BioNTech (Nasdaq: BNTX) gains EU approval for 2026-2027 XFG COVID-19 shot
Rhea-AI Filing Summary
BioNTech SE, together with Pfizer, reports that the European Commission has granted marketing authorization for their 2026-2027 COVID-19 vaccine formula targeting the XFG variant, for active immunization of individuals 6 months of age and older.
The authorization, based on EMA Emergency Task Force and CHMP assessments, applies across all 27 EU Member States plus Iceland, Liechtenstein and Norway. Data cited indicate the monovalent XFG-adapted vaccine elicits strong immune responses against multiple contemporary SARS-CoV-2 lineages and maintains a favorable safety and efficacy profile. Pfizer and BioNTech have already begun manufacturing at risk and expect shipments to start soon to support seasonal vaccination campaigns. The partners note that more than five billion doses of their COVID-19 vaccines have been distributed globally and that they have submitted data for the updated vaccine to regulators worldwide.
Positive
- None.
Negative
- None.
Key Figures
Age indication: 6 months of age and older
Cumulative doses distributed: more than five billion doses
Jurisdictions with authorization: 27 EU Member States plus Iceland, Liechtenstein and Norway
+1 more
4 metrics
Age indication
6 months of age and older
Population eligible for the 2026-2027 XFG-targeting COVID-19 vaccine in Europe
Cumulative doses distributed
more than five billion doses
Global distribution of Pfizer-BioNTech COVID-19 vaccines to date
Jurisdictions with authorization
27 EU Member States plus Iceland, Liechtenstein and Norway
Geographic scope of EC marketing authorization for the XFG-adapted vaccine
Season covered
2026-2027
COVID-19 vaccination season for which the XFG variant formula is authorized
Key Terms
marketing authorization, monovalent XFG-adapted COVID-19 vaccine, Emergency Task Force (ETF), Committee for Medicinal Products for Human Use (CHMP), +2 more
6 terms
marketing authorization regulatory
"the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027"
An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.
monovalent XFG-adapted COVID-19 vaccine medical
"data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses"
Emergency Task Force (ETF) regulatory
"based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency"
Committee for Medicinal Products for Human Use (CHMP) regulatory
"The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation"
The Committee for Medicinal Products for Human Use is the group of scientific experts at the European medicines regulator that assesses whether a medicine is safe, effective and high quality for use in people and issues the regulator’s formal scientific opinion. Investors watch its opinions because they act like a building inspector’s stamp for a drug — a positive opinion clears the path to sales across a large market and reduces regulatory risk, while a negative opinion can block or delay commercial plans.
Summary of Product Characteristics regulatory
"Please see here for the full Summary of Product Characteristics for the Pfizer-BioNTech COVID-19 vaccine."
A summary of product characteristics is the official, detailed description of a medicine’s approved uses, dosages, safety information and how it should be used, prepared by regulators and manufacturers. Investors care because it defines the legal label and market scope for a drug—the ‘instruction manual’ that determines which patients can receive it, what claims can be made, and what safety issues might limit sales, similar to how a product spec sets boundaries for a consumer device.
myocarditis medical
"Myocarditis (inflammation of the heart muscle) and pericarditis have occurred in some people"
Inflammation of the heart muscle that can weaken the heart’s ability to pump and cause symptoms such as chest pain, shortness of breath, or abnormal heart rhythms. Investors care because myocarditis can affect healthcare costs, clinical trial outcomes, regulatory decisions, product safety perceptions, workforce availability, or lead to legal and reputational risks for companies, similar to how a car engine problem can halt a business until it's fixed.
AI-generated analysis. How Rhea-AI works. Not financial advice.
FAQ
What did BioNTech (BNTX) announce in this July 2026 Form 6-K?
BioNTech reported that the European Commission granted marketing authorization for the 2026-2027 Pfizer-BioNTech COVID-19 vaccine targeting the XFG variant, for active immunization against COVID-19 in individuals 6 months of age and older across the European Union and associated countries.
Which regions are covered by the new Pfizer-BioNTech XFG COVID-19 vaccine authorization for BNTX?
The marketing authorization is valid in all 27 EU Member States as well as Iceland, Liechtenstein and Norway. EU Member States and Norway will be supplied either under the EC contract or according to individual government policies for the 2026-2027 COVID-19 vaccination season.
What data support BioNTech’s (BNTX) 2026-2027 XFG-adapted COVID-19 vaccine?
