NEW YORK & MAINZ, Germany - Pfizer Inc. (NYSE:) and BioNTech SE (Nasdaq:NASDAQ:) announced today that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the authorization of their Omicron JN.1-adapted monovalent COVID-19 vaccine, COMIRNATY JN.1, for use in individuals aged 6 months and older.
This recommendation is based on a comprehensive review of data, including pre-clinical and epidemiological studies, which suggest that the updated vaccine generates a robust immune response against multiple sublineages of the JN.1 variant of SARS-CoV-2. The European Commission is expected to make a decision on the recommendation shortly, allowing for immediate distribution to EU member states upon authorization.
The companies have been manufacturing doses of the updated vaccine in anticipation of increased demand during the upcoming fall and winter season. The CHMP's endorsement relies on evidence supporting the safety and efficacy of Pfizer and BioNTech's COVID-19 vaccines, including data indicating a substantially improved response against several JN.1 sublineages compared to their previous Omicron XBB.1.5-adapted vaccine.
Pfizer and BioNTech are also engaging with the U.S. Food and Drug Administration (FDA) for approval of their Omicron KP.2-adapted vaccine for the same age group. They will continue to monitor the evolving situation of COVID-19 and adapt their vaccines accordingly to address global health needs.
The COVID-19 vaccines developed by Pfizer and BioNTech utilize BioNTech's proprietary mRNA technology. BioNTech holds the marketing authorization for COMIRNATY and its adapted versions in various regions globally, including the European Union, the United Kingdom, and others.
The announcement comes as part of ongoing efforts by Pfizer and BioNTech to adapt their vaccine strategy to the changing landscape of the COVID-19 pandemic, ensuring continued protection against emerging variants. This information is based on a press release statement.
In other recent news, BioNTech continues to make strides in its oncology ventures, with its investigational drug BNT324/DB-1311 receiving Fast Track designation from the FDA for the treatment of metastatic castration-resistant prostate cancer.
This comes as H.C. Wainwright maintains a Buy rating on BioNTech, citing promising developments. Evercore ISI has also assigned an "In Line" rating, emphasizing the company's ongoing transition and potential for COVID and flu combination vaccines.
BioNTech, alongside Pfizer, Moderna (NASDAQ:), and Novavax (NASDAQ:), has reported encouraging results for their updated COVID-19 vaccines, designed for the 2024-25 season. Upon approval, these vaccines are expected to be more effective in neutralizing recent strains like KP.2. Novavax anticipates being able to supply their vaccine by autumn, pending regulatory approval.
BioNTech's FY23 revenues were reported at 3.8 billion, falling below expectations, with a FY24 revenue guidance in the range of 2.53.1 billion. The company's R&D expenses are projected to increase, aligning with the company's ambitions for its development programs.
Novavax has entered a licensing agreement with Sanofi (NASDAQ:) valued at a minimum of $1.2 billion for its COVID vaccine, providing a significant boost to the company. For 2024, Novavax forecasts revenues ranging from $400 million to $600 million. The company is currently awaiting a decision from the FDA regarding the acceptance of its COVID-19 vaccine targeting the JN.1 variant.
As Pfizer Inc. and BioNTech SE gain momentum with their latest Omicron JN.1-adapted COVID-19 vaccine, BioNTech's financial and operational metrics provide a nuanced view of the company's current market position. According to InvestingPro data, BioNTech currently holds a market capitalization of $19.64 billion, reflecting investor confidence in the company's value and potential for growth.
In terms of valuation, BioNTech's price-to-earnings (P/E) ratio stands at a high 160.71, indicating that investors may be expecting higher earnings growth in the future compared to the market average. This high earnings multiple is further contextualized by the company's strong free cash flow yield, a metric that suggests BioNTech is generating a healthy amount of cash relative to its share price, as highlighted in one of the InvestingPro Tips.
Another key metric to consider is the company's gross profit margin, which at 79.38% for the last twelve months as of Q1 2024, demonstrates BioNTech's ability to retain a significant portion of its revenue after accounting for the cost of goods sold. This robust margin is indicative of strong operational efficiency and pricing power.
