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.
Dr. Scott Atlas, a science adviser to President Donald Trump who was skeptical of measures to control the coronavirus outbreak, is leaving his White House post.
A White House official confirmed that the Stanford University neuroradiologist, who had no formal experience in public health or infectious diseases, resigned at the end of his temporary government assignment. Atlas confirmed the news in a Monday evening tweet.
Atlas joined the White House this summer, where he clashed with top government scientists, including Dr. Anthony Fauci and Dr. Deborah Birx, as he resisted stronger efforts to contain the COVID-19 pandemic that has killed more than 267,000 Americans.
Atlas has broken with government experts and the overwhelming consensus of the scientific community to criticize efforts to encourage face covering to slow the spread of the virus. Just weeks ago on Twitter he responded to Michigan’s latest virus restrictions by encouraging people to “rise up” against the state’s policies.
His views also prompted Stanford to issue a statement distancing itself from the faculty member, saying Atlas “has expressed views that are inconsistent with the university’s approach in response to the pandemic.”
“We support using masks, social distancing, and conducting surveillance and diagnostic testing,” the university said Nov. 16. “We also believe in the importance of strictly following the guidance of local and state health authorities.”
Atlas defended his role in his resignation letter, saying, “I cannot think of a time where safeguarding science and the scientific debate is more urgent.”
Atlas was hired as a “special government employee,” which limited his service to government to 130 days in a calendar year — a deadline he reached this week.
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.”
Noting that the new Covid-19 infection declined globally for the first time since September, the World Health Organization (WHO) urged people to deal the things with ‘extreme caution’.
Updating reporters during his regular briefing from Geneva, Director-General Tedros Adhanom Ghebreyesus described the global decline as fragile, brought on by falling cases in Europe, thanks to the difficult but necessary measures countries put in place in recent weeks, reports UN News.
“Gains can easily be lost,” the agency chief said, noting that COVID-19 is still on the rise in most other world regions, with an attendant increase in deaths.
No time for complacency
Tedros cautioned against complacency, especially with the holiday season approaching in many cultures and countries. Being with family and friends is not worth placing anyone at risk.
“We all need to consider whose life we might be gambling with in the decisions we make,” he said.
To be sure, the pandemic will change the way people celebrate, Tedros said. It will be important to follow local and national guidelines. For many, this is a season for staying home, avoiding crowded shopping centres, or ideally, making use of online shopping if possible.
“Avoid gatherings with many different households and families coming together,” he said.
If travelling is essential, take precautions, he said maintain distance from others and wear a mask in airports and train stations, as well as on planes, trains and buses. Carry hand sanitiser or wash hands frequently with soap and water. If feeling unwell, “don’t travel,” he insisted.
A mother carries her daughter as they wearing face masks wait to receive a coronavirus antibody test from health workers at a village in Bali, Indonesia.AP File Photo
Disrupted services, increased risks for people living with HIV
People living with HIV also may have an increased risk of severe disease or death from Covid-19, he said.
A record 26 million people are on antiretroviral treatment – but the pace of increase has slowed, leaving 12 million people who are living with HIV without treatment. “12 million is big,” he assured.
A WHO survey of 127 countries earlier this year found that more than one quarter reported partial disruption to antiretroviral treatment.
However, with support from WHO, the number of countries reporting disruptions in HIV services has declined by almost 75 percent since June. Only nine still report disruptions and only 12 report a critically low stock of antiretroviral medicines.
Such successes are mainly due to countries implementing WHO guidelines, he said, including providing longer antiretroviral prescriptions for 3 to 6 months, so patients can avoid health facilities. WHO also has worked closely with manufacturers and partners to ensure adequate supply of treatment.
'Innovation, Innovation, Innovation'
Moreover, he said countries also have introduced adaptations and innovations during Covid-19. In Africa, for example, many have built their testing system for Covid-19 on the existing lab infrastructure for HIV and tuberculosis. In Thailand, the Government has maintained pre-exposure prophylaxis services and tele-health counselling for men who have sex with men. And many countries have introduced more self-testing for HIV to support self-care.
WHO is urging all countries to maintain these innovations as part of the “new normal”, Tedros said, and to help expand testing and treatment.
With Worlds AIDS Day on December 1, he called for preserving the “incredible” gains made over the past 10 years: New HIV infections have declined by 23 percent since 2010, and AIDS-related deaths have fallen by 39 percent.
Hope above all
“If the pandemic has taught us anything, it is that in the face of an urgent health threat, the world can come together in new ways to defeat it,” he assured.
The world can defeat the pandemic using existing tools and the vaccines now in the pipeline.
“The most important thing is, we need to have hope,” he said. And solidarity to work together.
The viral pandemic is accelerating a transformation of America’s holiday shopping season.
Few people showed up at the mall this weekend, with millions of pandemic-wary shoppers staying home to shop online.
The result? Overall holiday sales are projected to rise a slight 0.9% in November and December — and even that modest gain will be due to an explosion in online shopping, according to the research firm eMarketer. It expects online sales to jump nearly 36%, while sales at physical stores fall 4.7%.
The online rush was on fully display Monday, known as Cyber Monday, a day of sales promoted by retailers back in 2005. Once the final numbers are tallied up, this year’s Cyber Monday is projected to become the biggest online shopping day in American history.
Here’s how this holiday shopping season is shaping up:
Black Friday, typically the frenzied kick-off of the holiday shopping season, was eerily quiet this year. Health officials had warned shoppers to stay home, and stores followed suit by putting their best deals online to discourage crowds.
Half as many people shopped inside stores this Black Friday than last year, according to retail data company Sensormatic Solutions.
“Black Friday was really Bleak Friday,” says David Bassuk, a member of the retail practice at the consulting firm AlixPartners.
Online was a decidedly different story. Sales hit a record $9 billion on Black Friday — up a sharp 22% from last year, according to Adobe Analytics, which tracks online shopping.
CYBER MONDAY STILL ON TOP
Even though shoppers had access to weeks of online deals, many held out for bargains that they could get only on Cyber Monday, the Monday after Thanksgiving.
Amazon offered 30% off on board games and discounts on many of its gadgets. Target had 40% off Legos and robot vacuums for $75 off.
Cyber Monday is expected to generate as much as $12.7 billion in sales — a 35% jump from a year ago, according to Adobe Analytics.
A big unknown hanging over the shopping season is this: Will retailers and shippers be able to deliver all those online orders in time for Christmas? Retailers have been warning shoppers to buy early this year, because with far more people shopping online during the pandemic, shippers may become overwhelmed with packages to deliver.
Prolonged delays could send people back to physical stores closer to Christmas, if many people eventually decide that old-fashioned stores are a more reliable way to obtain their gifts on time, said Charlie O’Shea, a retail analyst at Moody’s.