UK regulators today approved Pfizer / BioNTech's Covid-19 vaccine, which paves the way for mass vaccination in just a few days.
Officials said the batch – which Britain has ordered 40 million doses of – will be made available "starting next week" when Health Secretary Matt Hancock said "aid is on the way".
Department of Health and Welfare officials made the announcement just after 7am this morning as England exited its second national lockdown and stores reopened for "Wild Wednesday".
Mr. Hancock said, “Help is on the way. The MHRA has officially approved the Pfizer / BioNTech vaccine for Covid-19.
& # 39; The NHS is ready to start vaccinating early next week. The UK is the first country in the world to have a clinically approved vaccine to supply. & # 39;
Pfizer / BioNTech's Covid-19 vaccine has been approved by the regulator
An employee in the Pfizer laboratories where he does research and development. Vials with the life-saving sting are seen when an employee is working on the Covid-19 vaccine
In other coronavirus developments today:
- Boris Johnson received his brutal post-lockdown steps from the Commons last night thanks to Sir Keir Starmer's tacit support after witnessing the biggest Tory insurrection in this Parliament when more than 50 Tories defied the whip.
- The lockdown in England is over and shoppers took advantage of their new freedom to line up outside Primark before dawn for the wild Wednesday pre-Christmas bargains.
- Nursing home residents can finally hug their families again after ministers announced one The national introduction of rapid tests means that relatives who are free of Covid can be visited again for the first time since March.
- Private hospitals received millions in funding this summer, although most roughly two-thirds of the additional capacity, according to leaked documents, was underutilized.
- The UK recorded another 13,430 Covid infections and 603 deaths last night as the second wave of the disease continues to subside.
A spokesman for the DHSC added, "The government today accepted the recommendation from the Independent Medicines and Health Products Regulatory Authority (MHRA) to approve Pfizer / BioNTech's Covid-19 vaccine.
& # 39; This follows months of rigorous clinical studies and a thorough analysis of the data by experts at MHRA who have concluded that the vaccine meets its strict safety, quality and efficacy standards.
& # 39; The Joint Vaccination and Immunization Committee (JCVI) will also shortly publish its latest recommendations for the priority groups to receive the vaccine, including nursing home residents, health and care workers, the elderly and the clinically extremely vulnerable .
"The vaccine will be available across the UK from next week."
A graphic of EU, US, Canada, UK, Japan, and Australia vaccine orders
WHO WILL GET THE JAB, WHEN AND HOW?
What is in the making in the UK?
The government has received 40 million doses of the Pfizer / BioNTech vaccine, 10 million of which are due in the UK by the end of the year.
Patients require two doses, which means that not enough shots have been secured for the entire UK population.
How is a vaccine introduced?
Behind the scenes, work has been done to ensure that NHS staff are ready to deliver priority shocks to the most vulnerable, as well as to health and care workers.
The NHS Nightingale Hospitals are also intended as locations for mass vaccination clinics.
In addition, NHS officials have announced that "roving teams" will be deployed to vaccinate residents and workers in nursing homes.
According to current information, the vaccines under development require two doses per patient with an interval of 21 to 28 days between doses.
The government has also put in place new regulations that will allow more healthcare workers to administer flu and potential Covid-19 vaccines.
Who is at the top of the list to get a coronavirus vaccine?
The Joint Committee on Vaccination and Immunization (JCVI) has been looking into data on who has the worst effects of the coronavirus and who is at the highest risk of death.
The preliminary guide states that the order of priorities should be as follows:
- Older adults in a nursing home and nursing home workers
- Everyone aged 80 and over, as well as health and social workers
- Everyone aged 75 and over
- All persons over the age of 70 and persons at extreme clinical risk, with the exception of pregnant women and persons under 18 years of age
- Everyone aged 65 and over
- Adults aged 18 to 65 in a risk group
- Everyone aged 60 and over
- Everyone aged 55 and over
- Everyone aged 50 and over
Speaking to Sky News, Hancock added that there would be three ways the vaccine could be dispensed.
He said, “The first is the hospitals themselves, and of course we have such facilities.
50 hospitals across the country are already set up and waiting to receive the vaccine once it's approved. It can be done now.
“Also vaccination centers, which will be big centers where people can get vaccinated. You will now be set up.
& # 39; There will also be a community rollout including general practitioners and pharmacists.
