Cost of living crisis may be factor in low whooping cough jab rates, experts say – The Guardian

Cost of living crisis may be factor in low whooping cough jab rates, experts say – The Guardian

Cost of living crisis may be factor in low whooping cough jab rates, experts say – The Guardian

Cost of living crisis may be factor in low whooping cough jab rates, experts say – The Guardian

May 13, 2024

Health

Analysis shows rates of uptake of six-in-one vaccine lowest in the most deprived areas of England

Sat 11 May 2024 05.00 EDT

Public health officials are facing calls to improve whooping cough vaccine rates in Englands most deprived areas, with experts fearing the housing and cost of living crises may be contributing to low uptake.

Rates of people having taken the six-in-one vaccine, which protects against whooping cough among other diseases, is at the lowest level in the 10% most deprived local authorities in England, according to a Guardian analysis of UK Health Security Agency data.

This week it was revealed the UK may be experiencing its biggest outbreak of whooping cough in two decades, with five deaths reported among infants who developed the disease in England between January and March.

The Guardians analysis shows that 87% of the children living in the most deprived local areas of England had been fully vaccinated at the age of one, as of December 2023. This compares with 94% of those living in the wealthiest parts of England.

London had the lowest rate of vaccination, with 86.2% of children having taken the three doses of the vaccine at 12 months compared with 95.6% in the north-east. But even when London was excluded, the most deprived areas in England still had the worst coverage.

The cost of living crisis, precarious and poor housing, and the current socioeconomic climate have all been cited by experts as reasons for poor vaccine uptake in the most deprived communities across England.

Dr Ben Kasstan-Dabush, an assistant professor in global health and development at the London School of Hygiene & Tropical Medicine, said the deaths of the five infants from whooping cough reflected the strain and limitations that the immunisation and public health systems are working under.

The lower levels of vaccine uptake in deprived areas should not be dismissed as simply due to vaccine hesitancy, but rather due a wide range of factors, according to Kasstan-Dabush.

If we look at urban settings like London, the populations are much more mobile, and diverse and living in extremes of inequality. We live in a context of an awful cost of living crisis which is putting parents under immense strain, and this is going to affect what theyre able to do with their priorities, Kasstan-Dabush said.

Those in very financially precarious situations, their ability to get to the vaccination points might look different.

He added that in a mobile population, people could fall through the cracks of the system, which can affect the vaccination services offered.

Having vaccination centres embedded in community centres, such as Sure Start childrens centres, could be part of the solution to improving vaccine uptake in harder to reach communities, according to Kasstan-Dabush. I think the need for flexibility and creativity in immunisation services is most needed in these areas, he added.

Prof Andrew Preston from the University of Baths Milner Centre for Evolution, said the need for vaccines to be primarily administered by GPs might contribute to lower uptake in deprived communities, and that widening access to vaccination could help.

Looking at all the issues over access to GP appointments, its clear that those socioeconomically deprived areas, those that are most stretched for access to GP services, and of course our vaccinations tend to be given through healthcare centres predominantly, Preston said.

We learned the lessons during the pandemic. We saw that we had improved vaccine uptake if we made it really, really easy for people to access the vaccine, so not just having to get an appointment with a healthcare professional.

So whether we could think about doing it through pharmacists seems to be the solution at the moment, given how stretched GP surgeries and healthcare workers are.

He added that people living in precarious housing and frequently having to move was also a factor in low uptake levels among more deprived communities.

I think weve seen with the housing crisis that there are people moving around a lot more. And of course, if youre not registering with your local GP or youre struggling to do it, particularly with infant vaccinations [people] could slip through the cracks.

Among the local areas with the lowest rates, 13 of the top 20 are in London. Other areas outside London with the lowest coverage are Rochdale, Salford, Liverpool, Knowsley and Blackburn with Darwen in the north-west and Birmingham.

In terms of the UK, England has the lowest coverage of the vaccine protecting against whooping cough, with 91.3% of children having completed immunisation at 12 months compared with 94.8% in Scotland, 94.5% in Wales and 92% in Northern Ireland.

Babies are given the six-in-one vaccine which includes protection against whooping cough and other five diseases at eight, 12 and 16 weeks. The four-in-one preschool booster vaccine, which is given at children at the age of three, also includes protection against whooping cough.

