Clinical Contributors to this Story Thomas Bader, M.D. contributes to topics such as Medical Quality.
Hackensack NJ, With countries across the world beginning their COVID-19 vaccination plans, there’s a lot of information to consider before signing up to get your first shot.
As always while making a medical decision, you should talk to your doctor about the vaccine. Your doctor should have the latest information about the vaccine, availability and when you can it.
New Brunswick NJ, earlier this week, New Jersey based Johnson & Johnson (J&J) reportedly announced that is reducing the size of its ongoing US SARS-CoV-2 vaccine clinical trial. The ongoing COVID-19 surge in the US actually benefits the trial by increasing the rate that participants are exposed and infected, meaning that the trial can meet its designated endpoint (e.g., specific number of cases) with fewer participants. In a recent press conference Dr. Moncef Slaoui, co-lead of Operation Warp Speed, emphasized that, while Pfizer and Moderna are moving closer to receiving Emergency Use Authorization, the J&J and AstraZeneca candidates are critical to the US government’s goal of vaccinating all Americans by summer 2021. J&J temporarily paused the Phase 3 clinical trials earlier this year in order to investigate an adverse event in the trial group, but it resumed the trial on October, 23.
Clinical Contributors to this Story Ihor Sawczuk, M.D. contributes to topics such as Medical Research, Urology.
Hackensack NJ, The United States has begun to roll out COVID-19 vaccines in an effort to help stop the pandemic. Millions of people will line up across the country to get the vaccine, expected to be approved by the U.S. government.
For many, we’ve never really thought about the approval process that every vaccine, including the COVID-19 vaccine, must go through before getting approved for public use. It’s an extensive and rigorous process to ensure it’s safe before it can be distributed to the community.
Ridgewood NJ, in a new a new National Bureau of Economic Research paper says the media here in the U.S. went too far and created a climate of fear and even panic. In their paper titled “Why Is All COVID-19 News Bad News?” Scholars from Dartmouth College and Brown University analyzed the tone of COVID-19 related news articles written since January 1. They found a big difference in the way US media covered the pandemic compared to media in other countries.
the staff of the Ridgewood compiled from the CDC website
Ridgewood NJ, In the United States, there is not yet an authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). The federal government, through Operation Warp Speedexternal , has been working since the pandemic started to make one or more COVID-19 vaccines available as soon as possible. Although CDC does not have a role in developing COVID-19 vaccines, CDC has been working closely with health departments and partners to develop vaccination plans for when a vaccine is available.
With the possibility of one or more COVID-19 vaccines becoming available before the end of the year, here are things you need to know about where those plans currently stand.
Ridgewood NJ, Johns Hopkins Center for Health Security is reporting that according to multiple reports, the US CDC plans to issue COVID-19 vaccination cards so that individuals can verify their vaccination status, much like cards used for other vaccinations, such as the ICVP “yellow card” for yellow fever. Additionally, the CDC is reportedly designing templates for buttons and stickers that health departments and providers can provide to vaccinated individuals, similar to the “I Voted” stickers handed out to many voters on election day. These templates will be included in the CDC’s SARS-CoV-2 vaccination toolkit to “educate and promote vaccination.”
Washington DC, U.S. Immigration and Customs Enforcement (ICE) is preparing for a surge in anticipated fraud by criminal networks related to COVID-19 vaccines and treatments. In response, ICE Homeland Security Investigations (HSI) has launched Operation Stolen Promise 2.0, the next phase of strategic efforts to identify and prevent the production, sale and distribution of unapproved or unauthorized COVID-19 products and drugs.
Ridgewood NJ, As New Jersey confronts an intense second wave of COVID-19, one key finding from the first months of the pandemic provides a note of hope: The mortality rate for patients hospitalized with the disease in New Jersey dropped from 25.3 percent during April to 6 percent in August.
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
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.
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.
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.
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.
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.
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.
