FDA Grants Full Approval To Pfizer-BioNTech Vaccine |
Expiration Dates Extended For Broadened Ultra-Cold Storage Conditions |
On Monday the U.S. Food and Drug Administration (FDA) approved the COVID-19 Pfizer-BioNTech vaccine biologics license application (BLA) for individuals 16+. It is the first of the three available COVID-19 vaccines to receive official approval from the FDA. The vaccine can now be administered when a public health emergency isn't in effect. As there is not yet enough data to include 12-to-15-year-olds or those immunocompromised persons eligible for a third dose under the full BLA approval, the original emergency use authorization (EUA) remains in place. The BLA approval for Pfizer includes a name change for the vaccine to Comirnaty (koe-mir’-na-tee). It is the same vaccine and the same dosage; only the name has changed. Because of the current supply of Pfizer in the marketplace, you will see both names co-circulating. The EUA has been updated to permit administration of vaccine labeled Comirnaty to persons 12-15 and those who are immunocompromised and eligible for the third dose. Vaccines labeled Comirnaty may be used interchangeably with Pfizer to complete a vaccine series or offer a third dose. There is no need to re-start a vaccine series begun with Pfizer if Comirnaty is the only vaccine available to you. Additionally, there is no need to re-start the vaccine series if a patient did not receive their second dose of any mRNA vaccine within the recommended time frame.
With the announcement also came official notice that Pfizer's expiration dates have been extended by three months (90 days), from six to nine months. No changes have been made to the vaccine itself to enable extension of expiry dating. It is based on stability data generated on batches manufactured over approximately the past nine months of vaccine development. Cartons and vials of Pfizer-BioNTech COVID-19 vaccine with an expiry date of August 2021 through February 2022 printed on the label may remain in use for three months beyond the printed date as long as authorized storage conditions between -90°C to -60°C (-130°F to -76°F) have been maintained. Please note: the ultra-cold temperature range has been broadened to include -90° C (-130°F). Frozen vials stored at -25°C to -15°C and refrigerated vials (2°C to 8°C) are NOT eligible for extension. The extended expiration date is effective immediately for all currently available batches that have not yet expired. (Expiration dates extension does NOT apply to vials dated July 2021 and earlier.)
Read additional details, fact sheets, talking points, and information on updated expiry dates for vaccine maintained in ultra-cold storage from the Division of Public Health Update on the FDA approval of the Pfizer vaccine.
The Moderna and Johnson & Johnson vaccines will continue to be administered through the EUA as the FDA reviews data about their real-world use. The Pfizer COVID-19 vaccine was the first vaccine to receive EUA, which is why it is the first to have enough data to receive full approval. Moderna has also submitted an application for full approval for its COVID-19 vaccine, which is currently being reviewed by the FDA.
In a White House speech on Monday in response to the Pfizer-BioNTech vaccine approval, President Biden urged businesses to require employee vaccinations stating, "Do what I did last month and require your employees to get vaccinated or face strict requirements."
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Testing For COVID-19 In Children: Re-Issued Health Advisory |
Answers To Help Confusion/Concerns With Testing Children |
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The Delaware Division of Public Health (DPH) has re-issued a health advisory with updated information to provide those in the medical community who care for children, an update on testing for SARS-CoV-2 in children with suspected coronavirus disease 2019 (COVID-19). The American Academy of Pediatrics (AAP) supports the implementation of public health surveillance that tests at a population level to identify local outbreaks of coronavirus disease 2019 (COVID-19) in communities, in partnership with health care providers and local public health departments. The AAP recommends using molecular tests such as reverse transcription polymerase chain reaction tests that have been approved by the Food and Drug Administration (FDA). Other FDA-approved tests may be considered if necessary. A list of the most common scenarios in which to consider testing for all patients, including children, as well as providing additional considerations is outlined in the re-issued health advisory. Providers who are not currently testing for COVID-19 are encouraged to either write a prescription/referral for testing or direct patients to de.gov/gettested to identify a testing location near them.
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Governor Carney Signs House Bill 100 |
Legislation Expands Mental Health Services In Delaware Elementary Schools |
Last week Governor John Carney signed House Bill 100, which greatly expands mental health services in Delaware elementary schools. The Governor and bill sponsors have agreed to support technical changes to the bill in January to protect the intent of the legislation and ensure districts use additional funding to hire mental health professionals and support highest-needs students. The Fiscal Year 2022 budget includes $8 million to implement House Bill 100 and must be used to hire mental health professionals in Delaware elementary schools and cannot be supplanted. The legislation will be fully funded in Fiscal Year 2024. Starting then, districts can work with the Delaware Department of Education and submit supplantation plans to ensure resources are reaching the highest-needs students. Read the press release.
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Prescribe Benzodiazepines Legally And Responsibly |
Protect The Health Of Your Patients |
The stakes have never been higher for you to be at the very top of your game in prescribing or even suggesting, benzodiazepines and non-benzodiazepines for patients.
- Delaware's Benzodiazepines and Non-Benzodiazepines Hypnotic Prescribing Law requires a provider to obtain a signed parental permission when prescribing the drugs to individuals 18 years of age or younger.
- A 2018 study revealed that of the one-in-eight adults who used "benzos" in the previous year, 17% were misusing.
- Since the start of the COVID-19 pandemic, benzodiazepine use has increased by 34%.
- One-third of opioid overdose deaths involve benzodiazepines.
- There are significant risks that come with benzodiazepine use (misuse, dependence in as little as two months, life-threatening when combined with alcohol or other pain killers, death from overdose, can cause dementia later in life).
- Awareness levels about the benefits and dangers of benzodiazepines are far below where they need to be.
