Category: Flu Vaccine

Page 10«..9101112..2030..»

Finland to receive first EU procured bird flu shots – POLITICO Europe

June 8, 2024

The contract is currently for 640,000 doses, with the possibility to buyup to 40 million dosesover four years.

HERA, which has been in talks with Seqirus for months, approached the company last year to ask it to update its zoonotic flu vaccine to the dominant circulating avian flu strain. But to do so, Seqirus asked for a minimum guarantee of sale, to make the transaction profitable something HERA could guarantee through the joint procurement.

Seqiruss adapted zoonotic influenza vaccine was given the backing of the European Medicines Agency (EMA) in April.

Follow this link:

Finland to receive first EU procured bird flu shots - POLITICO Europe

Bird flu in 2024: Is there a vaccine? – The Atlanta Journal Constitution

June 5, 2024

Q: Is there a bird flu vaccine?

A: Yes. Studies suggest two candidate vaccine viruses appear well-matched to protect against the H5N1 strain circulating among dairy cattle and birds, according to the Centers for Disease Control and Prevention.

Both of the vaccine candidates are in the nations stockpile in limited quantities. And BARDA (The Biomedical Advanced Research and Development Authority which is part of the U.S Department of Health and Human Services) has enough building blocks for vaccines including adjuvants, potent substances which can trigger a stronger immune response from a vaccine to make millions of doses.

Q: How long would it take for them to become available?

Should the U.S. need vaccines, the federal government has hundreds of thousands of vaccines ready to ship, a spokesperson for the federal governments Administration for Strategic Preparedness and Response, told The Atlanta Journal-Constitution.

It could have over 100 million doses shipped within about three to four months.

Mass production could scale up quickly if needed, according to federal authorities.

But its not so simple. Pharmaceutical companies can be called to make vaccines for flu, but these vaccines would be manufactured on the same production lines used for seasonal flu.

Before starting large-scale manufacturing, federal officials would need to think through the implications of disrupting seasonal flu production for a new shot.

Q: Would the vaccine really work? What if the bird flu strain evolves?

The CDC says it is monitoring any changes in the strain and the vaccine can be altered to protect newer strains.

But some experts are skeptical and dont think theres been enough testing done yet to know how well the two candidate vaccines would really work, especially since the virus would need to change to make it a threat to people.

Q: Is a bird flu vaccine needed now?

No. Right now, the H5N1 bird flu remains primarily an animal health issue.

Who might need a vaccine and how many doses might be needed depend on how the virus changes and how widespread it becomes, according to the CDC.

More here:

Bird flu in 2024: Is there a vaccine? - The Atlanta Journal Constitution

U.S. Will Make Millions of Bird Flu Vaccines This Summer – HealthDay

June 5, 2024

MONDAY, June 3, 2024 (HealthDay News) -- As the H5N1 avian flu continues to spread among dairy cows in the United States, nearly 5 million doses of flu vaccine are now being prepared for possible use in humans.

Since the outbreak in livestock began this spring, bird flu has been confirmed in three humans who worked on dairy farms in Texas and Michigan, and health experts are concerned the virus could mutate to the point where it could spread easily among humans.

In response, vaccine maker CSL Seqirus announced last week that it has been tasked with making the additional doses of flu vaccine at its North Carolina plant.

"It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration," the company noted in anews release.

The CDC [U.S. Centers for Disease Control and Prevention] maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners, Marc Lacey, global executive director for pandemic at CSL Seqirus, said in the news release. This agreement... will help support the U.S. governments ability to respond swiftly in the event that the current avian flu situation changes.

The new vaccine doses combine an antigen that targets the H5 portion of the H5N1 virus with an ingredient designed to boost the immune response triggered by the vaccine.

While the production of these new flu vaccine doses is set to be completed "later this summer," they may not be ready for use right away.

The U.S. Food and Drug Administration has previously approved other vaccines for potential H5N1 pandemics, including avaccineby Seqirus, but it isn't certain how soon the FDA might clear use of the new shots.

"If it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory pathways to take the appropriate steps to ensure vaccines are available in the timeliest manner possible," an FDA spokesperson told CBS News.

It is unclear who would be prioritized for the first shots if they are eventually rolled out for the public, CBS News reported.

A panel of the CDC's outside vaccine advisers issetto meet June 26 to discuss H5N1 alongside its routine votes on seasonal flu vaccines.

