Category: Vaccine

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.

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"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

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

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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FDA Action Alert: Dynavax, Ascendis and BMS - BioSpace

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

Whooping cough

Government adviser says low take-up of jab among pregnant women is putting young infants at particular risk

Fri 10 May 2024 07.42 EDT

More babies will die from whooping cough in the UK unless vaccination rates go up to slow the spread of the infection, a leading expert has warned, citing low take-up of jabs among pregnant women as a particular concern.

Prof Sir Andrew Pollard, a consultant paediatrician and the chair of the Joint Committee on Vaccination and Immunisation, which advises the government, said under-vaccination was putting the most vulnerable those who are too young to have been vaccinated at greatest risk.

He said the only thing that could be done about rising cases was to ensure higher vaccination rates.

He added: But very importantly, for this very vulnerable group, those who are too young to be vaccinated, is the vaccination rates in pregnant women.

Very worryingly, those have fallen from a peak of about 75% of women being vaccinated during pregnancy to under 60% today, and thats what puts these very young infants at particular risk.

He said for most of the last decade there had not been many cases of whooping cough because were all protected by the high vaccination rates, but as soon as vaccination rates started to fall, we see cases rising, the same as the situation with the measles outbreak.

He said: The troubling thing is that if we continue to have high rates of spread and low rates of vaccination, there will be more babies severely affected and sadly there will be more deaths.

Figures for England show 59.3% of pregnant women between October and December 2023 were vaccinated against whooping cough, almost 16% down on the same quarter in 2016-17. London has particularly low rates, at 36.8%.

Having the vaccine in pregnancy helps bridge the immunity gap from when babies are born until they themselves can be vaccinated.

Data for 2022-23 shows 91.8% of children had had their whooping cough vaccines by their first birthday, with experts saying this figure also needs to be higher.

Figures released on Thursday showed five babies in England died between January and the end of March after being diagnosed with whooping cough.

More than 2,700 whooping cough cases have been reported across England so far in 2024, more than three times the number recorded in the whole of last year.

The UK Health Security Agency (UKHSA) figures show there were 2,793 cases reported to the end of March. That compares with 858 cases for the whole of 2023.

Dr Gayatri Amirthalingam, a consultant epidemiologist for the UKHSA, said: Whooping cough can affect people of all ages, but for very young babies it can be extremely serious. Our thoughts and condolences are with those families who have so tragically lost their baby.

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Whooping cough will kill more babies unless UK vaccination rates rise, says expert - The Guardian

10 May 2024

Image source, Getty Images

Professor Sir Andrew Pollard, head of the UK's vaccine committee, said the youngest were at greatest risk and more pregnant women should be vaccinated.

If the disease continues to spread, more babies will die, he warned.

The whooping cough vaccine is offered to babies and pre-school children.

The "only thing we can actually do" about rising cases of whooping cough is to ensure higher vaccination rates, Prof Pollard told BBC Radio 4's Today programme.

"Very important - for this very vulnerable group, those who are too young to be vaccinated - is the vaccination rate in pregnant women," he added.

"Worryingly, those have fallen from a peak of about 75% of women being vaccinated during pregnancy to under 60% today, and that's what puts these very young infants at particular risk."

London has particularly low vaccination rates of 36.8%.

UK health officials say there have been 1,319 cases of whooping cough in England in March, up from 900 in February, giving a total of nearly 2,800 so far this year.

The bacterial infection, which can develop into prolonged bouts of coughing, is a cyclical disease, with peaks seen every three to five years.

The last peak year came in 2016, when there were nearly 6,000 cases in England.

Half of cases seen so far this year have been in the under-15s, with the highest rates in babies under three months, who are most at risk. The five babies who died this year - the first deaths since 2019 - were all under three months old.

"The troubling thing is that if we continue to have high rates of spread and low rates of vaccination, there will be more babies severely affected, and sadly there will be more deaths," Prof Pollard said.

A steady decline in uptake of the vaccine and the very low number of infections seen during the pandemic, were both factors in the rise in cases, the UK Health Security Agency said.

This also happened with other infections, because restrictions on socialising during the pandemic meant that diseases which normally spread widely were stopped in their tracks, and a peak year was therefore overdue.

In September 2023, the number of two-year-olds who completed their routine six-in-one vaccinations, which includes protection against pertussis, was 92.9%, down from 96.3% in March 2014.

Uptake of the maternal pertussis vaccine, which is offered during every pregnancy and provides some protection to babies in the first few months of life, has also dropped.

The first signs are similar to a cold, with a runny nose and sore throat.