The NHS also recommends that pregnant women are vaccinated against whooping cough to help protect their babies.

A Department of Health and Social Care spokesperson said: Our sympathies are with the families of the children in these tragic cases.

We are committed to improving vaccination uptake rates to fully protect the public from preventable diseases and are urging people to make sure they and their children have received all appropriate jabs. The vaccine is proven to be safe and effective.

The UK Health Security Agency and NHS England have also been engaging local communities to highlight the importance of vaccination and make sure people know how to access the jabs as quickly as possible.

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Jacob Rees-Mogg claims UK government ‘downplayed’ risks of AstraZeneca COVID vaccine – Yahoo News UK

Jacob Rees-Mogg claims UK government ‘downplayed’ risks of AstraZeneca COVID vaccine – Yahoo News UK

May 13, 2024

Jacob Rees-Mogg has claimed the government downplayed risks of the AstraZeneca COVID vaccine during the pandemic after it was announced the jab was being withdrawn from the worldwide market.

On Wednesday, pharmaceutical giant AstraZeneca confirmed the AZ vaccine developed by Oxford scientists during the pandemic would no longer be distributed, citing a decline in demand.

The firm is being sued in a class action lawsuit amid allegations its vaccine caused fatalities and serious injury in dozens of instances. According to media reports, the drugmaker has previously admitted in court documents that the vaccine causes side-effects such as blood clots and low blood platelet counts.

On Thursday, Tory MP Rees-Mogg told his GB News show viewers that Boris Johnson's government had deliberately minimised the vaccines risks.

The vaccine was, and remains for the overwhelming majority of the population, safe," he said. Yet we've always known that all medical interventions carry some form of risk. We know it now and we knew it then and these were downplayed. So regardless of how rigorous the safety regulations were, the vaccine was new and lacked long term data.

Whilst the rollout was, on the whole, successful, we now know that they were not as effective as we first hoped. And although the side effects were rare, they were real.

Rees-Mogg supported the rollout of the jab, saying it saved many lives and allowed the lockdown to end.

However, he claimed the government partially coerced people to take the vaccine by threatening to remove freedoms.

Rees-Mogg, who attended cabinet meetings at the time as leader of the House of Commons, added: A well-intentioned government was using an element of coercion to increase vaccine take-up and, therefore, the second order effects of a lack of transparency have been damaging to confidence and have encouraged some of the conspiracy theories.

So while over egging the pudding may solve a problem in the short term, it can create more in the long term.

Rees-Mogg suggested that a major problem was that the nature of the rollout had encouraged conspiracy theories, which could cause the public to lose trust in the government. He said: And this could have very serious consequences if, for example, a contagion more serious, more deadly than COVID-19 were to hit these shores, people would be less likely to listen to what the governments say.

He urged authorities to learn from the rollout of vaccines and said in the future individuals should be given the facts, the risks as well as the good information to allow them to make their own choices.

The AstraZeneca vaccine was widely lauded in December 2020 when it was approved for use in the UK. Then health secretary Matt Hancock described it as "great British success story" while Johnson labelled it a "triumph for British science".

The AZ vaccine was first administered to 82-year-old Brian Pinker on 4 January 2021 being being distributed widely the the UK and overseas over the coming weeks and months.

In mid-March 2021, more than a dozen European countries, including Germany and France, paused the use of the vaccine following reports of blood coagulation disorders in recipients. However, they resumed the roll-out days later after EU and British regulators shored up confidence in the shot, saying its benefits outweigh the risks.

The European Medicines Agency's (EMA) "clear" conclusion following an investigation into 30 cases of unusual blood disorders was that the vaccine's benefits in protecting people from coronavirus-related death or hospitalisation outweighed the possible risks, though it said a link between blood clots in the brain and the shot could not be definitively ruled out.

AstraZeneca acknowledged the issue in a statement on 14 March, but insisted that their evidence showed "no evidence of an increased risk of pulmonary embolism, deep vein thrombosis (DVT) or thrombocytopenia".

On 16 March 2021, the UK's chief medical officer Professor Chris Whitty acknowledged there were risks after the blood clot reports, but insisted the benefits outweighed the risks. He told a COVID press conference there were "real issues that we always have to think about with all drugs", but they were "so much smaller than the benefits of getting the vaccine".

"The risk-benefit is really strongly in favour of getting vaccinated," he added.

