The European Medicines Agency said Tuesday that AstraZeneca and Oxford University have submitted an application for their COVID-19 vaccine to be licensed across the European Union.
The EU regulator said it received a request for the vaccine to be green-lighted under an expedited process and that it could be approved by Jan. 29 “provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete.”
The EMA, the drugs agency for the 27-nation EU, has already approved two other coronavirus vaccines, one made by American drugmaker Pfizer and Germany’s BioNTech and another made by U.S. biotechnology company Moderna. Switzerland approved the Moderna vaccine on Tuesday and plans to immunize about 4% of its population using that and the Pfizer-BioNTech shot.
Britain gave its approval to the Oxford-AstraZeneca vaccine last month and has been using it. India approved it this month.
As part of its strategy to obtain as many different COVID-19 vaccines as possible for Europeans, the EU said it had concluded early talks with French biotech company Valneva to secure up to 60 million doses of vaccine.
Valneva previously signed a deal with Britain to provide tens of millions of doses of its shot, which is developed using similar technology to that used to make flu vaccines. The EU has sealed six vaccine contracts for up to 2 billion doses, many more than are necessary to cover its population of approximately 450 million.
The Oxford-AstraZeneca vaccine is expected to be a key vaccine for many countries because of its low cost, availability and ease of use. It can be kept in refrigerators rather than the ultra-cold storage that the Pfizer vaccine requires. The company has said it will sell it for $2.50 a dose and plans to make up to 3 billion doses by the end of 2021.
Researchers claim the Oxford-AstraZeneca vaccine protected against disease in 62% of those given two full doses and in 90% of those initially given a half dose because of a manufacturing error. However, the second group included only 2,741 people -- too few to be conclusive.
Questions also remain about how well the vaccine protects older people. Only 12% of study participants were over 55 and they were enrolled later, so there hasn’t been enough time to see whether they develop infections at a lower rate than those not given the vaccine.
The U.S. Food and Drug Administration says it will not consider approving the Oxford-AstraZeneca vaccine until data are available from late state research testing the shot in about 30,000 people.
A persistent blizzard has blanketed large parts of Spain with 50-year record levels of snow, killing at least four people and leaving thousands trapped in cars or in train stations and airports that had suspended all services as the snow kept falling on Saturday.
The bodies of a man and woman were recovered by the Andalucía region emergency service after their car was washed away by a flooded river near the town of Fuengirola. The Interior Ministry said a 54-year-old man was also found dead in Madrid under a big pile of snow. A homeless man died of hypothermia in the northern city of Zaragoza, the local police department reported.
More than half of Spain’s provinces remained on alert Saturday afternoon, five of them on their highest level of warning, for Storm Filomena. In the capital, authorities activated the red alert for the first time since the system was adopted four decades ago and called in the military to rescue people from vehicles trapped on everything from small roads to the city’s major thoroughfares.
More than 50 centimeters (20 inches) of snow fell in the capital. By 7 a.m. on Saturday, the AEMET national weather agency had recorded the highest 24-hour snowfall seen since 1971 in Madrid.
Sandra Morena, who became trapped late on Friday as she commuted to her night shift as a security guard in a shopping center, arrived home, on foot, after an army emergency unit helped her out on Saturday morning.
“It usually takes me 15 minutes but this time it has been 12 hours freezing, without food or water, crying with other people because we didn’t know how we were going to get out of there,” said Morena, 22.
“Snow can be very beautiful but spending the night trapped in a car because of it is no fun,” she added.
AEMET had warned that some regions would be receiving more than 24 hours of continuous snowfall due to the odd combination of a cold air mass stagnant over the Iberian Peninsula and the arrival of the warmer Storm Filomena from the south.
The storm is expected to move northeast throughout Saturday but it is expected to be followed by a cold snap, the agency said.
Transport Minster José Luis Ábalos warned that “snow is going to turn into ice and we will enter a situation perhaps more dangerous than what we have at the moment.”
He added that the priority was to assist those in need but also to ensure the supply chain for food and other basic goods.
“The storm has exceeded the most pessimistic forecasts we had,” Ábalos added.
Carlos Novillo, head of the Madrid emergency agency, said that more than 1,000 vehicles had become trapped, mostly on the city’s ring road and the main motorway that leads from the capital to the south, toward the Castilla La Mancha and Andalucia regions.
“The situation remains of high risk. This is a very complex phenomenon and a critical situation,” Novillo said Saturday morning in a message posted on social media.
“We ask all those who remain trapped to be patient, we will get to you,” he added.
Airport operator AENA said that the Adolfo Suárez Madrid-Barajas International Airport, the main gateway in and out of the country, would remain closed throughout the day after the blizzard bested machines and workers trying to keep the runways clear of snow.
All trains into and out of Madrid, both commuter routes and long-distance passenger trains, as well as railway lines between the south and the northeast of the country, were suspended, railway operator Renfe said.
The storm had caused serious disruptions or closed altogether over 650 roads by Saturday morning, according to Spain’s transit authorities, which urged people to stay indoors and avoid all non-essential travel.
