Covid vaccine approved for use in the UK and could be rolled out in Leeds next week

The Pfizer/BioNTech Covid-19 vaccine has been approved for use in the UK.

By Abbey Maclure
Wednesday, 2nd December 2020, 7:22 am

Officials said the vaccine will be made available “from next week”.

Plans are "well on track" for rolling out Covid-19 vaccines across Leeds to the most vulnerable people this month, Leeds City Council have said.

Health and care workers, people over 80 and care home residents will be the first to get a vaccine, likely to start from next week.

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Prime Minister Boris Johnson (centre) watches workers perform quality testing during the 'fill and finish' stage of the manufacturing process of Covid-19 vaccines (Image: PA Wire/Paul Ellis)

Vaccination sites are being considered within the NHS, but also in community settings in Leeds.

The mass-vaccination of the public in Leeds is expected to start early in the new year.

A Department of Health and Social Care spokesman said: “The Government has today accepted the recommendation from 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 a thorough analysis of the data by experts at the MHRA who have concluded that the vaccine has met its strict standards of safety, quality and effectiveness.

“The Joint Committee on Vaccination and Immunisation (JCVI) will shortly also publish its latest advice for the priority groups to receive the vaccine, including care home residents, health and care staff, the elderly and the clinically extremely vulnerable.

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

The council's director of public health, Victoria Eaton, has confirmed the council is working with the NHS to plan how to deploy the vaccines in Leeds.

Speaking at a meeting last week, Ms Eaton said: "It's really positive news about where we are heading with the vaccine, both before Christmas and in the new year.

"We've got this great news that we have three potential vaccines. We're well on track with our plans with NHS colleagues about how we want to deploy those in Leeds.

"We're looking at a variety of sites both in the NHS and in broader community settings - looking at what that plan might look like, which is at scale for a city the size of Leeds.

“It will start with health and care workers, people who are over 80 and also care home residents, but will very quickly in the new year move to mass-vaccination of the public.

"This is a real priority to make sure we get this right for the city and we want to make sure that everything else we do supports that goal."

How has a Covid vaccine been approved so quickly?

Traditionally vaccines can take years to research and develop, so how has a vaccine been approved for use so quickly?

– How has this come about so quickly?

The timetable for developing and approving a Covid vaccine has been condensed due to the coronavirus crisis.

– What is the usual process for developing a vaccine?

Traditionally vaccine development takes several years and includes various processes, including design and development stages followed by clinical trials – which in themselves need approval before they even begin.

The trials take place in three sequential stages – also known as phases. The research will show whether a vaccine generates antibodies but also protects people from disease. They will also identify any safety issues.

Once the trials are complete, the information gathered by researchers is sent to regulators for review.

This is thoroughly analysed by clinicians and scientists before being approved for widespread use.

Then, after approval from regulators, people can start to receive the vaccine.

– Is this different because of the pandemic?

The process looks slightly different in the trials for a Covid vaccine.

While the early design and development stages look similar, the clinical trial phases have overlapped – instead of taking place sequentially.

– But won’t that mean that safety is compromised?

Even though some phases of the clinical trial process have run in parallel rather than one after another, the safety checks have still been the same as they would for any new medicine.

The Medicines and Healthcare products Regulatory Agency (MHRA) has adopted the phrase “safety is our watchword”.

Regulators have said they will “rigorously assess” the data and evidence submitted on the vaccine’s safety, quality and effectiveness.

And, in most clinical trials, any safety issues are usually identified in the first two to three months – a period which has already lapsed for most vaccine frontrunners.

– How are regulators acting so quickly?

Regulators have been carrying out “rolling reviews”, which means that instead of going through reams of information at the conclusion of the trials, they have been given access to the data as the scientists work.

A rolling review of the vaccine data started several months ago.

This means regulators can start to look at scientific data earlier than they traditionally would do, which in turn means the approval process can be sped up.

Regulators sometimes have thousands of pages of information to go over with a fine-tooth comb – which understandably takes time.

Once all the data available on the vaccine is submitted, MHRA experts will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from Covid-19 and the level of protection it provides.

After this has been done, advice is sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM).

– What does ‘approved for use’ mean?

For a medicine to be used in the UK it has to be granted a licence. This means that it has been through all the rigorous safety and efficacy checks and regulators are confident in the findings of the clinical trials.

By reviewing the data as they become available, the MHRA can reach its opinion sooner on whether or not the medicine or vaccine should be licensed without compromising the thoroughness of their review.

– So what data will the regulator look at?

The information provided to the MHRA will have included what the vaccine contains, how it works in the body, how well it works and its side-effects, and who it is meant to be used for.

This data must include the results of all animal studies and clinical trials in humans, manufacturing and quality controls, consistency in batch production, and testing of the final product specification.

The factories where the vaccines are made are also inspected before a licence can be granted to make sure that the product supplied will be of the same consistent high standard.

– What is the difference between the MHRA and the CHM?

The MHRA is the British regulator of medicines and medical devices, ensuring their safety, quality and effectiveness.

The CHM advises ministers on medicinal products. It is made up of an independent group of advisers responsible for advising on the need for, and content of, risk management plans for new medicines.

It also advises officials on the impact of new safety issues on the balance of risks and benefits of licensed medicines.

The CHM also offer advice on “applications for both national and European marketing authorisations”.

– Haven’t pharmaceutical companies already started making vaccines?

Yes. Usually large-scale production and distribution begins only after regulatory approval. But in the case of Covid-19 vaccines, pharmaceutical firms have begun manufacturing before final approval had been granted – taking on the risk that they may be forced to scrap their work.

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