Ridgewood NJ, Eli Lilly, the pharmaceutical giant, launched a direct-to-consumer website yesterday, providing its customers with the option to obtain third-party prescriptions for its medications, including the newly approved weight loss injectable Zepbound (similar to Novo Nordisk’s Wegovy/Ozempic). Through the site, users can connect to a telehealth service, enabling them to quickly receive prescriptions before making a purchase.
New Brunswick NJ, on Jan. 10, attorneys for Children’s Health Defense (CHD) filed an appeal in the United States Court of Appeals for the Third Circuit challenging the New Jersey District Court judge’s Sep. 22, 2022 dismissal of CHD’s Aug. 16, 2021 lawsuit against Rutgers and university officials for their COVID-19 vaccine requirement for students to attend classes, whether in person or remotely. The mandate that began at the start of the 2021 Fall semester now requires full vaccination and boosters for students, faculty and staff.
Paramus NJ, Valley’s Vaccination Center, located at 599 Valley Health Plaza in Paramus will be hosting additional evening vaccination sessions, by appointment only, for individuals looking to receive their primary two-dose vaccination series (Pfizer or Moderna) or their COVID-19 booster (Pfizer or Moderna).
NEW YORK NY, Pfizer Inc. (NYSE: PFE) today announced final results from an analysis of all 2,246 adults enrolled in its Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) trial of its novel COVID-19 oral antiviral candidate PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets). These results were consistent with the interim analysis announced in November 2021, showing PAXLOVID significantly reduced the risk of hospitalization or death for any cause by 89% compared to placebo in non-hospitalized, high-risk adult patients with COVID-19 treated within three days of symptom onset. In a secondary endpoint, PAXLOVID reduced the risk of hospitalization or death for any cause by 88% compared to placebo in patients treated within five days of symptom onset, an increase from the 85% observed in the interim analysis. The EPIC-HR data have been shared with the U.S. Food and Drug Administration (FDA) as part of an ongoing rolling submission for Emergency Use Authorization (EUA).
Ridgewood NJ, Pfizer announced last week that its investigational antiviral pill to treat COVID-19 reduced the risk of COVID-19-related hospitalization or death from any cause by 89% when compared to a placebo among patients treated within 3 days of symptom onset. The planned interim results come from a Phase 2/3 clinical trial examining the pill—which is called Paxlovid and is taken in combination with an older antiviral named ritonavir—among COVID-19 patients recovering at home who are at high risk of developing severe disease. The company said it plans to submit the data to the US FDA as soon as possible to request emergency use authorization (EUA) for the antiviral. This is the second oral pill that has shown positive results in clinical trials for treating people with COVID-19 at home and could help alleviate the strain of the pandemic on hospitals. The other antiviral, molnupiravir, being developed by Merck and Ridgeback Biotherapeutics, reduced the risk of hospitalization and death by about half, and UK regulators granted conditional authorization to the pill last week. Clinical trial data for both drugs have not yet been peer-reviewed or published in a journal.
Englewood Cliffs NJ, Pfizer board member Dr. Scott Gottlieb told CNBC’s “Squawk Box” on Friday. The Covid-19 pandemic could be over in the U.S. by the time President Joe Biden’s workplace vaccine mandates take effect on January 4th.
Washington DC, today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Ridgewood NJ, Pfizer has developed a pill designed to stop Covid-19. It is now starting human trials on the drug, which showed no significant risks or safety concerns during its animal studies. The human trials will be split into three phases and run for 145 days. Another 28 days will be added to the trial period for screening and dosing. The drug attacks the spine of the SARS-CoV-2 virus and stops it from replicating in the nose, throat, and lungs. It is classed as a protease inhibitor.
Ridgewood NJ, Pfizer has started stage one clinical trials on an oral pill designed to be an early intervention for Covid-19. The pill has demonstrated potent in-vitro antiviral activity against SARS-CoV-2. It can be used with other antivirals to create a treatment that complements vaccination. The pill is a protease inhibitor. It binds to a viral enzyme to prevent the virus from replicating in the cell. More information about the clinical trials will be shared on April 6.
Ridgewood NJ, It’s a milestone day for Valley Hospital! Valley has administered 50,000 doses of the Moderna, Pfizer, and Johnson & Johnson COVID-19 vaccines! They will continue to open up appointments as the vaccine becomes available. You can check appointment availability here: https://www.valleyhealth.com/vaccine.
Ridgewood NJ, new guidelines from the Centers for Disease Control and Prevention (CDC) suggest it is safe for fully vaccinated people to gather indoors with each other without masks. “If you and a friend, or you and a family member are both vaccinated, you can have dinner together” without wearing masks or without distancing, CDC Director Rochelle Walensky told reporters on Monday.
Washington DC, the White House Chief Medical Advisor Dr. Anthony Fauci said on Sunday he would take the newly approved Johnson & Johnson Covid-19 vaccine and urged Americans to take whichever shot is available when they are eligible.
Ridgewood NJ, Valley’s first shipment of the Pfizer #COVID19 vaccine arrived late Thursday afternoon. Valley in now able to be able to begin to vaccinate our doctors, nurses, and other staff who continue to battle on the frontlines of the pandemic. Valley Hospital is offering the vaccine in accordance with guidance from state and federal health officials for the fast and equitable distribution of the vaccine. In time, Valley and all healthcare providers expect to receive supplies large enough to begin vaccinating the public, and we will communicate those details to you when that day is in sight.
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%.
Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints