Category: Vaccine

Novavaxs updated protein-based non-mRNA COVID-19 vaccine is now available for use in Taiwan for the prevention of COVID-19 in individuals aged 12 and older. Doses have been distributed by Taiwans Centers for Disease Control (CDC) and are now available at vaccination clinics across the country. The addition of a protein-based vaccine will diversify the countrys vaccine portfolio and provide a non-mRNA option to help protect against COVID-19.

Non-clinical datashowed that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to subvariants JN.1, BA.2.86, EG.5.1, FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against currently circulating variants.1, 2

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine in Taiwan are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the fall 2023 vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov and http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

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Novavax's Updated Protein-based Non-mRNA COVID-19 Vaccine Available in Taiwan Vaccination Centers - Jan 23 ... - Novavax Investor Relations

Johannesburg It seems hard to believe that Africa's biggest killer is a tiny insect, but almost every minute, an African child dies with malaria. The continent bears the brunt of the mosquito-borne disease, with 95% of the fatal cases recorded every year, and children under the age of 5 make up about 80% of those deaths.

The malaria parasite spreads to people bitten by infected mosquitos, and causes initial symptoms including high fever, headache and chills.

But finally, after four decades in the making, there's hope for the widespread prevention of malaria infections across Africa as a new vaccine is rolled out across the continent.

click to expand

History was made Monday in Cameroon as the first routine vaccination program against the mosquito-borne illness got underway. Cameroon hoped to vaccinate roughly 250,000 children over the next two years.

"The arrival of the vaccines marks a historic step in our efforts to control malaria, which remains a major public health threat in the country," said Dr. Malachie Manaouda, Cameroon's Minister of Public Health.

"We have been waiting for a day like this," Mohammed Abdulaziz, the head of disease control and prevention at the Africa CDC, told journalists at a news conference to mark the launch. "We are not just witnessing history, but actively participating in a transformative chapter in Africa public health history. It brings more than just hope a reduction in the mortality and morbidity associated with malaria."

The RTS,S/AS01 vaccine, also known as Mosquirix, was developed by British pharmaceuticals giant GlaxoSmithKline in conjunction with the Path Malaria Vaccine Initiative. It was recommended for use in such widespread fashion by the World Heath Organization in 2021, and is being rolled out in 19 countries in addition to Cameroon after having undergone successful trials in Ghana and Kenya.

The plan is for some 30 million doses of the vaccine to be administered in the coming months across all participating nations.

According to the WHO, malaria cases were up by almost 5 million in 2022 compared to the previous year. The increase in infections has been attributed largely to rising resistance to insecticides in the mosquitoes that carry the parasite, along with disruptions in health care and supply chains caused by the COVID-19 pandemic.

The WHO recommends a four-dose plan for children around five months of age, with a fifth dose in high-risk areas. The trials showed that vaccinating kids before the rainy season, while also administering anti-malarial drugs, cut deaths by nearly two-thirds.

Two million children in Ghana, Kenya and Malawi have already been vaccinated in a pilot program, and the WHO said studies of those children showed a 30% reduction in severe malaria symptoms.

A second vaccine, R21, developed by Oxford University and produced by the Serum Institute of India, completed a final regulatory step in December and is expected to be distributed in seven countries beginning in May or June. That vaccine's approval reassured health officials on the continent amid concerns that the eagerness of nations to participate in the program could lead to shortages.

Both vaccines, in trials, prevented half of malaria cases in the year after vaccination. Neither vaccine stops transmission of the disease.

The rollout will face challenges in many of the countries about to get the vaccine, as they struggle with transport and other infrastructure hurdles, leading those in charge of the program to suggest that local health workers schedule malaria vaccine shots in conjunction with other vaccinations, such as measles.

Health officials have warned the Ministries of Health in the initial 20 countries that the success of the vaccines will also depend on local health officials' level of preparation, including the continued provision and use of bed nets and spraying of insecticides.

Ten other countries have expressed an interest in the vaccine already, and officials involved expect that number to increase.

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Malaria mass-vaccination program launches in Cameroon, bringing hope as Africa battles surging infections - CBS News

Its Advice Week! InOn Second Thought, well revisit questions from the archives and dig into how much has changed since Slate began giving advice in 1997and how much hasnt.Read all stories here.

For todays edition, we dug through Slates archives and unearthed questions sent to Prudie from the 2010s. Weve asked todays columnists to weigh in with modern-day sensibilities.

