Category: Flu Vaccine

WASHINGTON (TND) A new mRNA vaccine is being tested on cows and dairy workers in an attempt to deal with the global bird flu outbreak.

FLCCC Alliance Senior Fellow Dr. Brooke Miller says that research into how these vaccines affect food sources and agricultural practices has been very opaque and more needs to be done to see how a consumer may be affected.

For more on how Miller is calling for transparent review before these vaccines go into livestock, watch the video player above or visit The National Desks YouTube channel for his full interview.

Originally posted here:

Research lacking on new bird flu vaccine going into livestock: Doctor - WOAI

Pfizer and BioNTech have announced top-line results from a late-stage study of their mRNA-based combination vaccine for influenza and COVID-19.

The partners have been evaluating the candidate against a licensed flu vaccine and their own licensed COVID-19 vaccine given at the same visit in more than 8,000 healthy adults aged 18 to 64 years.

The trial met one of its two primary immunogenicity endpoints, with a single dose of the combination candidate demonstrating comparable responses against SARS-CoV-2 versus the companies COVID-19 vaccine.

Despite eliciting higher influenza A immune responses compared to the standard flu vaccine comparator, the combination candidate showed weaker results against the influenza B strain.

The companies said they are now evaluating adjustments to the vaccine aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

The combined vaccine approach could alleviate the impact of both COVID-19 and flu while offering a combined administration, potentially simplifying immunisation practices for healthcare providers and patients.

Annaliesa Anderson, senior vice president and head, vaccine research and development at Pfizer, said: We are committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this.

[These] results provide insight and direction towards achieving this goal, and we remain optimistic about our combination COVID-19 and influenza programme, for which we are evaluating the next steps.

Ugur Sahin, chief executive officer and co-founder of BioNTech, added: The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of Pfizers and our combination vaccine programme against influenza and COVID-19.

The announcement comes just two months after Moderna shared positive phase 3 results for its own flu/COVID-19 combination vaccine candidate.

The immune responses from a single dose of mRNA-1083 were found to be non-inferior to the flu and COVID-19 vaccine comparators co-administered in the study, with the candidate also demonstrating statistically significantly higher immune responses against three influenza virus strains and against SARS-CoV-2.

Follow this link:

Pfizer and BioNTech share late-stage results for COVID-19/flu combination vaccine - PMLiVE

Dive Brief:

Pfizer and BioNTech are in a race with rival Moderna to develop vaccines that can simultaneously protect against multiple respiratory viruses, hoping the convenience of one shot will spur an uptick in flagging immunizations.

The undertaking has proven difficult, forcing the makers of mRNA shots to search for doses that are potent against multiple pathogens while minimizing side effects. The eventual financial reward is also unclear, as the timing of COVID and flu spikes arent currently lining up, complicating the utility of a single shot at a particular time, Evercore ISI analyst Umer Raffat wrote in a research note.

Both groups have found trouble with influenza B viruses, which are less common than their A counterparts.

For example, Modernas initial flu vaccine struggled against influenza B before adjustments led to the success of a combination shot in a Phase 3 trial earlier this year. Pfizer last year reporteda flu-only shot also failed to generate a sufficient immune response against influenza B, and on Friday reported similar issues with its combination vaccine.

Those stumbles could leave the door open for Sanofi and Novavax, which this year partnered to develop a protein-based combination vaccine. Leerink Partners analyst David Risinger noted that dose optimization is well-characterized with those shots, potentially making their path through testing less complicated.

Still, Pfizer and BioNTechintend to press forward with combination shots. On Friday, executives from both companies claimed theyre committed to pursuing multi-pronged vaccines. Todays results provide insight and direction towards achieving this goal, said Annaliesa Anderson, Pfizers head of vaccine R&D, in the statement.

We are dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases, added BioNTech CEO Ugur Sahin.

Theyre also still working on a vaccine only directed at the flu. A Phase 2 study of a new trivalent shot spurred a meaningful immune response against influenza B. By that measure, it also surpassed an existing shot against influenza A, the companies said.

View original post here:

Pfizer, BioNTech stumble in effort to develop combination flu, COVID shot - BioPharma Dive

Key Takeaways

Shares of Pfizer (PFE) and American depositary receipts (ADRs) of BioNTech (BNTX) dropped in intraday trading Friday following disappointing results from a late-stage study of the drugmakers' combined COVID-19 and flu vaccine in adults.