After about a week, the infection can develop into coughing bouts that last a few minutes and are typically worse at night.

Young babies may make a distinctive "whoop" or have difficulty breathing after a bout of coughing.

The bacterial infection spreads through coughs and sneezes.

People of all ages can catch whooping cough, but it is most serious for young children and babies.

Health experts are urging those not vaccinated to come forward to get the jab.

The whooping cough vaccine is routinely given as part of the:

If you are pregnant, you should also have the whooping cough vaccine - ideally between 16 and 32 weeks.

Children who have not been vaccinated can still get the jab up to the age of 10. Vaccination offers enough protection that, if the child is infected, the illness will be mild.

Prof Kamila Hawthorne, who chairs the Royal College of GPs, said it was "highly concerning" that such a high number of whooping cough cases had been confirmed.

She said whooping cough was an uncomfortable experience for most patients, causing restless nights and shortness of breath - but for some it could be "far more serious".

Dr David Elliman, consultant in community child health at Great Ormond Street Hospital in London, said: "While the vaccines against whooping cough are not 100% protective, they enormously reduce the chances of babies dying.

"Parents should ensure that their babies are immunised on time, but as importantly, that they get the vaccine when pregnant."

He also said the rise in cases of this infection, as well as of measles, should be "a wake-up call to the NHS", adding: "For too long, successive governments have paid lip service to the importance of preventative healthcare. It is now time that appropriate resources are provided to back up the rhetoric."

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Whooping cough: Vaccine expert 'very worried' by whooping cough deaths - BBC.com

Novavax stock more than doubled after signing a $1.2 billion licensing agreement with French drugmaker Sanofi to co-commercialize its combination COVID and influenza vaccine.

Gaithersburg, Maryland-based Novavax has signed a $1.2 billion licensing agreement with French drugmaker Sanofi to co-commercialize its combination COVID and influenza vaccine.

Novavax stock more than doubled after the announcement.

It puts Novavax on solid footing, after restructurings last year that led to massive job cuts and cost reductions that cut its operating expenses in half last year.

Under terms of the Sanofi agreement, Sanofi also receives a license to commercialize Novavaxs current stand-alone, protein-based COVID vaccine.

Today we announce the beginning of an exciting new chapter for Novavax with the launch of a strategically important partnership with one of the worlds leading vaccine companies. We believe the combined strength of Novavax and Sanofi will enable us to better fulfill our mission of developing and improving access to life-saving vaccines, said John C. Jacobs, President and Chief Executive Officer of Novavax.

Novavax will receive an upfront payment of $500 million, and another $700 million if certain development and launch milestones are met. It will also receive royalties on vaccine sales. Sanofi is taking a 5% stake in Novavax as part of the agreement.

The Novavax combination COVID and influenza vaccine is currently in late-stage clinical trials, and could receive regulatory approval as early as 2026.

The Novavax COVID vaccine differs from those made by Pfizer and Moderna, whose vaccines use mRNA technology. However, it was late to market with its vaccine during the early days of the pandemic, with FDA approval slow to come. The FDA gave emergency use authorization to its vaccine in July of 2022, almost a full year after Pfizer and Moderna vaccines were approved.

Novavax promotes its protein-based COVID vaccine as a viable alternative for those who dont want the mRNA versions. It is also more shelf-stable.

Novavax reported a first quarter net loss of $148 million, compared to a net loss of $294 million in the same quarter a year earlier. The companys first quarter revenue was $94 million ,compared to $81 million a year earlier. The company also severely reduced its research and development expenses, to $93 million last quarter, compared to $247 million in the first quarter of 2023.

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Maryland-based Novavax soars on big vaccine deal - WTOP

Ten days after AstraZeneca admitted side effects of its Covid vaccine in rare cases, the company has withdrawn the shots, renamed Vaxzveria in 2021, from the global market. It has cited a surplus of available updated vaccines that target new variants of the virus as the reason for its decision. The vaccine majors moves have generated negative sentiments bordering on panic, including among some people in India where AstraZeneca partnered with the Serum Institute of India to develop Covishield the bulwark of the countrys fight against Covid. Such responses might not be surprising given that social media is the prime source of information for a sizable section and the means to distinguish science from pseudoscience are not always at hand. But knee-jerk reactions from other quarters have also not helped. Especially unfortunate are the politically loaded comments about Covishield during the Lok Sabha election campaigns.

