J&J tests new two-dose regimen for COVID-19 vaccine candidate

• In addition to the single-dose regimen ENSEMBLE study, Johnson & Johnson (NYSE:JNJ) unit, Janssen has now initiated the two-dose regimen ENSEMBLE 2 trial. The company is investigating multiple doses and dosing regimens to evaluate its long-term efficacy.
• The big pharma’s vaccine, JNJ-78436735, is currently in a major 60,000-subject Phase 3 known as ENSEMBLE assessing whether it can prevent coronavirus infections with a single shot.
• Early data have already shown it can produce an immune response at one dose.
• Phase 3 ENSEMBLE 2 trial will study the safety and efficacy of a two-dose regimen of the investigational Janssen vaccine candidate versus placebo for the prevention of COVID-19 in up to 30,000 participants, running parallel to its ongoing ENSEMBLE phase 3.
• J&J is already running a one-shot-and-done program, which puts it at an advantage over rivals Pfizer/BioNTech and Moderna, which need two.
• While some drugmakers have been set back by the challenge of manufacturing enough doses, J&J is well on its way to producing 1B doses of its COVID-19 vaccine in 2021 and is looking ahead to 2022, said Paul Lefebvre, vice president of strategic initiatives and COVID-19 vaccine supply chain at J&J's Janssen unit, in an interview.
• Back in April, J&J signed on New Jersey-based CDMO Catalent to lock down manufacturing capacity at its Bloomington, Indiana plant, to hit a manufacturing goal set by January.
• In July, Maryland's Emergent Biosolutions joined the fold, inking a five-year pact to churn out drug substance.
• Also, Johnson & Johnson signed on Michigan's Grand River to meet its 100M dose supply order with the U.S. for $1B, or $10 per dose. Elsewhere, J&J is relying on its own sites in Europe to make drug substance.
• J&J just this week finalized a deal to provide up to 200M doses to Europe, with the option to sell another 200M shots at a later date should the vaccine pass muster in clinical trials.
• Separately, Johnson & Johnson is shipping 30M doses to the U.K.
• The drugmaker also teamed up with Aspen Pharmacare to manufacture J&J's vaccine at its facility in Port Elizabeth, South Africa, and Biological E in August agreed to manufacture the shot in India.
• With those partnerships in place, J&J feels confident it can meet its lofty supply goals.
• "The sheer speed of execution is challenging, and also the sheer volume that we need to produce. I think every manufacturer is facing the same challenges," Lefebvre said.
• Also, J&J has pledged 500M doses to low-income markets starting in mid-2021.
• https://seekingalpha.com/news/3636937-j-and-j-tests-new-two-dose-regimen-for-covidminus-19-vaccine-candidate
  
  

Pfizer sets out pilot delivery program for COVID-19 vaccine

• The pilot delivery program is being closely watched as the vaccine must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).
• Rhode Island, Texas, New Mexico, and Tennessee were picked due to their differences in overall size, diversity of populations, immunization infrastructure, and urban/rural settings.
• Pfizer (NYSE:PFE) notes that the four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration.
• The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization from the FDA.
• https://seekingalpha.com/news/3636939-pfizer-sets-out-pilot-delivery-program-for-covidminus-19-vaccine
  
  

Biden coronavirus adviser wants US to distribute vaccine globally before to all Americans

Oncologist Dr. Zeke Emanuel, one of 10 advisory board members named to Democratic President-elect Joe Biden's coronavirus task force, has pushed the U.S. and other countries to not hoard a coronavirus vaccine.

Emanuel, who served as a key architect of the Affordable Care Act under the Obama administration, co-authored a paper in September in which he encouraged officials to follow the "Fair Priority Model," which calls for a "fair international distribution of vaccine," rather than what he and his co-authors characterized as "vaccine nationalism."

The model allows the country that produces the vaccine to hold onto enough of a supply to reach a threshold for herd immunity ("Rt below 1"). Beyond that, the model supports distributing the vaccine internationally, which means giving away or selling doses of the vaccine before it's available to every citizen in that country, Emanuel explained to Scientific American.