The companies reported that just one of two endpoints was reached in a Phase 3 trial of the experimental treatment which used the Pfizer-BioNTech COVID-19 drug and Pfizers flu medicine. While positive responses to COVID-19 and influenza A viruses were seen, they were not for influenza B.

The companies said they are "evaluating adjustments to the candidate" and will discuss the results with health officials.

BioNTech Chief Executive Officer (CEO) Dr. Ugur Sahin explained that both firms are "dedicated to developing combination vaccines which provide broader protection against multiple respiratory diseases," and that the insights gained from this trial "are highly valuable and will play a crucial role in guiding the further development."

Included in the announcement was an update on a Phase 2 study of Pfizer's experimental second-generation trivalent influenza mRNA vaccine, which the drug maker said "showed encouraging data demonstrating robust immunogenicity against all strains compared to a standard of care influenza vaccine."

Pfizer shares, which began the day roughly flat for the year, and BioNTech ADRs slipped 1.9% and 2.9%, respectively, as of 1:30 p.m. ET Friday. BioNTech ADRs are down about 20% in 2024.

Read the rest here:

Pfizer, BioNTech Combination Flu and COVID-19 Shot Misses 1 of 2 Endpoints - Investopedia

Pfizer and BioNTech have been among the leaders in the race to bring a combined COVID-19 and influenza vaccine to market, but have stumbled in the final straight.

The companies reported mixed results in their phase 3 trial of their mRNA vaccine, which includes antigens for influenza A and B, as well as the SARS-CoV-2 virus that causes COVID-19, and have said they will need to tweak the formulation.

The problem is a lower-than-expected antibody response for influenza B in the 8,000-subject study, which was designed to show non-inferiority to Pfizer and BioNTech's Comirnaty COVID-19 jab, as well as a commercially available flu vaccine, and demonstrate safety.

Last October, the companies reported "robust" antibody and T-cell responses against the viruses, in the same ballpark as approved vaccines, with a safety profile similar to Comirnaty in a phase 1/2 trial that prompted them to start a phase 3 programme.

In a joint statement, Pfizer and BioNTech said they are "evaluating adjustments to the candidate and will discuss next steps with health authorities." It's not clear yet what the delay to the programme could be, but if a new phase 3 trial is needed as seems likely if the constituents of the vaccine need to be modified it could be lengthy.

Pfizer's head of vaccine R&D, Annaliesa Anderson, said the company remains "committed to developing vaccines that will reduce the burden of respiratory diseases and believe that combination vaccines are the most efficient way to do this."

The slip-up hands an opportunity for mRNA vaccine rival Moderna to build a lead in the combined COVID-19/flu vaccine category.

In June, Moderna said its candidate met its objectives in a phase 3 trial, stimulating higher immune responses against influenza and SARS-CoV-2 than the licensed flu and COVID vaccines used as comparators in the study, which the company said could lead to approval in late 2025 or 2026.

Moderna's study looked at the vaccine in adults aged 50 and older, while Pfizer/BioNTech's trial focused on adults aged 18 to 64.

Other rivals, meanwhile, include Sanofi/Novavax, which are developing non-mRNA candidates under the terms of a $1.2 billion alliance agreed in May.

BioNTech's chef executive, Uur ahin, said: "The insights gained from this combination vaccine trial are highly valuable and will play a crucial role in guiding the further development of [] our combination vaccine programme against influenza and COVID-19."

Read the original here:

Pfizer and BioNTech's COVID/flu vaccine hits a hurdle - pharmaphorum

RICHLAND COUNTY, S.C. (WACH) The South Carolina Department of Public Health held a press conference for Immunization Awareness Month on Monday.

The press conference occurred at 10 a.m. in the Warren Derrick Classroom at Prisma Health Children's Hospital-Midlands.

The press conference focused on the importance of immunizations that protect people of all ages from different diseases and certain types of cancer.

It accompanies National Immunization Month, which is celebrated annually toraise awareness about the importance of vaccinations and encourage people to talk to healthcare providers about staying up to date on their vaccinations.

Vaccines are safe and effective at preventing life-threatening diseases in children and adults.

