School chaos fears as kids suspected of having whooping cough should be excluded for up to 3 weeks amid ‘worst – Daily Mail

School chaos fears as kids suspected of having whooping cough should be excluded for up to 3 weeks amid ‘worst – Daily Mail

School chaos fears as kids suspected of having whooping cough should be excluded for up to 3 weeks amid ‘worst – Daily Mail

School chaos fears as kids suspected of having whooping cough should be excluded for up to 3 weeks amid ‘worst – Daily Mail

May 11, 2024

Children and teachers with suspected whooping cough should be excluded from classes for up to three weeks, according to official guidance.

The UK Health Security Agency (UKHSA) says youngstersshould isolate for 21 days 'from the onset of symptoms' to avoid spreading the killer bug, if they have not had antibiotics.

However, it's feared thousands of kids with minor coughs could be kept at home needlessly by worried parents, leading to a repeat of the Covid self-isolation nightmare.

Tory MP David Davis criticised the advice as overly-cautious, saying children should be tested, treated and sent back to class.

He said: 'The obvious response would be to put them on antibiotics and return them to school as quickly as possible.

'We should have learned the lesson from Covid that children are robust in the face of most illnesses. It's vitally important to maintain the continuity of education.

'Being away from school for weeks on end can put children behind in critical areas of their study, and they may not recover.

'Plainly, the right approach is to is to use medical procedures to accelerate their return, not to take an overcautious delay which could do real damage to their education.'

Whooping cough has killed five babies this year amid fears of the worst outbreak in 40 years. Almost 3,000 cases have been reported so far this year, three times the total for the whole of 2023.

The illness can be diagnosed with a PCR test and treated with antibiotics, reducing the necessary isolation time to 48 hours. But it's feared under-pressure GPs may struggle to meet demand.

Official guidance on the UKHSA website states that children should be excluded from school for at least 21 days after symptoms start. Suspected cases should be reported to them, and text messages will be sent to parents whose children attend a school with a confirmed case.

Teachers and staff at nurseries and schools should also isolate if they suffer 'active uncontrollable coughing', it adds.

A spokesman for the UKHSA said: 'If anyone in your family is diagnosed with whooping cough, it's important they stay at home and do not go into work, school or nursery until 48 hours after starting antibiotics, or 3 weeks after symptoms start if they have not had antibiotics.

'This helps to prevent the spread of infection, especially to vulnerable groups. However, vaccination remains the best protection for babies and children.'

A whooping cough vaccine for pregnant women to protect their babies was introduced in October 2012. Immediately after that, the number of baby deaths fell.

The UKHSA has blamed the current outbreak on a steady decline in the uptake of vaccines among expectant mums.Experts say this is due to a mixture of vaccine hesitancy, lack of awareness and the cancellation of many 'non essential' services during the Covid pandemic.

However, it's believed that three of the five grieving mothers had jabs during pregnancy to protect their children.

In the 1980s, the government published terrifying adverts telling parents that whooping cough can cause vomiting, weight loss, brain damage and death in children.

Dr Saleyha Ahsan, a London-based A&E doctor, said the Department of Health should go back to publicising the deadly danger of the illness to boost vaccine uptake, as they did in the 1980s and '90s.

'There is a lack of knowledge about how deadly and dangerous whooping cough can be,' she said. 'In the 1980s there was lots of coverage about how dangerous whooping cough was.

'I was a teenager then and was terrified because I had two little baby sisters. I used to bug my mum to make sure they had their vaccines because I was terrified by the pictures I was seeing.

'Publicity works. In Australia they've really gone for it, and awareness there among the general public is significantly more than here. Our vaccine uptake has gone down to about 59.5 per cent, and in some parts of London it's down to 36 per cent. Those places are the ones with worst rates of really sick babies.

'I've spoken to mums who've lost their babies to whooping cough - every one is a massive advocate for the vaccine. It's about education and reassurance. It's not all down to mums, the healthcare profession has to take a role in this.'

She added childhood whooping cough vaccines stop working after 10 years, so the NHS should consider giving boosters to adults, as they do in the US.

'Education is needed for the public, for mums, and across the healthcare profession as well, because I didn't realise it and colleagues also didn't,' she said.

