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Pfizer vaccine in bottle

Green light for vaccine triggers UK’s largest scale vaccination campaign

Image credit: BioNTech SE 2020 via Reuters

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Covid-19 jab developed by Pfizer and BioNTech, setting in motion an unprecedented and challenging vaccination campaign.

The Department of Health and Social Care said that the regulator had approved the vaccination following “months of rigorous clinical trials and a thorough analysis of the data by experts”, making the UK the first country to approve the vaccination. The regulator concluded that it meets strict standards of safety, quality and effectiveness.

The vaccination has been shown to be 95 per cent effective, and works in all age groups.

The Prime Minister Boris Johnson tweeted: “It’s the protection of vaccines that will ultimately allow us to reclaim our lives and get the economy moving again.” Nadhim Zahawi, who has been appointed to oversee the vaccination campaign, tweeted: “Major step forward in the fight against Covid-19 today.” Scotland’s First Minister Nicola Sturgeon said that this is “the best news in a long time”.

The UK government has ordered 40 million doses of the vaccine, which will be enough to vaccinate 20 million people with two doses, given three weeks apart. The first 800,000 doses are set to arrive in the UK next week, with millions more doses in the coming weeks.

The Joint Committee on Vaccination and Immunisation, which advises ministers, said that the vaccine should first be offered to care home residents and workers. The next groups (in order of priority) are: those aged 80 and over and frontline health workers; those ages 75 and over; those 70 and over and 'clinically extremely vulnerable' people; those aged 65 and over or aged 16-64 with underlying high-risk health conditions; those aged 60 and over; those aged 55 and over; and those aged 50 and over. No decisions have been made about priorities for under-50s.

Experts warned that it will take many months to vaccinate just the vulnerable UK population and that people must continue to adhere to measures to limit transmission of the virus.

Professor Liam Smeeth, an expert in clinical epidemiology at the London School of Hygiene and Tropical Medicine, suggested that it is realistic to hope that by March or April the vast majority of people vulnerable to Covid-19 will have been immunised, with much of the population covered in time for the next winter.

Sir Simon Stevens, chief executive of NHS England, described the upcoming vaccination programme as the “largest-scale vaccination campaign in our country’s history”. England’s chief medical officer, Professor Chris Whitty, wrote on Twitter that “It will take until spring until the vulnerable population who wish to are fully vaccinated. We can’t lower our guard yet.”

Danny Mortimer, chief executive of the NHS Confederation, said: “This is the starting klaxon for people readying to deliver the vaccine. What’s ahead will be a marathon and not a sprint, with many months ahead to vaccinate everyone who needs it. This welcome news, however, does not mean we are immediately out of the woods. Our already-stretched NHS faces a monumental effort now to roll out the vaccine quickly and effectively.”

According to the PA news agency, once the vaccine arrives in the UK from Pfizer’s plant in Belgium, batches will be subjected to quality assurance at a central depot. It will then be moved to freezers for storage, where it will undergo a temperature check; it must be stored at -70°C, although it can be stable at 2-8°C for short periods of time. Public Health England will process orders from the NHS for next-day delivery to hubs around the UK.

Administration of the vaccine will require precision with regards to timing and temperature; the vaccine takes several hours to defrost, with extra time required to prepare for injection. The vaccination will be offered by hospitals, mass vaccination centres, GP surgeries, and pharmacies.

Chris Hopson, chief executive of NHS Providers, said: “The logistics of administering the Pfizer/BioNTech jab are formidable, but the NHS has been preparing for this, and trusts will play a key role. The health service has an excellent track record of delivering vaccination programmes – though this will be on an unprecedented scale, with added challenges because of the need to run mass vaccination centres and the requirement for cold storage.”

The MHRA emphasised that, while the Pfizer/BioNTech vaccination has been developed and approved in record time, it has undergone a rigorous approval process. Experts have studied records of 40,000 trial participants from various backgrounds, making up 1,000 pages of vaccine trial data.

“No corners have been cut [in assessing safety],” said Dr June Raine, head of the MHRA. “The safety of the public will always come first. This recommendation has only been given by the MHRA following the most rigorous scientific assessment of every piece of data so that it meets the required strict standards of safety, of effectiveness, and of quality.”

The development, trials, and approval of the Covid-19 vaccine have been accelerated due to previous work having been done on similar viruses, rapid access to generous funding, back-to-back human trials, and priority given to Covid-19 vaccines by medical regulators.

The MHRA is also beginning a rolling review of other vaccines in late-stage human trials, including the Moderna and AstraZeneca/Oxford vaccines, which do not need to be stored at such extreme temperatures as the Pfizer/BioNTech vaccine.

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