“Reasonable national partiality does not permit retaining more vaccine than the amount needed to keep the rate of transmission (Rt) below 1, when that vaccine could instead mitigate substantial COVID-19–related harms in other countries that have been unable to keep Rt below 1 through ongoing public-health efforts," the Science magazine article titled "An ethical framework for global vaccine allocation" argues.

"Associative ties only justify a government's giving some priority to its own citizens, not absolute priority," Emanuel wrote with his co-authors.

The Trump administration had said that the U.S. will share any coronavirus vaccine it develops with other countries after American needs are met and that the U.S. will not coordinate with the World Health Organization (WHO) on distribution.

"Our first priority of course is to develop and produce enough quantity of safe and effective FDA-approved vaccines and therapeutics for use in the United States," Health and Human Services Secretary Alex Azar said during an August visit to Taiwan.

"But we anticipate having capacity that, once those needs are satisfied, those products would be available in the world community according to fair and equitable distributions that we would consult in the international community on," Azar said.

Congress approved nearly $10 billion for the Trump administration's Operation Warp Speed, which is working with private companies to produce and distribute a vaccine in the U.S.

On Monday, Pfizer and BioNTech's coronavirus vaccine moved a step closer toward approval, with the company announcing 90% efficacy in its phase 3 clinical trial.

Emanuel and his co-authors argued against a proposal by the WHO to distribute vaccines globally at a rate proportional to each country's population, and dismissed the belief that high death toll could be avoided by providing vaccines to countries based on "the number of frontline health care workers, 

The WHO proposal fails to consider the fact that death is not the only form of harm, Emanuel argued, and that prioritizing seniors at higher risk would mean sending a disproportionate amount of vaccines to wealthier countries, where average life expectancies tend to be longer.

Instead, Emanuel and his co-authors advocated for focusing on preventing premature death, the consequences of school and business closures and reducing general transmission of the virus.

Emanuel came under focus over the weekend after a 2014 essay he wrote, in which he outlines why he doesn't want to live past 75, resurfaced.

Emanuel, 63, wrote that "by 75, creativity, originality and productivity are pretty much gone for the vast, vast majority of us" in his essay titled "Why I Hope to Die at 75."

"Since 1960, however, increases in longevity have been achieved mainly by extending the lives of people over 60. Rather than saving more young people, we are stretching out old age," Emanuel wrote.

Biden is 77.

Other coronavirus task force advisory board members selected by Biden include Rick Bright, who said he left his position at NIH under President Trump over the administration's embrace of hydroxychloroquine, and Dr. Atul Gawande, former CEO of Haven, a health care venture founded by Amazon, Berkshire Hathaway and JPMorgan Chase in 2018.

https://www.foxnews.com/politics/biden-coronavirus-adviser-emanuel-vaccine-distribution

Living With a Dog Increases Risk of Contracting COVID-19

A study carried out by researchers from the University of Granada (UGR) and the Andalusian School of Public Health has analyzed the main risk factors in the transmission of the SARS-CoV-2 virus during the national lockdown in Spain, between March and May 2020.

The study, published in the journal Environmental Research, has revealed that living with a dog and buying basic products in the supermarket with home delivery were two of the socio-demographic variables (of those analyzed) that most increased the risk of contracting COVID-19 during the period under study—by 78% in the case of living with a dog, and by 94% in that of supermarket home delivery.

The authors warn dog-owners of the need to take extreme hygiene measures in relation to their pets, as it is not yet clear whether the owners were infected because the animal acted as a host for the virus (and transmitted it) or due to having taken it out for a walk in public.

As explained by Cristina Sánchez González, a researcher at the UGR’s Biomedical Research Centre and the main author of this work, “in view of the rapid spread of the virus even during lockdown, we consider it important to study the socio-demographic characteristics, habits, and comorbidities of the SARS-CoV-2 infection in order to implement effective prevention strategies.”

To this end, the researchers designed a survey to capture variables of interest during the lockdown period that might help explain the exponential spread of the virus, despite the highly restrictive mobility conditions implemented nationally in Spain.

