COVID-19 Vaccine Providers Newsletter 04.24.2021

Johnson & Johnson/Janssen Updates

On April 23, 2021, CDC and FDA issued a press release recommending to lift the temporary pause of Johnson & Johnson’s Janssen (J&J/Janssen) COVID-19 Vaccine and resume vaccinations. This decision was based on the CDC’s Advisory Committee on Immunization Practices (ACIP) thorough safety review of 15 confirmed cases of thrombosis-thrombocytopenia syndrome (TTS) among nearly 8 million vaccinations with the J&J/Janssen vaccine, as of April 21, 2021. The 15 cases of TTS occurred in women aged 15-59 years (median 37 years) within 6-15 days after vaccination.  The CDC and FDA determined the following:

• Use of the J&J/Janssen COVID-19 Vaccine should be resumed in the United States.

• The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19.

• The FDA has determined that the available data show that the vaccine’s known and potential benefits outweigh its known and potential risks in individuals 18 years of age and older.

• At this time, the available data suggest that the chance of TTS occurring is very low, but the FDA and CDC will remain vigilant in continuing to investigate this risk.

• Healthcare providers administering the vaccine and vaccine recipients or caregivers should review the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Fact Sheet for Recipients and Caregivers, which have been revised to include information about the risk of this syndrome, which has occurred in a very small number of people who have received the Janssen COVID-19 Vaccine.

Also on April 23, the Virginia Department of Health issued a statement from the Virginia State Vaccination Coordinator, Dr. Danny Avula, to announce that VDH is following the federal recommendations to immediately resume vaccinations with the J&J/Janssen vaccine.

The American Society of Hematology has COVID-19 clinical materials, including FAQs about TTS, on their website.

Other Updates

Governor Ralph Northam recently announced several efforts aimed at increasing Virginia’s vaccinator workforce to support the continued expansion of COVID-19 vaccinations across the Commonwealth, including a new initiative to recruit eligible individuals interested in administering vaccines. More details can be found here.

• Healthcare providers who are now authorized to administer the COVID-19 vaccine in Virginia include but are not limited to dentists, dental hygienists, veterinarians, optometrists, and health professions students enrolled in an accredited Virginia program.

• Eligible providers may serve as vaccinators if they have the appropriate training and meet the supervision requirements.

• Eligible healthcare providers may register to volunteer as a COVID-19 vaccinator through either the Virginia Medical Reserve Corps (MRC) or the newly established Virginia Volunteer Vaccinator Registry (VVVR).

• Last month, the Governor issued Third Amended Executive Order Fifty-Seven to provide additional flexibility for vaccinators. All COVID-19 vaccine providers are responsible for ensuring that individuals who administer shots at their site are authorized by law to do so.

• If your hospital or private practice is providing community vaccination clinics and/or is open to the community (e.g. providing vaccines to community members outside of their existing patient pool or LTCF residents), you are eligible to request volunteer vaccinators from this webpage.

Virginia's COVID-19 vaccine eligibility opened for all Virginians age 16 and older on Sunday, April 18. Virginians seeking a vaccination opportunity can find and schedule appointments at vaccinate.virginia.gov or by calling 877-VAX-IN-VA (877-829-4682).

Individuals should be vaccinated regardless of whether they have already had COVID-19.

• This includes individuals who were infected within the past 90 days.

• For recently infected individuals, instruct them to wait until they have completed their 10-day isolation period and ensure that they are asymptomatic at the time of vaccination.

• If patients were treated for COVID-19 with monoclonal antibodies or convalescent plasma, vaccination should be delayed for 90 days.

Some people receiving a vaccination may experience a vasovagal reaction; that is, they may get light-headed, sweaty or they may briefly faint or lose consciousness (vasovagal syncope). Vasovagal reactions, also called neurocardiogenic syncope or reflex syncope, are the most common cause of fainting and are generally not harmful nor a sign of a more serious problem. People often have reported a history of fainting with vaccines or blood draws, so it is useful to screen for this. Being aware of vasovagal symptoms or history will help to prevent unexpected falls or injuries.

