The European Medicines Agency will convene a meeting on Dec. 29 to decide if there is enough data about the safety and efficacy of the COVID-19 vaccine developed by Pfizer and BioNTech for it to be approved, the regulator said Tuesday.
The agency also said Tuesday it could decide as early as Jan. 12 whether to approve a rival COVID-19 vaccine developed by Moderna Inc.
The German pharmaceutical company BioNTech and its U.S. partner Pfizer said earlier Tuesday that they had asked the regulator for speeded-up, conditional approval of their coronavirus vaccine, concluding the rolling review process they initiated with the agency on Oct. 6.
The move comes a day after rival Moderna said it was asking U.S. and European regulators to allow the use of its COVID-19 vaccine.
BioNTech said if the vaccine, currently named BNT162b2, is approved, its use in Europe could begin before the end of 2020.T he companies said last month that clinical trials with 44,000 participants showed the vaccine is 95% effective. The efficacy rate in particularly vulnerable older age groups was more than 94%, they said.
In a statement, the EU medicines regulator said it had already begun a “rolling review” of the Moderna vaccine based on laboratory data previously submitted by the company and would now assess data on how well that vaccine triggers an immune response and whether it is safe enough for broad use across Europe.
The agency said that “if the data are robust enough to conclude on quality, safety and effectiveness,” then it could approve the Moderna vaccine at a meeting scheduled for Jan. 12.
BioNTech and Pfizer have already submitted a request for emergency approval with the U.S. Food and Drug Administration and the U.K. regulator MHRA, as well as rolling submissions in other countries including in Australia, Canada and Japan.
“We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us,” Pfizer’s chief executive Albert Bourla said in a statement.
BioNTech said it stands ready to ship stockpiles of vaccines where they are needed when the Amsterdam-based agency or the FDA approve the vaccine.
“Depending on how the authorities decide we can start delivering within a few hours,” said BioNTech's chief operating officer, Sierk Poetting.
The European Union's top official said around 2 billion doses of potential COVID-19 vaccines have been secured for the bloc's 27 nations, with the first deliveries likely to start before the end of the year.
EU Commission President Ursula von der Leyen said EU nations have started working on their vaccination plans and on the logistics for delivering tens of millions of doses across the bloc, a major challenge for the EU.
“If everything goes well, the first European citizens might already be vaccinated before the end of December,” Von der Leyen said. “And it will be a huge step forward toward our normal life. In other words, I just wanted to say there is a light at the end of the tunnel.”
The Commission, the EU’s executive arm, has secured deals allowing to purchase doses with Moderna, AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer and CureVac.
Von der Leyen however urged EU citizens to remain “disciplined till we have reached finally a vaccination that is appropriate to eradicate this virus.”
Germany’s science minister said Tuesday that the same safety standards are being applied in the approval process for coronavirus vaccines as for other drugs and that this would be key to gaining the widest possible public acceptance for COVID immunization.
Anja Karliczek cited the fact that Europan regulators plan to hold a public hearing on Dec. 11 about the approval request by BioNTech and Pfizer.
Speaking to reporters in Berlin, Karliczek stressed that the vaccine will be voluntary and that authorities will work hard to inform the public about possible side effects that a small percentage of recipients might experience after immunization, such as headaches, exhaustion and fever.
Marylyn Addo, a doctor at Hamburg’s UKE hospital who is involved in the trials for a rival vaccine, said the rapid development of a vaccine was the result of enormous efforts by scientists, early funding and experience from previous vaccines.
The panicked 22-year-old is led to Consultation Room No. 2, with its easy-mop floor and honeycombed meshing over the window. Behind her, the psychiatric emergency ward’s heavy double doors — openable only with a staff member’s key — thud shut.
With anxious taps of her white sneakers, she confides to an on-duty psychiatrist how the solitude of the coronavirus lockdown and the angst of not finding work in the pandemic-battered job market are contributing to her maelstrom of anxieties. She is unnerved that she is starting to obsess about knives, fearful that her mental health might be collapsing.
