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EU regulator authorises AstraZeneca vaccine for all adults

Regulators authorised AstraZeneca's coronavirus vaccine for use in adults throughout the European Union on Friday, amid criticism the bloc is not moving fast enough to vaccinate its population.

The European Medicines Agency's expert committee unanimously recommended the vaccine to be used in people 18 and over, though concerns had been raised this week that not enough data exist to prove it works in older people.

The shot is the third COVID-19 vaccine given the greenlight by the European Medicines Agency, after ones made by Pfizer and Moderna. Both were authorised for all adults. The decision requires final approval from the European Commission, a process that occurred swiftly with the other vaccines.

Mary Williams, right, receives an injection of the Oxford/AstraZeneca vaccine at the mass vaccination centre in Newcastle Upon Tyne, England on January 11, 2021

"There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group," the regulator said, but added that "protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines.

"EMA's scientific experts considered that the vaccine can be used in older adults," the agency said.

RELATED: Johnson & Johnson announce details of single shot coronavirus vaccine

Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up at a time when countries face surging cases in a pandemic that has taken the lives of more than 400,000 people in the 27-nation bloc.

The EU bet heavily on the shot, which is cheaper and easier to handle than some other vaccines, with orders for 300 million doses to be delivered after authorisation and options for another 100 million doses.

Emer Cooke, the head of the EMA, said it was "a real pleasure" to authorise the vaccine.

Emer Cooke, the head of the European Medicines Agency, at the European Medicines Agency building in Amsterdam, the Netherlands, Friday Nov. 13, 2020

"None of them is a magic wand on its own, but together they provide tools and options to prevent different aspects of the disease," she said.

While the AstraZeneca vaccine has been authorised for all adults in other countries, only 12 per cent of the participants in its research were over 55 and they were enrolled later, so there hasn't been enough time to get results. But some doctors warned that restricting the vaccine's use in older people might worsen the pandemic's impact, since older people have suffered more severe disease and died at a higher rate from the coronavirus.

In its decision on Friday, the EMA assessed four trials in the UK, Brazil and South Africa. The agency said the research showed the vaccine proved to be about 60 per cent effective by reducing the number of people who got sick. The trials have not yet shown whether the vaccine can stop disease transmission.

Jack McDermott draws up the AstraZeneca/Oxford University COVID-19 vaccine at Acklam Road pharmacy on January 28, 2021 in Middlesbrough, England.

A separate study testing the AstraZeneca vaccine in the US is still underway.

Professor Andrew Pollard, director of the Oxford Vaccine Group that developed the shot together with AstraZeneca, welcomed the decision.

"The recommendation by the European Medicines Agency is an important milestone in extending access to the Oxford/ AstraZeneca vaccine in our region and providing further endorsement that, after the rigorous scrutiny of regulators, the vaccine can be used to help protect populations from the coronavirus pandemic," he said in a statement.

While politicians have blamed supply problems for the EU's slow roll-out, other factors, like onerous paperwork and poor planning, have also played a role. The EU has particularly lashed out at AstraZeneca after the drug-maker said it would initially supply less vaccine than originally anticipated.

Exacerbating concerns about supplies to the bloc, which is home to some 450 million people, Moderna told countries including Italy and Denmark the company would be delivering fewer vaccines than originally expected.

Jens Spahn, the German health minister, said Friday he understood many were waiting impatiently for the vaccine, but cautioned that "several hard weeks of vaccine shortage still lie before us."

Greg Hunt addresses concerns about AstraZeneca coronavirus vaccine

Before the EMA announcement, Spahn had said Germany would use the regulator's recommendation to decide whether the AstraZeneca vaccine should only be given to people aged 18-64 for now, as suggested in a draft recommendation by the country's independent vaccine advisory committee. Britain's medicines regulatory agency also acknowledged the limited data in older people but still cleared the shot last month for all adults, with some caution for pregnant women.

Julian Tang, a virologist at the University of Leicester, said he thought any recommendation to limit the vaccine's use to people under 65 was understandable, but "overly cautious."

The AstraZeneca shot appears to offer less protection than the other two vaccines given the greenlight by the EMA, the Pfizer and Moderna shots, which showed roughly 95 per cent efficacy rates.

Two more vaccine makers also recently announced results, with Novavax saying this week that its shot appears 89 per cent effective based on early findings and Johnson & Johnson saying its long-awaited single-shot vaccine was 66 per cent effective at preventing moderate to severe illness. If those vaccines are eventually licensed, that could help alleviate the pressure on the world's huge demand for the limited shots currently available.

The authorisation of the AstraZeneca vaccine comes amid a bitter dispute between the drug-maker and the bloc after the company said it would sharply reduce initial deliveries from 80 million doses to 31 million.