InvestingPro Tips reveal strategic moves by BioNTech's management, such as aggressive share buybacks, which could be a sign of the company's belief in its own undervaluation. Moreover, the company's financial stability is underscored by its position of holding more cash than debt, providing flexibility for future investments or to weather potential downturns.
While analysts anticipate a sales decline in the current year, it is worth noting that BioNTech is trading at a low revenue valuation multiple and near its 52-week low, potentially offering an attractive entry point for investors. The company's liquid assets exceed short-term obligations, ensuring near-term financial resilience.
For readers interested in a deeper analysis, there are 14 additional InvestingPro Tips available for BioNTech at https://www.investing.com/pro/BNTX. These tips provide further insights into the company's financial health and market expectations. To access these tips and more detailed metrics, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Heres a look at the state of COVID-19 in the U.S. as the Centers for Disease Control and Prevention establishes its latest advice on vaccinations.
About 300 COVID-19-associated deaths were occurring weekly in May, according to the most recent provisional CDC data. Thats the lowest since the beginning of the pandemic. Nearly 26,000 people died from COVID-19 in the U.S. in the week ending Jan. 9, 2021 the highest weekly toll in the pandemic.
The COVID-19 hospitalization rate is 1.5 per 100,000 hospital visits. Thats up from about 1.1 in mid-May. It peaked at 35 in early 2022.
Individual COVID-19 cases are no longer tracked, but health officials can analyze wastewater to help them get a big-picture look at where the virus may be spreading. The CDC describes current wastewater levels as low nationwide but inching up, with higher levels noted in Florida, Utah, California and Hawaii.
As of May 11, fewer than one-quarter of U.S. adults had received the latest COVID-19 shot. About 42% of people 75 and older those most vulnerable to severe disease and death from COVID-19 got the latest shots.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.
As of last month, less than one-quarter of US adults and 14 per cent of children were up to date in their Covid-19 shots
With fresh Covid-19 cases bubbling up in some parts of the country, health officials are setting course for a fall vaccination campaign.
An influential government advisory panel on Thursday recommended new shots for all Americans this fall. The director of the Centers for Disease Control and Prevention must endorse the recommendation.
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Officials acknowledged the need for vaccinations is not as dire as it was only a few years ago. Most Americans have some degree of immunity from being infected, from past vaccinations or both. Covid-19 deaths and hospitalizations last month were at about their lowest point since the pandemic first hit the United States in 2020.
But immunity wanes, new coronavirus variants keep emerging and there are still hundreds of Covid-19-associated deaths and thousands of hospitalizations reported each week.
What's more, health officials have reported upticks this month in Covid-19-associated emergency room visits and hospitalizations, and a pronounced increase in positive test results in the southwestern US
It's not clear whether that's a sign of a coming summer wave which has happened before or just a blip, said Lauren Ancel Meyers of the University of Texas, who leads a research team that tracks Covid-19.
We'll have to see what happens in the coming weeks," she said.
At a Thursday meeting at the CDC in Atlanta, infectious disease experts voted to recommend updated Covid-19 vaccines for Americans age 6 months and older.
Health officials have told Americans to expect a yearly update to Covid-19 vaccines, just like they are recommended to get a new shot each fall to protect against the latest flu strains.
Earlier this month, the Food and Drug Administration following the guidance of its own panel of expert advisers told vaccine manufacturers to target the JN.1 version of the virus. But a week later, the FDA told manufacturers that if they could still switch, a better target might be an offshoot subtype called KP.2.
On Thursday, the CDC advisory panel voted 11-0 for a new round of shots, which officials say should become available in August and September.
Many Americans aren't heeding the CDC's advice.
As of last month, less than one-quarter of US adults and 14 per cent of children were up to date in their Covid-19 shots. Surveys show shrinking percentages of Americans think Covid-19 is a major health threat to the US population, and indicate that fewer doctors are urging patients to get updated vaccines.
CDC officials on Thursday presented recent survey information in which about 23 per cent of respondents said they would definitely get an updated Covid-19 shot this fall, but 33 per cent said they definitely would not.
Meanwhile, the CDC's Bridge Access Program which has been paying for shots for uninsured US adults is expected to shut down in August because of discontinued funding. The program paid for nearly 1.5 million doses from September to last month.
"It is a challenge with this program going away, said the CDC's Shannon Stokley.
