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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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Ursula von der Leyen offers speedy response to Ukraine’s bid to join EU

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European Commission chief Ursula von der Leyen said the civilian deaths in the Ukrainian town of Bucha showed the “cruel face” of Russia’s army and pledged to try to speed Ukraine’s bid to become a member of the European Union.

During a visit to Bucha on Friday, where forensic investigators started to exhume bodies from a mass grave, Von der Leyen looked visibly moved by what she saw in the town northwest of Kyiv where Ukrainian officials say hundreds of civilians were killed by Russian forces.

Russia denies targeting civilians and has called the allegations that Russian forces executed civilians in Bucha while they occupied the town a “monstrous forgery”.

As EU officials were about to arrive in Kyiv, at least 50 people were killed and many more wounded in a missile strike at a railway station packed with civilians fleeing the threat of a major Russian offensive in eastern Ukraine.

At a news conference, Von der Leyen condemned what she called “the cynical behaviour” of those who wrote “for our children” on the weapons found near the scene.

Saying the EU could never match the sacrifice of Ukraine, Von der Leyen offered it a speedier start to its bid for bloc membership.

Handing the president, Volodymyr Zelenskiy, a questionnaire which will form a starting point for a decision on membership, she said: “It will not as usual be a matter of years to form this opinion but I think a matter of weeks.”

Zelenskiy told the same news conference he would come back with answers in a week.

“Russia will descend into economic, financial and technological decay, while Ukraine is marching towards the European future, this is what I see,” Von der Leyen said.

Earlier in Bucha, she told reporters: “The unthinkable has happened here. We have seen the cruel face of Putin’s army. We have seen the recklessness and the cold-heartedness with which they have been occupying the city.”

Von der Leyen’s trip to Kyiv was aimed at offering Zelenskiy moral and some financial support.

She pledged her support for Ukraine to “emerge from the war as a democratic country”, something, she said, the European Union and other donors would help with.

Josep Borrell, the EU’s chief diplomat, said he hoped the EU could allocate a further €500m (£420m) to Ukraine for arms purchases in a couple of days.

Zelenskiy has urged Brussels to do more to punish Russia, including banning purchases of Russian oil and gas, and has called on the EU to accept Ukraine as a full member.

Earlier, Borrell said oil sanctions were “a big elephant in the room“, with some concerns that a move to cut out Russian crude could cause a spike in prices that would be painful to European economies. He said a decision on exports would be raised on Monday in Brussels.

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Dutch officials drop case against Rijksmuseum over ‘racist’ word

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The director of the Rijksmuseum said he was “happy” as Dutch prosecutors announced they would not proceed with an investigation into complaints over a newly opened exhibition on Indonesian independence, the first of its kind in Europe.

The exhibition, Revolusi! Indonesia Independent, at the Netherlands’ national museum, has been a source a controversy since one of its curators, Bonnie Triyana, said the term “bersiap”, or stand by, would not be used in reference to the violent upheaval that followed a declaration of independence from the Dutch state.

Triyana claimed that use of the word, a battle cry for young Indonesians seeking independence, “takes on a strongly racist connotation” in the Netherlands today that “always portrays primitive, uncivilised Indonesians as perpetrators of the violence”. He said: “The team of curators has decided not to use the word bersiap as a common term referring to the violent period in Indonesia.”

In a sign of the ongoing sensitivity in Dutch society over the country’s colonial history, the comments drew a furious response in some quarters, with the head of the Federation of Dutch Indonesians, Hans Moll, accusing the Rijksmuseum of genocide denial by ignoring that “thousands of Dutch people were brutally tortured, raped and murdered by Indonesians because of their Dutch or European ethnicity”.

Complaints were made to the general prosecutor last month but Taco Dibbits, the Rijksmuseum’s director, said he had learned on the eve of the exhibition’s opening on Thursday that the justice ministry would not be proceeding with the case.

“I’m happy and had expected the decision that the case is not viable,” he said. “But I think it is very good that there is discussion about these concepts. It is our duty to broaden our view of history.”

Dibbits said the exhibition did make reference to the term bersiap but put it in the context of violence endured by a large range of people, and that the show explored the entire period from 1945 to 27 December 1949 when the Dutch withdrew.

He said: “The term ‘bersiap’ is used in the Netherlands by different communities that had to flee Indonesia and were repatriated during the revolution. It marks a very specific moment in time in the four and a half years of the revolution, the moment of the fall of 1945, when Indonesia has just declared itself independent and groups of insurgents executed extreme violence against several groups: Indo-Europeans, Moluccans on the Dutch side, and Chinese and others they thought were on the Dutch side. It takes place in the chaos just after the declaration of independence.

“We explain the source of the word, which started to be used in the Netherlands in the 1980s, and give it a historical context, but also speak about the violence against other groups during the revolution. We speak about violence in a much broader sense.”

Dibbits said he felt it was a “pity” that complaints had been made to the prosectors before the exhibition had opened. A second complaint, which is also not being pursued, was filed with prosecutors after Dibbits clarified before the opening that the bersiap concept would be referenced.

Dibbits said: “One claimed that not using the term was against history and the second complaint said the using of the term was against history.”

Indonesia became a member of the United Nations in 1950 and today the country counts about 270 million inhabitants across more than 17,000 islands.

The exhibition explores the personal stories of independence fighters, artists, diplomats, politicians, journalists and those seeking to maintain Dutch hold over the territory by displaying more than 200 objects, including privately owned keepsakes and paintings.

Dibbits said among the most powerful artefacts was a bundle of baby clothes made out of book covers, belonging to a young woman called Julia Nelisse. She had given birth to a daughter, Merani, in a leper colony in Pelantungan, modern-day Java, on 6 September 1947.

Corpses of fighters and civilians were regularly washing up on the river shore, which Nelisse laid out on cloth shrouds. Due to the lack of remaining cloth, she had to take the covers from books in the abandoned colony library to make into clothes. On show is a vest, a pillow and a nappy. “It is very emotional to see and brings it very close,” Dibbits said.

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Heidelberg shooting: One dead in gun attack on German students

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A lone gunman has killed one person and seriously injured three others inside a lecture hall at Heidelberg University in the south-west of Germany, before shooting himself dead.

He was an 18-year-old German student.

German police said the shooter, who was armed with two guns, had used a “long gun”, and fired shots around the amphitheatre “wildly”.

The bloodshed triggered a large operation at the university’s campus in the Neuenheimer Feld area.

Police asked people to avoid the area so rescue workers and emergency services could move around freely.

German media reported that the gunman appeared to have no religious or political motive.

Police have searched his flat in the city of Mannheim, and found a WhatsApp message he had sent shortly beforehand, in which he spoke of punishing people.

Heidelberg is a university town with about 160,000 inhabitants.

The country has some of the strictest gun laws in Europe, and school shootings are rare. Anyone under 25 is required to pass a psychological evaluation before getting a gun licence.

Police initially said four victims had been wounded, with a later update confirming one had died in hospital.

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