Category: Coronavirus

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COVID Vaccinations Launch Next Week in the United Kingdom

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the staff of the Ridgewood blog

London UK, the U.K. has become the first country in the world to approve the coronavirus vaccine from Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX), which has been shown to offer up to 95% protection against COVID-19. The first 800,000 doses will be available in the U.K. from next week (another 40M doses are on order). Two doses three weeks apart are required for protection and will first be offered to frontline health care workers and nursing home residents, followed by older adults. Other countries aren’t far behind: The U.S. and the EU also are vetting the Pfizer shot along with a similar vaccine made by competitor Moderna (NASDAQ:MRNA), and a similar nod by the FDA is expected as early as next week

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Germbuster System offers Preventative monthly two-step Process Amidst Second Covid19 Wave

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the staff of the Ridgewood blog
Redbank  NJ, Bedside nurses are not the only RNs keeping us safe from the COVID19 pandemic. Gina Dehmer, RN, BSN, an Environmental Health Nurse focused on Infection Control, along with her business partner and environmental contractor and consultant Gary Syzmanski, has created a suite of preventative services for all indoor environments, commercial and residential, to protect those inside from a host of germs—including COVID19.

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BREAKING: Moderna to apply for Emergency use Authorization for COVID-19 Vaccine Candidate Today

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the staff of the Ridgewood blog

CAMBRIDGE  Mass ,  Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.

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Johns Hopkins University Newsletter Pulls Study Challenging Deadliness of COVID19

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the staff of the Ridgewood blog

Ridgewood NJ, Johns Hopkins University Newsletter ran a study from Genevieve Briand, assistant program director of the Applied Economics master’s degree program at Hopkins, that looked at the effect of COVID-19 on U.S. deaths according to data from the CDC. Dr. Genevieve Briand at Johns Hopkins University noted some critical accounting errors done at the national level.

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AstraZeneca Faces Hurdles to Regulatory Approval of COVID19 Vaccine

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 the staff of the Ridgewood blog
Ridgewood NJ, previously reported on the Ridgewood blog that AstraZeneca issued a press release regarding preliminary results from the Phase 3 clinical trials of its candidate SARS-CoV-2 vaccine, developed in collaboration with Oxford University (UK). According to Johns Hopkins Center for Health Security ,the press release indicates that the vaccine demonstrated 90% efficacy when administered as an initial half-dose followed by a full dose a month later. Interestingly, however, the vaccine was 62% efficacious in participants who received 2 full doses over the same period of time, resulting in an overall efficacy of 70%. No serious adverse events were identified in the trials. In total, the Phase 3 portion of the trials included more than 11,000 participants, and the researchers identified 131 COVID-19 cases. As has been the case throughout the pandemic, the data published via press release have not yet been peer reviewed, although the researchers reportedly intend to publish the full data in the near future.

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FDA to Convene on Pfizer and BioNTech COVID Vaccine December 10th

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the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security , the US FDA announced that its Vaccines and Related Biological Products Advisory Committee will convene on December 10 to review the Emergency Use Authorization (EUA) requests submitted by Pfizer and BioNTech for their candidate SARS-CoV-2 vaccine. FDA Commissioner Dr. Stephen Hahn emphasized that while the advisory board “will review the request as expeditiously as possible,” it is unclear how long the review process will take. That being said, this represents another major step toward authorization for a SARS-CoV-2 vaccine. The FDA intends to livestream the meeting via its YouTube, Facebook, and Twitter accounts as well as from the FDA website.

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Regeneron COVID Antibody Treatment Gets Emergency Use Authorization from the FDA

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Ridgewood NJ, according to Johns Hopkins Center for Health Security , the US FDA issued an Emergency Use Authorization (EUA) for another monoclonal antibody treatment for COVID-19. The newest EUA is for a combination therapy using casirivimab and imdevimab, developed by Regeneron Pharmaceuticals, which are monoclonal antibodies that target the receptor binding domain for the SARS-CoV-2 spike protein. Similar to the previous FDA EUA for the Eli Lilly monoclonal antibody treatment, this combination is authorized for use in mild or moderate COVID-19 patients (aged 12 years and older) who are not currently hospitalized but who are at high risk of progressing to severe disease. It is not authorized for patients who are currently hospitalized or receiving supplemental oxygen therapy for COVID-19 or an underlying health condition. The 2 products must be administered together.

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US Supreme Court Blocks New York Governor Andrew Cuomo Coronavirus Limits

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the staff of the Ridgewood blog

Washington DC, The U.S. Supreme Court on Wednesday night blocked New York Gov. Andrew Cuomo from reimposing strict attendance caps at worship services in areas hit hard by the novel coronavirus.