Amid fears doses from AstraZeneca could be diverted outside the bloc, EU officials are expected to propose measures Friday that could be used to block vaccine shipments to non-EU countries.

The AstraZeneca vaccine has already been authorised in several countries, including Britain, India, Argentina and Mexico. The World Health Organisation is also reviewing it; a recommendation from the UN health agency would allow its purchase and distribution to developing countries from a global program known as COVAX.

Single malt scotch whisky fetches over $70,000 at auction

A 72-year-old bottle of Glen Grant single malt whisky from Scotland fetched more than $70,000 at an auction in Hong Kong on Friday.

It is the first time that the 1948 Glen Grant whisky, by independent bottler Gordon & MacPhail, was offered in an auction.

It is number 88 of 290 decanters bottled by the company and was auctioned off by Bonhams, fetching a price of 421,600 Hong Kong dollars ($70,754) including premium.

READ MORE: One of the last privately-owned Botticelli portraits has sold for a record $120 million

The bottle had a book estimate of 300,000 to 380,000 Hong Kong dollars ($50,365 to $63,796).

The whisky, the oldest from the Glen Grant distillery, is in a Dartington crystal decanter with an American black walnut presentation box.

Despite the economic uncertainty brought by the pandemic, interest in rare whiskies remains high.

Compared to other investment commodities, collectable whisky has done well in the past 10 years with a four-fold increase in prices, said Christopher Pong, wine and whisky specialist at Bonhams.

Other whiskies featured in Friday's auction included a 35-year-old Hibiki whisky from Japan in a Kutani ceramic decanter that sold for 372,000 Hong Kong dollars ($62,463).

Small explosion near Israeli Embassy in New Delhi

A "very low intensity" device exploded on Friday near the Israeli Embassy in the Indian capital, but there were no injuries and little damage, police said.

New Delhi police said the only damage was to the windows of three cars parked nearby, which were shattered by the blast.

A preliminary investigation "suggests a mischievous attempt to create a sensation," police said in a statement.

Police cordoned off the area and were investigating.

Israel's foreign ministry said in a statement that "there are no casualties and no harm was done to the building. All Israeli diplomats and embassy staff are safe and sound."

Indian External Affairs Minister Dr Subrahmanyam Jaishankar tweeted that he "Spoke just now to Israeli Foreign Minister Gabi Ashkenazi about the explosion outside the Israeli Embassy."

"We take this very seriously," he said in the tweet.

"(I) assured him of the fullest protection for the Embassy and Israeli diplomats.

"(The) matter is under investigation and no effort will be spared to find the culprits."

https://twitter.com/DrSJaishankar/status/1355156267451478022?s=20

The New Delhi Television news channel said the explosive device had ball bearings wrapped in a plastic bag and was left on the pavement outside the embassy.

There was no immediate police confirmation.

The blast in the high-security zone occurred while India's president and prime minister were attending a ceremony marking the end of Republic Day celebrations.

The venue is about 1.4 kilometres from the Israeli Embassy.

In 2012, an explosion under an Israeli Embassy car in New Delhi injured four people, including the wife of a diplomat.

Police said two men riding on a motorbike planted the explosive device under the car when it stopped at a traffic signal. The device exploded soon afterwards.

Johnson & Johnson announce details of single shot coronavirus vaccine

Johnson & Johnson's (J&J's) long-awaited coronavirus vaccine appears to protect against COVID-19 with just one shot — though not as strong as some two-shot rivals, it's still potentially helpful for a world in dire need of more doses.

"If it's a single-dose vaccine, then a billion vaccine doses would translate into a billion people vaccinated," Dr Dan Barouch of Harvard Medical School, who helped develop the vaccine said.

Another advantage is that the J&J shot is expected to cost as little as US$10 ($13) and doesn't require cold storage like some rival vaccines do.

READ MORE: Queensland announces six Pfizer vaccine hubs

J&J said on Friday, in the US and seven other countries, the single-shot vaccine was 66 per cent effective overall at preventing moderate to severe illness, and much more protective — 85 per cent — against the most serious symptoms.

There was some geographic variation.

The vaccine worked better in the US — 72 per cent effective against moderate to severe COVID-19, compared to 57 per cent in South Africa, where it was up against an easier-to-spread mutated virus.

"Gambling on one dose was certainly worthwhile," Dr Mathai Mammen, global research chief for J&J's Janssen Pharmaceutical unit, told The Associated Press.

"The level of protection against moderate and severe COVID-19 infection was 72 per cent in the US, 66 per cent in Latin America and 57 per cent in South Africa, 28 days post-vaccination."

With vaccinations off to a rocky start globally, experts had been counting on a one-dose vaccine that would stretch scarce supplies and avoid the logistics nightmare of getting people to return for boosters.