The wintry weather even halted the country’s soccer league, with some of the La Liga top teams unable to travel for games. Saturday’s match between Spanish league leader Atlético Madrid and Athletic Bilbao was postponed after the plane carrying Bilbao’s team on Friday was unable to land in the capital and had to turn around.
The regions of Castilla La Mancha and Madrid, home to 8.6 million people altogether, announced that schools would be closed at least on Monday and Tuesday.
Despite the numerous branches and even whole trees toppled by the weight of the snow, the blizzard also yielded surreal images that entertained many Madrileños, including a few brave skiers and a man on a dog sled that was seen on videos widely circulated on social media.
Lucía Vallés, a coach for a Madrid-based ski club who usually has to travel to faraway mountains with her clients, was thrilled to see the white layers of snow accumulating literally at her doorstep.
“I never imagined this, it has been a gift,” the 23-year-old said. “But I’ve never had so many photographs taken of me,” she added as she slid past the late 18th-century building that hosts the Prado Museum.
The European Union's drug agency on Friday approved doctors drawing up to six doses from each vial of the coronavirus vaccine made by BioNTech-Pfizer, a move that could speed up the pace of vaccinations in the 27-nation bloc.
The European Medicines Agency said its human medicines committee recommended updating the product information for the vaccine to clarify that each vial contains six doses instead of the five that were advised when it originally greenlighted the Pfizer-BioNTech vaccine on Dec 21.
German Health Ministry spokesman Hanno Kautz told reporters in Berlin that the change would come into effect immediately, boosting available doses of the vaccine by 20 percent.
Many doctors across the EU have already been drawing six doses of the vaccine from each vial, a practice that is already permitted in the United States, Britain and elsewhere.
Pharmaceutical companies regularly put more vaccine than necessary into vials so minimum dosage can be ensured even if there is some spillage.
The news came shortly after the EU’s executive arm said it had secured 300 million extra doses of the Pfizer-BioNTech vaccine. European Commission President Ursula von der Leyen said the new agreement to buy more doses will double the amount ordered by the 27-nation bloc.
The EU commission later detailed in a statement that it offered to member states to purchase an additional 200 million doses of the vaccine, with the option to acquire another 100 million doses.
“This would enable the EU to purchase up to 600 million doses of this vaccine, which is already being used across the EU. The additional doses will be delivered starting in the second quarter of 2021,” the EU said. Von der Leyen said 75 million of the extra doses would be available during the second quarter, with the rest being delivered throughout 2021.
Combined with a contract with Moderna for its vaccine, the EU now has the capacity to vaccinate 380 million people, Von der Leyen said, more than 80 percent of the EU's population.
The EU has sealed six vaccine contracts for up to 2 billion doses, with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, Pfizer-BioNTech and CureVac. But only the Pfizer-BioNTech and Moderna vaccines have been approved for use so far in the 27-nation bloc.
Von der Leyen's announcement came amid growing criticism, notably in Germany, about the decision to let the commission handle vaccine purchases for all EU member nations. Vaccination programs in the EU have gotten off to a slow start, and some EU members have been quick to blame the European Commission for a perceived failure to deliver the right number of doses.
The EU has defended its strategy, insisting that vaccination programs have just started and that large deliveries are foreseen for around April.
“We were faced with a situation where we had huge demand, but the production capacity had not kept pace with that as yet. Now, we have a positive step forward," von der Leyen said.
Amid reports that some EU countries tried to secure separate deals with vaccine manufacturers, von der Leyen also made clear that such negotiations would violate the agreement accepted by all the bloc's members.
“We have all agreed, legally binding, that there would be no parallel negotiations, no parallel contract," she said. “So, the framework we are all working in is a framework of 27. Together we are negotiating, together we are procuring and together we are bringing forward this vaccination process."
The European Union’s medicines agency was meeting Wednesday to consider giving the green light to Moderna Inc.'s COVID-19 vaccine, a decision that would give the 27-nation bloc a second vaccine to use in the desperate battle to tame the virus rampaging across the continent.
The meeting of the European Medicines Agency's human medicines committee (CHMP) comes amid high rates of infections in many EU countries and strong criticism of the slow pace of vaccinations across the region of some 450 million people.
The EMA has already approved a coronavirus vaccine made by American drugmaker Pfizer and Germany's BioNTech. Both vaccines require giving people two shots.
Ahead of the meeting on the Moderna vaccine, the agency said in a tweet that its experts were “working hard to clarify all outstanding issues with the company.” It did not elaborate on what those issues were. Moderna also declined to comment.
Early results of large, still unfinished studies show both the Moderna and the Pfizer-BioNTech vaccines appear safe and strongly protective, although Moderna’s is easier to handle since it doesn’t need to be stored at ultra-frozen temperatures.
The United States, Canada and Israel have already approved use of the Moderna vaccine. The U.S. gave it the green light for emergency use in people over 18 years on Dec. 18, followed by Canada five days later with an interim authorization also for people over 18. Israel authorized the vaccine on Monday.
If the EU agency joins the list, its decision will have to be confirmed by the bloc's executive commission in Brussels before vaccinations with the Moderna shot can begin.
