Babak Belurs

Rabu, 30 Desember 2020

COVID-19: Second dose of COVID vaccines to be given later after guidelines change - Sky News

The second dose of the coronavirus vaccines will be given later than originally planned, experts have said.

Live COVID updates from UK and around world

The move is to ensure more people are given a first dose to help fight the UK's rising coronavirus infection rate, with the second dose administered up to three months later.

Speaking at a briefing at Downing Street, Professor Wei Shen Lim, chair of the Joint Committee of Vaccinations and Immunisations, said the "immediate urgency" was for the rapid rollout of the new Oxford/AstraZeneca vaccine and to ensure high levels of uptake.

He said: "We recommend delivery of the first vaccine should be prioritised for both the Pfizer/BioNTech and the Oxford/AstraZeneca vaccine.

"This will allow the greatest number of people to receive the vaccine in the shortest possible time - and that will protect the greatest number of lives."

But Professor Sir Munir Pirmohamed, chair of the Commission on Human Medicine Expert Working Group which looked into the efficacy and safety of the Oxford vaccine warned it did not take effect until after three weeks, so safety measures should be followed in the interim.

A first dose of the jab gives around 70% effectiveness from three weeks after immunisation.

However, he said it was 80% effective when there was a three-month interval between the first and second doses.

He added: "We examined the half-dose regime but we felt that the results were not borne out by the full analysis."

The Oxford vaccine was approved for use in the UK earlier by the Medicines and Healthcare products Regulatory Agency (MHRA).

The first doses of the Oxford jab are due to be given on Monday amid rising coronavirus cases in the UK.

The panel also outlined new advice for dosage of the first approved vaccine - the Pfizer/BioNTech vaccine.

Previous guidance had suggested the second dose could be taken up to 21 days after the first, but today that changed to at least 21 days after the initial vaccine.

And it also announced changes to the advice for those with allergies and for those pregnant or breastfeeding women.

Dr Raine, chief executive of the MHRA, said previous advice had not recommended its use by pregnant and breastfeeding women due to "an initial lack of evidence on a precautionary basis".

But she told a briefing: "Now that we have reviewed further data that has become available, the Commission on Human Medicines has advised that the vaccine can be considered for use in pregnancy when the potential benefits outweigh the risks, following an individual discussion with every woman.

"And as the COVID-19 vaccine AstraZeneca is the same, women should always be discussing benefits and risks of having the vaccine with their health professional, reaching a decision together based on individual circumstances, and women who are breastfeeding can now also be given the vaccine, subject to that individual discussion."

On the issue of those with allergies, the advice also changed.

Dr Raine said growing evidence from a pool of at least 800,000 people in the UK and probably 1.5 million people in the US who have had the vaccine, had "raised no additional concerns".

This, she continued, "gives us further assurance that the risk of anaphylaxis can be managed through standard clinical guidance and an observation period following vaccination of at least 15 minutes.

"And so the Commission on Human Medicines has now advised that anyone with allergy to food or other medicine or vaccine can have the Pfizer/BioNTech vaccine.

"Of course, anyone with a history of allergic reaction to this vaccine, or its ingredients, should not."

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2020-12-30 13:30:00Z
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U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca - The New York Times

Health officials hope to soon vaccinate a million people per week as the country’s hospitals are overwhelmed by cases of a new, more contagious coronavirus variant.

LONDON — Britain on Wednesday became the first country to give emergency authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, clearing the path for a cheap and easy-to-store shot that much of the world will rely on to help end the pandemic.

In a bold departure from prevailing strategies around the world, the British government also decided to begin giving as many people as possible a first dose of coronavirus vaccines, rather than holding back supplies for quick second shots, greatly expanding the number of people who will be inoculated.

That decision put Britain at the vanguard of a far-reaching and uncertain experiment in speeding up vaccinations, one that some scientists believe will curb the suffering wrought by a pandemic that has been killing hundreds of people each day in Britain and thousands more around the world.

The effects of delaying second doses as a way of giving more people the partial protection of a single dose are not fully known. Britain, believed by experts to be the first country to undertake such a plan, will also delay second doses of the Pfizer-BioNTech vaccine, which has been in use there for several weeks and has been shown in clinical trials to have considerable efficacy after a single dose.

Some participants in the clinical trial of the Oxford-AstraZeneca vaccine were given the two doses several months apart. British regulators said on Wednesday that the first dose of the vaccine had 70 percent efficacy in protecting against Covid-19 in the period between that shot taking effect and a second shot being administered, though those figures held for a limited subset of trial participants and have not been published.

How the Oxford-AstraZeneca Vaccine Works

An adenovirus helps prime the immune system to fight the coronavirus.

Together, the two moves by Britain — authorizing the Oxford-AstraZeneca vaccine and lengthening the gap between doses — offered the clearest signal yet of how countries still in the grip of the virus might hasten the pace of vaccination programs.

The Oxford-AstraZeneca shot is poised to become the world’s dominant form of inoculation. At $3 to $4 a dose, it is a fraction of the cost of some other vaccines. It can be also shipped and stored in normal refrigerators for six months, rather than in the ultracold freezers required by vaccines from Pfizer-BioNTech and Moderna, making it easier to administer to people in poorer and harder-to-reach parts of the world.

“This is very good news for the world — it makes a global approach to a global pandemic much easier,” said Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. Of the decision to delay the second doses, he said, “In a pandemic, it will be better to get more people some level of protection than to have all of the people being vaccinated get full protection.”

Instead of administering the two shots of the coronavirus vaccines within a month as was originally planned, clinicians in Britain will wait as long as 12 weeks to give people second doses, the government said. Matt Hancock, the health secretary, said people would start receiving the AstraZeneca vaccine early next week.

For Britain, where hospitals are overwhelmed by a deluge of cases of a new, more contagious variant of the virus, the decision by its drug regulator offered some hope of a reprieve. The health service is preparing to soon vaccinate a million people per week at makeshift sites in soccer stadiums and racecourses.

The Royal Free Hospital in London. British hospitals are flooded with coronavirus patients. — Andrew Testa for The New York Times

When given in two full-strength doses, AstraZeneca’s vaccine showed 62 percent efficacy in clinical trials — considerably lower than the roughly 95 percent efficacy achieved by Pfizer and Moderna’s shots. For reasons that scientists do not yet understand, AstraZeneca’s vaccine showed 90 percent efficacy in a smaller group of volunteers who were given a half-strength initial dose.

British regulators authorized the vaccine at two full-strength doses, saying that the more promising results from the other regimen were not borne out by a full analysis. They cautioned that the promising results for efficacy after a single dose of the vaccine held only in a limited number of trial participants.

In recent days, the Oxford scientists who developed the vaccine have voiced some support for delaying second doses. Andrew Pollard, the director of the Oxford Vaccine Group, said in a radio interview on Monday that it made “a lot of sense to get started with as many people as possible” by delaying the second dose.

Coronavirus Vaccine Tracker

A look at all the vaccines that have reached trials in humans.

Britain’s health service must now figure out how to persuade people to take a vaccine that appears less effective than other available shots, but that nevertheless could hasten the end of the pandemic.

The authorization relied on data from late-stage clinical trials in Britain and Brazil. India’s drug regulator is also expected to decide soon whether to authorize the vaccine, which is being manufactured there by a local vaccine producer, the Serum Institute.

A decision is further off in the United States, where the Food and Drug Administration is waiting for data from a separate clinical trial. The study was halted in September and delayed for nearly seven weeks — much longer than in other countries — as regulators investigated whether an illness in a participant in Britain was related to the vaccine. American regulators ultimately allowed the trial to proceed.

Andrew Testa for The New York Times

AstraZeneca has set more ambitious manufacturing targets than other vaccine makers, saying that it expects to be able to make up to three billion doses next year. At two doses per person, that would be enough to inoculate nearly one in five people worldwide. The company has pledged to make it available at cost around the world until at least July 2021 and in poorer countries in perpetuity.

But the company has also been dogged by communication blunders that have damaged its relationship with United States regulators and raised doubts about whether the vaccine will stand up to intense public and scientific scrutiny. Those blunders have set back the vaccine’s timeline in the United States, where key F.D.A. officials were stunned to learn of the pause in its clinical trials in September not from AstraZeneca, but from the news media.

These setbacks have not dampened enthusiasm in Britain for the country’s leading homegrown vaccine, one that analysts have said could right the course of Prime Minister Boris Johnson’s careening tenure if rolled out quickly.

