Category: Flu Vaccine

The UK division of CSLS is Britains biggest end-to-end vaccine manufacturer by some margin. Its main business revolves around manufacturing the jabs which protect against seasonal flu, its products being used throughout the NHS and across Europe.

Its a tricky job, a primary skill being in matching the annual jab with the anticipated seasonal flu strain some six months ahead of its actual arrival. If youve seen one flu season, youve seen one flu season, says Mr Hilton, quoting an industry axiom.

The Liverpool plant makes all its vaccines in the old fashioned way - by growing the virus in fertilised chicken eggs before deactivating it for use in vaccines. The company has the capacity to take delivery of 575,000 eggs a day - enough to make 40 litres of a single strain of vaccine over an incubation period of 13-14 days.

The eggs are of a very different categorisation to those found in the supermarket. They come from 21 specialist bio-secure hatcheries in which the chickens and their eggs are kept protected from any bugs that could be passed on. They may not be free range but they are pathogen free, says Mr Hilton.

We spend a lot of time and effort to make sure we are ready to spring [into action] if there is a pandemic - just the strain of the virus needs to be plugged in.

Go here to see the original:

The Liverpool vaccine factory preparing for a H5N1 bird flu pandemic - The Telegraph

Summary

What CDC knows

Vaccines are an effective tool for protecting Americans against the most severe effects of many infectious diseases. The Advisory Committee on Immunization Practices (ACIP) is an advisory panel made up of external experts who advise CDC on the use of vaccines for the prevention of infectious diseases. ACIP met June 26-28 and voted unanimously on several recommendations.

What CDC is doing

The CDC director adopted all the vaccine recommendations that ACIP voted on. These are now official CDC public health guidance for the safe use of the vaccines in the United States and will be published as official recommendations in the Morbidity and Mortality Weekly Report (MMWR). CDC will communicate these recommendations to the public, healthcare providers, and public health professionals to ensure everyone has the information needed to protect their health from vaccine-preventable diseases.

CDC relies on an external advisory panel of medical experts to make recommendations that shape policy for vaccine-preventable infectious diseases in the United States.

The group, known as the Advisory Committee on Immunization Practices (ACIP), typically meets in Atlanta at least three times a year. ACIPs decisions on vaccines are important. The CDC director reviews each decision and they become official agency policy once adopted, helping protect the health of all Americans.

At its most recent meeting June 26-28, 2024, ACIP reviewed data on disease burden and vaccine effectiveness and safety, among other data. ACIP voted on vaccine recommendations for the upcoming respiratory virus season, as well as for recommendations for vaccines to protect against some bacterial diseases. The following decisions have now been adopted by the CDC director.

ACIP offered clearer guidance around the use of the respiratory syncytial virus (RSV) vaccines for older adults. RSV vaccines for older adults became available for the first time in the United States last year.

Older adults are at higher risk of developing severe RSV. The initial recommendations called for adults 60 years and older to receive one dose of the RSV vaccine based on shared clinical decision making, that is, a conversation between patient and healthcare provider about whether the shot was appropriate for them based on their health conditions. In the context of new data that are now available on RSV vaccines for older adults, the recommendations were updated to be more specific and streamlined.

The updated RSV vaccine recommendations for adults 60 years and older are age- and risk-based. ACIP now recommends all adults 75 years of age and older receive a single dose of RSV vaccine. Adults 60 to 74 years of age should get a single dose of RSV vaccine if they are at increased risk of severe RSV disease. Adults ages 60 to 74 are at higher risk if they have certain chronic medical conditions, such as lung or heart disease, or if they live in a nursing home or long-term care facility.

RSV vaccination is currently recommended as a one-time dose. If you have already received RSV vaccination, another dose is not recommended for you at this time.

RSV immunization recommendations to protect infants, either through maternal vaccination or RSV antibody given to the baby after birth, stayed the same. CDC continues to recommend RSV immunizations to protect all babies from severe RSV.

Data continue to show the importance of vaccination to protect against COVID-19. ACIP recommends new 2024-2025 COVID-19 vaccines as authorized by the Food and Drug Administration (FDA) for everyone 6 months of age and older. FDA recently recommended that vaccine manufacturers use the KP.2 variant of the JN.1 lineage, if feasible, for fall vaccines, to more closely match circulating variants. This recommendation will take effect as soon as the new vaccines are available, which is anticipated in early September.

ACIP reaffirmed its recommendation for routine annual influenza vaccination of all people ages 6 months and older who do not have contraindications. Updated 2024-2025 flu vaccines will all be trivalent and will protect against an A(H1N1), an A(H3N2), and a B/Victoria lineage virus.

For solid organ transplant recipients aged 18 through 64 years who are taking immunosuppressive medication regimens, ACIP now recommends high-dose (HD-IIV3) and adjuvanted (aIIV3) inactivated influenza vaccines as acceptable options for influenza vaccination, without a preference over other age-appropriate inactivated or recombinant influenza vaccines.

As for pneumococcal disease, ACIP recommends a new vaccine that provides protection against serotypes of the bacteria that commonly cause disease in adults. A new 21-valent pneumococcal conjugate vaccine (PCV21) is now an option for adults ages 19 years and older who currently have a recommendation to receive a dose of PCV.