“The lockdown — let’s not pretend otherwise — worries me,” the young woman explains through her surgical mask, as the psychiatrist, Irene Facello, listens intently.
“I want to be reassured,” the woman says, “that I’m not going mad.”
Forcing millions of people to once again stay home — cutting them off from families and friends, shuttering businesses they invested in, university classes that fed their minds and nightspots where they socialized — has, for now, begun to turn back the renewed coronavirus surge in France that pushed it in November past the bleak milestone of 52,000 dead.
But the costs to mental health have been considerable. With numbers now falling for French COVID-19 patients in intensive care, psychiatrists are facing a follow-up wave of psychological distress. Health authorities’ surveying points to a surge of depression most acute among people without work, those in financial hardship and young adults.
The Rouvray Hospital Center in the Normandy town of Rouen is among places where psychiatrists are finding themselves on the front line of the pandemic’s mental-health fallout. They are fearful that a growing crisis of depression, anxiety and worse may be on the horizon as more livelihoods, futures and hopes are lost to the pandemic. Associated Press journalists spent 10 hours in the sprawling 535-bed facility, the day after French President Emmanuel Macron laid out a blueprint stretching into mid-January for the gradual lifting of lockdown restrictions.
At the psychiatric emergency unit, as Facello sends the 22-year-old home with a prescription for anti-anxiety drugs and an appointment to see her again in two weeks, the double doors swing open once more.
It is another young woman, aged 25, a linguistics student. She is steered to Consultation Room No. 1, where she sits silently in the gloom as night falls.
On the ward’s whiteboard, which lists patients’ names and details, an abbreviated initial diagnosis handwritten on a slip of paper uses acronyms to spell out how closely she may have brushed with the irreparable. For the past week, it says, she’d suffered “IDS” — suicidal ideas — and imagined “IMV,” or voluntarily ingesting medicines.
The ward’s chief psychiatrist, Sandrine Elias, gently teases out of the student how the lockdown has left her completely alone, with classes suspended.
It isn’t the sole cause of her malaise. Elias learns that the young woman had a difficult adolescence, with suicide attempts. Isolation during the epidemic has only amplified the student’s distress. In a quiet voice, she tells Elias that it “confronts us with ourselves.”
“I’m a stay-at-home type of person, but this absolute constraint is a real weight,” she says.
Elias promptly decides to hospitalize her. Supervised rest and medication, Elias determines, can help her through.
“You need a framework, to be taken into care. All alone, in your studio apartment, it’s not possible,” the psychiatrist says. “It’s very good that you came here.”
Not all of those seeking help have previous psychiatric histories. Mental health professionals say lockdowns and curfews have also destabilized people who, in less challenging times, might have surmounted difficulties by talking them through with family and friends rather than ending up in psychiatric treatment wards.
“Being alone between four walls is terrible,” Elias says. “The halting of life like this, it reverberates on people. It is not good.”
Nathan, a 22-year-old student, came through the emergency ward two days earlier. The log book shows he was admitted at 5:20 p.m. and was moved that evening to a longer-stay unit.
There, in Room 14, he told psychiatrist Olivier Guillin that he’d sought emergency help “because I felt that my morale was declining very rapidly, that I was at the point of tipping over, with suicidal thoughts.”
Similar thoughts had first laid him low in the summer, after France’s initial lockdown from March to May. They struck again when the country was confined for a second time from Oct. 30. His university shuttered. His political science classes went virtual. Rather than be alone in his student flat, he moved back with his parents in Rouen, severed from his support network and ruminating on his uncertain future.
“The first lockdown didn’t really have much of an effect on me,” he tells Guillin, but the second one “really sank me.”
“Being confined again, having to always stay in a limited perimeter, not being able to see my friends as often as usual, it disordered me,” he says.
