COVID-19 Vaccine Providers Newsletter 06.08.2022

Posted on by Daniel Harker

CDC

  • New: HAN Health Advisory: COVID-19 Rebound After Paxlovid Treatment
    • On May 24, 2022, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to update healthcare providers, public health departments, and the public on the potential for recurrence of COVID-19 or “COVID-19 rebound.” Paxlovid (nirmatrelvir with ritonavir) continues to be recommended for early-stage treatment of mild to moderate COVID-19 among persons at high risk for progression to severe disease.
    • COVID-19 rebound has been reported to occur between 2 and 8 days after initial recovery and is characterized by a recurrence of COVID-19 symptoms or a new positive viral test after having tested negative. A brief return of symptoms may be part of the natural history of SARS-CoV-2 (the virus that causes COVID-19) infection in some persons, independent of treatment with Paxlovid, and regardless of vaccination status.
    • Limited information currently available from case reports suggests that persons treated with Paxlovid who experience COVID-19 rebound have had mild illness; there are no reports of severe disease. There is currently no evidence that additional treatment is needed with Paxlovid or other anti-SARS-CoV-2 therapies in cases where COVID-19 rebound is suspected.
    • Regardless of whether the patient has been treated with an antiviral agent, risk of transmission during COVID-19 rebound can be managed by following CDC’s guidance on isolation, including taking other precautions such as masking.
  • Updated:
    • Stay Up to Date with Your COVID-19 Vaccines
      • Updated with booster recommendations for children ages 5-11 years.
    • COVID-19 Vaccines for People who are Moderately or Severely Immunocompromised
      • Children ages 5 through 11 years who are moderately or severely immunocompromised should receive a total of 4 doses of Pfizer-BioNTech COVID-19 vaccine to stay up to date. The 4 doses include a primary series of 3 doses, plus 1 booster (4th dose).
      • People ages 12 years and older who are moderately or severely immunocompromised should receive a total of 5 doses of mRNA COVID-19 vaccine to stay up to date. The 5 doses include a primary series of 3 doses of Pfizer-BioNTech or Moderna COVID-19 vaccine, plus 2 boosters of Pfizer-BioNTech or Moderna COVID-19 vaccine. Note that Pfizer-BioNTech COVID-19 vaccine is the only vaccine currently available for teens aged 12–17 years.
    • COVID-19 Vaccine Boosters
      • The “Getting Your COVID-19 Booster” tool was updated with booster recommendations for 5 to 11 year olds and stronger second booster recommendations for people aged 12 years and older who are immunocompromised and people aged 50 years and older.
    • COVID-19 Vaccines for People Vaccinated Outside the United States
      • The updated guidance includes recommendations for people who received COVID-19 vaccines outside of the United States. CDC recommends that people who received a COVID-19 vaccine that FDA has not authorized or approved, or that WHO does not list for emergency use, start COVID-19 vaccination over with an FDA-authorized or approved COVID-19 vaccine. Before receiving an FDA-authorized or approved COVID-19 vaccine, wait at least 28 days after the last dose of the non-FDA-authorized or approved vaccine.