PCV21 includes eight new pneumococcal serotypes that are not contained in currently available pneumococcal vaccines. It no longer includes certain serotypes that used to be common before the introduction of PCV but are now infrequent among the general adult population.

The recommendation for the new vaccine comes at a time when an increase in the incidence of invasive pneumococcal disease in the United States has been reported after reduction in incidence early in the COVID-19 pandemic.

Invasive Haemophilus influenzae type b (Hib) disease is a rare but serious bacterial infection that disproportionally affects American Indian and Alaska Native infants. Until now, PedvaxHIB was the only Hib vaccine preferentially recommended over other Hib vaccine options for these infants because it provides a protective antibody response after the first dose.

ACIP voted to recommend that Vaxelis be included in the preferential recommendation for American Indian and Alaska Native infants based on the Hib component. New immunogenicity dataafter the first dose of Vaxelis are available now and supported the recommendation.

For more information on what was discussed and voted on at the ACIP meeting, click here.

Read the original:

CDC Updates Vaccine Recommendations - CDC

While flu vaccine effectiveness varies year-to-year, research shows that flu vaccines are typically between 40% and 60% effective during years when the most prevalent flu strains match the strains in the vaccine. This means the vaccine reduces your risk of catching the flu by 40% to 60%.

The vaccine also reduces the likelihood of severe illness, hospitalization, and death. Because of this, the Centers for Disease Control and Prevention (CDC) recommends that everyone ages 6 months and over gets the flu vaccine (with very rare exceptions).

There are nine different flu vaccines available for the 20232024 flu season. All of them protect against the same four strains of flu. Heres what you should know about flu vaccine effectiveness and types of flu vaccines.

Verywell / Theresa Chiechi

Each year, the flu vaccine is designed to protect against the flu strains that scientists believe will be most common. However, the effectiveness of the flu vaccine depends on which flu strains are most prevalent and how they compare to the strains that the vaccine protects against.

Because of this, flu vaccine effectiveness varies from year to year. Scientists dont yet have final estimates for the effectiveness of the flu vaccine for the 20222023 season, but preliminary data show a range of 39%-44% effectiveness in adults.

The CDC tracks seasonal flu vaccine effectiveness each year. Over the past 17 years, the highest effectiveness was in the 2010-2011 season, when it was 60% effective.

Here are the effectiveness rates over the past five seasons for which data are available:

During the 20202021 flu season, the CDC didnt estimate the effectiveness of the vaccine because transmission of the flu was historically low, likely due to COVID-19 precautions that also protect against the flu.

The flu vaccine (flu shot or nasal spray vaccine) significantly reduces the risk of contracting the flu. Consider the 20192020 season: People who had the vaccine were 39% less likely to get the flu than those who did not.

In addition to preventing illness, the flu vaccine also reduces the risk of hospitalization and death. Heres what researchers have found about the flu vaccine:

In addition to protecting you, getting the flu vaccine can keep you from contracting the flu and passing it to others, including infants and the elderly, who are at higher risks for complications.

Pregnant people who get the vaccine help protect their baby from the flu (passing on the protective antibodies developed by the vaccine), which can be valuable during the first six months of life when a child is not able to be vaccinated.

There are a number of factors that influence how effective the flu vaccine is every year. The most important is strain matchingwhether the strains that the vaccine protects against match the most widely circulating flu strains during a given season.

In addition to the construction of the vaccine, there are more personal factors that influence vaccine effectiveness.

To decide which strains are covered by the flu vaccine, data on flu infections are collected from around the globe. Using that, the World Health Organization (WHO) meets twice a year to decide which strains to focus on in the vaccines.

For the Northern Hemisphere, the WHO makes a recommendation in February. In the United States, the Food and Drug Administration (FDA) has the final say in which strains are included in the vaccine.

The decision about which strains to include is based on projections that are made using past data. This gives time to manufacture the vaccine.

It takes two weeks for the flu vaccine to become optimally effective. Because of that, the CDC recommends that all people get the flu vaccine during September or October, before flu infections become widespread.

Getting the vaccine too late can leave you exposed to early infection from the flu. On the other hand, vaccine protection begins to wane after several months. Adults ages 65 and older are generally not vaccinated early (July or August) due to this.

The CDC recommends the vaccine (even later in the season) for people who didn't get vaccinated in by October since flu can spread throughout the spring.

CDC data show that within a given year, the protection that the flu vaccine offers can vary based on age due to immune changes over time. Theres no way to predict which age groups the flu vaccine will be most or least effective for in a given season.

The CDC recommends that people age 65 and older receive a higher-dose or adjuvanted flu vaccine.

Vaccines rely on a person's immune system responding to the vaccine by producing antibodies, which are proteins that have specific targets, in this case on the influenza virus.

If a person has an impaired immune system due to a health condition, they may not mount the desired immune response, reducing the vaccine's effectiveness. There are a wide variety of health conditions that can impair your immune system response.

This is one reason that everyone should be vaccinated. By having less risk of getting and spreading the flu, they protect those who have impaired immunity and, therefore, can't benefit as much from vaccinating themselves.

There are nine types of flu vaccines (shots and nasal spray) available for the 2022-2023 season. All nine protect against the same four strains of flu. Because they protect against four they are called quadrivalent vaccines.

The CDC doesnt recommend one type of vaccine over the others. However, some people, including people under the age of 2, over the age of 65, who have allergies, or are pregnant, have special considerations and should talk to their doctor about which vaccine is best.