The security of hospitalization and medication have quickly started to stabilize him. Resting on his bedside table was a Rubik’s Cube that he’d solved.
Guillin, who heads several units at the hospital and has 200 medical staff working under him, says they are seeing a sharp increase in young adults seeking help with anxieties, depression, addictions and other difficulties. He’s bracing for more.
“We’ll very likely see the crest of the wave in the months to come,” he says.
The pandemic has also had other mental health repercussions that are less evident but no less devastating.
Guillin still rues the death of a patient who killed herself during the first lockdown, 48 hours after what turned out to be their final appointment. She wore a mask to that meeting, to protect against the virus. It interfered with his reading of the depth of her distress, he says.
“She was a very expressive lady and there, with the mask, I incorrectly evaluated things,” he says. “Retrospectively, I tell myself that perhaps, without the mask, I would have been more alert and done more.”
Patients have also been hurt by the diversion of resources from mental health to battling COVID-19.
The electroconvulsive therapy that had been helping Laura, a student, emerge from her severe depression was thrown into disarray when anesthesiologists — who are needed to put her to sleep while electrical currents passed through her brain — were requisitioned to care for virus patients.
“My morale went downhill shortly after that, and the suicidal ideas came back,” she tells Guillin.
Laura says for her, the therapy is “as urgent as COVID-19.” She says prioritizing virus patients “is a bit stupid and mean.” Now, instead of being released from the hospital by mid-November as she’d hoped, Laura has had to stay.
In the emergency ward, for the third time in two hours, another young woman comes in through the double doors, dressed in black, looking hollow. With Room 1 already occupied by the 25-year-old, the 18-year-old high school student is shown into Room 2. After her initial interview by a nurse and a caregiver, she curls up on her chair.
The nurse, Sebastien Lormelet, and the caregiver, Anita Delarue, exchange notes in the staff room where the teenager’s name and admission time, 5:02 p.m., are written in black marker on the whiteboard.
“The lockdown has a lot to do with it, because she says that the first one was hard. With the second one, now, if she could slip away, she would,” Delarue says.
“She wouldn’t withstand a third one.”
French activists fear that a proposed new security law will deprive them of a potent weapon against abuse — cellphone videos of police activity — threatening their efforts to document possible cases of police brutality, especially in impoverished immigrant neighborhoods.
French President Emmanuel Macron’s government is pushing a new security bill that makes it illegal to publish images of police officers with intent to cause them harm, amid other measures. Critics fear the new law could hurt press freedoms and make it more difficult for all citizens to report on police brutality.
“I was lucky enough to have videos that protect me,” said Michel Zecler, a Black music producer who was beaten up recently by several French police officers. Videos first published Thursday by French website Loopsider have been seen by over 14 million viewers, resulting in widespread outrage over police actions.
Two of the officers are in jail while they are investigated while two others, also under investigation, are out on bail.
The draft bill, still being debated in parliament, has prompted protests across the country called by press freedom advocates and civil rights campaigners. Tens of thousands of people marched Saturday in Paris to reject the measure, including families and friends of people killed by police.
“For decades, descendants of post-colonial immigration and residents in populous neighborhoods have denounced police brutality,” Sihame Assbague, an anti-racism activist, told The Associated Press.
Videos by the public have helped to show a wider audience that there is a “systemic problem with French police forces, who are abusing, punching, beating, mutilating, killing,” she said.
Activists say the bill may have an even greater impact on people other than journalists, especially those of immigrant origin living in neighborhoods where relationships with the police have long been tense. Images posted online have been key to denouncing cases of officers’ misconduct and racism in recent years, they argue.
Assbague expressed fears that, under the proposed law, those who post videos of police abuses online may be put on trial, where they would face up to a year in jail and a 45,000-euro ($53,000) fine.
“I tend to believe that a young Arab man from a poor suburb who posts a video of police brutality in his neighborhood will be more at risk of being found guilty than a journalist who did a video during a protest,” she said.
