COVID-19 Vaccine FAQs

COVID-19 Vaccination Information

UPDATED INFO: 9-3-2022

On September 1, 2022, the Centers for Disease Control (CDC) endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendations for use of updated COVID-19 boosters from Pfizer-BioNTech for people ages 12 years and older and from Moderna for people ages 18 years and older.  The vaccines can now be administered to qualifying patients under the FDA issued Emergency Use Authorization (EUA).

Updated COVID-19 boosters add Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since previous vaccination by targeting variants that are more transmissible and immune-evading.

The Moderna COVID-19 Omicron (bivalent) booster is authorized for use in individuals 18 years of age and older as a single booster dose administered at least 2 months after either:

  • Completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

Moderna COVID-19 Omicron (bivalent) boosters are supplied as a multidose vial with a dark blue cap and gray border label and administered as a 0.5 mL dose. 

The Pfizer COVID-19 Omicron (bivalent) booster is authorized for use in individuals 12 years of age and older as a single booster dose administered at least 2 months after either:

  • Completion of primary vaccination with any authorized or approved
    monovalent1 COVID-19 vaccine, or
  • Receipt of the most recent booster dose with any authorized or
    approved monovalent COVID-19 vaccine.

The Pfizer COVID-19 Omicron (bivalent) booster is currently supplied in a multidose vial with gray cap and label with gray border administered as a 0.3 mL dose. Do not dilute prior to use.

Storage/handling and additional information can be found in the emergency use authorizations (EUAs) found here

Pfizer EUA: https://bit.ly/PfizerOmicronEUA

Moderna EUA: https://bit.ly/ModernaOmicronEUA

As a reminder, If your pharmacy offers the original (monovalent) COVID-19 boosters for ages 12 years and older, halt immediately. However, those original mRNA vaccines (Pfizer and Moderna) remain authorized and recommended for use as the primary series. 

The Interim Clinical Considerations for the Use of COVID-19 Vaccines will be updated in the next few days.  This information will be updated on the WV BOP website under FAQ COVID-19 Vaccine FAQ.

The COVID-19 Omicron (bivalent) booster does not have to be the same type as the primary series.  For example, if the patient had a Pfizer primary series, they may receive a Moderna COVID-19 Omicron (bivalent) booster.  While the primary series must be completed with the same vaccine, the booster dose can be different. 

The CDC recommends that everyone age 12 and up should get an updated COVID-19 booster this fall to stay up-to-date on vaccinations. The same is true for people who completed their primary series or received one or two boosters: they should get an updated booster dose at least two months after their last shot.

Some studies indicate that there may be an improved immune response with increased time between infection and vaccination.  Thus, individuals who recently had COVID-19 may consider delaying any COVID-19 vaccination, including the updated booster dose, by 3 months from the start of their symptoms or positive test.

These COVID-19 Omicron (bivalent) booster doses have started arriving in WV and will continue to do so over the next week.

WV immunization law allows vaccines to be provided that follow the CDC’s recommended immunization schedule for adults, children, and adolescents (§15-12-3. Immunizations).  This is to notify you that the CDC has updated these recommendations related to COVID-19 vaccinations.

The FDA has authorized, Advisory Committee on Immunization Practices has met and recommended and the CDC has concurred with the recommendation for Pfizer 6 months through 4 years, Moderna 6 months through 5 years, and Moderna 6 years through 17 years.

Information below is directly from Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States available at https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html

Vaccination schedule

The recommended schedule and use of each COVID-19 vaccine product approved under BLA or authorized under EUA varies by the age and immune status of the recipient. There are two vaccination schedules: one for people who are not moderately or severely immunocompromised and one for people who are moderately or severely immunocompromised.

Vaccination providers should ensure the correct age-appropriate product is administered based on the recipient’s age on the day of vaccination (Table 1). Vaccine doses should be administered by the intramuscular route and in accordance with the recommended intervals for that age group (3). For guidance on timing of vaccination in specific situations, see Transitioning from a younger to older age group, Considerations for extended intervals for COVID-19 vaccine primary series doses, and COVID-19 vaccination and SARS-CoV-2-infection.

COVID-19 vaccine use terminology is defined in Box 2.

See Appendices B (People who received COVID-19 vaccine outside the United States) and C (People who received COVID-19 vaccine as part of a clinical trial) for recommendations for these populations.

Table 1. COVID-19 vaccine products currently approved or authorized in the United States*

Moderna

COVID-19 vaccine products currently approved or authorized in the United States: Moderna
Age indication Vaccine composition Vaccine vial cap color Label border color Dilution required Primary series Booster dose
Dose Injection volume Dose Injection volume
6 months–5 years Monovalent Dark blue Magenta No 25 µg 0.25 mL NA NA
6–11 years† Monovalent Dark blue Purple No 50 µg 0.5 mL NA NA
12–17 years Monovalent Red Light blue No 100 µg 0.5 mL NA NA
18 years and older Monovalent Red Light blue No 100 µg 0.5 mL NA NA
18 years and older Bivalent Dark blue Gray No NA NA 50 µg 0.5 mL