On March 10, 2015, Should I Secretly Vaccinate? wrote to Dear Prudence:

My son and daughter-in-law are well-educated, responsible people. But once they had their first child (my now-18-month-old darling grandson), they did their own research and decided not to vaccinate him for fear of pumping poison into his body and risking autism. My DIL has particularly strong views about this, and weve had many vocal arguments over the issue. Finally she decided she didnt want to fight me anymore, and the last time I brought this up she refused to bring my grandson to see me for several weeks. I know that due to herd immunity the chances of his catching a serious illness are not high, but I am still appalled hes exposed to risks unnecessarily. I am about to look after him for five days while his parents go on a trip and I am thinking I will just take him to the doctor myself and get him immunized.

At the time, Prudence replied:

I marvel with distress that in 2015 we are fighting the vaccination wars. It is deeply disturbing that people who should be able to weigh discredited so-called studies instead believe garbage, and so are willing to endanger their children and others. I sincerely hope this madness burns itself out before a lot more people get hurt. Youre right that herd immunity should protect your grandson, but that is fading as large numbers of people refuse to vaccinate. The only solution seems to be for government to toughen the vaccination laws and close the loopholes that allow people to opt out for philosophical and so-called religious reasons. The laws need to make clear: no shot, no school. In the meantime, however, you cannot take your grandson to be vaccinated. For one thing, you dont have the standing to do this. For another, if it came out that you did, that would likely effectively end your relationship with your grandson. Its just not worth it. Lets hope this little boy does not get whooping cough, or measles or any of the other awful childhood diseases that medical science effectively wiped out, and misinformed parents are bringing back.

Care and Feedings advice from the future:

Oooooof. Well, this certainly hasnt gotten any better since 2015. Indeed, now weve got a whole new disease against which crackpots can refuse to vaccinate their children, thus (among many other dire consequences) increasing the chance of exposing their older, at-risk relatives to danger! And even though public trust in childhood vaccines has improved in the wake of COVID, more people now believe that parents rights should trump school vaccine requirements.

I have racked my brain for like half an hour to try to find a way to advise this letter-writer to whisk away that toddler and get someone to stick a bunch of needles in him. I cant get there, alas, as morally justifiable as I think it would be. (Talk about a victimless crime! This is a crime that literally could save the victims life.) But Prudie is correct that the letter-writer risks never seeing this grandchild again if they get caught.

What a drag, though. If you are this grandparent, and despite Prudies advice just went and did the damn thing anyway, please write to me and let me know. I will buy you a beer.

On July 14, 2011, Badgered asked: My little sister has a beautiful 18-month-old boy. Four times since his birth, she has entered him in most beautiful baby photo contests. During these contests family members receive email and Facebook reminders every day. Sometimes the competitions are open for a month or longer. I told her after the second contest that I do not want to be asked to vote anymore. I explained that I love my nephew but am uncomfortable with a competition where children are judged on appearance. I also told her that the contest rules allow these companies to use her childs image for free in any way they like. She has ignored all this and once again started with the email reminders. I feel harassed. Am I justified in my disdain?

At the time, Prudence replied:

We are constantly hearing about social trends (fast food, texting, gay marriage) that supposedly have the power to destroy the American family. But with the most beautiful baby contest I think your sister has actually found one that will turn evolution on its head and make people come to loathe their youngest and cutest family members. Anyone receiving such daily reminders would be tempted to pour the contents of a sippy cup on the parent responsible for this pestering. Tell your sister you understand she gets a kick out of these contests (leave out the moralizing), but the reminders are clogging your inbox and youd appreciate if she could she take you off the list. If she doesnt, just keep hitting delete and try to remember this is not your nephews fault.

Care and Feedings advice from the future:

This is really funny. Almost quaint, really, when the Facebook updates I most often receive from relatives are spam posts from bots reading I cant believe shes gone Im miss you RIP . I would almostalmost!welcome messages from a sibling urging me to vote for their child in a Most Beautiful Baby contest, if those messages also included beautiful photos of their baby.

Prudies advice is correct. Explaining to the sister why these contests are objectionable will get the letter-writer nowhere, other than that the sister will be angry with them. But youre within your rights to ask even a close relative to stop sending you unnecessary messages! And theyre within their rights to ignore you, so keep that delete finger limber. Or quit Facebook!

On July 7, 2011, Whos on the Cake? asked: I am pleased New York is legalizing gay marriage. I have supported gay rights for years and am proud that we are striving for a more equal America. Last night my family was watching a movie and there was a wedding scene. My 3-year-old son asked, Whos getting married? It occurred to me that Im not sure what to say to him about a man marrying a man or a woman marrying a woman. I want my son to understand the world in which we live, but I think it could be too confusing an issue to introduce the new paradigm.