“Due to the storage conditions for this vaccine at -70 ° C, you can of course support this rollout wherever you have these facilities.
"But they will also be there when the AstraZeneca vaccine is approved, as it does not meet these cold storage requirements and is therefore easier to implement operationally."
He added, "We are the first country in the world where a clinically approved vaccine can be introduced."
A few days ago, hospitals in England were told to prepare for a Covid-19 vaccine to roll out in just 10 days. According to reports, the NHS staff were the number one priority to get him.
The first shipments of the vaccine developed by Pfizer / BioNTech should take place between December 7th and 9th.
This vaccine, which gave early results suggesting the shock is 95 percent effective, needs to be stored at extremely low temperatures.
A hospital executive was told to expect the vaccine to be delivered to NHS staff on December 7th the following week.
On November 20, the Minister of Health announced that he had formally asked the Medicines Agency to evaluate the Pfizer / BioNTech vaccine for use in the UK.
Matt Hancock hailed it as "another major step forward in combating this pandemic".
But he said while regulator approval saw a rollout that could begin next month "there is still a long way to go".
And the MHRA confirmed last Monday that it had received the necessary data to continue its verification that the Pfizer / BioNTech vaccine met the required standards.
From the moment the Pfizer vaccine leaves the factory in Belgium, it can only be withdrawn four times from minus 70 ° C before being injected into a patient's arm.
Sir Simon Stevens, executive director of the NHS in England, said the vaccination program was "the largest vaccination campaign in our country's history".
In a statement, he said: & # 39; This is an important next step in our response to the coronavirus pandemic and hospitals are about to launch the first phase of the largest vaccination campaign in our country's history.
& # 39; The NHS has been shown to have extensive vaccinations from the winter flu shot to BCG. Once the final hurdles are cleared and the vaccine arrives at hospitals in England, health care workers will bring people this groundbreaking vaccination, a program that will be rolled out across the country in the coming months. & # 39;
Pfizer / BioNTech's shock is shipped in special suitcase-sized storage containers that keep it at extremely low temperatures until administered with dry ice.
Dedicated GPS trackers mean that the vaccine's temperature can be monitored remotely to make sure it stays at the right heat to keep it effective.
Details of how the vaccine might be transported and stored came out of concerns that the NHS may have difficulty handling a vaccine that needs to be stored at -70 ° C.
Each of the containers, known as the "dispatcher", holds around 1,000 cans and is equipped with heat sensors so that the pharmaceutical company can track the location and temperature of the frozen vaccine bottles.
The thermal shipping systems can be charged with dry ice if needed, Pfizer said. Vaccines are sent by air and road, but not by boat due to time constraints.
And once the vaccine has been transported, it can be stored in the refrigerator at 2-8 ° C for up to five days, which is quite possible in a standard medicine refrigerator in a family doctor's office.
Mr Hancock told Sky News: 'This is a challenging introduction and the NHS in all parts of the UK stand ready to make it happen. They are used to dealing with such vaccines and drugs in such conditions.
"It's not easy, but we have these plans in place. So I spoke to my colleagues in the decentralized countries this morning to make sure we are all ready to introduce this vaccine … by early next week."
In November, Mr Hancock said the introduction of a Covid vaccine to the masses could be a "mammoth logistics operation".
HOW DO THE OXFORD, MODERNA AND PFIZER / BIONTECH Vaccines compare?
Moderna and Pfizer / BioNTech have both released interim clinical trial results for their end-stage vaccines, both of which indicate that they are extremely effective.
Oxford University has published the results of its second phase, showing that the sting induces an immune response and is safe to use. It's not yet clear how well it protects against coronavirus in the real world.
How to Compare:
PFIZER (US) & BIONTECH (DE)
mRNA vaccine – Genetic material from the coronavirus is injected to stimulate the immune system to make "spike" proteins and learn how to attack them.
mRNA vaccine – both Moderna, Pfizer and BioNTech vaccines work the same way.
Recombinant Viral Vector Vaccine – A harmless cold virus taken from chimpanzees has been engineered to produce the "spike" proteins and look like the coronavirus.
94.5% effective (90 positive in the placebo group, 5 positive in the vaccine group).
95% effective (160 positive in the placebo group, 8 positive in the vaccine group).