Amal Bentounsi’s brother, Amine, was shot in the back and killed by a police officer in 2012. The officer was sentenced to a five-year suspended prison sentence. Along with other families of victims, in March she launched a mobile phone app called Emergency-Police Violence to record abuses and bring cases to court.
“Some police officers already have a sense of impunity. ... The only solution now is to make videos,” she told the AP. The app has been downloaded more than 50,000 times.
“If we want to improve public confidence in the police, it does not go through hiding the truth,” she added.
The proposed law is partly a response to demands from police unions, who say it will provide greater protection for officers.
Abdoulaye Kante, a Black police officer with 20 years of experience in Paris and its suburbs, is both a supporter of the proposed law and strongly condemns police brutality and violence against officers.
“What people don’t understand is that some individuals are using videos to put the faces of our (police) colleagues on social media so that they are identified, so that they are threatened or to incite hatred,” he said.
“The law doesn’t ban journalists or citizens from filming police in action ... It bans these images from being used to harm, physically or psychologically,” he argued. “The lives of officers are important.”
A “tiny fraction of the population feeds rage and hatred” against police, Jean-Michel Fauvergue, a former head of elite police forces and a lawmaker in Macron’s party who co-authored the bill, said in the National Assembly. “We need to find a solution.”
Justice Minister Eric Dupond-Moretti has acknowledged that “the intent (to harm) is something that is difficult to define.”
In an effort to quell criticism, lawmakers from Macron’s party announced Monday they would rewrite the criticized article of the bill, which will be debated by the Senate early next year.
Activists consider the draft law just the latest of several security measures to extend police powers at the expense of civil liberties. A statement signed by over 30 groups of families and friends of victims of police abuses said since 2005, “all security laws adopted have constantly expanded the legal field allowing police impunity.”
Riots in 2005 exposed France’s long-running problems between police and youths in public housing projects with large immigrant populations.
In recent years, numerous security laws have been passed following attacks by extremists.
Critics noted a hardening of police tactics during protests or while arresting individuals. Hundreds of complaints have been filed against officers during the yellow vest movement against economic injustice, which erupted in 2018 and saw weekends of violent clashes.
Interior Minister Gerald Darmanin said out of 3 million police operations per year in France, some 9,500 end up on a government website that denounces abuses, which represents 0.3%.
France’s human rights ombudsman, Claire Hedon, is among the most prominent critics of the proposed law, which she said involves “significant risks of undermining fundamental rights.”
“Our democracy is hit when the population does not trust its police anymore,” she told the National Assembly.
Britain’s foreign minister said Sunday there is only about a week left for the U.K. and the European Union to strike a post-Brexit trade deal, with fishing rights the major obstacle to an agreement.
As talks continued between the two sides in London, Foreign Secretary Dominic Raab said “I think we are into the last week or so of substantive negotiations.”
The U.K. left the EU early this year, but remained part of the 27-nation bloc’s economic embrace during an 11-month transition as the two sides tried to negotiate a new free-trade deal to take effect Jan. 1. Talks have already slipped past the mid-November date long set as a deadline for agreement to be reached if it is to be approved by lawmakers in Britain and the EU before year’s end.
Despite the stalemate, Raab told Sky News that “there’s a deal to be done.”
He said the two sides had made progress on “level playing field” issues — the standards the U.K. must meet to export into the EU.
The biggest hurdle appears to be fish, a small part of the economy with an outsized symbolic importance for Europe’s maritime nations. EU countries want their boats to be able to keep fishing in British waters, while the U.K. insists it must control access and quotas.
“On fisheries, there is a point of principle: As we leave the transition, we are an independent coastal state and we’ve got to be able to control our waters,” Raab said.
EU chief negotiator Michel Barnier, who met through the weekend with U.K. counterpart David Frost, has said there are still “significant divergences.”
