The d COVID-19 vaccine is tailed to the Omicron XBB.1.5 sublineage of SARS-CoV-2 is recommended f individuals 6 months of age older
Recommendation based on pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates an improved response against multiple XBB-related sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, EG.5.1 (Eris), which continue to dominate globally1
Doses will be ready to ship to applicable EU member states immediately upon authization by the European Commission
NEW YK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) BioNTech SE (Nasdaq: BNTX) today announced that the Committee f Medicinal Products f Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authization f the companies’ Omicron XBB.1.5-adapted monovalent COVID-19 vaccine (COMIRNATY® Omicron XBB.1.5) administered as a single dose f individuals 5 years of age older, regardless of pri COVID-19 vaccination histy. The Committee has also recommended the d vaccine f children 6 months through 4 years of age as part all of the primary three-dose vaccination series, depending on how many pri doses they received, as single dose f those with a histy of completion of a COVID-19 primary vaccination course pri SARS-CoV-2 infection.
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The European Commission (EC) will review the CHMP’s recommendation is expected to make a final decision soon. Following a decision from the EC, the d vaccine will be ready to ship to applicable EU member states immediately. Pfizer BioNTech have been manufacturing the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall winter season when the dem f COVID-19 vaccination is expected to increase.2
“This season’s vaccine is ready to ship as soon as the final regulaty decision is made, so that people across Europe can better help protect themselves against COVID-19 illness as the risk rises,” said Albert Bourla, Chairman Chief utive Officer at Pfizer. “It's been nearly a year since many citizens in the European Union were vaccinated against COVID-19 the d fmulation provides the opptunity f them to receive a vaccine me closely matched to current sublineages."
“As COVID-19 is expected to adopt a seasonal pattern, similar to other respiraty viruses, we remain committed to providing COVID-19 vaccines that are better matched to relevant circulating variants sublineages to people wldwide, to suppt vaccinations in the upcoming fall winter season,” said Prof. Ugur Sahin, M.D., CEO Co-founder of BioNTech. “Omicron XBB-related sublineages are antigenically distant from pri Omicron strains continue to account f the vast majity of COVID-19 cases globally. The d COVID-19 vaccine aims to further improve protection against severe illness hospitalization.”
The CHMP’s recommendation is based on the full body of previous clinical, non-clinical, real-wld evidence suppting the safety efficacy of the COVID-19 vaccines by Pfizer BioNTech. Further, the application included pre-clinical data showing that the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple XBB sublineages, including XBB.1.5, XBB.1.16, XBB.2.3, compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Additional pre-clinical data demonstrate that serum antibodies induced by the d COVID-19 vaccine, when compared to the Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine, also effectively neutralize the globally dominant recently WHO-designated variant of interest EG.5.1 (Eris).3
Pfizer BioNTech have also filed an application with the U.S. Food Drug Administration (FDA) requesting approval of their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine f individuals 6 months of age older. A decision is expected in the coming days. The companies have submitted data f the d COVID-19 vaccine to other regulaty authities around the wld.
The COVID-19 vaccines (COMIRNATY®) by Pfizer BioNTech are based on BioNTech’s proprietary mRNA technology were developed by both companies. BioNTech is the Marketing Authization Holder f COMIRNATY its adapted vaccines (COMIRNATY iginal/Omicron BA.1; COMIRNATY iginal/Omicron BA.4/BA.5) in the United States, the European Union, the United Kingdom, Canada other countries, the holder of emergency use authizations equivalents in the United States (jointly with Pfizer) other countries.
INDICATION & AUTHIZED USE
AUTHIZED USE
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (iginal Omicron BA.4/BA.5) is FDA authized under Emergency Use Authization (EUA) f active immunization to prevent conavirus disease 2019 (COVID-19) caused by severe acute respiraty syndrome conavirus 2 (SARS-CoV-2) in individuals 6 months of age older.
EMERGENCY USE AUTHIZATION
Pfizer-BioNTech COVID-19 Vaccine has not been approved licensed by FDA, but has been authized f emergency use by FDA, under an EUA to prevent Conavirus Disease 2019 (COVID-19) f use in individuals aged 6 months of age older. The emergency use of this product is only authized f the duration of the declaration that circumstances exist justifying the authization of emergency use of the medical product under Section 564(b) (1) of the FD&C Act unless the declaration is terminated authization revoked sooner.
