NEW YORK and MAINZ, GERMANY, January 24, 2022 — Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication of new results from two laboratory studies demonstrating that three doses of the Pfizer-BioNTech COVID-19 Vaccine (BNT162b2) elicited antibodies that neutralize the Omicron variant (B.1.1.529).

Data published in the peer-reviewed journal Science, includes readouts of sera data from 51 vaccinated individuals that received two or three doses of BNT162b2 as well as a study evaluating the neutralization potential of serum antibodies from a subset of vaccinated individuals against the live virus. Both data sets confirm previously announced initial study results demonstrating that serum antibodies induced by BNT162b2 neutralize the SARS-CoV-2 Omicron variant after immunization with three doses. In comparison, sera from individuals who received two doses of the COVID-19 vaccine revealed limited neutralization titers against the Omicron variant in both data sets, indicating that two doses of BNT162b2 may not be sufficient to protect against infection with the new variant. However, based on observations that around 85% of epitopes in the spike protein recognized by CD8+ T cells are not affected by the mutations in the Omicron variant, the companies believe two doses may still induce protection against severe disease.

Separately, data from a live virus laboratory study conducted with the University of Texas Medical Branch (UTMB) that support and further extend these findings were posted on the preprint server bioRxiv. Sera taken 1-month following a third dose showed a 22-fold increase in neutralization titers against Omicron compared to titers just prior to the third dose (7.9 to 8.8 months after second dose), suggesting more robust protection against the new variant may be achieved with the current COVID-19 vaccine series plus a booster dose. Additionally, the neutralizing titer levels against Omicron after immunization with three doses were similar to antibody titer levels after two doses against wild-type and other variants that emerged before Omicron. Further, from 1 to 4 months after a third dose, neutralization titers against wild-type and Omicron decreased by 1.6 and 2.0 times, respectively, suggesting similar waning for both variants. All sera effectively neutralized Omicron at 4 months following a third dose.

Pfizer and BioNTech have put into place a robust booster research program to help ensure that the vaccine continues to offer a high degree of protection. Moving forward, the companies will be evaluating the immunogenicity and efficacy of an additional dose of both the current formulation and an Omicron based vaccine in the clinical setting. The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required.

About the Pfizer-BioNTech Laboratory Study
To evaluate the effectiveness of BNT162b2 against the Omicron variant, Pfizer and BioNTech immediately tested a panel of 51 human immune sera obtained from the blood of individuals that received two or three 30-µg doses of the current Pfizer-BioNTech COVID-19 Vaccine, using a pseudovirus neutralization test (pVNT). Each serum was tested simultaneously for its neutralizing antibody titer against pseudovirus bearing the wild-type SARS-CoV-2 spike protein as well as the Beta, Delta and Omicron spike variant. The third dose significantly increased the neutralizing antibody titers against the Omicron pseudovirus by 23-fold. Neutralization against the Omicron pseudovirus after three doses of BNT162b2 was comparable to the neutralization against the wild-type SARS-CoV-2 pseudovirus observed in sera from individuals who received two doses of the companies’ COVID-19 vaccine. The geometric mean titer (GMT) of neutralizing antibodies against the Omicron pseudovirus measured in the samples was 164 (after three doses), compared to 413 against the Delta pseudovirus (after three doses) and 160 against the ancestral strain (after two doses). The requirement of a third dose to effectively neutralize Omicron was confirmed using a replicating live SARS-CoV-2 virus neutralization assay in a subset of participants suggesting that three doses of BNT162b2 may protect against Omicron-mediated COVID-19. Following a third dose the neutralizing GMT against the Omicron variant was 106 after 1 month compared to a GMT of 368 against the ancestral strain 21 days after the second dose. Data on the persistence of neutralizing titers over time after a booster dose of BNT162b2 against the Omicron variant will be collected.

About the Pfizer and University of Texas Medical Branch (UTMB) Study
The study utilized four panels that included human immune sera from the blood of individuals who had received two or three 30-µg doses of the BNT162b2 vaccine. The first panel included sera from 20 individuals, collected 2 or 4 weeks after the second dose. The second panel included sera from 22 individuals collected on the day of administration of a booster dose. The third and fourth panels were collected 1 and 4 months after the third dose, respectively. This study did not measure other immune indicators, including T cells and non-neutralizing antibodies.

The Pfizer-BioNTech COVID-19 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 other countries, 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
HOW IS THE VACCINE GIVEN?

The vaccine will be given as an injection into the muscle.

Primary Series:
In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart. In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

Booster Dose:

A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose
WHAT IS THE INDICATION AND AUTHORIZED USE?
The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

a 2-dose primary series to individuals 5 years of age and older
a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
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 EUA to provide:
a 2-dose primary series to individuals 12 through 15 years of age
a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series
EUA Statement
Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

IMPORTANT SAFETY INFORMATION
Individuals should not get the 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 1 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, more commonly in males under 40 years of age than among females and older males. 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
Additional 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); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are 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
Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.

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 https://www.vaers.hhs.gov 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.

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Fact Sheets and Prescribing Information for individuals 12 years of age and older

Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap
Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap
EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)

Fact Sheets for individuals 5 through 11 years of age

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap
Recipients and Caregivers Fact Sheet (5 through 11 years of age)

About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice
The information contained in this release is as of January 24, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. etc. etc.

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