European Union orders 100 million additional doses of COMIRNATY® bringing total doses to 300 million for 27 EU member states
All 300 million doses expected to be delivered in 2020 and 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they will supply an additional 100 million doses of COMIRNATY®, the companies’ COVID-19 Vaccine, to the 27 European Union (EU) member states in 2021.
This announcement is a result of the European Commission’s (EC) decision to exercise its option to purchase an additional 100 million doses under its Advanced Purchase Agreement signed on November 11, 2020. This agreement brings the total number of doses to be delivered to the EU to 300 million.
“We remain committed to moving as quickly and safely as possible to bring this vaccine to more people in Europe, as the deadly virus continues to spread at an alarming rate.” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “In partnership with the European Commission, member states and healthcare providers, we will be able to reach a total of 150 million Europeans across the continent.”
“The additional 100 million doses will be delivered in 2021 supporting the vaccination campaigns which started two days ago in all 27 member states. Our goal remains to bring a safe and effective COVID-19 vaccine to as many people as we can all around the world,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.
COMIRNATY, will be produced in BioNTech’s and Pfizer’s manufacturing sites in Europe. The distribution of COMIRNATY by the EU member states will continue to be determined according to the populations identified in EU and national guidance.
Pfizer and BioNTech announced on November 11, 2020, that they reached an agreement with the European Commission to supply 200 million, with an option for the European Commission to request an additional 100 million doses. The companies previously stated their potential to supply up to 1.3 billion doses worldwide by the end of 2021 (subject to manufacturing capacity).
AUTHORIZED USE IN THE EU:
COMIRNATY® ▼ (the Pfizer-BioNTech COVID-19 Vaccine) has been granted conditional marketing authorisation by the European Medicines Agency to prevent coronavirus disease 2019 (COVID-19) in people from 16 years of age. The European Medicines Agency’s (EMA’s) human medicines committee (CHMP) has completed its rigorous evaluation of COMIRNATY®, concluding by consensus that sufficiently robust data on the quality, safety and efficacy of the vaccine are now available.
IMPORTANT SAFETY INFORMATION:
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine
The efficacy, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of COMIRNATY® may be lower in immunosuppressed individuals.
As with any vaccine, vaccination with COMIRNATY® may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
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 (38.4%), 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%)
There is limited experience with use of COMIRNATY® in pregnant women. Administration of COMIRNATY® in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
It is unknown whether COMIRNATY® is excreted in human milk.
Interactions with other medicinal products or concomitant administration of COMIRNATY® with other vaccines has not been studied.The black equilateral triangle denotes that additional monitoring is required to capture any adverse reactions. This will allow quick identification of new safety information.
Individuals can help by reporting any side effects they may get. Side effects can be reported to EudraVigilance or directly to BioNTech using email medinfo@biontech.de, telephone +49 6131 9084 0, or via the website www.biontech.de.
Jasmina Alatovic- photo BioNTech