China Sinopharm's coronavirus vaccine taken by about 1M in emergency use

 Nearly one million people have taken an experimental coronavirus vaccine developed by China National Pharmaceutical Group (Sinopharm) through the country’s emergency use programme, the firm said late on Wednesday.

China launched the emergency use programme in July, which so far includes three vaccine candidates for essential workers and other limited groups of people even as clinical studies have yet to be completed to prove their safety and efficacy.

No serious adverse reaction has been reported from those who received the vaccine in emergency use, Sinopharm said in an article on social media WeChat, citing Chairman Liu Jingzhen from a recent media interview.

Two vaccine candidates developed by Sinopharm's subsidiary China National Biotec Group (CNBG) and third one developed by Sinovac Biotech SVA.O have been used for the emergency programme.

It’s unclear which vaccine Liu referred to, and Sinopharm was not immediately available to comment.

Sinopharm’s vaccines, which use inactivated virus unable to replicate in human cells to trigger immune responses, require two doses, clinical trial registration data showed.

The experimental vaccines are undergoing Phase 3 clinical trials overseas that have recruited nearly 60,000 people, and blood samples of more than 40,000 participants have been taken 14 days after they took the second dose, the article said citing Liu, without breaking down the numbers for each vaccine.

Among construction project employees, diplomats and students who went abroad after taking Sinopharm’s vaccine, no one has been infected, it added.

But experts have cautioned against using data solely from emergency use programme, without comparable results from a clinical trial-standard control group, to determine a vaccine’s effectiveness.

https://www.reuters.com/article/us-health-coronavirus-vaccine-sinopharm/china-sinopharms-coronavirus-vaccine-taken-by-about-a-million-people-in-emergency-use-idUSKBN27Z0PY

Oxford COVID-19 trial will look at interim Phase III data after 53 infections

 Oxford University will start an initial analysis of data from its late-stage trial of the experimental COVID-19 vaccine it is developing with AstraZeneca after 53 infections among its volunteers, the study’s chief investigator said on Thursday.

The Oxford Vaccine Group’s director, Andrew Pollard, said in a media briefing there were “lots of cases” of infections in its Phase III trial in Britain, Brazil and South Africa.

The first two sets of interim data from vaccine trials from Pfizer and BioNTech last week and Moderna on Monday were released after more than 90 infections among volunteers.

Pfizer had planned to publish initial data after about 60 infections, but it exceeded its target after the big jump in infections recently in the United States.

Pollard’s comments came after data published on Thursday showed the Oxford/AstraZeneca vaccine in Phase II studies produced a strong immune response in older adults, suggesting that those at higher risk of serious illness and death from COVID-19 could be protected.

Pollard said there was no attempt to release the study in the same week as those companies’ data, the first from late-stage vaccine trials, but rather the study happened to be ready for publication.

Earlier on Thursday, he said he expected Phase III data to be released by Christmas.

The Phase III results showing efficacy of the vaccine will be released via AstraZeneca, in the same way they have been published by other drugmakers over the past week or so, Pollard said.

He said the trial would also publish the findings in a peer-reviewed medical journal but initial data would likely be released before then.

https://www.reuters.com/article/us-health-coronavirus-oxford-vaccine/oxford-covid-19-trial-will-look-at-interim-phase-iii-data-after-53-infections-investigator-idUSKBN27Z1EC

CDC recommends Americans don't travel for Thanksgiving

 The U.S. Centers for Disease Control and Prevention said it recommends Americans do not travel during the Thanksgiving holiday next week to mitigate the spread of COVID-19 as cases of the virus spike around the country.

The travel recommendation is a “strong recommendation,” not a requirement, CDC official Henry Walke said on a call with reporters Thursday. The government agency said it was making the recommendation after many states across the country have experienced a surge in coronavirus cases in recent weeks.

“We’re alarmed with the exponential increase in cases, hospitalizations, and deaths,” Walke said.

The CDC advised against gathering with anyone who hasn’t lived in the same household for at least fourteen days, the incubation period for the coronavirus. Officials said they were also posting recommendations on their website on how to stay safe during the holidays for those Americans that do choose to travel.

Thanksgiving and Christmas are typically the busiest times of year for domestic travel as Americans gather with friends and family around the country. Shares in airlines and hotel companies have plummeted since the beginning of the outbreak as public officials have advised against unnecessary travel.

https://www.reuters.com/article/us-health-coronavirus-cdc-thanksgiving/cdc-recommends-americans-dont-travel-for-thanksgiving-idUSKBN27Z2LB

U.S. COVID-19 hospitalizations up nearly 50% in 2 weeks, usher in new shutdowns

 The number of people hospitalized with COVID-19 in the United States has jumped nearly 50% in the last 14 days, straining the nation’s healthcare system and forcing states to impose new restrictions to curb the alarming spread of the coronavirus.

Nearly 79,000 people in the United States were hospitalized with the virus on Thursday, a Reuters tally shows, the most at any time during the pandemic, following sharp rises in infection rates around the country and particularly the Midwest.

New social restrictions aimed at slowing community spread and lowering the infection rate were taking effect this week, including the abrupt closing of New York City’s public schools on Thursday as the city’s 7-day positive test rate average hit 3%. Restaurants, bars, fitness centers and entertainment venues in Minnesota were ordered closed starting on Friday through at least Dec. 18.

