COVID Pharma Update
FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
The U.S. Food and Drug Administration (@US_FDA) issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions.
Innovative Product ExoFlo™ From Direct Biologics Fulfills Unmet but Urgent Medical Need in COVID-19 Treatment
As intensive care units across the country fill to capacity, hospital beds are in dangerously short supply, and deaths from COVID-19 continue to spike, doctors from medical centers coast to coast are reporting on the remarkable healing properties of ExoFlo, an innovative life-saving therapy that leverages the anti-inflammatory and regenerative effects of bone-marrow derived mesenchymal stem cells, when used on their most seriously ill COVID-19 patients. The physicians note that utilizing ExoFlo, administered as a single IV infusion, is safe and efficacious and is saving lives on a consistent basis.
Monoclonal antibody treatment helps couple recover quickly from COVID-19
When Bob and Joyce Wachsmuth were diagnosed with COVID-19, their care team told them about two programs that could help with their care and recovery: remote patient monitoring and monoclonal antibody therapy. They quickly signed on for both according to the Mayo Clinic.
HHS: Providers should order antibody therapies directly from distributor
The American Hospital Association (@ahahospitals) reports Authorized health care providers should now order the monoclonal antibody therapy bamlanivimab and antibody cocktail casirivimab/imdevimab directly from the sole distributor, AmerisourceBergen Corp., the Department of Health and Human Services announced Friday.
White House says it is working to speed early production of J&J COVID-19 vaccine
Reuters reports that the Biden administration is exploring every option for increasing manufacturing of Johnson & Johnson’s COVID-19 vaccine, which is under regulatory review, and said on Friday that currently expected levels of early doses were less than hoped.
FDA says Covid vaccines that target new variants won’t need large clinical trials to win approval
CNBC reports that the Food and Drug Administration said that modified Covid-19 vaccines against new, emerging variants may be authorized without the need for lengthy clinical trials.
Some Covid-19 Vaccines Are Effective After One Dose, Can Be Stored in Normal Freezers, Data Show
The Wall Street Journal reports that in a win for global vaccination goals, the BioNTech-Pfizer vaccine is shown to generate a strong response with one dose and to maintain potency in standard freezers for two weeks.
FDA allows storage, transport of Pfizer vaccine at higher temperatures
The U.S. Food and Drug Administration on approved storage and transportation of COVID-19 vaccine developed by Pfizer Inc and German partner BioNTech SE at standard freezer temperatures for up to two weeks instead of ultra-cold conditions.
Vaccine Administration and Management
National Governors Association Letter to President Regarding Vaccine Distribution
The Executive Committee of the National Governors Association (@NatlGovsAssoc) recently sent a letter to President Biden regarding the vaccine distribution process.
EZ STAK and Wellness Systems, Inc. launch Charlie Station — a medical-grade portable unit that can be adapted to a variety of uses.
As the war against COVID-19 rages on, EZ STAK (@ezstakllc) and Wellness Systems, Inc. announced the launch of what is believed to be the pandemic’s first mobile testing and vaccination station. Designed for rapid and secure deployment, the U.S.-built Charlie Station can also be modified for non-COVID uses and is eligible for FEMA funding.
Ensuring Equity in COVID-19 Vaccine Distribution
To ensure our nation’s underserved communities and those disproportionately affected by COVID-19 are equitably vaccinated against COVID-19, the Health Resources and Services Administration (HRSA) and the Centers for Disease Control and Prevention (CDC) are launching a program to directly allocate a limited supply of COVID-19 vaccine to select HRSA-funded health centers starting the week of February 15.
Software Management Tools
Terazo Partners with Twilio On Innovative COVID-19 Vaccine Outreach & Delivery Solutions
Terazo (@terazosays) a software and managed services firm based in Richmond, Va., announced its collaboration with Twilio in developing innovative COVID vaccine outreach and delivery solutions.
Quickbase Helps Local Governments Overcome Vaccine Distribution Barriers to Get Half a Million Requests for Shots in Arms in Less than 2 Months
Quickbase (@quickbase), a no-code operational agility platform, announced the deployment of coronavirus vaccine distribution applications, accelerating shots in arms with local governments and healthcare systems.
New Covid Program and App Connects People & Volunteers
All Life Transitions, LLC (AllLT) announced the launch of a National Volunteer Matching Program which enables individuals seeking a COVID-19 vaccination anywhere in the US to find neighborhood vaccination centers.
Armanino Unveils Vaccine Registration & Administration System to Assist Government Agencies in Vaccine Rollout
Armanino LLP (@armaninollp), a U.S. accounting and business consulting firm, announced its continued investment in COVID-19-related work with the successful deployment of its Vaccine Registration & Administration System (VRAS) in multiple jurisdictions and new vaccination progress modules in its COVID Recovery Tracker.
COVID1Stop – Where You Can Save Your Covid Information
All Life Transitions is offering their brand new app called COVID1Stop (@Covid1Stop) which is the Premier Smartphone app for recording Covid information. COVID1Stop gives the user complete control of his or her personal data by saving all information in a personalized digital vault based on bank level security standards.
Previon™ and Spectrum Solutions™ Partner to Deliver First Provider-Ordered COVID-19 At-Home PCR Test Kit
Previon (@previon_usa), a company providing at-home patient testing kits, healthcare screening and patient engagement communications, announced it has partnered with Spectrum Solutions™, manufacturer of the first FDA EUA-authorized saliva collection kit for COVID-19 testing. The companies will collaborate to aid any organization in delivering at-home COVID-19 test kits throughout the United States.
Mobile Healthcare Services Brings Customized COVID-19 Testing Programs to Massachusetts
Mobile Healthcare Services (MHS), a company in bridging gaps in healthcare accessibility, has launched in Massachusetts, offering a variety of customized COVID-19 testing program options and conducting more than 30,000 mobile COVID-19 tests per month to help mitigate the spread of the novel coronavirus.
Experity Tapped by CityMD to Optimize Operations and Truncate Patient Wait Times
Experity (@experityhealth) announced it was selected by CityMD to help shorten wait times and improve the overall patient experience at the leading urgent care provider in the New York metropolitan area. CityMD has implemented Experity’s virtual line system at each of its 137 locations for patients requesting COVID-19 diagnostic testing.
Primary Care Physicians Should Play Key Role in COVID-19 Vaccine Distribution by Shawn Martin, CEO/EVP, American Academy of Family Physicians (@aafp) – It is critical that we further engage primary care physicians to help us reach the necessary COVID-19 vaccination rate. Here are reasons why these physicians are best positioned with patients to move the needle.
COVID Vaccine-Scheduling Apps Protected Against HIPAA Violations by Devin Partida, Editor-in-Chief, ReHack.com (@rehackmagazine) – On Jan. 20, the Office for Civil Rights (OCR) issued a notice of enforcement regarding HIPAA regulations and COVID-19 vaccine-scheduling apps. The update states that the OCR won’t impose HIPAA noncompliance penalties related to good-faith use of these services. This suspension of penalties, retroactively effective to Dec. 11, 2020, could have a considerable impact on vaccine rollout.
Pfizer-BioNTech: COVID-19 Vaccine Trial in Pregnant Women Begins; New Storage Data Submitted to FDA
MPR reports that a global phase 2/3 study evaluating the Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccine, BNT162b2, in preventing COVID-19 in healthy pregnant women has been initiated.
We have compiled a playlist from all our shows and podcasts on our network that discuss the current COVID-19 pandemic.
HealthcareNOW Radio rounded up some health IT resources being offered by companies to help healthcare professionals, American citizens and all of those affected in the fight against the coronavirus.