Having ordered 100 million doses, 40 million of which are supposed to be available by March, Britain has made the AstraZeneca shot the linchpin of its vaccination strategy. Since authorizing Pfizer’s vaccine on Dec. 2, Britain has used it to vaccinate hundreds of thousands of people. But the country has struggled to administer it beyond hospitals and doctor’s offices, leaving some of its highest-priority recipients, like nursing home residents, still vulnerable.

Andrew Testa for The New York Times

“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” Pascal Soriot, AstraZeneca’s chief executive, told The Times of London in an interview published on Saturday. The company has released no evidence of efficacy rates as high as Pfizer or Moderna’s. “I can’t tell you more because we will publish at some point,” Mr. Soriot told The Times.

Oxford scientists published interim findings from the vaccine’s clinical trials in The Lancet this month. Forthcoming final results from those trials are not expected to be significantly different from the interim data, as is typical in clinical research.

AstraZeneca’s U.S. trial had enrolled more than 27,000 participants as of last week, just short of its goal of 30,000. The trial could have results and, if positive, lead to an emergency authorization in the United States in February or March, Moncef Slaoui, the head of Operation Warp Speed, the U.S. federal effort to fast-track coronavirus vaccines, said in a news conference last week.

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2020-12-30 12:16:00Z
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COVID-19: Second dose of COVID vaccines to be given later after guidelines change - Sky News

The second dose of the coronavirus vaccines will be given later than originally planned, experts have said.

The move is to ensure more people are given a first dose to help fight the UK's rising coronavirus infection rate, with the second dose administered up to three months later.

Speaking at a briefing at Downing Street today, Professor Wei Shen Lim, chair of the Joint Committee of Vaccinations and Immunisations, said the "immediate urgency" was for the rapid rollout of the new Oxford-AstraZeneca vaccine and to ensure high levels of uptake.

"We recommend delivery of the first vaccine should be prioritised for both the Pfizer/BioNTech and the Oxford-AstraZeneca vaccine.

"This will allow the greatest number of people to receive the vaccine in the shortest possible time - and that will protect the greatest number of lives," he added.

But Professior Sir Munir Pirmohamed, chair of the Commission on Human Medicine Expert Working Group which looked into the efficacy and safety of the new vaccine warned it did not take effect until after three weeks, so safety measures should be followed in the interim.

But he said it was 80% effective three months after the first dose.

He added: "We examined the half-dose regime but we felt that the results were not borne out by the full analysis."

The Oxford/AstraZeneca vaccine was approved for use in the UK earlier today by the Medicines and Healthcare products Regulatory Agency (MHRA).

How do the various vaccines compare?

The first doses of the Oxford jab are due to be given on Monday amid rising coronavirus cases.

The panel also outlined new advice for dosage of the first approved vaccine - the Pfizer/BioNTech vaccine.

Previous guidance had suggested the second dose could be taken up to 21 days after the first, but today that changed to at least 21 days after the initial vaccine.

And it also announced changes to the advice for those with allergies and for those pregnant or breastfeeding women.

Dr Raine, chief executive of the MHRA, said previous advice had not recommended its use by pregnant and breastfeeding women due to "an initial lack of evidence on a precautionary basis".

On the issue of those with allergies, the advice also changed.

Dr Raine said growing evidence from a pool of at least 800,000 people in the UK and probably 1.5 million people in the US who have had the vaccine, had "raised no additional concerns".

This, she continued, "gives us further assurance that the risk of anaphylaxis can be managed through standard clinical guidance and an observation period following vaccination of at least 15 minutes.

"And so the Commission on Human Medicines has now advised that anyone with allergy to food or other medicine or vaccine can have the Pfizer/BioNTech vaccine.

"Of course, anyone with a history of allergic reaction to this vaccine, or its ingredients, should not."

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Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK - BBC News

The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases.

The UK has ordered 100 million doses - enough to vaccinate 50 million people.

This will cover the entire population, when combined with the full order of the Pfizer-BioNTech jab, Health Secretary Matt Hancock said.

It comes as millions more people in England are expected to be placed under the toughest tier four restrictions.

On Tuesday, 53,135 new Covid cases were recorded in the UK - the highest single day rise since mass testing began - as well as 414 more deaths within 28 days of a positive test.

Dr June Raine, head of the Medicines and Healthcare Regulatory products Agency (MHRA), said the vaccine would save tens of thousands of lives, adding "no corners have been cut" in assessing the safety and effectiveness of the jab.

Prime Minister Boris Johnson called the vaccine development "a triumph" for British science, adding: "We will now move to vaccinate as many people as quickly as possible."

