Delaware News


FDA Authorizes Bivalent COVID-19 Boosters; CDC Sign-Off Expected By Weekend

Division of Public Health | Date Posted: Wednesday, August 31, 2022


FDA Authorizes Bivalent Covid-19 Boosters; CDC Sign-Off Expected By This Weekend, With First Doses Being Administered As Early As Next Weekend

DOVER, DE (August 31, 2022) – On Aug. 31, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to Pfizer and Moderna for their new bivalent boosters, meaning vaccine could start shipping to states that pre-ordered as early as Friday.  The Centers for Disease Control and Prevention’s (CDC) advisory committee meets Thursday and Friday, Sept. 1 and 2, to discuss specifics regarding who should receive the boosters.  The committee is expected to vote during that time, and if approved, a formal sign-off is then required from the CDC director before vaccine administration can begin.

The Division of Public Health (DPH) has preordered approximately 17,000 doses of the bivalent boosters for DPH clinics and enrolled medical providers, in addition to the supply being sent directly to pharmacies and Federally Qualified Health Centers. Delivery is expected later this week or early next week with administration potentially beginning soon after Labor Day or the following week. 

The Moderna and Pfizer bivalent boosters both target two strains of COVID-19 – the original strain of the virus and two of the Omicron variants (BA.4 and BA.5), the current most widespread variants in the world.  Only individuals who have completed their primary vaccination series (two doses of Pfizer or Moderna or one dose of Johnson & Johnson) are eligible to receive the bivalent booster.  Those who have recently received Novovax are not yet eligible for any booster at this time.

“Should the CDC Advisory Committee and the CDC Director sign off on authorizing the use of bivalent boosters, this will be another important step forward in keeping Delawareans protected against serious outcomes from COVID-19,” said DPH Interim Director Dr. Rick Hong. “Delaware providers are well-positioned to begin administering the bivalent booster within a few days of the final approval being given.” 

If you have not been vaccinated or have not completed your primary series, visit de.gov/getmyvaccine for a list of locations offering vaccine. The original formulations of Pfizer, Moderna, J&J and Novovax will continue to be used.  Booster doses use reduced amounts of the original vaccines.

Individuals are eligible for the bivalent booster two months since their last primary or booster dose of any vaccine.  As of today, the current monovalent booster will not be available to persons 12 and older; the FDA is removing authorization for those boosters to reduce provider confusion for staff administering vaccines.

The Pfizer bivalent booster is currently authorized for ages 12 and older while Moderna’s is currently authorized for 18 years of age and older.  Individuals may choose to receive either the Pfizer or Moderna bivalent booster, regardless of which primary series vaccine or original booster dose they had previously.   

Authorization for administration to those under age 12 is expected in the near future, but the timeline is not yet clear.  Parents are encouraged to have their children complete the primary series of the current vaccines so that they will be eligible for the bivalent booster in the future.  In August, while there was a decrease in COVID-related hospitalizations for most adult age groups, hospitalizations for all youth age groups increased, demonstrating the importance of young children becoming fully vaccinated as soon as possible to prevent serious illness, hospitalization, and death.  As such, parents of children under 12 should consider having them receive the original booster at this time to increase their defenses against the virus with back to school and other group activities now occurring.

For the latest information on bivalent boosters, visit de.gov/boosters.  When locations begin administering the bivalent booster, updated information will be available at de.gov/getmyvaccine on how and where to obtain a booster. Information on all things COVID-19 can be found at the DPH website de.gov/coronavirus.  COVID-19 data for Delaware is available at https://myhealthycommunity.dhss.delaware.gov/locations/state.

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Anyone who is deaf, hard of hearing, Deaf-Blind or speech disabled can contact DPH by dialing 711 first using specialized devices (i.e. TTY, TeleBraille, voice devices). The 711 service is free and to learn more about how it works, please visit delawarerelay.com.

Delaware Health and Social Services is committed to improving the quality of the lives of Delaware’s citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations.

