May 24, 2021: “Pfizer Inc. announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the FDA under a EUA.
The primary objective in the trial is to describe safety when both vaccines are co-administered, with follow-up six months after vaccination.
Secondary objectives are to describe immune responses produced by each of the vaccines.
The trial will include 600 adults who will be recruited from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine trial and will have received their second dose of the vaccine at least six months prior to entering the coadministration study.
The participants are being randomized to one of three groups:
- 20vPnC plus Pfizer-BioNTech COVID-19 Vaccine booster, which is a third dose of the Pfizer-BioNTech COVID-19 Vaccine
- 20vPnC plus placebo
- Pfizer-BioNTech COVID-19 Vaccine booster plus placebo
About Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 Vaccine, developed with BioNTech SE based on its proprietary mRNA technology, has been shipped to 91 countries and territories around the world as part of an emergency use authorization or conditional marketing authorization.
BioNTech is the Marketing Authorization Holder in the European Union and the holder of emergency use authorizations or equivalent in the United States (jointly with Pfizer), United Kingdom, Canada, and other countries in advance of a planned application for full marketing authorizations in these countries.
The Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under a EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE AUTHORIZATION PRESCRIBING INFORMATION:
- Do not administer Pfizer BioNTech COVID-19 Vaccine to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the Pfizer BioNTech COVID-19 Vaccine
- Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of Pfizer BioNTech COVID-19 Vaccine
Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/).
- Syncope (fainting ) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting
- Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the Pfizer‑BioNTech COVID-19 Vaccine
- The Pfizer‑BioNTech COVID-19 Vaccine may not protect all vaccine recipients
- In clinical studies, adverse reactions in participants 16 years of age and older included pain at the injection site (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), fever (14.2%), injection site swelling (10.5%), injection site redness (9.5%), nausea (1.1%), malaise (0.5%), and lymphadenopathy (0.3%)
- In a clinical study, adverse reactions in adolescents 12 through 15 years of age included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%)
- Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions, diarrhea, vomiting, and pain in extremity (arm) have been reported following administration of the Pfizer-BioNTech COVID-19 Vaccine outside of clinical trials
Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of the Pfizer-BioNTech COVID-19 Vaccine.
- Available data on Pfizer‑BioNTech COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy
- Data are not available to assess the effects of Pfizer‑BioNTech COVID-19 Vaccine on the breastfed infant or on milk production/excretion
- There are no data available on the interchangeability of the Pfizer-BioNTech COVID-19 Vaccine with other COVID-19 vaccines to complete the vaccination series. Individuals who have received one dose of Pfizer-BioNTech COVID-19 Vaccine should receive a second dose of Pfizer-BioNTech COVID-19 Vaccine to complete the vaccination series
- Vaccination providers must report Adverse Events in accordance with the Fact Sheet to VAERS at https://vaers.hhs.gov/reportevent.html or by calling 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine EUA” in the description section of the report
- Vaccination providers should review the Fact Sheet for Information to Provide to Vaccine Recipients/Caregivers and Mandatory Requirements for Pfizer-BioNTech COVID-19 Vaccine Administration Under Emergency Use Authorization
- Before administration of Pfizer-BioNTech COVID-19 Vaccine, please see Emergency Use Authorization (EUA ) Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers ) including Full EUA Prescribing Information available at www.cvdvaccine-us.com”
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-study-exploring-coadministration-its-20
