Delaware’s COVID Vaccination Plan
Delaware is vaccinating any individual over the age of 6 months To schedule your vaccine appointment, please click vaccinerequest.delaware.gov or call 1-833-643-1715!
Information about the vaccine:
- For the public
- For medical providers
- Moderna offers office hours and webinars about pediatric indications for COVID-19 vaccine
- For agencies, organizations, and businesses
- IAC’s COVID-19 Vaccine Resource
FDA Authorizes Moderna and Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose in Younger Age Groups
On October 12, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna COVID-19 Vaccine, Bivalent and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent to authorize their use as a single booster dose in younger age groups.
CDC Recommends the First Updated COVID-19 Booster
On September 1, CDC Director Rochelle P. Walensky, M.D., M.P.H., 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.
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.
CDC Endorses COVID-19 Vaccinations for Everyone 6 Months of Age and Older, and Boosters for Everyone 5 Years and Older
On June 18, 2022, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the Advisory Committee on Immunization Practices’ (ACIP) recommendation that all children 6 months through 5 years of age should receive a COVID-19 vaccine. This expands eligibility for vaccination to nearly 20 million additional children and means that all Americans ages 6 months and older are now eligible for vaccination.
FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age
On June 17, 2022, the U.S. Food and Drug Administration authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
- For the Moderna COVID-19 Vaccine, the FDA amended the emergency use authorization (EUA) to include use of the vaccine in individuals 6 months through 17 years of age. The vaccine had been authorized for use in adults 18 years of age and older.
- For the Pfizer-BioNTech COVID-19 Vaccine, the FDA amended the EUA to include use of the vaccine in individuals 6 months through 4 years of age. The vaccine had been authorized for use in individuals 5 years of age and older.
CDC Endorses Moderna Vaccine
On February 4, 2022, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for use of Moderna’s vaccine for people ages 18 years and older.
FDA Approves Moderna Vaccine
On January 31, 2022, the FDA announced the second approval of a 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.
CDC Recommends Booster Doses for Children aged 12-15 Years
An expert panel that advises the CDC on vaccines voted overwhelmingly yesterday to recommend that children aged 12 to 15 should get a Covid-19 booster dose five months after the second dose in their primary series. The 13-to-1 vote also changed the recommendation for 16- and 17-year-olds, saying they should get a booster as well, going beyond just a suggestion to do so if they wished.
CDC Shortens Time Between Second and Booster Dose of Pfizer Vaccine
January 4, 2022. The CDC shortened the time between a second dose of Pfizer vaccine and booster to five months (no change for J&J or Moderna shots). And the agency said some immunocompromised kids ages 5 to 11 may receive an additional primary vaccine shot 28 days after the second shot, in line with the guidance for similar people 12 and up.
FDA Authorizes Booster Dose of all Three US COVID-19 Vaccines
November 19, 2021. Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The Centers for Disease Control and Prevention also signed off later in the day.
CDC Recommends Pfizer COVID-19 Vaccine for Children 5-11 Years
November 2, 2021. Today, CDC Director Rochelle P. Walensky, M.D., M.P.H., endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation that children 5 to 11 years old be vaccinated against COVID-19 with the Pfizer-BioNTech pediatric vaccine. CDC now expands vaccine recommendations to about 28 million children in the United States in this age group and allows providers to begin vaccinating them as soon as possible.
FDA Issues Emergency Use Authorizations for Moderna and Johnson & Johnson Vaccines
On October 20, 2021, the FDA amended the Moderna COVID-19 Vaccine EUA to allow for a single booster dose of the Moderna COVID-19 Vaccine administered at least 6 months after completion of the primary series to individuals 65 years of age and older, 18-64 years of age at high risk of severe COVID-19, and 18-64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
On October 20, 2021, the FDA authorized a single booster dose of the Janssen (Johnson & Johnson) COVID-19 Vaccine administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
On October 20, 2021, the FDA authorized the use of a heterologous (“mix and match”) booster dose for the currently available (i.e. FDA-authorized or approved) COVID-19 vaccines.
FDA Approves First COVID-19 Vaccine
On August 23, 2021, the US Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
Guillain-Barre Syndrome (GBS) added as a side effect to Johnson & Johnson (Janssen) COVID-19 EUA Fact Sheet.
On July 13, 2021, the Food and Drug Administration added Guillain-Barre Syndrome (GBS) as a side effect to the Johnson & Johnson (Janssen) COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers and for Healthcare/Vaccination Providers. The GBS reports were made to the Vaccine Adverse Events Reporting System (VAERS), part of the U.S. vaccine monitoring system. Based on an analysis of VAERS data, there have been 100 preliminary reports of GBS following vaccination with the vaccine after approximately 12.5 million doses administered in the US. Although available evidence suggests an association between the vaccine and an increased risk of GBS, it is insufficient to establish a causal relationship.
ACIP Recommends Pfizer-BioNTech COVID-19 Vaccine in Adolescents Aged 12-15 Years
On May 10, 2021, the Food and Drug Administration expanded Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12–15 years. On May 12, 2021, after a systematic review of all available data, the Advisory Committee on Immunization Practices made an interim recommendation for use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12–15 years for the prevention of COVID-19.