READ MORE | Person and cats quarantined after exposure to rabid fox in Lexington County

This years event focused on HPV vaccination, which the Centers for Disease Control and Prevention recommends for all 11- to 12-year-olds.

The HPV vaccine has the potential to prevent more than 90% of HPV-attributable cancers, which is why children must get vaccinated for HPV.

HPV causes more than 9 out of every 10 cases of cervical cancer, as well as many vaginal, vulvar, penile, anal and oropharynx (mouth and throat) cancers.

READ MORE | Forest Acres council meeting to finalize plans for park at old Richland mall site

South Carolina has increased HPV vaccination coverage in recent years, but coverage remains lower than the national average.

In South Carolina, 70% of 13-17-year-olds have received one dose of the HPV vaccine, compared to 76% across the nation. 54% of South Carolinians aged 13-17 are up-to-date with HPV vaccination compared to 63% of children in the US.

Children who get the vaccine before 15 only need two doses. After turning 15, three doses are needed.

DPH announced that the Medical University of South Carolina's (MUSC) Hollings HPV Vaccination Van was selected by DPH and the S.C. Immunization Coalition as the Association of Immunization Managers 2024 South Carolina Immunization Champion Award during Monday's event.

The vaccination vantravels across South Carolina to make HPV vaccinations accessible to rural and medically underserved communities.

As important as vaccines are for children, adults benefit from vaccines as well.Keeping up-to-date with vaccines for shingles, pneumococcal pneumonia, mpox, flu, COVID-19, RSV and others can also protect your health and those around you.

Talk to your health care provider or your childs pediatrician to stay up to date on shots.

Here is the original post:

Department of Public Health, Prisma Health and MUSC unite to enhance vaccine awareness - wpde.com

Monday, the World Health Organization (WHO) unveiled an important new initiative aimed at accelerating the development and accessibility of messenger RNA (mRNA) vaccines for human avian influenza (H5N1) in low- and middle-income countries.

The initiative will be led by Sinergium Biotech, a company based in Argentina, which has committed to sharing its expertise in manufacturing mRNA vaccines for avian influenza with the WHO's Technology Transfer Hub. This collaboration is expected to facilitate the rapid and affordable production of the vaccine for developing nations, according to the WHO.

The mRNA Technology Transfer Hub program involves manufacturers in 15 countries, although not all are fully operational. Participants in the program include Biovac in South Africa and Institut Pasteur in Senegal. Notably, the South African facility was established after major pharmaceutical companies such as Moderna and Pfizer declined to share the technical knowledge required to replicate their COVID vaccines due to intellectual property concerns.

Sinergium has already developed candidate H5N1 vaccines and aims to demonstrate their effectiveness through preclinical models. Once the preclinical data is completed, the technology, materials, and expertise will be shared with other production partners. This approach is expected to expedite the development of H5N1 vaccine candidates and strengthen efforts for pandemic preparedness, as stated by the WHO.

Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, emphasized that the initiative reflects the goals of the mRNA Technology Transfer Programme to promote increased research, development, and production in low- and middle-income countries. This, in turn, aims to ensure a more effective and equitable response to future pandemics.

This collaboration is significant as it marks the first instance of a vaccine developer voluntarily sharing its findings with a network of partner manufacturers established by the WHO. The WHO clarified that although Sinergium's mRNA flu vaccine has not yet undergone human testing, it will need to undergo clinical trials before it can be utilized.

by RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

More:

New Initiative Aimed At Advancing H5N1 Vaccine: WHO - RTTNews

The initiative is being led by Argentinian manufacturer Sinergium Biotech.

July 29, 2024, 3:00 PM ET

4 min read

The World Health Organization announced Monday that it has launched an initiative to help accelerate the development of a human bird flu vaccine using messenger RNA (mRNA) technology.

The project, which will be led by Argentinian pharmaceutical company Sinergium Biotech, will aim to identify vaccine candidates for manufacturers in low- and middle-income countries, the WHO said.

The Centers for Disease Control and Prevention (CDC) has previously said the risk of bird flu, also known as avian influenza, to the general public is low and there is currently no evidence of human-to-human transmission. Federal health officials have also prepared millions of vials of an available non-mRNA bird flu vaccine as a precautionary measure, just in case it becomes necessary.

mRNA technology is the same type that was used in the development of COVID vaccines. Most vaccines use a weakened or inactive virus to stimulate an immune response, but mRNA vaccines teach the body how to make proteins that can trigger an immune response and fight off an infection.