The Delaware Division of Public Health "HelpIsHereDE" webpage has resources to help talk with your patients effectively and make sure they use these medications safely.
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FDA Approves Solid Tumor Diagnostic Test |
Test Identifies Solid Tumors That Could Turn Cancerous |
Roche Diagnostics announced the U.S. Food and Drug Administration (FDA) approval of the VENTANA MMR RxDx Panel, a companion diagnostic test to help identify patients with solid tumors that are deficient in DNA mismatch repair (MMR). The test evaluates a panel of MMR proteins in tumors to provide important treatment information.
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Delaware Issuing August Emergency Benefits For Those Eligible |
Benefits Issued As Part Of SNAP, TANF, and GA Assistance Programs |
The Delaware Division of Social Services announced it will issue emergency benefits for August to eligible households as part of the state’s ongoing response to the COVID-19 public health crisis. Benefits will be issued as part of the Supplemental Nutrition Assistance Program (SNAP) and two cash assistance programs – Temporary Assistance for Needy Families (TANF) and General Assistance (GA). The SNAP emergency food benefit will be issued Wednesday, Aug. 25, and should be available on recipients’ Electronic Benefit Transfer (EBT) cards Thursday, Aug. 26. TANF and GA households should receive an emergency cash benefit check on or after Wednesday, Aug. 25.
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Events And Educational Offerings |
What Health Care Providers Need To Know About Information Sharing And The Information Blocking Regulation |
The Office of the National Coordinator for Health Information Technology (ONC) is hosting a series of clinician-focused webinars to discuss the information blocking requirements of the 21st Century Cures Act. ONC experts will explain how ONC supports secure, appropriate sharing of electronic health information and how information sharing leads to more affordable and equitable care and improved care quality. This initial webinar is a physician-focused presentation covering key aspects of their regulations focused on information blocking and is an opportunity to ask questions and get answers from ONC’s experts. This webinar will be held on September 14, 2021, from 1-2 pm EST. Register for the webinar. Note: If you’re unable to join the live presentation, you can still register to receive a link to access a recording of the webcast.
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MSD Hot Topic CME: Performance Of Late Career Physicians |
MSD will present a virtual Hot Topic CME session on Thursday, September 23, 2021, from 6:00-7:00 p.m. "Performance of Late Career Physicians" will discuss physician aging and competency, as well as review the history, rationale, and implementation of age-based physician assessment programs. Presenters will be James M. Ellison, MD, MPH and Richard M. Plotzker, MD. There is no fee for MSD members to participate. This activity has been approved for a maximum of 1 AMA PRA Category 1 Credit™. Registration is required.
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Third Annual "Health Challenge Delaware" |
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Progressive Health of Delaware is offering a free online event to help people lead healthier lives. You and your patients are invited to join for four zoom meetings being held on Tuesdays in October in which you, your peers, and your mentor will work together on a healthy journey. Information and registration.
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Beebe Healthcare announced that William M. Chasanov II, DO, MBA, FACP, was recently promoted to the position of Vice President, Chief Population Health Officer. A practicing physician in Infectious Disease and Travel Medicine, Dr. Chasanov sees patients at Beebe Infectious Disease in Lewes and serves as Beebe Healthcare's COVID-19 Medical Director. In addition, he is a member of the Medical Society of Delaware and serves as a member on the MSD Holding Company Board of Directors and on the Bylaws Committee. Congratulations, Dr. Chasanov!
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Visitation Policy Modified
Due to increasing transmission rates of COVID-19 in the community, ChristianaCare is returning to limited visitation at its facilities and will also require proof of COVID-19 vaccination or a negative COVID-19 test not older than 72 hours for all visitors. Patient visitation guidelines went into effect Monday, August 23.
CRISPR in the Classroom
ChristianaCare announced its Gene Editing Institute and DETV have partnered in the creation of an educational video series to inspire high school students to consider a career in gene editing. The CRISPR in the Classroom video series is available to schools across the United States and serves as a supplemental resource alongside the Gene Editing Institute's CRISPR in a Box Educational Toolkit™, which provides teachers and students real-life experience with CRISPR. One of the main purposes of the videos is to allow for deeper conversations about inequity in access to science education and medical treatments for people of color and to discuss the realities of the need for more scientists of color.
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Katherine Callaghan, MD - General Pediatrics, Delaware Pediatrics |
MSD's Members are afforded a seven-day review period from the date of this publication to comment regarding applicants for membership. Please contact Michelle Seymour at (302) 224-4905 or Michelle.Seymour@medsocdel.org with any questions or concerns.
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The Latin phrase Rerum Cognoscere translates to learn, examine, or become aware of facts or things. In this section, we highlight measurable items of interest in health care from MSD, Delaware, the US, and the world. |
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145
Number of health systems requiring mandatory COVID-19 vaccinations for their workforce as a condition of employment since Pfizer's vaccine approval (as of August 23).
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30%
Percentage of unvaccinated people in polls who said they were waiting for full vaccine approval to get vaccinated.
Joint Statement from AMA, AHA, ANA
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11th
Ranking of the US health system on quality and accessible care among 11 high-income countries surveyed.
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September 11 - Society of Critical Care Medicine, Fundamental Critical Care Support, hybrid event (this is the date of the in-person portion taking place at Bayhealth Kent Campus, Dover.
December 13 - 2021 Communicable Disease Summit "How 2020 Changed the World," 8:00 a.m.-3:00 p.m., virtual and in-person at John H. Ammon Medical Education Center, ChristianaCare Newark Campus (limited to 70 in-person attendees).
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Was the information in this newsletter useful? If so, forward to a friend to let them know the value of your Medical Society of Delaware membership. |
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