Food & Drug Administration: COVID-19 Webpage
The FDA has regulatory processes in place to facilitate the development of COVID-19 vaccines that meet the FDA’s rigorous scientific standards.
DPH Statement on FDA and CDC’s decision to lift the pause of Johnson & Johnson Vaccine
Friday, April 23, 2021, the CDC and FDA recommended lifting the pause on the use of the Johnson&Johnson Janssen vaccine, after the CDC’s Advisory Committee on Immunization Practices (ACIP) met and voted to recommend use of the vaccine continue. The Delaware Division of Public Health (DPH) will provide updated FDA materials to providers and is updating the FDA materials for providers and the public on its website. The CDC has indicated additional communication and materials will be available next week.
CDC Meeting to discuss J&J Vaccine after rare blood clotting cases
The CDC’s Advisory Committee of Immunization Practices is meeting on April 14, 2021, to discuss next steps on Johnson & Johnson’s COVID-19 vaccine after the CDC and FDA recommended the day before that states stop using it while six serious cases of clotting problems (cerebral venous sinus thrombosis) are being investigated.
Read more
Real-World Study Confirms mRNA vaccines’ efficacy against COVID-19
New COVID-19 vaccine data confirm the very high efficacy of both the Moderna and the Pfizer-BioNTech vaccines in healthcare workers, first responders, and essential workers. In almost 4,000 study participants in six states from December to March, the risk of infection was reduced by 90% 14+ days after vaccination.
Read more
Johnson & Johnson Vaccine
On February 27, 2021, the Food and Drug Administration (FDA) issued the Emergency Use Authorization (EUA) for the Janssen Biotech, Inc. COVID-19 Vaccine to prevent COVID-19 caused by SARS-CoV-2 virus in people 18 years of age and older. The EUA allows the Johnson & Johnson COVID-19 vaccine to be distributed in the United States.
Fact Sheet – Patient & Caregiver (6 pages)
Fact Sheet – Healthcare Providers (23 pages)
From the Public Health Collaborative, resources to support vaccine efforts among refugee, immigrant, and migrant communities.
Moderna Vaccine
On December 18, 2020, the Food and Drug Administration (FDA) issued the Emergency Use Authorization (EUA) for the Moderna COVID-19 Vaccine to prevent COVID-19 caused by SARS-CoV-2 virus in people 18 years of age and older. The EUA allows the Moderna COVID-19 vaccine to be distributed in the United States.
Fact Sheet – Recipients & Caregivers (5 pages)
Interview with ZDoggMD and Dr. Paul Offit
ICD Co-Chair Stephen Eppes, MD, receives his first dose of the COVID-19 vaccine!
Pfizer-BioNTech mRNA Vaccine
On December 11, the Food and Drug Administration (FDA) issued the first Emergency Use Authorization (EUA) for a vaccine to help prevent COVID-19 caused by SARS-CoV-2 virus in people 16 years of age and older. The EUA allows the Pfizer-BioNTech COVID-19 vaccine (also known as BNT162b2) to be distributed in the United States.
FDA’s action aligns with the recommendation of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), which determined on December 10 that the totality of scientific evidence available indicates that the benefits of vaccination with the Pfizer-BioNTech COVID-19 vaccine outweigh its risks for use in people 16 years or older.
More information about the vaccine here.
Fact Sheet – Recipients & Caregivers (6 pages)
Fact Sheet – Healthcare Providers (29 pages)
Read more here
Moderna mRNA Vaccine
November 16, 2020. Moderna announced that the Data Safety Monitoring Board for the Phase 3 study of mRNA-1273 has met the statistical criteria pre-specified in the study protocol for efficacy, with an efficacy of 94.5%. The COVE study has enrolled more than 30,000 participants in the US and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID). Read more
EUA information here
Vaccine Development
- Phase III Clinical trials (Europe or US) – 5
Vaccine Candidates
Novavax (NVX-CoV2373) – This vaccine candidate exhibited a robust neutralizing antibody response in early trials, and the preliminary safety profile is reassuring. Up to 30,000 adults are expected to be enrolled in the phase 3 trial.
- Dosage and Administration: 0.5 mL dose, 2 IM doses given 21 days apart
- Packaging: Multidose vials, 10 doses per vial, without preservative
- Storage: Shipped and stored at 2° to 8° C (36° to 46° F), no reconstitution required
Janssen, a subsidiary of Johnson & Johnson (Ad26.COV2.S) – This vaccine candidate also elicited robust neutralizing antibody responses and was generally well tolerated. Although the trial was paused to assess one serious adverse event that occurred in a trial participant, subsequent review by the independent Data Safety and Monitoring Board (DSMB) allowed the trial to resume. An estimated 60,000 persons will be enrolled in the phase 3 clinical trial.
- Dosage and Administration: 0.5 mL dose, 1 IM dose
- Packaging: Multidose vials, 5 doses per vial, without preservative
- Storage: Shipped and stored at 2° to 8° C (36° to 46° F) for up to 3 months, no reconstitution required
New resources for the public and healthcare providers are frequently added to CDC’s COVID-19 Vaccines website. The agency’s Vaccinate with Confidence strategy provides a national framework for reinforcing confidence in COVID-19 vaccines.