And England's chief medical officer Chris Whitty praised the "considerable collective effort that has brought us to this point".

'2021 year of hope and recovery'

Vaccination centres will now start inviting patients to come and get the Oxford-Astra Zeneca vaccine from next week.

It is considered essential because it is easier to store and distribute - it can be kept at normal fridge temperature unlike the Pfizer-BioNTech jab that has to be kept at -70C.

There is also more confidence about supply as it is UK-made, whereas the Pfizer-BioNTech jab has to be shipped in from Belgium.

The hope is around two million patients a week could soon be vaccinated with two vaccines now approved.

British Medical Association GP leader Dr Richard Vautrey said it "should certainly be possible" if there is good supply.

Speaking on BBC Breakfast, Mr Hancock said it marked a "significant moment" in the fight against the virus, adding that "2021 can be a year of hope and recovery because we can see our way out of the pandemic".

More than 600,000 people in the UK have been vaccinated with the Pfizer-BioNTech jab since Margaret Keenan became the first in the world to be given a Covid vaccine outside of a clinical trials.

Prof Andrew Pollard, director of the Oxford Vaccine Group, told BBC Radio 4's Today programme the vaccine approval was an "astonishing achievement" in science and clinical research.

But he said there was still "more work to do", warning: "It's not over yet."

"Our colleagues in hospital are facing some real horrors caused by this virus. The next steps are critical," he said.

Meanwhile, the health secretary has said that more areas will be placed under England's toughest tier four - "stay at home" - restrictions.

Mr Hancock will set out further details of the changes in the House of Commons later.

He has urged people to "stay in this new year" regardless of what tier their local area is under - in a bid to slow the spread of the virus.

Education Secretary Gavin Williamson will also be making a statement later about the return of schools in England in January.

The new vaccine approval comes after Public Health England said the country was facing "unprecedented" levels of infections, and health officials in parts of Wales, Scotland and the south of England voiced concerns about the increasing pressure on the NHS.

Graphic showing how the Oxford vaccine works

Who will get the vaccine?

Priority groups for immunisation have already been identified, starting with care home residents, the over 80s and health and care workers.

Eventually the programme will see all over 50s and younger adults with health conditions offered one of the jabs.

That is more than 25 million in total.

As well as approval of the Oxford-AstraZeneca vaccine, the government announced the immunisation campaign will now shift to giving as many people as possible their first dose of vaccine with a second dose following within 12 weeks.

When the Pfizer-BioNTech jab started being given the aim was to give the second dose after three weeks.

But based on advice from the Joint Committee on Vaccination and Immunisation the aim now is to give as many vulnerable people some protection from Covid-19 - irrespective of the jab they are given.

Trials showed two full doses of the Pfizer-BioNTech jab were 95% effective at preventing infection, while the Oxford-AstraZeneca one showed 62% effectiveness - although even in cases where people were infected there were no cases of serious illness.

Trials of the Oxford-AstraZeneca vaccine also showed when people were given a half dose then a full dose effectiveness hit 90%.

But there was not enough clear data to approve the half-dose, full-dose idea.

However, unpublished data suggests that leaving a longer gap between the first and second doses increases the overall effectiveness of the jab.

All the vaccines are expected to be equally effective against the new variants of the virus that have emerged.

Do you have any questions about the coronavirus vaccine? Email haveyoursay@bbc.co.uk.

WhatsApp: +44 7756 165803
Tweet: @BBC_HaveYourSay
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2020-12-30 10:31:00Z
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Covid-19: Oxford-AstraZeneca coronavirus vaccine approved for use in UK - BBC News

The Oxford-AstraZeneca vaccine has been approved for use in the UK, with the first doses due to be given on Monday amid rising coronavirus cases.

The UK has ordered 100 million doses - enough to vaccinate 50 million people.

This will cover the entire population, when combined with the full order of the Pfizer-BioNTech jab, Health Secretary Matt Hancock said.

It comes as millions more people in England are expected to be placed under the toughest tier four restrictions.

On Tuesday, 53,135 new Covid cases were recorded in the UK - the highest single day rise since mass testing began - as well as 414 more deaths within 28 days of a positive test.

Prime Minister Boris Johnson called the vaccine development "a triumph" for British science, adding: "We will now move to vaccinate as many people as quickly as possible."