At the time, Prudence replied:

This came up for me a few years ago when my favorite section of the Sunday New York Times, the wedding announcements, started carrying same-sex weddings. I had the paper open on the dining room table and my then-elementary-school-aged daughter walked by and her eye was caught by a photo of two men. She pointed and said, Mom, whats this one? It was easy to explain to her that while most weddings are between a man and a woman, sometimes theyre between two men or two women. She realized she already knew something about this, since shed gone to school with kids who had two dads or two moms. What shed never seen evidence of before was a same-sex wedding. But absorbing this new paradigm took only a few questions and a few minutes. Your son is just 3 years old, so theres no need to explain to him the fine points of the legalization of gay marriage. In the coming years hell see that families dont always consist of a father and mother, because many of his classmates will have single parents, and a few will have same-sex parents. Because you are perfectly comfortable with this fact, youll be able to follow his lead and answer what questions he has. And if he seems anxious about this, it may just be that he wants reassurance that his family is going to remain the way it already is.

Care and Feedings advice from the future:

Good answer, Prudie. Kids remain extremely skilledbetter than adults, maybe!at learning and accepting new information. I vividly remember my then-kindergarten-aged daughter sitting in the back seat of the car with a friend, and them discussing with keen interest and total approval the fact that sometimes men marry men or women marry women, and then her friend saying, with serene confidence, Thats called being jay.

On Sept. 23, 2010, Daddys Gone asked:

Last year, my husbands company went out of business. After 10 months of unemployment, he finally has a new job, and its everything we hoped for, with one exception: The hours are so long that my husband cant see our 16-month-old son. Its a techie company where the employees roll into the office around 10 a.m. and leave around 8 p.m. My husband sometimes has to work until 10 p.m. or later. He has tried getting into work at 8 a.m. and leaving at 6 p.m. But when he arrives, all the lights are off, and when he leaves, his co-workers hassle him about taking off early. After having Daddy around all day for the past 10 months, his sudden absence is really hard on our son, whos been mostly hysterical since my husband took this job. I want my husband to work more regular hours, so he can at least see our son every dayI just cant keep him up after 8 p.m. However, my husband doesnt want to make waves at this new job. How do we solve this?

At the time, Prudence replied:

Sure, it was fun for your son to have Mommy and Daddy to himself for almost a year, but all of you have to accept that there are adjustments to be made now that Daddy has something called a job. And not only is it a job; its a great job. So please stop undermining your husbandsyour whole familysgood fortune by insisting he work hours that will put him at odds with the companys culture. Maybe after your husband has proved his worth, he can tweak his work schedule, but now is not that time. The obvious, happy solution here is that if your husband is rolling into the office at 10 a.m., that should give him a nice block of time in the morning to spend with your son. They surely could have almost an hour together, and the advantage of this is that your son will be fresh and alert, not whiny and ready for bed. Your son misses his father, but perhaps part of his hysteria comes from picking up on your distress at having dinner alone every night. Maybe you should get together with friends with young children one or two nights a week for a communal dinner. Or you can swap babysitting with a friend so you can take a needed break and go to a movie or the gym. When you feel yourself resenting your husbands hours, look around at all the desperate out-of-work people and be glad your 10-month idyll has come to an end.

Care and Feedings advice from the future:

This letter sure comes from the pasta past before COVID transformed office culture in many white-collar jobs. I cringe a little reading Prudie scolding this mom for undermining her husbands job in a work environment that seemswhile not uncommon, I understand, for Silicon Valley startupspretty rigid and family-unfriendly.

And yet, even in the past, there were other ways to handle such situations. In 2010, I was unemployeder, freelancingwith a young child. A year later, Slate offered me a job, and I remember quite vividly the debates I had, very early on, with my managers about my desire to be out of the office in time to make and eat dinner with my family. I certainly didnt think it was my obligation to shut up and accept the expectation among Slate editors that everyone stays in the office until 6:30. I made my case that I could start my day early, leave early, and work from home in the evening, and still get all my work done just fine. Twelve years later, Im still here.

Now, Slate is an unusual workplace, in that it institutionally prizes debate and dissentand therefore I felt more empowered, from the get-go, to argue with the bosses than many new employees might feel. But 2024 employees have much more leverage on these issues than they used to, thanks to historically low unemployment and, happily, a greater recognitioneven among techie companiesof the value of fostering work-life balance.

