Drugmaker Pfizer has begun the process to earn full U.S. regulatory approval for its COVID-19 vaccine for people aged 16 and older.
That gives Pfizer and German partner BioNTech a shot at winning the first full approval from the U.S. Food and Drug Administration.
The two companies say they’ve started a “rolling submission” of data from their studies of the two-dose vaccine, first giving the FDA data from laboratory and human testing. That includes their latest analysis from a key late-stage study that followed the participations for up to six months after they received their second dose. The companies plan to soon submit data on manufacturing quality controls and the factories making the vaccine.
Remote court hearings may not be perfect, but they do not violate a defendant's rights, according to Massachusetts Supreme Judicial Court.
In a lengthy opinion Wednesday, the SJC said courts are within their rights to hold videoconference hearings during the pandemic. But the same opinion also says in some cases, judges can wait to hold in-person hearings.
"The Commonwealth's interest in protecting the public health during the COVID-19 pandemic is significant and, combined with its interest in the timely disposition of a case, would, in many instances, outweigh the defendant's interest in an in-person hearing," wrote Justice Elspeth Cypher. "Accordingly, we conclude that a virtual motion to suppress hearing is not a per se violation of the defendant's right to be present in the midst of the COVID-19 pandemic."
A COVID-19 field hospital at the DCU Center in Worcester is expected to close for good within the next couple of weeks, UMass Memorial Health Care said in a statement.
The 220-bed field hospital was first set up last spring, then reopened in December to treat patients during a second surge of coronavirus cases. It stopped taking new patients in March but remained in place and ready to reopen in the event of another surge.
Now it is being demobilized.
It treated more than 1,000 people, operator UMass Memorial Health Care said in a statement Tuesday.
“It has had a definite positive impact on COVID patient care in the region,” the statement said. “This includes caring for the nearly 650 patients that were treated there during the second wave and serving as a relief valve for hospitals in the region that would have been challenged to create more surge space without its existence.”
The U.S. Food and Drug Administration is expected to authorize Pfizer's COVID-19 vaccine for youngsters ages 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
The announcement is set to come a month after the company found that its shot, which is already authorized for those age 16 and older, also provided protection for the younger group.
Cambridge-based biotech company Moderna will provide up to 500 million doses for the U.N.-backed program to ship coronavirus vaccines to needy people in low- and middle-income countries, but shipments won’t begin until the fourth quarter, the company and program leaders said Monday.
The advance purchase agreement from Gavi, the Vaccine Alliance, comes just days after the World Health Organization announced emergency approval of the Moderna vaccine that paves the way for its inclusion in the U.N.-backed COVAX program.
Gavi, a Geneva-based public-private partnership, has been scrambling to try to strike deals with vaccine makers at the same time as trying to persuade rich countries that have secured millions of doses — some of which they aren’t even using — to donate them to poorer ones.
It was early in the pandemic last year when Dr. Joshua Morganstein started receiving calls from military veterans who were staffing hospitals. They were calling to tell him how part of their combat training was helpful in dealing with the stress of fighting COVID-19.
Morganstein, the assistant director at the Center for the Study of Traumatic Stress in Maryland, said likening COVID to fighting a war is true in a lot of ways.
"You're going into a situation that is extremely stressful, that is likely to go on for an extended period of time and is going to involve situations that are dangerous," he told WBUR.
But there are differences. Health care workers had to fight a battle there was no training for. American soldiers train for wars.
"We can see our enemies when we go into battle. We know when we've been injured," Morganstein said. "And we don't worry about the enemy coming home and killing our family."
For over a year, health care workers have been combating an invisible enemy, worried they could bring the danger home to their loved ones. And for that length of time, Morganstein has been working with hospitals to create, what the military calls Combat Operational Stress Control. It's an approach that emphases early intervention to reduce stress, improve well-being and decrease the chance of people burning out.
Morganstein personally has experience with the military's approach to reducing stress.
In 2009, Morganstein — a member of the Air Force — was deployed to Afghanistan as the lead psychiatrist for soldiers. There, he got paired up with someone called a "battle buddy." Each was charged with looking after their buddy's mental and physical health.
