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The vaccine approval will finally be shortened from 20 to 5 days


The approval of Covid vaccine batches is to be accelerated drastically in an enormous push for the stab campaign.

Amid growing concerns about the slow pace of the rollout, sources told The Mail that testing would be reduced from up to 20 days to just four days.

The drug and health regulator in charge of controls is also said to be adding staff to speed up the mass vaccination program.

It has just approved a second shipment of 500,000 cans of the Oxford Jab that delivers over a million.

The vaccine is vital as it is much easier to distribute than the Pfizer version, which must be stored at minus 70 ° C.

MPs have questioned why there were only half a million cans of Oxford's jab available in the first week – despite promises that 30 million would be ready last September.

Coronavirus deaths surged above 1,000 yesterday for the first time since April, while cases climbed to another record high of 62,322.

The mail highlighted a number of vaccine rollout issues that are critical to reducing the pandemic and lifting coronavirus restrictions.

A government source yesterday admitted that the initial rollout of the Oxford Stitch was "slow" but promised a big acceleration towards the end of this week.

Meanwhile, Vaccines Minister Nadhim Zahawi said Public Health England was "on one foot" to give doses every day of the week.

More details will be announced tonight when NHS England General Manager Sir Simon Stevens appears at a press conference on Downing Street.

The plan is expected to include:

  • Hundreds of primary care practices are receiving their first Oxford vaccines today, which will accelerate the roll-out in nursing homes.
  • Seven huge vaccination centers will open next week in London, Newcastle, Manchester, Birmingham, Bristol, Surrey and Hertfordshire.
  • Community pharmacies that join the vaccination program within days, despite fears they will be excluded;
  • Super drug used as part of the NHS vaccination effort;
  • Drive-through vaccinations in the parking lots of the Morrisons stores starting Monday;
  • 1,000 vaccination centers will be up and running by the end of the week, including hospitals and general practitioners.
  • According to a report last night, doctors are supposed to prioritize shocks over other treatments.

The drug and health regulator in charge of controls is also said to be adding staff to speed up the mass vaccination program

The drug and health regulator in charge of controls is also said to be adding staff to speed up the mass vaccination program

Doubts about the plan to inject 13 million vulnerable people by mid-February have grown since Boris Johnson slammed the country into lockdown Monday night

Doubts about the plan to inject 13 million vulnerable people by mid-February have grown since Boris Johnson slammed the country into lockdown Monday night

A nurse administers the Oxford-AstraZeneca vaccine to a patient at the Pontcae Medical Practice on January 4th in Merthyr Tydfil, Wales. Oxford-AstraZeneca's COVID-19 vaccine was administered in a handful of hospitals before being rolled out to hundreds of GP-run locations across the country

A nurse administers the Oxford-AstraZeneca vaccine to a patient at the Pontcae Medical Practice on January 4th in Merthyr Tydfil, Wales. Oxford-AstraZeneca's COVID-19 vaccine was administered in a handful of hospitals before being rolled out to hundreds of GP-run locations across the country

Bumps eliminated as a general practitioner are hit by delays in care

Older people urgently had to cancel Covid vaccination appointments because doctors did not receive their supplies on time. Patients across the country booked for their first push have since been contacted to learn they will have to wait longer.

Many GPs say they still haven't received their first batch of the vaccine, despite being promised before Christmas. Some say they received multiple canceled shipments. Frontline NHS workers are also missing out on vaccinations. In one case, employees stood in line for hours outside a hospital to cancel their appointments due to a planning error.

It has sparked new fears that Boris Johnson will fail to deliver on his promise to protect 13 million of the most vulnerable Britons by the middle of next month. Last night, Professor Martin Marshall, chairman of the Royal College of GPs said, “We have to have more than two million vaccinations a week – this is a challenging but necessary goal. "Last minute changes to vaccine delivery schedules, as some general practitioners report, only create confusion for patients and a lot of hard work for practices that need to quickly adjust their schedules and minimize them."

Doubts about the plan to inject 13 million vulnerable people by mid-February have grown since Boris Johnson slammed the country into lockdown Monday night.

Topics included the bureaucracy that voluntary vaccines faced, the delivery of batches to nursing homes, the distribution network, and the time it took to approve each batch.

So far, the MHRA's National Institute for Biological Standards and Control has checked batches individually at their Hertfordshire site.

This time-consuming process has been blamed for slowing deployment. Only 530,000 of the four million available doses of the Oxford Jab had passed ratings before last night.

The process has been changed to allow more than one batch to be assessed at the same time, reducing the timescale from up to 20 days to just four or five.