I think what most rubbed me the wrong way about Prudies response was the intimation that this mother was undercutting the familys future security by worrying about their present happiness. I dont at all begrudge a mother in this situation wishing her husband would make some waves and advocate for himself. I would, in fact, argue that a husband facing this problem owes it to his family to take action. And he owes it to other parents at the company, fathers and mothers both, to make a strong case for a more flexible schedule. His company ought to rethink an office culture that has employees hassling their co-workers for the crime of wanting to see their children before they go to bed. If they refuse, its time for him to start looking for another joband this time, to make his work/life requirements clear from the beginning.

Dan

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Childhood vaccination advice: What to do when a family member won't immunize a child. - Slate

Lareb could not find sufficient evidence to link the COVID-19 vaccines to cases of Long Covid, the side effects center said on Wednesday. The center stressed that more research is needed.

The center received over 2,200 reports from people with symptoms that started within 28 days after getting vaccinated and lasted for more than six months. Lareb did further investigation into 78 of the 2,282 reports, which involved a combination of typical complaints that resemble Long Covid.

The combinations of complaints are very diverse, just like with Long Covid, Lareb said. They include shortness of breath, fatigue, malaise, chest pain, palpitations, dizziness, headaches, muscle pains, and joint complaints. Also mentioned are brain fog, difficulty thinking, reduced ability to concentrate, difficulty finding words, inability to cope with stimuli and memory loss.

Just over half of the 78 investigated cases were medically examined. Sixteen got a medical diagnosis, eleven of which were Long Covid. In about half of these reports, no medical research has been done into the possible causes of the complaints, or this is unknown, Lareb said. It is not clear whether there are possible other causes, such as a coronavirus infection. Not everyone was even tested for the coronavirus.

Lareb, therefore, concluded that it had insufficient evidence to say there is a link between these symptoms and the Covid-19 vaccines. The Medicines Evaluation Board came to the same conclusion.

But Lareb director Agnes Kant stressed to NRC that more research is needed. The timing of the symptoms, among other things, is striking, she said. We see a pattern in which a large proportion of the complaints arose in the first three days after vaccination.

GP Eline Hofman pointed out to the Volkskrant that Lareb looked at just over 3 percent of the over 2,200 reports it received up to 16 August 2023. That raises the question: what does the other 97 percent have? She, too, thinks more research is needed, calling the Lareb report one piece of the puzzle.

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"Insufficient evidence" to link Covid-19 vaccine with Long Covid; More research needed - NL Times

Key Takeaways

Toxic shock syndrome (TSS) is a rare but potentially life-threatening condition thats caused by toxin-producing bacteria. When most people think of toxic shock, the first risk factor that leaps to mind is usually high absorbency tampons. But TSS isnt just linked to tampons or even menstruationanyone can develop it. If it goes untreated, TSS can lead to organ failure and even death.

New research from Austria has offered a glimpse into a future where it could be much easier to prevent TSS: with a vaccine.

The candidate vaccine, rTSST-1v, has completed a successful phase 2 clinical trial in which it showed it could offer protection for at least two years. Of the 126 participants in the study, more than 80% developed protection against TSS after the first dose.

The vaccine candidate is a detoxified version of TSST-1, the toxin responsible for 75% of all TSS cases, Andreas Roetzer, PhD, head of vaccine research and development at Biomedical Research & Bio-Products, told Verywell.

Staphylococcus aureus (staph) is often the cause of TSS, but Streptococcus pyogenes (strep) can also cause it.

Heres how the vaccine works and what the approval process could look like.

The TSS vaccine is designed to get the body to make neutralizing antibodies, which can prevent the onset of TSS. According to Roetzer, the neutralization aspect is key because it could stop symptoms and reduce the need for antibiotic treatment.

Depending on the expected efficacy of the vaccine, it could prevent all hospitalizations from TSS, Sharon Nachman, MD, a board-certified pediatric infectious disease specialist at Stony Brook Medicine, told Verywell.

The vaccines trial data has been promising so far, showing that most participants had a four-fold increase in antibodies after getting the first round of the vaccine (seroconversion). And 18 months later, over 85% of participants had protection after getting the third shot.

If approved, the TSS vaccine would be given intramuscularly, like a tetanus shot. Roetzers team plans to do follow-up trials 60 months after the initial vaccination and expects that a two-dose vaccine would be enough to provide life-long protection.

While Roetzer said that toxic shock syndrome is relevant for premenopausal women as soon as menarche (menstruation) starts, the vaccine is intended for everyone.

Since using menstrual products like tampons is a known risk factor for TSS (and menstrual toxic shock syndrome is used to differentiate it from other risk factors), young teens would likely be one of the priority groups for the vaccine.