The emergency created by an unknown contagion required due procedures including clinical trials and schedules to be compressed. But the crisis also galvanised scientists, medical experts and policymakers to push the frontiers of their disciplines and domains. Vaccine hesitancy tested the persuasion skills of local officials and healthcare workers. Its a testimony to such initiatives that social and economic activities return to normalcy about two years after the virus unleashed its virulence. Vaccination ensured that the contagion took on a significantly less aggressive form after the lethal second wave in the summer of 2021 when the bulk of the countrys population had not received the shots. Hospitalisation and fatality rates remained low even during periods of spike in infection after the second wave.

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Covid inoculation drives are now subjects of intensive research. Thats how it should be. These studies help generate nuanced information about the safety and efficacy of the vaccines, that could not have been generated with the volunteer size of the trials. Scientists can today draw on databases that comprise inoculated people across nations and continents. Besides helping epidemiologists understand how the jabs work on diverse sections of people, and reaffirming the potency of the shots, such studies shine the light on rare adverse reactions, including thrombosis and thrombocytopenia Syndrome (TTS) blood clots and low levels of platelets associated with the AstraZeneca vaccine. Such research will help vaccine developers refine their methods. Technologies used in the Covid jabs whether the viral vector of AstraZeneca or the mRNA technique of some other developers are part of a larger battle against infectious diseases. Alarmist reactions against the Covid jabs could raise the head of vaccine hesitancy and hurt the fight against other contagions.

The Indian Express Pvt Ltd

First uploaded on: 10-05-2024 at 08:05 IST

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AstraZeneca withdraws vaccine: No need to panic - The Indian Express

Trust in science, vaccines, health experts and authorities is declining, causing preventable infections like measles to become much more common.

In Sweden, until the late 1960s, people drove on the left. But on September 3, 1967, the road rules changed. En masse, Swedes switched to driving on the right. If even a small percentage of drivers had rebelled and were still rebelling, Sweden today would be a synonym for chaos and death. Instead, Sweden might as well mean safety. It has the lowest driving death rate of any country in the European Union.

Why the success? Everyone trusted everyone else to make the switch. Of course, it was never likely to fail. Nigeria made a similarly smooth change in 1972 as did Samoa in 2009. With or without a switch, wherever in the world people drive, they usually do so on the basis of trust in, and respect for, road rules and other drivers following them.

What road rules are to crashes, vaccines and broader preventive healthcare are to illnesses and diseases. When trust in the former wanes, theres a lot more of the latter. And in many places, when it comes to health, thats exactly whats happening. Trust in science, vaccines, health experts and authorities is declining. So preventable infections are becoming more common.

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Last month, the organisation I lead made a payout from our International Federation of the Red Cross Disaster Response Emergency Fund (IFRC-DREF) to the Red Cross Society of Bosnia and Herzegovina. Most often, we use that fund to help national Red Cross or Red Crescent societies in the immediate aftermath of floods, droughts or mass population movements. This time the fund was used to help Bosnia deal with a measles outbreak caused by falling levels of vaccination. The rate of vaccination across the country is now below 60 percent, with parents increasingly reluctant to vaccinate their children. Since January there have been almost 3,000 cases about three-quarters of unvaccinated children under nine. The Red Cross Society of Bosnia and Herzegovina will spend much of its allocated funds on mobile information units, travelling through affected areas to persuade people of the merits of getting a jab.

As one Red Cross colleague leading the response says, people are afraid of vaccinations: There is lots of misinformation. Young parents, especially, are choosing not to vaccinate their children.

The Red Cross Society of Bosnia and Herzegovina will work closely with communities to build trust. Lecturing wont work; real community engagement and accountability should. Red Cross members will listen carefully to peoples opinions and will collaboratively design ways to build acceptance of why vaccines are so important. Building and sustaining trust within communities wont happen overnight, but its essential. Communities play a key role in preventing and controlling epidemics. They need to be involved in co-designing solutions from the start and being involved throughout.

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Bosnia and Herzegovina is far from alone in this. Kyrgyzstans measles outbreak began at the end of last year. The Red Crescent Society there is leading the campaign to debunk misinformation and discourage vaccine hesitancy; theyre aiming to reach 120,000 people. Over recent months, other national Red Cross and Red Crescent Societies have been supporting vaccination campaigns in The Philippines, Afghanistan, Pakistan, Burkina Faso, the Democratic Republic of the Congo, and Guinea.

In fact, almost everywhere in the world, measles cases are up. Across 41 countries in Europe, the World Health Organization (WHO) reported a 40-fold increase in 2023 compared with 2022. They called that an alarming rise. I call that an understatement. There are pockets of measles popping up across the United States where case numbers are at their highest in years. Overall, worldwide there was almost a doubling in cases, year on year between 2022 and 2023. So far, the numbers for 2024 are on track to be worse.

