On September 22, 2021 Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") reported plans to expand their agreement with the U.S. government by providing an additional 500 million doses of the companies’ COVID-19 vaccine at a not-for-profit price for donation to low- and lower-middle-income countries and the organizations that support them (Press release, BioNTech, SEP 22, 2021, View Source [SID1234590133]). This expanded agreement brings the total number of doses to be supplied to the U.S. government for donation to these countries to one billion.
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Consistent with the initial agreement, the U.S. government will allocate doses of the Pfizer-BioNTech COVID-19 Vaccine to 92 low- and lower-middle-income countries as defined by Gavi’s COVAX Advanced Market Commitment (AMC) and the 55 member states of the African Union. Deliveries of the initial 500 million doses began in August 2021, and the total one billion doses under the expanded agreement are expected to be delivered by the end of September 2022. The current plan is to produce these doses in Pfizer’s U.S. facilities located in Kalamazoo, MI, Andover, MA, Chesterfield, MO, and McPherson, KS.
"COVID-19 is a virus that knows no borders, and as a result has had a devastating grip on our world. This is the reason we unleashed the full power of our resources to develop a safe and effective vaccine against this virus and help ensure everyone – regardless of their financial condition, race, religion or geography – has the potential to access it," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "In just nine months, Pfizer and BioNTech have delivered our COVID-19 vaccine to 130 countries and territories in every region of the world – and our expanded collaboration with the U.S. will help us bring even more doses to those in need. I want to thank President Biden for his unwavering leadership in working to put an end to this tragic pandemic, not just in the U.S., but worldwide."
"BioNTech, Pfizer and our partners are working day and night to make our vaccine available to people around the world. We are therefore particularly excited and grateful to mark the next milestone in collaboration with the U.S. government, which will further accelerate the delivery of our vaccine to people in the poorest regions," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "In the short term, we have pledged to deliver at least one billion doses this year and at least one billion doses next year to low- and middle-income countries. In parallel, we are exploring how to build a sustainable mRNA production infrastructure in low-income countries to democratize access to vaccines in the mid- and long-term. This applies to both individual production steps and complete manufacturing."
Overall, Pfizer and BioNTech have shipped more than 1.5 billion COVID-19 vaccine doses worldwide. The companies are firmly committed to working towards equitable and affordable access for COVID-19 vaccines for all people around the world, actively working with governments and health partners worldwide, and have pledged to provide two billion doses to low- and middle-income countries in 2021 and 2022 – at least one billion each year. In addition to the supply agreement with the U.S. government, this includes direct supply agreements with individual country governments and a direct supply agreement with COVAX for 40 million doses in 2021.
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 United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
U.S. Indication & Authorized Use
COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.
It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
It is also authorized under Emergency Use Authorization (EUA) to be administered for emergency use to:
prevent COVID-19 in individuals 12 through 15 years, and
provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
EUA Statement
This emergency use of the product has not been approved or licensed by FDA, but has been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and 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.
Important Safety Information
Individuals should not get the Pfizer-BioNTech COVID-19 Vaccine if they:
had a severe allergic reaction after a previous dose of this vaccine
had a severe allergic reaction to any ingredient of this vaccine
Individuals should tell the vaccination provider about all of their medical conditions, including if they:
have any allergies
have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disorder or are on a blood thinner
are immunocompromised or are on a medicine that affects the immune system
are pregnant, plan to become pregnant, or are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone.
Side effects reported with the vaccine include:
There is a remote chance that the vaccine could cause a severe allergic reaction
A severe allergic reaction would usually occur within a few minutes to one hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
chest pain
shortness of breath
feelings of having a fast-beating, fluttering, or pounding heart
Side effects that have been reported with the vaccine include:
severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); diarrhea; vomiting; arm pain
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The vaccine is still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away
There is no information on the use of the vaccine with other vaccines.
Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit View Source or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.
Please click here for full Prescribing Information (16+ years of age). Please click here for Fact Sheet for Vaccination Providers (12+ years of age).