Some studies indicate that a higher-dose vaccine or an adjuvanted flu vaccine (one with an additional substance called an adjuvant that enhances the body's immune response to an antigen) creates a stronger immune response) produce a stronger immune response and are therefore more effective for this population.

The CDC recommends people age 65 and older receivea higher-dose vaccine or an adjuvanted flu vaccine (one with an additional substance called an adjuvant that enhances the body's immune response to an antigen). Three vaccines are specifically recommended for this population:

According to the CDC, people who have severe allergies to an ingredient in the flu vaccine or who have had a severe reaction to the flu vaccine should not get a flu shot.

Most flu vaccines are made using eggs or egg protein, but the CDC states that people with egg allergies can get any flu vaccine, regardless of the severity of their allergy. The CDC previously had recommended that people with egg allergies should get their flu shots in an inpatient or outpatient setting. For those interested in an egg-free flu shot, the two egg-free vaccine options are:

Pregnant people can get any flu vaccine except for FluMist, which contains a live virus.

FluMist Quadrivalent is a vaccine administered via a nasal spray. It is approved for people ages 2 through 49. However, its the only vaccine that contains a live, weakened virus, and it should not be used by pregnant or immunocompromised people. Talk to your healthcare provider about whether FluMist is safe for you.

There are five flu vaccines approved for babies 6 months and older. They are:

The flu vaccine needs two weeks to become fully effective, and protection is thought to last for at least six months. But a person's antibody levels in response to the vaccine can decrease over time, and different flu strains may be circulating.

Because of that and because each year the vaccine is tailored to the most concerning flu variants, people should get a flu vaccine annually.

Side effects of the flu vaccine are usually mild and go away without treatment in a few days. Common side effects include:

Rarely, allergic reactions occur, often within minutes of the vaccine being administered. If you experience swelling, racing heart or trouble breathing, seek medical attention immediately. Extremely rarely (no more than one or two cases per million people who receive the flu vaccine) a person may develop Guillain-Barr syndrome, an autoimmune disease.

The flu vaccine can prevent illness, hospitalization, and death. The CDC recommends that everybody aged 6 months and older get the vaccine every year (with very rare exceptions). The effectiveness of the vaccine varies since the vaccine only protects against certain strains of flu. Over the past five years, the effectiveness of the flu vaccine has ranged from 29%40%.

Deciding whether to vaccinate can be a big decision. Although the flu is a common illness, it can be deadly, particularly for people over the age of 65. The flu vaccine isnt 100% effective, but it does significantly reduce the risk of illness, hospitalization, and death.

If you have questions about the vaccine, talk to your doctor about whether it is right for you or your children.

The flu vaccine first became available in the 1930s, and it became widely available in 1945.

Flu vaccine effectiveness varies from year to year. It depends on how well the strains in the vaccine match the strains that are most prevalent in a given year.

Yes, the CDC says that the flu vaccine and COVID-19 vaccine, including boosters, can be administered at the same time.

The flu shot is made with either killed or weakened flu virus. The shots also contain inactive ingredients, including preservatives.

Continued here:

What to Know About Flu Vaccine Effectiveness - Verywell Health

Three people who worked with infected poultry in Colorado are believed to have contracted avian influenza, state health officials said Friday, potentially bringing the number of U.S. cases identified in humans since April to seven.

The workers contracted mild symptoms after culling infected poultry at a farm with a commercial egg operation and tested presumptive-positive for the flu, the Colorado Department of Public Health and Environment said in a statement.

The Centers for Disease Control and Prevention will confirm the testing and will send a team to Colorado to investigate how the workers might have contracted the virus, the agency said Friday. The CDC will also analyze the virus sequences to determine whether the virus has mutated.

The virus which has caused outbreaks in dairy cattle and poultry this spring and summer has posed a low risk to the general public because its unlikely to be spread from person to person. It could pose a higher risk if it mutates to spread easily between people, however, so the virus has a pandemic potential that makes human cases concerning, the CDC said.

These preliminary results again underscore the risk of exposure to infected animals, the CDC said. Historically, most human cases of bird flu infection have happened in people who are not wearing recommended personal protective equipment.

The agencys low-risk assessment for the public remained unchanged after the report of presumed cases. There has been no sign of increases in flu activity in the states affected by outbreaks in poultry and cows, the CDC said Friday.

The three presumed cases would be the first confirmed in humans in the United States exposed to infected birds; the four already confirmed this spring were all in people exposed to cattle. The first was in a Texas dairy worker, followed by two separate cases in Michigan and a fourth this month in a Colorado dairy farm employee.

The three newly affected workers developed cold symptoms and pinkeye; none was hospitalized, state health officials said. The other four infected workers also reported eye inflammation or pinkeye.

The bird flu outbreak has affected more than 99 million poultry and 151 dairy herds in the United States. The virus has also been detected in more than 9,500 wild birds, according to the CDCs latest count.

Poultry outbreaks have been identified nationwide, while 12 states have had outbreaks in dairy cows. In the past month, the virus has been detected in poultry flocks in Colorado, Iowa and Minnesota, according to the U.S. Department of Agriculture.

The federal government has offered money to dairy farmers with infected herds in exchange for testing their cattle, trying to incentivize testing and security measures that could help control the outbreak. The U.S. government has also planned to make bird flu vaccine available as soon as this month and awarded money to Moderna to develop an mRNA-based vaccine.

