PFIZER AND BIONTECH ANNOUNCE PHASE 3 TRIAL DATA SHOWING HIGH EFFICACY OF A BOOSTER DOSE OF THEIR COVID-19 VACCINE
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-?g booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster. These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial.
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?These results provide further evidence of the benefits of boosters as we aim to keep people well-protected against this disease,? said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. ?In addition to our efforts to increase global access and uptake among the unvaccinated, we believe boosters have a critical role to play in addressing the ongoing public health threat of this pandemic. We look forward to sharing these data with health authorities and working together to determine how they can be used to support the rollout of booster doses around the world.? ?These important data add to the body of evidence suggesting that a booster dose of our vaccine can help protect a broad population of people from this virus and its variants,? said Ugur Sahin, M.D., CEO and Co-Founder of BioNTech. ?Based on these findings we believe that, in addition to broad global access to vaccines for everyone, booster vaccinations could play an important role in sustaining pandemic containment and a return to normalcy.? All trial participants previously completed the primary two-dose series of the Pfizer-BioNTech vaccine, and then were randomized 1:1 to receive either a 30-?g booster dose (the same dosage strength as those in the primary series) or placebo. The median time between second dose and administration of the booster dose or placebo was approximately 11 months. Symptomatic COVID-19 occurrence was measured from at least 7 days after booster or placebo, with a median follow-up of 2.5 months. During the study period, there were 5 cases of COVID-19 in the booster group, and 109 cases in the non-boosted group. The observed relative vaccine efficacy of 95.6% (95% CI: 89.3, 98.6) reflects the reduction in disease occurrence in the boosted group versus the non-boosted group in those without evidence of prior SARS-CoV-2 infection. Median age of participants was 53 years, with 55.5% of participants between 16 and 55 years, and 23.3% of participants 65 years and older. Multiple subgroup analyses showed efficacy was consistent irrespective of age, sex, race, ethnicity, or comorbid conditions. The adverse event profile was generally consistent with other clinical safety data for the vaccine, with no safety concerns identified. Pfizer and BioNTech plan to submit detailed results from the trial for peer-reviewed publication. The companies also plan to share these data with the U.S. Food and Drug Administration, European Medicines Agency, and other regulatory agencies around the world as soon as possible. On?September 22, 2021, a booster dose of the Pfizer-BioNTech COVID-19 Vaccine was authorized for emergency use by the U.S. FDA for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. On October 20, 2021, a booster dose of the vaccine also was authorized for emergency use by the U.S. FDA in eligible individuals who have completed a primary vaccination with a different authorized COVID-19 vaccine. In addition, a booster dose of the vaccine is?authorized?in the European Union and other countries, with recommendations for populations varying based on local health authority guidance. 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 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 to you as an injection into the muscle. Primary Series: The vaccine is administered as a 2-dose series, 3 weeks apart. A third dose may be administered at least 4 weeks 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 to individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- A single booster dose may be administered to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
- 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 be administered to provide:
- a two-dose primary series in individuals 12 through 15 years;
- a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and
- a single booster dose in individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
- a two-dose primary series in individuals 12 years of age and older;
- a third primary series dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise; and
- a single booster dose in individuals:
- 65 years of age and older
- 18 through 64 years of age at high risk of severe COVID-19
- 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
- a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. Booster eligibility and schedule are based on the labeling information of the vaccine used for the primary series.
- had a severe allergic reaction after a previous dose of this vaccine
- had a severe allergic reaction to any ingredient of this vaccine
- 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
- 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); 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 your healthcare provider if you have any side effects that bother you or do not go away
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Pfizer: Media Relations +1 (212) 733-1226 PfizerMediaRelations@pfizer.com Investor Relations +1 (212) 733-4848 IR@Pfizer.com BioNTech: Media Relations Jasmina Alatovic +49 (0)6131 9084 1513 Media@biontech.de Investor Relations Sylke Maas, Ph.D. +49 (0)6131 9084 1074 Investors@biontech.de Source: Pfizer Inc.