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FDA Authorizes Bivalent COVID-19 Boosters; CDC Sign-Off Expected By Weekend

Division of Public Health | Date Posted: Wednesday, August 31, 2022


FDA Authorizes Bivalent Covid-19 Boosters; CDC Sign-Off Expected By This Weekend, With First Doses Being Administered As Early As Next Weekend

DOVER, DE (August 31, 2022) – On Aug. 31, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization to Pfizer and Moderna for their new bivalent boosters, meaning vaccine could start shipping to states that pre-ordered as early as Friday.  The Centers for Disease Control and Prevention’s (CDC) advisory committee meets Thursday and Friday, Sept. 1 and 2, to discuss specifics regarding who should receive the boosters.  The committee is expected to vote during that time, and if approved, a formal sign-off is then required from the CDC director before vaccine administration can begin.

The Division of Public Health (DPH) has preordered approximately 17,000 doses of the bivalent boosters for DPH clinics and enrolled medical providers, in addition to the supply being sent directly to pharmacies and Federally Qualified Health Centers. Delivery is expected later this week or early next week with administration potentially beginning soon after Labor Day or the following week. 

The Moderna and Pfizer bivalent boosters both target two strains of COVID-19 – the original strain of the virus and two of the Omicron variants (BA.4 and BA.5), the current most widespread variants in the world.  Only individuals who have completed their primary vaccination series (two doses of Pfizer or Moderna or one dose of Johnson & Johnson) are eligible to receive the bivalent booster.  Those who have recently received Novovax are not yet eligible for any booster at this time.

“Should the CDC Advisory Committee and the CDC Director sign off on authorizing the use of bivalent boosters, this will be another important step forward in keeping Delawareans protected against serious outcomes from COVID-19,” said DPH Interim Director Dr. Rick Hong. “Delaware providers are well-positioned to begin administering the bivalent booster within a few days of the final approval being given.” 

If you have not been vaccinated or have not completed your primary series, visit de.gov/getmyvaccine for a list of locations offering vaccine. The original formulations of Pfizer, Moderna, J&J and Novovax will continue to be used.  Booster doses use reduced amounts of the original vaccines.

Individuals are eligible for the bivalent booster two months since their last primary or booster dose of any vaccine.  As of today, the current monovalent booster will not be available to persons 12 and older; the FDA is removing authorization for those boosters to reduce provider confusion for staff administering vaccines.

The Pfizer bivalent booster is currently authorized for ages 12 and older while Moderna’s is currently authorized for 18 years of age and older.  Individuals may choose to receive either the Pfizer or Moderna bivalent booster, regardless of which primary series vaccine or original booster dose they had previously.   

Authorization for administration to those under age 12 is expected in the near future, but the timeline is not yet clear.  Parents are encouraged to have their children complete the primary series of the current vaccines so that they will be eligible for the bivalent booster in the future.  In August, while there was a decrease in COVID-related hospitalizations for most adult age groups, hospitalizations for all youth age groups increased, demonstrating the importance of young children becoming fully vaccinated as soon as possible to prevent serious illness, hospitalization, and death.  As such, parents of children under 12 should consider having them receive the original booster at this time to increase their defenses against the virus with back to school and other group activities now occurring.

For the latest information on bivalent boosters, visit de.gov/boosters.  When locations begin administering the bivalent booster, updated information will be available at de.gov/getmyvaccine on how and where to obtain a booster. Information on all things COVID-19 can be found at the DPH website de.gov/coronavirus.  COVID-19 data for Delaware is available at https://myhealthycommunity.dhss.delaware.gov/locations/state.

###

Anyone who is deaf, hard of hearing, Deaf-Blind or speech disabled can contact DPH by dialing 711 first using specialized devices (i.e. TTY, TeleBraille, voice devices). The 711 service is free and to learn more about how it works, please visit delawarerelay.com.

Delaware Health and Social Services is committed to improving the quality of the lives of Delaware’s citizens by promoting health and well-being, fostering self-sufficiency, and protecting vulnerable populations.

image_printPrint

Related Topics:  , , , , , , ,


Graphic that represents delaware news on a mobile phone

Keep up to date by receiving a daily digest email, around noon, of current news release posts from state agencies on news.delaware.gov.

Here you can subscribe to future news updates.