When a Centers for Disease Control and Prevention advisory committee voted Tuesday to recommend residents of long-term care facilities should be at the front of the line — with health care providers — for Covid-19 vaccines, the lone dissenting voice came from a researcher who studies vaccines in older adults.
Helen Keipp Talbot — who is known by her middle name — raised serious concerns during the meeting of the Advisory Committee on Immunization Practices about using the vaccines in the frail elderly, noting there are no data yet to suggest the vaccines work in this population.
All the U.S.-based Phase 3 trials of Covid vaccines have to include people 65 and older. But none has specifically tested the vaccines in people who are in long-term care. One can’t assume findings in people over age 65 who are healthy enough to be accepted for a clinical trial are indicative of everyone in that demographic, she said.
At an earlier ACIP meeting, Talbot warned that vaccinating this population at the start of the vaccine rollout is risky, because long-term care residents have a high rate of medical events that could be confused as side effects of vaccination and undermine confidence in the vaccines. “And I think you’re going to have a very striking backlash of, ‘My grandmother got the vaccine and she passed away,’” she said at the time.
Health care workers and elderly people living in long-term care facilities should receive top priority for COVID-19 vaccines in the United States if, as expected, one or more becomes available next month in limited supply. That’s what a group that advises the U.S. Centers for Disease Control and Prevention (CDC) on such fraught issues decided today in a near unanimous vote.
After hearing detailed presentations from CDC scientists who explained the rationale for this specific prioritization scheme, the Advisory Committee on Immunization Practices (ACIP) voted 13 to 1 to support their proposal. Under the scheme, the first phase of vaccination, known as 1a, would begin with about 21 million healthcare workers and about 3 million adults who live longterm care facilities. As spelled out in the four-hour long virtual meeting, these groups are at highest risk of becoming seriously ill or even dying from COVID-19, and protecting them first, in turn, reduces the burden on society.
“I agree strongly with the decision of the committee,” says Stanley Perlman, a veteran coronavirus researcher and clinician at the University of Iowa who advised the ACIP but is not part of it. “The discussions were incredibly thoughtful with everyone recognizing that we needed to make difficult choices. Of course these allocation issues will become irrelevant once there are enough doses of useful vaccines.”
CDC representatives spelled out the allocation plans for Phase 1b and 1c, but the advisory committee did not discuss those today. The proposed phase 1b would target “essential workers”—for example, school staff, police, grocery workers, and bus drivers–while phase 1c would target adults over 65 and adults of any age who have high-risk medical conditions. The CDC now must decide on whether to accept the phase 1a recommendation, and then states and local jurisdiction will make the final decisions about this and later prioritizations.
Instead, a day before Thanksgiving, the state is now asking people who travel from any U.S. state or territory except immediate neighbors New York, Connecticut, Pennsylvania, and Delaware to voluntarily self-quarantine for 14 days after arriving.
Murphy is also urging people to avoid all unnecessary travel to and from the state.
Pfizer and BioNTech on Friday submitted to the US Food and Drug Administration for emergency use authorization for their coronavirus vaccine candidate.
This is the first coronavirus vaccine to seek regulatory clearance in the United States.
“It is with great pride and joy and even a little relief that I can say that our request for emergency use authorization for our Covid-19 vaccine is now in the FDA’s hands,” Pfizer CEO Albert Bourla said in a video shared on Friday. “This is a historic day, a historic day for science and for all of us. It took just 248 days to get from the day we announced our plans to collaborate with BioNTech to our FDA submission day.
“We have operated at extraordinary speed in our clinical development program, from concept to regulatory filing, while always maintaining our focus on safety.”
The vaccine, known as BNT162b2, could potentially be available for use in high-risk populations in the United States by the middle to end of December, Pfizer and BioNTech said in a statement earlier Friday. The vaccine requires two doses a few weeks apart, and protection is achieved 28 days after the first shot.
The submission to the FDA is based on results from the Phase 3 clinical trial of Pfizer’s vaccine, which began in the United States on July 27 and enrolled more than 43,000 volunteers.
Small businesses in New Jersey struggled to pay their November rent at a higher rate than businesses across the country, according to a new study.
And it’s even worse for minority-owned businesses.
Sixty-seven percent of minority-owned businesses surveyed in the state couldn’t afford to pay their full November rent. That compares to 44% of minority-owned businesses nationwide, said the November Rent Poll by Alignable, an online network of small business owners with more than 5 million members.
The survey questions showed New Jersey businesses — in many categories — are faring worse than the national average:
35% of New Jersey business couldn’t pay their full rent in November compared to 32% nationally
37% of women-owned businesses in the state couldn’t pay their full rent compared to 35% nationally
When it comes to cash reserves, small businesses in New Jersey are also doing hurting more, the study said.
In New Jersey, 42% of small businesses reported that their cash reserves will run out by the end of the year. That number compares to 22% nationally.
The survey also found 16% of New Jersey small business owners are already out of cash reserves. Nationally, it’s 12%.
New Jersey counties and municipalities now have the authority to order nonessential businesses to close at 8 p.m. to help slow the spread of the coronavirus under a new rule Gov. Phil Murphy signed Thursday as the state deals with a second wave of the pandemic.
The announcement came the same day new restrictions go into effect for Garden State bars and restaurants that limit the hours of operation for indoor service and also for interstate indoor school sports.
“Municipalities and counties do not have to impose additional operating-hours restrictions if they do not wish to do so,” Murphy said after he announced his plans to sign the new executive order at his latest coronavirus briefing in Trenton.