The court ruled 5-4 to bar Cuomo from enforcing his Oct. 6 “Cluster Initiative” against houses of worship that sued to challenge the restrictions.

Cuomo’s initiative had created color-coded limits on mass gatherings and business operations, in an effort to stem the outbreak in New York City areas that were experiencing a surge in cases, according to Bloomberg News.

 

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March For Your Rights Rally to Support Small Business

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the staff of the Ridgewood blog
Morristown NJ, on Sunday morning at 10am to 12pm the March For Your Rights peaceful protest was held.  The protests was held for the right  to run your business, go to work and go to school . The message is one of personal responsibility. Organizers asked attendees to please wear your mask and in the Gathering areas as well as along the March route, please wear your masks and practice social distancing to demonstrate that mandates are not required for people to act responsibly.

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Researchers Say COVID Reinfections possible but tend to be milder compared to the original infection

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Ridgewood NJ, according to Johns Hopkins Center for Health Security researchers from the La Jolla Institute for Immunology published (preprint) results from a study on longer-term immunity against SARS-CoV-2 conferred by natural infection. The study evaluated 185 individuals with previous SARS-CoV-2 infection. All participants, and the majority experienced COVID-19 disease but were not hospitalized. Most of the participants provided a single blood sample between 6 and 240 days after symptom onset, with 41 collected at least 6 months after symptom onset. A subset of 38 participants provided multiple samples over a period of several months. The researchers found that antibodies against the spike protein of SARS-CoV-2 were relatively stable and memory B cells were abundant after 6 months, leading to optimism that immunity against the virus could mitigate the risk of severe COVID-19 disease for “many years.”

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University of Oxford-AstraZeneca Coronavirus Vaccine Produces Strong Immune Response in Older Adults

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the staff of the Ridgewood blog

University of Oxford , The ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults aged 56-69 and those over 70 years of age. The data, published today in The Lancet, suggest that one of the groups most vulnerable to serious illness, and death from COVID-19, could build immunity.

British pharmaceutical giant AstraZeneca, which is working in collaboration with the University of Oxford, has previously said interim data showed their experimental vaccine had produced an immune response in older and younger adults.

Older adults have been shown to be at higher risk from COVID-19 and should be considered to be a priority for immunisation should any effective vaccine be developed for the disease. Reporting on data from a Phase II trial of the ChAdOx1 nCov-2019 vaccine, the authors write that volunteers in the trial demonstrate similar neutralising antibody titres, and T cell responses across all three age groups (18-55, 56-79, and 70+).

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FDA Approves Home Test Kits for COVID

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the staff of the Ridgewood blog

Ridgewood NJ, according to Johns Hopkins Center for Health Security the US FDA granted Emergency Use Authorization to the first fully at-home SARS-CoV-2 diagnostic test kit. The Lucira COVID-19 All-In-One Test Kit must be prescribed by a healthcare provider, but it can be performed by individuals at home. The manufacturer recommends that children under 14 years old should have the test performed by a healthcare provider in order to maximize the chances of obtaining a valid result. The kit comes with a nasal swab, a test tube with detection reagents, and a small test machine. Once the used nasal swab is swirled around the test tube for the requisite amount of time, the user inserts the tube into the machine, which will automatically process the sample and provide visual indication of the results. The test kit will light up as positive, negative, or inconclusive results in around 30 minutes.

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Rutgers Recruiting 2,000 Participants for Johnson & Johnson Phase 3 COVID-19 Vaccine Trial

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the staff of the Ridgewood blog

New Brunswick NJ, Rutgers University is a clinical trial site for the Janssen Pharmaceutical Companies of Johnson & Johnson’s phase 3 clinical research study to evaluate the safety and efficacy of Janssen’s COVID-19 vaccine candidate.

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Pfizer Says Final data Shows Covid Vaccine is 95% Effective ,Will Submit to FDA in coming ‘days’

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the staff of the Ridgewood blog

NEW YORK & MAINZ, Germany,  Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that, after conducting the final efficacy analysis in their ongoing Phase 3 study, their mRNA-based COVID-19 vaccine candidate, BNT162b2, met all of the study’s primary efficacy endpoints. Analysis of the data indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%.

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Rutgers-Eagleton Poll Claims Four in Ten New Jerseyans Say They Won’t Get COVID-19 Vaccine

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New Brunswick NJ, while polling has produced less than stellar results in the last 20 years , so take this with a grain of salt , according  a recent Rutgers-Eagleton Poll between 36 percent and 47 percent of New Jerseyans say they will “probably” or “definitely” not get vaccinated against COVID-19, with response rates varying depending on how the question is asked, according to the latest Rutgers-Eagleton Poll.

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