Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher

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Pfizer and BioNTech Announce Updated Clinical Data for Omicron BA.4/BA.5-Adapted Bivalent Booster Demonstrating Substantially Higher

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced updated data from a Phase 2/3 clinical trial demonstrating a robust neutralizing immune response one-month after a 30-µg booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)). Immune responses against BA.4/BA.5 sublineages were substantially higher for those who received the bivalent vaccine compared to the companies’ original COVID-19 vaccine, with a similar safety and tolerability profile between both vaccines. These results reinforce the previously reported early clinical data measured 7 days after a booster dose of the bivalent vaccine, as well as the pre-clinical data, and suggest that a 30-µg booster dose of the Omicron BA.4/BA.5-adapted bivalent vaccine may induce a higher level of protection against the Omicron BA.4 and BA.5 sublineages than the original vaccine.

“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “These updated data also provide confidence in the adaptability of our mRNA platform and our ability to rapidly update the vaccine to match the most prevalent strains each season.”

“These data demonstrate that our BA.4/BA.5-adapted bivalent vaccine works as conceptually planned in providing stronger protection against the Omicron BA.4 and BA.5 sublineages,” said Prof. Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “In the next step and as part of our science-based approach we will continue to evaluate the cross-neutralization of the adapted vaccine against new variants and sublineages. Our goal is to provide broader immunity against COVID-19 caused by SARS-CoV-2, including Omicron and other circulating strains.”

For the analyses, sera were drawn before (baseline) and one month after administration of a 30-µg booster dose (fourth dose) of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine. A subset of individuals, evenly stratified between those who had evidence of prior SARS-CoV-2 infection and those who did not, was selected for ages 18 to 55 years (n=38) and older than 55 years and older (n=36). A comparator group of participants older than 55 years of age (n=40) who received a 30-µg booster dose (fourth dose) of the companies’ original COVID-19 vaccine as part of a prior study was randomly selected, while ensuring the same equal stratification. Participants receiving the bivalent vaccine had their prior booster dose approximately 10-11 months earlier, whereas those who received the original vaccine had their prior booster dose approximately 7 months earlier. Despite this difference, pre-booster antibody titers were similar for both.

Among the overall study population who received the Omicron BA.4/BA.5-adapted bivalent vaccine, there was a substantially higher increase in Omicron BA.4/BA.5-neutralizing antibody titers compared to pre-booster levels. For individuals 18 to 55 years of age, the geometric mean titer (GMT) against Omicron BA.4/BA.5 was 606, representing a 9.5-fold rise (95% CI: 6.7, 13.6) from pre-booster levels. For individuals older than 55 years, the GMT was 896, representing a 13.2-fold rise (95% CI: 8.0, 21.6) from pre-booster levels. By contrast, participants over 55 years of age who received a 30-µg booster dose of the companies’ original COVID-19 vaccine had a lower neutralizing antibody response against Omicron BA.4/BA.5 measured one month post booster. For these participants, the GMT was 236, representing a 2.9-fold rise (95% CI: 2.1, 3.9). Therefore, the Omicron BA.4/BA.5 neutralizing antibody titers were approximately 4-fold higher for the bivalent vaccine compared to the companies’ original Covid-19 vaccine in individuals over 55 years of age.

Further, when examining those with or without evidence of prior SARS-CoV-2 infection who received a booster dose of the bivalent vaccine, there was a significant increase in neutralizing antibodies against Omicron BA.4/BA.5 in both groups, which was greater in those without prior infection. These data highlight the potential benefit of the bivalent vaccine for all populations regardless of previous SARS-CoV-2 infection. The safety profile remains favorable for the bivalent vaccine and consistent with the original vaccine.

Pfizer and BioNTech have shared these data with the U.S. Food and Drug Administration (FDA) and plan to share with the European Medicines Agency (EMA) and other global health authorities as soon as possible. A booster dose of the BA.4/BA.5-adapted bivalent vaccine has been authorized for emergency use by the FDA for ages 5 years and older and has also been granted marketing authorization in the EU by the European Commission following a positive opinion from the EMA for ages 12 years and older. An application for marketing authorization of the BA.4/BA.5 booster has been submitted to the EMA for children ages 5 through 11.