While the CDCsaysthe risk to the general public remains low, the agency has warned that workers on dairy farms and in production facilities are at higher risk of infection and it has urged the industry to take safety precautions.

Thelatest human case of bird fluin Michigan involved respiratory symptoms for the first time, officials announced Thursday, which could make it easier for the virus to spread from person to person.The two previous patients only experienced eye symptoms.

"Simply put, someone who's coughing may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis," the CDC's Nirav Shah said Thursday, CBS News reported.

The CDC is now investigating whether the strain that infected the latest Michigan patient might have developed key mutations that could raise its risk of spread among humans, CBS News reported.

"The mere fact that this individual displayed some respiratory symptoms, again we should be alert, but in and of itself is not a cause to change course or suggest that we're at an inflection point," Shah told reporters.

More information

The U.S. Centers for Disease Control and Prevention has more on bird flu.

SOURCE: CSL Seqirus, news release, May 30, 2024; CBS News

Follow this link:

U.S. Will Make Millions of Bird Flu Vaccines This Summer - HealthDay

H5N1 bird flu: Does Canada have vaccines ready for an outbreak? – Global News

June 5, 2024

As the bird flu outbreak continues spreading south of the border, Canadian officials are in talks with several pharmaceutical companies about potential agreements to produce an avian flu vaccine for humans.

Story continues below advertisement

There is no avian influenza vaccine available in Canada for public use, according to Health Canadas website. Canada is also not currently stockpiling human avian flu vaccines, but this could change in the future, according to federal health officials.

The Public Health Agency of Canada (PHAC) has proactively met with pandemic influenza vaccine suppliers (e.g., GSK, Seqirus and Sanofi) with whom we have an agreement for domestic or off-shore vaccine manufacturing to discuss pandemic influenza vaccine preparedness activities in order to inform steps that could be taken against avian influenza, a PHAC spokesperson told Global News in a Friday email.

These activities include obtaining an H5N1 candidate vaccine virus, and the possibility of producing pre-pandemic vaccine if and when production capacity is freed up from producing the seasonal influenza vaccines.

The bird flu virus has been spreading among more animal species in scores of countries since 2020. It was detected in U.S. dairy herds in March, and since then atleast three people all workers at farms with infected cows have been diagnosed with bird flu, although the illnesses were considered mild.

Story continues below advertisement

But earlier versions of the same H5N1 flu virus have been highly lethal to humans in other parts of the world. Officials are taking steps to be prepared if the virus mutates in a way that makes it more deadly or enables it to spread more easily from person to person.

While it is rare for the virus to spread to humans, experts warn that it could mutate and become more transmissible, posing a significant health threat due to its potential lethality.

The bird flu has surprised us over and over and over, said Kerry Bowman, a professor of bioethics and global health at the University of Toronto. People didnt predict it wouldjump to mammals and that mammals would give it to each other. But then look what happened.

Canada has increased its surveillance of bird flu in dairy cows and milk. As of May 24, the Canadian Food Inspection Agency (CFIA) has also confirmed that Canadas milk supply remains free of avian flu fragments after testing came back negative.

Story continues below advertisement

Although the risk may be low, and the virus has not been detected in Canada, experts like Maxwell Smith, a bioethicist at Western University in London, Ont., believe its never too early to start preparing for a potential bird flu pandemic.

Its much easier and much preferable to intervene now, even though the risk is very low at the present moment for transmission into humans, he told Global News.

Even though we will have to spend some resources now and make a little bit of an investment and think about these questions, its far better doing that now than having to address the questions that will emerge if there were a human-based pandemic of H5n1.

A lesson learned from the COVID-19 pandemic is that we never want to be too late in preparing for a potential pandemic, warned Dr. Shayan Sharif, an avian immunologist and associate vice president of research at the University of Guelph.

Story continues below advertisement

Should we be thinking about [vaccines]? Yes, absolutely. Its always good to be prepared, he said. The virus is not a pandemic at the moment, and we want to make sure that it would never become a pandemic. But if it does, then we need to have vaccines, and vaccines would need to be tested for their safety and for their efficacy. And all of those things would take some time, and we want to be prepared for that possibility.

He added that while it takes time to distribute doses within Canada if we have learned anything from the COVID-19 pandemic, it is that vaccinating people in one country alone is not sufficient to eradicate the disease.

You have to have global endeavors to vaccinate almost everyone on the face of the planet. So we need to have plans in place for not only vaccinating Canadians, but also vaccinating the entire world, Sharif said.