Testing the efficacy and safety of a TSS vaccine could take several years, according to Nachman. A lot of the timing will depend on who the key populations are determined to be. For example, a study focused on preventing TSS in teens who are just starting to have periods would require observing how well the vaccine works over a fairly long time.

Nachman said that the vaccine would also need to undergo a phase 3 clinical trial to prove that its safe and effective at preventing TSS on a larger scale. That part of the trial would typically involve several hundred to several thousand patients.

While we dont have a vaccine yet, there are treatments for TSS, including:

Its also important to remember that TSS doesnt just affect women who have menstrual cyclesit can strike patients with weak immune systems, chronic wound infections, chronic illness, and people having surgery. An approved TSS vaccine would likely reduce the need for antibiotics and prevent hospitalizationsand could even save lives.

Toxic shock syndrome (TSS) isnt just linked to tampons; it can happen to anyone, including people with chronic wounds and illnesses, as well as those having surgery. A vaccine for TSS is in the works and could someday help prevent the potentially life-threatening infection.

National Library of Medicine: MedlinePlus. Toxic shock syndrome.

Schoergenhofer C, Gelbenegger G, Hasanacevic D, et al. A randomized, double-blind study on the safety and immunogenicity of rTSST-1 variant vaccine: phase 2 results. EClinicalMedicine. 2024;67:102404. doi:10.1016/j.eclinm.2023.102404

TeensHealth. Toxic shock syndrome.

Billon A, Gustin MP, Tristan A, et al. Association of characteristics of tampon use with menstrual toxic shock syndrome in France. EClinicalMedicine. 2020;21:100308. doi:10.1016/j.eclinm.2020.100308

Centers for Disease Control and Prevention. Streptococcal toxic shock syndrome.

By Kayla Hui, MPH Kayla Hui, MPH is the health and wellness ecommerce writer at Verywell Health.She earned her master's degree in public health from the Boston University School of Public Health and BA from the University of Wisconsin-Madison.

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Vaccine for Toxic Shock Syndrome Shows Promise in Clinical Trial - Verywell Health

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Another 19 African countries have plans to join the programme bringing more than just hope to a continent that suffers the vast majority of malaria deaths

Mon 22 Jan 2024 10.13 EST

The rollout of the worlds first malaria vaccine began in Cameroon on Monday, which is said to be a transformative chapter in Africas public health history.

The RTS,S vaccine 662,000 doses of it will be administered to children in the west African country, the first to be vaccinated after successful trials of the drug in Ghana, Kenya and Malawi between 2019 and 2021.

It marks a scaling up of the fight against malaria in Africa, where 95% of deaths from the disease occur, most among children under five.

We are not just witnessing but actively participating in a transformative chapter in Africas public health history, said Dr Mohammed Abdulaziz, the division head at the Africa Centres for Disease Control and Prevention, headquartered in Ethiopia, at a joint online briefing with the World Health Organization. For a long time we have been waiting for a day like this it brings more than just hope, it brings a reduction in the mortality and morbidity associated with malaria.

Public health experts say communication with the public will be crucial to the vaccines success to ensure that it is trusted, that people bring their children back for all four doses, and that people understand it will be most effective when combined with other measures, such as sleeping under insecticide-treated bed nets.

We need messaging, we need communication, and we need to use trusted voices, said Abdulaziz. We need to use health workers who are very close to the community. We need to listen to the community, to what they are saying and also monitor how we are being received.

Kate OBrien, the director of the WHOs immunisations and vaccines department, said that based on the trial data, RTS,S also known as Mosquirix would saves tens of thousands of lives.

Another 19 African countries plan to introduce the vaccine this year, with hopes that 6.6 million children could be reached. Deliveries are due for Burkina Faso, Liberia, Niger and Sierra Leone.

Mbianke Livancliff, from the Cameroon nonprofit Value Health Africa, said there has been excitement in the country since the vaccines were delivered in November. The organisation has held community meetings and open discussions to introduce people to the vaccine and its approval process, to deal with peoples concerns and stave off any potential hesitancy.

It has been an exciting moment. Families are excited, they are happy to have this major development and they are saying this is effective and this is what we have been waiting for, Livancliff said.

In the Cameroon city of Douala, at the private Angels Clinic, six-month-old Nobah Adel screamed as she was scratched by the needle administering her first dose of the vaccine on Monday morning.

Even if she cries, Im very happy today, said her mother, Dani Widal, who heard about the vaccine campaign a week ago. I have three children and all are always sick with malaria. I hope that the vaccine will finally help her not to be sick like her brother and her sister.