Study based on 2,086 individuals

This study, carried out throughout Spain, sought to shed light on other possible routes of transmission of the COVID-19 disease, risk factors, and the effectiveness of the hygiene measures recommended by the Authorities, in order to detect critical points of exposure to the virus and thus minimize its spread—not only in this pandemic but also for any future events that could compromise public health.

Based on a sample of 2,086 individuals, 41% of the population surveyed were aged between 40 and 54 years and had studied to degree (44%) or postgraduate (32%) level. This collective presented a prevalence of the disease of 4.7%.

The results showed that the risk of suffering from COVID-19 is 60 times higher among those who cohabit with a COVID-19 patient. In addition, of all the socio-demographic variables analyzed, the one with the most powerful effect in terms of increasing the risk of contracting the disease (by up to 78%) was living with a dog and taking it for a walk. By contrast, having cats or other types of pets had no significant effect on the prevalence of the disease.

“The results of our research warn of increased contagion among dog-owners, and the reason for this higher prevalence has yet to be elucidated. Taking into account the current scarcity of resources to carry out the diagnosis of SARS-CoV-2 in humans, the possibility of diagnosis in dogs is extremely unlikely,” notes Sánchez González.

These results point to cohabiting with dogs as being a strong risk factor for COVID-19 infection, although further studies are needed to determine whether the reason for this sharp increase in the risk of SARS-CoV-2 infection is due to transmission between humans and dogs, to the dog acting as a vehicle for the virus, or to the increased contact with other vehicles for the virus (that is, objects or surfaces where the virus is present). The latter could be caused by greater exposure to the virus due to the unhygienic behaviors and habits of dogs when out in the street and their subsequent return to the home.

“At the international level, there are several studies that have obtained results similar to ours regarding Coronavirus infection in dogs, but it is necessary to dig deeper on this issue and establish whether this prevalence of the virus among dog-owners is due to one reason or another,” explains the UGR researcher.

Sánchez González warns that, “in the midst of a pandemic and in the absence of an effective treatment or vaccine, preventive hygiene measures are the only salvation, and these measures should also be applied to dogs, which, according to our study, appear to directly or indirectly increase the risk of contracting the virus.”

The researcher also points out that “from a scientific point of view, there is no justification for children’s playgrounds being closed to prevent infections while parks, where dogs are walked, are allowed to remain open, when there are numerous objects there that can act as vehicles for SARS-CoV-2. At the same time, we should not rule out the possibility that the virus may be transmitted via fecal matter.”

Disinfecting supermarket products

In this study, the effect of certain variables—gender, age, educational level, type of residence, size of household, cohabitation with children or adolescents, the presence of workers among the household members, the presence of domestic workers in the home during lockdown, or having any type of pet other than a dog—was found to have no statistical significance.

The most effective hygiene measure in helping to reduce the prevalence of the disease was to disinfect products purchased from the market once back home (which reduced the risk by 94%). This was found to be more effective than other hygiene measures, such as the use of facemasks, gloves, disinfecting with ethanol or bleach, disinfecting shoes, and washing clothes when returning home.

Among mobility variables that were studied, those with the greatest effect in terms of increasing the prevalence of the virus were working outside the home (which increased the risk by 76%) and the use of public transport (particularly the underground system or tram network). A higher prevalence of the disease was also detected among those surveyed who had purchased their basic products at a supermarket and then used the home delivery service, compared to those who brought their shopping home themselves (the risk increased by 94% among the former group).

The authors emphasize that this was an epidemiological study, which neither addresses the mechanisms surrounding the virus nor establishes causal relationships. This was a descriptive study in which the selected variables were statistically associated with prevalence.

Reference: “The spread of SARS-CoV-2 in Spain: Hygiene habits, sociodemographic profile, mobility patterns and comorbidities” by Miguel Rodríguez-Barranco, Lorenzo Rivas-García, José L. Quiles, Daniel Redondo-Sánchez, Pilar Aranda-Ramírez, Juan Llopis-González, María José Sánchez Pérez and Cristina Sánchez-González, 22 September 2020, Environmental Research.
DOI: 10.1016/j.envres.2020.110223

https://scitechdaily.com/are-dogs-spreading-sars-cov-2-study-finds-living-with-a-dog-increases-risk-of-contracting-covid-19/