Bowman mentioned that Canada has the infrastructure to manufacture these vaccines but is not activating it at this time.

Story continues below advertisement

One reason, he highlighted, is that doing so would disrupt the production of seasonal influenza vaccines for the 2024 and 2025 seasons, which is crucial for Canadians.

If we go into high gear with mass production, its going to knock out the preparation for the flu vaccines for, late 24 into 25, Bowman said. We wont have the capacity [for both].

Another hurdle with vaccines is ensuring they are made with the current strain of H5N1, which could mutate again. Similar to the influenza virus, bird flu viruses are capable of rapid genetic changes through mutations.

Trending Now

The U.S. government has a stockpile of H5N1 vaccines and has partnerships with three pharmaceutical companies: GSK, CSL Seqirus and Sanofi. These companies have seasonal influenza production capacity and say they would be able to scale up production of avian flu vaccines if needed, according to the Associated Press.

Story continues below advertisement

On May 30, CSL Seqirus announced that it was in the works to manufacture and deliver around 4.8 million doses of pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain. It is estimated to be complete in the late summer of 2024.

CSL Seqirus, located in North Carolina, manufactures an FDA-approved cell-based H5N1 vaccine called Audenz.

And the pharmaceutical company Moderna already has a bird flu mRNA vaccine in very early-stage human testing. In a statement, Moderna confirmed that we are in discussions with the U.S. government on advancing our pandemic flu candidate, the Associated Press reported.

These messenger RNA vaccines are made using a small section of genetic material from the virus. The genetic blueprint is designed to teach the body how to make a protein used to build immunity.

Similar work has been going on at Pfizer. Company researchers in December gave human volunteers an mRNA vaccine against a bird flu strain thats similar to but not exactly the same as the one in cows. Since then, researchers have performed a lab experiment exposing blood samples from those volunteers to the strain seen in dairy farms, and saw a notable increase in antibody responses, Pfizer told the Associated Press.

Story continues below advertisement

In the event of a bird flu pandemic, the World Health Organization (WHO) has stated that it is on standby, ready to trigger and ramp up vaccine production for the virus.

Story continues below advertisement

Speaking at a media conference on May 8, Dr. Maria Van Kerkhove, director of pandemic preparedness with the WHO, saidalthough there has not been any human-to-human transmission of the H5N1 virus, there is a system in place.

And through those systems, theres an ongoing risk assessment of the viruses, looking at the viruses themselves, the different mutations, the characteristics of those viruses. And through that system, there are candidate vaccine viruses that are recommended to be considered for production, she explained.

Within that system, we have two that are H5N1 viruses that could be used to ramp up vaccine production. We have not triggered that system yet.

However, she added that the WHO has access to real-time production of these bird flu vaccines. If production is triggered, there there are billions of vaccines that could be produced within the first year if necessary, based on the manufacturing technologies that we have.

When asked why vaccines arent available now, Dr. Michael Ryan, who leads the WHOs response to disease outbreaks, explained that while vaccine candidates are in place, its imperative that they work against the current strain.

Story continues below advertisement

He added that producing billions of bird flu vaccines would hinder the production of influenza vaccines.

We produce hundreds of millions of seasonal flu vaccines every year that we would have to switch production. So its not you can just press the button will begin producing pandemic H5 vaccines. You have to stop producing your seasonal vaccine. Ryan said. This requires a very careful consideration.

with files from the Associated Press and Global News Katherine Ward

Subscribe to updates from GlobalNews

Unsubscribe from GlobalNewsupdates

Read more:

H5N1 bird flu: Does Canada have vaccines ready for an outbreak? - Global News

Penn researchers made an avian flu vaccine using a technique that created COVID vaccines – Republican & Herald

June 5, 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

Link:

Penn researchers made an avian flu vaccine using a technique that created COVID vaccines - Republican & Herald

U.S. to make millions of bird flu vaccine doses this summer, as cases grow – CBS News

June 2, 2024

Some 4.8 million doses of flu vaccine are now being prepared for use in response to the growing U.S. outbreak of highly pathogenic avian influenza, or H5N1, officials say.

The order for the doses to be filled into vials comes as the Centers for Disease Control and Prevention is investigating a growing number of human cases linked to the unprecedented outbreak of the virus in dairy cattle this year.

The supplies will be pulled from a "pre-pandemic" stockpile funded by the federal Administration for Strategic Preparedness and Response. Vaccinemaker CSL Seqirus has been tasked with manufacturing the doses at its North Carolina plant.