Now, during the pandemic, hospitals have been asking him how to apply the same concept with health care workers.
Morganstein believes hospitals can use the same strategy to help health care workers deal with the pandemic by pairing them with a colleague to check on their well-being.
"I think there are three main areas someone can quickly ask about: How are things at home? How are things at work? And how are you sleeping?"
Massachusetts General Hospital (MGH) is one of the latest hospitals to start a battle buddy program. Dr. Kerri Palamara is a physician at MGH and also helms a group there called the Workplace Well-Being Collaborative. And there was a moment last year when things became overwhelming.
"I felt like no matter what, I couldn't give enough of myself to any of the people who needed me," Palamara said. "I remember it was one of those 'How's the week going?' and I was like 'I'm drowning. I am absolutely drowning. And I haven't had a day off, but I feel like I can't take a day off because I'm so overwhelmed.'"
Palamara says she's in charge of helping people maintain their well-being at MGH.
"How does it look if the well-being lady can't keep it together?" she said.
But Palamara says she felt lucky, because she had an informal support group. She knows, however, everyone who works at the hospital isn't so fortunate. . . and then she remembered a Q&A with Morganstein last summer.
"I think there are three main areas someone can quickly ask about: How are things at home? How are things at work? And how are you sleeping?"Dr. Joshua Morganstein
"There's a bunch he's done about the battle buddy program and he got me thinking about it," she remembered.
Since MGH launched its own version of the battle buddy program two weeks ago, 45 people have signed up. And Palamara says it's not just aimed at pairing up nurses and doctors — anyone with an MGH badge can be a part of the program. Meaning, theoretically, a custodian and a brain surgeon could get paired together.
Palamara said the first step will be giving guidance on ways to check in on each other. Like asking how's your day going? Or what's making you feel good?
"Giving people language," Palamara explained. "Questions to ask, prompts that they can use but also responses so that if you hear certain language you can say 'I'm worried about you.' "
NYC Health + Hospitals began using a battle buddy program late last year.
Jeremy Segall is the chief wellness officer there and said it's already started to show results.
"I got a cold call from an emergency room physician that said that they were contemplating suicide, and it was getting worse and worse and worse and worse," he recounted. "And moving toward a plan. This is a real story."
Then Segall said this physician started going to monthly emotional support meetings with colleagues where they found out about mental health resources.
"And they're now in counseling," Segall said. "And I got a call for them to tell me that that saved their life. True story."
The program at MGH is much newer, but Dr. Palamara thinks it will be a success if it manages to build community and quell loneliness. And she hopes the battle buddy system will remain at the hospital long after the pandemic is over.
"There is no going back to normal, because we're all different now. And our world is different," Palamara said. "But also, clinician well-being and health care worker well-being was a problem before COVID, so even going back to normal doesn't mean that we're okay."
Resources: You can reach the National Suicide Prevention Lifeline at 1-800-273-TALK (8255) and the Samaritans Statewide Hotline (call or text) at 1-877-870-HOPE (4673). Call2Talk can be accessed by calling Massachusetts 211 or 508-532-2255 (or text c2t to 741741).
Of all the events that could be held at Lombardo's function hall in Randolph, a court trial is a new one.
The popular wedding and prom venue is one of seven satellite court locations the Massachusetts Trial Court is using to resume jury trials quickly while accommodating pandemic-related concerns about ventilation and physical distancing in many of the state's aging courthouses. Six-person jury trials began at the alternate locations this month.
Except for the metal detectors, the lobby at Lombardo's isn't dramatically altered. Up a large winding staircase, under a massive chandelier, just past the grand piano are ballrooms filled with lawyers, court officers, a judge and a jury.
Several court officers try to project the decorum of a courtroom, making announcements about when to be seated and when court is in recess.
"Whether it's in this building or the courthouse in Massachusetts, there was not much different except for the environment and the chandelier," says Quincy District Court Judge Mark Coven, who presided over a motor vehicle homicide trial at Lombardo's last week.
Judge Coven says the courts, along with the defense and prosecution, prioritized cases for trial.