By 17 March, 25 million people in the UK had received their first vaccine dose, with approximately 12 million adults having been given the AZ vaccine.

On 7 April 2021, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued updated information on the possible risk of extremely rare and unlikely to occur specific types of blood clots following vaccination with the AstraZeneca jab.

The regulator said the benefits of vaccination continue to outweigh any risks but advised careful consideration be given to people who are at higher risk of specific types of blood clots because of their medical condition.

The UK regulator had found a total of 30 cases of blood clot events after AZ vaccine use. The EU drug regulator also found a link between the vaccine and blood clots and said it was up to countries to decide how to handle AstraZeneca distribution.

Oxford then paused a vaccine study in children and advised alternative vaccines to be given to the under-30s.

Data subsequently showed that people were more likely to get blood clots if they contracted COVID compared to taking the AZ vaccine. Many countries had, by then, restricted the AZ vaccine to older populations.

According to analysis by Professor Christina Pagel of research published in the British Medical Journal in 2023, COVID was 190 times more likely to give people blood clots in veins than the AZ vaccine and 1.4 times more likely for brain clots.

It is widely accepted that the AZ vaccine - and other COVID jabs - saved millions of lives during the devastating pandemic. In the first year, vaccinations were estimated to have prevented 19.8 million COVID-19 deaths worldwide, according to an Imperial College study.

Further analysis by Airfinity showed the AZ and Pfizer/BioNTech vaccines saved more 12 million lives in the first year of use.

Professor Adam Finn, Professor of Paediatrics, University of Bristol, said following AstraZeneca's decision to remove its vaccine from the market: This vaccine saved very large numbers of lives in many countries around the world particularly in 2021 and 2022, both because it was developed and tested so rapidly and because AZ made it available at very low cost so that it could be used in many of the poorer countries in the world.

Prof Jonathan Ball, Deputy Director of Liverpool School of Tropical Medicine and Professor of Molecular Virology, Liverpool School of Tropical Medicine (LSTM), said: "We seem to forget how desperate the global population were for an effective COVID-19 vaccine, and the AZ vaccine saved millions of lives. However, there were relatively early indications that the vaccine was associated with very rare, but very serious complications, and eventually other vaccines, particularly those capable of giving protection against newly emerging variants of concern have come to the fore.

With almost everything we do there is a harm-benefit assessment that we have to make, and at the peak of the pandemic the AZ vaccine brought far more benefit than harm that would still be the case, but now more effective and safer avenues are available.


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Novavax soars 146% on $1.2 billion Sanofi vaccine licensing deal – The Economic Times

Novavax soars 146% on $1.2 billion Sanofi vaccine licensing deal – The Economic Times

May 13, 2024

Novavax Inc. shares surged after the company signed a $1.2 billion licensing agreement with Sanofi that includes commercializing a combined Covid-19 and flu shot.

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Novavax shares rose as much as 146% in early trading in New York and the stock is on track for its biggest one-day increase on record. The stock was trading at $10.30 a share on Friday, although this is still well off a peak of about $320 in early 2021.

The pact links two big players in the vaccine world that both missed out on the rush to develop and commercialize Covid shots quickly during the pandemic. Amid various setbacks, Sanofi and Novavax ceded tens of billions of dollars in sales to nimbler messenger-RNA developers including the Pfizer-BioNTech alliance and Moderna Inc.

Sanofi will also have a non-exclusive license to use Novavaxs Matrix-M adjuvant in other vaccine products. Novavax will still have the right to develop its own combined Covid-flu vaccine at its own cost.

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Moderna and Pfizer are both assessing mRNA-based combination vaccines, and though Sanofi believes its non mRNA-based flu product wont be improved, the potential to offer a non-mRNA-based combination as an alternative looks a sensible move, she said.

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Novavax soars 146% on $1.2 billion Sanofi vaccine licensing deal - The Economic Times
Novavax shares soar on license deal with Sanofi at lofty valuation – ETHealthWorld

Novavax shares soar on license deal with Sanofi at lofty valuation – ETHealthWorld

May 13, 2024

By Patrick Wingrove and Bhanvi Satija

London: Novavax on Friday said it had struck a licensing deal worth at least $1.2 billion with Sanofi for its COVID-19 vaccine in exchange for a stake that valued the U.S. biotech firm at double its current market capitalisation.

