Category: Vaccine

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How safe is AstraZeneca’s Covid jab? What are the side effects? And why do victims only have a 3-year cut-off – Daily Mail

May 9, 2024

By Emily Stearn, Health Reporter For Mailonline 11:39 08 May 2024, updated 14:58 08 May 2024

AstraZeneca's Covid vaccine once heralded as a 'triumph for science' is being withdrawn worldwide.

The jab, developed withOxford University, can no longer be used in the European Union after the company voluntarily pulled its 'marketing authorisation', coming into effect today.

Similar applications to withdraw the vaccine will be made in other countries which had previously approved it, including the UK. Around 50million doses were given in Britain.

While creditedwith saving more than 6million lives, the jab known as Vaxzevria has come under intense scrutiny in recent months over a rare but fatal side effect.

In February, thepharmaceutical titanadmitted in documents lodged with the High Court that it 'can, in very rare cases, cause thrombocytopenia syndrome (TTS)'.

So why has the jab now been withdrawn? Are you at risk if you had Vaxzevria? And what do you have to prove if you have been injured by the AstraZeneca vaccine?

Here, MailOnline explains everything you need to know.

Why has it been withdrawn?

Fifty-one families are currently pursuing legal action against AstraZeneca, arguing its 'defective' jab was to blame for their injuries and deaths of loved ones.

However, the Cambridge-based drug manufacturer denies the decision to withdraw the vaccine is related to the court case. Instead, it insists Vaxzevria is being removed from markets for commercial reasons.

The company said in court documents that the vaccine is reportedly no longer being manufactured or supplied, having been superseded by updated vaccines that tackle newer variants.

In a statement today, the company said:'According to independent estimates, over 6.5million lives were saved in the first year of use alone and over three billion doses were supplied globally.

January 2020: Oxford University scientists start working on a Covid vaccine after the World Health Organization declares the spread of the virus a 'Public Health Emergency of International Concern'

March 2020: Then Prime Minister Boris announced the first national lockdown. That same month, the Government invests 88million in the development of the Oxford vaccine

April 2020: Alongside AstraZeneca, scientists start the first clinical trials of their new vaccine. This involved 1,000 volunteers in the UK

July 2020: Results from phase two trials of AstraZeneca's jab are published

4 December 2020:Covid jab rollout begins with the Pfizer vaccine. Over-80s and care home workers are given priority

8 December 2020:Phase three trial results of theAstraZeneca's jab are published. These are what health officials will use to approve the jab for use in the UK

30 December 2020:AstraZeneca's jab is approved for emergency use

4 January 2021: FirstAstraZeneca doses start being dished out.Brian Pinker, 82, is the first person to receive the jab outside of clinical trials

8 January 2021: Frontline NHS staff start being offered vaccines

8 February 2021: Over-70s are called forward

14 February 2021: Roll-out opens up to Brits with underlying heath conditions, as well as the over-65s

28 February 2021: All over-60s are invited for jabs

11March 2021:European countries start suspending use of the AstraZeneca jab after death of a 60-year-old woman from a blood clot

17 March 2021: Over 50s start being offered Covid jabs in the UK

19 March 2021: Several European countriesreverse decision to suspendAstraZeneca jab after initialinvestigations find no link to reported blood clots

31 March 2021: People living with vulnerable adults are called forward to get a Covid vaccine in the UK, even if they are younger than eligible age groups

7 April 2021:UK restricts the use of the AstraZeneca vaccine to over-30s over a small but statistically significant risk of blood clots in younger people

30 April 2021: Over-40s are called forward for Covid jabs

7 May 2021: Restriction of the AstraZeneca vaccine is widened to include over-40s

August 2022: Government sources say they will not order anymore AstraZeneca Covid vaccines instead focuses on mRNA alternatives

March 2023: Dozens of patients and families launch legal action against AstraZeneca due to

April 2023: Widower of a BBC presenter Lisa Shaw who died after having the vaccine said he has 'no alternative' but to sue AstraZeneca

4 August 2023: Anish Tailor, whose wife Alpa died in March 2021 after receiving her first AstraZeneca dose, filed a product liability claim against AstraZeneca at London's High Court.His lawyer says he has nearly 50 other clients who will formally sue AstraZeneca in the coming months

17 August 2023: IT engineer Jamie Scott, who suffered a brain haemorrhage the day after his first AstraZeneca jab starts a legal case against the company. The law firm representing Mr Scott says it represents around 40 other individuals or bereaved families

'Our efforts have been recognised by governments around the world and are widely regarded as being a critical component of ending the global pandemic.