Trust is far from the only issue at play, and often not the biggest. Supply chains can be unreliable, with health facilities often out of stock or without staff able to vaccinate. Some people cant get to places where there are medical supplies available or cant get to them when immunisations are being offered.

But even where and when they can, they all too frequently do not.

So why the hesitancy about vaccines and suspicion of wider preventive healthcare precautions? In part, its a reluctance to trust healthcare professionals in the wake of misinformation that grew during the COVID-19 pandemic. I was in East Africa earlier this year where dreadful cholera outbreaks spread across many countries. Certainly as I saw in Zambia early detection of new cases is crucial, as is disinfection and establishing reliable sources of clean water. But building back trust matters, too. Neighbours of people infected with cholera are sceptical that their houses need to be disinfected as well as those of people with the disease. In Comoros where they are experiencing their first cholera outbreak in 17 years, people report being suspicious of the disinfectant sprays healthcare professionals use. IFRC-DREF grants have been made to four countries dealing with cholera since the start of the year, with a more extensive emergency appeal in place for Zimbabwe. Collaboratively building trust is at the heart of the work the money pays for.

In the 1960s, the terms mis- and disinformation were still decades away. There was no TikTok or WhatsApp to supercharge rumours.

Nowadays its not enough to have a solution to a problem; we have to engage communities and work with them to create trust in that solution. That is at the core of the work of the Red Cross and Red Crescent network.

The views expressed in this article are the authors own and do not necessarily reflect Al Jazeeras editorial stance.

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With measles on the rise, rebuilding trust in vaccines is a must - Al Jazeera English

An mRNA vaccine triggered the immune system to target brain tumours, a small study showed.

A promising human clinical trial on four patients may pave the way for a new treatment of glioblastoma, an aggressive form of brain cancer.

Researchers from the University of Florida in the US developed an mRNA cancer vaccine which triggers the immune system to target the tumour.

Approximately 19,000 individuals in the EU are believed to be affected by this condition annually.

The approach to treating glioblastoma has seen little evolution since the early 2000s, primarily relying on chemotherapy, radiotherapy, and surgical interventions. The average survival duration for patients diagnosed with this condition is about 15 months.

The team published their findings in the peer-reviewed journal Cell earlier this month. The vaccine uses the immune system to fight cancers that are difficult to treat.

It employs a version of mRNA technology similar to what's used in COVID-19 vaccines but with a couple of tweaks.

For one, the vaccine uses cells from the patient's own tumour to create a personalised treatment.

Additionally, it includes a newly developed delivery system to generate a rapid immune response.

"Instead of us injecting single particles, were injecting clusters of particles that are wrapping around each other like onions, like a bag full of onions," senior author Elias Sayour, said in a statement.

"And the reason weve done that in the context of cancer is these clusters alert the immune system in a much more profound way than single particles would," he added.

Scientists took genetic material called RNA from each patient's surgically removed tumour.

They then amplified the messenger RNA (mRNA), which contains instructions for what's inside every cell, including tumour cells.

Next, they wrapped this mRNA in special lipid nanoparticles creating a high-tech package. When these modified tumour cells were injected back into the patients' bloodstream, they looked like viruses, triggering an immune system response.

"In less than 48 hours, we could see these tumours shifting from what we refer to as 'cold' - immune cold, very few immune cells, very silenced immune response - to 'hot,' very active immune response," Sayour said.

That was very surprising given how quick this happened, and what that told us is we were able to activate the early part of the immune system very rapidly against these cancers, and thats critical to unlock the later effects of the immune response.

The study is the result of encouraging findings from seven years of research that began with experiments in preclinical mouse models and progressed to a clinical trial involving ten pet dogs with advanced brain cancer.

Dogs can also develop spontaneous brain tumours that result in terminal outcomes, the researchers said.

The ten pet dogs lived a median of 139 days, while the median survival of dogs with this condition is 30 to 60 days.

Professor Duane Mitchell, co-author of the paper, said that these results were "a really important finding because oftentimes we dont know how well the preclinical studies in animals are going to translate into similar responses in patients".

"And while mRNA vaccines and therapeutics are certainly a hot topic since the COVID pandemic, this is a novel and unique way of delivering the mRNA to generate these really significant and rapid immune responses that were seeing across animals and humans".

A Phase 1 clinical trial will now test the vaccine in up to 24 adult and paediatric patients to confirm the findings.

Further research is needed to find the best method to trigger the immune system while limiting potential side effects.

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Scientists develop new mRNA vaccine to target aggressive brain cancer - Euronews