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UK regulator approves Oxford/AstraZeneca coronavirus vaccine

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UK regulators have approved the use of the Oxford University/AstraZeneca coronavirus vaccine, which is cheaper and easier to distribute than some rivals and could in time offer a route out of the pandemic for large parts of the world.

The UK government said it would follow a new immunization strategy for the vaccine, which will prioritize giving the first in a series of two vaccine doses to as many people as possible, before administering a second dose up to 12 weeks later.
This will apply to both the newly approved Oxford/AstraZeneca vaccine and the Pfizer/BioNTech vaccine which is already being administered.
“This is important because it means that we can get the first dose into more people more quickly and they can get the protection the first dose gives you,” UK Health Secretary Matt Hancock told Sky News on Wednesday.
“The scientists and the regulators have looked at the data and found that you get what they call ‘very effective protection’ from the first dose. The second dose is still important — especially for the long-term protection — but it does mean that we will be able to vaccinate more people more quickly than we previously could.”
The UK is the first country to approve the Oxford University/AstraZeneca vaccine, which will be rolled out there from January 4. The news represents a glimmer of hope for the UK at a time when its health services are struggling to cope with soaring infection rateslinked to a new, more contagious variant of the virus.
The approval comes weeks after the country became the first in the world to start inoculating its citizens with the rival Pfizer/BioNTech coronavirus vaccine. Margaret Keenan, 91, received her second dose of that vaccine on Wednesday, three weeks after she became the first patient outside of clinical trials to receive it.
The Oxford University/AstraZeneca vaccine has the potential swiftly to protect millions more people around the world as and when other nations’ regulators grant approval.
AstraZeneca has promised to supply hundreds of millions of doses to low and middle-income countries, and to deliver the vaccine on a not-for-profit basis to those nations in perpetuity.
The vaccine is significantly cheaper than others which have been approved and, crucially, it would be far easier to transport and distribute in developing countries than its rivals since it does not need to be stored at freezing temperatures.
Hancock said Wednesday that the UK had 100 million doses of the Oxford/AstraZeneca vaccine on order, which, combined with 30 million doses of the Pfizer/BioNTech vaccine, would be enough to vaccinate the entire UK adult population.
The country already has 530,000 doses of the Oxford/AstraZeneca vaccine ready to begin inoculations on Monday, he told the House of Commons. “Today’s news means that everyone who wants one can get a vaccine,” Hancock said, adding that AstraZeneca is due to supply millions more doses from the beginning of February.
Earlier, Hancock told Sky News the NHS was “standing ready to deploy, at the sort of pace that is needed to be able to help us to get out of this pandemic by the spring.”
UK Prime Minister Boris Johnson tweeted that the vaccine’s approval was “truly fantastic news — and a triumph for British science.” He added: “We will now move to vaccinate as many people as quickly as possible.”

‘No corners cut’

The UK’s National Health Service (NHS) is coming under increasing pressure as Covid-19 cases soar in many regions. The UK recorded a further 53,135 coronavirus cases on Tuesday, breaking its daily record since the pandemic began for a second day in a row.
More areas of England were move into the toughest level of restrictions from Thursday, amid attempts to limit the spread of the new, more infectious variant. Three-quarters of England’s population will be under the strict rules, which mandate the closure of all non-essential retail, gyms, close-contact services such as hair salons, and all hospitality venues.
Hancock told the House of Commons that more than 21,000 people were currently in hospital with coronavirus in England. “Unfortunately this new variant is spreading across most of England,” he warned.
Some scientists have called on the government to impose even tougher restrictions to rein in the virus’ spread, such as delaying children’s return to in-person teaching in schools next year or imposing a full national lockdown.
Authorities declared a major incident Wednesday in the county of Essex, northeast of London, in response to “significant growing demand” on local hospitals after a surge in coronavirus cases there.
Dr. June Raine, chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) — the UK regulatory body — told a televised Downing Street briefing Wednesday that the newly approved Oxford/AstraZeneca vaccine could save “tens of thousands” of lives.
And she insisted that the public could have every confidence in its safety, effectiveness and quality.
“Our teams of scientists and clinicians have very carefully, methodically and rigorously reviewed all the data on safety, on effectiveness and on quality as soon as they have become available, and have done so around the clock, looking at all the tests and trials … no corners, whatsoever, have been cut,” she said.
Professor Wei Shen Lim, chair of the Joint Committee on Vaccination and Immunisation, told the briefing that “we can expect that the amount of vaccine available for use in the UK will substantially increase, very very soon. This increase in the vaccine supply will in turn allow a much higher rate of vaccine deployment across the UK, to all parts of the country.”
He added that the second vaccine dose was still important “because it may impact on the duration of protection.”
Both approved vaccines will be used across the UK, Lim said. “To facilitate rapid deployment within a mass vaccination program, and to avoid substantial vaccine wastage, it may be that in certain settings, one vaccine is offered in preference over another,” he said, adding that the deployment of both vaccines would allow for “rapid and high levels of vaccine uptake” across the country.
The Oxford/AstraZeneca vaccine can be kept at refrigerator temperatures of 2 to 8 degrees Celsius (36 to 46 degrees Fahrenheit) for at least six months.
Moderna’s vaccine has to be stored at minus 20 degrees Celsius (minus 4 degrees Fahrenheit) — or at refrigerator temperatures for up to 30 days — and the Pfizer/BioNTech vaccine has to be stored at minus 75 degrees Celsius (minus 103 degrees Fahrenheit), and used within five days once refrigerated at higher temperatures.
The vaccines are based on different technology. AstraZeneca’s offering — like Johnson & Johnson’s vaccine and Russia’s Sputnik V — uses an adenovirus to carry genetic fragments of coronavirus into the body.