Widal had queued with her daughter for three hours to get the vaccine. I live in a neighbourhood where there are a lot of mosquitoes. I spend more than 30,000 francs [39] every three months because of malaria.

Kamela Isabelle Madjouwou, a nurse at the centre, said a malaria vaccine was essential. Cameroon recorded more than 6m cases in 2022 and malaria accounted for 12% of deaths among children under five in 2021. The vaccine will reduce mortality and the consequences of this terrible disease, she said.

Thomas Breuer, the chief global health officer at GlaxoSmithKline, which produced the vaccine said it was a significant development: After more than 35 years of dedicated work with our partners to develop the worlds first malaria vaccine, Mosquirix, its rewarding to see it in routine use for the first time. Were excited that more malaria-endemic countries are preparing to introduce the vaccine over the coming months.

A second malaria vaccine, R21/Matrix-M, produced by the University of Oxford, is due to be rolled out later this year.

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World first: malaria vaccine rollout begins in Cameroon - The Guardian

Published: Jan. 24, 2024 at 10:33 a.m. ET

By Chris Wack

Capricor Therapeutics shares were up 7% at $4.42 after the company said its proprietary StealthX exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen.

The stock hit its 52-week low of $2.68 on Nov. 10, and is down 3% in the past 12 months.

Project...

By Chris Wack

Capricor Therapeutics shares were up 7% at $4.42 after the company said its proprietary StealthX exosome-based multivalent vaccine for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen.

The stock hit its 52-week low of $2.68 on Nov. 10, and is down 3% in the past 12 months.

Project NextGen is an initiative by the U.S. Health and Human Services Department to advance a pipeline of new, innovative vaccines providing broader and more durable protection for Covid-19.

As part of Project NextGen, the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor's StealthX vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases would oversee the study.

The StealthX vaccine is a proprietary vaccine developed internally by Capricor using exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models showed the StealthX vaccine resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile.

Write to Chris Wack at chris.wack@wsj.com

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Capricor Therapeutics Shares Rise 7% After Collaboration for Covid-19 Vaccine - MarketWatch

Infants born to unvaccinated mothers who had COVID-19 during pregnancy were at high risk for developing neonatal respiratory distress, the longitudinal, cohort COMP study found.

The odds of developing respiratory distress were threefold higher (OR 3.06, 95% CI 1.08-10.21) in infants born to unvaccinated mothers diagnosed with COVID-19 while pregnant compared with COVID-exposed infants born to COVID-vaccinated mothers, Mary Catherine Cambou, MD, of the University of California Los Angeles (UCLA), and colleagues reported in Nature Communications.

"This was not something we were expecting to see, as none of the babies were diagnosed with COVID-19 themselves," co-author Karin Nielsen-Saines, MD, also from UCLA, told MedPage Today in an email. "We also noted that respiratory distress was not transient and lasted several days."

However, when pregnant participants had received at least one mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of their infants developing neonatal respiratory distress dropped to 0.33 (95% CI 0.10-0.96) -- a 67% decline, the authors pointed out.

Maternal COVID-19 disease severity also appeared to be associated with the incidence of neonatal respiratory distress. Thirteen percent of pregnancies met criteria for severe or critical COVID-19. Among infants with respiratory distress, 21% were born to mothers with severe or critical COVID-19, while only 6% of babies without respiratory distress were born to women with severe disease (P=0.009).

Approximately 56% of infants with respiratory distress were either late preterm or term deliveries and 44% were preterm. "We were surprised to find out that [the results] could not be explained by prematurity alone," Nielsen-Saines said.

Notably, a proteomic subanalysis revealed that preterm infants with respiratory distress had significantly heightened inflammatory responses (OR 10.87, P=0.0036), cellular responses (OR 31.88, P=0.0002), and chemotactic responses (OR 109.7, P=0.0108), when compared with a control group of infants from healthy, unexposed pregnancies.

"The molecular analysis showed that a possible mechanism to explain this phenomenon is dysregulation of the airway cilia," Nielsen-Saines said. "Another marker that was elevated was [immunoglobulin E], which is associated with inflammation and allergic responses, as in the case of reactive airway disease."

The study followed mother-infant pairs that included 221 mothers with laboratory-confirmed SARS-CoV-2 infection during pregnancy and 227 exposed fetuses. Between April 2020 and August 2022, 199 infants were born. Seventeen percent of neonates were diagnosed with respiratory distress. In infants unexposed to COVID-19, respiratory distress typically has a much lower incidence of just 5.2% to 6.4%, and is usually more common in preterm infants with less mature lung anatomy, the authors noted.