And England's chief medical officer Chris Whitty praised the "considerable collective effort that has brought us to this point".

The Oxford-AstraZeneca vaccine was designed in the first months of 2020, tested on the first volunteer in April, and has since been through large-scale clinical trials involving thousands of people.

It is the second jab to be approved in the UK after the Pfizer-BioNTech vaccine was given the go-ahead in December.

Unlike the Pfizer-BioNTech jab, which needs ultra cold storage at -70C, the Oxford-AstraZeneca can be stored in a standard fridge so will be easier to deliver to care homes and GP surgeries.

AstraZeneca's chief executive Pascal Soriot told BBC Radio 4's Today programme the company will "progressively ramp up" the vaccination programme, and will be able to deliver up to two million doses a week.

More than 600,000 people in the UK have been vaccinated since Margaret Keenan became the first in the world to be given it outside of a clinical trial.

Analysis box by James Gallagher, health and science correspondent

The approval of the Oxford-AstraZeneca vaccine marks a major turning point in the pandemic.

It will lead to a massive expansion in the UK immunisation campaign aimed at getting life back to normal.

The shift to giving as many people as possible the first doses of either approved vaccine effectively doubles the number of people given some protection.

The second dose, which gives maximum protection, will come up to three months later.

However, the next couple of months still look bleak.

Health officials have spoken of "unprecedented" levels of infection and some hospitals are struggling with the number of patients.

The restrictions we are all living under are likely to get tougher before vaccines make a tangible difference and sets us on the path to normality.

Prof Andrew Pollard, director of the Oxford Vaccine Group, told BBC Radio 4's Today programme the vaccine approval was an "astonishing achievement" in science and clinical research.

But he said there was still "more work to do", warning: "It's not over yet."

"Our colleagues in hospital are facing some real horrors caused by this virus. The next steps are critical," he said.

Meanwhile, the health secretary has said that more areas will be placed under England's toughest tier four - "stay at home" - restrictions.

Mr Hancock will set out further details of the changes in the House of Commons later.

He has urged people to "stay in this new year" regardless of what tier their local area is under - in a bid to slow the spread of the virus.

Education Secretary Gavin Williamson will also be making a statement later about the return of schools in England in January, Mr Hancock said.

Who will get the vaccine?

Priority groups for immunisation - including the elderly, care home residents and health and care workers - have already been identified.

The immunisation campaign will now shift to giving as many people as possible their first dose of vaccine.

The aim will be to give as many vulnerable people some protection from Covid-19.

The decision is based on advice from the Joint Committee on Vaccination and Immunisation.

A Department of Health and Social Care spokesperson said: "The priority should be to give as many people in at-risk groups their first dose, rather than providing the required two doses in as short a time as possible.

"Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer term protection."

How effective is the Oxford vaccine?

There are three figures doing the rounds - 62%, 70% and 90%.

The first analysis of the trial data showed 70% of people were protected from developing Covid-19 and nobody developed severe disease or needed hospital treatment.

The figure was just 62% when people were given two full doses of the jab and 90% when they were first given a half dose and then a full one.

The Medicines and Healthcare products Regulatory Agency (MHRA) has approved two full doses of the Oxford-AstraZeneca vaccine.

However, unpublished data suggests that leaving a longer gap between the first and second doses increases the overall effectiveness of the jab.

There was not enough clear data to approve the half-dose, full-dose idea.

All the vaccines are expected to be equally effective against the new variants of the virus that have emerged.

How does it work?

The vaccine is a genetically modified common cold virus that used to infect chimpanzees.

It has been altered to stop it causing an infection in people and to carry the blueprints for part of the coronavirus, known as the spike protein.

Once these blueprints are inside the body they start producing the coronavirus' spike protein, which the immune system recognizes as a threat and tries to squash it.

Then, when the immune system comes into contact with the virus for real, it already knows what to do.

Follow James on Twitter.

Do you have any questions about the coronavirus vaccine? Email haveyoursay@bbc.co.uk.

WhatsApp: +44 7756 165803
Tweet: @BBC_HaveYourSay
Please read our terms & conditions and privacy policy

Or use this form to get in touch:

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Rabu, 30 Desember 2020

COVID-19: Second dose of COVID vaccines to be given later after guidelines change - Sky News

More from Covid-19

U.K. Authorizes Covid-19 Vaccine From Oxford and AstraZeneca - The New York Times

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'2021 year of hope and recovery'

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