'It's important. It's a highly contagious disease, it's easily spread, it's very difficult to diagnose, and if it reaches a child under two months, it can kill them. It's a discussion we need to have.'

Kerry Pearson, from Dartford, Kent, has urged all pregnant women to take the whooping cough jab after her newborn Polly spent 10 days in a coma with the infection.

In April, at just two weeks old, she developed a rattly cough that left her struggling to breathe.

She said: 'I knew nothing about whooping cough it was just something from my grandparents' era. There's no treatment and no cure, we're just having to wait and it's unbearable.

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'If I'd had the vaccine during my pregnancy I'd have passed on the antibodies in my breastmilk. The vaccine should be routinely offered with every pregnancy.

'I just want people to be aware, you should have the whooping cough vaccine when you're pregnant.If you're not offered it then please demand it.'

'If you're an anti-vaxxer please reconsider this is deadly to infants it's not worth the risk. Nothing is worth going through what we're going through.

'We need to educate people about the vaccine and the symptoms.

'Whooping cough is dangerous to newborns and I want people to know what to look out for.'

What is whooping cough?

Whooping cough is a serious and highly contagious respiratory disease that infects the lungs and breathing tubes.

Also called pertussis, it's caused by the bacteria Bordetella pertussis. After or between bouts of coughing, patients may gasp for air and produce the characteristic 'whoop' noise.

The disease is also sometimes called the '100-day cough' as it can last for 612 weeks.

It is most serious in babies under six months as it can cause breathing difficulties, dehydration, pneumonia and seizures.

It is generally less severe in older children and adults.

What are the symptoms?

Typically, the first signs of whooping cough are similar to a cold, such as a runny nose and sore throat, though a high temperature is uncommon.

After about a week, coughing bouts will start that last for a few minutes and are worse at night.

Many infants and younger children with whooping cough have the coughing fits and accompanying whoop, but not all do.

And sometimes babies don't cough or whoop as older kids do but may show signs of difficulties breathing.

The infection is generally milder in teenagers and adults than in babies and children, especially those who have been vaccinated.

How does it spread?

Whooping cough is very contagious and can be spread through tiny drops of fluid from an infected person's nose or mouth.

It can be spread when an infected person sneezes, coughs, or laughs. Others can catch it by inhaling the drops or getting the bacteria on their hands and then touching their mouths or noses.

Symptoms usually appear about 7 to 10 days after exposure symptoms can appear up to 21 days after a person is infected.

People are most contagious at the earliest stages and for up to about two weeks after the cough begins.

Why are cases rising?

More than 2,700 whooping cough cases have been reported across the country so far in 2024, with 1,319 cases reported in March alone, according to the UKHSA.

This compares to 858 cases throughout the entirety of 2023.

Cases of whooping cough peak every four or so years but the pandemic saw a dramatic fall in the incidence of whooping cough and other respiratory infections as a result of reduced mixing of people.

Professor Andrew Preston from the University of Baths Milner Centre for Evolution, said cases have been rising since the end of restrictions and a peak year had been expected to arise soon.

Vaccination rates in infants have declined compared to pre-pandemic levels, down from over 96 per cent coverage to just under 93 per cent last year.

Likewise, uptake of the maternal booster dropped from a high of 70 per cent to under 60 per cent.

This has left many more young babies and infants susceptible to infection.

Who can get the jab?

The vaccine is routinely offered three times including to women in pregnancy as it can protect the baby during the first few weeks of life.

Doctors suggest the best time to have it is soon after the 16th week of pregnancy.

The 6-in-1 vaccine is then offered to babies at 8, 12 and 16 weeks of age and a booster at 3 years and 4 months.

Older children and adults arent routinely vaccinated, except during pregnancy or a whooping cough outbreak.

My child is vaccinated, can they still get whooping cough?

Yes. Vaccines are never 100 per cent effective but do offer the best defence against the disease.

As with Covid jabs, even if they do not stop your child getting the illness, the likelihood is that it will be less severe.

As well as reducing overall severity, people who are vaccinated are likely to suffer from the cough for a shorter period.

Is whooping cough treatable?