'As multiple, variant Covidvaccines have since been developed, there is a surplus of available updated vaccines.

'This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied.

'AstraZeneca has therefore taken the decision to initiate withdrawal of the marketing authorisations for Vaxzevria within Europe.'

What did the original trial data show about side effects?

Tens of thousands of volunteers, including ones in the UK and the US, willingly rolled up their sleeves to take part in original trials.

Heavily scrutinised data suggested two doses of the AstraZeneca jab offered about 70 per cent protection against becoming ill. This meant developing any symptoms, as opposed to being hospitalised.

Other studies calculated that a single dose reduced the likelihood of hospitalisation by up to 94 per cent.

Analysis of the phase 3 trial, the final hurdle typically needed to be cleared before any drug gets approved for widespread human use, noted no safety concerns.

Yet, like with all forms of medication, AstraZeneca's jab carried a range of potential side effects.

Officials knew about mild ones thanks to the massive trials, with recipients mostly complaining of routine issues like headaches.

And people who were subsequently vaccinated were warned about them ahead of getting any needle in their arm.

Common side effects, which health bosses say can affect more than 10 per cent of recipients, include fatigue, 'flu-like'symptoms, and pain in the arms or legs.

Stomach pain, a rash and excessive sweating were uncommon, strikes roughly one in 100 people who get vaccinated.

According to the pharmaceutical titan, rare (approximately one in 1,000) issues included facial drooping on one side.

It was only once the door was opened for millions more Brits to get the jab, as the UK did during the first few months of 2021, that another complication was spotted.

Officials noted a small, yet significant trend in cases of vaccine-induced immune thrombotic thrombocytopenia (VITT, or TTS)that allowed them to raise the alarm in the first week of April.

It causes blood clots to form in various parts of the body, including the brain, heart, lungs, kidneys, and the legs. It is an urgent medical emergency.

These blood clots, like any others, can be deadly depending on where they form or if they break up and travel to parts of the body like the brain.

Estimates suggest the risk of blood clots occurring from taking AstraZeneca's jab is in the region of one in 50,000.

Am I at risk now if I had the jab back in 2021?

Side effects from the AstraZeneca vaccine generally only occurred within the first four weeks of receiving it.

There is currently no evidence of a long-term risk from having had the jab, doctors insist.

As jabs are given as a single dose at a time, experts claim adverse effects generally only occur a short time after receiving the injection unlike with medication that people take for years.

Additionally, given the sheer quantity of people who received the AstraZeneca jab, some 50million in the UK and over 2.5billion globally, long-term effects would likely have been spotted by now, experts say.

How do you prove you have been injured by Vaxzevria?

The Vaccine Damage Payment Scheme,which has been around since the 70s, offers people, or their families, a tax-free sum of 120,000.

Established back in 1979, the policy covers covers an array of vaccines recommended by the Government, including measles, mumps and rubella and is meant to reassure people that, in the unlikely event something goes wrong, the state will provide support.

Under current rules however,strict eligibility criteria means those affected must either have been killed or be left 60 per cent disabled due to a vaccine.

This means a person theoretically judged to be only 59 per cent disabled will not get a penny.

The extent of a person's disability is based on an assessment by a doctor and can include both physicaldisablement, such as the loss of a limb, or mentaldisablement, such as a decline cognitive function.

It also means there is no escalation of the sum received.

So, for example, someone who is completely paralysed by a vaccine would receive the same 120,000 as someone who lost a leg.

Going blind or deaf counts as being 100 per cent disabled.

Brits can only make a claim for a child once they are two years old.Adults must apply within six years of having a vaccine.

What is the three year cut-off for compensation claims?

Government officials caution it can take at least six months to process a Vaccine Damage Payment claim. Covid vaccine specific claims 'will take longer'.

Under theConsumer Protection Act 1987, Brits also have a right to sue vaccine producers if a jabdefect has caused personal injury.

Lawyers representing 51 victims and families are currently undertaking such action against AstraZeneca,arguing the vaccine was 'a defective product' that was 'not as safe as consumers generally were reasonably entitled to expect'.

The pharmaceutical titan has strongly denied these claims.