"I think we've got to look at the seriousness of the crimes because they've been pending for some time, and there's obviously deaths involved and people have a right to bring their cases to trial," Coven says.
Even with the makeshift courtrooms, only a limited number of trials are being held to start to chip away at an estimated backlog of 3,700 cases that were put off because of the pandemic. Many states are grappling with how to hold trials while protecting people from the virus. Jury trials are now resuming in all but six states.
Even with the makeshift courtrooms, only a limited number of trials are being held to start to chip away at an estimated backlog of 3,700 cases that were put off because of the pandemic.
Norfolk County District Attorney Mike Morrissey, whose office prosecuted the motor vehicle homicide case, says with 20 murder trials pending in his county alone, and ventilation problems in his main courthouse, something had to be done.
"There's probably 220 people in the House of Correction that are awaiting trial right now," Morrissey explains. "Those are just the people locked up. Then, there's hundreds of other cases that we still have in the district court and a lot of victims that are looking for their day in court. And so it's important that we move ahead."
Inside the repurposed ballroom, Judge Coven sits on a raised platform in the front of the room, flanked by U.S. and state flags. The defense and prosecution attorneys are at tables facing the judge. The witness stand is a wooden podium in the middle of room — what might have been the dance floor — facing jurors, who sit on banquet chairs, appropriately spaced apart. Everything is surrounded by plexiglass.
"Some of the feedback I'm getting from people is that they would just as soon try cases here than they would in some of the courthouses in our county," Morrissey says.
Defense attorney Joseph Simons says the biggest difference in a trial at an alternate site is in the preparation. He says there have been several meetings to make sure the trial would go forward as scheduled. This motor vehicle homicide trial has been put off for more than a year as constitutional speedy trial considerations have been largely exempted because of the pandemic.
"We've had a lot of clients just waiting for their day in court with the deadlines just getting pushed back and pushed back," Simons says. "So yeah, it's kind of weird, but it feels good. It feels like we're getting back on track."
"We've had a lot of clients just waiting for their day in court with the deadlines just getting pushed back and pushed back. So yeah, it's kind of weird, but it feels good. It feels like we're getting back on track."Joseph Simons, a defense attorney
After deliberating for almost a day in a nearby ballroom, the jury makes its decision. As in a courtroom, a court officer escorts them in to announce the verdict.
"Not guilty," the jury forewoman announces.
At the not guilty verdict, the defendant reacts emotionally, bracing himself with his hands on the table in front of him. Simons reaches over plexiglass to touch his client's shoulder. Judge Coven thanks the jurors and everyone involved for what he calls a "successful experiment."
"This was an important case because we're just beginning the resumption of jury trials after a year of not doing jury trials," Coven tells the jury. "Many people have been waiting — not just defendants, but families and victims. So you've enabled us to do this in a way that shows us that it can be done, even under difficult circumstances."
DA Morrissey says these trials help pave the way for more complicated cases — ones with bigger juries, more witnesses and tighter security to try those incarcerated. Those people will be held in a retrofitted adjoining nightclub.
"You get into the rhythm of picking a jury and how to handle a jury, how to a segregate a jury, how to keep people safe," Morrissey says, "and then I assume that they'll be ready to deal with someone in a lockup situation within the coming week or two."
Massachusetts is paying more than $360,000 to hold trials at Lombardo's for the next four months. The Trial Court also has a three-and-a-half-month lease with the Cape Codder Resort & Spa in Hyannis for $170,323; and one-year leases with the Holiday Inn in Pittsfield for $854,100, the former Eastfield Mall Cinemas site in Springfield for $715,800 and a former courthouse in Greenfield for $1,049,314. Some space is also being used at the federal court house in Boston for Suffolk County jury trials.
Lombardo's General Manager Dave Lombardo says the arrangement helps his business, which has been hurt by the pandemic.
"It's a win-win for everyone," Lombardo says. "They're able to get some cases through and work on their backlog. And we were able to get some of our associates back to work. So it was a match that worked out for everybody, and we're really happy with it."
As to how much of a dent these new venues might make in the backlog and whether there's a greater risk of appeals, well, as they say, the jury is still out.
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