Yes, although treatment depends on age and how long it has been since catching the infection.

Children under 6 months who are very ill and people with severe symptoms will usually be admitted to hospital for treatment.

People diagnosed during the first 3 weeks of infection may be prescribed antibiotics to take at home.

These will help stop the infection spreading to others but may not reduce the symptoms.

Those who have had whooping cough for more than 3 weeks will not normally need treatment as they are no longer contagious and antibiotics are unlikely to help.

Rest, drinking plenty of fluids and painkillers such as paracetamol or ibuprofen, should be taken for a fever.

Cough medicines are unlikely to be effective and are often not suitable for young children so should be avoided.

What should I do if Im worried my child has it?

First, call your GP or NHS 111 and explain the symptoms.

They may then arrange for you or your child to come in for tests and treatment.

If you or your child are taking antibiotics for whooping cough, you need to be careful not to spread the infection to others.

The NHS recommends those infected stay away from nursery, school or work until 2 days after the start of antibiotic treatment or, if not taking antibiotics 3 weeks from when the coughing bouts started.

Childrens mouths and nose should be covered with a tissue when coughing or sneezing and these should be disposed of immediately.

Hands should be washed regularly with soap and water.

My child isnt vaccinated. Am I too late?

No. It is best to have vaccines on time, but they can still have whooping cough as part of the 6-in-1 vaccine up to the age of 10.

Babies are given 3 doses of the 6-in-1 vaccine as part of the NHS vaccination schedule at 8, 12 and 16 weeks.

They are also offered a 4-in-1 pre-school booster, aged 3 years 4 months If your child has missed their 6-in-1 vaccinations, contact their GP surgery.


Original post: School chaos fears as kids suspected of having whooping cough should be excluded for up to 3 weeks amid 'worst - Daily Mail
FDA Approves WGc-043, EB Virus-Related mRNA Therapeutic Cancer Vaccine for Use in Clinical Trials – Pharmacy Times

FDA Approves WGc-043, EB Virus-Related mRNA Therapeutic Cancer Vaccine for Use in Clinical Trials – Pharmacy Times

May 11, 2024

The FDA has approved the cancer vaccine, WGc-043 (WestGene), an Epstein-Barr (EB) virus-related mRNA therapeutic cancer vaccine, for an investigational new drug (IND) application. The IND application allows the vaccine to be used in clinical trials with human subjects, which can be significant in the fight against cancers and serve as a positive advancement in cancer treatment.1

Image credit: monticellllo | stock.adobe.com

The IND approval offers a new hope to patients who have advanced EB virus-related cancers. EB virus is highly associated with more than 10 malignancies, including different types of cancer (nasopharyngeal carcinoma [NPC], natural killer T-cell lymphoma [NKTL], as well as gastric, lung, breast, liver, esophageal, and cervical cancers) and autoimmune diseases (eg, multiple sclerosis and systemic lupus erythematosus).1

According to experts, the WGc-043 vaccine has promising efficacy, a low toxicity, broad applicability, efficient scalability, and cost effectiveness. The vaccine has already completed investigator-initiated trials that treated NPC and NKTL, and demonstrated superior efficacy and safety compared with other available mRNA therapeutic vaccines.1

Currently, a phase 1 clinical trial (NCT05714748) is recruiting participants to determine a therapeutic candidate vaccine that targets EB virus-related malignant tumors in patients who were between 18 and 70 years of age that failed second-line standard therapy. The investigators used 20 g as the starting point, and doses increased using an escalation scheme. Each participant received 1 corresponding dose, and an intramuscular injection was administered again every 7 days. After 4 doses, the fifth dose was given after a 1-month interval. The trials primary end points were frequency and number of adverse events (AEs), objective response rate, progression-free survival, and overall survival (OS).2

Another mRNA-based vaccine, mRNA-4157, showed efficacy in prolonging recurrence-free survival (RFS) in patients with resected high-risk melanoma when used in combination with pembrolizumab (Keytruda; Merck & Co) and when used as an adjuvant therapy. The randomized, open-label, phase 2 trial (NCT03897881) that mRNA-4157 plus pembrolizumab was evaluated in had also demonstrated a reduced risk of death by approximately 44% compared to pembrolizumab alone.3