• Those under 30 years of age are more likely to faint after vaccination, and reports from the Vaccine Adverse Event Reporting System (VAERS) show that fainting after vaccinations is common in adolescents. One study of VAERS reports found that 62% of syncope reports were among adolescents 11 to 18 years old.

• Fainting itself is generally not serious, but harm from related falls or other accidents can cause injury. The main concern is head injury. In the aforementioned study, 7% of the syncope reports were coded as serious; 12% of these involved head injuries. Although fainting itself might or might not be preventable, it is important to prevent injuries when people do faint.

All healthcare professionals who administer vaccines should be aware of the potential for syncope after vaccination and the related risk of injury caused by falls. This holds true for COVID-19 vaccines as well. Appropriate measures should be taken to prevent injuries from fainting, including:

1. Before vaccination, ask patients if they have fainted before while getting a vaccine or giving blood. If the answer is affirmative, they are more likely to faint after COVID-19 vaccination.

2. Give patients a beverage, a snack, or some reassurance about the vaccination.

3. Have the patient seated or lying down for the vaccination.

4. Be aware of symptoms that precede fainting (e.g., weakness, dizziness, pallor).

5. Ensure patients are sitting or lying down during their 15 to 30-minute post-vaccination observation period.

6. If a patient faints after vaccination, medical personnel should observe the patient until she or he regains consciousness so that further treatment needs can be determined.

Additional resources can be found here:

1. CDC | Fainting (Syncope) after Vaccination

2. CDC | Pink Book: Syncope Section

• Mondays, Wednesdays, and Fridays, 4 - 5 pm: VDH Office Hours for Providers (including VaXMaX assistance)

• April 26, 3 pm: CDC COVID-19 Partner Update: Keeping up With Critical Diabetes Care and Prevention During COVID-19

• April 27, 2 - 3 pm: Johnson & Johnson/Janssen COVID-19 Vaccine and Thrombosis with Thrombocytopenia Syndrome (TTS): Update for Clinicians

• April 28, 12 - 1 pm: VDH Webinar: Unsure about Getting a COVID-19 Vaccine? A Candid Conversation with an Expert

• April 29, 12 - 1pm: National Foundation for Infectious Diseases Webinar: COVID-19 Communications: Real-World Insights to Promote Vaccine Acceptance

As part of a White House commitment to make it easier for individuals to access COVID-19 vaccines nationwide, CDC is encouraging all jurisdictions and COVID-19 vaccine providers to enroll and report inventory in VaccineFinder (COVID Locating Health Portal). Providers can show their locations to the public by turning on the “public display” function in the portal, ensuring a more robust public search experience for website visitors. The goal is to enhance the number of providers that are currently searchable on VaccineFinder by Thursday, April 22. Please note:

• For sites reporting directly into VaccineFinder: All locations will default to NOT display to the public until the provider sets the location to ‘public display’ through the portal. Providers can update the display to the public function at any time, and the changes will show on vaccinefinder.org within 5 hours.

• Providers can update their provider public display details via the VaccineFinder portal to ensure the website directs people to the next step for scheduling a vaccine appointment for their locality.

In response to concerns of access barriers some immigrants are facing regarding documentation requests before receiving COVID-19 vaccination, and individuals inappropriately being sent bills for COVID-19 vaccine fees, HRSA developed two fact sheets to help both patients and providers better understand their rights and responsibilities regarding access to COVID-19 vaccines. The COVID-19 vaccines are free to all individuals living in the United States and these resources will help to empower patients and educate providers on this fact.

• Patient Fact Sheet: English and Spanish

• Provider Fact Sheet in English and Spanish

• The general website for COVID-19 Care for Uninsured Adults

• Additional VDH guidance for providers on COVID-19 vaccine coding, billing, and reimbursement can be found here, located on our COVID-19 website for Health Professionals.

Next week is National Infant Immunization Week, a yearly observance highlighting the importance of protecting children two years and younger from vaccine-preventable diseases (VPDs). This year, in particular, it’s critical for providers to ensure that families stay on track for children’s routine checkups and recommended vaccinations — even during COVID-19.