Novavax

COVID-19 vaccine products currently approved or authorized in the United States: Novavax
Age indication Vaccine composition Vaccine vial cap color Label border color Dilution required Primary series Booster dose
Dose Injection volume Dose Injection volume
12 years and older Monovalent Royal blue No color No 5 µg rS and
50 µg of Matrix-M™ adjuvant
0.5 mL NA NA

Pfizer-BioNTech

COVID-19 vaccine products currently approved or authorized in the United States: Pfizer-BioNTech
Age indication Vaccine composition Vaccine vial cap color Label border color Dilution required Primary series Booster dose
Dose Injection volume Dose Injection volume
6 months–4 years Monovalent Maroon Maroon Yes 3 µg 0.2 mL NA NA
5–11 years Monovalent Orange Orange Yes 10 µg 0.2 mL 10 µg 0.2 mL
12 years and older Monovalent Gray Gray No 30 µg 0.3 mL NA NA
12 years and older Bivalent Gray Gray No NA NA 30 µg 0.3 mL

Janssen

COVID-19 vaccine products currently approved or authorized in the United States: Janssen
Age indication Vaccine composition Vaccine vial cap color Label border color Dilution required Primary series Booster dose
Dose Injection volume Dose Injection volume
18 years and older Monovalent Blue No color No 5×1010 viral particles 0.5 mL 5×1010 viral particles 0.5 mL

Abbreviations: NA = not authorized; rS = recombinant spike protein

*Illustrations of the different vaccine vial cap and label border colors are available from FDA for Moderna and Pfizer-BioNTech COVID-19 vaccines. Additional product-specific information is available from CDC for all FDA-authorized or -approved vaccines.

Moderna COVID-19 Vaccine supplied in a vial with a dark blue cap and a label with a teal border stating “Age 6y through 11y” is currently not available. Moderna COVID-19 Vaccine supplied in a vial with a dark blue cap and a label with a purple border stating “BOOSTER DOSES ONLY Booster dose: 0.5mL” is FDA-authorized for use in children ages 6–11 years as a primary series dose. It is not authorized for the booster dose.

Vials of the Pfizer-BioNTech COVID-19 Vaccine with a maroon vial cap and maroon label border may state “Age 2y to < 5y” or “Age 6m to <5 yr.” Carton labels may state “For age 2 years to <5 years” or “For age 6 months to <5 years.” Vials with either printed age range can be used for children ages 6 months–4 years.

Box 2. Terminology for COVID-19 vaccine use

Primary series: Initial vaccination which can range from a single dose to a 3-dose series depending on the vaccine product and a person’s age and immune status.

Additional dose: A dose of vaccine administered after the primary series to people who may be less likely to mount a protective immune response after initial vaccination. People who are moderately or severely immunocompromised and who received Janssen COVID-19 Vaccine for their primary series are recommended to receive an additional dose using an mRNA vaccine.

Booster dose: A subsequent dose of vaccine administered to enhance or restore protection which might have waned over time after primary series vaccination.

  • Homologous booster dose: The same vaccine manufacturer used for the booster dose and the primary series.
  • Heterologous booster dose (mix-and-match booster): A different vaccine manufacturer used for the booster dose and the primary series.

Monovalent vaccine: The vaccine product is based on the original (ancestral) strain of SARS-CoV-2.

Bivalent vaccine (“updated vaccine”): The vaccine product is based on the original (ancestral) strain of SARS-CoV-2 and the Omicron BA.4 and BA.5 (BA.4/BA.5) variants of SARS-CoV-2.

 
 
 
 

COVID-19 vaccination guidance for people who are not moderately or severely immunocompromised

Overview

 

For primary series vaccination, Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines are recommended; only monovalent vaccines are approved or authorized for primary series doses. The same vaccine product should be used for all doses of the primary series (see Interchangeability of COVID-19 vaccine products).

For booster vaccination, Moderna and Pfizer-BioNTech are recommended. Recommendations vary based on age and primary series product. People ages 12 years and older are recommended to receive 1 age-appropriate bivalent mRNA booster dose after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). This new booster recommendation replaces all prior booster recommendations for this age group. Monovalent mRNA vaccines are no longer authorized as a booster dose for people ages 12 years and older.

Children ages 5–11 years are recommended to receive 1 monovalent mRNA booster dose if eligible (i.e., if a booster dose is FDA-authorized for use in a specified population).

For information on the timing of COVID-19 vaccination (primary series and booster doses) after SARS-CoV-2 infection, see COVID-19 vaccination and SARS-CoV-2 infection.

Information about age-specific vaccine products and dosages can be found in Table 1.