FDA 

  • Novavax
    • Yesterday FDA's independent committee of scientists, VRBPAC, met to discuss and vote on whether Novavax should receive Emergency Use Authorization (EUA).
      • This vaccine uses a protein adjuvant provided in 2 doses 21 days apart to people 18 years of age and up.
      • The committee voted 21-0 (1 abstention) that it receive the EUA to ensure an alternative to existing vaccines available in the US for multiple reasons (allergy, hesitancy).
      • The recorded session can be found here and the meeting documents can be found here.
      • Our federal partners confirmed yesterday that the US government will purchase this vaccine and there will be a small allocation available in the future but it is likely not until August 2022 that this vaccine will be able to be distributed. 
      • The FDA Commissioner will take action next but we do not have a timeline for this.
      • If EUA is issued, we expect ACIP to still meet to discuss this vaccine recommendation and the CDC Director to make final recommendations. There is no timeline posted for these actions.
      • In the meantime VDH is posting a "banner" on the  https://www.vdh.virginia.gov/covid-19-vaccine/ to let the public know VDH is aware of Novavax and will update as more information becomes available.
  • FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID-19 Vaccines - On May 23, 2022, the Food and Drug Administration (FDA) revised the dates of the upcoming Vaccines and Related Biological Products Advisory Committee meetings due to new data from sponsors and expected submissions of emergency use authorization (EUA) requests. The new dates are as follows:
    • June 14 will be the new meeting date for the FDA and its advisory committee of external experts to discuss Moderna’s COVID-19 vaccine EUA request for 6 years through 17 years of age.
    • June 15 will be the new meeting date for the Moderna COVID-19 vaccine EUA request for 6 months through 5 years of age and Pfizer-BioNTech’s COVID-19 vaccine EUA request for 6 months through 4 years of age, based on expected completion of an EUA submission.
    • Information on how to view the meetings can be found here: Vaccines and Related Biological Products Advisory Committee June 14-15, 2022 Meeting Announcement 

VDH

  • Pediatric (6m - under 5 years of age)
    • We have received several inquiries from parents who have called their pediatrician and local health department to ask questions about the upcoming 6mo - under 5 years of age vaccine rollout. We understand that access to, and the consistency of, information plays a critical role in a successful response, so we're sharing the linked talking points. In particular, it will be important to reiterate that we are in close coordination with our provider partners and that all children seeking the vaccine will have access within a few weeks of its approval and release. VDH is also posting a "banner" on the  https://www.vdh.virginia.gov/covid-19-vaccine/ to let the public know VDH is working through the distribution of these vaccines and that parents should contact their child's pediatrician and keep checking the VDH websites as more information becomes available.  
  • Preordering for the second threshold of the Pfizer (under 5 years of age) and Moderna (under 6 years of age) COVID-19 vaccines for younger children closes at 12 PM on June 10, 2022. If you would like to request vaccine, please work with the allocation lead for your health district.
    • Vaccine requested from threshold 1 is scheduled to arrive on June 20, 2022 (Juneteenth observed). If your facility has requested vaccine from threshold 1, please ensure someone will be on-site to receive the shipment.
    • Vaccine requested from threshold 2 is scheduled to arrive on June 23, 2022 or later.
  • 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

  • Building a Village: Community Linkages for COVID-19 Vaccines and Beyond
    • Ahead of a potential Emergency Use Authorization of the COVID-19 vaccine for children under 5 years of age, please join the Health Resources and Services Administration (HRSA) for a special Town Hall event to identify partnership opportunities and provide a more comprehensive system of services and care for childhood COVID-19 vaccines and beyond. The event will feature panelists from HRSA’s Maternal and Child Health Bureau, Bureau of Primary Health Care, and Health Systems Bureau.
    • The special town hall event will be held on Thursday, June 9, 3-4:30 p.m. ET.
    • Registration can be found here.

Helpful Resources

VDH External Web Updates

  • Updated: Health Professionals page - Added new first vaccine booster recommendations for 5 to 11 year old children and (separately) strengthened ("should" vs "may") second booster recommendations for immunocompromised people ages 12 years and older and those 50 years and older
  • Facts About COVID-19 page - Updated section about vaccines with "more than a million people have died of COVID-19", and general language edits.
  • Health Professionals page - Added 2 new topics to "Hot Topics" section: "COVID-19 rebound after Paxlovid treatment" & "COVID-19 vaccine first booster dose recommendations extended to include 5-11 year old children". Added 1 new MMWR: "Frequency of Long COVID conditions among U.S. COVID-19 patients".
  • Vaccination FAQs -
    • Updated vaccine dashboard with recent changes
    • Updated factsheets for Pfizer-BioNtech COVID-19 vaccines
    • Updated status of COVID-19 vaccines for younger children and booster recommendations for children aged 5-11 years
    • Incorporated recent changes strengthening second booster recommendations for certain individuals and the definition of “up to date.”

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