Pfizer and BioNTech cite data showing the monovalent XFG-adapted vaccine induces a strong immune response against circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1, and that it demonstrates a favorable safety and efficacy profile based on cumulative clinical and real-world evidence.
Who is eligible for BioNTech’s (BNTX) newly authorized XFG COVID-19 vaccine in Europe?
The 2026-2027 XFG-targeting vaccine is authorized for individuals 6 months of age and older for active immunization to prevent COVID-19 caused by SARS-CoV-2. This broad age indication supports both pediatric and adult vaccination across the European Union and associated countries.
How are Pfizer and BioNTech (BNTX) preparing supply for the 2026-2027 XFG COVID-19 vaccine?
Pfizer and BioNTech have initiated manufacturing at risk of the monovalent XFG-adapted vaccine and state that shipping will begin soon to ensure rapid access ahead of the respiratory disease season, when demand for COVID-19 vaccination is expected to rise.
How extensive is global use of Pfizer-BioNTech COVID-19 vaccines according to BNTX?
The companies state that more than five billion doses of Pfizer-BioNTech COVID-19 vaccines have been distributed globally. This cumulative figure underpins their experience with mRNA COVID-19 vaccination and supports the safety and efficacy database referenced for the XFG-adapted formulation.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
FOR THE MONTH OF JULY 2026
COMMISSION FILE NUMBER 001-39081
BioNTech SE
(Translation of registrant’s name into English)
(Translation of registrant’s name into English)
An der Goldgrube 12
D-55131 Mainz
Germany
+49 6131-9084-0
(Address of principal executive offices)
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F: Form 20‑F ☒ Form 40‑F ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7): ☐
DOCUMENTS INCLUDED AS PART OF THIS FORM 6-K
On July 29, 2026, BioNTech SE and Pfizer Inc.announced that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The press release is attached as Exhibit 99.1.
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BioNTech SE | ||||||||||||||
By: | /s/ Ramon Zapata-Gomez | By: | /s/ Dr. Sierk Poetting | |||||||||||
Name: Ramon Zapata-Gomez | Name: Dr. Sierk Poetting | |||||||||||||
Title: Chief Financial Officer | Title: Chief Operating Officer | |||||||||||||
Date: July 29, 2026
EXHIBIT INDEX
Exhibit | Description of Exhibit | ||||
99.1 | European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union | ||||
Exhibit 99.1
European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union
•Data indicate that the 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, induces a strong immune response against contemporary circulating and emerging lineages
•More than five billion doses of the Pfizer-BioNTech COVID-19 vaccines distributed globally
•Vaccine demonstrates a favorable safety and efficacy profile
•Shipping will begin soon to ensure rapid access of this season’s vaccine
NEW YORK and MAINZ, GERMANY, July 29, 2026 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The ETF stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”1
The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. EU Member States as well as Norway, will be supplied either via the EC contract or according to individual country government policies.
The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation from July 23, 2026 based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and efficacy of the Pfizer and BioNTech COVID-19 vaccine as well as manufacturing/quality and non-clinical data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2
The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.
1 ETF. ETF recommends updating COVID-19 vaccines to target XFG variant. Updated May 29, 2026. Accessed June 25, 2026. https://www.ema.europa.eu/en/news/etf-recommends-updating-covid-19-vaccines-target-xfg-variant
2 Vaccines and Related Biological Products Advisory Committee. Meeting Presentation - 2026-2027 COVID-19 Vaccine Formula: Pfizer/BioNTech Supportive Data. May 28, 2026. Accessed June 25, 2026. https://www.fda.gov/media/192765/download
EU SUMMARY OF PRODUCT CHARACTERISTICS
Please see here for the full Summary of Product Characteristics for the Pfizer-BioNTech COVID-19 vaccine.
IMPORTANT SAFETY INFORMATION
•You or your child should NOT get COMIRNATY® (COVID-19 Vaccine, mRNA) if you or your child had a severe allergic reaction after a previous dose of COMIRNATY or any Pfizer-BioNTech COVID-19 vaccine or to any ingredient in these vaccines
•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, the vaccination provider may ask you or your child to stay at the place where you or your child received the vaccine for monitoring after vaccination. Signs of a severe allergic reaction can include:
oDifficulty breathing
oSwelling of the face and throat
oA fast heartbeat
oA bad rash all over the body
oDizziness 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, including COMIRNATY and Pfizer-BioNTech COVID-19 vaccines. Myocarditis and pericarditis following administration of mRNA COVID-19 vaccines have occurred most commonly in males 12 years through 24 years of age. In most of these people, symptoms began within a week following vaccination. You should seek medical attention right away if you or your child have any of the following symptoms after receiving the COMIRNATY, particularly during the 2 weeks after receiving a dose of the vaccine:
oChest pain
oShortness of breath
oFeelings of having a fast-beating, fluttering, or pounding heart
oAdditional 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
•People with weakened immune systems may have a reduced immune response to COMIRNATY
•Vaccination with COMIRNATY may not protect all people who receive the vaccine
Before getting COMIRNATY, tell your vaccination provider about all of your or your child’s medical conditions, including if you or your child:
•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 your 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, swollen lymph nodes (lymphadenopathy), decreased appetite, diarrhea, vomiting, dizziness
These may not be all the possible side effects of COMIRNATY. Ask your or your child’s healthcare provider about any side effects that concern you.
