On May 20, 2021 Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) reported that the BioNTech Europe GmbH has entered into an agreement with Turkey’s Ministry of Health to supply 60 million additional doses of the companies’ COVID-19 vaccine, with an option for an additional 30 million doses. On December 25, 2020, the two companies announced an initial agreement to provide 30 million doses of the Pfizer-BioNTech vaccine to Turkey (Press release, BioNTech, MAY 20, 2021, View Source [SID1234580352]). This second supply agreement brings the total number of doses to be supplied to Turkey to up to 120 million, all of which will be delivered in 2021.
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"Our goal is to deliver as many doses of our COVID-19 vaccine as possible to people around the world to help end this pandemic, reduce COVID-19-related hospitalisations and return to a normal life. We are grateful to be able to make an important contribution to Turkey’s vaccination efforts and for the trust placed in us," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
"We are hopeful that this agreement will further boost Turkey’s COVID-19 vaccination drive. Pfizer is committed to contributing to public health in Turkey and very proud to have a global partner such as BioNTech in the global fight against the pandemic," said M. Cem Açık, Pfizer Country Manager Turkey.
The vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. 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.
AUTHORIZED USE IN THE U.S.:
The Pfizer-BioNTech COVID-19 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 (e.g., 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 (View Source)
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 online at View Source For further assistance with reporting to VAERS call 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
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.