SUZHOU, China (Reuters) – BioNTech’s Chinese partner Shanghai Fosun Pharmaceutical Group does not plan to run further clinical trials of the German firm’s coronavirus vaccine candidate that has completed early-stage trials in China, an executive said.
Fosun will focus instead on seeking Chinese approval for BioNTech’s other experimental vaccine which is in final-stage human trials in the United States, Fosun’s Chief Medical Officer Hui Aimin told Reuters in an interview.
The vaccine candidate developed by BioNTech and U.S. drugmaker Pfizer Inc is under real-time regulatory review in Europe and could seek emergency use authorisation in the United States after enough safety data is provided as early as this month.
But the candidate known as BNT162b2 missed an earlier window to be tested in China, as Fosun had rushed into Phase 1 trials of a slightly less satisfactory candidate, BNT162b1, before early trials data overseas showed BNT162b2 is safer.
Hui said he did not regret testing BNT162b1 without waiting for more complete data.
“For ordinary vaccines, it does not matter if you wait for a few days, or a month,” Hui said. “But for (COVID-19 vaccines), how many more people would have died had you waited just for one day?”
Hui said Fosun was applying for a bridge study for BNT162b2, designed to evaluate whether the large trial data gathered overseas could be extrapolated to the populace of China.
A bridge clinical trial is required for pharmaceutical products which are approved abroad but do not have data to show that ethnic differences can affect their efficacy and safety, China’s National Medical Products Administration said.
Hui expected the late-stage candidate could be greenlighted for use in China “around the same time” as the vaccine’s global clearance.
Fosun is licensed to exclusively develop and commercialize COVID-19 vaccine products developed by using BioNTech’s mRNA technology in mainland China, Hong Kong, Macau and Taiwan. In return it agreed to pay up to $85 million in licensing fees and invest $50 million for a stake in the German firm.
(Reporting by Roxanne Liu in Suzhou and Tony Monroe in Beijing; Editing by Miyoung Kim, Stephen Coates and Raju Gopalakrishnan)
HOMEWOOD-FLOSSMOOR, IL — It’s nearly time to fall back — and fall back into the biannual debate over whether we Americans should continue the practice of setting our clocks back, as we will Sunday, Nov. 1, and forward for daylight saving time.
That means the sun will set at 4:45 p.m. in Homewood-Flossmoor.
Nov. 1 is the earliest date possible for the end of daylight saving time, which officially occurs at 2 a.m. during normal sleeping hours. But let’s be real — there’s nothing normal about 2020 or the sleep schedules many of us are keeping, and that has reinvigorated the argument that Congress should make the switch back to standard time permanent.
Mental health experts warn that pandemic restrictions and job loss already are metaphorically plunging America into darkness — a mental health disaster unseen in our lifetimes.
In a mid-July KFF Tacking Poll, 53 percent U.S. adults said their mental health had been negatively affected due to worry and stress over the pandemic, a jump of more than 20 points from March, when the national mental health advocacy nonprofit added the question to polling.
The poll revealed some other mental health red flags: 36 percent had difficulty sleeping; 32 percent had difficulty eating; 12 percent increased their use of alcohol or drugs; and 12 percent said chronic conditions had worsened due to worry and stress over the coronavirus.
Winter depression is real, even without a pandemic. The days will continue to get shorter as we move toward the winter solstice on Dec. 21; and falling back to standard time makes the change more abrupt, triggering for many seasonal affective disorder, or SAD, a type of depression that occurs during the late fall and early winter. The exact cause of SAD isn’t known, but research suggests limited sunlight is a reason, and the symptoms usually dissipate as the days grow longer and daylight saving time returns on the first Sunday in March.
“SAD is not a minor condition, but because people typically experience it only during certain months, they don’t see it as a serious issue. However, it is imperative to treat,” Dr. Paolo Cassano, a psychiatrist who specializes in low-level-light therapy at Harvard-affiliated Massachusetts General Hospital, told Harvard Health Publishing.
The pandemic has energized a movement to make daylight saving time permanent. Several states have passed legislation to do away with the twice-a-year time switch, but these laws can’t take effect until there’s change in the federal statute. The13 states where legislatures have approved bills favoring year-round DST are Arkansas, Delaware, Florida, Georgia, Idaho, Louisiana, Maine, Oregon, South Carolina, Tennessee, Utah, Washington and Wyoming.
California’s voters authorized year-round DST in 2018, but action on the referendum is still pending in their state Legislature.
In Illinois, all legislation is pending and was drafted in 2019.
Florida Sens. Marco Rubio and Rick Scott cited studies from the American Journal of Public Health, the Brookings Institution and the U.S. Department of Energy in their proposal last month to keep
President TrumpDonald John TrumpIvanka Trump, Jared Kusher’s lawyer threatens to sue Lincoln Project over Times Square billboards Facebook, Twitter CEOs to testify before Senate Judiciary Committee on Nov. 17 Sanders hits back at Trump’s attack on ‘socialized medicine’ MORE and Democratic nominee Joe BidenJoe BidenFacebook, Twitter CEOs to testify before Senate Judiciary Committee on Nov. 17 Sanders hits back at Trump’s attack on ‘socialized medicine’ Senate GOP to drop documentary series days before election hitting China, Democrats over coronavirus MORE are offering opposing visions of responding to the coronavirus crisis as a new wave of cases mounts just ahead of Election Day.
Biden warned of a “dark winter” at Thursday night’s debate as new cases in the United States near a record high and hospitalizations rise again.
Despite this worsening outlook, Trump struck an optimistic message, saying the virus is “going away” and the country is “rounding the turn.”
Biden is hammering Trump over his response to the virus, which has killed more than 220,000 Americans so far. The country is now averaging about 60,000 cases per day, a number that is rising as the weather gets colder. Hospitalizations, after falling in the late summer, are now rising again too.
The former vice president immediately followed up the debate with a speech on responding to the pandemic on Friday.
“He’s given up, he’s quit on you, he’s quit on your family,” Biden said of Trump. “We don’t have to be held prisoner by this administration’s failures.”
Biden and Trump diverge not just on their outlooks, but in how forcefully they would marshal the powers of the federal government.
Biden is calling for new investments in rapid tests that can be done at home and called for a seven-fold increase in testing on Friday. Trump has repeatedly downplayed the need for more testing and blamed testing for showing the country has more cases.
Biden says he will urge every governor to impose a mask mandate and encourages their use, while Trump has repeatedly mocked masks and rarely worn one himself. A study published in the journal Nature Medicine on Friday estimated that 130,000 lives could be saved through the end of February if everyone wore a mask.
On Friday, Trump was surrounded in the Oval Office by dozens of people, almost all maskless, for an event on Sudan launching into new relations with Israel.
Biden is calling for “evidence-based national guidance” on when schools and businesses should open or close, depending on the level of virus circulating in an area.
Trump, in contrast, says “we have to open our country” and has gone on the attack against Biden for being open to further lockdowns.
Pressed on that issue at the debate, Biden said, “I’m going to shut down the virus, not the country,” while leaving open the possibility of future closures of high-risk businesses like bars and gyms, places that experts have identified as significant sources of spread.
Sensing the Republican attacks, Biden emphasized again on Friday: “I’m not