In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or www.pfizersafetyreporting.com.
Please click here for full Prescribing Information and Patient Information for COMIRNATY.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
Pfizer Disclosure Notice
The information contained in this release is as of July 29, 2026. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information about the Pfizer-BioNTech COVID-19 vaccine, including its potential benefits, manufacturing and supply, expectations regarding demand for COVID-19 vaccination and an approval by the European Commission to update the marketing authorization for the Pfizer-BioNTech COVID-19 vaccine to target the XFG variant of the JN.1 lineage for the 2026-2027 season, 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, uncertainties regarding the commercial success of the Pfizer-BioNTech COVID-19 vaccine; 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; 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 applications may be filed with regulatory authorities in particular jurisdictions for the Pfizer-BioNTech COVID-19 vaccine for any potential indication, including for the 2026-2027 COVID-19 vaccine formula; whether and when any such applications that may be pending or filed for the Pfizer-BioNTech COVID-19 vaccine 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 the Pfizer-BioNTech COVID-19 vaccine 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 the Pfizer-BioNTech COVID-19 vaccine; risks and uncertainties related to changes to vaccine or other healthcare policy in the EU, the U.S. or other jurisdictions; the risk that demand for any products may be reduced or no longer exist or not meet expectations which may lead to reduced revenues or excess inventory on-hand and/or in the channel or other unanticipated charges; uncertainties related to recommendations and coverage for, and the public’s adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for the Pfizer-BioNTech COVID-19 vaccine or any potential future COVID-19 vaccines; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on our business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
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 limited to, statements concerning:
BioNTech’s efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; regulatory submissions and regulatory approvals or authorizations, including an approval by the European Commission to update the marketing authorization for the Pfizer-BioNTech COVID-19 vaccine to target the XFG variant of the JN.1 lineage for the 2026-2027 season; expectations regarding manufacturing, distribution and supply; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccine’s response against multiple SARS-CoV-2 lineages, including the XFG variant of the JN.1 lineage and other circulating sublineages; expectations regarding anticipated changes in COVID-19 vaccine demand, including changes to the ordering environment; and expected regulatory recommendations to adapt vaccines to address new variants or sublineages. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.
The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events, and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; BioNTech’s pricing and coverage negotiations with governmental authorities, private health insurers and other third-party; the future commercial demand and medical need for initial or annual booster doses of a COVID-19 vaccine; the impact of tariffs and escalations in trade policy; the availability of raw materials to manufacture a vaccine; our vaccine’s formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery; competition from other COVID-19 vaccines or related to BioNTech’s other product candidates, including those with different mechanisms of action and different manufacturing and distribution constraints, on the basis of, among other things, efficacy, cost, convenience of storage and distribution, breadth of approved use, side-effect profile and durability of immune response; the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for BioNTech’s product candidates; the ability of BioNTech’s COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; the impact of COVID-19 on BioNTech’s development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTech’s COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market BioNTech’s COVID-19 vaccine and, if approved, its product candidates; BioNTech’s ability to manage its development and related expenses; regulatory developments in the United States and other countries; BioNTech’s ability to effectively scale
its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.
You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech's Report on Form 6-K for the period ended March 31, 2026, and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at https://www.sec.gov/. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.
CONTACTS
Pfizer:
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Media Relations
+1 (212) 733-1226
PfizerMediaRelations@pfizer.com
Investor Relations
+1 (212) 733-4848
IR@pfizer.com
+1 (212) 733-4848
IR@pfizer.com
BioNTech:
Media Relations
Jasmina Alatovic
Media@biontech.de
Media Relations
Jasmina Alatovic
Media@biontech.de
Investor Relations
Douglas Maffei, Ph.D.
Investors@biontech.de
Douglas Maffei, Ph.D.
Investors@biontech.de