New Brunswick NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately following authorization.
West Long Branch NJ, More Americans express concern about the impact of Covid-19 now than at any time during the pandemic according to the Monmouth (“Mon-muth”) University Poll. President Joe Biden gets positive marks for his first steps in dealing with the crisis, although most continue to say the American public is not doing its part. A bare majority of the public is ready to get the coronavirus vaccine as soon as it is available to them, while others take a wait-and-see attitude and a sizable 1 in 4 say they will avoid getting the vaccine at all if they can help it. Continue reading MONMOUTH NATIONAL POLL: 1 IN 4 SAY ‘NO THANKS’ TO VACCINE
Ridgewood NJ, COVID cases appear to have peaked around January 6 or so nationally. In the two weeks since that peak, it has been all downhill with cases, percent positive, emergency room visits, and hospitalizations dropping substantially. Nationally hospitalizations have declined for the 23rd straight day!
NEW BRUNSWICK NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19.
GAITHERSBURG MD, Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government’s Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.
Ridgewood NJ, Health “experts” now claim two masks are better than one. Following the razor blade theory of the more blades give you a closer shave Dr. Anthony Fauci doubled down on masks on Monday saying two face masks are better than one. The “infectious diseases specialist” advised that double-masking is a logical way to curb the spread of the coronavirus.
Trenton NJ, for those New Jerseyans who have received the first Covid-19 vaccine dose, there’s another wave of confusion about how to get the second dose within the recommended time frame.
Assembly Republican Leader Jon Bramnick is calling for Legislative hearings to fix the problem.
Clinical Contributors to this Story Juan C. Ravell, M.D. Hackensack Meridian Health
Hackensack NJ, The Pfizer-BioNTech and Moderna COVID-19 vaccines were given Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in mid-December 2020. Prior to authorization by the FDA, these vaccines underwent the same rigorous safety and effectiveness standards as all other vaccines. Quickly, vaccine distribution began, starting with health care professionals on the frontlines of patient care.
The Covid-19 pandemic has affected everyone around the world since its arrival in 2020. Most of us have been affected by Covid-19, whether it be knowing someone who has experienced it or known people who have lost a loved one because of it. At present, it shows no sign of abating.
Ridgewood NJ, according to Johns Hopkins Center for Health Security, a new study published in the US CDC’s Emerging Infectious Diseases journal describes in-flight transmission of SARS-CoV-2 among passengers on a flight from Dubai, UAE, to Auckland, New Zealand—with a stop in Kuala Lumpur, Malaysia. Upon arrival in New Zealand, all passengers were subjected to mandatory 14-day quarantine, with testing conducted at approximately Day 3 and Day 12. Testing identified 7 SARS-CoV-2 infections among the passengers, including 5 that tested negative prior to their departure. Genomic analysis of specimens collected from each passenger found that the viral genome in 6 of the 7 passengers was identical, with 1 mutation present in the seventh passenger. Combined with the timeline of symptoms and positive tests, this suggests that the infection was transmitted among the passengers, rather than from multiple sources prior to travel. While testing negative prior to travel will likely decrease the number of imported cases, by denying travel for those who are already infectious, negative tests only indicate the current state of infection and cannot detect individuals who will be infectious after that point. Travel screening can mitigate the risk of importing cases or transmission during travel, but it cannot prevent them.
Ridgewood NJ, Any resident who wishes to obtain a COVID-19 vaccine must register on the State of NJ site, which is: covid19.nj.gov/vaccine. Once registered, an email will let you know if you are eligible at the present time or if you will have to wait for a future date, based on the current guidelines (the current guidelines are attached to this email). If you are eligible for a vaccine at this time, a list of sites where the vaccine is being given will be provided. Choose the location where you wish to go, and register for that site. Continue reading Any resident who wishes to obtain a COVID-19 vaccine must register on the State of NJ site
Trenton NJ, as of Tuesday, 233,555 vaccine doses have been administered in New Jersey . Of those doses, more than 212,000 were the first dose, while more than 21,000 people had received their second dose of the vaccine. The dashboard will be updated daily with the latest numbers reported as of 9:30 a.m.
Ridgewood NJ, according to the Johns Hopkins Center for Health Security in December 2020, the US CDC updated its COVID-19 quarantine guidance to offer several options that allow individuals to shorten their 14-day quarantine period following a known exposure to SARS-CoV-2. Specifically, individuals who are unable to quarantine for the full 14 days can end their quarantine after 10 days if they exhibit no symptoms or after 7 days if they test negative on Day 5 or later. The CDC’s MMWR published 2 recent studies that provide analysis of the transmission risk associated with shorter quarantine periods.
Ridgewood NJ , according to the Johns Hopkins Center for Health Security ,since the onset of the pandemic, health experts and officials have studied the role of immunity conferred by natural infection. While reports of are relatively rare, the potential for reinfection does exist. In light of this risk, the US CDC emphasizes that individuals who were previously infected and recovered should still get vaccinated due to the “severe health risks” and uncertainty regarding the duration of natural immunity. Additionally, the degree of natural immunity “varies from person to person.” The duration of the immunity conferred by vaccination remains uncertain as well, but research is still ongoing via clinical trials. Depending on the duration of immunity following vaccination, it may be necessary for individuals to receive regular boosters to provide longer-term protection.
New Brunswick NJ, Interim Phase 1/2a data were published today in the New England Journal of Medicinedemonstrating that the Company’s single-dose investigational COVID-19 vaccine candidate (JNJ-78436735) – being developed by the Janssen Pharmaceutical Companies of Johnson & Johnson – provided an immune response that lasted for at least 71 days, the duration of time measured in this study in participants aged 18-55 years. A preview of part of these interim data was posted on medRxiv in September 2020.