Table 2. COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised

Ages 6 months through 11 years

Table 2. COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised: Ages 6 months through 11 years
Primary series manufacturer Age
group
Number of primary doses Number of monovalent booster doses Recommended monovalent booster dose Interval between 1st and 2nd primary dose* Interval between 2nd and 3rd primary dose Interval between primary series and booster dose
Moderna 6 months–5 years 2 NA NA 4–8 weeks NA NA
Moderna 6–11 years 2 NA NA 4–8 weeks NA NA
Pfizer-BioNTech 6 months–4 years 3 NA  NA 3–8 weeks At least 8 weeks NA
Pfizer-BioNTech 5–11 years 2 1 Pfizer-BioNTech 3–8 weeks NA At least 5 months

Ages 12 through 17 years

Table 2. COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised: Ages 12 through 17 years
Primary series manufacturer Age
group
Number of primary doses Number of bivalent booster doses Recommended bivalent booster dose† Interval between 1st and 2nd primary dose* Interval between primary series and booster dose‡
Moderna 12–17 years 2 1 Pfizer-BioNTech 4–8 weeks At least 2 months
Novavax 12–17 years 2 1 Pfizer-BioNTech 3–8 weeks At least 2 months
Pfizer-BioNTech 12–17 years 2 1 Pfizer-BioNTech 3–8 weeks At least 2 months

Ages 18 years and older

Table 2. COVID-19 vaccination schedule for people who are not moderately or severely immunocompromised: Ages 18 years and older†
Primary series manufacturer Age
group
Number of primary doses Number of bivalent booster doses Recommended bivalent booster dose† Interval between 1st and 2nd primary dose* Interval between primary series and booster dose‡
Moderna 18 years and older 2 1 Moderna or Pfizer-BioNTech 4–8 weeks At least 2 months
Novavax 18 years and older 2 1 Moderna or Pfizer-BioNTech 3–8 weeks At least 2 months
Pfizer-BioNTech 18 years and older 2 1 Moderna or Pfizer-BioNTech 3–8 weeks At least 2 months

Abbreviation: NA = not authorized

*An 8-week interval between the first and second primary series doses of Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines may be optimal for some people ages 6 months–64 years, especially for males ages 12–39 years, as it may reduce the small risk of myocarditis and pericarditis associated with these vaccines. A shorter interval (3 weeks for Novavax and Pfizer-BioNTech; 4 weeks for Moderna) between the first and second doses remains the recommended interval for people who are moderately or severely immunocompromised; adults ages 65 years and older; and in situations in which there is increased concern about COVID-19 community levels or an individual’s higher risk of severe disease.

For people ages 12 years and older, 1 bivalent mRNA booster dose is recommended after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). The bivalent Moderna booster dose is authorized for people ages 18 years and older; the bivalent Pfizer-BioNTech booster dose is authorized for people ages 12 years and older.

The bivalent booster dose is administered at least 2 months after completion of the primary series. For people who previously received a monovalent booster dose(s), the bivalent booster dose is administered at least 2 months after the last monovalent booster dose.

Schedule: ages 6 months through 11 years

Moderna COVID-19 Vaccine

  • Children ages 6 months–5 years: A 2-dose primary series separated by 4–8 weeks is recommended. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Moderna primary series.
  • Children ages 6–11 years: A 2-dose primary series separated by 4–8 weeks is recommended. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Moderna primary series.

Pfizer-BioNTech COVID-19 Vaccine 

  • Children ages 6 months–4 years: A 3-dose primary series is recommended. The first and second doses are separated by 3–8 weeks and the second and third doses are separated by at least 8 weeks. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Pfizer-BioNTech primary series.
  • Children ages 5–11 years: A 2-dose primary series and 1 booster dose is recommended. The primary series doses are separated by 3-8 weeks and the booster dose is administered at least 5 months after completion of the primary series. Currently, the monovalent Pfizer-BioNTech booster dose is authorized for children in this age group who receive a Pfizer-BioNTech primary series.

Schedule: ages 12 through 17 years

Moderna COVID-19 Vaccine

  • Adolescents ages 12–17 years: A 2-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. The primary series doses are separated by 4-8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Moderna primary series.

Novavax COVID-19 Vaccine

  • Adolescents ages 12–17 years: A 2-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. The primary series doses are separated by 3-8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Novavax primary series.

Pfizer-BioNTech COVID-19 Vaccine

  • Adolescents ages 12–17 years: A 2-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. The primary series doses are separated by 3-8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Pfizer-BioNTech primary series.

Schedule: ages 18 years and older

Moderna COVID-19 Vaccine 

  • Adults ages 18 years and older: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. The primary series doses are separated by 4–8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

Novavax COVID-19 Vaccine

  • Adults ages 18 years and older: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. The primary series doses are separated by 3–8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series.

Pfizer-BioNTech COVID-19 Vaccine 

  • Adults ages 18 years and older: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. The primary series doses are separated by 3–8 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

Previous vaccination with Janssen COVID-19 Vaccine

People ages 18 years and older who received the Janssen COVID-19 Vaccine primary series dose are recommended to receive 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) at least 2 months after completion of the primary series dose (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

See Appendix A for additional information on Janssen COVID-19 Vaccine.

Considerations for extended intervals for COVID-19 vaccine primary series doses

An 8-week interval between the first and second primary series doses of Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines may be optimal for some people as it may reduce the small risk of myocarditis and pericarditis associated with these COVID-19 vaccines.

COVID-19 vaccines are FDA-approved or FDA-authorized for a 3-week (Novavax and Pfizer-BioNTech) or 4-week (Moderna) interval between the first and second dose. A 3- or 4-week interval continues to be the recommended interval for people who are moderately or severely immunocompromised, adults ages 65 years and older, and in situations when the fullest possible protection needs to be achieved sooner (e.g., increased concern about COVID-19 community levels or an individual’s higher risk for severe disease).

Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines are safe and effective at the FDA-approved or FDA-authorized intervals, but a longer interval may be considered for some populations. While absolute risk remains small, an elevated risk for myocarditis and pericarditis has been observed among mRNA COVID-19 vaccine recipients, particularly in males ages 12–39 years (see COVID-19 vaccination and myocarditis and pericarditis). Cases of myocarditis and pericarditis were identified in clinical trials of Novavax COVID-19 Vaccine and through passive surveillance during post-authorization use outside the United States.

The risk of vaccine-associated myocarditis and pericarditis might be reduced by extending the interval between the first and second primary series doses of these vaccines. Some studies in adolescents (ages 12–17 years) and adults have shown the small risk of myocarditis and pericarditis associated with mRNA COVID-19 vaccines might be reduced and peak antibody responses and vaccine effectiveness may be increased with an interval longer than 4 weeks. Extending the interval beyond 8 weeks has not been shown to provide additional benefit.

 
 
 
 

COVID-19 vaccination guidance for people who are moderately or severely immunocompromised

People with immunocompromising conditions or people who take immunosuppressive medications or therapies are at increased risk for severe COVID-19. Because the immune response following COVID-19 vaccination may differ in people who are moderately or severely immunocompromised at the time of vaccination, specific guidance for this population is provided; see also COVID-19 vaccination and EVUSHELD™.

Overview

 

For primary series vaccination, Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines are recommended; only monovalent vaccines are approved or authorized for primary series doses. The same vaccine product should be used for all doses of the primary series (see Interchangeability of COVID-19 vaccine products).

For booster vaccination, Moderna and Pfizer-BioNTech are recommended. Recommendations vary based on age and primary series product. People ages 12 years and older are recommended to receive 1 age-appropriate bivalent mRNA booster dose after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). This new booster recommendation replaces all prior booster recommendations for this age group. Monovalent mRNA vaccines are no longer authorized as a booster dose for people ages 12 years and older.

Children ages 5–11 years are recommended to receive 1 monovalent mRNA booster dose if eligible (i.e., if a booster dose is FDA-authorized for use in a specified population).

Information about age-specific vaccine products and dosages can be found in Table 1.

People who are or who become moderately or severely immunocompromised should follow the COVID-19 vaccination schedule according to their age and immune status at the time of eligibility for that dose. For example, people who become moderately or severely immunocompromised after completing a 2-dose mRNA primary series do not need additional primary doses; however, they should follow the schedule for people who are moderately or severely immunocompromised for the booster dose. For situations in which diminished vaccine efficacy is anticipated, see Additional considerations for vaccination outside of the FDA and CDC dosing intervals on a case-by-case basis.

For information on the timing of COVID-19 vaccination (primary series and booster doses) after SARS-CoV-2 infection, see COVID-19 vaccination and SARS-CoV-2 infection.

Table 3. COVID-19 vaccination schedule for people who are moderately or severely immunocompromised

Ages 6 months through 11 years

Table 3. COVID-19 vaccination schedule for people who are moderately or severely immunocompromised: 6 months through 11 years
Primary series manufacturer Age
group
Number of primary doses Number of monovalent booster doses Recommended monovalent booster dose Interval between 1st and 2nd primary dose Interval between 2nd and 3rd primary dose Interval between primary series and booster dose
Moderna 6 months–5 years 3 NA NA 4 weeks At least 4 weeks NA
Moderna 6–11 years 3 NA NA 4 weeks At least 4 weeks NA
Pfizer-BioNTech 6 months–4 years 3 NA NA 3 weeks At least 8 weeks NA
Pfizer-BioNTech 5–11 years 3 1 Pfizer-BioNTech 3 weeks At least 4 weeks At least 3 months

Ages 12 through 17 years

Table 3. COVID-19 vaccination schedule for people who are moderately or severely immunocompromised: 12 through 17 years†
Primary series manufacturer Age
group
Number of primary doses Number of bivalent booster doses Recommended bivalent booster dose* Interval between 1st and 2nd primary dose Interval between 2nd and 3rd primary dose Interval between primary series and booster dose†
Moderna 12–17  years 3 1 Pfizer-BioNTech 4 weeks At least 4 weeks At least 2 months
Novavax 12–17 years 2 1 Pfizer-BioNTech 3 weeks NA At least 2 months
Pfizer-BioNTech 12–17 years 3 1 Pfizer-BioNTech 3 weeks At least 4 weeks At least 2 months

Ages 18 years and older

Table 3. COVID-19 vaccination schedule for people who are moderately or severely immunocompromised: 18 years and older†
Primary series manufacturer Age
group
Number of primary doses Number of bivalent booster doses Recommended bivalent booster dose* Interval between 1st and 2nd primary dose Interval between 2nd and 3rd primary dose Interval between primary series and booster dose†
Moderna 18 years and older 3 1 Moderna or Pfizer-BioNTech 4 weeks At least 4 weeks At least 2 months
Novavax 18 years and older 2 1 Moderna or Pfizer-BioNTech 3 weeks NA At least 2 months
Pfizer-BioNTech 18 years and older 3 1 Moderna or Pfizer-BioNTech 3 weeks At least 4 weeks At least 2 months

Abbreviation: NA = not authorized

*For people ages 12 years and older, 1 bivalent mRNA booster dose is recommended after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). The bivalent Moderna booster dose is authorized for people ages 18 years and older; the bivalent Pfizer-BioNTech booster dose is authorized for people ages 12 years and older.