IMPTANT SAFETY INFMATION
Tell your vaccination provider about all of your medical conditions, including if you:
have any allergies
have had myocarditis (inflammation of the heart muscle) pericarditis (inflammation of the lining outside the heart)
have a fever
have a bleeding disder are on a blood thinner
are immunocompromised are on a medicine that affects the immune system
are pregnant, plan to become pregnant, are breastfeeding
have received another COVID-19 vaccine
have ever fainted in association with an injection
The vaccine may not protect everyone
A person should NOT get Pfizer-BioNTech COVID-19 Vaccine, Bivalent if they have had a severe allergic reaction after a previous dose of Pfizer-BioNTech COVID-19 Vaccine*, Pfizer-BioNTech COVID-19 Vaccine, Bivalent, COMIRNATY® (COVID-19 Vaccine, mRNA) 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 1 hour after getting a dose of the vaccine. F this reason, your vaccination provider may ask you to stay at the place where you received the vaccine f moniting after vaccination. If you experience a severe allergic reaction, call 9-1-1 go to the nearest hospital
Seek medical attention right away if you have any of the following symptoms:
difficulty breathing, swelling of the face throat, a fast heartbeat, a bad rash all over the body, dizziness, weakness
Myocarditis (inflammation of the heart muscle) pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA). The observed risk is higher among adolescent males adult males under 40 years of age than among females older males, 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. Seek medical attention right away if the vaccine recipient has any of the following symptoms:
Chest pain
Shtness of breath difficulty breathing
Feelings of having a fast-beating, fluttering, pounding heart
Additional symptoms, particularly in children, may include:
Fainting
Unusual persistent irritability
Unusual persistent po feeding
Unusual persistent fatigue lack of energy
Persistent vomiting
Persistent pain in the abdomen
Unusual persistent cool, pale skin
Fainting can happen after getting injectable vaccines, including Pfizer-BioNTech COVID-19 Vaccine, Bivalent. F this reason, your vaccination provider may ask you to stay at the place where you received the vaccine f moniting after vaccination
People with weakened immune systems may have a reduced immune response to Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Side effects that have been repted with Pfizer-BioNTech COVID-19 Vaccine, Bivalent, Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA) include:
Severe allergic reactions
Non-severe allergic reactions such as rash, itching, hives, 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 of these vaccines. Call the vaccination provider healthcare provider about bothersome side effects side effects that do not go away.
Individuals should always ask their healthcare providers f medical advice about adverse events. Rept vaccine side effects to the US Food Drug Administration (FDA) the Centers f Disease Control Prevention (CDC) Vaccine Adverse Event Repting System (VAERS). The VAERS toll-free number is 1‐800‐822‐7967 rept online to www.vaers.hhs.gov/reptevent.html. In addition, individuals can rept side effects to Pfizer Inc. at www.pfizersafetyrepting.com by calling 1-800-438-1985
Please click f Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vaccination Provider Recipient Caregiver EUA Fact Sheets
*The iginal Pfizer-BioNTech COVID-19 Vaccine is no longer authized f use in the United States.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science our global resources to bring therapies to people that extend significantly improve their lives. We strive to set the stard f quality, safety value in the discovery, development manufacture of health care products, including innovative medicines vaccines. Every day, Pfizer colleagues wk across developed emerging markets to advance wellness, prevention, treatments cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the wld's premier innovative biopharmaceutical companies, we collabate with health care providers, governments local communities to suppt exp access to reliable, affdable health care around the wld. F me than 170 years, we have wked to make a difference f all who rely on us. We routinely post infmation that may be imptant to invests on our website at www.pfizer.com. In addition, to learn me, please visit us on follow us on Twitter at X (twitter.com) Pfizer Inc. (@pfizer_news) / X (twitter.com), Pfizer | LinkedIn, youtube.com/pfizer like us on Facebook at Pfizer - Home | Facebook.
Pfizer Disclosure Notice
The infmation contained in this release is as of August 30, 2023. Pfizer assumes no obligation to fward-looking statements contained in this release as the result of new infmation future events developments.