At a median follow-up point of 101 and 105 weeks, recurrence or death was reported in 24 of 107 patients (22.4%) in the vaccine plus pembrolizumab arm, and in the pembrolizumab alone arm, it was 20 of 50 patients (40%). Additionally, RFS rates (95% CI) at 18 months were 78.6% (69.0%, 85.6%) in those who received the combination regimen compared with 62.2% (46.9%, 74.3%) in the monotherapy arm. The combination had also demonstrated a reduction in the risk of recurrence or death by 44% (HR = 0.561; 95% CI: (0.309, 1.017). There were no clinically meaningful AEs, according to the investigators, with treatment-related AEs reported being grade 1 or 2 in severity. The most common grade 3 AE in this trial related to mRNA-4157 was fatigue.3

Additionally, a more recent vaccine demonstrated positive improvements in survival; however, this vaccine was not mRNA-based. Similar to the prior study, this second-generation vaccine was also administered in patients who had melanoma, and the findings demonstrated positive OS rates in both the second-generation vaccine and a first-generation vaccine, but OS was better in those who received the prior. Additionally, younger men with earlier-stage melanoma were shown to benefit from vaccination more than other participants. At 10 years, OS estimates were 0.840.05 (SE) and 0.720.11 for men and women, respectively.4

The WGc-043 vaccine was developed by WestGene, a biotech company that specializes in mRNA technology. Currently, the company has a pipeline of over 20 mRNA-based therapeutic products that target a variety of diseases. If successfully launched, WGc-043 will provide a treatment option for patients who either have advanced EB virus-positive solid tumors or hematologic malignancies.1


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Is There a Vaccine for Bird Flu? – Verywell Health

Is There a Vaccine for Bird Flu? – Verywell Health

May 11, 2024

Key Takeaways

In the current bird flu outbreak, the virus has been detected in dairy cattle herds across nine states and infected at least one person. CDC health officials say two existing H5N1 candidate vaccine viruses are available for manufacturers if the bird flu virus spreads more easily to humans.

The CDC has developed a candidate vaccine virus nearly identical to the protein in the current strain. If needed, this could be used to produce a vaccine for humans. According to a preliminary analysis, the vaccine is expected to offer good protection against the current H5N1 strain.

Both vaccine candidates are in the governments stockpile in limited quantities, and hundreds of thousands of prefilled syringes and vials are ready to ship.

Theres no word yet from health officials on the potential risks and side effects of the bird flu vaccine.

As of now, theres no evidence that bird flu is spreading between people. But if we started seeing transmission to humans, a vaccine could help, said William Schaffner, MD,an infectious disease specialist and professor at the Vanderbilt University School of Medicine.

Having a vaccine ready to go ensures that public health officials are prepared just in case its needed, Schaffner added.

A blueprint is on the shelf, ready to put into the manufacturers hands for them to start making doses if necessaryall that preliminary work has been done, saidJohn Sellick, DO, an infectious disease expert and professor of medicine at the University at Buffalo SUNY.

Sellick added that a vaccine isnt usually produced before theres a major health issue, but its part of pandemic preparedness and thinking ahead.

If the virus develops the capacity to spread readily from person to person, the general consensus is that were in for another pandemic, Sellick said. Vaccination is the foundation of the response, putting it into as many arms as possible to prevent hospitalizations and deaths.

The biggest concern about bird flu now is in dairy farm workers, who are at the highest risk of exposure. But you could also make the argument that people who work on poultry farms could potentially get into trouble as well, he said.

Sellick added that people who work in the manufacturing of dairy and poultry products may need a vaccine, too.

However, a lot of unknowns remain with the development of bird flu and a vaccine. This is like COVID all over again, Sellick said. The virus will tell us whats happening.

Sellick noted that bird flu hasnt been able to spread readily in humans. Theres nothing we can do except to continue to do surveillance and be ready, just in case, he said.

Theres no bird flu vaccine right now. However, two candidate vaccine viruses are readily available to be made into vaccines if the virus spreads more easily to and between people.

By Korin Miller Miller is a health and lifestyle journalist with a master's degree in online journalism. Her work appears in The Washington Post, Prevention, SELF, Women's Health, and more.