The Maryland-based drugmaker's stock more than doubled in Friday trading to $8.97 following the deal as the company also removed a warning notice from February last year that raised doubts about it being in business. At their peak in 2021, shares traded at about $332.

The deal also entitles Novavax to an upfront cash payment of $500 million and future payments contingent on certain milestones, as well as royalties.

continued below

"A company like Sanofi, that has pioneered protein recombinant-based vaccines for decades, validating and actually needing what Novavax has as their next pipeline innovation engine is very powerful," said B. Riley Securities analyst Mayank Mamtani.

The French drugmaker made nearly $7.5 billion in sales from its vaccines last year.

Novavax CEO John Jacobs said during a call with analysts that the company expected the deal with Sanofi to be worth further billions of dollars in the future.

"The majority of what we see as the future value of this deal comes from the anticipated royalties that will be ongoing from Sanofi's ability to sell our COVID vaccine and their own combination vaccine or vaccines," he said.

Jacobs said the company would consider similar deals for its other experimental vaccines, which include a standalone influensa shot.

SHORT SELLERS FEEL PAIN

The cash infusion is likely to strengthen the balance sheet of the vaccine maker, whose shares lost more than 98 per cent of their value since the early days of pandemic as it struggled to get its vaccine to the market in a timely manner.

Novavax has become a target for both short sellers who bet that the value of the stock will fall, and an activist shareholder pushing for changes.

About 35.5 per cent of Novavax's publicly available shares are shorted. Friday's rise is squeezing out short sellers, who are buying back stock to exit their position.

The bearish investors had lost roughly $255 million on paper, according to analytics firm S3 partners.

The deal is "a step in the right direction for shareholders", hedge fund Shah Capital, which has been pushing for a shake-up of Novavax's board, said.

Separately, Novavax cut its 2024 sales forecast, excluding contributions from the Sanofi deal, to between $400 million and $600 million from $800 million to $1 billion previously.

It also reported a net loss that narrowed to $148 million in the first quarter from $294 million a year ago.

(Reporting by Patrick Wingrove in New York, Bhanvi Satija, Medha Singh, Shubham Kalia and Sriparna Roy in Bengaluru, and Tassilo Hummel in Paris; Editing by Shinjini Ganguli and Arun Koyyur)


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Novavax shares soar on license deal with Sanofi at lofty valuation - ETHealthWorld
FDA Action Alert: Dynavax, Ascendis and BMS – BioSpace

FDA Action Alert: Dynavax, Ascendis and BMS – BioSpace

May 13, 2024

Pictured: A scientist with pill bottles in front of FDA headquarters/Taylor Tieden for BioSpace

May will be relatively slow for the FDA, with only four big target action dates. Among other announcements, the regulator is scheduled to release its verdicts on a hepatitis B vaccine for adults on hemodialysis and two potential indications for BMS's CAR-T therapyBreyanzi.

Read below for more.

Dynavax Proposes Hepatitis B Vaccine for Patients on Hemodialysis

Today is the day by which the FDA is scheduled to publish its decision on Dynavax Technologies sBLA seeking to expand the label of its hepatitis B vaccine Heplisav-B for use in adults on hemodialysis.

Heplisav-B won its initial U.S. approval in 2017 for the prevention of hepatitis B, caused by all known subtypes of the virus, in adults aged 18 years and above. According to its label, Heplisav is a recombinant protein vaccine comprised mainly of the hepatitis B surface antigen, which can prime the body to protect against the virus infection.

Heplisav-B is designed to be administered in two doses, and is the only approved hepatitis B shot that completes the vaccination series in one month. The U.K.s Medicines and Healthcare products Regulatory Agency granted Heplisav-B Marketing Authorization in February 2023.

Dynavax reported that Heplisav-B brought in $213 million in net revenues in 2023, representing a 69% year-over-year increase. As of the end of December 2023, Heplisav-B controlled approximately 42% of the U.S. hepatitis B vaccine market, up from 35% at the end of 2022.

In a statement accompanying the companys full-year results, CEO Ryan Spencer said that Heplisav-B saw record revenue growth in 2023 and became the market share leader in two largest growth segments. These achievements will help Dynavax establish Hepliav-B as the leading vaccine in the U.S. adult hepatitis B vaccine market, he said.