Moderna said Monday that it is increasing its estimate for global vaccine production in 2021 from 500 to 600 million doses. The company said it is “continuing to invest and add staff to build up to potentially 1 billion doses for 2021.”
Both Moderna’s and Pfizer-BioNTech’s shots are mRNA vaccines, made with a groundbreaking new technology. They don’t contain any coronavirus – meaning they cannot cause infection. Instead, they use a piece of genetic code that trains the immune system to recognize the spike protein on the surface of the virus, ready to attack if the real thing comes along.
The EU officially began giving out Pfizer-BioNTech vaccination shots on Dec. 27, but the speed of each nation's inoculation program has varied widely. France vaccinated around 500 people in the first week, while Germany vaccinated 200,000. The Dutch were only beginning to give out vaccine shots Wednesday, the last EU nation to start doing so.
A British judge on Monday rejected the United States’ request to extradite WikiLeaks founder Julian Assange to face espionage charges, saying he was likely to kill himself if held under harsh U.S. prison conditions.
In a mixed ruling for Assange and his supporters, District Judge Vanessa Baraitser rejected defense arguments that the 49-year-old Australian faces a politically motivated American prosecution that rides roughshod over free-speech protections. But she said Assange’s precarious mental health would likely deteriorate further under the conditions of “near total isolation” he would face in a U.S. prison.
“I find that the mental condition of Mr. Assange is such that it would be oppressive to extradite him to the United States of America,” the judge said.
She said Assange was “a depressed and sometimes despairing man” who had the “intellect and determination” to circumvent any suicide prevention measures taken by American prison authorities.
The U.S. government said it would appeal the decision. Assange’s lawyers said they would ask for his release from a London prison where he has been held for more than a 18 months at a bail hearing on Wednesday.
Assange, who sat quietly in the dock at London’s Central Criminal Court for the ruling, wiped his brow as the decision was announced. His partner Stella Moris, with whom he has two young sons, wept.
Outside court, Moris said the ruling was “the first step towards justice,” but it was not yet time to celebrate.
“I had hoped that today would be the day that Julian would come home,” she said. “Today is not that day, but that day will come soon.”
The ruling marks a dramatic moment in Assange’s years-long legal battles in Britain — though likely not its final chapter.
It’s unclear whether the incoming Biden administration will pursue the prosecution, initiated under President Donald Trump.
Assange’s American lawyer, Barry Pollack, said the legal team was “enormously gratified” by the British court’s decision.
“We hope that after consideration of the U.K. court’s ruling, the United States will decide not to pursue the case further,” he said.
Moris urged Trump to pardon Assange before he leaves office later this month.
“Mr. President, tear down these prison walls,” she said. “Let our little boys have their father.”
U.S. prosecutors have indicted Assange on 17 espionage charges and one charge of computer misuse over WikiLeaks’ publication of leaked military and diplomatic documents a decade ago. The charges carry a maximum sentence of 175 years in prison.
Lawyers for Assange argue that he was acting as a journalist and is entitled to First Amendment protections of freedom of speech for publishing documents that exposed U.S. military wrongdoing in Iraq and Afghanistan.
Lawyers for the U.S. government denied that Assange was being prosecuted merely for publishing, saying the case “is in large part based upon his unlawful involvement” in the theft of the diplomatic cables and military files by U.S. Army intelligence analyst Chelsea Manning.
The British judge sided with U.S. lawyers on that score, saying Assange’s actions, if proven, would “amount to offenses in this jurisdiction that would not be protected by his right to freedom of speech.” She also said the U.S. judicial system would give him a fair trial.
The defense also argued during a three-week hearing in the fall that Assange risked “a grossly disproportionate sentence” and detention in “draconian and inhumane conditions” if he was sent to the United States.
The judge agreed that U.S. prison conditions would be oppressive. She accepted evidence from expert witnesses that Assange had a depressive disorder and an autism spectrum disorder.
“I accept that oppression as a bar to extradition requires a high threshold. ... However, I am satisfied that, in these harsh conditions, Mr. Assange’s mental health would deteriorate causing him to commit suicide with the ‘single minded determination’ of his autism spectrum disorder,” the judge said in her ruling.
The prosecution of Assange has been condemned by journalists and human rights groups, who say it undermines free speech around the world.
They welcomed the judge’s decision, even though it was not made on free-speech grounds.
“This is a huge relief to anyone who cares about the rights of journalists,” The Freedom of the Press Foundation tweeted.
Assange’s legal troubles began in 2010, when he was arrested in London at the request of Sweden, which wanted to question him about allegations of rape and sexual assault made by two women. In 2012, Assange jumped bail and sought refuge inside the Ecuadorian Embassy, where he was beyond the reach of U.K. and Swedish authorities — but also effectively a prisoner, unable to leave the tiny diplomatic mission in London’s tony Knightsbridge area.
The relationship between Assange and his hosts eventually soured, and he was evicted from the embassy in April 2019. British police immediately arrested him for breaching bail in 2012.
Sweden dropped the sex crimes investigations in November 2019 because so much time had elapsed, but Assange has remained in London’s high-security Belmarsh Prison throughout his extradition hearing.