The bivalent booster dose is administered at least 2 months after completion of the primary series. For people who previously received a monovalent booster dose(s), the bivalent booster dose is administered at least 2 months after the last monovalent booster dose.

Schedule: ages 6 months through 11 years

Moderna COVID-19 Vaccine

  • Children ages 6 months–5 years: A 3-dose primary series is recommended. The first and second doses are separated by 4 weeks and the second and third doses are separated by at least 4 weeks. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Moderna primary series.
  • Children ages 6–11 years: A 3-dose primary series is recommended. The first and second doses are separated by 4 weeks and the second and third doses are separated by at least 4 weeks. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Moderna primary series.

Pfizer-BioNTech COVID-19 Vaccine

  • Children ages 6 months–4 years: A 3-dose primary series is recommended. The first and second doses are separated by 3 weeks and the second and third doses are separated by at least 8 weeks. Currently, a booster dose using any COVID-19 vaccine is not authorized for children in this age group who receive a Pfizer-BioNTech primary series.
  • Children ages 5–11 years: A 3-dose primary series and 1 booster dose is recommended. For the primary series, the first and second doses are separated by 3 weeks and the second and third doses are separated by at least 4 weeks. The booster dose is administered at least 3 months after completion of the primary series. Currently, the monovalent Pfizer-BioNTech booster dose is authorized for children in this age group who receive a Pfizer-BioNTech primary series.

Schedule: ages 12 through 17 years

Moderna COVID-19 Vaccine 

  • Adolescents ages 12–17 years: A 3-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. For the primary series, the first and second doses are separated by 4 weeks and the second and third doses are separated by at least 4 weeks. The bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Moderna primary series.

Novavax COVID-19 Vaccine

  • Adolescents ages 12–17 years: A 2-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. For the primary series, the first and second doses are separated by 3 weeks. The bivalent mRNA booster dose is administered at least 2 months after completion of the primary series. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Novavax primary series.

Pfizer-BioNTech COVID-19 Vaccine

  • Adolescents ages 12–17 years: A 3-dose primary series and 1 age-appropriate bivalent mRNA booster dose is recommended. For the primary series, the first and second doses are separated by 3 weeks and the second and third doses are separated by at least 4 weeks. The bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose. Currently, the bivalent Pfizer-BioNTech booster dose is authorized for adolescents in this age group who receive a Pfizer-BioNTech primary series.

Schedule: ages 18 years and older

Moderna COVID-19 Vaccine

  • Adults ages 18 years and older: A 3-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended.  For the primary series, the first and second doses are separated by 4 weeks and the second and third doses are separated by at least 4 weeks. The bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

Novavax COVID-19 Vaccine

  • Adults ages 18 years and older: A 2-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. The primary series doses are separated by 3 weeks and the bivalent mRNA booster dose is administered at least 2 months after completion of the primary series.

Pfizer-BioNTech COVID-19 Vaccine

  • Adults ages 18 years and older: A 3-dose primary series and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech) is recommended. For the primary series, the first and second doses are separated by 3 weeks and the second and third doses are separated by at least 4 weeks. The bivalent mRNA booster dose is administered at least 2 months after completion of the primary series (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

Previous vaccination with Janssen COVID-19 Vaccine

People who are moderately or severely immunocompromised ages 18 years and older who received the Janssen COVID-19 Vaccine primary series dose are recommended to receive a second (additional) dose using a monovalent mRNA vaccine and 1 bivalent mRNA booster dose (Moderna or Pfizer-BioNTech). The primary series dose and the additional dose are separated by at least 4 weeks. The bivalent mRNA booster dose is administered at least 2 months after the additional dose (for people who have not received any booster doses), or at least 2 months after the last monovalent booster dose.

See Appendix A for additional information on Janssen COVID-19 Vaccine.

COVID-19 vaccination and EVUSHELD™

In addition to following the recommended COVID-19 vaccination schedule, tixagevimab/cilgavimab (EVUSHELD™), a combination of two monoclonal antibodies, should be administered to people who are moderately or severely immunocompromised every 6 months for pre-exposure prophylaxis to supplement vaccine protection. Per the product EUA, EVUSHELD™ is given at least 2 weeks after COVID-19 vaccine. People may initiate EVUSHELD™ at any time after this interval, including between doses in the primary series and primary and booster doses. Providers should consult CDC’s EVUSHELD™ guidance and current treatment guidelines for more information on the use of EVUSHELD™ as pre-exposure prophylaxis. Such use of monoclonal antibodies, however, is not a substitute for COVID-19 vaccination.

