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Archive for the ‘Health law’

FDA Expands EUA for Pfizer-BioNTech COVID-19 Vaccine to Include 12-15-Year-Olds

FDA logoThe U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12-15 years of age.  From 3/1/2020 through 4/30/2021, approximately 1.5 million COVID-19 cases in individuals 11-17 years of age have been reported to the U.S. Centers for Disease Control.  Based on immunogenicity and an analysis of COVID-19 cases, the FDA has determined the Vaccine’s known and potential benefits outweigh the known and potential risks, supporting the Vaccine’s use in this population.  As part of the original EUA request, Pfizer Inc. submitted a plan to continue monitoring the Vaccine’s safety, and this plan has been updated to include the newly authorized adolescent population.  Updated Fact Sheets are also now available for Healthcare Providers Administering the Vaccine and for Recipients and Caregivers.  For more information, see the FDA Coronavirus Disease 2019 page.

Watch for Incentives to Get Vaccinated

A recent New York Times article details some of the incentives that are now being offered or under consideration for people to get a COVID vaccine shot. Scientists have stated that 70-85% of the population need to be vaccinated or otherwise immune to stop transmission of the virus, so incentives may make a difference for those who are hesitant or haven’t yet made the effort to get vaccinated. The portion of the US population currently vaccinated stands at about 33%.

Some interesting incentives include:

  • A $100 savings bond for those 16-35 (West Virginia)
  • $50 gift cards for anyone who drives someone to get vaccinated (Detroit)
  • A free beer or drink to those who get vaccinated (New Jersey and Connecticut)

Sports teams are getting involved too, with several teams offering free tickets to fans who get vaccinated at the ball park.

U.S. DHHS BARDA Coronavirus Response Information

image of BARDA logoThe U.S. Department of Health and Human, Public Health Emergency Medical Countermeasures Biomedical Advanced Research and Development Authority (BARDA) “provides an integrated, systematic approach to the development of the necessary vaccines, drugs, therapies, and diagnostic tools for public health emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases (IEID).”  Currently prominent on the BARDA website is its Coronavirus Response page, which includes information on Emergency Use Authorizations for vaccines, diagnostics and therapeutics (aka COVID-19 MCM Portfolio); the BARDA COVID-19 Response Timeline; COVID-19 Therapeutic Clinical Trials; and Medical Countermeasure Support Service Partners.  The BARDA Coronavirus Response page also includes a link to the Government Response to Coronavirus, COVID-19 portal, which provides links to numerous government agency information pages.

“Get the Shot” Info on Ohio COVID-19 Vaccination Program Website

image hand injecting vaccine into covid cellThe state government of Ohio COVID-19 Vaccination Program website now includes a “Get the Shot” section, which provides general information on, and a link to, Ohio’s Vaccine Management Solution (VMS) page.  Perhaps most importantly, the VMS page allows one to check their eligibility for a COVID-19 vaccine and book an appointment.  The VMS page also includes handy links to COVID-19 vaccine Myth-Busters and FAQs.  Also new on Ohio’s COVID-19 Vaccination Program website is information on COVID-19 Mass Vaccination Clinics in Ohio.  Currently, just one of the planned 18 Clinics is taking appointments – the Cleveland site at Cleveland State University’s Wolstein Center (appointments available via Ohio’s Vaccine Management Solution (VMS) page or by calling 1-833-4-ASK-ODH).

Centralized Vaccine Website Coming Soon for Ohio

Governor DeWine announced that a statewide vaccination scheduling portal known as VMS is in development and the first phase has been completed. During the second phase of the launch, which is currently ongoing, the state is working to get a large number of providers signed up before making it public. Once completed, the third phase will begin and the portal will be opened to the public. There is currently not a timeframe for when the portal will be available to Ohio citizens to make vaccine appointments.