Pfizer and BioNTech Provide Update on mRNA-based Combination Vaccine Program Against Influenza and COVID-19 in Individuals 18-64 Years of Age
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In a Phase 3 trial,
and BioNTech’s combination vaccine candidate against influenza and COVID-19 met one of its two primary immunogenicity objectivesPfizer - The trial did not meet one of its primary immunogenicity objectives of non-inferiority against the influenza B strain despite obtaining higher influenza A responses and comparable COVID-19 responses versus the comparator vaccines
- The companies are evaluating adjustments to the candidate and will discuss next steps with health authorities
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Pfizer also provides update on its separate Phase 2 second-generation trivalent influenza mRNA vaccine trial which showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine
Update on Phase 3
The Phase 3 randomized, observer-blinded study (NCT06178991) enrolled more than 8,000 adults 18 through 64 years of age to evaluate the safety, tolerability, and immunogenicity of a single dose combination vaccine candidate against influenza and COVID-19. In this clinical trial, the vaccine candidate was compared to a licensed influenza vaccine and the companies’ licensed COVID-19 vaccine given at the same visit. The primary immunogenicity objectives were to demonstrate that the antibody responses to influenza (hemagglutination inhibition, “HAI”) and to SARS-CoV-2 (neutralizing titer, “NT”) elicited by the combination vaccine candidate were non-inferior (“NI”) to standard of care (“SOC”). Compared to a licensed influenza vaccine, the tIRV formulation was noteworthy for eliciting robust influenza A responses, including a continued trend of higher influenza A responses versus a licensed influenza vaccine, while it showed lower geometric mean titers (“GMT”) and seroconversion against the influenza B strain. In addition, the formulation demonstrated comparable responses against SARS-CoV-2 versus the companies’ licensed COVID-19 vaccine. No safety signals with the combination vaccine have been identified in an ongoing safety data review. Participants
“We are encouraged by the robust immunogenicity we saw with our combination vaccine against influenza A, which was similar to what we had seen for our initial quadrivalent influenza vaccine where we saw superior relative vaccine efficacy against a comparator flu vaccine,” said
“We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases,” said Prof.
Update on
Pfizer’s Phase 2 trial (NCT06436703) to evaluate second-generation candidates against influenza was initiated earlier this year and enrolled 450 participants 18-64 years of age,
About Influenza
Influenza causes an estimated 140,000 to 710,000 hospitalizations, 12,000 to 52,000 deaths1 and about
With circulating influenza strains continually changing, predicting the best match for the next season’s vaccine is difficult for global health experts as those strains are chosen more than six months before the start of the flu season that they target. The flexibility of mRNA technology and its rapid manufacturing could potentially allow better strain matches in future years, and in a pandemic influenza situation, mRNA technology could enable rapid, large-scale manufacturing of vaccines.
INDICATION, AUTHORIZED USE AND IMPORTANT SAFETY INFORMATION
INDICATION
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine for use in people 12 years of age and older to protect against coronavirus disease 2019 (COVID-19).
IMPORTANT SAFETY INFORMATION
- You should NOT receive COMIRNATY® (COVID-19 Vaccine, mRNA) if you had a severe allergic reaction to a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine* or to any ingredient in these vaccines.
*COMIRNATY (2023-2024 Formula) is made the same way as Pfizer-BioNTech COVID-19 Vaccine (Original monovalent) and Pfizer-BioNTech COVID-19 Vaccine, Bivalent, but it encodes the spike protein of SARS-CoV-2 Omicron variant lineage XBB.1.5 (Omicron XBB.1.5).
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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. For this reason, your vaccination provider may ask you to stay at the place where you received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
- Difficulty breathing
- Swelling of your face and throat
- A fast heartbeat
- A bad rash all over the body
- Dizziness and weakness
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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, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following COMIRNATY 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. You shouldseek medical attention right away if you or your child 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
- 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
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Before getting COMIRNATY, tell your vaccination provider about all of your medical conditions, including if you:
- have any allergies
- had a severe allergic reaction after receiving a previous dose of any COVID-19 vaccine
- 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
Additional side effects that have been reported with COMIRNATY or Pfizer-BioNTech COVID-19 vaccines include:
- Non-severe allergic reactions such as rash, itching, hives, or swelling of the face
- Injection site reactions: pain, swelling, redness, arm pain
- General side effects: tiredness, headache, muscle pain, chills, joint pain, fever, nausea, feeling unwell, lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness.
These may not be all the possible side effects of COMIRNATY. Ask your healthcare provider about any side effects that concern you.
You may report side effects to the FDA/
Please click here for full Prescribing Information and Patient 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
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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
- Pfizer-BioNTech COVID-19 Vaccine may not protect everyone
-
Tell your vaccination provider about all of your child’s medical conditions, including if your child:
- has 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 is on a blood thinner
- is immunocompromised or is 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
- Arm pain
- Fainting in association with injection of the vaccine
- Chills
- Joint pain
- Fever
- Injection site swelling
- Injection site redness
- Nausea
- Feeling unwell
- Swollen lymph nodes (lymphadenopathy)
- Decreased appetite
- Diarrhea
- Vomiting
- 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
In addition, individuals can report side effects to
Please click here for Pfizer-BioNTech COVID-19 Vaccine Healthcare Providers Fact Sheet and Vaccine Recipient and Caregiver EUA Fact Sheet.
About
At
Pfizer Disclosure Notice
The information contained in this release is as of
This release contains forward-looking information about Pfizer’s investigational modified RNA (modRNA) influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations, Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, the flu and COVID/flu combination programs, Pfizer’s respiratory vaccines portfolio and mRNA technology, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data, including uncertainties regarding the outcome of the ongoing Phase 2 trial of Pfizer’s second-generation influenza vaccine candidates in adults 65 years of age and older; uncertainties regarding the future development of Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu and combination vaccine formulations and Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19, including whether or when any such candidates will advance to future studies or phases of development; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when biologic license applications may be filed in any jurisdictions for Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu or combination vaccine formulations or Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19 for any potential indications or for any other potential vaccine or product candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu or combination vaccine formulations, Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19 or any such other potential vaccine or product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu or combination vaccine formulations, Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19 or any such other potential vaccine or product candidates, including development of products or therapies by other companies; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding Pfizer’s mRNA influenza vaccine candidates, potential next-generation mRNA flu or combination vaccine formulations, Pfizer’s and BioNTech’s mRNA-based combination vaccine candidate for influenza and COVID-19 or any such other potential vaccine or product candidates and uncertainties regarding the commercial impact of any such recommendations; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers, including our relationship with
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended
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BioNTech Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not be limited to, statements concerning: the collaboration between
You should review the risks and uncertainties described under the heading “Risk Factors” in
1 Disease Burden of Flu.
2 Putri et al, Vaccine. 2018 Jun 22;36(27):3960-3966. doi: 10.1016/j.vaccine.2018.05.057
3 Flu & People 65 Years and Older.
4 Vaccine Effectiveness: How Well do the Flu Vaccines Work?
5 Flu Disparities Among Racial and Ethnic Minority Groups
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