You may have had a combined vaccination against a number of the diseases listed. For example, you might have been vaccinated against DTP (diphtheria, tetanus and pertussis) or MMR (measles, mumps and rubella).

You may also be able to get a payment if you're severely disabled because either:

Source: Gov.uk

Those injured or bereaved, however only have three yearsfrom the date of their injury or death in which to bring a claim.

Last month,Sarah Moore, a partner at law firm Leigh Day, who is representing alleged victims, told MailOnline the true toll of people injured may never be uncovered.

'The criteria for what constituted VITT was really only published and made available to the clinical community from the beginning of March (2021),' she said.

'We may never know if there were other injuries that could have been related to the vaccine before March 2021.

For the claims we are bringing, those injured or bereaved have three years from the date of their injury or the death in which to bring a claim so unfortunately in many cases that cut off has now been reached.'

How many Brits have been injured by the jab?

TTS is thought to be linked to at least 81 deaths in the UK, according to figures collated by UK drug watchdog, the MHRA.

Not all are proven, however. And not every family is seeking legal action.

No figures are provided for the number of people left disabled from AstraZeneca's Covid jab.

According to figures released by NHS Business Services Authority (NHSBSA) under freedom of information laws, the payment scheme has received more than 11,000 Covid vaccine claims as of April 2.

Of these, 168 claims for state-funded financial support have now been approved.

Fewer thanfive were Pfizer and Moderna, withthe remaining claims all AstraZeneca.

The successful claims cover those affected by VITT.

Others developedGuillain-Barre syndrome, anaphylaxis or suffered other blood clots.

More than 4,800 claims have been rejected, including 324 who were unsuccessful because they failed to meet the 60 per cent threshold.

'Althoughthe claims met the criteria for causation, the independent medical assessor recommended that the vaccine has not caused severe disablement,' the NHSBSA said.

When were officials first aware of the risk?

Health officials first identified cases of VITT linked to AstraZeneca's jab in Europe as early as March 2021, just over two months after the vaccine was first deployed in the UK.

However, it wasn't until April that year that evidence became clear enough that the jab started to be restricted.

Spooked officials first restricted the jab to only people over 30. They then narrowed this to only over-40s in May 2021.

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How safe is AstraZeneca's Covid jab? What are the side effects? And why do victims only have a 3-year cut-off - Daily Mail

Vaccines Have Saved a Staggering 154 Million Lives in The Last 50 Years – ScienceAlert

May 9, 2024

Vaccination saves lives an astounding 154 million of them since 1974 when the World Health Organization (WHO) launched its expanded global immunization programme, according to new research.

The goal of the programme was to make vaccines available to all children, and while there are enduring challenges in that regard, the upshot is abundantly clear in the multitude of deaths that were averted in the past 50 years, the vast majority of which children under 5.

"We also discovered that measles vaccination accounted for 60 percent of the total benefit of vaccination over the 50-year period, which was also the greatest driver of lives saved," says Andrew Shattock, an infectious disease modeler at the Telethon Kids Institute in Australia, who led the study.

The findings are a timely reminder of just how well vaccination works, protecting not only the vaccinated but also the most vulnerable within our communities, including young children, the elderly, and immunocompromised people from infectious diseases.

But that protection only goes so far. Just months ago, experts warned that the US was close to reaching a dangerous tipping point where vaccination rates had dropped so low that unvaccinated people were no longer necessarily protected by the vaccinated community, which could lead to otherwise preventable deaths.

Global trends are similarly concerning. A record number of children weren't vaccinated against measles in 2021, leading to numerous outbreaks of the infectious disease around the world in subsequent years, including the US a country that had eliminated the disease in 2000.

Experts suggest vaccine complacency and apathy, rather than hesitancy, have been driving factors behind the precipitous decline in vaccination rates.

Part of the problem might be that when vaccines work to prevent disease, we see fewer cases and outbreaks, removing the most emotive reminders of the risks of failing to vaccinate populations. As the saying goes, vaccines are victims of their own success.

Smallpox was the first and only infectious disease to have been globally eradicated with vaccines, with the last known natural case in 1977.

In more recent memory, WHO said in 2023 that vaccination programmes were on the brink of eradicating wild poliovirus from Afghanistan and Pakistan, the two countries in which polio is still endemic, but challenges remain.

