Your Coronavirus Update for September 28; stay up to date with Elite.
More than 33 million cases of coronavirus (COVID-19) have been diagnosed worldwide as of Sunday evening, including at least 1 million deaths. Healthcare officials in the United States have reported more than 7.1 million positive COVID-19 cases and at least 205,000 deaths. Source: Johns Hopkins University & Medicine
CDC Provided Recommendations For Halloween & Thanksgiving
Officials with the Centers For Disease Control & Prevention (CDC) are asking healthcare providers to help inform the public about potentially safe alternatives to traditional Halloween and Thanksgiving celebrations during the pandemic.
Although many people will engage in their traditional gatherings, perhaps in part due to the ongoing confusion that coronavirus poses as experts continue to learn more about the condition, the CDC advises that a Halloween costume mask is not a substitute for a cloth mask, and should not be used unless it is made of two or more layers of breathable fabric that covers the mouth and nose and doesn’t leave gaps around the face. A costume mask should also not be worn over a protective cloth mask because it can be dangerous if the costume mask makes it difficult to breathe. Instead, consider using a Halloween-themed cloth mask, the CDC recommends.
Also, if screaming is likely occur at any gathering, greater distancing is advised because the greater the distance, the lower the risk of spreading a respiratory virus, the CDC states.
Identified lower-risk Halloween activities that can be safe alternatives, according to the CDC, and go slightly beyond simply staying home or virtual gatherings, include:
- Carving or decorating pumpkins outside, at a safe distance, with neighbors or friends.
- A Halloween scavenger hunt where children are given lists of Halloween-themed things to look for while they walk outdoors from house to house while viewing Halloween decorations at a distance.
Identified moderate-risk Halloween activities, according to the CDC, include:
- Participating in one-way trick-or-treating where individually wrapped bags are lined up for families to grab and go while continuing to social distance (such as at the end of a driveway or at the edge of a yard). The CDC urges providers to remind their communities that if they are preparing goodie bags to wash their hands with soap and water for at least 20 second before and after preparing bags.
- Having a small-group, outdoor, open-air costume parade where people are distanced more than six feet apart.
- Attending a costume party held outdoors where protective masks are used and people can remain more than six feet apart.
- Going to an open-air, one-way, walk-through haunted forest where appropriate mask use is enforced and people can remain more than six feet apart.
- Visiting pumpkin patches or orchards where people use hand sanitizer before touching pumpkins or picking apples, wearing masks is encouraged or enforced, and people are able to maintain social distancing.
- Having an outdoor Halloween movie night with local family friends with people spaced at least six feet apart.
Identified lower-risk Thanksgiving activities that can be safe alternatives, according to the CDC, include:
- Having a small dinner with only people who live in one household.
- Preparing traditional family recipes for family and neighbors, especially those at higher risk of severe illness from COVID-19, and delivering them in a way that doesn’t involve contact with others.
- Having a virtual dinner and sharing recipes with friends and family.
- Shopping online rather than in person on the day after Thanksgiving or the next Monday.
Identified moderate-risk Thanksgiving activities, according to the CDC, include:
- Having a small outdoor dinner with family and friends who live in the same community.
- Attending a small outdoor sports event with safety precautions in place.
The CDC advises that these considerations are meant to supplement, not replace, any state, local, territorial, or tribal health and safety laws, rules, and regulations. Healthcare providers are asked to remind their community members that when planning to host a holiday celebration to assess current COVID-19 levels in their communities to determine whether to postpone, cancel, or limit the number of attendees.
J&J Announces Plans For Phase 3 Vaccine Trial
A large-scale, multi-country Phase 3 trial for a COVID-19 vaccine candidate has been launched by Johnson & Johnson (J&J), officials recently announced. The drug is by J&J’s Janssen Pharmaceutical Companies and the initiation of the ENSEMBLE trial follows positive interim results from the company’s Phase 1/2A clinical study that has reportedly demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), the ENSEMBLE trial will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19, officials said.
J&J is expected to develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and scientific principles, officials said.
“As COVID-19 continues to impact the daily lives of people around the world, our goal remains the same – leveraging the global reach and scientific innovation of our company to help bring an end to this pandemic,” said Alex Gorsky, J&J’s chairman and chief executive officer, in a prepared statement. “This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process. We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
This vaccine candidate leverages the company’s AdVac® technology platform, which was also used to develop and manufacture Janssen’s European Commission approved Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates, officials said. The AdVac platform has reportedly been used to vaccinate more than 100,000 people across Janssen’s investigational vaccine programs. If successful, it is estimated that the vaccine would remain stable for two years at -20 °C and at least three months at 2-8° C, making the candidate compatible with standard vaccine distribution channels and would not require new infrastructure to get it delivered to those who need it, officials said.
The Phase 3 study is a randomized, double-blind, placebo-controlled clinical trial designed with significant representation from those who are over age 60. The trial will reportedly include those participants with and without comorbidities associated with an increased risk for progression to severe COVID-19 and will aim to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. In order to evaluate the effectiveness of the vaccine candidate, countries and clinical trial sites that have a high incidence of COVID-19 and the ability to achieve a rapid initiation will be activated, officials said.
ENSEMBLE is being initiated in collaboration with the Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS.
In parallel, the Company has also agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland on a separate Phase 3 clinical trial in multiple countries to explore a two-dose regimen of Janssen’s vaccine candidate, officials said.
Study May Explain Why Kids Recover More Often
A new study that has analyzed immune responses in children and adults who have been diagnosed with COVID-19 has found that children produce higher levels of cytokines that 1) help to prompt immune system response early in an infection and 2) attempt to stop the virus from replicating. The Immune Responses to SARS-CoV-2 Infection in Hospitalized Pediatric and Adult Patients study1 also claims that children evaluated in a New York City hospital system had shorter lengths of stay, less need for mechanical ventilation, and lower mortality rates than adults. Research done through the study reportedly looked at blood and cell samples and found that kids can become infected and become very sick, but generally do better when infected. Age-associated differences may reflect differences in immune responses and be evolutionary, the authors claim.
- Pierce CA, Preston-Hurlburt P, Dai Y. Immune responses to SARS-CoV-2 infection in hospitalized pediatric and adult patients. Science Translational Medicine. 2020. DOI: 10.1126/scitranslmed.abd5487