"It utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response within six months of a pandemic declaration," CSL Seqirus said in a release.

The doses combine bulk stockpilesof two key ingredients: an "antigen" targeted at the H5 portion of the H5N1 virus with an "adjuvant" designed to boost the immune response triggered by the vaccine.

While manufacturing of these new bird flu doses is set to be completed by "later this summer," the vaccines still may not be immediately ready for use.

"I do want to decouple availability and manufacturing completion, because there is of course that regulatory component that would be needed to either approve or authorize actual use of the doses," ASPR's David Boucher told reporters Thursday.

The FDA has previously approved other vaccines to prepare for potential H5N1 pandemics, including a vaccine by Seqirus. It is unclear how soon the FDA could grant authorization to clear use of the new shots.

"While CDC's current risk assessment to the general public is low, if it is determined that the U.S. population needs to be vaccinated to prevent H5N1 influenza, then the FDA will use its regulatory pathways to take the appropriate steps to ensure vaccines are available in the timeliest manner possible," an FDA spokesperson said in a statement.

Boucher also said that authorities have so far not decided whether to recommend use of the vaccines. It is unclear who would be prioritized for the first shots if they are eventually deemed to be needed and rolled out for the public.

"If that changes in the future, we would be looking at the population for whom vaccination would be recommended and then making any decisions on prioritization at that time," said Boucher.

A panel of the CDC's outside vaccine advisers, which has discussed previous pandemic vaccines, is scheduled to meet in June to discuss H5N1 alongside its routine votes on recommendations for seasonal flu vaccines.

While the CDC says the risk to the general public from H5N1 remains low for now, the agency has warned that workers in places like dairy farms and production facilities are now at higher risk of infection and it has urged the industry to take precautions.

At least three workers at U.S. dairy farms have tested positive this year after working directly with infected cows.

The latest case in Michigan developed respiratory symptoms, officials announced Thursday, which could make it easier for the virus to spread from person to person.

"Simply put, someone who's coughing may be more likely to transmit the virus than someone who has an eye infection like conjunctivitis," the CDC's Nirav Shah said Thursday.

However, Shah said there is no evidence that person-to-person spread has happened so far. Contacts of the patient have so far not tested positive. Previous H5N1 spillovers around the world from different strains have also fizzled out after limited spread between people.

The CDC is now looking to see if the strain that infected the latest Michigan patient might have developed key mutations that could raise its risk of spread.

"The mere fact that this individual displayed some respiratory symptoms, again we should be alert, but in and of itself is not a cause to change course or suggest that we're at an inflection point," Shah said.

Alexander Tin is a digital reporter for CBS News based in the Washington, D.C. bureau. He covers the Biden administration's public health agencies, including the federal response to infectious disease outbreaks like COVID-19.

Read more here:

U.S. to make millions of bird flu vaccine doses this summer, as cases grow - CBS News

Scientists concerned over eggs for bird flu vaccine – CBS News

June 2, 2024

Watch CBS News

Eggs are a major tool in making vaccines that could potentially protect people from a bird flu outbreak -- but with the virus leading to the culling of birds, some scientists are worried. CBS News medical contributor Dr. Cline Gounder has more.

Be the first to know

Get browser notifications for breaking news, live events, and exclusive reporting.

Read the rest here:

Scientists concerned over eggs for bird flu vaccine - CBS News

The Chicken and Egg Problem of Fighting Another Flu Pandemic – Kaiser Health News

June 2, 2024

By Arthur Allen May 31, 2024

Even a peep of news about a new flu pandemic is enough to set scientists clucking about eggs.

They worried about them in 2005, and in 2009, and theyre worrying now. Thats because millions of fertilized hen eggs are still the main ingredient in making vaccines that, hopefully, will protect people against the outbreak of a new flu strain.

Its almost comical to be using a 1940s technology for a 21st-century pandemic, said Rick Bright, who led the Health and Human Services Departments Biomedical Advanced Research and Development Authority (BARDA) during the Trump administration.

Its not so funny, he said, when the currently stockpiled formulation against the H5N1 bird flu virus requires two shots and a whopping 90 micrograms of antigen, yet provides just middling immunity. For the U.S. alone, it would take hens laying 900,000 eggs every single day for nine months, Bright said.

And thats only if the chickens dont get infected.

The spread of an avian flu virus has decimated flocks of birds (and killed barn cats and other mammals). Cattle in at least nine states and at least three people in the U.S. have been infected, enough to bring public health attention once again to the potential for a global pandemic.