Separately, Pfizer and BioNTech are continuing to monitor immunogenicity of the BA.4/BA.5 bivalent booster against emerging Omicron subvariants. The companies also initiated a Phase 1/2/3 trial in September 2022, in September 2022, to evaluate the safety, tolerability and immunogenicity of different doses and dosing regimens of the companies’ Omicron BA.4/BA.5-adapted bivalent vaccine among children 6 months through 11 years of age.

The Pfizer-BioNTech COVID-19 Vaccines (COMIRNATY®), which are based on BioNTech’s proprietary mRNA technology, were developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder for BNT162b2 Wild Type and BNT162b2 Bivalent (WT/OMI BA.4/BA.5) 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.

About the Phase 2/3 Study

This arm of the multicenter, randomized, controlled Phase 2/3 trial (NCT05472038) has enrolled about 900 healthy volunteers 12 years of age and older in the U.S. who have received at least three doses of an authorized COVID-19 vaccine. During the trial, participants aged 18 years and older received either a 30-µg or 60-µg booster dose (fourth booster) of Pfizer and BioNTech’s Omicron BA.4/BA.5-adapted COVID-19 vaccine and participants aged 12 through 17 years received a 30-µg booster (fourth booster) of the same vaccine. Comparisons to support potential full licensure and registrations globally will be made with a control group who previously received a fourth dose with the original vaccine.

U.S. INDICATION & AUTHORIZED USE

Pfizer-BioNTech Covid-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is FDA-authorized under Emergency Use Authorization (EUA) for use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either:

• completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine; or
• receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

*Monovalent refers to any authorized and approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2 virus

COMIRNATY® (COVID-19 Vaccine, mRNA)

INDICATION

COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine approved 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.

AUTHORIZED USE

COMIRNATY® (COVID-19 Vaccine, mRNA) is FDA-authorized under Emergency Use Authorization (EUA) to provide:

Primary Series

• a third primary series dose to individuals 12 years of age and older who have certain kinds of immunocompromise

Pfizer-BioNTech COVID-19 Vaccine

AUTHORIZED USES

Pfizer-BioNTech COVID-19 Vaccine is FDA authorized under Emergency Use Authorization (EUA) for use in individuals 6 months and older to provide:

Primary Series

• a 3-dose primary series to individuals 6 months through 4 years of age
• 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 with certain kinds of immunocompromise

EMERGENCY USE AUTHORIZATION

Emergency uses of the vaccines 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 aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.

IMPORTANT SAFETY INFORMATION

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), COMIRNATY® (COVID-19 Vaccine, mRNA) and Pfizer-BioNTech COVID-19 Vaccine

Tell your vaccination provider about all of your medical conditions, including if you:

• 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

• You should not get COMIRNATY (COVID-19 Vaccine, mRNA), the Pfizer-BioNTech COVID-19 Vaccine, or the Pfizer-BioNTech COVID-19 Vaccine, Bivalent if you have had a severe allergic reaction after a previous dose of COMIRNATY or the Pfizer-BioNTech COVID-19 Vaccine or any ingredient in these vaccines

• There is a remote chance that these vaccines 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, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If you experience a severe allergic reaction, call 9-1-1 or go to the nearest hospitalSeek medical attention right away if you have any of the following symptoms: difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness

• Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received COMIRNATY® (COVID-19 vaccine, mRNA) or Pfizer-BioNTech COVID-19 Vaccine. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and the observed risk is highest in males 12 through 17 years of age. In most of these people, symptoms began within a few days following receipt of the second dose of vaccine. The chance of having this occur is very low

Side effects that have been reported with these vaccines 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
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Unusual and persistent cool, pale skin

These may not be all the possible side effects of the vaccine. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away. Individuals should always ask their healthcare providers for medical advice about adverse events.

Report vaccine side effects to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) Vaccine Adverse Event Reporting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 or report online to www.vaers.hhs.gov/reportevent.html. In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985.

COMIRNATY® Full Prescribing Information and EUA Fact Sheets for Vaccination Providers and Recipients and Caregivers Fact Sheets:

EUA Fact Sheet for Vaccination Providers (12 Years & Up), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 Years), BIVALENT (Original and Omicron BA.4/BA.5), DO NOT DILUTE, Orange Cap

COMIRNATY® Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap

EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap

EUA Fact Sheet for Recipients and Caregivers (12 years of age and older)

EUA Fact Sheet for Recipients and Caregivers (5 through 11 years of age)

EUA Fact Sheet for Recipients and Caregivers (6 months through 4 years of age)

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