An early federal response that was slow and fractured drew frustration from some officials and experts, The Washington Post reported in April, and some have called for more robust testing of cattle.

People should avoid exposure to sick or dead animals, including birds and cows, and avoid animal feces and litter, the CDC said. Anyone who becomes sick after working with cows or poultry that could be infected should call their doctor or the state health department, Colorado officials advised.

Proper cooking kills bird flu virus; health officials say it remains safe to eat properly handled and cooked poultry and eggs. Commercially available milk, which is pasteurized, is also considered safe, though the CDC recommends avoiding unpasteurized, or raw, milk.

Read this article:

Three Colorado poultry workers are presumed to have bird flu, CDC says - The Washington Post

(Precision Vaccinations News)

CSL Seqirus today announced that it has commenced shipping its differentiated portfolio of influenza vaccines. This year, the company's influenza vaccines are being produced as trivalent influenza vaccineformulations, in compliance with the U.S. Food and Drug Administration'sdirective in 2024 to remove the B/Yamagata strain.

For the 2024-2025 influenza vaccine portfolio, CSL Seqirus isthe leadingmanufacturer offering a differentiated influenza vaccine option approved for use in people six months and older.

For example, FLUCELVAXis the first and only cell-based influenza vaccine indicated for use in people six months and older.

"Influenza continues to pose a significant threat, as evidenced by recent flu seasons," said Dr.Gregg Sylvester, Chief Health Officer, CSL Seqirus, in a press release on July 9, 2024.

"As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes."

CSL Seqirus is part of CSL, a global leader in the protection of public health and one of the largest influenza vaccine providers in the world.

Go here to read the rest:

First Cell-based Trivalent Flu Shots Ship in the USA - Precision Vaccinations

News Corp Australia uses software that manages crawler bot traffic on our websites. If you receive this message and are not a crawler bot (and are just a reader or subscriber), please try these steps first:

Your IP address is: 66.45.249.130 | Your reference number is: 0.6f24c317.1720676743.11887d48

News Corp Australia.

See more here:

No, its not too late to get the flu vaccine - Kidspot

On July 3, the U.S. Centers for Disease Control and Prevention (CDC) reported the fourth human case associated with an ongoing, multistate outbreak of bird flu in dairy cows this year. This marks the first case in Colorado and follows one case in Texas and two cases in Michigan, as CMM previously reported.

As with the previous cases, the infected individual is a worker on a dairy farm where cows tested positive for the bird flu virus. The person only reported eye symptoms and has since recovered.

The CDC has been watchinginfluenza surveillance systemsclosely, particularly in affected states, and reported no signs of unusual influenza activity in people.

In May, the CDC recommended farm workers wear personal protective equipment (PPE) to combat bird flu spread, but emphasized that the health risk to the U.S. general public remains low.

Still, last week Reuters reported the U.S. government awarded US$176 million to Moderna to advance bird flu vaccine development for humans. Late-stage testing for humans is expected to begin in 2025 and will focus on safety and immune response. Already, two dozen companies are working to develop a bird flu vaccine for cattle.

As of July 5, the U.S. Department of Agriculture has confirmed 140 cases in 12 states, with Idaho, Colorado, Michigan and Texas reporting the most cases. Since 2020, bird flu has become endemic in bird populations, causing an animal pandemic affecting at least 26 mammal species, according to a previous CMM report. Tests so far indicate that the virus detected in dairy cattle is the same clade that has been affecting wild birds and commercial poultry flocks.

Go here to see the original:

Fourth Human Case of Bird Flu Reported, Vaccine on the Way - CMM

BRIDGEWATER, N.J., July 10, 2024 /PRNewswire/ -- Sanofi today started shipping its first influenza (flu) vaccines across the U.S. in preparation for the 2024/25 flu season. Following this first shipment, additionalshipmentsof the full Sanofi flu vaccine portfolio will continue through October to healthcare provider offices, pharmacies and other immunizers to support fall immunization campaigns. With over 125 years of heritage in helping protect global public health,Sanofi is a world leader in vaccines, helping to vaccinate more than 500 million people annually.

ThomasGrenierHead of Vaccines, North America, Sanofi "Today, we began shipping flu vaccines for the upcoming season, a moment that underscores our long-standing commitment to providing global protection against disease. Getting a flu shot is imperative to not only help protect against flu infection, but also to help reduce the risks of its potentially severe complications, which can lead to hospitalizations, especially in those most vulnerable. Sanofi understands what these populations need out of their flu shots and works tirelessly from start to finish to provide proven and specific solutions."

All flu vaccines provided bySanofi to the US market are trivalent, meaning they offer protection against the current three strains of influenza (two influenza A strains and one influenza B strain).These strains were selected based on a collaborative review of influenza surveillance by the U.S. Food and Drug Administration (FDA), World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), among other public health experts, as the strains most likely to cause illness in the upcoming flu season.

Annual flu vaccination is one of the best ways to help protect against flu and its complications. Public health authorities worldwide reiterate their recommendations for eligible people to be vaccinated every year.