Among pregnant individuals enrolled in the study, 68% were unvaccinated prior to infection. Severe or critical COVID-19 occurred in 16% in this group, compared with only 4% of those who were vaccinated. "The greatest number of COVID-19 cases among mothers in this cohort was in winter 2020, when the ancestral variants were circulating," the authors wrote. However, most pregnant persons had received a COVID-19 vaccine before the Alpha variant emerged, they said.

Researchers found no association between neonatal respiratory distress and the pregnancy trimester when mothers had COVID-19. They also found no association between respiratory distress and maternal race or ethnicity. Half of the pregnant persons in the study identified as Black, Hispanic, or Latina, 25% as white, and 24% as Asian, mixed race, or other.

The study sample size was small and therefore results should be interpreted with caution, the authors noted. Also, participants in the study received treatment from a large tertiary and quaternary medical center, and they may have been sicker than the general population, the authors said.

Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.

Disclosures

The study was funded by the Simons Foundation Autism Research Initiative, the UCLA W.M. Keck Foundation COVID-19 Research Award Program, and the National Institutes of Health.

The authors reported no competing interests.

Primary Source

Nature Communications

Source Reference: Man OM, et al "Respiratory distress in SARS-CoV-2 exposed uninfected neonates followed in the COVID Outcomes in Mother-Infant Pairs (COMP) study" Nat Commun 2024; DOI: 10.1038/s41467-023-44549-5.

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Maternal Vaccination Lowers Odds of Respiratory Distress in COVID-Exposed Infants - Medpage Today

Opinion

Only one case was confirmed in Scotland last year. In England and Wales, more than 200 children were diagnosed in the last four weeks of 2023 alone

Wed 24 Jan 2024 03.00 EST

The UK was once so good at dealing with measles that in 2017 and 2021 the World Health Organization declared that we had successfully attained elimination status for the disease, meaning that not one endemic case had been detected in the prior year. But those days are over, with more than 200 children diagnosed with measles in England and Wales in the last four weeks of 2023. The UK Health Security Agency has declared a national incident not only because of the cases appearing, but also owing to overall low MMR vaccination rates, which leave a very large population of children at risk of infection.

Incredibly, about 25% of children in parts of London enter school unvaccinated. NHS England data suggests that more than 3.4 million children under 16 across the country are unvaccinated. This puts them at considerable risk, and measles is incredibly infectious. One person can infect about 12 to 18 others, and it spreads through respiratory means, such as coughing, sneezing and breathing. If about 95% of the population is vaccinated the virus stops circulating as it cant find susceptible hosts, but it appears vaccination rates in many areas are below that number.

Just two doses of vaccine should confer lifelong sterilising immunity, meaning those fully vaccinated are not only protected from infection but are also very unlikely to transmit the virus to anyone else. So whats the best way to get kids vaccinated? Scotland offers a lesson here. In Scotland, 95.9% of children had one dose by the time they were five years old, while 89.7% had two doses. The result? There was only one laboratory-confirmed case of measles in Scotland during all of 2023. Edinburgh University researchers suggest that Scotlands increase in vaccination rates during the Covid-19 pandemic may have been linked to flexible working for parents (which meant they could attend vaccination appointments) and mobile vaccination centres.

This is a basic premise in global health: if you want parents to vaccinate their children, make it accessible, free and easy, so it can fit within their daily commitments and constraints. And thats true whether its Uganda, Pakistan, Scotland or England. As Kirsten Watters, Camdens council director of health and wellbeing, said: When talking to parents, we know that most do intend to vaccinate their children, and theyve got high levels of confidence and trust. Its just that theyre finding it difficult to organise those appointments. The majority of parents do end up vaccinating their children, but it only takes a few barriers inability to make an easy appointment, faraway vaccine centres, confusing or inaccessible messaging to drop the vaccination rate a few percentage points below the critical 95% threshold, and the virus can begin to take hold.

And yes, there are other issues, such as general hesitancy about vaccines after Covid-19 and the growing online conspiracy movement, as well as genuine concerns about whether vaccines are necessary, given potential side effects. The pandemic definitely introduced many people to the world of anti-vax theory and doubt, to say nothing of previous issues such as Andrew Wakefields study in 1998 falsely linking MMR vaccination to autism, the influence of which has proved stubbornly hard to dislodge despite its having been discredited. But we shouldnt overstate antivax sentiment. The fact that vaccination rates are vastly different in some pockets of the UK coverage is about 90% in the south-west, for instance tells us the main difference is probably logistical. We need outreach to communities and better rollout of vaccines to areas of low coverage, all mediated through trusted health professionals.