If there is no deal, New Year’s Day will bring huge disruption, with the overnight imposition of tariffs and other barriers to U.K.-EU trade. That will hurt both sides, but the burden will fall most heavily on Britain, which does almost half its trade with the EU.
Diplomats like to remain neutral but Nanaia Mahuta let the veil slip a little when a winner was declared in the U.S. election by tweeting a smiley-face emoji.
Mahuta, the first indigenous Maori woman to be appointed New Zealand’s foreign affairs minister, suppresses a real-life smile when asked about it.
“Look, what I can say is that there were encouraging signs in those speeches,” she said in an interview with The Associated Press. She said the victory speech by Vice President-elect Kamala Harris was “inspirational to many women around the world.”
Mahuta, 50, was a surprise pick for the role, despite being a respected performer in Parliament for almost half her life, since she was first elected in 1996 at age 26. She is part of the most diverse group of lawmakers ever appointed to the top roles in Cabinet after Prime Minister Jacinda Ardern won a second term in a landslide victory last month.
Mahuta said she felt joyous at being chosen and promised to bring a new perspective to foreign affairs.
She didn’t have to wait long for her first contentious moment. New Zealand has long been cautious of criticizing China, its largest trading partner.
But Mahuta last week took the step of joining Australia, Canada, the U.K. and the U.S. in condemning China for imposing new rules to disqualify legislators in Hong Kong.
China reacted with anger.
“Be careful not to get poked in the eye,” Chinese foreign ministry spokesperson Zhao Lijian said in response, referring to the “Five Eyes” military alliance among the five countries.
Mahuta said she had talked with Ardern before deciding to sign the statement and felt it was a natural progression to “turn the dial up” and join with other countries. She said she thinks the relationship with China is mature enough to withstand such disagreements.
Still, it will pose a challenge for Mahuta to find the right balance to strike with an increasingly assertive China and a combative U.S. For now, Mahuta said she intends to focus on building relationships with New Zealand’s immediate island neighbors in the Pacific, even if the coronavirus prevents her traveling there in person.
“This could be the period of the Zoom diplomacy,” she said.
People around the world have been curious about Mahuta’s moko kauae, or sacred facial tattoo, which she got four years ago to celebrate her heritage, ancestors and connection to Papatuanuku, or Mother Earth.
“The most common question is, did it hurt?” she laughs.
The answer? Not really, because her mind went to a different place.
She said wearing the moko makes her more mindful “in how you want to be as a person, how you treat other people. So that it’s almost like a compass.”
Thirty years ago, before there was a revival of Maori culture in New Zealand, facial tattoos tended to be associated with gang members. Mahuta said she still finds negative reactions to hers in some parts of the country, but these days most people recognize it as an affirmation of culture.
Mahuta is the daughter of the late Sir Robert Mahuta, a key figure in the Tainui tribe who helped settle a groundbreaking financial claim with the government for land that was taken during colonization.
Mahuta said her father was her mentor and a tough taskmaster. But it was the students she met as a university tutor who convinced her to go into politics, not her dad.
“I think if he had his way, I wouldn’t be in politics, I’d be in the tribe,” she said.
Lara Greaves, a lecturer in politics at the University of Auckland, said Mahuta is well prepared for her role because she has spent her whole life steeped in high-level cultural diplomacy in Maori society.
“I think it’s a really positive move,” Greaves said.
She said the surprise at Mahuta’s appointment -- her own included — likely reflected the dominance that men still have internationally in foreign affairs.
Mahuta said she’d like to see more women involved.
“I’m a part of a very small group of women who have now reached out and linked arms to say, well, there’s is a lot that we can do together,” she said.
In her office, Mahuta points out various artifacts that have meaning for her — the baskets of knowledge from the Pacific, the pictures of the prime minister who invited her ancestor into Parliament. And then she gets to the Silvanian Families village in the corner.
“I have a 7-year-old daughter who’s made part of this office hers,” Mahuta said. “One of the things I’ve learned when I’ve been in Parliament is to make it family friendly.”