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Diet and metabolic health may influence flu vaccine effectiveness – AOL

Diet and metabolic health may influence flu vaccine effectiveness – AOL

May 11, 2024

A recent mouse study found that dietary interventions led to better metabolic biomarkers and improved flu vaccine response. Friso Gentsch/picture alliance via Getty Images This article originally appeared on Medical News Today

The World Health Organization estimates that vaccination efforts have saved154 million livesin the last fifty years.

Multiple factors can influence vaccine effectiveness, and researchers are interested in studying the best ways to increase vaccine efficacy.

A study conducted in mice with obesity found that dietary interventions resulting in weight loss led to better metabolic biomarkers and improved flu vaccine effectiveness.

The results highlight the potential impact of a balanced diet and metabolic health on vaccine response.

The World Health Organization (WHO) estimates that immunization efforts have helped save 154 million people over the past 50 years. This information highlights the helpfulness of vaccines.

However, certain immunizations, such as the flu vaccine, are not always as effective as wed like them to be due to various factors.

A recent mouse studyexamined how healthy dietary interventions prior to vaccination could influence metabolic health and increase flu vaccine effectiveness. The findings show that improved metabolic health led to better immune function, which increased the vaccine response.

Future research could explore how these findings, recently published inNature Microbiology, could apply to humans.

The researchers note that obesity is associated with a higher risk of severe infectious diseases, including the flu.

While this heightened risk makes it more critical for this group to get vaccinated, researchers note that obesity can also decrease the effectiveness of flu vaccines.

For the study, they tested a few different scenarios to see if dietary changes helped prior to and after vaccination.

They took two groups of mice and fed one group a lean diet and the other a high fat diet. The mice then received a flu vaccine. After vaccination, some mice that were on the high fat diet were switched to the control diet. Mice then received a lethal dose of the flu virus, homotypic H1N1, after either 4 weeks or 12 weeks on the control diet.

Researchers found that switching to a healthy diet post-vaccination did not improve survival despite the weight loss that the previously obese mice experienced.

The previously obese mice had only a 24% survival rate after 4 weeks on the control diet and a 28% survival rate after 12 weeks on the control diet. However, the results suggested that dietary changes to lose weight after vaccination may help control viral spread.

The results were much different when the dietary changes were made pre-vaccination. To test this, researchers had certain obese mice switch to the lean control diet 4 weeks before vaccination. This switch allowed for several systemic measurements of metabolic dysfunction to return to normal and for weight loss to occur.

Researchers observed an improved immune response in these mice, particularly among their T cells, and decreased morbidity and mortality.

After exposure to the flu virus, the formerly obese mice had a 100% survival rate. The results suggest that specific dietary changes and weight loss may help improve the flu vaccines effectiveness.

The research also adds to what we know about how obesity may impact immune response, which will be an area for continued research.

We have known since the 2009 H1N1 flu epidemic that people with obesity are at increased risk of severe flu and death, and we have seen similar findings with COVID-19. It is not entirely clear why, however it could be decreased lung function and/or other factors, non-study authorMarci Drees, MD, chief infection prevention officer and hospital epidemiologist for ChristianaCare, told Medical News Today.

Its important to remember that this study was conducted in mice, and of course, mice are not humans so it is certainly not definitive in terms of proving that people with obesity dont respond as well to flu vaccines, Drees said.

The studys main limitation is that it was conducted in mice, meaning further investigation is needed before these findings could be applied to humans.

Researchers also note they were limited in their ability to determine certain factors, as they had a low sample size of mice on the high fat diet who survived exposure to the flu. They acknowledge the need fora morein-depth investigation of how nutrition affects immune cell function during vaccination and infection.

There have been some small studies in the past that showed that people with obesity were more likely to get the flu, even if vaccinated, compared to vaccinated people who were not obese and despite having good levels of antibodies against the flu strains in the vaccines that year, Drees said.

There is a lot more that needs to be studied in this area to better understand the interactions between obesity, the flu virus, and the flu vaccine.