As one of the largest providers of influenza vaccines to the United States with a range of options,Sanofi meets immunization needs across the lifespan, from children as young as six months of age through adults 65 years of age and older. This year's 2024/25 U.S. influenza season portfolio includes Fluzone High-Dose (Influenza Vaccine), Flublok (Influenza Vaccine) and Fluzone (Influenza Vaccine).

Indication and Important Safety Information forFluzone High-Dose (Influenza Vaccine), Flublok (Influenza Vaccine) and Fluzone (Influenza Vaccine)

What areFluzone (Influenza Vaccine), Flublok (Influenza Vaccine), and Fluzone High-Dose (Influenza Vaccine)?

Fluzone, Flublok, and Fluzone High-Dose are vaccines indicated for the prevention of disease caused by influenza A and B strains contained in the vaccine. Fluzone is given to people 6 months of age and older. Flublok is given to people 18 years of age and older. Fluzone High-Dose is given to people 65 years of age and older.

IMPORTANT SAFETY INFORMATION FORFLUZONE (INFLUENZA VACCINE), FLUBLOK (INFLUENZA VACCINE), AND FLUZONE HIGH-DOSE (INFLUENZA VACCINE)

Fluzone, Flublok, or Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction to any component of the vaccine (including eggs or egg products for Fluzone and Fluzone High-Dose). In addition, Fluzone and Fluzone High-Dose should not be given to anyone who has had a severe allergic reaction after a previous dose of any influenza vaccine.

Tell your health care provider if you have ever hadGuillain-Barr syndrome (severe muscle weakness) after a previous influenza vaccination.

If Fluzone, Flublok, or Fluzone High-Dose are given to people with a compromised immune system, including those receiving therapies that suppress the immune system, the immune response may be lower than expected.

Vaccination withFluzone, Flublok, or Fluzone High-Dose may not protect all people who receive the vaccine.

Fainting has occurred following vaccination withFluzone, Flublok, and Fluzone High-Dose. Procedures should be in place to avoid injury from fainting.

ForFluzone, in children 6 months through 8 years of age, the most common side effects were pain or tenderness and redness where you got the shot, irritability, drowsiness (6 month through 35 months), and muscle pain (3 years through 8 years). In adults 18 years through 64 years of age, the most common side effects were pain where you got the shot, headache, and muscle pain. In adults over 65 years of age, the most common side effects were pain where you got the shot, headache, muscle pain, and general discomfort.

For Flublok, in adults 18 through 64 years of age, the most common side effects were pain where you got the shot, headache, tiredness, and muscle pain. In adults 65 years of age and older, the most common side effects were pain where you got the shot, tiredness and headache.

ForFluzone High-Dose, in adults 65 years of age and older, the most common side effects were pain where you got the shot, muscle pain, tiredness, and headache.

ForFluzone, Flublok, and Fluzone High-Dose, other side effects may occur.

For more information, talk to your healthcare professional and refer to the full Prescribing and Patient information forFlublok, Fluzoneor Fluzone High-Dose.

About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people's lives. Our team, across the world, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY.

ContactsSandrine Guendoul|+ 33 6 25 09 14 25 |sandrine.guendoul@sanofi.com Evan Berland| +1 215 432 0234 |evan.berland@sanofi.com Timothy Gilbert|+ 1 516 521 2929 |timothy.gilbert@sanofi.com

Investor RelationsThomas Kudsk Larsen| +44 7545 513 693 |thomas.larsen@sanofi.comAliz Kaisserian| + 33 6 47 04 12 11 |alize.kaisserian@sanofi.comArnaud Delpine|+ 33 6 73 69 36 93 |arnaud.delepine@sanofi.comFelix Lauscher|+ 1 908 612 7239 |felix.lauscher@sanofi.comKeita Browne| + 1 781 249 1766 |keita.browne@sanofi.comNathalie Pham|+ 33 7 85 93 30 17 |nathalie.pham@sanofi.comTarik Elgoutni|+ 1 617 710 3587 |tarik.elgoutni@sanofi.com Thibaud Chtelet| + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com

Sanofi Forward-Looking StatementsThis media update contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that pandemics or other global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2023. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

MAT-US-2406730-v1.0-07/2024

View original content:https://www.prnewswire.com/news-releases/sanofi-ships-us-influenza-vaccines-for-the-202425-season-302194084.html

SOURCE Sanofi

Excerpt from:

Sanofi ships U.S. influenza vaccines for the 2024/25 season - StockTitan

AMA Update covers a range of health care topics affecting the lives of physicians, residents, medical students and patients. From private practice and health system leaders to scientists and public health officials, hear from the experts inmedicineon COVID-19, medical education, advocacy issues, burnout, vaccines and more.

Featured topic and speakers

Is a new COVID vaccine coming out? Which RSV vaccine is better? Are there new PCV vaccines? Which vaccines can be given together? When is the new flu shot available?

Our guest is Sandra Fryhofer, MD, AMAs liaison to the Advisory Committee on Immunization Practices (ACIP), and a member of ACIPs COVID-19 Vaccine Workgroup. AMA Chief Experience Officer Todd Unger hosts.

Unger: Hello and welcome to the AMA Update video and podcast. New vaccines with new recommendations were just voted on last week by the ACIP, the CDC's Advisory Committee on Immunization Practices. And back with us today to share all those details is the AMA's in-house vaccine expert and ACIP liaison, Dr. Sandra Fryhofer in Atlanta. I'm Todd Unger, AMA's chief experience officer in Chicago. Dr. Fryhofer, thanks for joining us again today.