Fortunately, the government has announced a vaccination campaign in England, recruiting teachers, GPs, and community leaders to promote vaccination, and rolling out pop-up vaccination centres in convenient locations such as schools. If the approach works, it needs to be built into the yearly campaign, so that vaccination rates never dip this low again.

I remember giving talks at global health meetings in 2003 and 2004, making the case for reducing the price of the measles vaccine for poor countries so that health ministries could acquire doses and save childrens lives. At that time, measles was considered a problem in low- and middle-income countries. We thought the problem had been solved in Britain and the United States.

Measles was once a common and deadly disease for children here. In 1962, Roald Dahls daughter Olivia died at the age of seven from measles complications. When a safe combined MMR vaccine was approved, the beloved childrens author advocated for parents to take it up. In a letter reflecting on the low uptake of measles vaccination in 1986, he wrote: It is not yet generally accepted that measles can be a dangerous illness. Believe me, it is. In my opinion, parents who now refuse to have their children immunised are putting the lives of those children at risk.

Eliminating most viruses is a tall order, but its a realistic target for measles given the MMR vaccine. Measles, mumps and rubella are all nasty diseases that should be stuck in the past. Dahls daughter didnt have the choice of a vaccine, but children in Britain today dont have to suffer the same fate. They live in 2024, not 1962.

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If you think its anti-vaxxers driving measles cases up in the UK, think again and look to Scotland - The Guardian

23 January 2024

Image source, Getty Images

There was an "alarming" nearly 45-fold increase in measles cases in Europe last year, the World Health Organization (WHO) says.

Health chiefs are warning that cases are still rising and "urgent measures" are needed to prevent further spread.

Some 42,200 people were infected in 2023, compared to 941 during the whole of 2022.

The WHO believes this is a result of fewer children being vaccinated against the disease during the Covid pandemic.

In the UK, health officials said last week that an outbreak of highly contagious measles in the West Midlands could spread rapidly to other towns and cities with low vaccination rates.

More than 3.4 million children under the age of 16 are unprotected and at risk of becoming ill from the disease, according to NHS England.

Millions of parents and carers are being contacted and urged to make an appointment to ensure their children are fully vaccinated against measles. The measles, mumps and rubella (MMR) vaccine is given in two doses - the first around the age of one and the second when a child is about three years and four months old.

The vaccine is very effective at protecting against measles, but only 85% of children starting primary school in the UK have had both jabs.

Speaking about the situation in Europe, Dr Hans Kluge, regional director at the WHO, said: "We have seen, in the region, not only a 30-fold increase in measles cases, but also nearly 21,000 hospitalisations and five measles-related deaths. This is concerning.

"Vaccination is the only way to protect children from this potentially dangerous disease."

Measles can be a serious illness at any age. It often starts with a high fever and a rash, which normally clears up within 10 days - but complications can include pneumonia, meningitis, blindness and seizures.

Babies who are too young to have been given their first dose of vaccine, pregnant women and those who have weakened immune systems are most at risk. During pregnancy, measles can lead to stillbirth, miscarriage and a baby being born with a low birth weight.

All countries in the European region are being asked to detect and respond to measles outbreaks quickly, alongside giving vaccines to more people.

The WHO said measles had affected all age groups last year - young and old alike.

Overall, two in five cases were in children aged 1-4, and one in five cases were in adults aged 20 and above.

Between January and October 2023, 20,918 people across Europe were admitted to hospital with measles. In two countries, five measles-related deaths were also reported.

Vaccination rates for the first dose of the MMR vaccine, which protects against measles, slipped from 96% in 2019 to 93% in 2022 across Europe. Uptake of the second dose fell from 92% to 91% over the same period.

That seemingly small drop in vaccination take-up means more than 1.8 million children in Europe missed a measles vaccination during those two years.

"The Covid-19 pandemic significantly impacted immunisation system performance in this period, resulting in an accumulation of un-[vaccinated] and under-vaccinated children," the WHO reported.

With international travel booming once again, and social-distancing measures removed, the risk of measles spreading across borders and within communities is much greater - especially within under-vaccinated populations, it said.

Even countries that have achieved measles elimination status are at risk of large outbreaks, the WHO warned.

It says that 95% of children need to be vaccinated with two doses against measles in all communities to prevent the spread of the highly-contagious disease.

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Alarming 45-fold rise in measles in Europe - WHO - BBC.com