About 1.2 million US Covid-19-associated deaths have been reported since early 2020, according to the CDC. The toll was most intense in the winter of 2020-2021, when weekly deaths surpassed 20,000. About 1 out of every 100 Americans ages 75 and older were hospitalized with Covid-19 in the last four years, CDC officials said Thursday.
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The updated COVID-19 vaccine is tailored to the Omicron JN.1 lineage of SARS-CoV-2 and is recommended for individuals 6 months of age and older
Recommendation is based on pre-clinical and epidemiological data showing that the JN.1-adapted monovalent COVID-19 vaccine generates an improved immune response against multiple JN.1 sublineages
Doses will be ready to ship to applicable EU member states immediately upon authorization by the European Commission
NEW YORK & MAINZ, Germany, June 27, 2024--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, "Pfizer") and BioNTech SE (Nasdaq: BNTX, "BioNTech") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization for the companies Omicron JN.1-adapted monovalent COVID-19 vaccine (COMIRNATY JN.1) 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 World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition and the European Medicines Agency's Emergency Task Force (ETF) to update COVID-19 vaccines to target the SARS-CoV-2 variant JN.1 for the 2024-2025 vaccination campaign. ETF stated that "evidence indicates that targeting JN.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve."1,2
The European Commission (EC) will review the CHMPs recommendation and is expected to make a final decision soon. Following the EC decision, the updated vaccine will be available to ship to applicable EU member states immediately. Pfizer and BioNTech have been manufacturing the Omicron JN.1-adapted monovalent COVID-19 vaccine at risk to ensure supply readiness ahead of the upcoming fall and winter season when the demand for COVID-19 vaccination is expected to increase.2
The CHMPs recommendation is based on the full body of previous clinical, non-clinical, and real-world evidence supporting the safety and efficacy of the COVID-19 vaccines by Pfizer and BioNTech. The application also included manufacturing and pre-clinical data showing that the JN.1-adapted monovalent COVID-19 vaccine generates a substantially improved response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages, compared with the companies Omicron XBB.1.5-adapted monovalent COVID-19 vaccine.3
Pfizer and BioNTech are starting rolling applications with the U.S. Food and Drug Administration (FDA), per recent FDA recommendation, requesting approval of their Omicron KP.2-adapted monovalent COVID-19 vaccines for individuals 6 months of age and older. The companies will continue to monitor the evolving epidemiology of COVID-19 and make appropriate preparations to meet global public health needs.
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The COVID-19 vaccines (COMIRNATY) by Pfizer and BioNTech are based on BioNTechs proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for COMIRNATY and its adapted vaccines (COMIRNATY Original/Omicron BA.4/5; COMIRNATY Omicron XBB.1.5) in the United States, the European Union, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.
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).
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:
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 should seek 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:
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/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, 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
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
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 childs 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 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.
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 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 June 27, 2024. 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 Pfizers efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162b2 mRNA vaccine program, and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (COVID-19 Vaccine, mRNA) (BNT162b2) including an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage, including a submission to the European Medicines Agency (EMA) for an Omicron-adapted monovalent COVID-19 vaccine, based on the JN.1 lineage, expectations regarding the demand for COVID-19 vaccines, planned regulatory submissions, qualitative assessments of available data, potential benefits, expectations for clinical trials, potential regulatory submissions, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply involving 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 clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data (including Phase 1/2/3 or Phase 4 data), including the data discussed in this release for BNT162b2, any monovalent or bivalent vaccine candidates or any other vaccine candidate in the BNT162 program in any of our studies in pediatrics, adolescents, or adults or real world evidence, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies, in real world data studies or in larger, more diverse populations following commercialization; the ability of BNT162b2, any monovalent or bivalent vaccine candidates or any future vaccine to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when additional data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when submissions to request emergency use or conditional marketing authorizations for BNT162b2 in additional populations, for a potential booster dose for BNT162b2, any monovalent or bivalent vaccine candidates or any potential future vaccines (including potential future annual boosters or re-vaccination), and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2, any monovalent or bivalent vaccine candidates or any other potential vaccines that may arise from the BNT162 program, including a potential variant-based, higher dose, or bivalent vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations), any monovalent or bivalent vaccine candidates (including the submission to the EMA for an Omicron-adapted monovalent COVID-19 vaccine candidate, based on the JN.1 lineage), or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccines benefits outweigh its known risks and determination of the vaccines efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; 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 which, for our COVID-19 vaccine, resulted in significant inventory write-offs in 2023 and could continue to result in inventory write-offs, or other unanticipated charges; challenges related to the transition to the commercial market for our COVID-19 vaccine; uncertainties related to the publics adherence to vaccines, boosters, treatments or combinations; risks related to our ability to accurately predict or achieve our revenue forecasts for our COVID-19 vaccine or any potential future COVID-19 vaccines; potential third-party royalties or other claims related to our COVID-19 vaccine; the risk that other companies may produce superior or competitive products; risks related to the availability of raw materials to manufacture or test a vaccine; challenges related to our vaccines formulation, dosing schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or potential future annual boosters or re-vaccinations or new variant-based vaccines; the risk that we may not be able to maintain or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements will be reached; uncertainties regarding 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; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.