This release contains fward-looking infmation about Pfizer’s effts to combat COVID-19, the collabation between BioNTech Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program, Pfizer –BioNTech's COVID-19 vaccines, defined collectively herein as COMIRNATY (including regulaty applications pending with the European Commission the U.S. Food Drug Administration (FDA) f an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine, data submitted f an Omicron XBB.1.5-adapted monovalent COVID-19 vaccine to other regulaty authities, qualitative assessments of available data, potential benefits, expectations regarding dem f COVID-19 vaccination, expectations f clinical trials, potential regulaty submissions, the anticipated timing of data readouts, regulaty submissions, regulaty approvals authizations anticipated manufacturing, distribution supply) involving substantial risks uncertainties that could cause actual results to differ materially from those expressed implied by such statements. Risks uncertainties include, among other things, the uncertainties inherent in research development, including the ability to meet anticipated clinical endpoints, commencement / completion dates f clinical trials, regulaty submission dates, regulaty approval dates / launch dates, as well as risks associated with pre-clinical clinical data (including Phase 1/2/3 Phase 4 pre-clinical data f COMIRNATY, any vaccine cidate in the BNT162 program, including the data discussed in this release) in any of our studies in pediatrics, adolescents, adults real wld evidence, including the possibility of unfavable new pre-clinical, clinical safety data further analyses of existing pre-clinical, clinical safety data further infmation regarding the quality of pre-clinical, clinical safety data, including the risk that additional data against newer Omicron sublineages could differ from previously repted data; the ability to produce comparable clinical other results f COMIRNATY, any vaccine cidate any other vaccines that may result from the BNT162 program any other COVID-19 program, including the rate of vaccine effectiveness safety tolerability profile observed to date, in additional analyses of the Phase 3 trial additional studies, in real wld data studies in larger, me diverse populations following commercialization; the ability of COMIRNATY, any vaccine cidate any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that use of the vaccine will lead to new infmation about efficacy, safety, other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that pre-clinical clinical trial data are subject to differing interpretations assessments, including during the peer review/publication process, in the scientific community generally, by regulaty authities; whether when additional data from the BNT162 mRNA vaccine program other COVID-19 programs will be published in scientific journal publications , if so, when with what modifications interpretations; whether regulaty authities will be satisfied with the design of results from existing future pre-clinical clinical studies; whether when submissions to request emergency use conditional marketing authizations f COMIRNATY any future vaccines in additional populations, f a potential booster dose f COMIRNATY, any vaccine cidate any potential future vaccines (including potential future annual boosters re-vaccinations), / other biologics license / emergency use authization applications amendments to any such applications may be filed in particular jurisdictions f COMIRNATY, any vaccine cidates any other potential vaccines that may arise from the BNT162 program, if obtained, whether when such emergency use authizations licenses, existing emergency use authizations, will expire terminate; whether when any applications that may be pending filed f COMIRNATY (including any requested amendments to the emergency use conditional marketing authizations including the applications pending with the FDA the European Commission f the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine), any vaccine cidates other vaccines that may result from the BNT162 program any other COVID-19 program may be approved by particular regulaty authities, which will depend on myriad facts, including making a determination as to whether the vaccine’s benefits outweigh its known risks determination of the vaccine’s efficacy , if approved, whether it will be commercially successful; decisions by regulaty authities impacting labeling marketing, manufacturing processes, safety / other matters that could affect the availability commercial potential of a vaccine, including the authization approval of products therapies developed by other companies; disruptions in the relationships between us our collabation partners, clinical trial sites third-party suppliers, including our relationship with BioNTech; the risk that dem f any products may be reduced, no longer exist not meet expectations, which may lead to excess inventy on-h / in the channel reduced revenues; challenges related to uncertainties regarding the timing of a transition to the commercial market f any of our products; uncertainties related to the public’s adherence to vaccines boosters; risks related to our ability to achieve our revenue fecasts f COMIRNATY any potential future COVID-19 vaccines; the risk that other companies may produce superi competitive products; risks related to the availability of raw materials to manufacture test a vaccine; challenges related to our vaccine’s fmulation, dosing schedule attendant stage, distribution administration requirements, including risks related to stage hling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine fmulations, booster doses potential future annual boosters re-vaccinations new variant-based next generation vaccines potential combination respiraty vaccines; the risk that we may not be able to maintain manufacturing capacity access to logistics supply channels commensurate with global dem f our vaccines, which would negatively impact our ability to supply our vaccines within the projected time periods; whether when additional supply purchase agreements will be reached existing agreements will be completed renegotiated; uncertainties regarding the ability to obtain recommendations from vaccine advisy technical committees other public health authities uncertainties regarding the commercial impact of any such recommendations; pricing access challenges; challenges related to public confidence in, awareness of COMIRNATY; uncertainties around future changes to applicable healthcare policies guidelines issued by the U.S. federal government in connection with the declared termination of the federal government’s COVID-19 public health emergency as of May 11, 2023; trade restrictions; potential third party royalties other claims; the uncertainties inherent in business financial planning, including, without limitation, risks related to Pfizer’s business prospects, adverse developments in Pfizer’s markets, adverse developments in the U.S. global capital markets, credit markets, regulaty environment economies generally; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations financial results; competitive developments.
A further deion of risks uncertainties can be found in Pfizer’s Annual Rept on Fm 10-K f the fiscal year ended December 31, 2022 in its subsequent repts on Fm 10-Q, including in the sections thereof captioned “Risk Facts” “Fward-Looking Infmation Facts That May Affect Future Results”, as well as in its subsequent repts on Fm 8-K, all of which are filed with the U.S. Securities Exchange Commission available at www.sec.gov www.pfizer.com.
