CytoDyn (OTCQB:CYDY) has reached the requisite number of enrolled patients in its Phase 3 trial of leronlimab in COVID-19 patients with severe-to-critical symptoms to perform an interim analysis following the 28-day phase of the trial, with results anticipated by mid-October.
The study has three phases lasting 28 days: Screening Period, Treatment Period, and Follow-Up Period. The primary outcome measured is all-cause mortality at Day 28.
Secondary outcomes measured are all-cause mortality at Day 14, change in clinical status of subject at Day 14 and Day 28, and change from baseline in Sequential Organ Failure Assessment score at Day 14.
Recently, the Data Safety Monitoring Committee completed its first safety review of patients from 149 of 169 patients enrolled and did not raise any concerns regarding safety, thereby recommending the trial to continue as planned.
The European pharmaceuticals vaccine lobby is pushing the EU for certain liability protections as drugmakers around the world rush to develop a coronavirus vaccine.
It would give them a “comprehensive no-fault and non-adversarial compensation system, and an exemption from civil liability” if there are problems with the vaccines, “in order to compensate for such high risks taken by manufacturers.”
Vaccines Europe represents drugmakers including AstraZeneca (NYSE:AZN), GlaxoSmithKline (NYSE:GSK), Janssen (NYSE:JNJ), Merck (NYSE:MRK), Novavax (NASDAQ:NVAX), Pfizer (NYSE:PFE), Sanofi (NASDAQ:SNY), Takeda (NYSE:TAK), Abbott (NYSE:ABT) and CureVac (NASDAQ:CVAC).
Several of the firms are in advanced talks with the EU over vaccine supplies, while some have already reached deals with either the U.S. or the EU.
Last month, AstraZeneca reportedly secured exemption from future product liability claims on its vaccine candidate, which it is developing in partnership with the University of Oxford.
Retail and service industry workers should not argue with anti-maskers, according to updated guidance from the Centers for Disease Control and Prevention (CDC).
As part of new guidance for workplace safety, the agency said employees should not attempt to force customers to follow COVID-19 prevention policies if the customers appear to be upset or violent.
“Don’t argue with a customer if they make threats or become violent,” the CDC said.
The CDC recommended that businesses institute policies such as mask-wearing, social distancing and customer limits but warned that workers could be threatened or assaulted for enforcing them.
According to the CDC, workplace violence can include threats, verbal assaults such as swearing and insulting, and physical assaults such as slapping and choking the employees.
The CDC outlined a variety of steps businesses can take, ranging from conflict resolution training to installing security systems or panic buttons and identifying designated safe areas employees can go to if they feel they are in danger.
Some of the country’s largest retailers have mandated customers wear masks, but there have been several high-profile violent confrontations between employees and customers who refuse.
“Threats and assaults can happen in any workplace, but may be more likely to occur in retail, services (e.g., restaurants), and other customer- or client-based businesses,” the CDC said.
Recently, a teenage employee at a Sesame Street theme park near Philadelphia was punched in the face after asking two guests to wear masks. The employee needed jaw surgery.
In another example, a 17-year-old hostess at a Chili’s in Baton Rouge, La., was assaulted by a group of diners after she told a large party they were not allowed to be seated together because of physical distancing laws.
Ventilation inspection teams began Tuesday the task of inspecting 1,700 New York City public schools to make sure classrooms are safe to reopen by September, officials said.
“This is what it takes to guarantee our schools are safe,” de Blasio said. “That’s the effort that’s going on right now.”
About 100 teams, of about two to four engineers each, will inspect ventilation systems, windows and fans in 1,700 public schools in the eight days between Tuesday and Sept. 1, CEO Lorraine Grillo said.
Classrooms with locked windows will see them opened, classrooms without windows will get improved airflow, Grillo said.
“The goal here is to have air flowing through these classrooms,” Grillo said. “We’re doing everything we can to make sure these buildings are safe.”
Classrooms deemed unfit will either see issues addressed or the spaces taken offline and results will be posted online by Sept. 4, Chancellor Richard Carranza said.
“We’re taking a united approach,” Carranza said.
When faced with a question about ventilation during colder months, de Blasio argued global warming meant there would be more days this winter when teachers could open classroom windows.
“It’s not new,” de Blasio said Tuesday. “It’s not mysterious to school leaders to think about this option.”
Carranza noted 243 schools submitted outdoor learning plans since Monday’s announcement, but added he has not yet viewed the plans.
“Our approach is to flatten the bureaucracy,” Carranza said. “I’m just very excited.”
The mayor said indoor restaurant dining remained infeasible for New York City because eating inside remains, according to Senior Health Advisor Dr. Jay Varma, “a high risk activity.”
Yet when reporters raised concerns about the spread of COVID-19 during lunch hours, when students will be eating at their desks and presumably talking loudly among each other, the mayor laughed.
The breadth of the humoral immune response following SARS-CoV-2 infection was indicated to be important for recovery from COVID-19. Recent studies have provided valuable insights regarding the dynamics of the antibody response in symptomatic COVID-19 patients. However, the information regarding the dynamics of the serological and cellular memory in COVID-19 recovered patients in scarce. It is imperative to determine the persistence of humoral memory in COVID-19 recovered patients as it will help to evaluate the susceptibility of recovered patients to re-infection. Here, we describe the dynamics of both the SARS-CoV-2 specific serological and B cell response in COVID-19 recovered patients. We found that symptomatic SARS-CoV-2 patients mount a robust antibody response following infection however, the serological memory decays in recovered patients over the period of 6 months. On the other hand, the B cell response as observed in the SARS-CoV-2 specific memory B cell compartment, was found to be stable over time. Moreover, the frequency of SARS-CoV-2 specific B cell plasmablasts was found to be associated with the SARS-CoV-2 specific antibody levels. These data, suggests that the differentiation of short-lived plasmablasts to become long-lived plasma cells is impaired and the main contributor of antibody production are the short-lived plasmablasts. Overall, our data provides insights regarding the humoral memory persistence in recovered COVID-19 patients. Notwithstanding the insights from this study, it is still to be determined if the persistence of SARS-CoV-2 memory B cells can be considered as a correlate of protection in the absence of serological memory.