Description of moderate and severe immunocompromising conditions and treatment

Moderate and severe immunocompromising conditions and treatments include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell therapy or hematopoietic cell transplant (HCT) (within 2 years of transplantation or taking immunosuppressive therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced HIV infection (people with HIV and CD4 cell counts less than 200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV) or untreated HIV infection
  • Active treatment with high-dose corticosteroids (i.e., 20 mg or more of prednisone or equivalent per day when administered for 2 or more weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis factor (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory

Factors to consider in assessing the general level of immune competence in a patient include disease severity, duration, clinical stability, complications, comorbidities, and any potentially immune-suppressing treatment. Age or place of residence alone (e.g., residence in a long-term care setting), independent of a patient’s medical condition, should not be used to determine the level of immune competence.

For additional information about the degree of immune suppression associated with different medical conditions and treatments, providers can consult ACIP’s general best practices for vaccination of people with altered immunocompetence, the CDC Yellow Book, and the Infectious Diseases Society of America policy statement, 2013 IDSA Clinical Practice Guideline for Vaccination of the Immunocompromised Host.

Considerations for COVID-19 revaccination

Revaccination is defined as repeating 1 or more dose(s) of vaccine. COVID-19 revaccination should be with Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine (Table 3) regardless of vaccine administered for initial vaccination. Recipients of HCT or CAR-T-cell therapy should undergo revaccination for the monovalent primary series and bivalent booster doses received prior to or during treatment. There is no revaccination for monovalent booster doses. Revaccination cannot exceed the number of primary series and booster doses currently authorized (see Table 3). Revaccination should start at least 3 months (12 weeks) after transplant or CAR-T-cell therapy.

Revaccination may also be considered for patients who received 1 or more doses of COVID-19 vaccine (primary series and bivalent booster doses) during treatment with B-cell-depleting therapies (e.g., rituximab, ocrelizumab) that were administered over a limited period (e.g., as part of a treatment regimen for certain malignancies). There is no revaccination for monovalent booster doses. Revaccination cannot exceed the number of primary series and booster doses currently authorized. The suggested interval to start revaccination is about 6 months after completion of the B-cell-depleting therapy. Timing of vaccination for patients who receive B-cell-depleting therapies on a continuing basis (e.g., for treatment of certain autoimmune conditions such as rheumatoid arthritis or multiple sclerosis) is addressed in Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies.

A patient’s clinical team is best positioned to determine the degree of immune compromise, need for revaccination, and appropriate timing of revaccination.

Considerations for timing of COVID-19 vaccination in relation to immunosuppressive therapies

Administration of COVID-19 vaccines should not be delayed in patients taking immunosuppressive therapies. Whenever possible, COVID-19 vaccines should be administered at least 2 weeks before initiation or resumption of immunosuppressive therapies. For patients who receive B-cell-depleting therapies on a continuing basis, COVID-19 vaccines should be administered approximately 4 weeks before the next scheduled therapy.

Timing of COVID-19 vaccination should take into consideration current or planned immunosuppressive therapies, optimization of both the patient’s medical condition and anticipated response to vaccination, and individual benefits and risks.

The utility of serologic testing, cellular immune testing, or B-cell quantification to assess immune response to vaccination and guide clinical care has not been established. Such testing outside of the context of research studies is not recommended at this time.

Self-attestation of immunocompromised status

People can self-attest to their moderately or severely immunocompromised status and receive COVID-19 vaccine doses wherever vaccines are offered. Vaccinators should not deny COVID-19 vaccination to a person due to lack of documentation.

Additional considerations

On a case-by-case basis, providers caring for moderately or severely immunocompromised patients may administer Moderna, Novavax, and Pfizer-BioNTech COVID-19 vaccines outside of the FDA and CDC dosing intervals when, based on their clinical judgment, the benefits of vaccination are deemed to outweigh the potential and unknown risks for the recipient. However, providers should not routinely administer doses of COVID-19 vaccine beyond those recommended in this guidance.

Vaccinated people who are moderately or severely immunocompromised should be counseled about the potential for a reduced immune response to COVID-19 vaccines. They and their close contacts should continue to follow current prevention measures.

 
 
 
 

Timing, spacing, and interchangeability of COVID-19 vaccines

The following considerations related to the timing, spacing, and interchangeability of COVID-19 vaccines apply to the recommendations and schedules for people who are not moderately or severely immunocompromised and people who are moderately or severely immunocompromised.

4-Day grace period

Doses administered up to 4 days before the minimum interval, known as the 4-day grace period, are considered valid. This applies to primary series and booster doses. If a dose is administered prior to the 4-day grace period, see Appendix D. Doses administered at any time after the recommended interval are valid.

Interchangeability of COVID-19 vaccine products

Primary series

In general, the same monovalent vaccine product should be used for all doses in the primary series.

A mixed primary series composed of any combination of Moderna, Novavax, and Pfizer-BioNTechCOVID-19 vaccines is not authorized; data on the safety and efficacy of a mixed primary series are limited. If a mixed primary series is inadvertently administered, the series is complete, and doses do not need to be repeated.

Children ages 6 months–4 years who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered at least 8 weeks after the second dose to complete the 3-dose primary series.

