COVID-19 Vaccine Providers Newsletter 02.02.2022

Posted on by Daniel Harker
  • FDA
    • New: Spikevax and Moderna COVID-19 Vaccine. The FDA has approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older. The fact sheet, package insert, and letter of authorization have been updated.
      • Moderna COVID-19 Vaccine remains available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromised, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine. It is also authorized for use as a heterologous (or “mix and match”) single booster dose.
  • Updated: In Vitro Diagnostics EUAs – Molecular and Antigen Diagnostic Tests for SARS-CoV-2 - The update added details about the design of SARS-CoV-2 diagnostic tests, including:
    • Which authorized molecular and antigen diagnostic tests are designed with single or multiple viral targets.
    • Tests with single targets are more susceptible to changes in performance due to viral mutations, meaning they are more likely to fail to detect new variants.
    • Tests with multiple targets are more likely to continue to perform well when new variants emerge.
  • CDC
    • Important reminders about COVID-19 vaccine schedule for patients who are immunocompromised:
      • Additional Primary Shot and Booster Shot
      • After completing an mRNA primary series (Pfizer or Moderna), moderately or severely immunocompromised people aged 5 years and older should get an additional primary shot (3rd dose). No additional primary shot is recommended for recipients of the Johnson & Johnson vaccine at this time.
      • Everyone aged 12 years and older, including immunocompromised people, should also get a booster shot. This means that immunocompromised people who received an mRNA primary series can receive 4 doses total. If you are eligible for an additional primary shot, you should get this dose first before you get a booster shot.
      • The CDC website displays the dosing schedule, as well as criteria for patients who are immunocompromised.
  • Ivermectin Products are Not Approved by FDA to Prevent or Treat COVID-19
    • The U.S. Food and Drug Administration (FDA) has not authorized or approved using ivermectin to prevent or treat COVID-19 in humans and has cautioned about the potential risks of using ivermectin for COVID-19. This medication is FDA-approved to treat certain infections caused by internal and external parasites, but is not authorized or approved by the FDA to prevent or treat COVID-19. During the COVID-19 pandemic and recent surges of COVID-19 cases, rates of ivermectin prescriptions dispensed from retail pharmacies have increased, as has use of ivermectin-containing veterinary products available over the counter but not intended for human use. U.S. poison control centers have experienced a rise in calls reporting ivermectin misuses and overdoses and reports of more people experiencing adverse effects.
    • Adverse effects of ivermectin overdose include:
      • Gastrointestinal symptoms such as nausea, vomiting, and diarrhea
      • Low blood pressure (hypotension)
      • Neurologic effects such as decreased consciousness, confusion, hallucinations, central nervous system depression, seizures, coma, and death
    • Ivermectin may also increase sedative effects of other medications such as benzodiazepines and barbiturates.
  • VDH has been notified of suspicious phone calls from persons claiming to be from VDH
    • VDH will only contact someone when it has been 'customer initiated' - Meaning, the person called VDH first and we were returning their call to assist with their specific situation.  In no circumstance would VDH ever ask for their SS#, however we may verify their Name, Address, DOB, etc...just like the call center does today.
  • New Pediatric Pfizer Vaccine for <5 Years of Age
    • VDH received some tentative information about the upcoming roll-out of the pediatric vaccine for the under five year-old population, which is below. All of the information is subject to change, and is just the preliminary information shared.
      • The doses are likely to be available for those between 6 months and 4 years of age
      • It will be separately packaged vaccine, and it will have a Maroon cap
      • It is likely to be either a 2 or a 3 series
      • The release of the vaccine is expected to be around mid-April
      • Like for the 5 - 11 year old vaccine release, doses are expected to be able to  be drawn down prior to all regulatory hurdles being completed, so prepositioning will likely take place
    • As additional information is released, we will work to share it as soon as we can.
  • J&J Vaccine to be Sunsetted
    • VDH has been officially informed that the J&J vaccine is being sunsetted. A final date has not been provided, but in the near future doses will be removed from Vaxmax and they will no longer be able to be drawn down. Additional information will follow regarding the instructions on how to treat the inventory currently in the field.
  • For questions about VaxMaX and its functionality, please visit the VaxMaX Help website, which includes reference guides and tutorial videos.

Best Practice Spotlight

Upcoming Events

  • ACIP meeting
    • February 4 at 10:00 am ET - 5:00 pm ET
    • To Join: Click Here (Registration not required)
  • COCA Call-What Clinicians Need to Know About Multisystem Inflammatory Syndrome in Children
    • Date/Time: February 10 at 2:00 pm ET - 3:00 pm ET
    • Weblink Access
    • Webinar ID:160 617 0121
    • Passcode: 731625
    • Telephone: 1-669-254-5252

Helpful Resources

    • Q: What should I do if I have ongoing exposure to COVID-19 from someone I live with?
      • Begin quarantine immediately and continue to quarantine throughout the isolation period of the person with COVID-19.
      • Continue to quarantine for an additional 5 days starting the day after the end of isolation for the person with COVID-19.
      • Get tested at least 5 days after the end of isolation of the infected person that lives with them. If you test negative, you can leave the home but should continue to wear a well-fitting mask when around others at home and in public until 10 days after the end of isolation for the person with COVID-19.
      • Isolate immediately if you develop symptoms of COVID-19 or test positive.
      • Get tested at least 5 days after your first exposure.
      • Get tested again at least 5 days after the end of isolation for the person with COVID-19.
      • Isolate immediately if you develop symptoms of COVID-19 or test positive.
      • Wear a well-fitting mask when you are around the person with COVID-19, and do this throughout their isolation period.
      • Wear a well-fitting mask around others for 10 days after the infected person’s isolation period ends.
      • If you are not up to date on COVID-19 vaccines and have ongoing exposure to COVID-19, you should:
      • If you are up to date with COVID-19 vaccines and have ongoing exposure to COVID-19, you should:
    • Travel
    • Updated: Requirement for Proof of COVID-19 Vaccination for Air Passengers - Added clarifying language and FAQs about vaccination requirement for noncitizen, nonimmigrants flying to the United States. If they are not fully vaccinated, they will not be able to board a flight unless they have an exception. They do not need to be boosted to meet the requirement.
    • Updated: Guidance for traveling following illness or infection and close contact (in the yellow box) was clarified.
    • Updated (from January 14): Ending Isolation and Precautions for People with COVID-19 -  Guidance for healthcare professionals caring for patients in the community. Updated guidance to reflect new recommendations for isolation for people with COVID-19. Added new recommendations for duration of isolation for people with COVID-19 who are moderately or severely immunocompromised.

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.

VDH COVID-19 Vaccination Response: Healthcare Professionals Website