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UK Becomes First in the World to Approve Pfizer Coronavirus Vaccine after ‘rigorous trials’

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Britain is to begin vaccinating frontline workers against coronavirus, after the UK medicines regulator gave temporary approval to the Pfizer jab, according to The Telegraph.

The Army will begin delivering supplies within hours with the first injections of NHS staff taking place next week.

Britain has ordered 40 million doses of the vaccine developed by BioNTech and Pfizer, but only 10 million vials are expected to be available before the end of the year, with an initial batch of 800,000.

The emergency approval means that Britain will be ahead of the US in receiving the jab even though it was developed using US government funding.

A Department of Health and Social Care spokesman said on Wednesday: “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 vaccine will be made available across the UK from next week.”

Each person needs two jabs which means only one in 13 people can be immunised with current supplies.

The Joint Committee on Vaccination and Immunisation (JCVI) initially said that care home residents and staff should be first in line for the shots, followed by those aged over 80 and general health workers.

However, the Pfizer jab must be shipped in dry ice at -103F (-75C) and only lasts for five days once stored in a fridge at usual temperatures of 35.6F to 46.4F  (2 to 8C) so it is impractical to roll it out in care homes.

It means that only NHS staff will get the jab initially, and care homes may need to wait until the Oxford or Moderna vaccines become available, as both can be stored at normal fridge temperatures.

On Saturday, the government announced that Nadhim Zahawi, a junior minister at the Department for Business, would oversee the vaccine roll-out.

There are also fears that the vaccination programme will take far longer than normal because, as it is a new vaccine, patients will be asked to wait 15 minutes after their jab to check there are no immediate side-effects.

What’s in the pipeline for the UK?

The Government has secured 40 million doses of the Pfizer vaccine, with 10 million due in the UK by the end of the year. The Department of Health and Social Care said the vaccine will be available from next week.

Patients need two doses, meaning not enough shots have been secured for the entire UK population.

How will a vaccine be rolled out?

The NHS has been preparing for a mass vaccination programme for several weeks with up to 1,500 GP practices and drive-through centres ordered to open from 8am to 8pm every day, each dispensing at least 1,000 jabs a week.

Under the current plans, local clusters of about five practices covering approximately 50,000 patients, known as Primary Care Networks, will combine to organise vaccine delivery and the health service is hoping to immunise one million people per week.

It could mean transforming one surgery into a vaccine hub while moving the normal services usually performed there to the neighbouring practices or hiring new premises altogether.

The government has previously said that the first injections could take place from Dec 7 and several hospitals had been warned to expect stocks by next week. But some are likely to receive supplies earlier.

The British Medical Association (BMA) has struck a deal in principle on behalf of GPs to administer Covid vaccines in all parts of the country but it still remains for GP practices – which are private businesses – to sign up to the contract individually.

A letter from Doctors’ Association UK GP Committee to Matt Hancock, the Health Secretary, and NHS leaders has warned that surgeries may be deterred from participating if the costs of hiring extra staff, laying on transport to vaccination hubs, installing fridges and reconfiguring surgeries to cope with the flow of patients is paid retrospectively.

A Medscape poll of 308 UK doctors found 4 in 10 would not have a Covid-19 vaccine as soon as one is approved by the MHRA with the majority saying safety was their biggest worry.

Nearly six in 10 also said that vaccination for healthcare staff should not be compulsory.

GPs have been told they can scale back other work as the vaccination programme takes precedence and will be paid £12.58 for each vaccine dose administered.

Medical and nursing students, retired medics, pharmacists and vets are being drafted in to help manage the huge enterprise.

Vaccines usually need to be authorised by the European Medicines Agency (EMA) but the UK’s Medicines and Healthcare Products Regulatory Agency can allow emergency use if there is an urgent public need.

Who is top of the list to get a coronavirus vaccine?

The Joint Committee on Vaccination and Immunisation (JCVI) has examined data on who suffers the worst outcomes from coronavirus and who is at highest risk of death.

NHS staff were told to get their winter flu jab by the end of November because there needs to be at least a week between the two vaccinations.

After care homes, the JCVI has recommended that the population be vaccinated in five-year groups starting with the over-75s.

Priority for those under 50 is yet to be determined, but may be done by ethnicity, or risk. For example those in public facing jobs, such as bus drivers, may be immunised first.

Its interim guidance says the order of priority should be:

1. Older adults in a care home and care home workers

2. All those who are 80 years of age and over and health and social care workers

3. All those who are 75 years of age and over

4. All those who are 70 years of age and over and clinically extremely vulnerable individuals, excluding pregnant women and those under 18 years of age

5. All those who are 65 years of age and over

6. Adults aged 18 to 65 years in an at-risk group

7. All those aged 60 and over

8. All those aged 55 and over

9. All those aged 50 and over

Don’t vaccines take a long time to produce?

In the past it has taken years, sometimes decades, to produce a vaccine.

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

But in the trials for a Covid-19 vaccine, things look slightly different. A process which usually takes years has been condensed to months.

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

And pharmaceutical firms have begun manufacturing before final approval has been granted – taking on the risk that they may be forced to scrap their work.

The new way of working means that regulators around the world can start to look at scientific data earlier than they traditionally would do.

How many doses has the UK secured?

The UK has secured access to 100 million doses of the AstraZeneca/Oxford University vaccine, which is almost enough for most of the population.

It also belatedly struck a deals for seven million doses of the jab on offer from Moderna in the US.

The deals cover four different classes: adenoviral vaccines, mRNA vaccines, inactivated whole virus vaccines and protein adjuvant vaccines.

The UK has secured access to:

– 100 million doses of the Oxford vaccine

– 60 million doses of the Novavax vaccine

– Some 30 million doses from Janssen

– 40 million doses of the Pfizer/BioNTech vaccine – the first agreement the firms signed with any government

– 60 million doses of a vaccine being developed by Valneva

– 60 million doses of protein adjuvant vaccine from GlaxoSmithKline (GSK) and Sanofi Pasteur

– Seven million doses of the jab on offer from Moderna in the US.

What do they cost?

Pfizer/BioNTech is making its vaccine available not-for-profit.

According to reports, the Moderna vaccine could cost about £28 per dose and the Pfizer candidate could cost around £15.

Researchers suggest the Oxford vaccine could be relatively cheap to produce, with some reports indicating it could be about £3 per dose.

AstraZeneca said it will not sell it for a profit, so it can be available to all countries.

However, the details of the deals made by the UK Government have not been made public.

– How do we know the vaccines are safe?

Researchers reported their trials do not suggest any significant safety concerns. SOURCE: The Telegraph

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