62% – 90% effective, depending on the dosage.
Moderna confirmed that countries placing smaller orders, such as the UK's five million cans, will pay between £ 24 and £ 28 per dose. The US has secured 100 million doses for $ 1.525 billion (£ 1.16 billion), suggesting it will cost $ 15.25 (11.57 pounds) per dose.
The US pays $ 1.95 billion (£ 1.48 billion) for the first 100 million doses, which is the equivalent of $ 19.50 (£ 14.80) per dose.
Estimated to cost £ 2.23 per dose. The UK's full 100 million dose supply could add up to just £ 223 million.
The UK has ordered five million cans that will be available from March 2021. Moderna will produce 20 million cans this year, which is expected to remain in the US.
The UK has already ordered 40 million cans, 10 million of which could be available in 2020. The first vaccinations are expected in December.
The UK has already ordered 100 million cans and is expected to come first to get the cans once approved.
What side effects does it cause?
Moderna said the vaccine was "generally safe and well tolerated". Most of the side effects were mild or moderate, but included pain, fatigue and headache, which "generally" were short-lived.
Pfizer and BioNTech did not provide a breakdown of the side effects, but said the Data Monitoring Committee "did not report any serious safety concerns."
Oxford said there were no serious safety concerns. Mild side effects were relatively common in small studies. Many participants reported that their arm hurt after the shock and that they later suffered from headache, fatigue, or muscle pain. Further data is collected.
HOW IS A VACCINE APPROVED SO QUICKLY?
Traditionally, vaccines can take years to research and develop. How was a vaccine approved for rapid use?
How did that come about so quickly?
The schedule for the development and approval of a Covid vaccine was shortened due to the coronavirus crisis.
What is the common procedure for developing a vaccine?
Vaccine development traditionally takes several years and involves various processes, including the design and development phases, followed by clinical trials, which in and of themselves need to be approved before they even begin.
The experiments take place in three successive phases – also known as phases. Research will show whether a vaccine creates antibodies but also protects people from disease. They also identify any security issues.
After the studies are complete, the information gathered by the researchers is sent to the regulators for review.
This is thoroughly analyzed by clinicians and scientists before it is approved for wide use.
After regulatory approval, people can get the vaccine.
Is that different because of the pandemic?
In the studies for a Covid vaccine, the procedure looks a little different.
While the early design and development phases look similar, the clinical trial phases have overlapped – rather than one after the other.
But doesn't that mean security is at risk?
Although some phases of the clinical trial process were parallel rather than sequential, the safety checks were still the same as for any new drug.
The Regulatory Authority for Medicines and Health Products (MHRA) has adopted the term "safety is our catchphrase".
The regulatory authorities have announced that they will "strictly assess" the data and evidence submitted regarding the safety, quality and effectiveness of the vaccine.
In most clinical trials, safety issues are usually identified in the first two to three months – a period that has already passed for most vaccine front-runners.
How do regulators act so quickly?
The regulators have carried out ongoing reviews, which means they have been given access to the data as the scientists work, rather than going through tons of information at the end of the studies.
A rolling review of vaccine data began a few months ago.
This means regulators can start reviewing scientific data earlier than before, which in turn means the approval process can be accelerated.
Regulators sometimes have thousands of pages of information to go through with a fine tooth comb – which understandably takes time.
As soon as all the data available on the vaccine are available, the MHRA experts will carefully and scientifically review the safety, quality and effectiveness data – how they protect people from Covid-19 and what level of protection they offer.
Once this is done, advice will be sought from the government's independent advisory body, the Commission for Medicinal Products for Human Use (CHM).
What does "approved for use" mean?
In order for a medicine to be used in the UK, it must be licensed. This means that all rigorous safety and efficacy tests have been passed and the regulatory authorities are confident of the results of the clinical trials.
By reviewing the data as it becomes available, the MHRA can come to an earlier opinion on whether or not the medicine or vaccine should be approved without compromising the thoroughness of its review.
What data will the regulator check?
The information provided to the MHRA includes what the vaccine contains, how it works in the body, how well it works, what side effects it has and who it is for.
This data must include the results of all animal and human clinical studies, manufacturing and quality controls, batch production consistency, and review of the final product specification.
The factories that manufacture the vaccines are also inspected before a license can be granted to ensure that the product supplied is of the same consistently high standard.
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