The Pfizer / BioNTech coronavirus vaccine approval on Wednesday was celebrated as the light at the end of the lockdown tunnel that was finally able to restore the UK to pre-pandemic normalcy.
But the breakthrough, which has been shown to be 95 percent effective at blocking Covid-19 infection, has raised a number of logistical hurdles that make it difficult to get the vaccine to those who need it most, including nursing homes .
The problems arise from the fact that the vaccine is made from volatile genetic material known as mRNA, which is constantly under threat from destruction by other molecules in the environment.
Messenger RNA is used by human cells to carry messages and give instructions. Pfizer's push instructs the body to produce the coronavirus' unique spike protein and train the immune system to detect and fight off future infections.
However, due to the naturally rapid reversal of the lifespan of mRNA, it is inherently a short-lived molecule that is only supposed to exist for a few hours.
This presents a significant problem when attempting to get the mRNA vaccine into a human because under normal conditions it breaks down and becomes unusable.
There aren't many proven ways to ensure the vaccine's long-term survival. A tried and tested method is extremely cold temperatures that stop all movements and reactions and prevent any form of decomposition of the mRNA. However, the vaccine must be given at room temperature because the mRNA must be mobile.
The Pfizer / BioNTech coronavirus vaccine approval on Wednesday was hailed as the light at the end of the lockdown tunnel that was finally able to restore the UK to pre-pandemic normalcy. But the breakthrough, which has been shown to be 95 percent effective at blocking Covid-19 infection, has raised a number of logistical hurdles that make it difficult to get the vaccine to those who need it most difficultly
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If the vaccine is left out for too long before injection, it will become too warm and the mRNA will begin to decay naturally. If this is then injected into a person, it will not work properly, the body will not make spike protein, and there will be no immune response. This person is still prone to Covid-19.
Light and temperature can give the mRNA molecule energy and accelerate the already rapid decay process. To preserve the Pfizer vaccine, it must be stored at extremely low temperatures, around -70 ° C and kept in dark glass vials to protect it from light.
These precise conditions must be followed throughout the vaccine's journey. Once removed from the freezer and thawed, it can only be stored in standard medical refrigerators for five days before it “spoils”.
The manufacturers of the sting warn that it cannot be transported for a maximum of six hours at normal refrigerator temperatures, as it is feared that movement in warmer conditions will break down the vaccine even faster.
Pfizer and BioNTech have created special pizza box-sized shipping containers that are packed with dry ice and keep the vaccines frozen at -70 ° C.
Each box contains 975 vials, which is almost 5,000 doses as each vial contains five doses. This means that it has only been proven safe to dispense between 975 and 4,875 doses at a time.
But the UK regulator did No permission has yet been given to split the batches into smaller doses as insufficient evidence has emerged from Pfizer's studies. This technique does not affect how well the push works.
Further testing will be carried out to see if the batches can be safely broken down into smaller packages and to see if they will remain stable at higher temperatures and require less stringent storage.
Smaller batches would allow the vaccines to be delivered to local centers and nursing homes, but they cannot be used until the Health Products Regulatory Authority (MHRA) provides evidence that the process is equally effective.
Messenger RNA, or mRNA, is a single-stranded piece of genetic material. It is used by human cells to carry messages and give instructions.
The double helix of DNA is split in half, a molecular substitution occurs, and it is then sent from the nucleus into the cytoplasm to relay the message.
How did the UK become the first country in the world to approve a covid vaccine?
Britain became the first country in the world to treat the US and the rest of Europe with a clinically approved coronavirus vaccine on Wednesday.
Pfizer / BioNTech received the green light from the Medicines and Health Products Regulatory Authority (MHRA) within a week of receiving the results of the latest trials of the vaccine.
It usually takes months, if not years, for regulators to review data from vaccine studies and determine whether they are safe, effective, and whether the studies are of a high standard.
But new laws passed the MHRA's ability to keep top-end Covid vaccines under a "rolling review" during the pandemic.
This allowed officials to review data from the studies in real time and approve the vaccine as part of an emergency clearance.
The European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the United States have also carried out ongoing reviews of Pfizer's sting.
But the regulators there say You are aiming for a longer-term approval, for which, according to your own statements, more checks and proof must be submitted than for the temporary approval by the MHRA.
The MHRA must approve every batch of Pfizer vaccine immediately and could theoretically withdraw approval at any time, while approval in the EU and the US would take a year before renewal.
Both the EMA and FDA have safety concerns about the speed at which the MHRA approved treatment.
Dr. June Raine, CEO of MHRA, has assured the British, however, that “no compromises were made” in the approval process and that the sting was assessed “with the greatest care”.