The company expects continued growth for Heplisav-B in 2024, anchored by the upcoming potential approval. Dynavax forecasts net product revenues of $265 million to $280 million for Heplisav-B this year.

Ascendis Tries Again for Hypoparathyroidism Approval for TransCon PTH

The FDA is scheduled on May 14 to release its verdict on Ascendis Pharmas resubmission for its investigational drug TransCon PTH (palopegteriparatide), which is being proposed as a treatment for adults with hypoparathyroidism.

Designed to be orally available and formulated to be long-acting, TransConPTH is a prodrug of the parathyroid hormone that works by restoring physiologic levels of the hormone for 24 hours each day. This mechanism of action could potentially allow it to counter hypoparathyroidism, a rare disorder characterized by the insufficiency of parathyroid hormone, in turn leading to low calcium and high phosphate levels.

Patients with hypoparathyroidism experience weakness, muscle cramps and headaches, and the condition can lead to long-term complications such as calcium deposits in the eyes, brain and kidneys. Currently, hypoparathyroidism is managed through high-dose therapy with calcium and active vitamin D, which does not optimally control the condition.

Ascendis first submitted a drug application for TransCon PTH in 2022, which the FDA rejected in May 2023, citing manufacturing concerns. The regulator did not identify problems with the drugs safety or efficacy, and it did not ask for additional studies.

Currently, TransCon PTH is approved in the U.K. and European Union, where it is marketed under the brand name Yorvipath.

BMS Awaits Two Verdicts for CAR-T Therapy Breyanzi

To close out the month, BMS is looking at two target action dates for its CAR-T therapy Breyanzi (lisocabtagene maraleucel): May 23 for relapsed or refractory follicular lymphoma (FL) and May 31 for relapsed or refractory mantle cell lymphoma (MCL).

In FL, Breyanzi is backed by the Phase II single-arm TRASCEND FL study, which, with 213 enrolled patients, is the largest clinical trial so far to assess a CAR T therapy in relapsed or refractory indolent non-Hodgkin lymphoma, including FL.

BMS presented data from TRANSCEND FL in December 2023, showing that Breyanzi elicited a 95.7% complete response rate in patients with high-risk relapsed or refractory FL when used in the second-line setting. Median progression-free survival had not been reached at the time.

Meanwhile, BMS is backing Breyanzis MCL application with findings from the MCL cohort of the TRANSCEND NHL 001 study. Published in December 2023 in the Journal of Clinical Oncology, results from the pivotal Phase I trial demonstrated significant and clinically meaningful treatment responses in heavily pre-treated patients, most of whom achieved a complete response.

Breyanzi is a CAR-T cell therapy that works by targeting the CD19 surface protein, which is commonly expressed on B cells. Once bound to CD19, Breyanzi proliferates, induces the release of proinflammatory cytokines and cell death in cancer cells. The FDA first approved Breyanzi in February 2021 for relapsed or refractory B-cell lymphoma.

In March 2024, Breyanzi picked up two new approvals, one for chronic lymphocytic leukemia and the other for small lymphocytic leukemia.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.


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POSTPONED – Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement … – FDA.gov

POSTPONED – Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement … – FDA.gov

May 13, 2024

On This Page Date: May 16, 2024 Time: 8:30 AM - 4:30 PM ET What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

THIS MEETING IS POSTPONED. The May 16, 2024, VRBPAC Meeting has been rescheduled for June 5, 2024. This new date will allow for additional time to obtain surveillance data and other information so the VRBPAC Committee will have more up-to-date information when discussing and making recommendations. FDA does not anticipate that the date change will impact COVID-19 vaccine availability for the Fall.

Please note that all meeting participants will be joining this advisory committee meeting through an online teleconferencing and/or video conferencing platform.

How to Attend:

CBER plans to provide a free of charge live webcast of the Vaccines and Related Biological Products Advisory Committee Meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Agenda On May 16, 2024, the Committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 Formula for COVID-19 vaccines. The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.

Meeting Materials FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDAs website at the time of the advisory committee meeting. Background material and the link to the online teleconference and/or video conference meeting will be available at theAdvisory Committee calendar.

Scroll down to the appropriate advisory committee meeting link. The meeting will include slide presentations with audio and video components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information FDA intends to issue an amended Federal Register Notice with details of this meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check FDAs website at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

You may submit comments as follows:

Electronic Submissions

Written/Paper Submissions

Instructions: All submissions received must include the Docket No. FDA-2023-N-1553 for Vaccines and Related Biological Products Advisory Committee (VRBPAC); Notice of Meeting; Establishment of a Public Docket; Request for Comments. Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.

Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION. FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the Search box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Silver Spring, MD 20993-0002, 202-657-8533, CBERVRBPAC@fda.hhs.gov; or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area).

ORAL PRESENTATIONS Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time.

Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, along with their names, email addresses, direct contact phone numbers of proposed participants, and an indication of the approximate time requested to make their presentation on or before 12 p.m. Eastern Time on May 1, 2024.

Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by 6 p.m. Eastern Time May 3, 2024.

Webcast Information CBER plans to provide a free of charge live webcast of the Vaccines and Related Biological Products Advisory Committee Meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible.

Contact Information

Official FR Notice

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agencys website or call the committees Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDAs advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committees Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).


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POSTPONED - Vaccines and Related Biological Products Advisory Committee May 16, 2024 Meeting Announcement ... - FDA.gov
Study shows clear benefit from COVID-19 vaccination for heart failure patients – News-Medical.Net

Study shows clear benefit from COVID-19 vaccination for heart failure patients – News-Medical.Net

May 13, 2024

Heart failure patients who are vaccinated against COVID-19 have an 82% greater likelihood of living longer than those who are not vaccinated, according to research presented today at Heart Failure 2024, a scientific congress of the European Society of Cardiology (ESC).Heart Failure is a life-threatening syndrome affecting more than 64 million people worldwide.

Patients with heart failure should be vaccinated against COVID-19 to protect their health. In this large study of patients with heart failure, COVID-19 vaccination was associated with a lower likelihood of contracting the infection, being admitted to hospital because of heart failure, or dying from any cause during a six-month period compared with remaining unvaccinated."

Dr. Kyeong-Hyeon Chun,study authorof the National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea

Previous studies have shown the safety of COVID-19 vaccination in patients with cardiovascular diseases including heart failure,and that COVID-19 outcomes are worse in patients with heart failure compared to those without heart failure.However, there has been little research on how vaccines work specifically in patients with heart failure. This nationwide, retrospective study examined the prognosis of heart failure patients according to COVID-19 vaccination status.

This study used the Korean National Health Insurance Service database, which covers nearly all residents of the Republic of Korea, to obtain information on vaccinations and clinical outcomes. Participants who received two or more doses of COVID-19 vaccine were defined as "vaccinated", and those who were not vaccinated or had received just one dose were defined as "unvaccinated".

The study included 651,127 patients aged 18 years or older with heart failure. The average age was 69.5 years and 50% were women. Of the total study population, 538,434 (83%) were defined as vaccinated and 112,693 (17%) as unvaccinated. To control for factors that could influence the relationship between vaccination status and outcomes, the researchers performed 1:1 matching of vaccinated and unvaccinated patients according to age, sex, other health conditions (e.g. high blood pressure, diabetes, high cholesterol, etc.), income, and region of residence. This resulted in 73,559 vaccinated patients and 73,559 unvaccinated patients for the comparative analyses.

The median follow-up was six months. Vaccination was associated with an 82% lower risk of all-cause mortality, 47% lower risk of hospitalisation for heart failure,and 13% reduced risk of COVID-19 infectioncompared with no vaccination. Regarding cardiovascular complications, vaccination was associated with significantly lower risks of stroke, heart attack, myocarditis/pericarditis, and venous thromboembolism compared to no vaccination.

Dr. Chun said: "This was the first analysis of COVID-19 vaccine effectiveness in a large population of heart failure patients, and the first to show a clear benefit from vaccination. The study provides strong evidence to support vaccination in patients with heart failure. However, this evidence may not be applicable to all patients with heart failure, and the risks of vaccination should be considered in patients with unstable conditions."


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Study shows clear benefit from COVID-19 vaccination for heart failure patients - News-Medical.Net
Researchers hopeful new vaccine works against new coronaviruses | interest.co.nz – Interest.co.nz

Researchers hopeful new vaccine works against new coronaviruses | interest.co.nz – Interest.co.nz

May 11, 2024

The rapid development of vaccines that protect against COVID was a remarkable scientific achievement that saved millions of lives. The vaccines have demonstrated substantial success in reducing death and serious illness after COVID infection.

