Category: Corona Virus Vaccine

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Here are the numbers: COVID-19 is ticking up in some places, but levels remain low – The Associated Press

June 29, 2024

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.

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Here are the numbers: COVID-19 is ticking up in some places, but levels remain low - The Associated Press

Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European … – Yahoo Finance

June 29, 2024

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 http://www.vaers.hhs.gov/reportevent.html. In addition, you can report side effects to Pfizer Inc. at 1-800-438-1985 or http://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 http://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 http://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 http://www.Pfizer.com. In addition, to learn more, please visit us on http://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 http://www.sec.gov and http://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 http://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 http://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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Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron JN.1-adapted COVID-19 Vaccine in the European ... - Yahoo Finance

As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign – KEYT

June 29, 2024

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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As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign - KEYT

As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign – bedfordgazette.com

June 29, 2024

State Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington Washington D.C. West Virginia Wisconsin Wyoming Puerto Rico US Virgin Islands Armed Forces Americas Armed Forces Pacific Armed Forces Europe Northern Mariana Islands Marshall Islands American Samoa Federated States of Micronesia Guam Palau Alberta, Canada British Columbia, Canada Manitoba, Canada New Brunswick, Canada Newfoundland, Canada Nova Scotia, Canada Northwest Territories, Canada Nunavut, Canada Ontario, Canada Prince Edward Island, Canada Quebec, Canada Saskatchewan, Canada Yukon Territory, Canada

