- FDA Grants Priority Review for the Biologics License Application for Pfizer-BioNTech COVID-19 Vaccine (07/16/21 Pfizer News Release) - The U.S. Food and Drug Administration (FDA) has formally accepted the company’s Biologics License Application (BLA) requesting licensure (approval) of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals aged 16 years and older and has granted the application priority review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in January 2022. Currently, the vaccine is authorized for emergency use to prevent COVID-19 in individuals aged 12 years and older.
- Virginia Hospital & Healthcare Association (VHHA) Statement Supporting COVID-19 Vaccine Requirements for Hospital and Health System Employees (07/19/21 VHHA News Release) - “VHHA supports hospitals and health systems amending their existing vaccine policies to require COVID-19 vaccines for their health care employees. VHHA recognizes that each hospital and health system is unique and encourages each hospital and health system to determine the appropriate time to implement a requirement. Hospital and health system employee vaccination against COVID-19 will maintain the long-term ability of our health care system to respond to the pandemic, to safely care for patients by protecting them from infection, and to mitigate the spread of the virus within health care facilities and among clinicians, patients, and their families and friends. Implementing COVID-19 vaccine requirements will help accomplish these goals, while protecting the patients and communities served by our hospitals and health systems.”
- Vaccination FAQs - Updates include the recommendation for immunocompromised people to continue to take all precautions until otherwise advised by their healthcare provider. The American Society of Transplantation, American Society of Transplant Surgeons and International Society for Heart and Lung Transplantation have also issued a joint statement about vaccine efficacy in organ transplant recipients.
- Biden-Harris Administration Provides $100 Million to Rural Health Clinics for COVID-19 Vaccine Outreach in Their Communities to Increase Vaccinations (07/22/21 HHS News Release) - The U.S. Department of Health and Human Services (HHS) provided nearly $100 million to rural health clinics across the country to support outreach efforts to increase vaccinations in rural communities. The funds will go to more than 1,980 Rural Health Clinics (RHCs) who will use these resources to develop and implement additional vaccine confidence and outreach efforts.
- CDC MMWR: Changes in Influenza and Other Respiratory Virus Activity During the COVID-19 Pandemic — United States, 2020–2021 - Nonpharmaceutical interventions introduced to mitigate the impact of COVID-19 reduced transmission of common respiratory viruses in the United States. Influenza viruses and human metapneumovirus circulated at historic lows through May 2021. In April 2021, respiratory syncytial virus activity increased. Common human coronaviruses, parainfluenza viruses, and respiratory adenoviruses have been increasing since January and February 2021. Rhinoviruses and enteroviruses began to increase in June 2020. Clinicians should be aware of increased circulation, sometimes off season, of some respiratory viruses and consider multi-pathogen testing. In addition to recommended preventive actions, fall influenza vaccination campaigns are important as schools and workplaces resume in-person activities with relaxed COVID-19 mitigation practices.
- New policy statement from the American Hospital Association (AHA) regarding vaccination of healthcare workers (7/21/21):
- “The evidence is clear: COVID-19 vaccines are safe and effective in reducing both the risk of becoming infected and spreading the virus to others,” said Rick Pollack, AHA’s president and CEO. “The AHA supports hospitals and health systems that choose, based on local factors, to mandate COVID-19 vaccines for their workforce. Doing so will help protect the health and well-being of health care personnel and the patients and communities they proudly serve.”
- The full policy statement from the AHA on the vaccination of healthcare workers can be found here.
- The press statement is here.
Best Practice Spotlight
- Joint Statement from Virginia Health Care Organizations Encouraging People to be Vaccinated Against COVID-19 (7/21/21)
Full statement is available here.
- A conversation with Dr. Anthony Fauci and Healthcare Providers:
- “How can you, as a healthcare provider, best approach your vital role in addressing vaccine hesitancy and educating patients about the COVID-19 vaccines?” August 3 at 6 pm-7 pm EDT - registration required here
- Vaccine Unit Pharmacy Office Hours: These sessions will begin on Thursday, July 8 at 4:00 pm, and occur every other week moving forward for the months of July and August. Attendance is open to all partners, and although optional, we encourage you all to attend so we can provide vaccination updates in Virginia, share best practices, and field your questions and concerns. Please forward and extend the invite to your member pharmacies.
- Next session is August 5, 2021 at 4:00 pm. To join, click here
- Back to School Resources:
- Virginia Department of Health (VDH) and the Virginia Department of Education (DOE) have worked together to launch a new "Healthy Back to School" campaign, which advertises to parents to visit this new website. The advertisement will run until the end of August and asks parents to prepare for school by taking their child to the doctor and dentist (for regular checkup and vaccinations), and to check with their school about COVID-19 policies. It then provides links to more information about these topics. Future campaigns to promote routine immunizations will also use this webpage.
- Interim Guidance for COVID-19 Prevention in Virginia PreK-12 Schools was updated in response to the State Health Commissioner’s Public Health Order which ended on July 25, 2021. This updated guidance gives school divisions the ability to implement local mask policies based on community level conditions and public health recommendations. Virginia guidance strongly recommends divisions adopt the following for the 2021-2022 school year:
- Elementary schools should implement a requirement that students, teachers, and staff wear masks indoors, regardless of vaccination status, until vaccination is available for children under 12 years old and there has been sufficient time to allow for children younger than 12 years old to be fully vaccinated.
- At a minimum, middle and high schools should implement a requirement that students, teachers and staff who are not fully vaccinated wear masks indoors. While school divisions regularly confirm school-required immunization records of their students, they should consult with their counsel in determining if and how to confirm student and staff COVID-19 vaccinations.
- All schools may want to consider universal masking for specific reasons as outlined in certain circumstances by the CDC.
- All schools should be prepared to adjust local mask policies as local public health conditions evolve throughout the year.
- The full press release is available here.
- CDC's Project Firstline has released new resources on multi-dose vial safety. The resources were created to help healthcare workers understand and confidently apply the right infection control actions when giving vaccines to patients. The learning resources include a 3½ minute video, a checklist to ensure multi-dose vaccine vials are used safely and correctly every time, and a multi-dose vial session plan to assist with designing effective training.
Information about the COVID-19 vaccination program is changing frequently. This newsletter will offer regular updates to providers who have submitted an intent to vaccinate or signed the CDC provider agreement within Virginia.