Researchers can often design mRNA vaccines more quickly than they can produce the live or weakened pathogens needed for a traditional vaccine.

The initiative is part of the WHO's mRNA Technology Transfer Program, which has a goal of building capacity in low- and middle-income countries to produce mRNA vaccines.

Sinergium Biotech has already developed candidates for H5N1 vaccines, according to the WHO. The company is looking to perform proof-of-concept studies, in which researchers decide whether to continue studying the product based on its efficacy.

If the proof-of-concept study is successful, Sinergium said it plans to share the "technology, materials and expertise" with other manufacturing partners so they can develop the vaccine themselves.

"This initiative exemplifies why WHO established the mRNA Technology Transfer Programme -- to foster greater research, development and production in low- and middle-income countries, so that when the next pandemic arrives, the world will be better prepared to mount a more effective and more equitable response," WHO Director-General Dr. Tedros Adhanom Ghebreyesus said in a statement.

The WHO says that avian influenza viruses are a "significant public health risk" because they spread widely in animals and have the potential to cause a future pandemic. However, the global health agency indicated that its preparedness efforts are an example of being proactive, rather than reactive, by increasing access to vaccines.

In the United States, there have been 13 human cases of bird flu since April of this year, according to an update last week from the CDC. All the human patients either came into contact with sick dairy cows or infected poultry, according to the CDC.

The U.S. government has also awarded Moderna $176 million to develop and test an mRNA vaccine that could be used for bird flu, Reuters reported in early July.

See original here:

WHO launches initiative to develop mRNA vaccines against bird flu - ABC News

Question: Is it too early to get a flu shot? I know theres been a lot of attention on summer COVID-19, but Im more concerned about the flu because of a friends bad experience, and also because I am current on my COVID-19 boosters.

Answer: September and October are the best months for most people to get a flu shot, according to the U.S. Centers for Disease Control and Prevention. Flu vaccination in July and August is not recommended for most people, but there are several considerations regarding vaccination during those months for specific groups, it says, noting that:

>> Pregnant women in their third trimester can get a flu vaccine in July or August to protect their babies from flu after birth, when they are too young to get vaccinated.

>> Children who need two doses of the flu vaccine should get their first dose of vaccine as soon as it becomes available. The second dose should be given at least four weeks after the first.

>> Vaccination in July or August can be considered for children who have healthcare visits during those months if there might not be another opportunity to vaccinate them.

Otherwise, adults, especially those 65 years old and older, and pregnant women in the first or second trimester should avoid getting their flu shot in July and August, unless they wont be able to get vaccinated in September or October, the CDC says.

Vaccination closer to the peak winter flu season is recommended because protection could decrease over time.

The CDC says that nearly everyone 6 months of age and older should get an annual flu shot. The updated 2024-2025 flu vaccines, which should be widely available before September, will be trivalent and will protect against an H1N1, H3N2 and a B/Victoria lineage virus, the CDC says.

Nationwide its estimated that more than 44,900 people died of flu complications during the 2023-2024 flu season, according to the CDC.

Q: I didnt get the most recent COVID-19 booster shot, and I figured I would wait until the new shot is out this fall, but a lot of people I know are getting COVID-19, so Im wondering about my options now.

A: The CDC website says people who have never been vaccinated against COVID-19 and those who have been vaccinated but feel they need additional protection and are eligible for another dose might consider getting the currently available 2023-2024 COVID vaccine. This decision should be made in consultation with your healthcare provider and you should consider that receiving the currently available COVID-19 vaccine could delay your eligibility to immediately get the updated 2024-2025 vaccine once it becomes available this fall.

Theres generally a four-month interval between COVID-19 doses.

Those who might benefit from a summer dose include people 65 years of age and older, those who are moderately or severely immunocompromised or have underlying medical conditions, people living in long-term care facilities, people of any age who have not received any doses of COVID- 19 vaccine, and pregnant women, especially those in late pregnancy, the CDC says.

Nationwide in 2023 more than 75,500 people died from COVID-19, the agency says.

Q: With the voting stuff, please emphasize that the voted ballot must be received by 7 p.m. Aug. 10 you cant just drop it in the mail that day. I was confused about this the first year we voted by mail, and my vote ending up not counting.

