UK prepares to fast-track coronavirus vaccine
UK prepares to fast-track coronavirus vaccine and train an army of health workers including pharmacists, midwives and paramedics to give the jab when a safe one is discovered
- Rules will allow a ‘temporary authorisation’ for a vaccine without a full license
- It will not shortcut any scientific trials but will reduce paperwork needed
- Huge numbers of medical workers will be trained to give jabs to increase speed
The British Government is drawing up new rules to fast-track a coronavirus vaccine when one is found to be safe and effective.
A change to current laws could allow the UK to sidestep the European Medicines Agency and get a jab to patients faster without waiting for approval from the EU.
And the Government is also training up an army of medical workers to be able to give out the jabs in order to speed up the process.
This could include pharmacists, midwives, paramedics, physiotherapists and occupational therapists and the workforce is set to be trained by October.
The race to find a vaccine for Covid-19 is hurtling ahead with scientists around the world designing and trialling dozens of candidates in the hope that one will work.
One of the most promising has been developed in the UK by Oxford University and is already in large-scale human trials to test its effectiveness.
When one is proven to work safely, officials will scramble to get it to as many people as possible to avoid another devastating wave of deaths like the one this spring.
A jab is not expected to be found until 2021 but British officials are drawing up emergency plans now in case one is proven to work before Christmas, they said.
The UK Government is training up an army of medical workers to be able to give out coronavirus jabs in order to speed up the process when a working one is found (stock image)
Deputy chief medical officer for England, Dr Jonathan Van Tam, said today: ‘We are making progress in developing Covid-19 vaccines which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future.
‘If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met.
BRITONS ‘WILL BE FIRST’ TO GET OXFORD VACCINE IF IT WORKS, JOHNSON PLEDGES
Britain ‘will be first’ to get doses of Oxford University’s Covid-19 vaccine if it works, Number 10 confirmed amid claims Donald Trump is aiming to fast-track the experimental vaccine into use before the US election this autumn.
White House insiders this week claimed the US President is considering pushing for approval for emergency use of the experimental jab, which is one of the world’s most promising candidates.
Early trials have shown promising results, with tests showing the vaccine — being mass-produced by pharmaceutical firm AstraZeneca — is safe to use in humans and appears to provoke an immune response.
But AstraZeneca insisted it has not entered any negotiation with the US and Prime Minister Boris Johnson’s spokesman said the company had entered into ‘a number of agreements with other countries’ but that the UK would be ‘first’ in line.
On the news that Mr Trump was considering fast-tracking the vaccine, one of the UK’s top medical officers warned that there should be ‘fair distribution’ of any working jab and that richer countries should not hoover up all the supplies.
The only country in the world to have approved a vaccine against Covid-19 so far is Russia. But it came under fire for doing so without proper clinical trials.
Risks of using jabs that have not been tested thoroughly include damaging side effects or administering one that doesn’t really work. If something goes wrong with an official vaccine, it could further dent already-fragile public faith in vaccinations.
Boris Johnson’s official spokesman said on Monday: ‘AstraZeneca have entered into a number of agreements with other countries.
‘They have the global licensing agreement with Oxford, but we have been clear: once it has been found to be effective, we have signed a deal for 100million doses which means that once it is effective the UK will get first access.’
An statement from AstraZeneca added: ‘AstraZeneca has not discussed emergency use authorization with the US government and it would be premature to speculate on that possibility.
‘Late stage Phase II/III trials for AZD1222 are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year.’
‘The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.’
The new rules being drafted will not shortcut the path a vaccine must take before it is approved for human use, and rigorous clinical trials must still be completed.
It is intended, instead, to speed up the approval process by giving the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) the power to issue a ‘temporary authorisation’ without waiting for the jab to be fully licensed by Europe.
Rules during the Brexit transition period – which doesn’t end until 2021 – mean any new medicine for coronavirus must be licensed by the European Medicines Agency.
But the new rule – for which officials are holding a three-week consultation – would mean that if scientists prove their vaccine works and is safe, the MHRA could approve it and get it used in Britain before it’s licensed by the European Union.
This will not cut short safety trials or any of the scientific work but will mean less paperwork has to be done before the jab can be used.
Dr Christian Schneider, a director of standards in the MHRA, said: ‘Whilst the existing licensing system or a new UK one from next year, is the preferred and expected route to supply any vaccine, these new measures will strengthen the regulatory regime and our ability to protect public health.’
The rules are being drafted now in case a working vaccine is found before the end of the year, while the Brexit transition period is still going.
Drug manufacturers are so hopeful that their jabs will work that they are already manufacturing millions of them without knowing whether they will be used.
As well as speeding up the process of getting it from labs to patients, the British Government is planning to speed up the vaccination programme once it starts.
It will do this by training huge numbers of staff to give out the vaccines so there can be a constant flow of jabs being administered.
More doctors and nurses will be given the relevant training and health workers in other parts of the NHS may also be trained up.
Student doctors and nurses, and staff such as midwives, paramedics and physiotherapists could be among the newly trained staff.
There are around 1.1million people working in the NHS and officials say ‘no options are off the table’ in who they could train up.