An MHRA spokesperson said: “We are working closely with manufacturer AstraZeneca to ensure that batches of the vaccine are released as quickly as possible.

“Biological medicines like vaccines are inherently complex and independent tests, such as those conducted by the National Institute, are critical to ensuring quality and safety.

"The institute has expanded its capacity to ensure that multiple batches can be tested at the same time and that this can be done as quickly as possible without compromising quality and safety."

The delivery of the Oxford Jab to 775 GP surgeries, which will take place starting today, is another crucial step.

This will enable vaccination to be significantly accelerated in nursing homes where only 10 percent of residents have previously received the bite.

The 25 percent of deaths caused by Covid-19 (see graph on the right) are the highest percentage so far during the second wave, and this means that the total number of people who died this week is significantly higher than at the same time in previous years (graphic on the left)

The 25 percent of deaths caused by Covid-19 (see graph on the right) are the highest percentage so far during the second wave, and this means that the total number of people who died this week is significantly higher than at the same time in previous years (graphic on the left)

NHS statistics show that people under the age of 40 rarely die from Covid-19. 100 of the 17,572 deaths in November and December in this age group

NHS statistics show that people under the age of 40 rarely die from Covid-19. 100 of the 17,572 deaths in November and December in this age group

So far, only hospitals have received the Oxford vaccine.

On the Commons yesterday, Tory MPs called on Mr Johnson to speed up the introduction of the vaccine so that lockdown restrictions can be lifted as soon as possible.

Huw Merriman, a member of Bexhill and Battle, said: "Any injection in the arm should be viewed as a student who can return to the classroom."

Mr Zahawi said Public Health England agreed to distribute the vaccine seven days a week, amid concerns that they would not work on Sundays.

He told talkRadio: “If you have to deliver on a Sunday, you will deliver on a Sunday. They have been delivering six days a week so far as the NHS told the vaccines to go out.

“You're on track seven days a week to get more vaccines. The head of PHE has said that they have always stood on whatever seven day foundation they wish, and they will continue to do so.

"That is absolutely a priority for her and for the entire NHS."

Appointments for Covid-19 jabs will be AXED because the general practitioners did not receive the vaccine on time

Elderly people have canceled urgently needed Covid vaccination appointments because doctors did not receive their supplies on time.

Patients across the country booked for their first push have since been contacted to learn they will have to wait longer.

Many GPs say they still haven't received their first batch of the vaccine, despite being promised before Christmas. Some say they received multiple canceled shipments.

Frontline NHS workers are also missing out on vaccinations. In one case, employees stood in line for hours outside a hospital to cancel their appointments due to a planning error.

Patients across the country booked for their first push have since been contacted to learn they will have to wait longer

Patients across the country booked for their first push have since been contacted to learn they will have to wait longer

Many GPs say they still haven't received their first batch of the vaccine, despite being promised before Christmas

Many GPs say they still haven't received their first batch of the vaccine, despite being promised before Christmas

It has sparked new fears that Boris Johnson will fail to deliver on his promise to protect 13 million of the most vulnerable Britons by the middle of next month. Last night, Professor Martin Marshall, Chairman of the Royal College of GPs said, “We need to have more than 2 million vaccinations a week – this is a challenging but necessary goal.

"Last minute changes to vaccine delivery schedules, as some general practitioners report, only create confusion for patients and a lot of hard work for practices that need to quickly adjust their schedules and minimize them."

Pharmacies promise

Vaccination Minister Nadhim Zahawi has insisted pharmacists will help give shocks after criticizing them for being ignored.

Pharmacy workers across the country give flu shots every winter, so should have the skills to give Covid injections.

The President of the Royal Pharmaceutical Society, Sandra Gidley, told Radio 4's Today program yesterday: “There are more than 11,000 pharmacies. You have an army of trained vaccines ready, willing, and able. & # 39;

Mr. Zahawi said there would be a "massive acceleration" of shocks and "we will make sure the community pharmacies and the independent sector are involved".

Senior Labor MP Kevan Jones told how a group of doctors in his constituency in North Durham were promised a delivery on December 16.

The family doctors on Chester-le-Street were then told that the deliveries would not arrive until January 4th – and they now expect "at the earliest" today.

Even when the shipment arrives, it will only contain one batch of Pfizer's 975-dose vaccine and a "possibility" of 400 doses of the AstraZeneca vaccine. This is not enough for all nursing home residents.

Mr Jones warned Vaccination Secretary Zahawi in a letter last night: “The local GPs have drawn up extensive plans for the vaccine to be administered, but this is not being supported by vaccines that don't arrive or government increases in expectations that can't are hit. & # 39;

In Sussex, Meads Medical Center had to cancel appointments booked for the next week after a scheduled delivery of the Pfizer vaccine to care for those over 80 was canceled. Now only a small amount of the AstraZeneca vaccine is expected.