In the following exceptional situations, a different, age-appropriate COVID-19 vaccine may be administered to complete a primary series at a minimum interval of 28 days from the last COVID-19 vaccine dose. No VAERS report is required.

  • The same vaccine is not available
  • The first dose is unknown
  • A person starts but is unable to complete a primary series with the same COVID-19 vaccine due to a contraindication.

People who received Janssen COVID-19 Vaccine after a dose of another COVID-19 vaccine should be considered to have received a valid, single-dose Janssen primary series.

Booster vaccination

For booster vaccination, age-appropriate mRNA vaccines are recommended. Any homologous or heterologous age-appropriate mRNA vaccine can be used if a booster dose is FDA-authorized for use in a specified population.

Coadministration of COVID-19 vaccines with other vaccines

COVID-19 vaccines may be administered without regard to timing of other vaccines. This includes simultaneous administration of COVID-19 vaccine and other vaccines on the same day. However, there are additional considerations if administering an orthopoxvirus vaccine (see below).

Extensive experience with non-COVID 19 vaccines has demonstrated that immunogenicity and adverse event profiles are generally similar when vaccines are administered simultaneously as when they are administered alone. Studies that compared coadministration of COVID-19 vaccines and seasonal influenza vaccines with separate administration of these vaccines found similar levels of immunogenicity and similar or slightly higher reactogenicity; no specific safety concerns were identified.

In accordance with general best practices, routine administration of all age-appropriate doses of vaccines simultaneously is recommended for children, adolescents, and adults for whom no specific contraindications exist at the time of the healthcare visit.

Orthopoxvirus vaccination:

  • If an orthopoxvirus vaccine is recommended for prophylaxis in the setting of an orthopoxvirus (e.g., monkeypox) outbreak, orthopoxvirus vaccination should not be delayed because of recent receipt of a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine; no minimum interval between COVID-19 vaccination with these vaccines and orthopoxvirus vaccination is necessary.
  • People, particularly adolescent or young adult males, might consider waiting 4 weeks after orthopoxvirus vaccination (either JYNNEOS or ACAM2000) before receiving a Moderna, Novavax, or Pfizer-BioNTech COVID-19 vaccine because of the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and mRNA (i.e., Moderna and Pfizer-BioNTech) and Novavax COVID-19 vaccines and the unknown risk for myocarditis and pericarditis after JYNNEOS.

Best practices for multiple injections include:

  • Label each syringe with the name and the dosage (amount) of the vaccine, lot number, initials of the preparer, and exact beyond-use time, if applicable.
  • Administer each injection in a different injection site; separate injection sites by 1 inch or more, if possible.
  • Administer the COVID-19 vaccine and vaccines that may be more likely to cause a local reaction in different limbs, if possible.

See ACIP’s general best practices and Epidemiology and Prevention of Vaccine-Preventable Diseases (Pink Book) for further information.

Transitioning from a younger to older age group

People should receive the recommended age-appropriate vaccine product and dosage based on their age on the day of vaccination. If a person moves from a younger age group to an older age group during the primary series or between the primary series and the booster dose, they should receive the vaccine product and dosage for the older age group for all subsequent doses.

However, FDA authorization allows for dosing options for certain age transitions for Moderna COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine as described below. Refer to Table 1 for information about age-specific vaccine products and dosages.

Moderna COVID-19 Vaccine

Children who will turn from age 5 years to 6 years: FDA authorization of the Moderna COVID-19 Vaccine allows children who will turn from age 5 years to 6 years between doses in the primary series to receive, for any primary dose: (1) the Moderna COVID-19 Vaccine product authorized for children ages 6 months–5 years or (2) the Moderna COVID-19 Vaccine product authorized for children ages 6–11 years.

Children who will turn from age 11 years to 12 years: FDA authorization of the Moderna COVID-19 Vaccine allows children who will turn from age 11 years to 12 years between doses in the primary series to receive, for any primary dose: (1) the Moderna COVID-19 Vaccine product authorized for children ages 6–11 years or (2) the Moderna COVID-19 Vaccine product authorized for people ages 12 years and older.

Pfizer-BioNTech COVID-19 Vaccine

Children who will turn from age 4 years to 5 years: FDA authorization of the Pfizer-BioNTech COVID-19 Vaccine allows children who will turn from age 4 years to 5 years between any dose in the primary series to receive:

  • A 2-dose primary series using the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 5–11 years
or
  • A 3-dose primary series initiated with the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 6 months–4 years. Each of doses 2 and 3 may be with the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 6 months–4 years, or the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 5–11 years.

Children who will turn from age 11 years to 12 years: FDA authorization of the Pfizer-BioNTech COVID-19 Vaccine allows children who will turn from age 11 years to 12 years between doses in the primary series to receive, for any primary dose: (1) the Pfizer-BioNTech COVID-19 Vaccine product authorized for children ages 5–11 years or (2) the Pfizer-BioNTech COVID-19 Vaccine product authorized for people ages 12 years and older.