Everyone who is included in the programme will go through a ‘robust training programme’, the Department of Health said.
Ministers are also reported to be considering drive-through vaccine clinics which work in a similar way to the regional coronavirus testing centres.
People could be able to drive to centres specially set up – possibly in GP surgery car parks, for example – and get the vaccine without having to go into a clinic or hospital.
This could make the process faster and make social distancing easier.
The car park plan was drawn up for flu vaccinations in the coming months, The Times reported, but it’s possible that it could be used for a Covid-19 jab in future.
WHICH TOP VACCINE CANDIDATES HAVE THE UK SECURED DEALS FOR?
1. GlaxoSmithKline and Sanofi Pasteur: 60million doses
The Government revealed on July 29 it had signed a deal with pharmaceutical giants GlaxoSmithKline (GSK) and Sanofi Pasteur
If the vaccine proves successful, the UK could begin to vaccinate priority groups, such as frontline health and social care workers and those at increased risk from coronavirus, as early as the first half of next year, the Department for Business, Energy & Industrial Strategy (BEIS) said.
Human clinical studies of the vaccine will begin in September followed by a phase 3 study in December.
The vaccine is based on the existing technology used to produce Sanofi’s seasonal flu vaccine. Genetic material from the surface protein of the SARS-CoV-2 virus is inserted into insect cells – the basis of Sanofi’s influenza product – and then injected to provoke an immune response in a human patient.
2. AstraZeneca (manufacturing University of Oxford’s): 100million
AstraZeneca, which is working in partnership with Oxford University, is already manufacturing the experimental vaccine after a deal was struck on May 17.
Professor Sarah Gilbert, who is leading the Oxford team, is confident the jab could be ready for the most vulnerable people by the end of the year.
Her comments came after the results from the first phase, published in The Lancet on July 20, showed promise.
The team have genetically engineered a virus to look like the coronavirus – to have the same spike proteins on the outside – but be unable to cause any infection inside a person. This virus, weakened by genetic engineering, is a type of virus called an adenovirus, the same as those which cause common colds, that has been taken from chimpanzees.
3. BioNTech/Pfizer: 30million
US drug giant Pfizer – most famous for making Viagra – and German firm BioNTech were revealed to have secured a deal with the UK Government on July 20.
It reported positive results from the ongoing phase 2/3 clinical trial of one called BNT162b1 on July 1. The company is still running phase 2 trials at the moment.
Pfizer’s vaccine is one called an mRNA vaccine, which do not directly inject bits of the virus into the body but send genetic material.
mRNA vaccines programme the body to produce parts of the virus itself by injecting the body with a molecule that tells disease-fighting cells what to build. The immune system then learns how to fight it.
4. Valneva: 60million
The Government has given Valneva — whose vaccine is understood to be in the preclinical stages of development — an undisclosed amount of money to expand its factory in Livingston, Scotland.
While the Government revealed a 60million dose deal on July 20, the company said it had reached agreement in principle with the UK government to provide up to 100million doses.
Valneva’s jab is an inactivated whole virus vaccine, meaning it injects a damaged version of the coronavirus itself into the body.
The virus has been destroyed in a way that makes it unable to cause infection, but the body still recognises it as a dangerous intruder and therefore mounts an immune response which it can remember in case of a real Covid-19 infection.
5. Janssen (Johnson & Johnson): 30million
The Government has agreed to buy 30million doses of a vaccine made by Janssen if it works.
Officials have agreed to help the company in its development of the jab by part-funding a global clinical trial. The first in-human trials of Janssen’s jab began in mid-July and are being done on adults over the age of 18 in the US and Belgium.
The jab is named Ad26.COV2-S, recombinant, and is a type of jab called a viral vector recombinant vaccine.
Proteins that appear on the outside of the coronavirus are reproduced in a lab and then injected into the body to stimulate an immune reaction.
The ‘Ad’ part of the vaccine’s name means it works using an adenovirus – a virus best known for causing the common cold – as a vehicle to transport the coronavirus genetics into the body.
6. Novavax: 60million
Britain has ordered 60million doses of a vaccine being developed by the US-based company Novavax. It will help to fund late-stage clinical trials in the UK and also boost plans to manufacture the vaccine in Britain.
Novavax’s jab, named NVX-CoV2373, showed positive results in early clinical trials.
It produced an immune response in 100 per cent of people who received it, the company said, and was safe and ‘generally well-tolerated’.
Novavax’s candidate is also a recombinant vaccine and transports the spike proteins found on the outside of the coronavirus into the body in order to provoke the immune system.
7. Imperial College London: Unknown quantity
Imperial College London scientists are working on Britain’s second home-grown hope for a jab. The candidate is slightly behind Oxford’s vaccine in terms of its progress through clinical trials, but is still a major player.
The UK Government is understood to have agreed to buy the vaccine if it works but details of a deal have not yet been publicised.
Imperial’s jab is currently in second-phase human trials after early tests showed it appeared to be safe.
Imperial College London will try to deliver genetic material (RNA) from the coronavirus which programs cells inside the patient’s body to recreate the spike proteins. It will transport the RNA inside liquid droplets injected into the bloodstream.
Source: Read Full Article