Castle Medical Center and Abbey Medical Center in Kenilworth, Warwickshire, had to cancel appointments for those over 80 last week due to insufficient doses. A similar story was told by a general practitioner in south London, Dr. Rosemary Leonard. She wrote on Twitter: “We rarely want to go, but we don't have vaccines. WHY? & # 39;

Meanwhile, NHS staff in Scotland were left standing in the cold outside the Royal Infirmary in Glasgow for hours to get bumped as there were no staff on duty to administer them.

Some went in chaos on Tuesday without a vaccination. NHS Greater Glasgow and Clyde have apologized.

A government spokesman said last night: "This is the largest vaccination program in the history of the NHS.

"It's accelerating every day, and we will have vaccinations in over 1,000 locations by the end of this week."

The routine appointments have to be interrupted in the fight for the vaccination against the coronavirus, the doctors are informed

by Ben Spencer and Victoria Allen for the Daily Mail

General practitioners are being asked to take back routine appointments so they can prioritize Covid vaccinations, it was alleged last night.

The instructions sent to doctors state that the bumps should be the top priority – other "nonessential" activities may be postponed for weeks.

NHS England has already advised operations to focus on vaccine delivery, with jab dates taking precedence over everything else.

The British Medical Association, the medical trade organization, is also calling on general practitioners to "re-prioritize and postpone other activities in the coming weeks," The Daily Telegraph reported last night. The guidelines suggest that if not urgent, health workers should not stop essential work in order to speed up the pace of adoption.

Guidelines sent to physicians state that bumps should be the top priority - other "non-essential" activities may be postponed for weeks. Pictured is a patient receiving the Oxford-AstraZeneca vaccine at the Pontcae Medical Practice on January 4th

The instructions sent to doctors state that the bumps should be the top priority – other "nonessential" activities may be postponed for weeks. Pictured is a patient receiving the Oxford-AstraZeneca vaccine at the Pontcae Medical Practice on January 4th

It follows growing concern over the sluggish start to the UK vaccination campaign, with only 530,000 Oxford pokes cleared for use this week. This was a tiny fraction of the 30 million doses the UK had promised to be ready in time for the vaccine to be approved.

Use pubs, polling stations and offices, urges Blair

Tony Blair urged Boris Johnson to open thousands of polling stations and empty offices as coronavirus vaccination centers.

The former prime minister (pictured below) said it was necessary to accelerate the vaccination program dramatically in order to "save our economy".

He called for a change in the drug and health product regulator and the government to support the production of glass vials needed for the vaccines.

The former prime minister said there was a need to dramatically speed up the vaccination program

The former prime minister said there was a need to dramatically speed up the vaccination program

Mr Blair called for a lot more transparency on who should be poked and when – to keep the public's trust alive. And he called for more pharmacists and family doctor offices to deliver bursts.

Mr Blair said his plan would deliver 5 million a week by the end of March – meaning more than half the population would have been vaccinated by then. "Nobody questions the monumental scale of the Covid-19 challenge or the specific task of introducing mass vaccination," said the former chairman in a foreword to a report by the Tony Blair Institute for Global Change.

& # 39; The NHS has done an exceptional job to vaccinate so many people so far. But the reality is … we need to get on a whole new footing and speed up this program dramatically.

"Public confidence would also be greatly increased if the plan to achieve this goal were completely transparent."

Mr Blair said there were 50,000 polling stations that should be used, as well as empty offices and even pubs. He said the operations should take longer and called for the red tape to be cut so that 5,500 pharmacists can deliver the vaccine.

Testing the starting doses took 20 days – with only one batch tested, until that number was doubled yesterday. Officials have now made an effort to address the problem, cutting the time it takes to approve each batch to four days. The regulatory authorities can now test several batches at the same time.

However, a swift acceleration is needed if the UK is to vaccinate the massive amounts needed to ease Covid restrictions.

Eight months ago, when the nation was still in the grip of the first wave, Economy Minister Alok Sharma insisted that adequate doses would be available.

He announced that the government had signed a contract with AstraZeneca to manufacture 100 million doses of the Oxford vaccine, 30 million of which would be ready by September.

Results were delivered at the end of November – the vaccine worked. And AstraZeneca insisted it could deliver enough vaccine to fill 20 million injections by the end of 2020.

Though a little less than the 30 million Mr Sharma had promised, it would still be a strong start, despite the company admitting that only 4 million of these were in vials and ready to go.