She told a press conference on Downing Street yesterday that experts "worked carefully and methodically around the clock through tables, analysis and graphs for every single element of data."
More than 1,000 pages of data have been examined, she said.
& # 39; The way we work in an ongoing review ensures that our teams of clinicians and scientists work in parallel to complete all work according to strict guidelines for safety, efficacy and quality.
"The vaccine was only approved because these rigorous tests were carried out and followed."
Dr. Raine added, “When you climb a mountain, prepare and prepare. We started this in June.
& # 39; When the interim results became available on November 10th, we were at base camp and by the time we received the final analysis we were ready for the final sprint that continues to lead us to this day.
"That is the exemplary nature of the work done, and the public deserves nothing less."
Another part of the cell then reads its genetic sequence – the message – and does what it is told, which often means making a particular protein. After the blueprint is provided, the mRNA molecule is destroyed by another part of the cell.
The vaccine was designed to deliver a piece of mRNA into human cells that instructs the body to make the SARS-CoV-2 spike protein, thereby triggering an immune response.
Britain has ordered 40 million cans of the burst – which requires two cans 21 days apart – and expects 10 million shots before the new year, including 800,000 as of next week.
Vaccine experts advising the UK government said nursing homes should come first for the Pfizer / BioNTech coronavirus sting, which the UK became the first country in the world to approve yesterday.
However, Number 10 has admitted that the sector will not be given a priority, as the logistics of getting the fragile vaccine are “daunting” and elderly hospital patients are now likely to come first.
Officials are unable to individually deliver vials of the vaccine to 411,000 nursing home residents in the UK due to the ban on dividing the doses.
Wales earlier said that in current conditions it is impossible to bring the shock to nursing homes, while Boris Johnson described the process as "an immense logistical challenge" but did not rule it out entirely.
Sir Simon admitted last night that mass hospitalization would begin, with patients over 80, nursing home staff and some vulnerable people to be the first to arrive.
Jonathan Van-Tam, Deputy Chief Medical Officer for England, told a press conference on Downing Street last night: “As soon as it is legally and technically possible to get the vaccine into nursing homes, we will do so.
& # 39; But this is a complex product with a very fragile culture. This is not a yogurt that can be taken out of the refrigerator and put in several times. & # 39;
The UK is expected to receive its first batch of the vaccine from Pfizer / BioNTech within hours after hundreds of thousands of doses were shipped from Belgian factories yesterday. Professor Van-Tam confirmed this morning that the first shipment will be "very soon".
Vic Rayner, executive director of the National Care Forum, said the organization was waiting "to be given a clear strategy" to get the vaccine "through the door of the nursing home."
She said, "The vaccine has been billed as life-saving and it needs to be given to those who need it most … not falling on the first hurdle because there is no well-thought-out logistical plan."
Care England professor Martin Green, who represents households across the country, said, "With this in mind, the Oxford vaccine needs to be approved as soon as possible to protect nursing home residents from Covid-19."
The vaccine can be removed from the shipping container and placed in a stationary medical refrigerator for up to five days before it goes off. Alternatively, it can be kept in its original shipping container for 30 days when topped up with dry ice once a week.
However, manufacturers say it currently only lasts six hours when shipped – even in special cooling bags that keep it chilled at the same temperature as in a refrigerator – and that general practitioners are racing against time to make sure that the cans are used and are not lost.
Further scientific studies on the storage and transportation of the vaccine are likely to change this when there is enough data to show it is safe to keep for long periods of time. But BioNTech, the German company that owns the vaccine, said yesterday that despite current restrictions, it should still be possible to get it to nursing homes.
For now, at least, this means that it will be easier for vulnerable people to visit hospital centers across England and get personal vaccinations where medical professionals are not faced with time constraints.
Dr. Frank Atherton, chief medical officer for Wales, also claimed the vaccine could not be agitated more than four times prior to injection for fear it could become unstable and ineffective.
By the time it reaches UK hospitals, it will have been transported down the supply chain three times – first at Pfizer's manufacturing facility in Belgium, before ending up at hospitals and hubs in the UK where it can be managed.
Long-term storage of the Pfizer vaccine is not a problem. 50 hospitals and vaccination centers across the country are already equipped with freezers cold enough to keep them at -70 ° C – 13 in the Midlands, eight in the North West, South East and South West, seven in East England and London and each only one in Yorkshire and the North East.
Professor Anthony Harnden, vice chairman of the Joint Committee on Vaccination and Immunization (JCVI), said today the body's priority list for vaccines is "flexible".
