chart of vaccine orders from the EU, US, Canada, UK, Japan and Australia

A scientist from the Pfizer lab in New York is working on the new vaccine to fight the deadly virus

A scientist from the Pfizer lab in New York is working on the new vaccine to fight the deadly virus

A scientist from the Pfizer lab in New York is working on the new vaccine to fight the deadly virus

Health Secretary Matt Hancock tweeted, “Help is on the way. The MHRA has formally approved the Pfizer / BioNTech vaccine for Covid-19.

The NHS is ready to start vaccinating early next week.

“The UK is the first country in the world to have a clinically approved vaccine.”

A few days ago, hospitals in England were told to prepare for the introduction of a Covid-19 vaccine within 10 days, it has been reported, with NHS staff first in line to receive it.

The first deliveries of the vaccine made by Pfizer / BioNTech were scheduled between December 7 and December 9.

This vaccine, which reported early results suggesting the shot is 95 percent effective, should be stored at extremely low temperatures.

A senior hospital director had been told to expect the vaccine on December 7 to be given to NHS staff the following week.

On Nov. 20, the health secretary said he had formally asked the drug regulator to review the Pfizer / BioNTech vaccine for use in the UK.

Matt Hancock called it “another significant step forward in tackling this pandemic.”

But he said that while the regulator’s approval would see a rollout ready to begin next month, there is “ still a long way to go. ”

And the MHRA confirmed last Monday that it had received the necessary data to assess whether the Pfizer / BioNTech vaccine meets the required standards.

From the moment the Pfizer vaccine leaves the factory in Belgium, it can only be extracted from minus 70C four times before being injected into a patient’s arm.

HOW DO THE OXFORD, MODERNA AND PFIZER / BIONTECH VACCINES COMPARE?

Moderna and Pfizer / BioNTech have both released interim results from the final phase clinical trials of their vaccines, both suggesting they are extremely effective.

Oxford University has published the second phase findings showing that the shot elicits an immune response and is safe to use – it’s not yet clear how well it protects against coronavirus in the real world.

Here’s how they compare:

PFIZER (USA) & BIONTECH (DE)

mRNA Vaccine – Coronavirus genetic material is injected to trick the immune system into making ‘spike’ proteins and learning how to attack them.

mRNA vaccine – the vaccines from Moderna as well as Pfizer and BioNTech work in the same way.

Recombinant Viral Vector Vaccine – a harmless cold virus from chimpanzees has been processed to produce the ‘spike’ proteins to look like the coronavirus.

94.5% effective (90 positive in the placebo group, 5 positive in the vaccine group).

95% effective (160 positive in the placebo group, 8 positive in the vaccine group).

62% – 90% effective, depending on the dosage.

Moderna confirmed that it will charge countries placing smaller orders, such as the UK’s five million doses, between £ 24 and £ 28 per dose. The US has secured 100 million doses for $ 1.525 billion (£ 1.16 billion), suggesting it will cost $ 15.25 (£ 11.57) per dose.

The US will pay $ 1.95 billion (£ 1.48 billion) for the first 100 million doses, a cost of $ 19.50 (£ 14.80) per dose.

It is expected to cost £ 2.23 per dose. The full dose of 100 million in the UK could be as little as £ 223 million.

The UK has ordered five million doses to be available from March 2021. Moderna will produce 20 million doses this year and is expected to remain in the US.

The UK has already ordered 40 million doses, of which 10 million could be available by 2020. First vaccinations expected in December.

The UK has already ordered 100 million doses and is expected to be first in line to get it approved once.

What side effects does it cause?

Moderna said the vaccine is “generally safe and well-tolerated.” Most side effects were mild or moderate, but included pain, fatigue and headache, which were ‘generally’ of short duration.

Pfizer and BioNTech did not provide a breakdown of the side effects, but said the Data Monitoring Committee “did not report any serious safety concerns.”

Oxford said there have been no serious security concerns. Mild side effects were relatively common in small studies, with many participants reporting that their arm hurt after the shot and that they later developed a headache, exhaustion, or muscle pain. More data is being collected.

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