Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV

•  ABRYSVO recommended by CDC Advisory Committee for pregnant persons 32 through 36 weeks gestation to help protect infants from respiratory syncytial virus (RSV) from birth through first six months of life
• RSV maternal immunization recommendation adds to Pfizer’s respiratory vaccines offerings already available to help protect against RSV in older adults, COVID-19, and pneumococcal pneumonia in adults

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) shared today it has broadened its portfolio of respiratory vaccines recommended by the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) following a favorable vote for ABRYSVO™ [Respiratory Syncytial Virus Vaccine], the company’s bivalent RSV prefusion F (RSVpreF) vaccine, as a maternal immunization. This is the first-ever fall in which eligible individuals can receive Pfizer vaccines to help protect against RSV, COVID-19, and pneumococcal pneumonia.

“This fall marks the start of the annual respiratory infection season in the Northern Hemisphere, and we are prepared with vaccines against multiple infectious diseases and — for the first time in history — an available RSV vaccine to help prevent disease in two at-risk populations,” said Luis Jodar, PhD, Chief Medical Affairs Officer, Vaccines/Antivirals and Evidence Generation, Pfizer. “Today’s ACIP recommendation for maternal immunization with ABRYSVO reinforces the wide-ranging impact vaccines can have, including helping protect infants immediately at birth from the potentially severe and life-threatening complications that can develop from RSV. Approximately 75 percent of RSV-related hospitalizations in newborns and infants occur in the first six months of life.”

Today, ACIP recommended:

• Maternal RSV vaccine for pregnant people during 32 through 36 weeks gestation, using seasonal administration, to prevent RSV lower respiratory tract infection in infants

This provisional recommendation will be official once it is reviewed and adopted by the director of the CDC. The ACIP recommendation follows the U.S. Food and Drug Administration’s (FDA) approval of ABRYSVO in August as the first and only maternal vaccine for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age.

The action today by ACIP comes on the heels of recent and previous recommendations from the CDC.

• After FDA authorization and approval of our Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula earlier this month, ACIP recommended everyone 6 months and older get an updated COVID-19 vaccine to protect against COVID-19 illness this fall and winter.

• ABRYSVO is currently available and recommended using shared clinical decision making for adults 60 years of age and older to help protect against RSV disease. With more than 77 million individuals aged 60 and older in the U.S.¹, the recommended use of this vaccine can help prevent the potentially serious consequences associated with RSV, which leads to the hospitalization of more than 60,000 of these adults each year.²

• PREVNAR 20^® has been recommended by the CDC since October 2021 to help prevent pneumococcal disease among adults aged 65 years or older and adults 19-64 years old with certain medical conditions, such as asthma, diabetes or other risk factors. Pneumococcal pneumonia results in more than 180,000 adult hospital admissions and more than 150,000 adult outpatient visits in the U.S. each year.³

About ABRYSVO

Pfizer currently is the only company with an RSV vaccine to help protect older adults, as well as infants through maternal immunization. In May 2023, the FDA approved ABRYSVO for the prevention of LRTD caused by RSV in individuals 60 years of age or older. This was followed by the ACIP’s official recommendation of the vaccine for use in adults 60 years of age and older, which occurred in June 2023.

In August 2023, Pfizer announced that the European Medicines Agency (EMA) granted marketing authorization for ABRYSVO for both older adults and maternal immunization to help protect infants. In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVpreF as a maternal immunization to help protect infants against RSV. In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization to help protect infants against RSV.

Pfizer has also initiated two additional clinical trials evaluating ABRYSVO. One trial is being conducted in children ages two to less than 18 years who are at higher risk for RSV disease. ⁴ A second trial is evaluating adults ages 18 to 60 years at higher risk for RSV due to underlying medical conditions such as asthma, diabetes and COPD, and adults ages 18 and older who are immunocompromised and at high risk for RSV.8 Pfizer also plans post-marketing studies and surveillance programs to further describe the safety of ABRYSVO.

INDICATIONS FOR ABRYSVO

ABRYSVO^TM is a vaccine indicated for:

• the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in people 60 years of age and older
• pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

IMPORTANT SAFETY INFORMATION FOR ABRYSVO

• ABRYSVO should not be given to anyone with a history of severe allergic reaction (e.g., anaphylaxis) to any of its components
• For pregnant individuals: to avoid the potential risk of preterm birth, ABRYSVO should be given during 32 through 36 weeks gestational age
• Fainting can happen after getting injectable vaccines, including ABRYSVO. Precautions should be taken to avoid falling and injury during fainting
• Adults with weakened immune systems, including those receiving medicines that suppress the immune system, may have a reduced immune response to ABRYSVO
• Vaccination with ABRYSVO may not protect all people
• In adults 60 years of age and older, the most common side effects (≥10%) were fatigue, headache, pain at the injection site, and muscle pain
• In pregnant individuals, the most common side effects (≥10%) were pain at the injection site, headache, muscle pain, and nausea,
• In clinical trials where ABRYSVO was compared to placebo, infants born to pregnant individuals experienced low birth weight (5.1% ABRYSVO versus 4.4% placebo) and jaundice (7.2% ABRYSVO versus 6.7% placebo

View the full ABRYSVO Prescribing Information.

INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION

INDICATION FOR COMIRNATY

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.

IMPORTANT SAFETY INFORMATION

• You should NOT receive COMIRNATY^® (COVID-19 Vaccine, mRNA) if you have had a severe allergic reaction to any ingredient of COMIRNATY or a previous dose of a Pfizer-BioNTech COVID-19 vaccine

• There is a remote chance that COMIRNATY 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 or your pre-teen or teenager experience a severe allergic reaction, call 9-1-1 or go to the nearest hospital. 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

• Authorized or approved mRNA COVID-19 vaccines show increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart), particularly within the first week following vaccination. For COMIRNATY, the observed risk is highest in males 12 through 17 years of age. Seek medical attention right away if you have any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
  • chest pain
  • shortness of breath
  • feelings of having a fast-beating, fluttering, or pounding heart

    Additional symptoms, particularly in children, may include:

    • Fainting
    • Unusual and persistent fatigue or lack of energy
    • Persistent vomiting
    • Persistent pain in the abdomen
    • Unusual and persistent cool, pale skin

• Fainting can happen after getting injectable vaccines including COMIRNATY. Your vaccination provider may ask you to sit or lie down for 15 minutes after receiving the vaccine

• People with weakened immune systems may have a reduced immune response to COMIRNATY

• COMIRNATY may not protect all vaccine recipients

• 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 most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

  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.

  You should always ask your 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. You can also report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click here for full Prescribing Information for COMIRNATY

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)* is FDA authorized under Emergency Use Authorization (EUA) to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months through 11 years of age.

*Hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine

EMERGENCY USE AUTHORIZATION

Pfizer-BioNTech COVID-19 Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals aged 6 months through 11 years of age. 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

• A person should NOT get Pfizer-BioNTech COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of any Pfizer-BioNTech COVID-19 vaccine or to any ingredients in these vaccines.

• 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, the vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. If your child experiences a severe allergic reaction, call 9-1-1, or go to the nearest hospital. 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, or 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 mRNA COVID-19 vaccines. Myocarditis and pericarditis following Pfizer-BioNTech COVID-19 vaccines have occurred most commonly in adolescent males 12 through 17 years of age. In most of these individuals, symptoms began within a few days following vaccination. The chance of having this occur is very low. Seek medical attention right away if your child has any of the following symptoms after receiving the vaccine, particularly during the 2 weeks after receiving a dose of the vaccine:
  • Chest pain
  • Shortness of breath or difficulty breathing
  • Feelings of having a fast-beating, fluttering, or pounding heart

Additional symptoms, particularly in children, may include:

• Fainting
• Unusual and persistent irritability
• Unusual and persistent poor feeding
• Unusual and persistent fatigue or lack of energy
• Persistent vomiting
• Persistent pain in the abdomen
• Unusual and persistent cool, pale skin
• Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination
• People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine
• The Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
• Tell your vaccination provider about all of your medical conditions, including if you:
  • have any allergies
  • has had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
  • has a fever
  • has a bleeding disorder or are on a blood thinner
  • is immunocompromised or are on a medicine that affects the immune system
  • is pregnant or is breastfeeding
  • has received another COVID-19 vaccine
  • has ever fainted in association with an injection
• Side effects that have been reported with Pfizer-BioNTech COVID-19 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/tenderness
  • 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
  • Dizziness
  • Irritability

These may not be all the possible side effects. Serious and unexpected side effects may occur. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away.

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. Please include “Pfizer-BioNTech COVID-19 Vaccine(2023-2024 Formula) EUA” in the first line of box #18 of the report form.

In addition, individuals can report side effects to Pfizer Inc. at www.pfizersafetyreporting.com or by calling 1-800-438-1985

Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet

INDICATIONS FOR PREVNAR 20

Prevnar 20 is a vaccine approved for:

• the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older
• the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years.
• the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older
  • The indication of Prevnar 20 for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study

IMPORTANT SAFETY INFORMATION

• Prevnar 20 should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria toxoid
• Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups
• A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your healthcare provider about the infant’s medical status when deciding to get vaccinated with Prevnar 20.
• In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.
• In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.
• In individuals 18 years of age and older, the most common side effects (>10%) were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Additionally, injection site swelling was also common in adults 18 through 59 years of age

View the full prescribing information for PREVNAR 20^®.