Updated advice

Previously, the team developing the Oxford/AstraZeneca vaccine said it had an “an average efficacy of 70%,” with one dosing regimen showing an efficacy of 90%.
But the experts who gave Wednesday’s Downing Street briefing said a full analysis of the trial data had not borne out the team’s finding that that regimen — in which a half dose was followed by a full dose — was more effective. The MHRA approved the vaccine at two full doses, which has an efficacy of 62%.
Prof. Munir Pirmohamed, chair of the Commission on Human Medicines’ Expert Working Group, said the trial data had led scientists to recommend giving as many people as possible their first dose of vaccine with a second dose following within 12 weeks.
“Because of the design of the trial, some people got second doses at different time intervals. This allowed for an analysis of the effectiveness of the vaccine if you were to be able to delay between 4-12 weeks,” he said. “This showed that the effectiveness was high, up to 80% when there was a three month interval between first and second doses, which is the reason for our recommendation.”
Pirmohamed noted that partial immunity only kicked in 22 days after the first dose and urged people to continue to follow social distancing guidelines even once they have had their first jab.
UK government scientific adviser Professor Calum Semple welcomed what he called a new, “sophisticated approach,” telling Sky News that a “one-dose approach to start with will protect a great many people.” According to Semple, evidence from vaccine trials has shown that a single dose has not only prevented people from getting severe disease, but also has prompted a “very good immune response” in frail and elderly people.
However, some scientists called for greater clarity over the data underpinning the latest vaccine approval and the country’s new immunization strategy.
Dr. Jonathan Stoye, of the Francis Crick Institute, told the UK’s Science Media Centre that important questions remained unanswered, including the real efficacy of the vaccine, how well it worked in older people and whether it prevented transmission between people.
“It remains unclear exactly how much protection is offered, and the regulators are using unpublished data to come to their judgment,” said Dr. Simon Clarke, Associate Professor in Cellular Microbiology at the University of Reading.
“When questioned, the regulators floated an efficacy of 70% between 22 days and 12 weeks, but it seems likely that this is a fleeting maximum rather than a consistent level of protection. The vaccine’s efficacy after two doses is 62%, so it looks likely that the higher number would only be very short-lived.
“At a time of increasing rates of infection, hospitalization and death from Covid-19, greater clarity is urgently needed over any risks associated with extending the second dose window to 12 weeks.”
The UK also updated its advice on administration of the Pfizer/BioNTech vaccine Wednesday.
It now recommends an interval of at least 21 days between the first and second dose, rather than requiring the second dose to be 21 days after the first.
The vaccine can now be considered for use in pregnancy when the potential benefits outweigh the risks, following an individual discussion with every woman, Raine said. Woman who are breastfeeding can now also be given the vaccine, subject to that individual discussion.
The vaccine can also now be given to people with allergies, provided they are not allergic to any of the ingredients in the vaccine, she said.

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Magdalena Andersson: Sweden’s first female PM returns after resignation

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bbc– Sweden’s first female prime minister has been reappointed to the top job after political turmoil forced her to resign within hours of taking the post last week.

MPs backed Social Democratic Party leader Magdalena Andersson by a narrow margin in a new vote on Monday.

She will attempt to lead a one-party government until an election in September next year.

She stood down as PM last Wednesday after her coalition collapsed.

Just hours earlier, Ms Andersson had been elected as Sweden’s first female prime minister by a single vote in parliament.

But the 54-year-old economist’s plan for forming a new coalition government with the Green Party was thrown into disarray when her budget proposal failed to pass.

  • Sweden’s first female PM resigns hours after appointment

Instead, parliament voted for a budget drawn up by a group of opposition parties, including the far-right Sweden Democrats.

The Green Party said it would not accept a budget drafted by the far-right and walked away from the government, leading to its demise.

By convention, the prime minister in Sweden is expected to resign if a coalition party leaves government.

In Monday’s vote in Sweden’s parliament, the Riksdag, 101 of its 349 members voted yes, 75 abstained and 173 voted no.

To be appointed prime minister under Sweden’s political system, a candidate only needs to avoid a majority voting against them.

At a news conference after the vote, Ms Andersson said she was ready to “take Sweden forward” with a programme focused on welfare, climate change and crime.

But without the support of other parties, Ms Andersson will struggle to pass legislation in parliament, where the centre-left Social Democrats hold 100 of 349 seats.

After a week of drama, Magdalena Andersson’s prime ministerial career is back on track, but Sweden’s political soap opera is far from over.