Zip Code

Country United States of America US Virgin Islands United States Minor Outlying Islands Canada Mexico, United Mexican States Bahamas, Commonwealth of the Cuba, Republic of Dominican Republic Haiti, Republic of Jamaica Afghanistan Albania, People's Socialist Republic of Algeria, People's Democratic Republic of American Samoa Andorra, Principality of Angola, Republic of Anguilla Antarctica (the territory South of 60 deg S) Antigua and Barbuda Argentina, Argentine Republic Armenia Aruba Australia, Commonwealth of Austria, Republic of Azerbaijan, Republic of Bahrain, Kingdom of Bangladesh, People's Republic of Barbados Belarus Belgium, Kingdom of Belize Benin, People's Republic of Bermuda Bhutan, Kingdom of Bolivia, Republic of Bosnia and Herzegovina Botswana, Republic of Bouvet Island (Bouvetoya) Brazil, Federative Republic of British Indian Ocean Territory (Chagos Archipelago) British Virgin Islands Brunei Darussalam Bulgaria, People's Republic of Burkina Faso Burundi, Republic of Cambodia, Kingdom of Cameroon, United Republic of Cape Verde, Republic of Cayman Islands Central African Republic Chad, Republic of Chile, Republic of China, People's Republic of Christmas Island Cocos (Keeling) Islands Colombia, Republic of Comoros, Union of the Congo, Democratic Republic of Congo, People's Republic of Cook Islands Costa Rica, Republic of Cote D'Ivoire, Ivory Coast, Republic of the Cyprus, Republic of Czech Republic Denmark, Kingdom of Djibouti, Republic of Dominica, Commonwealth of Ecuador, Republic of Egypt, Arab Republic of El Salvador, Republic of Equatorial Guinea, Republic of Eritrea Estonia Ethiopia Faeroe Islands Falkland Islands (Malvinas) Fiji, Republic of the Fiji Islands Finland, Republic of France, French Republic French Guiana French Polynesia French Southern Territories Gabon, Gabonese Republic Gambia, Republic of the Georgia Germany Ghana, Republic of Gibraltar Greece, Hellenic Republic Greenland Grenada Guadaloupe Guam Guatemala, Republic of Guinea, Revolutionary People's Rep'c of Guinea-Bissau, Republic of Guyana, Republic of Heard and McDonald Islands Holy See (Vatican City State) Honduras, Republic of Hong Kong, Special Administrative Region of China Hrvatska (Croatia) Hungary, Hungarian People's Republic Iceland, Republic of India, Republic of Indonesia, Republic of Iran, Islamic Republic of Iraq, Republic of Ireland Israel, State of Italy, Italian Republic Japan Jordan, Hashemite Kingdom of Kazakhstan, Republic of Kenya, Republic of Kiribati, Republic of Korea, Democratic People's Republic of Korea, Republic of Kuwait, State of Kyrgyz Republic Lao People's Democratic Republic Latvia Lebanon, Lebanese Republic Lesotho, Kingdom of Liberia, Republic of Libyan Arab Jamahiriya Liechtenstein, Principality of Lithuania Luxembourg, Grand Duchy of Macao, Special Administrative Region of China Macedonia, the former Yugoslav Republic of Madagascar, Republic of Malawi, Republic of Malaysia Maldives, Republic of Mali, Republic of Malta, Republic of Marshall Islands Martinique Mauritania, Islamic Republic of Mauritius Mayotte Micronesia, Federated States of Moldova, Republic of Monaco, Principality of Mongolia, Mongolian People's Republic Montserrat Morocco, Kingdom of Mozambique, People's Republic of Myanmar Namibia Nauru, Republic of Nepal, Kingdom of Netherlands Antilles Netherlands, Kingdom of the New Caledonia New Zealand Nicaragua, Republic of Niger, Republic of the Nigeria, Federal Republic of Niue, Republic of Norfolk Island Northern Mariana Islands Norway, Kingdom of Oman, Sultanate of Pakistan, Islamic Republic of Palau Palestinian Territory, Occupied Panama, Republic of Papua New Guinea Paraguay, Republic of Peru, Republic of Philippines, Republic of the Pitcairn Island Poland, Polish People's Republic Portugal, Portuguese Republic Puerto Rico Qatar, State of Reunion Romania, Socialist Republic of Russian Federation Rwanda, Rwandese Republic Samoa, Independent State of San Marino, Republic of Sao Tome and Principe, Democratic Republic of Saudi Arabia, Kingdom of Senegal, Republic of Serbia and Montenegro Seychelles, Republic of Sierra Leone, Republic of Singapore, Republic of Slovakia (Slovak Republic) Slovenia Solomon Islands Somalia, Somali Republic South Africa, Republic of South Georgia and the South Sandwich Islands Spain, Spanish State Sri Lanka, Democratic Socialist Republic of St. Helena St. Kitts and Nevis St. Lucia St. Pierre and Miquelon St. Vincent and the Grenadines Sudan, Democratic Republic of the Suriname, Republic of Svalbard & Jan Mayen Islands Swaziland, Kingdom of Sweden, Kingdom of Switzerland, Swiss Confederation Syrian Arab Republic Taiwan, Province of China Tajikistan Tanzania, United Republic of Thailand, Kingdom of Timor-Leste, Democratic Republic of Togo, Togolese Republic Tokelau (Tokelau Islands) Tonga, Kingdom of Trinidad and Tobago, Republic of Tunisia, Republic of Turkey, Republic of Turkmenistan Turks and Caicos Islands Tuvalu Uganda, Republic of Ukraine United Arab Emirates United Kingdom of Great Britain & N. Ireland Uruguay, Eastern Republic of Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam, Socialist Republic of Wallis and Futuna Islands Western Sahara Yemen Zambia, Republic of Zimbabwe

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As COVID-19 ticks up in some places, US health officials recommend a fall vaccination campaign - bedfordgazette.com

Covid-19 outbreak in California: What is happening in the state? – EL PAS USA

June 26, 2024

Over the past few weeks, Google searches for the term FLiRT have increased by 98%. The spike in interest is due to the fact that SARS-CoV-2 the virus that causes Covid-19 continues to mutate. In April, a group of new viral strains called FLiRT variants was identified.

The term FLiRT comes from the technical names for their mutations. This is the term being used to describe a whole family of different variants including KP.2, JN.1.7, and any other variants starting with KP or JN that appear to have independently picked up the same set of mutations, explains the Johns Hopkins University.

According to an article from Yale University, to better understand how the FLiRT strains emerged, it is useful to see how the SARS-CoV-2 virus has changed over time, with new variants forming as mutations emerged in its genetic code. The article explains that the Omicron variant of SARS-CoV-2, which took hold in the United States in 2021, gave rise to various subvariants, including JN.1, which was identified in September 2023.