A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2023 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
Biopharmaceutical New Technologies (BioNTech) is a global next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. BioNTech exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global and specialized pharmaceutical collaborators, including Biotheus, DualityBio, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, MediLink, OncoC4, Pfizer and Regeneron. 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 be limited to, statements concerning: BioNTechs efforts to combat COVID-19; the collaboration between BioNTech and Pfizer; the rate and degree of market acceptance of BioNTechs COVID-19 vaccine, including the Omicron JN.1-adapted monovalent COVID-19 vaccine; qualitative assessments of available data and expectations of potential benefits, including the adapted vaccines response against multiple Omicron JN.1 sublineages, including KP.2, KP.3 and other currently circulating sublineages; regulatory submissions and regulatory approvals or authorizations and expectations regarding manufacturing, distribution and supply; 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 neither promises nor guarantees, and 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 BioNTechs 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; BioNTechs pricing and coverage negotiations with governmental authorities, private health insurers and other third-party payors after BioNTechs initial sales to national governments; the future commercial demand and medical need for initial or booster doses of a COVID-19 vaccine; the availability of raw materials to manufacture a vaccine; our vaccines 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 BioNTechs 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 BioNTechs ability to obtain and maintain regulatory approval for BioNTechs product candidates; the ability of BioNTechs COVID-19 vaccines to prevent COVID-19 caused by emerging virus variants; BioNTechs and its counterparties ability to manage and source necessary energy resources; BioNTechs ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTechs third-party collaborators to continue research and development activities relating to BioNTechs development candidates and investigational medicines; the impact of the COVID-19 pandemic on BioNTechs development programs, supply chain, collaborators and financial performance; unforeseen safety issues and potential claims that are alleged to arise from the use of BioNTechs COVID-19 vaccine and other products and product candidates developed or manufactured by BioNTech; BioNTechs and its collaborators ability to commercialize and market BioNTechs COVID-19 vaccine and, if approved, its product candidates; BioNTechs ability to manage its development and expansion; regulatory developments in the United States and other countries; BioNTechs ability to effectively scale BioNTechs production capabilities and manufacture BioNTechs products, including BioNTechs target COVID-19 vaccine production levels, and BioNTechs 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, 2024, and in subsequent filings made by BioNTech with the SEC, which are available on the SECs website at 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.
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AP Medical Writer
NEW YORK (AP) As COVID-19 bubbles up in some parts of the country, health officials are setting course for a fall vaccination campaign. The Centers for Disease Control and Prevention on Thursday recommended a new round of shots for all Americans this fall. Officials acknowledge that the need for vaccinations is not as dire as it was only a few years ago. Most Americans have some degree of immunity. COVID-19 deaths and hospitalizations last month were at about their lowest point since the pandemic first hit the United States in 2020. But immunity wanes and new coronavirus variants keep emerging. There are still hundreds of COVID-19-associated deaths and thousands of hospitalizations reported each week.
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The Commissioner of the Border Management Authority (BMA), Dr Michael Masiapato, has announced that port health officials have developed an outbreak preparedness plan to deal with Monkey Pox or Mpox.
In response to the 13 cases that have been confirmed by the National Department of Health, the BMA is implementing screening processes for travellers entering the country at all ports of entry.
