Pfizer applies for Covid vaccine approval in UK – raising hopes of roll out 'in weeks'
HOPES have been raised of a Covid vaccine roll out in the coming weeks after Pfizer today applied for approval in the UK.
Britain ordered 40 million doses of the jab – which was found to be 94 per cent effective at late-stage trials – enough for a third of the population.
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And now the UK's Medicines and Healthcare Regulatory Agency (MHRA) is reviewing the data to determine whether it meets safety standards.
It's the next major step forward in getting a safe, effective vaccine rolled out and ending the pandemic.
The US pharmaceutical giant has reported that their vaccine is 94 per cent in protecting people over 65 years old from Covid-19.
Trials have also suggested the Pfizer/BioNTech jab works equally well in people of all ages, races and ethnicities.
It comes as Oxford University today announced its vaccine could be up to 90 per cent effective in preventing the deadly bug.
The UK has bought 100 million doses of the Oxford/AstraZeneca jab, with four million expected to be rolled out by Christmas.
'ROAD TO RECOVERY'
As the first country to pre-order the Pfizer/BioNTech vaccine, Britain is expected to receive a total of 40 million doses by the end of 2021 – with the majority anticipated in the first half of next year.
It will only get the green light by the MHRA if it meets strict standards of quality, safety, and effectiveness, and if they are satisfied the vaccine can be consistently manufactured.
Health Secretary Matt Hancock said: “The whole country will be cheered by the news that Pfizer/BioNTech have formally reported the data from their clinical trials for their vaccine to the regulator.
"This is another important step on the road to recovery. We must now allow the MHRA’s renowned teams of scientists and clinicians to make an independent assessment of whether it meets their robust standards of quality, safety, and effectiveness.
“If approval is granted, the NHS will be ready to deliver."
Earlier, Mr Hancock announced that the MHRA will also assess whether the 90 per cent effectiveness dosing regime can be used with the Oxford jab.
One of the dosing patterns used by the scientists – and tested on about a third of those in the study – suggested 90 per cent effectiveness if one half dose is given followed by a further full dose.
Another dosing pattern showed 62 per cent efficacy when one full dose is given followed by another full dose.
The combined analysis from both dosing regimes resulted in an average efficacy of 70.4 per cent.
PRIMED AND READY
Experts behind the study believe that a smaller initial dose may prime the immune system to give a bigger, better response when it meets coronavirus.
The half dose regime is also thought to prevent transmission of the virus and experts hope regulators will approve this plan.
Mr Hancock said: "I'm really very pleased, I really welcome these figures – this data that shows that the vaccine in the right dosage can be up to 90 per cent effective.
"If this all goes well in the next couple of weeks, then we are looking at the potential of starting the vaccination programme next month for this Oxford-AstraZeneca vaccine as well as the Pfizer vaccine.
"But in all cases the bulk of the rollout will be in the new year.
"We are looking with high confidence now that after Easter things can really start to get back to normal."
The Oxford jab is likely to be rolled out in the UK from December, with the bulk of vaccination in the new year.
During the overall clinical trial, those given the vaccine did not suffer severe coronavirus and nobody required hospital treatment, while there were also no serious safety concerns related to the vaccine itself.
Business Secretary Alok Sharma said: “Today, we have renewed hope that we are on the brink of one of the most significant scientific discoveries of our time, as we reach the crucial last stage to finding a Covid-19 vaccine.
“While this news is a cause for celebration, we must make sure that this vaccine, like all new medicines, meets standards of quality, safety, and effectiveness. I urge the public to be patient while we wait for regulators to do a thorough assessment.
Britain’s 350million vaccine doses
THE government has ordered 350million doses of Covid-19 vaccine, with some ready to roll out by December 1.
This includes 40million doses of the promising Pfizer shot, which was revealed to be 90 per cent effect last week.
These are the other vaccines which the government has pre-ordered:
Oxford/AstraZeneca: 100million doses
A weakened virus that causes colds in chimpanzees, it has been shown to generate a strong immune response against Covid-19.
It has been genetically changed so that it is impossible for it to grow in humans, making it safe for children, the elderly and people with pre-existing conditions.
Currently in phase-3 trials in the UK, USA, South Africa, Japan, Brazil and Kenya, more than 50,000 test patients have been given the vaccine. Early reviews have shown it to be safe.
A company in Australia has already started making millions of vials in the expectation that trials will be successful.
Novavax: 60million doses
Contains purified piece of the virus that causes Covid-19. When it is administered, the body recognises it as “foreign” and mounts a protective immune response.
It has been shown to generate more antibodies than in patients recovering from severe Covid-19 infections.
Currently in phase-3 clinical trials in the UK and USA.
GSK/Sanofi: 60million doses
Uses the same protein as one of Sanofi’s seasonal flu vaccines coupled with a booster.
In phase-1 clinical trials but early results have been positive.
Valneva: 60million doses
An inactivated whole virus vaccine designed to prompt the body into creating high levels of Covid-19 antibodies.
The government has invested in Valneva’s manufacturing facility in Livingston, Scotland, to create a major UK vaccine factory.
Currently in pre-trial research, with trials due to start in December.
Pfizer/BioNTech: 40million doses
Prevents Covid-19 infection by targeting the virus’s “spike protein”, effectively disabling it before it can cause any damage.
Tested on 40,000 patients, it is currently in phase-3 trials, but the first interim analysis has shown it is 90 per cent effective.
Janssen: 30million doses
Uses a modified common cold virus to act like a Trojan horse that can deploy the Covid-19 virus’s “spike protein” to human cells, causing the body to generate antibodies.
Phase-3 trials among 60,000 patients were recently halted temporarily after an unexplained illness in one volunteer. Trials have since resumed.
= 350million doses in total
“Finding a vaccine is not going to end the pandemic overnight, but we are hopeful of being one step closer to defeating this terrible virus.”
The Department of Health said the NHS will be ready to begin vaccinating as soon as the first vaccine is approved and delivered to the UK.
Kate Bingham, chair of the UK's Vaccines Taskforce, said: “We are moving ever closer to having the means with which to help end this pandemic.
"But we must wait for the outcome of the MHRA assessment before we will truly know if we have our first approved vaccine.
“Irrespective of the outcome, which we all hope will be positive, this is a tremendous day for science.
"It is testament to the herculean efforts of the scientific and biopharmaceutical community and it makes me immensely proud.”
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