But with some other competing vaccines shown to be 95 per cent effective after two doses, a question is whether somewhat less protection is an acceptable trade-off to get more shots in arms quickly.

The company said within a week, it will file for emergency use authorisation from the US Food and Drug Administration and expects to supply 100 million doses to the US by June.

READ MORE: Australia seeking urgent advice from Norway after Pfizer vaccine deaths

Level of protection

The findings are currently preliminary from a study of 44,000 volunteers that isn't completed yet.

Researchers tracked illnesses starting 28 days after vaccination – about the time when, if participants were getting a two-dose variety instead, they would have needed another shot.

After day 28, no one who got vaccinated needed hospitalisation or died regardless of whether they were exposed to "regular COVID-19 or these particularly nasty variants," Dr Mammen said.

When the vaccinated did become infected, they had a milder illness.

Defeating the scourge that has killed more than 2 million people worldwide will require vaccinating billions, and the shots being rolled out in different countries so far all require two doses a few weeks apart for full protection.

Early data is mixed on exactly how well all the different kinds work, but shots made by Pfizer and Moderna appear to be about 95 per cent protective after the second dose.

But amid shortages, some countries have advised delaying the second dose of certain vaccines with little data on how that would affect protection.

"A vaccine that's inexpensive, that's a single dose, and that has no cold chain requirements — that's pretty good," Dr Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases told CNN.

Dr Fauci said the results would look even better if J&J did not have to compete against the 94 per cent and 95 per cent efficacy seen in trials of the Pfizer and Moderna vaccines.

"You know what the problem is? If this were out there and we didn't have the Moderna 94-95 per cent — we would have said wow, a 72 per cent effective vaccine that's even more effective against severe disease is really terrific," he said.

"It has a very good efficacy against severe disease."

How is it made?

All COVID-19 vaccines train the body to recognise the new coronavirus, usually by spotting the spikey protein that coats it. But they're made in very different ways.

J&J's shot uses a cold virus like a Trojan horse to carry the spike gene into the body, where cells make harmless copies of the protein to prime the immune system in case the real virus comes along.

Rival AstraZeneca makes a similar cold virus vaccine that requires two doses.

Both the AstraZeneca and J&J vaccines can be stored in a refrigerator, making them easier to ship and to use in developing countries than the frozen kind made by Pfizer and Moderna.

It's not clear exactly how well the AstraZeneca version, being used in Britain and several other countries, works.

Jack McDermott draws up the AstraZeneca/Oxford University COVID-19 vaccine at Acklam Road pharmacy on January 28, 2021 in Middlesbrough, England.

Tests in Britain, South Africa and Brazil suggested two doses are about 70 per cent effective although there are questions about how much protection older adults get. An ongoing US study may provide more information.

J&J said its vaccine works consistently in a broad range of people: A third of participants were over age 60, and more than 40 per cent had other illnesses putting them at risk of severe COVID-19, including obesity, diabetes and HIV.

J&J said the vaccine is safe, with reactions similar to other COVID-19 shots such as fever that occur when the immune system is revved up.

While it released few details, the company said there were no serious allergic reactions.

But occasionally other COVID-19 vaccines trigger such reactions, which can be reversed if promptly treated – and authorities have warned people to be on the lookout regardless of which type of vaccine is used.

J&J had hedged its bets with a study of a two-dose version of its vaccine, which is still underway.

Friday's interim results come on the heels of another vaccine in final testing.

Novavax reported this week that its vaccine appears 89 per cent effective in a UK study and that it also seems to work, though not as well, against new mutated versions of the virus circulating in Britain and South Africa.

A larger study in the US and Mexico is still enrolling volunteers.

Ram raid turns to farce as would-be robbers leave empty handed

Three men who rammed their way through the doors of a club in southern New South Wales have left with empty hands and damaged egos.

The attempted robbery, which was captured on CCTV, appeared to quickly unravel.

The trio rammed through the rear doors of the Leeton Soldiers Hotel in the state's Riverina.

READ MORE: Man jailed after ramming Louis Vuitton store, stealing luxury handbags

They were halted by a poker machine and forced to clear the way to their target, the ATM.

Finally, they lifted the heavy machine onto the tray of their ute, but crucially, made no attempt to tie it down.

"The cash machine has actually fallen off the tray and they have left empty handed," a police spokesperson said.

READ MORE: CCTV shows bumbling duo failing to rip ATM from shopping centre

No payday for the crooks, but a big mess for the hotel owners to clean up.

Detectives are now searching for anybody who may have spotted the distinctive getaway car, which was stolen from the area just two weeks earlier.

Police said the car was a Toyota Hilux 2015 ute, with "stripy paint" but new inquiries suggest the ute may now be painted in a camouflage design.

Anyone with information about this incident is urged to contact Crime Stoppers: 1800 333 000 or https://nsw.crimestoppers.com.au