FLiRT variants have become a significant concern in the United States due to their ability to spread rapidly and evade acquired immunity, both from previous infections and vaccines. Indeed, the variants are of such great concern, the Centers for Disease Control and Prevention (CDC) is now closely monitoring them.

The KP.3 variant comes from JN.1.11.1, a direct descendant of JN.1. The main concerns over the KP.3 variant are due to its genetic mutations, especially in the spike protein, which is crucial for the virus entry into human cells. These genetic mutations have led to a rapid increase in Covid-19 cases in densely populated regions, with California one of the most affected states in the United States.

Johns Hopkins University reported: At the end of March, the KP.2 variant was causing about 4% of infections in the U.S., according to the CDC, while its parental strain, JN.1, was causing over 50% of infections at that time. As of early May, KP.2 makes up about 28% of infections, overtaking JN.1 as the dominant variant. Now KP.3 is gaining ground.

Based on estimates from California Department of Public Health model, KP.3 is expected to be the dominant variant (41.9%).

People of different ages in the U.S. have been affected by the recorded Covid-19 cases due to the KP.3 variant. Some specialists say that, even if a person has had JN.1, they can become infected with the KP.3 variant, especially if their last infection with Covid-19 occurred several months ago.

At this time, common symptoms of the new Covid-19 KP.3 and other variants of the FLiRT strain are:

Californias Department of Public Health continues to recommend vaccination as the primary strategy to reduce the risk of severe illness, hospitalization, and death from Covid-19. But there are other easy measures to follow too:

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Covid-19 outbreak in California: What is happening in the state? - EL PAS USA

Increase in COVID-19 cases expected this summer – WWLP.com

June 26, 2024

SPRINGFIELD, Mass. (WWLP) COVID-19 is constantly showing us that its here to stay. 22News spoke with a health expert who talks about how we can protect ourselves from the disease this summer.

The COVID-19 summer wave is making its way across the U.S. as temperatures warm up. More people across the nation are starting to come down with the disease as they spend more time out at large gatherings. This COVID surge comes as temperatures warm up, which increases the transmission of the disease.

While COVID cant survive long in high temperatures, those warm temperatures cause more people to head inside where its much cooler. Diseases like COVID are able to spread quicker in low temperatures.

Dr. Robert Baldor with Baystate Health told 22News that many people think that COVID is gone but it is in fact still here and it is coming with a series of different strains and variants including KP.2, KP.3 and LB.1.

As COVID-19 spreads, older adults over the age of 65 and those who are immunocompromised are at higher risk of getting severely sick from COVID-19.

Dr. Baldor says its important for this group to take the proper safety precautions, Those people are more at risk. They should be thinking about masking and staying away from places at least for a little bit until we figure out what is going on. This is happening and its not clear if we are going to have a big breakout or not. I do not think it is going to be as bad because so many of us have been vaccinated.

According to the Massachusetts Department of Public Health, COVID-19 reported cases have increased since the end of April but only by a small amount. Last year, reported cases between July and September nearly tripled.

Dr. Baldor says vaccinations are another way to protect yourself from getting sick. He says a new vaccination is coming later this fall. In the meantime, if you are feeling sick it is important to stay inside to prevent others from getting sick.

WWLP-22News, an NBC affiliate, began broadcasting in March 1953 to provide local news, network, syndicated, and local programming to western Massachusetts. Watch the 22News Digital Edition weekdays at 4 p.m. on WWLP.com.

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SCOTUS Refuses To Hear Texas Group’s Lawsuit Over Coronavirus Vaccine 710am KURV – kurv

June 26, 2024

A Texas group is blasting the Supreme Courts rejection of their lawsuit over the FDAs emergency authorization of the COVID vaccine.

The group claimed the shot was dangerous, and criticized what it referred to as federal pro-vaccine propaganda. The activists were backed by the Childrens Health Defense, a nonprofit founded by presidential candidate Robert F. Kennedy Jr.

The Supreme Court on Tuesday said the group had no legal standing in its lawsuit.

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SCOTUS Refuses To Hear Texas Group's Lawsuit Over Coronavirus Vaccine 710am KURV - kurv

The Covid summer wave is here – NBC News

June 25, 2024

If more people around you seem to be coming down with Covid lately, thats because infections are indeed on the rise nationally.