Dr. Fryhofer: Well, Todd, thanks for having me back.

Unger: Dr. Fryhofer, the ACIP met for three days in June. Why don't you take us through some of the highlights?

Dr. Fryhofer: Well, it was a packed few days. ACIP made new recommendations for RSV, flu, COVID and pneumococcal vaccines. There was also an update on where we stand on the H5N1 bird flu outbreak in dairy cows.

Unger: Well, let's get into some of that. Why don't we start by talking about the new vaccine recommendations? Dr. Fryhofer, you also serve on the ACIP's COVID vaccine workgroup. So let's start with COVID vaccines. What should we expect for the fall, and who should get the vaccine?

Dr. Fryhofer: ACIP recommends everyone six months and older get a dose of the updated 2024-2025 COVID vaccine. So again, this is a universal recommendation, just like for flu. But understand, even though COVID is waned, it remains deadlier than flu. And uptake of last year's updated COVID vaccine has been very disappointing. Only 22.5% of adults and 14% of children have received it. We certainly hope uptake will be better this fall. Most Americans now have at least some immunity against COVID, but immunity wanes with time. And as the virus keeps changing, these updated vaccines provide a way to incrementally boost our immunity and keep us protected.

Unger: Dr. Fryhofer, where did we land on the formula for the new fall COVID vaccine? I know there's been some debate on that.

Dr. Fryhofer: Well, finalizing the recipe for that new vaccine has been a little tricky because the virus keeps changing and mutating. And lately, as you know, the virus has been flipping and "FLiRT-ing." The FLiRT variants got this nickname from the location of their mutations. There's an F for L at one position, an R for T at another, and they include any variants starting with KP or JN that has the same set of mutations.

So when VRBPAC, FDA's independent advisory committee, met on June 5, JN.1 had been dominated. KP.2 was on the rise. VRBPAC recommended a monovalent JN.1 formula. And initially, FDA did too. But over the next week, FDA continued to monitor what was circulating and made a slight change. The preferred recipe for the new JN.1 lineage formula is a COVID vaccine based on the KP.2 strain.

Unger: All right, well, thank you for the update there on the vaccine. Can you remind uswe talk about risk, who is most at risk of adverse outcomes from COVID?

Dr. Fryhofer: Two-thirds of COVID hospitalizations are in those aged 65 and older. And hospitalization rates are highest in those 75 and older and also in infants under six months old. And these little babies are too young to be vaccinated themselves. But maternal vaccination during pregnancy can help protect them. So that's why that's so important. Hospitalization rates are also high in adults aged 65 to 75. And unfortunately, we're still seeing racial and ethnic disparities in hospitalizations. COVID-associated hospitalizations are highest in American Indian, Alaska Native and in Black populations.

Unger: How did the COVID hospitalizations and deaths in children compare with, let's say, other vaccine preventable childhood illnesses?

Dr. Fryhofer: More pediatric hospitalizations and deaths occur each year associated with COVID than with other vaccine preventable diseases at the time those recommendations were made for children in the United States. And this includes hepatitis A, chickenpox, invasive pneumococcal disease, rubella, rotavirus and meningitis.

Unger: Dr. Fryhofer, it's clear that these vaccines are lifesaving for so many people. Why do you think the uptake has been so low?

Dr. Fryhofer: Focus group studies say older patients, those 65 and older, are most concerned about getting COVID and having to be hospitalized. Younger adults in their 20s are most concerned that they may unknowingly spread COVID to others. For children, the main reason parents gave for not having their child get the vaccine is concern about vaccine side effects. Other reasons include thinking the vaccine is not effective, which is not true, and that their child is unlikely to get very sick from COVID and we know that's not true either. So we really need to dispel these myths.

Another key point that really stood out is the power of physician recommendation. Adults and children who received a health care provider recommendation to get the COVID vaccine were more likely to get vaccinated. So physician recommendation is so important. We have to recommend these vaccines to our patients.

Unger: That is so important. Let's switch gears and talk about something different, which is RSV. I hear there is a new RSV vaccine. Tell us more about that.

Dr. Fryhofer: Yes, there is a new one. Now, until June 2024, there were just two RSV vaccines on the market, one by Pfizer called ABRYSVOthat does not contain an adjuvant, and one by GSK called AREXVY that does. And CDC does use these brand names. But with FDA's recent approval of Moderna's new mRNA RSV vaccine, MRESVIA, we now have three RSV vaccines to prevent severe RSV in older adults. This is Moderna's second ever licensed product, and it uses the same messenger mRNA platform as their COVID vaccines. All three of these RSV vaccines are licensed for those 60 and older.

Unger: Well, Dr. Fryhofer, going into this meeting, RSV vaccines had been recommended, as you say, by ACIP, those 60 and older, but under shared clinical decision making. Can you talk a little bit about what this means and what does ACIP recommend now?

Dr. Fryhofer: Shared clinical decision making means you and your patient have to discuss and decide. And these conversations are pretty easy for primary care physicians because we know our patients. But not everyone who administers vaccines is comfortable having them. The new recommendation is more specific and has both age-based and risk-based components.

Unger: Is there still that element of shared clinical decision making thathas that gone away, or is that still in place?