As of May 30, the only confirmed human cases of infection were dairy workers in Texas and Michigan, who experienced eye irritation. Two quickly recovered, while the third developed respiratory symptoms and was being treated with an antiviral drug at home. The viruss spread into multiple species over a vast geographic area, however, raises the threat that further mutations could create a virus that spreads from human to human through airborne transmission.

If they do, prevention starts with the egg.

To make raw material for an influenza vaccine, virus is grown in millions of fertilized eggs. Sometimes it doesnt grow well, or it mutates to a degree that the vaccine product stimulates antibodies that dont neutralize the virus or the wild virus mutates to an extent that the vaccine doesnt work against it. And theres always the frightening prospect that wild birds could carry the virus into the henhouses needed in vaccine production.

Once those roosters and hens go down, you have no vaccine, Bright said.

Since 2009, when an H1N1 swine flu pandemic swept around the world before vaccine production could get off the ground, researchers and governments have been looking for alternatives. Billions of dollars have been invested into vaccines produced in mammalian and insect cell lines that dont pose the same risks as egg-based shots.

Everyone knows the cell-based vaccines are better, more immunogenic, and offer better production, said Amesh Adalja, an infectious disease specialist at Johns Hopkins Universitys Center for Health Security. But they are handicapped because of the clout of egg-based manufacturing.

The companies that make the cell-based influenza vaccines, CSL Seqirus and Sanofi, also have billions invested in egg-based production lines that they arent eager to replace. And its hard to blame them, said Nicole Lurie, HHS assistant secretary for preparedness and response under President Barack Obama who is now an executive director of CEPI, the global epidemic-fighting nonprofit.

Most vaccine companies that responded to an epidemic Ebola, Zika, covid ended up losing a lot of money on it, Lurie said.

Exceptions were the mRNA vaccines created for covid, although even Pfizer and Moderna have had to destroy hundreds of millions of doses of unwanted vaccine as public interest waned.

Pfizer and Moderna are testing seasonal influenza vaccines made with mRNA, and the government is soliciting bids for mRNA pandemic flu vaccines, said David Boucher, director of infectious disease preparedness at HHS Administration for Strategic Preparedness and Response.

Bright, whose agency invested a billion dollars in a cell-based flu vaccine factory in Holly Springs, North Carolina, said theres no way in hell we can fight an H5N1 pandemic with an egg-based vaccine. But for now, theres little choice.

BARDA has stockpiled hundreds of thousands of doses of an H5N1-strain vaccine that stimulates the creation of antibodies that appear to neutralize the virus now circulating. It could produce millions more doses of the vaccine within weeks and up to 100 million doses in five months, Boucher told KFF Health News.

But the vaccines currently in the national stockpile are not a perfect match for the strain in question. Even with two shots containing six times as much vaccine substance as typical flu shots, the stockpiled vaccines were only partly effective against strains of the virus that circulated when those vaccines were made, Adalja said.

However, BARDA is currently supporting two clinical trials with a candidate vaccine virus that is a good match for what weve found in cows, Boucher said.

Flu vaccine makers are just starting to prepare this falls shots but, eventually, the federal government could request production be switched to a pandemic-targeted strain.

We dont have the capacity to do both, Adalja said.

For now, ASPR has a stockpile of bulk pandemic vaccine and has identified manufacturing sites where 4.8 million doses could be bottled and finished without stopping production of seasonal flu vaccine, ASPR chief Dawn OConnell said on May 22. U.S. officials began trying to diversify away from egg-based vaccines in 2005, when avian flu first gripped the world, and with added vigor after the 2009 fiasco. But with the resources we have available, we get the best bang for our buck and best value to U.S. taxpayers when we leverage the seasonal infrastructure, and thats still mostly egg-based, Boucher said.

Flu vaccine companies have a system that works well right now to accomplish their objectives in manufacturing the seasonal vaccine, he said. And without a financial incentive, we are going to be here with eggs for a while, I think.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFFan independent source of health policy research, polling, and journalism. Learn more about KFF.

This story can be republished for free (details).

We encourage organizations to republish our content, free of charge. Heres what we ask:

You must credit us as the original publisher, with a hyperlink to our kffhealthnews.org site. If possible, please include the original author(s) and KFF Health News in the byline. Please preserve the hyperlinks in the story.

Its important to note, not everything on kffhealthnews.org is available for republishing. If a story is labeled All Rights Reserved, we cannot grant permission to republish that item.