Non-study authorDr. Linda Yancey, director of infection prevention at the Memorial Hermann Health System in Houston, noted the following to MNT:

First off, this is a mouse study. It goes without saying that mice are not people. This looks like a nice foundational study to base future human trials on. Studies like these are more important than many people give them credit for because they prove something that everyone generally agrees upon a healthy diet and weight loss are good for you. While we all believe this to be true, it is nice to see solid scientific data backing this up.

The findings demonstrate that a healthy diet could affect vaccine effectiveness, but this doesnt mean that people with obesity should avoid vaccination.

As theCenters for Disease Control and Prevention (CDC)notes, people with a body mass index (BMI) of 40 or higher can be at an increased risk for flu complications. Thus, vaccination might be even moreimportantin this demographic.

People can talk with their doctors about personal risk factors that may increase complications if they get sick with the flu. They can also discuss any potential risks from the vaccine itself and how effective the vaccine may be for them.

While the study wont lead to immediate change in clinical practice or recommendations, weight loss among individuals who are obese is generally encouraged by healthcare professionals.

[The study] will need to be followed up by a human trial to see if the observation holds up, Yancey noted.

If so, then we could potentially recommend a healthy diet and weight loss in the weeks leading up to vaccination. However, this is a general recommendation for everyone already. So, there wouldnt be any big changes in overall health advice.

Dress said she wouldnt change any current recommendations based on this one study in mice, noting the following:

There are many health benefits to losing weight, and [a] better response to vaccines might be one of them. But that is really just a theory right now. I definitely would still highly promote influenza vaccine regardless of your weight and I would probably recommend it even more highly in persons with obesity because we know their risk of severe flu is higher.

So, I wouldnt want someone to not get vaccinated because they think the flu vaccine wont work for them there is also good evidence that even if you get the flu after being vaccinated, your risk of severe disease and death is lower. Persons living with obesity should discuss with their doctor what their options are for weight loss, but should still definitely get their annual flu shot.

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French, US drug firms team up for Covid-flu shot – The Bryan Times

French, US drug firms team up for Covid-flu shot – The Bryan Times

May 11, 2024

French pharmaceutical giant Sanofi and struggling US rival Novavax announced Friday an alliance to sell a Covid vaccine and develop another that combines with a flu shot.

Under a licensing deal worth up to $1.2 billion, the companies will co-commercialise Novavax's Covid-19 vaccine worldwide, except in some countries including India, Japan and South Korea, where the US firm already has partnership agreements.

Novavax will receive an upfront payment of $500 million and up to $700 million if it reachers certain milestones while Sanofi will take a five percent stake in the US company.

Sanofi will book sales of Novavax's protein-based Covid-19 vaccine from 2025.

The French group will be able to develop a combination flu-Covid vaccine using its own flu shots with the US company's Covid jab.

The announcement comes as pharmaceutical companies have reported drops in sales for Covid vaccines.

Novavax, which is highly dependent on its Covid vaccine, raised doubts last year about its ability to continue its business.

The Maryland-based firm was an early frontrunner in the global vaccine race, but fell behind after being hit by manufacturing and regulatory delays.

For Sanofi, the deal is a chance to develop a combination flu-Covid jab.

"With flu and Covid-19 hospital admission rates now closely mirroring each other, we have an opportunity to develop non-mRNA flu-Covid-19 combination vaccines offering patients both enhanced convenience and protection against two serious respiratory viruses," said Jean-Francois Toussaint, Sanofi's global head of vaccine research and development.


Visit link: French, US drug firms team up for Covid-flu shot - The Bryan Times
AstraZeneca announces global withdrawal of COVID-19 vaccine amid demand crunch – Moneycontrol

AstraZeneca announces global withdrawal of COVID-19 vaccine amid demand crunch – Moneycontrol

May 11, 2024

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AstraZeneca announced on Tuesday that it is globally withdrawing its COVID-19 vaccine, as reported by UK-based media outlet The Telegraph.The company cited an abundance of newer vaccine options available since the pandemic began.

Additionally, AstraZeneca plans to revoke marketing authorizations for its vaccine, Vaxzevria, within Europe due to reduced demand and discontinuation of production and supply.

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"As multiple, variant COVID-19 vaccines have since been developed there is a surplus of available updated vaccines," the company said.