It took another month for the Medicines and Health Products Regulator (MHRA) to confirm that the vaccine was safe and effective.

But by the time that approval was finally announced a little over a week ago, the four million cans had somehow shrunk to 530,000. With at least 25 million people in the government's priority vaccination groups, that number was scanty. Why were so few vaccines available?

AstraZeneca has been slightly too promising – enough has been made to give the UK an initial dose of 15 million – up from the previously promised 20 million. But it produced the four million vial vaccines it promised. Rather, the main delay was the MHRA batch test program. Due to the quality control requirements, each individual batch must be tested separately by both AstraZeneca and MHRA.

Quality control is carried out in the laboratory of the MHRA National Institute for Biological Standards and Control in Potters Bar, Hertfordshire. The NIBSC receives samples from each batch of vaccine and performs a series of tests.

One of the most complex elements is making sure that each vial contains the correct dose. Scientists also need to make sure the push does what it is intended to do. AstZeneca runs a series of tests and the NIBSC runs its own tests in parallel. When the two are done, they make sure the results match, and when they match, a batch test certificate is issued.

But by the time that approval was finally announced a little over a week ago, the four million cans had somehow shrunk to 530,000. With at least 25 million people in the government's priority vaccination groups, that number was scanty. Why were so few vaccines available?

AstraZeneca has been slightly too promising – enough has been made to give the UK an initial dose of 15 million – up from the previously promised 20 million. But it produced the four million vial vaccines it promised. Rather, the main delay was the MHRA batch test program. Due to the quality control requirements, each individual batch must be tested separately by both AstraZeneca and MHRA.

Eight months ago, when the nation was still in the grip of the first wave, Economy Minister Alok Sharma insisted that adequate doses would be available. Pictured here is Pat being given a dose at Poncae Medical Practice in Merthyr Tydfil

Eight months ago, when the nation was still in the grip of the first wave, Economy Minister Alok Sharma insisted that adequate doses would be available. Pictured here is Pat being given a dose at Poncae Medical Practice in Merthyr Tydfil

Quality control is carried out in the laboratory of the MHRA National Institute for Biological Standards and Control in Potters Bar, Hertfordshire. The NIBSC receives samples from each batch of vaccine and performs a series of tests.

One of the most complex elements is making sure that each vial contains the correct dose. Scientists also need to make sure the push does what it is intended to do. AstZeneca runs a series of tests and the NIBSC runs its own tests in parallel. When the two are done, they make sure the results match, and when they match, a batch test certificate is issued.

Until yesterday this had only happened once – on December 29th – when the first batch of 530,000 cans was approved. A second batch was certified yesterday, doubling the doses available. However, if the UK is to vaccinate the 13 million most vulnerable people on the top four levels of its priority list by mid-February, the process needs to accelerate rapidly.

Changes have been made so that the NIBSC can evaluate multiple lots at the same time.

The labor force in the laboratory, which normally employs 300 scientists, has also been increased. Government officials believe these changes will cut the time it takes to evaluate each batch from 20 days to four or five. When this is achieved, the vaccines begin to flow.

Show us proof that only one dose works, says BARRY JONES

by Barry Jones, Surgeon and Covid Vaccine Volunteer, for the Daily Mail

As a plastic surgeon who specializes in reconstructing the facial features of children affected by birth defects, I see the differences high-tech medicine can make for young people every day.

But ever since I volunteered for the Covid-19 vaccination program, I've been reminded that something as simple and quick as a sting can also be of great use.

In the center of a London hospital, where I gave up to 80 vaccinations a day, I saw many elderly people who had not left their homes since March last year.

For them, the shock offers some hope that this may change and they are so grateful to the dedicated staff and volunteers who work from 8 a.m. to 7 p.m. with a break of just half an hour.

Barry Jones (pictured) is a consulting plastic surgeon and has volunteered to help with vaccination. Since the UK became the first country in the world to approve the Pfizer / BioNTech vaccine in early December, we've been told that 95 percent of its effectiveness depends on two doses three weeks apart

Barry Jones (pictured) is a consulting plastic surgeon and has volunteered to help with vaccination. Since the UK became the first country in the world to approve the Pfizer / BioNTech vaccine in early December, we've been told that 95 percent of its effectiveness depends on two doses three weeks apart

However, I am concerned that their efforts could be undermined by the sudden U-turn in vaccination policy that Professor Jonathan Van-Tam, the deputy chief medical officer, outlined earlier this week.

Since the UK became the first country in the world to approve the Pfizer / BioNTech vaccine in early December, we've been told that 95 percent of its effectiveness depends on two doses three weeks apart.