Despite this success, the effects of the pandemic have been devastating, and it is critical to consider how to protect against future pandemic threats. As well as SARS-CoV-2 (the virus that causes COVID), previously unknown coronaviruses have been responsible for the deadly outbreaks of SARS (2003) and MERS (2012 outbreak with ongoing cases). Meanwhile, several circulating bat coronaviruses have been identified as having the potential to infect humans which could cause future outbreaks.

My colleagues and I have recently shown, in mice, that a single, relatively simple vaccine can protect against a range of coronaviruses even ones that are yet to be identified. This is a step towards our goal of what is known as proactive vaccinology, where vaccines are developed against pandemic threats before they can infect humans.

Interview with the author, Rory Hills.

Conventional vaccines use a single antigen (part of a virus that triggers an immune response) that typically protects against that virus and that virus alone. They tend not to protect against diverse known viruses, or viruses that have not yet been discovered.

In previous research, we have shown the success of mosaic nanoparticles at raising immune responses to different coronaviruses. These mosaic nanoparticles use a type of protein superglue technology that irreversibly links two different proteins together.

This superglue is used to decorate a single nanoparticle with multiple receptor-binding domains a key part of a virus located on the spike protein that come from different viruses. The vaccine is focused on a sub-group of coronaviruses called sarbecoviruses that includes the viruses that cause COVID, SARS and several bat viruses that have the potential to infect humans.

As a virus evolves, some parts of it change while other parts remain the same. Our vaccine incorporates evolutionarily related receptor-binding domains (RBDs), so a single vaccine trains the immune system to respond to the parts of the virus that remain unchanged. This protects against the viruses that are represented in the vaccine and, critically, also protects against related viruses that are not included in the vaccine.

Despite this success with mosaic nanoparticles, the vaccine was complex, making it difficult to produce on a large scale.

In a collaboration between the universities of Oxford, Cambridge and Caltech, we have now developed a simpler vaccine that still provides this broad protection. We achieved this by genetically fusing RBDs from four different sarbecoviruses to form a single protein that we call a quartet. We then use a type of protein glue to attach these quartets to a protein nanocage to make the vaccine.

When mice were immunised with these nanocage vaccines, they produced antibodies that neutralised a range of sarbecoviruses, including sarbecoviruses not present in the vaccine. This show the potential to protect against related viruses that may not have been discovered at the time that the vaccine was produced.

Along with this streamlined production and assembly process, our new vaccine elicited immune responses in mice that at least matched, and in many cases exceeded, those raised by our original mosaic nanoparticles vaccine.

Given the large fraction of the world vaccinated or previously infected with SARS-CoV-2, there was a worry that an existing response to SARS-CoV-2 would limit the potential to protect against other coronaviruses.

However, we have shown that our vaccine is able to raise a broad anti-sarbecovirus immune response even in mice that had previously been immunised against SARS-CoV-2.

Our next step is to test this vaccine in humans. We are also applying this technology to protect against other groups of viruses that can infect humans. All of this brings us closer to our vision of developing a library of vaccines against viruses with pandemic potential before they have had the opportunity to cross over into humans.

Rory Hills, PhD Candidate, Biochemistry, University of Oxford

This article is republished from The Conversation under a Creative Commons license. Read the original article.


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Researchers hopeful new vaccine works against new coronaviruses | interest.co.nz - Interest.co.nz
New vaccine effective against coronaviruses that haven’t even emerged yet – Science Daily

New vaccine effective against coronaviruses that haven’t even emerged yet – Science Daily

May 11, 2024

Researchers have developed a new vaccine technology that has been shown in mice to provide protection against a broad range of coronaviruses with potential for future disease outbreaks -- including ones we don't even know about.

This is a new approach to vaccine development called 'proactive vaccinology', where scientists build a vaccine before the disease-causing pathogen even emerges.

The new vaccine works by training the body's immune system to recognise specific regions of eight different coronaviruses, including SARS-CoV-1, SARS-CoV-2, and several that are currently circulating in bats and have potential to jump to humans and cause a pandemic.

Key to its effectiveness is that the specific virus regions the vaccine targets also appear in many related coronaviruses. By training the immune system to attack these regions, it gives protection against other coronaviruses not represented in the vaccine -- including ones that haven't even been identified yet.