Masiapato said at the airports, the first phase of screening occurs when the conveyance operator which is the captain of the aircraft and crew members provide a general declaration of health.
This is a document required to be completed by all conveyance operators where they declare that no travellers have reported or were found to be ill on board. This is in terms of International Health Regulations.
The Commissioner said the process that follows is where travellers are subjected to thermal screening for checking temperature.
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Source: South African Government News Agency
A pasteurization approach widely used in the dairy industry proved to be effective at killing bird flu in milk after all, the Food and Drug Administration announced Friday, after an earlier federal lab study raised questions about the approach.
The FDA says its new results are the latest to show that drinking pasteurized grocery store milk remains safe, despite an outbreak of highly pathogenic avian influenza, or HPAI H5N1, on dairy farms across at least eight states.
"We had a lot of anecdotal evidence. But we wanted to have direct evidence about HPAI and bovine milk. So we began to build this custom instrument that replicates, on a pilot scale, commercial processing," Prater said.
click to expand
It comes weeks after researchers at the National Institutes of Health found some infectious bird flu virus was able to survive pasteurization in lab tests.
Both the FDA and the earlier NIH researchers looked at an approach called "flash pasteurization" or high temperature short time processing, which heats milk for at least 15 seconds at 161F.
Unlike the NIH study, Prater said the study with the U.S. Department of Agriculture took longer to complete because it was designed to more accurately simulate all the steps that go into processing milk in the commercial dairy industry.
The FDA said the tests show the pasteurization process was killing the virus even before it reached the final stages when milk is held at the right temperature, offering a "large margin of safety."
"What we found in this study actually is that the virus is completely inactivated even before it gets into the holding tube," Prater said.
Virus is likely being spread from infected cows to other animals and to humans that have worked on dairy farms through droplets of raw milk teeming with the virus, the USDA has said.
Eric Deeble, acting senior adviser for USDA's H5N1 response, told reporters on Tuesday that none of the confirmed infected herds so far had been supplying raw milk.
Hundreds of pasteurized milk and other dairy product samples tested by the FDA so far from grocery stores have also so far not found any infectious virus, but fragments of dead virus have turned up suggesting missed infections.
Prater said a second round of testing is underway, which will also look at cheese made from raw milk.
Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.
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Despite assurances from the federal government that bird flu will be eradicated from the nations dairy cows, some experts worry the disease is here to stay.
Recently, Eric Deeble, USDA acting senior advisor for H5N1 response, said that the federal government hoped to eliminate the disease from the dairy herd without requiring vaccines.
Since the disease was first publicly identified in dairy cattle on March 25, there have been 129 reports of infected herds across 12 states. In the last four weeks, there has been a surge jumping from 68 confirmed cases on May 28 to nearly twice that many as of June 25. There are no cases in California.
So far, however, the dairy industry has proved reluctant to work with state and federal governments to allow for widespread testing of herds.
To some epidemiologists, this lack of close herd surveillance is a problem. They worry that the virus is spreading unchecked among dairy cows and other animals, and has taken up permanent residence.
David Topham, a professor of microbiology and immunology at the University of Rochesters Center for Vaccine Biology and Immunology, said he considers H5N1 to be endemic in animals in North America citing its prevalence in wild bird populations as well as its long staying power in domestic poultry.
No one knows how widespread it is in cattle, Topham said, because testing has largely targeted symptomatic cows and herds. But I suspect the closer we look, the more well find, and I dont know if were going to cull our entire cattle herds and start over again.
Topham said he understands the industrys reluctance to permit government scientists onto farms because were going to want to see everything, and were going to report everything that we see, and that might be bad for business. ... But until we have all that information, I dont think we will have control.
Federal officials have announced a pilot bulk milk testing program that includes Kansas, Nebraska, New Mexico and Texas. Farmers in these states can voluntarily enroll to have bulk milk samples tested for the virus. If their samples test negative for three weeks, they will be able to move their herds across state lines without additional testing something they are currently unable to do.
So far, only one herd in each state has signed up.
A USDA strike force investigated 15 infected Michigan dairy herds as well as eight turkey flocks in early April. It worked with the state of Michigan as well as individual farmers.