Have questions? Let us know at KHNHelp@kff.org

Continued here:

The Chicken and Egg Problem of Fighting Another Flu Pandemic - Kaiser Health News

BARDA signs on with CSL Seqirus for 4.8 million bird flu shots – FiercePharma

June 2, 2024

The United States Department of Health and Human Services has expanded its avian flu pandemic preparedness partnership with CSL Seqirus, lining up the vaccine specialist to complete the fill-finish process for the shots.

Execution of this stage will increase the arsenal of vaccines acquired by the Biomedical Advanced Research and Development Authority (BARDA) under its National Pre-Pandemic Influenza Vaccine Stockpile (NPIVS) program.

It is the fourth award from BARDA to CSL Seqirus related to preparations for a potential outbreak of avian influenza (HPAI) virus, which has been detected in wild birds and livestock throughout the U.S.

With this agreement, CSL Seqirus will deliver 4.8 million vaccine doses that are matched to the current H5N1 strain of the virus.

On Thursday, the CDC reported on the spread of H5N1 in dairy cattle and two cases of humans contracting the virus.

The CDC maintains the risk to public health as low. We are closely monitoring the situation because we are acutely aware of the threat that influenza virus strains like H5N1 can pose and take seriously our role in preparedness efforts alongside our government and public health partners, Marc Lacey, CSL Seqirus, Global Executive Director for Pandemic, said in a release.

CSL will provide the vaccines from its massive manufacturing site in Holly Springs, N.C. which was built through a public-private partnership between the company and BARDA 15 years ago.

The facility can deliver up to 150 million doses within six months of the declaration of a pandemic, CSL Seqirus said, with a second phase of manufacturing enabling more vaccines as needed.

Two years ago, CSL Seqirus gained a ready to respond designation, meaning that in the case of a pandemic, it would immediately shift from its usual production of seasonal flu shots to the manufacture of those for the emergency.

Of the potential $2 billion award amount from the government to CSL Seqirus, BARDA has obligated $1.1 billion to the company, with $139 million of that paid for, according to USASpending.com.

In October 2022, CSL Seqirus scored a $30 million contract from BARDA to conduct a phase 2 trial of its avian flu candidate. In August of last year, BARDA awarded a $46.3 million contract to the company for one bulk lot of HPAI vaccines.

Originally posted here:

BARDA signs on with CSL Seqirus for 4.8 million bird flu shots - FiercePharma

Pharmalittle: We’re reading about a deal for a Moderna bird flu shot, NIH trial shortcomings, and more – STAT

June 2, 2024

Rise and shine, everyone, another busy day is on the way. We can tell because countless birds are chirping outside our window, the pace of motor vehicles passing by is picking up, and the official mascots are busy foraging for snacks on the campus. As for us, we are engaged in the usual ritual of brewing cups of stimulation. Our choice today is orange cream. As always, you are invited to join us. Meanwhile, here is the latest menu of tidbits for you to digest as you embark on your journey, which we hope is satisfying and rewarding. On that note, time to get cracking. Best of luck, and do keep in touch.

The U.S. government is nearing an agreement to bankroll a late-stage trial of Modernas mRNA pandemic bird flu vaccine, hoping to bolster its pandemic jab stockpile as an H5N1 outbreak spreads through egg farms and among cattle herds, The Financial Times reports. The federal funding from the governments Biomedical Advanced Research and Development Authority, known as BARDA, could come as early as next month. The agreement is expected to total several tens of millions of dollars, and could be accompanied by a commitment to procure doses if the Phase 3 trials are successful. Bird flu has been detected on poultry farms in 48 states and in dairy cow herds across nine states.

Clinical trials that are funded by the U.S. National Institutes of Health often enroll fewer Black patients and other underrepresented racial groups than planned, STAT writes, according to a study of 30 such trials sampled by the Office of the Inspector General of the Department of Health and Human Services. Most NIH-funded clinical trials that were reviewed missed planned enrollment targets by varying degrees. Clinical trials most commonly recruited fewer Black, Native American and Alaska Native, and Asian participants than originally planned. Clinical trials missed targets for female participants more often than they did for male participants.

STAT+ Exclusive Story

Already have an account? Log in

Already have an account? Log in

Already have an account? Log in

Get unlimited access to award-winning journalism and exclusive events.

See original here:

Pharmalittle: We're reading about a deal for a Moderna bird flu shot, NIH trial shortcomings, and more - STAT

Page 10«..9101112..2030..»