For example, the new vaccine does not include the SARS-CoV-1 coronavirus, which caused the 2003 SARS outbreak, yet it still induces an immune response to that virus.

"Our focus is to create a vaccine that will protect us against the next coronavirus pandemic, and have it ready before the pandemic has even started," said Rory Hills, a graduate researcher in the University of Cambridge's Department of Pharmacology and first author of the report.

He added: "We've created a vaccine that provides protection against a broad range of different coronaviruses -- including ones we don't even know about yet."

The results are published today in the journal Nature Nanotechnology.

"We don't have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now," said Professor Mark Howarth in the University of Cambridge's Department of Pharmacology, senior author of the report.

He added: "Scientists did a great job in quickly producing an extremely effective COVID vaccine during the last pandemic, but the world still had a massive crisis with a huge number of deaths. We need to work out how we can do even better than that in the future, and a powerful component of that is starting to build the vaccines in advance."

The new 'Quartet Nanocage' vaccine is based on a structure called a nanoparticle -- a ball of proteins held together by incredibly strong interactions. Chains of different viral antigens are attached to this nanoparticle using a novel 'protein superglue'. Multiple antigens are included in these chains, which trains the immune system to target specific regions shared across a broad range of coronaviruses.

This study demonstrated that the new vaccine raises a broad immune response, even in mice that were pre-immunised with SARS-CoV-2.

The new vaccine is much simpler in design than other broadly protective vaccines currently in development, which the researchers say should accelerate its route into clinical trials.

The underlying technology they have developed also has potential for use in vaccine development to protect against many other health challenges.

The work involved a collaboration between scientists at the University of Cambridge, the University of Oxford, and Caltech. It improves on previous work, by the Oxford and Caltech groups,to develop a novel all-in-one vaccine against coronavirus threats. The vaccine developed by Oxford and Caltech should enter Phase 1 clinical trials in early 2025, but its complex nature makes it challenging to manufacture which could limit large-scale production.

Conventional vaccines include a single antigen to train the immune system to target a single specific virus. This may not protect against a diverse range of existing coronaviruses, or against pathogens that are newly emerging.


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New vaccine effective against coronaviruses that haven't even emerged yet - Science Daily
Researchers new vaccine technology shows efficacy against broad range of coronaviruses – PMLiVE

Researchers new vaccine technology shows efficacy against broad range of coronaviruses – PMLiVE

May 11, 2024

Researchers from the University of Cambridge, the University of Oxford and Caltech have collaboratively developed a new vaccine technology that has proven to provide protection against a wide range of coronaviruses, including those that have not yet emerged.

Published in Nature Nanotechnology and funded by the Biotechnology and Biological Sciences Research Council, the new proactive vaccinology approach aims to build a vaccine before the disease-causing pathogen emerges in preparation for future outbreaks.

Most conventional vaccines involve a single antigen to train the immune system to target a single specific virus, potentially not protecting against a diverse range of existing coronaviruses or against newly emerging pathogens.

Building on previous work conducted by the University of Oxford and Caltech, the novel all-in-one Quartet Nanocage vaccine works to train the bodys immune system to recognise specific regions of eight types of coronaviruses, including SARS-CoV-1, SARS-CoV-2 and several others circulating in bats that have the potential to cause a human pandemic.

For example, despite not including the SARS-CoV-1 coronavirus, the vaccine still induces an immune response to that virus.

Based on a nanoparticle structure a ball of proteins bound together by strong interactions the vaccine demonstrated an increased broad immune response in mice that were pre-immunised with SARS-CoV-2.

We dont have to wait for new coronaviruses to emerge, said professor Mark Howarth, department of pharmacology, University of Cambridge.

He continued: We know enough about coronaviruses and different immune responses to them that we can get going with building protective vaccines against unknown coronaviruses now.

Much simpler in design compared to other vaccines, the technology has the potential for use in vaccine development to protect against many other health challenges and the vaccine is intended to enter phase 1 clinical trials in early 2025.

Rory Hills, graduate researcher, department of pharmacology, University of Cambridge, said: Our focus [was] to create a vaccine that will protect us against the next coronavirus pandemic and have it ready before the pandemic has even started.

Weve created a vaccine that provides protection against a broad range of different coronaviruses including ones we dont even know about yet.


See the original post here: Researchers new vaccine technology shows efficacy against broad range of coronaviruses - PMLiVE