China has already granted emergency use authorisation to multiple COVID-19 vaccines developed by domestic drugmakers and started dosing key workers, according to local media reports.
Zheng Zhongwei, head of China’s COVID-19 vaccine development task force, made the revelation on Chinese television, saying that the vaccines were being used in people at high-risk of contracting SARS-CoV-2, including front-line medical staff, according to the China Daily news service.
Around 20,000 people have been vaccinated since emergency use was approved in July, focusing on healthcare workers and border control staff, and the plan is to scale up the programme before the winter to include other groups like those working in the transport and food industry, he said.
The identity of the shots cleared for emergency use isn’t yet clear. Several Chinese companies have started clinical trials of coronavirus vaccine candidates, and three shots based on inactivated SARS-CoV-2 from Sinovac and Sinopharm are heading for phase 3 testing, according to the World Health Organisation’s latest update on vaccine progress.
Another adenovirus-based vaccine from CanSino Biologics is also in late-stage development and has been approved for use in military personnel, according to the South China Morning Post.
Meanwhile, candidates from Sinopharm’s China National Biotec Group (CNBG) subsidiary are also heading for phase 3 trials outside China – namely in Peru, Morocco, Bahrain, United Arab Emirates and most recently Argentina – after getting approvals to start testing by regulators.
Faced with dwindling numbers of COVID-19 cases in China, CNBG is starting up studies of its inactivated vaccines overseas where outbreaks of the virus are still in full swing. China has gone several days without a locally-transmitted case of the infection.
One has been developed in collaboration with the Wuhan Institute of Biological Products, while the other is partnered with the Beijing Institute of Biological Products. Both have cleared phase 1/2 trials which according to Sinopharm showed they were safe and generated “high-titre” antibody responses against SARS-CoV-2.
China has said that it will prioritise access for countries from Africa, Latin America and the Mekong region – Myanmar, Laos, Thailand, Cambodia and Vietnam – when the vaccine is ready to be rolled out overseas.
Professor Chris Whitty, the UK’s chief medical officer, said over the weekend that he believes it is unlikely that a coronavirus vaccine will be widely available before winter 2021.
Meanwhile, the Financial Times has reported that the Trump administration is considering fast-tracking emergency-use approval of the ChAdOx1 adenoviral vaccine developed by the University of Oxford and AstraZeneca for use in the US ahead of the upcoming presidential election, after being slammed for his handling of the crisis.
That has been denied by the Department of Health and Human Services, but the pandemic continues to be a focus for political wrangling ahead of the election.
The first patients have been dosed in a trial of two AstraZeneca antibodies, collectively known as AZD7442, that are being developed to both treat and prevent coronavirus infections.
The phase 1 trial – funded by the US government – will take place in the UK and will test the safety of AZD7442 and its pharmacokinetic profile. It will enrol up to 48 people aged 18 to 55, and is expected to generate results before the end of the year.
AZD7442 is a combination of antibodies derived from convalescent plasma, taken from patients who have been infected with SARS-CoV-2 but have recovered.
The two antibodies were discovered by Vanderbilt University Medical Center and licensed to AZ in June. In animal and human cell models, the cocktail has been shown to block the binding of the SARS-CoV-2 virus to host cells and protect against infection.
The rationale behind the drug is the same as Regeneron’s REGN-COV2 antibody cocktail, which is further ahead in development having started phase 3 testing in early July, with preliminary data expected in the coming weeks.
REGN-COV2 advanced into phase 2/3 on the strength of a single phase 1 study, and the US government has already agreed a deal to scale up manufacturing and claim the first doses to be made.
Regeneron’s drug is being tested as a single intravenous dose in the treatment of established COVID-19, and as a subcutaneous dose in prevention studies involving household contacts of people infected with the coronavirus. A recently-started trial of the antibody is looking at a dosing frequency for subcutaneous injections of every four weeks.
Mene Pangalos, head of biopharmaceuticals R&D at AZ, says that AZD7442 has been developed using a half-life extension technology that “has the potential to improve both the effectiveness and durability of use in addition to reducing the likelihood of viral resistance.”
The half-life extended antibodies should afford at least six months of protection from COVID-19, according to AZ. If that profile is backed up in clinical testing it could mean that supplies of AZD7442 – which could be limited initially – will stretch further.
The FDA has just granted emergency use authorisation to the use of convalescent plasma to treat severe COVID-19 cases in the US – notably despite reservations among some health experts.
However, there are advantages to having off-the-shelf, standardised antibodies such as REGN-COV2 and AZD7442 that have been tested clinically and may reduce the risk of side effects.
Another approach that avoids the use of plasma itself was proposed by a group of companies that specialise in plasma-derived drugs back in April.
Led by Takeda and CSL Behring, the consortium – which also includes Biotest, BPL Group, LFB and Octapharma – is working on an “unbranded” hyperimmune immunoglobulin drug for SARS-CoV-2.