Cases are most likely increasing in 39 states and arent declining anywhere in the U.S., according to the Centers for Disease Control and Prevention evidence that an anticipated summer wave is underway.

The CDC no longer tracks Covid cases, but it estimates transmission based on emergency department visits. Both Covid deaths and ED visits have risen in the last week. Hospitalizations also climbed 25% from May 26 to June 1, the latest data available.

California in particular appears to be experiencing a notable rise in infections. The states data suggests high levels of coronavirus in wastewater, and Covid has gotten more prevalent there since May. The documented share of Covid tests in California that came back positive has risen from around 3% to 7.5% in the last month or so.

It looks like the summer wave is starting to begin, said Dr. Thomas Russo, chief of infectious diseases at the University at Buffalo Jacobs School of Medicine and Biomedical Sciences.

Covid infections have historically spiked over the summer, in part because of an increase in travel and people congregating indoors, where its cooler. This year appears to be no exception, though disease experts expect this seasons wave to be milder in terms of severe disease.

Several variants are likely to be contributing to the nationwide trend, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston.

Were seeing the start of an uptick of infections that is coincident with new variants that are developing: KP.2 and KP.3 and LB.1. It does appear that those variants do have an advantage over the prior ones, he said.

All three variants are descendants of JN.1, the version of the coronavirus that took over this winter, so experts think of them as cousins.

KP.2 became the dominant variant in the U.S. last month, and then KP.3 took over in early June. Along with a third variant that shares the same key mutations, KP.1.1, the group accounts for around 63% of Covid infections in the U.S. Some scientists collectively refer to the variants as FLiRT a reference to their amino acid changes.

LB.1 accounts for another 17.5% of Covid infections. Experts said its rapid growth indicates that its likely to become dominant soon, though scientists still want to study it more closely.

Its sort of the newest kid on the block, Barouch said. Theres not much known about it.

A preprint paper released this month, which hasnt been peer-reviewed, suggests that LB.1 is more infectious than the FLiRT variants and could be better at evading protection from vaccines or previous infections.

Assuming that preliminary data is true, that its more immune-evasive and that its more infectious than KP.2 and KP.3, thats a winning formula to infect more people, Russo said.

The CDC doesnt regularly track Covid symptoms over time, so its hard to know whether illnesses caused by any of the new variants look any different. For the most part, Covid symptoms have been consistent for the last two-plus years.

Variants aside, several other factors could help the virus spread this summer. Experts said cases will probably continue to rise as people retreat indoors to escape this months punishing heat wave and gather to celebrate the Fourth of July.

Russo recommended that people who are the most vulnerable to infection those who are older or immunocompromised or engage in riskier activities, such as attending large parties or gatherings consider getting the latest Covid vaccine now if they havent already.

He added that a monoclonal antibody drug called Pemgarda has been available since April for immunocompromised people. The antiviral medication Paxlovid should also help reduce the likelihood of hospitalization or death.

But most young, healthy people can hold out for the updated Covid vaccines expected to arrive this fall, experts said. The Food and Drug Administration advised vaccine manufacturers this month to target the KP.2 variant. The CDCs Advisory Committee on Immunization Practices is scheduled to meet Thursday to decide who should get those shots.

A vaccine targeting KP.2 vaccine wont be a direct match for the dominant strain come fall the variant declined in prevalence last week compared to two weeks before.

The virus already appears to be evolving beyond whats going to be the fall boosters, and its only June, Barouch said. Even so, he added, the updated vaccines should still protect against the various variants circulating right now.

Aria Bendix is the breaking health reporter for NBC News Digital.

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The Covid summer wave is here - NBC News

Supreme Court rejects COVID-19 vaccine appeals from nonprofit founded by Robert F. Kennedy Jr. – The Seattle Times

June 25, 2024

WASHINGTON (AP) The Supreme Court on Monday rejected two appeals related to COVID-19 vaccines from Childrens Health Defense, the anti-vaccine nonprofit founded by independent presidential candidate Robert F. Kennedy Jr.