The investigation was launched after local researchers identified a spillover event that went from infected cattle to a nearby poultry plant. The state and farmers wanted to know how it happened.
What the team found suggests the control Topham referred to may be elusive.
From surveys and observations, they found that cats and chickens were free to walk around without containment potentially migrating between nearby dairies and poultry farms. Some of these animals had become infected; several died.
Asked about their practices regarding isolation of newly introduced cattle, three out of 14 farms said they always isolated, another three said they never isolated, and the remainder didnt respond.
Then there was the dumping of unpasteurized, contaminated milk into the open waste lagoons on several of the farms. And the feeding of non-pasteurized milk to calves on three farms. Or the potentially contaminated manure that was stored, composted or applied to nearby fields. In one case, a farmer reported they had sold or given away potentially contaminated manure.
Finally there was the issue of humans: On every farm, there were visitors, carcass removal companies, milk suppliers, veterinarians and employees many of whom traveled between farms.
For instance, of the 14 dairies that reported information about their employees, three had employees that worked at other dairies, one had employees that worked at a poultry farm, and one had an employee who also worked at a swine farm. At four dairies, some of the employees were reported to have their own livestock at home.
As the authors reported, transmission between farms is likely due to indirect epidemiological links related to normal business operations ... with many of these indirect links shared between premises.
They noted there was no evidence to suggest waterfowl had introduced the virus to the Michigan herds.
Michael Payne, researcher and outreach coordinator at UC Davis School of Veterinary Medicine Western Institute for Food Safety and Security, said there was no one to blame for the lack of containment.
He said in the weeks and months before the disease was identified in cattle, researchers from across the nation scrambled to figure out what was happening to dairy cows in Texas that appeared listless and had diminished milk production.
Its not like people werent aware or concerned and trying to figure it out, he said. And then once it was identified, and it didnt seem to cause too much illness in cows or transfer to humans quickly, while there was urgency, the system fell into a series of incremental solutions negotiated among dozens of federal and state agencies.
He and Topham agree that no one can say for sure what the virus will do and where it will go next.
If it becomes endemic in cattle and is renamed bovine influenza, vaccines are likely to follow, as well as continuous surveillance and testing of dairy products.
Topham said that the biggest concern among epidemiologists now is how the virus will evolve as it continues to move largely unabated and undetected through cattle herds, resident farm animals and people.
There have been three human cases of H5N1 in U.S. dairy workers since March.
One key worry is that the virus may move with a dairy employee onto a small farm and then recombine inside a pig, dog or cat that is harboring another flu virus.
He and Payne agree that officials need to remain alert to signs that the virus is adapting in ways that could hurt humans.
Wastewater is one way to detect the location of the virus.
As of Tuesday, data from the academic research organization WastewaterSCAN show that levels of H5 influenza have been rising in wastewater samples from a facility in Boise, Idaho.
Asked about whether the regions health department was investigating, or if there was any idea where the H5 was coming from, Surabhi Malesha, communicable disease program manager at Central District Health in Idaho, said there was no way to know if the H5 signal was from H5N1 or another influenza subtype.
She said testing for H5 in wastewater had only recently started and therefore there is no way to compare this data from last year or the year before, and so we dont know what a baseline detection of H5 looks like.
Maybe we see H5 detections like this on a regular basis, and it is not of public health significance or importance. ... How do we define normalcy when we have nothing to compare the data to?
She said the findings were not a public health concern and her agency and the state do not need to really investigate into this, because this could be H5N1, or could be any other H5 strains, and it really does not affect the public in general.
Dennis Nash, distinguished professor of epidemiology and executive director of City University of New Yorks Institute for Implementation Science in Population Health, said that given the current situation, the wastewater sample should be considered H5N1 until proven otherwise. The only other H5 we know about is H5N2. And a man in Mexico City just died from that.
Nash said health officials should be trying to determine the source of the virus found in the wastewater: a nearby dairy herd, a milk processing site or raw milk that was dumped down the drain.
Idaho has reported 27 infected herds, although according to Malesha, none has been reported in the Central District.
You want to do everything you can to prevent these types of viruses from emerging, because once they do, we dont have a whole lot of control over them, Topham said. Because when the horse is out of the barn, its gone. So I think the question is, what do we need to do to keep this in check?