New Jersey health officials reported 3,877 new coronaviruscases on Tuesday – the highest daily positive tests since the April peak of the outbreak – and 21 additional deaths as the state prepares for a new curfew on indoor dining set to take effect on Thursday to slow the second wave surge.
Some of the new cases reported on Tuesday, however, may reflect a computer glitch that caused a delay in reporting on Monday when health officials announced 2,075 new positive tests. The state reported 3,207 positive tests on Saturday.
Still, the seven-day rolling average for new cases is now 2,568, an increase of 55% from a week ago, and a 233% increase from a month ago. The seven-day average hasn’t been that high since May 4 when unprecedented lockdown restrictions were still in place and the state was just emerging from the outbreak peak. New Jersey’s highest day for new daily cases was 4,391 on April 17.
“These numbers are devastating,” Gov. Phil Murphy said in a Tweet announcing the latest numbers. “We are still in the midst of a pandemic. Wear a mask. Social distance. Stay safe.”
Democrat Joe Biden defeated President Donald Trump to become the 46th president of the United States on Saturday, positioning himself to lead a nation gripped by a historic pandemic and a confluence of economic and social turmoil.
His victory came after more than three days of uncertainty as election officials sorted through a surge of mail-in votes that delayed processing. Biden crossed the winning threshold of 270 Electoral College votes with a win in Pennsylvania.
Trump refused to concede, threatening further legal action on ballot counting.
Biden, 77, staked his candidacy less on any distinctive political ideology than on galvanizing a broad coalition of voters around the notion that Trump posed an existential threat to American democracy. The strategy proved effective, resulting in pivotal victories in Michigan and Wisconsin as well as Pennsylvania, onetime Democratic bastions that had flipped to Trump in 2016.
Biden’s victory was a repudiation of Trump’s divisive leadership and the president-elect now inherits a deeply polarized nation grappling with foundational questions of racial justice and economic fairness while in the grips of a virus that has killed more than 236,000 Americans and reshaped the norms of everyday life.
Biden, in a statement, declared it was time for the battered nation “to unite and to heal.”
“With the campaign over, it’s time to put the anger and the harsh rhetoric behind us and come together as a nation,” he said. “There’s nothing we can’t do if we do it together.”
Whatever people thought they knew about the state of the presidential race a few weeks ago went out the window on Tuesday, turning Election Day into a tense night of counting and indecision and proving once again that there are no easy elections in a divided America.
Instead of President Trump prematurely declaring victory based on incomplete results from Election Day voting, or former vice president Joe Biden blowing out the electoral map on the strength of a massive blue wave of early votes, Election 2020 instead produced a night of nail-biting, stomach-churning results — with the possibility that the outcome would not be known for days.
With so many states undecided, it wasn’t clear whether this election would be a repeat of 2016, a shocker to the world and demoralizing to the Democrats, or something closer to 2018, when the Democrats’ seemingly slow start eventually became a wave that flipped the House. Either outcome seemed possible with so many states not called. As the night went on, the prospect for a close outcome in the electoral college continued to grow.
There was one clear echo from 2016: The three Northern states that secured Trump’s victory — Pennsylvania, Michigan and Wisconsin — appeared poised to play the decisive role again this year. But unlike many other states, none of the three began counting the massive numbers of early votes until Tuesday, meaning it could be days before the identity of the winner is known.
With the election in the balance, the counting of the mail ballots in those Northern states likely will result in legal challenges that could affect which ballots are and are not counted. The president has complained about mail ballots, claiming falsely that they are rife with fraud, and Republicans have sought to limit the time for ballots to arrive to be eligible for counting.
So how long will it take election officials to count ballots?
“The more people who cast the ballot that was mailed to them,the more likely we are to have completed results sooner,” said Alicia D’Alessandro, spokeswoman for the secretary of state. “The more people who vote in person, the longer the ballot counting process will extend beyond Election Day.”
And people are voting in droves.
New Jersey election officials have received more than 3.5 million mail-in ballots as of Monday. That’s more than half of the 6 million mail-in ballots that were sent out to active registered voters.
The counties have already started counting, thanks to a new law that allows them to start 10 days before Election Day,helping to speed up the process.
Businesses in Atlantic City are boarding up ahead of Tuesday’s election in preparation for potential unrest.
On Saturday, workers boarded up a number of national brand stores at the Tanger Outlets outdoor mall — including Forever 21, Coach, Famous Footwear and Guess.
“Some people are boarding up. We’re starting to see this nationwide, unfortunately. It’s not a good sight to see coming into town, but people want to protect their investments,” Mayor Marty Small told NJ Advance Media on Sunday. “They’re taking a precautionary measure.”
Tanger Outlets did not immediately return a request for comment on why some retailers were boarding up windows over the weekend.
Small said businesses in Atlantic City are likely preparing for possible mayhem after, in late May, a peaceful protest over the police killing of Minneapolis man George Floyd turned destructive, with people looting and breaking store windows at the Tanger Outlets.
One in five New York City tenants did not pay rent in September, by one estimate, and there is growing concern of “an eviction tsunami.”
As apartment vacancies climb, sale prices and rents are falling, but nowhere near the magnitude needed to compensate for scarce affordable housing options.
And while the flight of affluent residents to the suburbs appears to be overstated, major companies are downsizing and fewer people are commuting, setting the stage for a new reckoning over personal and business priorities.
Real estate is everyone’s business in New York City. The industry generated nearly $32 billion in taxes last year, 53 percent of the city’s tax revenue, and it employed more than 275,000 people, according to the Real Estate Board of New York and labor statistics. An inveterate source of obsession, envy and frustration, real estate colors the aspirations and agendas of countless people, companies and policymakers.