A: You are correct, and you are not the only reader who has mentioned this or asked for clarification. As you said, the postmark isnt the key factor. You may return your voted ballot by mail or in person at a designated place of deposit within your county. Voted ballots must be received by your County Elections Division by 7 p.m. on Election Day, the state Office of Elections says on its website.

Mahalo

Id like to thank some nice kids at the Kamiloiki skate park for encouraging my young son. They made room for him. I didnt say anything at the time because I didnt want to embarrass my son or the older kids, but I appreciate it. Grateful mom

Write to Kokua Line at Honolulu Star-Advertiser, 500 Ala Moana Blvd., Suite 7-500, Honolulu, HI 96813; call 808-529-4773; or email kokualine@staradvertiser.com.

Here is the original post:

Kokua Line: Is it too early for flu shot? - Honolulu Star-Advertiser

Image credit: New Africa | stock.adobe.com

A study published in Nature Communications shows a promising approach to developing a universal influenza vaccine with the intention of conferring lifetime immunity against an evolving virus after a single dose. According to the investigators, the one and done vaccine platform was tested against the virus that is believed to be the most likely to trigger the next pandemic.1

Should a deadly virus such as H5N1 infect a human and ignite a pandemic, we need to quickly validate and deploy a new vaccine, said co-corresponding authorDouglas Reed, PhD, associate professor of immunology at the University of Pittsburgh Center for Vaccine Research, in a news release.1

For this study, the investigators wanted to determine if lung-resident effector memory T cells induced by cytomegalovirus (CMV)-vectored vaccines that expressed conserved internal influenza antigens could protect against lethal influenza challenge. To measure this, the investigators administered Mauritian cynomolgus macaques (MCM)nonhuman primateswith cynomolgus CMV (CyCMV) vaccines that express the H1N1 1918 influenza M1, NP, and PB1 antigens (CyCMV/Flu), and challenge with heterologous, aerosolized avian H5N1 influenza. A total of 11 MCMs were included in the study, as well as a control group of unvaccinated primates who were exposed to the H5N1 virus.2

The problem with influenza is that its not just 1 virus. Like the SARS-CoV-2 virus, its always evolving the next variant and were always left to chase where the virus was, not where its going to be, explained senior authorJonah Sacha, PhD, professor and chief of the Division of Pathobiology at Oregon National Primate Research Center, Oregon Health and Science University, in the news release. It worked because the interior protein of the virus was so well preserved. So much so, that even after almost 100 years of evolution, the virus cant change those critically important parts of itself.1

The method, according to the investigators, involves administered small pieces of target pathogens into the common herpes virus CMVwhich infects most people in their lifetimesand typically produces mild to no symptoms in individuals. The virus acts as a vector that is designed to induce an immune response from the bodys own T cells. Additionally, the investigators note that this approach is different from common vaccines, including the flu vaccines, and are designed to induce an antibody response that targets the most recent evolution of the virus.1,2

According to the findings, all 6 unvaccinated MCMs died within 7 days post-infection because of acute respiratory distress, whereas 6 of the MCMs (54.5%) vaccinated for CyCMV/Flu survived. The investigators note that the MCMs that survived appeared to present correlations with the magnitude of lung-resident CD4+ T cells specific to influenza prior to challenge. These data, according to the investigators, demonstrate that CD4+ T cells targeting preserved internal influenza proteins and can protect against highly pathogenic heterologous influenza.2

Its exciting because in most cases, this kind of basic science research advances the science very gradually; in 20 years, it might become something, said Sacha in the news release. This could actually become a vaccine in 5 years or less. Its a very viable approach. For viruses of pandemic potential, its critical to have something like this. We set out to test influenza, but we dont know whats going to come next.1

The study suggests that CMV vaccines have the potential of generating effective and long-lasting immune responses against a wide variety of variants. Further, the promising findings support the need for additional research that explores effector memory T cell-based vaccines that can be used for the development of a universal influenza vaccine.1,2

I think it means within 5 to 10 years, a one-and-done shot for influenza is realistic, Sacha said. Its a massive sea change within our lifetimes. There is no question we are on the cusp of the next generation of how we address infectious disease.1

References

More here:

Research Results Show Promise Toward Development of a Universal Influenza Vaccine - Pharmacy Times