About BioNTech
Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies f cancer other serious diseases. The Company exploits a wide array of computational discovery therapeutic drug platfms f the rapid development of novel biopharmaceuticals. Its broad ptfolio of oncology product cidates includes individualized off-the-shelf mRNA-based therapies, innovative chimeric antigen recept CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulats, targeted cancer antibodies antibody-drug conjugate (ADC) therapies, as well as small molecules. Based on its deep expertise in mRNA vaccine development in-house manufacturing capabilities, BioNTech its collabats are developing multiple mRNA vaccine cidates f a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collabats, including DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi, Pfizer.
F me infmation, please visit www.BioNTech.com.
BioNTech Fward-looking Statements
This press release contains fward-looking statements within the meaning of the Private Securities Litigation Refm Act of 1995, as amended, including, but not be limited to, statements concerning: BioNTech’s effts to combat COVID-19; the collabation between BioNTech Pfizer; the rate degree of market acceptance of BioNTech’s COVID-19 vaccine, including the Omicron XBB.1.5-adapted monovalent COVID-19 vaccine; qualitative assessments of available data expectations of potential benefits; regulaty submissions regulaty approvals authizations expectations regarding manufacturing, distribution supply; expectations regarding anticipated changes in COVID-19 vaccine dem, including changes to the dering environment; expected regulaty recommendations to adapt vaccines to address new variants sublineages. In some cases, fward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” the negative of these terms other comparable terminology, although not all fward-looking statements contain these wds. The fward-looking statements in this press release are neither promises n guarantees, you should not place undue reliance on these fward-looking statements because they involve known unknown risks, uncertainties, other facts, many of which are beyond BioNTech’s control which could cause actual results to differ materially from those expressed implied by these fward-looking statements. These risks uncertainties include, but are not limited to: the uncertainties inherent in research development, including the ability to meet anticipated clinical endpoints, commencement / completion dates f clinical trials, regulaty submission dates, regulaty approval dates / launch dates, as well as risks associated with preclinical clinical data, including the data discussed in this release, including the possibility of unfavable new preclinical, clinical safety data further analyses of existing preclinical, clinical safety data; the nature of the clinical data, which is subject to ongoing peer review, regulaty review market interpretation; BioNTech's pricing coverage negotiations with governmental authities, private health insurers other third-party pays after BioNTech's initial sales to national governments; the future commercial dem medical need f initial booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccine’s fmulation, dosing schedule attendant stage, distribution administration requirements, including risks related to stage hling after delivery; competition from other COVID-19 vaccines related to BioNTech's other product cidates, including those with different mechanisms of action different manufacturing distribution constraints, on the basis of, among other things, efficacy, cost, convenience of stage distribution, breadth of approved use, side-effect profile durability of immune response; the ability to obtain recommendations from vaccine advisy technical committees other public health authities uncertainties regarding the commercial impact of any such recommendations; the timing of BioNTech's ability to obtain maintain regulaty approval f BioNTech's product cidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech's its counterparties’ ability to manage source necessary energy resources; BioNTech's ability to identify research opptunities discover develop investigational medicines; the ability willingness of BioNTech's third-party collabats to continue research development activities relating to BioNTech's development cidates investigational medicines; the impact of the COVID-19 pemic on BioNTech's development programs, supply chain, collabats financial perfmance; unfeseen safety issues potential claims that are alleged to arise from the use of BioNTech's COVID-19 vaccine other products product cidates developed manufactured by BioNTech; BioNTech's its collabats’ ability to commercialize market BioNTech's COVID-19 vaccine , if approved, its product cidates; BioNTech's ability to manage its development expansion; regulaty developments in the United States other countries; BioNTech's ability to effectively scale BioNTech's production capabilities manufacture BioNTech's products, including BioNTech's target COVID-19 vaccine production levels, BioNTech's product cidates; risks relating to the global financial system markets; other facts not known to BioNTech at this time.
You should review the risks uncertainties described under the heading “Risk Facts” in BioNTech’s Rept on Fm 6-K f the period ended June 30, 2023 in subsequent filings made by BioNTech with the U.S. Securities Exchange Commission (“SEC”), which are available on the SEC’s website at www.sec.gov. Except as required by law, BioNTech disclaims any intention responsibility f updating revising any fward-looking statements contained in this press release in the event of new infmation, future developments otherwise. These fward-looking statements are based on BioNTech’s current expectations speak only as of the date hereof.
1 Wld Health ganization. COVID-19 Weekly Epidemiological . Available at: https://www.who.int/emergencies/diseases/novel-conavirus-2019/situation-repts
2 Wiemken TL, Khan F, Nguyen JL, Jodar L, McLaughlin JM. Is COVID-19 seasonal? A time series modeling approach. medRxiv. 2022:2022.06.17.22276570.
3 Wld Health ganization. EG.5 Initial Risk uation. Available at: https://www.who.int/docs/default-source/conaviruse/09082023eg.5_ire_final.pdf?sfvrsn=2aa2daee_1
Categy: Vaccines