The withdrawal announcement comes at the heels of media reports suggesting that AstraZeneca has acknowledged in court documents that the vaccine can lead to side effects such as blood clots and low blood platelet counts.

The withdrawal process, initiated on March 5, officially took effect on May 7, according to The Telegraph. AstraZeneca, based in London, has diversified its focus into respiratory syncytial virus vaccines and obesity drugs following a slowdown in COVID-19 medicine sales.

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Sanofi strikes deal with Novavax, boosting the vaccine maker – STAT

Sanofi strikes deal with Novavax, boosting the vaccine maker – STAT

May 11, 2024

LONDON Novavax, the beleaguered maker of a Covid-19 vaccine, just got a boost of its own.

The French pharma company Sanofi on Friday said it had reached a licensing deal to sell Novavaxs Covid shot going forward as well as to try to combine the vaccine with Sanofis own flu shot. The pact includes a $500 million upfront payment, with up to $700 million more on the table if certain regulatory and launch milestones are reached.

While Novavaxs stock soared during the pandemic as the vaccine race was underway, the company failed to get its shot authorized in the U.S. market until July 2022, long after the makers of mRNA vaccines had reaped billions in sales. Sales have sputtered along since then, and last year, the Maryland-based company warned that that it may not be able to stay in business.

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Novavax Stock Doubles on $1.2B Sanofi Deal for COVID-19, Flu Vaccines – Investopedia

Novavax Stock Doubles on $1.2B Sanofi Deal for COVID-19, Flu Vaccines – Investopedia

May 11, 2024

Key Takeaways

Novavax (NVAX) shares more than doubled in intraday trading Friday after announcing a $1.2 billion deal to license its vaccine technology to French drugmaker Sanofi (SNY).

Novavax agreed to license its vaccine technology for COVID-19 and other possible future vaccines to Sanofi, as well as co-develop a combination vaccine designed to prevent both COVID-19 and the flu. Sanofi agreed to pay Novavax $500 million upfront, with another $700 million in possible payments depending on developmental and regulatory milestones.

"Together, we can broaden access to both our COVID-19 vaccine and our adjuvant to ensure more individuals can benefit from the protection vaccines can provide," Novavax Chief Executive Officer (CEO) John C. Jacobs said in a statement. "Novavax is now in a stronger position to refocus our efforts on leveraging our technology platform and novel adjuvant in R&D and pipeline expansion to help advance our mission of developing life-saving vaccines to fight infectious diseases."

The deal will allow Novavax to lift its "going concern" warning, Jacobs told CNBC. The company first issued the warning in early 2023 over concerns that it may not be able to financially survive as demand for COVID-19 vaccines waned.

As part of the deal, Sanofi is also taking a less than 5% equity stake in Novavax, and Novavax will receive royalty payments for future sales of its COVID-19 vaccine and the future combination COVID-19 and flu vaccine.

Alongside the Sanofi deal, Novavax also reported first-quarter results Friday morning that missed analyst estimates.

Novavax reported revenue for the first quarter of $93.9 million, shy of the $101.3 million analysts expected, according to estimates compiled by Visible Alpha. Novavax posted a loss of $147.6 million, or $1.05 per share, wider than the loss of $127.4 million, or 90 cents per share, that analysts projected.

Revenue increased by about $13 million from last year's first quarter, while it effectively cut its net loss in half from last year's mark of $293.9 million.

For the full fiscal year, Novavax lowered its projected revenue to $400 million to $600 million, down from the previous range of $800 million to $1 billion. However, the estimated $570 million the company expects to receive from Sanofi this year pushed its combined revenue and payments projections higher, to $970 million to $1.17 billion.

The company also said it is prepared to introduce a cost-cutting program over the next year, with goals of reducing its combined costs of research and development (R&D) and selling, general, and administrative expenses (SG&A) to below $500 million by the end of fiscal 2025. For fiscal 2024, Novavax projects that those expenses will be within a range of $700 million to $750 million.

Novavax shares were up over 120% by 10:30 a.m. ET Friday to $9.90.