Dr. Fryhofer: Shared clinical decision making no longer applies here. The age-based recommendation is for those 75 and older. And all adults age 75 and older should receive a single RSV vaccine dose. And if you already received a dose under the old recommendation, you don't need to get another one, at least for now. The risk-based recommendation applies to adults 60 up to 75. And for them, RSV vaccine is now recommended only for those with risk factors for severe RSV.

These risk factors include lung disease, heart disease, immune compromise, diabetes, obesity with a BMI of 40 or more, neurological conditions, neuromuscular conditions, chronic kidney disease, liver disorders and hematologic disorders. Also, frailty, as well as living in a nursing home or other long-term care facility are considered risk factors for severe RSV disease. So those 60 up to 75 without these risk factors are no longer recommended to receive it.

Unger: Thank you for that clarification. In terms of timing, what's the best time to get the RSV vaccine?

Dr. Fryhofer: The best time to get the RSV vaccine for the greatest benefit is late summer to early fall, so think August through October.

Unger: What about coadministration with other vaccines? We've talked about COVID. You mentioned flu, RSV. Is that still allowed?

Dr. Fryhofer: Yes. Coadministration of RSV vaccine with other adult vaccines, including flu, COVID, pneumococcal, Tdap and shingles vaccines is allowed and is acceptable.

Unger: I heard that the age indication for GSK's RSV vaccine, AREXVY, has been lowered to age 50. Did ACIP look at giving the vaccine to people in their 50s with risk factors for severe disease?

Dr. Fryhofer: Well, they did talk about it, but ACIP doesn't recommend it for people in their 50s, even for those at high risk for severe disease. Now, one of the main hesitations goes back to vaccine safety concerns. You may recall FDA's required post-marketing surveillance for GBS and atrial fibrillation from both manufacturers, and those vaccine surveillance studies are still ongoing. There's still many unanswered questions, and vaccine safety concerns were top of mind during ACIP deliberations. ACIP did clarify this is not a recommendation against use of RSV vaccines in adults in their 50s. It's because more information is needed to make a population-level policy recommendation.

Now, this may change as more is clarified about potential safety concerns. And there's still many other questions we have about RSV vaccinesdurability of protection, will a booster be needed, and if so, when? And will a booster restore the initial boost in immunity we get from that first shot? So there's much more we need to know about RSV vaccines.

Unger: Now, we've talked about RSV vaccination for adults 60, 75, and older. What about on the other end of the age range for babies? Is there anything new there?

Dr. Fryhofer: Yes. And as a reminder, we now have two new ways to protect little babies, a maternal RSV vaccine given to mom, but only the one by Pfizer called ABRYSVOthat doesn't have the adjuvant, and also a new long-acting monoclonal antibody, nirsevimab, given to baby. ACIP clarified that at this time, people who received a maternal RSV vaccine dose during a previous pregnancy are not recommended to receive additional doses during future pregnancies.

Now, this is different from what we do with Tdap. Tdap is recommended in each and every pregnancy to prevent pertussis in little babies. However, infants born to people who are vaccinated with RSV during a prior pregnancy should receive nirsevimab. These recommendations can be updated as additional data become available.

Unger: Is there anything new with the long-acting monoclonal antibody that's given to babies to prevent RSV?

Dr. Fryhofer: Yes. Nirsevimab really works well. A study published in March in MMWR showed nirsevimab is 90% effective at preventing RSV-associated hospitalization for infants in their first RSV season. And this is great news for families with little babies. Nirsevimab's recommended for infants up to eight months old during their first RSV season and for high-risk toddlers aged 8 to 19 months in their second RSV season. And you might remember last RSV season, nirsevimab supplies were limited and we had to prioritize doses. Fortunately, no supply shortages are expected for the upcoming season.

Unger: Dr. Fryhofer, there's also a new pneumococcal vaccine with a new ACIP recommendation. Can you tell us how this vaccine is different from other pneumococcal vaccines?

Dr. Fryhofer: A new PCV 21 pneumococcal vaccine has been FDA licensed for those aged 18 and older under an accelerated approval pathway. ACIP voted to recommend PCV 21 as an option for adults 19 and older, who currently have an indication to receive a dose of PCV. Now, there are two basic types of pneumococcal vaccines, polysaccharide vaccines, like PPSV 23, which do not produce memory B cells, and conjugate vaccines, which do trigger memory B cell production, and therefore induce long-term immunity. And these include PCV 15, PCV 20, and now PCV 21.

Unger: What's so special about this new PCV 21 vaccine? Or is it just PCV 20 plus one?

Dr. Fryhofer: No, it's not just PCV 20 plus one. What's unique about PCV 21 is it just didn't add additional coverage. It's 21 strains are different and include 11 unique serotypes not in PCV 20. Now, this is important because many of the cases we see in adult disease are caused by subtypes not covered in other FDA-approved pneumococcal vaccines. ACIP reviewed the evidence and says PCV 21 has greater coverage of the serotypes that cause invasive pneumococcal disease in adults as compared to PCV 20. IPD, invasive pneumococcal disease, includes bacteremic pneumonia, pneumococcal bacteremia and meningitis.

PCV 20 covers up to 58% of invasive disease in adults. PCV 21 provides much greater protection and covers up to 84% of the serotypes that cause invasive disease. PCV 21's additional protection from strains that cause invasive disease is very impressive, and it's licensed for both prevention of invasive pneumococcal disease and pneumococcal pneumonia.