Nursing homes are high on the JCVI's priority list of who should get a vaccine. However, due to logistical problems with the Pfizer stitch, there may be delays in passing it on to residents and employees.
When asked about the logistical problems in managing the Pfizer stitch, Prof. Harnden told BBC Radio 4's Today program: “We have always understood this at JCVI.
'Our clear job was to decide on prioritization groups, but that there would be storage, transport and administration restrictions for vaccine products and individual local circumstances.
“In our declaration we pointed out that the approach to this list is flexible, depending on what was actually feasible and logistical on site. So this is not entirely unexpected, but the clear list we have created is a list of priorities related to vulnerability. & # 39;
The UK military ran its largest vaccine distribution operation to date yesterday after the Pfizer vaccine sealed MHRA approval.
The exercise, code-named Exercise Panacea, took place at Ashton Gate Football and Rugby Stadium in Bristol. Approximately seven regional hubs are used to vaccinate the broader population as GP surgeries target high-risk patients and hospitals are used to immunize NHS and nursing home staff, as well as some patients.
In yesterday's exercise, 30 staff and volunteers were dragged around the building pretending to be different types of patients, from one with a side effect to one with symptoms or one who doesn't get the bump.
The stadium is scheduled to have vaccinations 12 hours a day, seven days a week. Other venues to be used as regional hubs include Nightingale Hospital in London's ExCeL Center, Leicester Racecourse and the Manchester Tennis and Football Center.
The NHS estimates that between now and April there will be between 75,000 and 110,000 people vaccinated each week at the stadium and other local facilities in Bristol and the neighboring towns of North Somerset and South Gloucestershire.
Yesterday's exercise follows an earlier live field exercise, codenamed Exercise Asclepius, held at Epsom Downs Racecourse in October to gauge the capabilities of mass vaccination centers.
Everything you need to know about the new Pfizer vaccine
IS IT SAFE?
Yes, it has been tested on 43,500 in six countries … and should offer one year of protection
Is it that big of a deal
The approval by the Medicines and Health Products Regulatory Authority (MHRA) means the UK will be the first country to receive an approved vaccine against coronavirus – an incredible feat.
WHEN DOES IT START?
Around 800,000 doses are expected to arrive at 50 hospitals in England just in time for the start of vaccination on Monday.
WHO WILL GET IT FIRST?
Because hospitals have large freezers to keep the vaccine in, they start the program. Those over 80 will get it first, most likely those patients who have already been booked for outpatient appointments. Hospitals will also begin vaccinating their own staff, as well as other NHS and nursing home staff.
AND NURSING HOME?
Nursing home residents are high on the priority list. However, due to the practical distribution of the vaccine, a delay of a few days, even a few weeks, can be expected before it is reached.
WHY KEEP IT?
Pfizer vaccine must be transported and stored at -70 ° C in containers with trays containing 975 doses. The original approval states that these bowls can only be divided shortly before vaccination begins. The NHS asked the MHRA to check whether doses with a larger gap can be removed from bowls before vaccination.
Who is in the queue?
The over 75 year olds and the over 70 year olds are next. People with serious illnesses – those who had to shield during the first wave – will be next, and then over 65 years old. Then people with diseases like diabetes and asthma. Then the over 60s, over 55s and over 50s.
AND EVERYONE ELSE?
The mass phase is slated to begin sometime in January. The order has yet to be completed but is likely based on the cast. The shock has not been approved for children under the age of 16 or pregnant women as it is not known whether it is safe for them.
IS THERE ENOUGH TO GO AROUND?
Britain has ordered 40 million doses from Pfizer – enough to vaccinate 20 million people. For everyone to get a sting, the MHRA must approve the Oxford-AstraZeneca vaccine.
HOW DO I KNOW I CAN GET THE JAB?
You will be contacted by your hospital or family doctor, probably by text message or letter.
WHO WILL GIVE ME THE JAB?
Doctors and nurses will lead the vaccination effort, supported by pharmacists, nursing home staff, volunteers and the armed forces. Retired NHS workers were encouraged to help.
How soon until I'm sure
Some protections will kick in around 12 days after the first bump, but it will take at least four to five weeks to take full effect. There is a three to four week break between the two doses and then another week until full protection is achieved.
And how long will I be protected?
That's not yet clear, but scientists believe that their shock should offer at least a year of protection.
IS IT SAFE?
Yes. The sting was tested on 43,500 people in six countries. Side effects were minimal and no safety concerns were raised.
Does it mean the end of COVID?
Experts are increasingly confident that the sting will mean an end to Covid restrictions at least early next year.
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