Vaccination after SARS-CoV-2 Infection

For information on the timing of COVID-19 vaccination (primary series and booster doses) after SARS-CoV-2 infection, see COVID-19 vaccination and SARS-CoV-2 infection.

 

The information below is from before the 9-3-2022 update.

 

Pfizer Pediatrics Training Video Information :

 See below for link and instructions:

 

Instructions:

-Click the below link or copy and paste into your browser:

https://wvpca.webex.com/wvpca/k2/e.php?RCID=b02ba402006c4e1859699e2c2fcb53c6

 

-Click the “View” button

-Enter the following password:  COVID5-11Vaccine

-Click the “OK” button

-Enter your registration information and click “Register”

-You will be automatically directed to the training video, click the arrow in the center of the screen to play

 

The US Department of Health and Human Services has EXTENDED the authority for authorized persons (including pharmacists, pharmacy interns, qualified pharmacy technicians as explained below) to give vaccinations to those ages three and up per ACIP and FDA guidance. This is found here https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID-Amendment-6.aspx It has been EXTENDED until October 1, 2024 or until withdrawn by US. DHHR.  This is distinct and separate from the WV Declaration of a State of Emergency. 

The FDA authorized and the CDC/ACIP recommended the Pfizer COVID-19 vaccine for adolescents age 12-15 years old.  Pharmacists may order AND administer while interns or pharmacy technicians may administer under the supervision of a registered immunizing pharmacist the Pfizer COVID-19 vaccine to ages 12-15 years per the PREP Act Amendment.

You can view the requirement indicating both FDA authorization AND being ordered according to ACIP’s COVID-19 vaccine recommendation at https://www.phe.gov/Preparedness/legal/prepact/Pages/4-PREP-Act.aspx

The CDC authorization can be found at https://www.cdc.gov/media/releases/2021/s0512-advisory-committee-signing.ht

1. To enroll your pharmacy as a COVID-19 WV Vaccine provider please email WV DHHR Chris Young at christopher.d.young@wv.gov and ask to have your pharmacy enrolled.

2.  Can my WV licensed pharmacy technician give COVID-19 vaccinations?

Yes.  The WV BOP voted to recognize the PREP Act Amendment linked here.

  1. The pharmacy technician must be CPhT.  He/she must complete one of the training programs listed here under the “PTCB-recognized Immunization Administration Education/Training Program”. The pharmacy technician does not have to have completed the PTCB Immunization Administration Assessment -Based Certificate Program, as this is not a requirement to meet the standard of the PREP Act. 
  2. The pharmacy technician must also complete an approved CPR program listed on the WV BOP website.
  3. These documents must be kept on file at the pharmacy where the technician is vaccinating.
  4. PLEASE REMEMBER:
  • This is ONLY during the COVID-19 State of Emergency.
  • The vaccination must be ordered by the supervising qualified pharmacist who is a registered immunizer
  • The supervising registered immunizing pharmacist must be readily and immediately available to the immunizing qualified pharmacy technicians.
  • The vaccine must be FDA-authorized or FDA-licensed.
  • In the case of a COVID-19 vaccine, the vaccination must be ordered and administered according to ACIP’s COVID-19 vaccine recommendation(s).
  • In the case of a childhood vaccine, the vaccination must be ordered and administered according to ACIP’s standard immunization schedule.
  • The qualified pharmacy technician must complete a minimum of two hours of ACPE- approved, immunization-related continuing pharmacy education during the relevant State licensing period(s).
  • The supervising registered immunizing pharmacist must comply with recordkeeping and reporting requirements of the jurisdiction in which he or she administers vaccines, including informing the patient’s primary care provider when available and submitting the required immunization information to the state or local immunization information system (vaccine registry).
  • The supervising registered immunizing pharmacist is responsible for complying with requirements related to reporting adverse events.
  • The supervising registered immunizing pharmacist must review the vaccine registry or other vaccination records prior to ordering the vaccination to be administered by the qualified pharmacy technician or State-authorized pharmacy intern.
  • The qualified pharmacy technician and State-authorized pharmacy intern must, if the patient is 18 years of age or younger, inform the patient and the adult caregiver accompanying the patient of the importance of a well-child visit with a pediatrician or other licensed primary-care provider and refer patients as appropriate.
  • The supervising registered immunizing pharmacist must comply with any applicable requirements (or conditions of use) as set forth in the CDC’s COVID-19 vaccination provider agreement and any other federal requirements that apply to the administration of COVID-19 vaccine(s).

3. .  Are there additional vaccinations that pharmacy technicians can administer?

According to the PREP Act, pharmacy technicians can administer

(1) vaccines that the Advisory Committee on Immunization Practices (ACIP) recommends to persons ages three through 18 according to ACIP's standard immunization schedule or

(2) seasonal influenza vaccine administered by qualified pharmacy technicians and interns that the ACIP recommends to persons aged 19 and older according to ACIP's standard immunization schedule; or

(3) FDA authorized or FDA licensed COVID -19 vaccines to persons ages three or older.

This PREP Act Amendment can be viewed here.

4.  Additional information regarding the CDC recommendations for Pfizer COVID-19 vaccination in 12-15 year olds:

Page Updated: 9/3/2022 6:38:18 AM