Unger: Is there any downside to using PCV 21 compared to the older versions of PCV since it covers more strains?

Dr. Fryhofer: Well, PCV 21 does not cover serotype 4, which is a major cause of invasive disease in certain populations. Adults experiencing homelessness are 100 to 300 times more likely to report invasive disease due to serotype 4. And adults in Alaska, especially Alaskan Natives, have an 88-fold increase in serotype 4 invasive disease.

Fortunately, serotype 4 is covered by other pneumococcal vaccines, including PCV 15, PCV 20 and PPSV 23. So we haven't heard the end of this story. And even higher valency pneumococcal vaccines, including a 25 valent and a 31 valent version, are under development, so much more to come. I'm sure I'll be back talking to you more about pneumococcal vaccines.

Unger: Thank you for the update on that. Let's talk about the other thing that we're aware of for the fall, and of course, that's the seasonal flu vaccine. What's new there?

Dr. Fryhofer: Well, this coming fall, the seasonal flu vaccine's going trivalent. FDA's removed the Yamagata flu B strain because it no longer appears to be circulating. And new CPT codes are ready to go, thanks to AMA's CPT editorial team. ACIP also made a special off-label recommendation for people aged 18 through 64 who've had a solid organ transplant and are on immunosuppressive medications. These high-risk patients can now be given one of the higher dose flu vaccines, including fluzone high-dose and also the adjuvanted flu vaccine, which are FDA approved only for those 65 and older.

Unger: Well, Dr. Fryhofer, that is a lot of great information. I just want to say, thank you so much for being here and for that quick run through of the highlights from ACIP's June meeting. That wraps up today's episode. To support important public health information like this, I encourage you to become an AMA member. You can join at ama-assn.org/join. We'll be back soon with another AMA Update. And in the meantime, you can find all our videos and podcasts at ama-assn.org/podcasts. Thanks for joining us today. Please take care.

Disclaimer: The viewpoints expressed in this video are those of the participants and/or do not necessarily reflect the views and policies of the AMA.

Get videos with expert opinions from the AMA on the most important health care topics affecting physicians, residents, medical students and patientsdelivered to your inbox.

Originally posted here:

New ACIP recommendations for RSV, COVID-19 and pneumococcal vaccines, plus updated flu vaccine - American Medical Association

The US government will pay Moderna $176 million to develop an mRNA vaccine against a pandemic influenzaan award given as the highly pathogenic bird flu virus H5N1 continues to spread widely among US dairy cattle.

The funding flows through BARDA, the Biomedical Advanced Research and Development Authority, as part of a new Rapid Response Partnership Vehicle (RRPV) Consortium. The program is intended to set up partnerships with industry to help the country better prepare for pandemic threats and develop medical countermeasures, the Department of Health and Human Services said in a press announcement Tuesday.

In its own announcement on Tuesday, Moderna noted that it began a Phase 1/2 trial of a pandemic influenza virus vaccine last year, which included versions targeting H5 and H7 varieties of bird flu viruses. The company said it expects to release the results of that trial this year and that those results will direct the design of a Phase 3 trial, anticipated to begin in 2025.

The funding deal will support late-stage development of a prepandemic vaccine against H5 influenza virus, Moderna said. But the deal also includes options for additional vaccine development in case other public health threats arise.

mRNA vaccine technology offers advantages in efficacy, speed of development, and production scalability and reliability in addressing infectious disease outbreaks, as demonstrated during the Covid-19 pandemic, Moderna CEO Stphane Bancel said in the announcement. We are pleased to continue our collaboration with BARDA to expedite our development efforts for mRNA-based pandemic influenza vaccines and support the global public health community in preparedness against potential outbreaks.

US health officials have said previously that they were in talks with Moderna and Pfizer about the development of a pandemic bird flu vaccine. The future vaccine will be in addition to standard protein-based bird flu vaccines that are already developed. In recent weeks, the health department has said it is working to manufacture 4.8 million vials of H5 influenza vaccine in the coming months. The plans come three months into the H5N1 dairy outbreak, which is very far from the initial hopes of containment.

The US is badly fumbling its response to the unprecedented outbreak, drawing criticism from US-based and international experts alike. Genetic analyses suggest that the virus has been spreading among the countrys dairy cattle since late last year. But it wasnt until months later, on March 25, that the US Department of Agriculture confirmed the first four infected herds in two states (Texas and Kansas). Since then, the outbreak has spread to around 140 herds in 12 statesat least.

Some farms are refusing to test, and experts expect that there is a significant number of undocumented herd infections, particularly given the widespread detection of inactivated H5N1 in the commercial milk supply. Furthermore, of the 140 herds with documented infections, federal officials do not know how many are still actively infected rather than recovered. It is unclear whether infected cows can become reinfected, and if so, how quickly after an infection.

While the risk to the general public is considered to be low currently, farm workers are at higher risk of contracting the infection. To date, there have been three confirmed infections among dairy farm workersone in Texas and two in Michigan, which has had a uniquely robust response to the outbreak. Still, with hundreds to thousands of farm workers at risk of contracting the virus, only 53 people in the country to date have been tested for H5 influenza.

Continued here:

US Government Awards Moderna $176 Million for mRNA Bird Flu Vaccine - WIRED