Ms Andersson still has to implement a budget put together by some of her right-wing rivals. Plus, she’s got to govern a fragile minority without the formal support of the Greens, who’ve been a crucial coalition partner since 2014.

All this has highlighted the complexities of having a deeply divided eight-party parliament. Some political commentators here are worried that Ms Andersson’s chaotic rise to power may have dented trust in the entire political system.

Once formed, Ms Andersson’s new government will remain in place until general elections, which are set to take place in September next year. Until then, she’s got just over nine months to prove herself to the public.

A former junior swimming champion from the university city of Uppsala, Ms Andersson began her political career in 1996 as political adviser to then-Prime Minister Goran Persson.

She has spent the past seven years as finance minister before becoming leader of the Social Democrats at the start of November.

She replaced Stefan Lofven, who resigned as prime minister after seven years in power.

Until Ms Andersson took over, Mr Lofven had remained prime minister of a caretaker government after being ousted in an unprecedented vote of no confidence in June.

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Covid: Europe region faces 700,000 more deaths by March – WHO

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bbc– A further 700,000 people could die of Covid by March in Europe and parts of Asia, the World Health Organization has warned.

The death toll already exceeds 1.5 million in the 53 countries of what the WHO terms as its Europe region.

The WHO warned of “high or extreme stress” in intensive care units in 49 of the nations by March 2022.

Europe is facing a surge in cases, prompting Austria to return to lockdown and others to consider fresh measures.

A number of countries – including France, Germany and Greece – could also soon make booster jabs a requirement for their citizens to be considered fully vaccinated.

But several countries have seen fierce protests against new measures. The Netherlands saw several nights of rioting over a partial lockdown.

In its assessment, the WHO warned Covid was the top cause of death in its Europe region.

“Cumulative reported deaths are projected to reach over 2.2 million by spring next year, based on current trends,” the WHO said on Tuesday.

Confirmed Covid-related deaths recently doubled to almost 4,200 a day, it added.

In Russia alone, the daily death toll has been recently topping 1,200.

A high number of unvaccinated people and the prevalence of the Delta variant in some countries were key factors behind high transmission rates in the Europe region, the WHO said.

The WHO Europe director, Dr Hans Kluge, urged those who were still unvaccinated to get the jab.

“All of us have the opportunity and responsibility to help avert unnecessary tragedy and loss of life, and limit further disruption to society and businesses over this winter season,” he said.

As well as European nations, the WHO also considers Israel and ex-Soviet states like Tajikistan and Uzbekistan as making up the region.

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Liverpool bomb investigators ‘discovering more by the hour’ says security minister

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independent– Security minister Damian Hinds has said counterterrorism police are “discovering more by the hour” about the Liverpool attack, as he suggested it was “not impossible” others could have been involved.

His remarks come after police named the failed bomber who died in the Liverpool Women’s Hospital explosion as 32-year-old Emad al-Swealmeen and the UK’s terror threat was raised to “severe” from “substantial”.

Addressing the situation, Mr Hinds stressed it could be “weeks” before the full picture of the attack is known, including the motivation and whether others were involved.

“It’s a live investigation and the police do have the space, the time, to be able to conduct that investigation fully and carry on their searches of the key address and carry on with the analysis,” he told Times Radio.

He said: “It’s not impossible that there could be other people involved. If that is the case, as the police said in their statement last night, they’ll make arrests quickly.

“I’m not in a position to be able to comment on the background of the individual, the deceased individual or to speculate about the case.”

In a separate interview on Sky News, the minister also said the Covid pandemic and lockdowns may have “exacerbated” the number of people self-radicalising online — an issue previously highlighted by experts.

He said: “It certainly is true that we’ve seen a move over time, a shift from these what we call directed attacks, part of a bigger organisation where people are following instructions, sometimes quite complex in their organisation, and move from that to more self-directed, some self-radicalised individuals or small groups, rarely totally, totally alone.”

He added: “There has been that move. During the lockdown periods there have been more people spending more time in front of computer screens and we know that when that happens for a very small minority, a very very small minority, there can be radicalisation.

“I’m afraid it’s not brand now — radicalisation, self-radicalisation on the internet, the propaganda, the way people make contact with each other, that is not a new development, but like a number of things the changes we saw through the coronavirus period, through lockdown changed the modus operandi and this case yes they will have exacerbated and increased the amount of time people are spending online”.

But he defended the decision to reduce the terror threat in February when quizzed on the issue, saying: “The alert level is determined independently of ministers — it’s not something I determine, or the Home Secretary determines.

“We have a body JTAC — Joint Terrorism Analysis Centre — who are experts in this area. They use the alert level the way that law enforcement, security services and others can calibrate what they are doing.

“We’ve been at a high alert for a very long time now and that’s the important,” he added.

Asked again on why the alert level was changed despite the risk of people becoming radicalised online during the pandemic, he added: “The alert level was substantial, meaning an attack was likely.”

He added: “These are not decisions that I made or ministers mind. We trust professionals and experts in the field. My opinion is that I absolutely trust them to make those correct judgments. “

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