New York City Mayor Bill de Blasio defended his decision to shut down the nation’s largest school district, noting that additional safety standards to reopen schools would be announced before Thanksgiving after consultation with Governor Andrew Cuomo.

“Our schools are going to come back, but they’re going to come back with additional safety standards,” de Blasio told CBS on Thursday.

Suzanna Riordan, a Brooklyn mother, said she burst into tears upon learning that her 7-year-old daughter would be denied in-school learning until at least after the Thanksgiving holiday weekend. Her daughter Olivia had been excited at the prospect of adding one more day of in-person education a week starting next week, Riordan said. But the excitement quickly turned into disappointment.

“Since September she’s gotten maybe seven days in school,” Riordan told Reuters. “And those are the days where...she comes home excited and happy and she gets to see other second graders. And that’s gone again.”

Governor Tim Walz of Minnesota, one of several Midwest states dogged by the country’s highest infection rates per capita, said his shutdown order was necessary as more than 90% of hospital intensive care unit (ICU) beds were already occupied in the eastern half of the state.

In nearby Wisconsin, 90.2% of ICU beds were occupied on Thursday, state data showed.

Health and government officials have warned that the dramatic rise in hospitalizations over the last couple of weeks may only get worse heading into winter, and urged Americans to limit their Thanksgiving holiday celebrations next week to small, single household gatherings.

The U.S. northeast region, which for months had successfully held the virus at bay after the crushing first wave in the spring, has seen the highest percentage jump in hospitalizations at 85.4% over the past 14 days, according to Reuters data. During that same period, hospitalizations in the Midwest have increased by 56.8%, in the West by 50.1%, and in the South by 34.4%.

Kansas, where the positive test rate was approaching 60% last week, became the latest state to issue a statewide mask mandate on Wednesday.

https://www.reuters.com/article/us-health-coronavirus-usa/u-s-covid-19-hospitalizations-rise-by-nearly-50-in-2-weeks-ushering-in-new-shutdowns-idUSKBN27Z2GJ

Indoor dining shutdown 'just a matter of time' - NYC's de Blasio

 

• An indoor dining shutdown for New York City is likely coming "in the next week of two," says Mayor de Blasio.
• His comments come one day after the city shut down in-person schooling, and Governor Cuomo warned The Big Apple could soon be placed in the so-called "orange zone," which means no indoor dining and outdoor dining would be limited to four folks per table.
• The restaurant scene in NYC is already somewhat devastated, and an indoor dining shutdown as we head into winter would be a tough pill for what's left. State Comptroller Thomas Di Napoli says sector employment was nearly 318K in 2019, dropped below 100K during the spring shutdown, and rebounded to 174K late last summer.
• https://seekingalpha.com/news/3638006-coronavirus-update-indoor-dining-shutdown-just-matter-of-time-nycs-de-blasio

Pfizer: Treatment Reduced Risk of Progression, Death in Lung Cancer

Pfizer Inc. said a late-stage study found that its Lorbrena treatment reduced the risk of progression or death among lung-cancer patients by 72%.

The Phase 3 trial involved people with previously untreated anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, Pfizer said Thursday.

The company still needs to figure out the overall survival of the drug trial, it said.

https://www.marketscreener.com/quote/stock/PFIZER-INC-23365019/news/Pfizer-Says-Treatment-Reduced-Risk-of-Progression-or-Death-Among-Lung-Cancer-Patients-31820145/

Roche Actemra helps sickest COVID-19 patients

 

 Roche's Actemra helped the sickest COVID-19 patients in a 303-patient study, the trial's lead investigator said on Thursday, bolstering what has been mixed evidence that the arthritis drug can be repurposed to help in the pandemic.

Actemra, an anti-inflammation drug also called tocilizumab, reached a "key efficacy endpoint" among critically ill patients, compared with patients who did not get immune modulation treatments, according to early REMAP-CAP trial data.

Anthony Gordon, Imperial College London professor of anaesthesia and critical care, said it remained unclear if Actemra kept people alive or shortened how long they needed intensive care support like mechanical ventilation, or both. Those details should be published in a couple of weeks, he said.

Even without specific data, however, Gordon said the study's early signal was robust, with a 99.75% probability that Actemra is better than getting no immune system modulator.

While survival benefit would be ideal, cutting need for intensive care support is also important, since it would reduce the burden on hospitals where occupancy has swelled during the second wave of coronavirus infections.

"We still think that is important," Gordon said on a call with reporters. "But obviously, we hope it improves both, and we're looking for that."

Actemra's trial results against COVID-19 have been mixed.

Roche said in September it helped cut the need for ventilators in hospitalised patients with COVID-19, though the drug failed in a separate study of patients hospitalised with severe COVID-19 related pneumonia.

Other treatments including interferon-beta-1a, interleukin-1 receptor antagonist and Sanofi's arthritis drug Kevzara are also in the REMAP-CAP study, but results are not yet available.

Gordon said the trial's placebo arm - in which patients got no immune modulator - would now be stopped and new patients would get the treatments.

The REMAP-CAP trial separately concluded that AbbVie's AIDS drug cocktail lopinavir/ritonavir didn't help in COVID-19, mirroring results from earlier studies.

https://www.marketscreener.com/quote/stock/ROCHE-HOLDING-AG-9364975/news/Roche-Actemra-helps-the-sickest-COVID-19-patients-study-shows-31821000/