Read the rest here: Novavax Stock Doubles on $1.2B Sanofi Deal for COVID-19, Flu Vaccines - Investopedia
Covishield side effects: Doctors’ group urges govt to review all Covid vaccines – Hindustan Times

Covishield side effects: Doctors’ group urges govt to review all Covid vaccines – Hindustan Times

May 11, 2024

In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India. (Also read | Covishield rolled back; should those jabbed with it need to worry? Experts answer)

At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible.

"The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as 'safe and effective', without scientific investigation and invoking epidemiology," Dr Tarun Kothari, a radiologist and an activist, said at the press conference.

The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said.

When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist.

There is an already low awareness around vaccine injuries, especially in India, she said.

Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added.

"The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination," Dr Kothari said.

The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well.

"We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families," Dr Mittal said.

Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated.

"Review science behind all Covid vaccines and audit their commercialisation," Dr Kothari said.

The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as 'Covishield' in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts.

The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement.

In India, the company's partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021.

AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe.

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Covishield side effects: Doctors' group urges govt to review all Covid vaccines - Hindustan Times
Covishield side effects: Doctors’ group urges govt to review all Covid vaccines – The Times of India

Covishield side effects: Doctors’ group urges govt to review all Covid vaccines – The Times of India

May 11, 2024

NEW DELHI: In the wake of pharmaceutical giant AstraZeneca admitting in a UK court that its Covid vaccine can cause blood clots in rare cases, a group of doctors on Thursday expressed deep concern over the safety of the Covishield vaccine manufactured by the Serum Institute of India. At a press conference, the doctors, under the banner of the Awaken India Movement (AIM), urged the government to review the science behind all Covid vaccines and audit their commercialisation as well as implementation of active surveillance and monitoring mechanism to ensure vaccine adverse events are identified as early as possible. "The government has wholly ignored the rising number of cases of tragic deaths post-Covid vaccination all the while and continues to promote Covid vaccines as 'safe and effective', without scientific investigation and invoking epidemiology," Dr Tarun Kothari, a radiologist and an activist, said at the press conference. The world is learning about a side effect of the Covid vaccine called Thrombosis with Thrombocytopenia Syndrome (TTS), he said. When the COVID-19 vaccines were being administered, not many people were aware that it was being done without the completion of phase-3 trials. Administration of COVID-19 vaccines was started without the manufacturers having complete information and data on the possible short-term or long-term side effects, or fatalities, said Dr Sujata Mittal, a gynaecologist and oncologist. There is an already low awareness around vaccine injuries, especially in India, she said. Thousands of women reported abnormalities in their menstrual cycles, which was confirmed much later as a side effect of the vaccine in a study published in September 2022, she added. "The Awaken India Movement (AIM) has been collecting details of Covid Vaccine deaths covered by media/social media in India and sharing them with various high authorities of the country since 2021, when the vaccination began. The government has failed to respond to our repeated requests to investigate deaths and debilitation from adverse effects of vaccination," Dr Kothari said. The AIM urged the government of India to compensate all the victims of Covid vaccines, including their family members, through a mechanism that involves vaccine manufacturers as well. "We also demand establishing fast track courts and vaccine courts to provide swift justice to the vaccine injured and their families," Dr Mittal said. Besides, active surveillance and monitoring mechanisms should be implemented to ensure vaccine adverse events are identified as early as possible and early treatment protocols must be created and widely publicised so that lives can be saved, she stated. "Review science behind all Covid vaccines and audit their commercialisation," Dr Kothari said. The United Kingdom-based AstraZeneca has started global withdrawal of its COVID-19 vaccine, which was provided in India as 'Covishield' in partnership with the Serum Institute of India, days after it admitted to rare side effects of blood clotting and lowering of platelet counts. The withdrawal has been initiated due to a surplus of available updated vaccines since the pandemic, the company said in a statement. In India, the company's partner Serum Institute of India said it has stopped the manufacturing and supply of additional doses of Covishield since December 2021 while reiterating that it had disclosed all rare to very rare side effects, including TTS, in the packaging insert in 2021. AstraZeneca had partnered with Oxford University to develop the COVID-19 vaccine, which was sold as Vaxzevria in Europe.


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Covishield side effects: Doctors' group urges govt to review all Covid vaccines - The Times of India