It has now been decided that the priority will be to give a first dose to as many people as possible, with the second dose not being needed until 12 weeks later.

In explaining the strategy, Professor Van-Tam claimed that the Pfizer / BioNTech vaccine was 89 percent effective between 15 and 21 days after the first dose. This increases to 95 percent after the second dose.

His argument, as always eloquently put, goes like this: "When a family has two elderly grandparents and two vaccines are available, it's no better to protect both 89 percent than to protect one 95 percent two quick doses and the other grandparent no protection at all? & # 39;

I understand the desire to vaccinate as many people as possible, and if these numbers are correct, you would have no argument from me.

However, both Pfizer and BioNTech, the manufacturers, have emphasized that in the only study to date with the new vaccine, two doses were used 21 days apart. This clearly showed that maximal immunity (95 percent) was not reached until seven days after the second dose.

There are no data for any other regimen, and the only preliminary immunity figure given in the Pfizer / BioNTech article (published in the New England Journal of Medicine) was 52 percent approximately 14 days after the first dose.

There's a big difference between 52 percent and 89 percent. Although a subsequent analysis of the US Food and Drug Administration figures found 88.9 percent efficacy after the first dose, it also states, “This cannot support a conclusion about the efficacy of a single dose of the vaccine as the observation time is dadurch begrenzt, dass die meisten Teilnehmer nach drei Wochen eine zweite Dosis erhielten.

"Die Studie hatte keinen Einzeldosisarm, um einen angemessenen Vergleich zu ermöglichen."

Mit dem größten Respekt für alle Beteiligten ist die Zahl von 89 Prozent eine Annahme, die auf einer retrospektiven Analyse der Daten beruht – und wird dennoch in dem vom Gemeinsamen Ausschuss für Impfung und Immunisierung am 31. Dezember veröffentlichten Papier wiederholt, dem Dokument, auf dem die Eine neue Änderung der Richtlinien wurde vorgenommen.

Ich bin weit davon entfernt, dies in Frage zu stellen. In der Tat hat die FDA selbst gefordert, dass das Impfprotokoll nicht ohne eine weitere klinische Studie geändert werden sollte.

"Ohne geeignete Daten, die solche Änderungen bei der Impfstoffverabreichung belegen, besteht ein erhebliches Risiko, dass die öffentliche Gesundheit gefährdet wird", sagte FDA-Kommissar Stephen Hahn letzte Woche.

Und die Europäische Arzneimittel-Agentur hat auch mehr klinische Daten gefordert, bevor eine solche Änderung vorgenommen wird.

Als Kliniker, der selbst viele Studien durchgeführt hat, stimme ich zu.

Der einzige Weg, um sicher zu sein, dass die von Professor Van-Tam vorgeschlagene Änderung der richtige ist, besteht darin, eine neue Studie in Auftrag zu geben, in der die Wirksamkeit einer zweiten Dosis nach 21 Tagen mit der nach 12 Wochen verglichen wird.

Bis mehr bekannt ist, besteht die Möglichkeit, dass die vorgeschlagene Abweichung von der angegebenen Dosis vielen Patienten und Mitarbeitern an vorderster Front eine unzureichende Immunität bietet und, schlimmer noch, möglicherweise die erste Dosis vollständig verschwendet.

Darüber hinaus gaben Patienten, die bereits eine erste Dosis erhalten hatten, ihre Zustimmung speziell für ein Zwei-Dosis-Regime, das um 21 Tage voneinander getrennt war.

Ihnen wurde betont, wie wichtig es ist, dass sie für die zweite Dosis zurückkehren. Nun wird vorgeschlagen, den zweiten Termin abzusagen.

Die Einwilligung nach Aufklärung ist ein Eckpfeiler der medizinischen Praxis, und es wird normalerweise nicht als ethisch oder rechtmäßig angesehen, ohne guten Grund davon abzuweichen.

Ja, es ist wichtig, dass wir das Impfprogramm so schnell wie möglich einführen, aber in den letzten neun Monaten wurde uns immer wieder gesagt, dass wir der Wissenschaft folgen sollen.

Und die Wissenschaft in Bezug auf diesen Impfstoff sagt zwei Dosen, die durch 21 Tage getrennt sind.

Es kann sein, dass Professor Van-Tam und seine Kollegen Zugang zu Daten haben, die der Rest von uns nicht hat. Wenn ja, sollten sie es veröffentlichen.

Bis dahin bin ich weiterhin besorgt, dass wir in Gefahr sind, aus den richtigen Gründen die falschen Dinge zu tun.

  • Barry Jones ist Honorary Consultant Craniofacial Surgeon am Great Ormond Street Hospital

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