The justices did not comment in letting stand rulings against the group from the federal appeals courts in New Orleans and Philadelphia.

In a case from Texas, the group joined parents in objecting to the U.S. Food and Drug Administrations authorization to administer coronavirus vaccines to children. In a case from New Jersey, Childrens Health Defense challenged a Rutgers University requirement, imposed in 2021, for most students to be vaccinated to attend courses on campus, though the school did not force faculty or staff to be vaccinated.

Childrens Health Defense has a lawsuit pending against a number of news organizations, among them The Associated Press, accusing them of violating antitrust laws by taking action to identify misinformation, including about COVID-19 and COVID-19 vaccines. Kennedy took leave from the group when he announced his run for president but is listed as one of its attorneys in the lawsuit.

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Covid-19 vaccinations advised as summer approaches – Royal Gazette

June 25, 2024

Updated: Jun 24, 2024 07:59 AM

Kim Wilson, the Minister of Health, receives her Covid-19 vaccination when it became available in 2021 (File photograph)

Residents were urged to keep up to date with Covid-19 vaccinations as increased travel and social gatherings were expected during the summer.

The Ministry of Healths epidemiology and surveillance unit reminded people to be mindful of potential risks associated with the coronavirus during this time of increased Covid-19 transmission in our community.

It was reported in The Royal Gazette this month that two hospital units were on isolation after patients tested positive for Covid-19, with some staff on leave at the time because of infections from the virus.

Kim Wilson, the health minister, said: While we have made progress in protecting against severe illness from Covid-19, this virus remains present in our community.

We will likely always have some cases and I urge everyone to continue taking precautions to avoid catching and spreading Covid-19.

The ministry said there was updated guidance from the US Centres for Disease Control and Prevention that focused on vaccination and prevention strategies.

It added: The CDC recommends that everyone stay up to date with Covid-19 vaccinations.

This means receiving all recommended doses, including at least one dose of the updated 2023-24 Covid-19 vaccine. This updated vaccine targets the XBB lineage of the Omicron variant.

The 2023-24 Covid-19 vaccines are available from the Hamilton Health Centre by appointment and at GP offices.

The ministry said: As the Covid-19 virus continues to change, updates to the Covid-19 vaccine can be expected in the future.

People who are 65 years and older and those with chronic diseases are eligible for additional doses.

They should consult with their physicians regarding the timing of additional doses to maintain optimal protection.

To help prevent the spread of Covid-19 and other respiratory viruses, persons who develop symptoms of or who test positive for a respiratory illness including fever, cough, and sore throat should stay home and away from others until 24 hours after the fever and other symptoms have resolved, without fever-reducing medication.

If testing positive for Covid-19, precautions such as physical distancing and mask wearing are recommended for an additional five days.

People at higher risk for severe illness, such as older adults and those with underlying health conditions, should seek healthcare immediately if they develop symptoms.

Early testing and treatment can help prevent severe disease.

The health ministry highlighted CDC advice that maintaining good hygiene practices including frequent hand washing wearing masks in crowded indoor settings and ensuring proper ventilation, could help reduce the spread of Covid-19, regardless of vaccination status.

It added: By following these guidelines, individuals can better protect themselves and their communities from Covid-19.

For more detailed information, you can visit the CDC's official pages on Covid-19 vaccination and respiratory virus guidance.

The ministry said summary updates on Covid-19 and other public health conditions could be found at gov.bm/health-information, which was updated weekly.

It added: While it doesn't provide specific Covid numbers, it does indicate if the country is seeing an increase in cases.

Health officials told the Gazette on June 11 that, up to that point, six deaths on the island this year were linked to the coronavirus, with 303 confirmed cases logged in 2024 to June 8.

A BHB spokeswoman said then that a long-term care unit at King Edward VII Memorial Hospital and a unit at the Mid-Atlantic Wellness Institute were under quarantine, with visits on hold, after an unspecified number of patients tested positive for the illness.

She added at the time: Some of our 1,800 staff members are also on leave due to Covid infections.

The BHB said: We may feel like Covid is behind us, but it is important to remember that its still circulating in the community.

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Covid-19 vaccinations advised as summer approaches - Royal Gazette

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