Earlier this year, a study revealed that no cases of cervical cancer have been detected in Scotland in anyone who received the human papillomavirus (HPV) vaccine when they were teenagers putting the country on track to eliminate cervical cancer in young women.

Acknowledging the known but rare side effects of vaccination, the effort of population-wide vaccination is clearly worth it. The new study from Shattock and colleagues adds to that evidence, showing how on the whole kids live longer when vaccination programs reach them.

Vaccination accounted for 40 percent of the observed decline in global infant mortality, the researchers found, with other likely contributors including improved sanitation, healthcare, and access to clean drinking water.

"In 2024, a child at any age under 10 years is 40 percent more likely to survive to their next birthday thanks to vaccination efforts over the past 50 years," Shattock says.

The WHO-funded study also found that for every life saved with vaccines, an average of 66 years of full health were gained, translating to a whopping total of 10.2 billion years of health that would have otherwise been stolen by childhood deaths.

If you're one of those lucky ones living well into adulthood, yet need another reason to stay up to date with your vaccinations, look no further: Multiple studies have recently underscored the link between viral infections, such as influenza and shingles for which vaccines are available and the risk of developing dementia, including Alzheimer's disease.

While vaccines won't prevent all infections, they can dramatically reduce the severity of illness and your chances of hospitalization which in turn, may potentially help prevent neurodegenerative disease.

Meanwhile, researchers are hard at work improving their techniques for developing vaccines and experimenting with new vaccine technologies to protect us against even more infectious diseases and cancers, too.

The research has been published in The Lancet.

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Vaccines Have Saved a Staggering 154 Million Lives in The Last 50 Years - ScienceAlert

Vaccination Likely Saved A Whopping 154 Million Lives Over The Last 50 Years – IFLScience

May 9, 2024

In 1974, the World Health Organization (WHO) launched its program to make vaccines accessible to children across the globe. Now, 50 years later, a new study suggests that vaccination has had a significant impact on public health, helping to avoid millions of deaths.

Though WHOs Expanded Programme on Immunization (EPI) began with the goal of vaccinating all children against seven diseases including the now-eradicated smallpox the list has since expanded to target 14 pathogens.

The new study examined the impact of the vaccines for these pathogens on both regional and global public health since the EPI commenced in June 1974 up until its 50-year anniversary in 2024.

This was achieved using mathematical and statistical modeling to provide estimates of three key measures: the numbers of deaths averted, the number of life-years gained, and the number of years of full health gained.

The results of the combined 22 models suggest that 50 years worth of global vaccination efforts has had a substantial impact: 154 million lives were estimated to have been saved since 1974 as a result of immunization, with death swapped for an average of 66 years of full health per person.

Where the program appears to have made its biggest impact in terms of age is on societys youngest. Modeling found that 101 million of the 154 millions deaths estimated to have been averted were of people younger than a year old. It also suggested that vaccination was responsible for 40 percent of the decline in global infant mortality, making it the biggest contributor to that reduction.

Whilst all of the vaccines included were found to have made their mark, the measles vaccine had the most significant impact even if measles has had something of a resurgence in the last few years.

[M]easles vaccination accounted for 60 per cent of the total benefit of vaccination over the 50-year period, which was also the greatest driver of lives saved, said Dr Andrew Shattock, who led the study, in a statement.

The authors conclude the results are a testament to what can be achieved through collaboration, and call for efforts to persist.

"Vaccines are among the most powerful inventions in history, making once-feared diseases preventable, added WHO Director-General Dr Tedros Adhanom Ghebreyesus in another statement. Thanks to vaccines, smallpox has been eradicated, polio is on the brink, and with the more recent development of vaccines against diseases like malaria and cervical cancer, we are pushing back the frontiers of disease.

With continued research, investment and collaboration, we can save millions more lives today and in the next 50 years.

The study is published in The Lancet.

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Vaccination Likely Saved A Whopping 154 Million Lives Over The Last 50 Years - IFLScience

Doctor with controversial COVID vaccine views has her medical license reinstated – ABC6OnYourSide.com

May 9, 2024

Doctor with controversial COVID vaccine views has her medical license reinstated

by BRUCE SHIPKOWSKI (Associated Press)

(SBG file photo)

An Ohio doctor who drew national attention when she told state legislators that COVID-19 vaccines made people magnetic has had her medical license reinstated after it was suspended for failing to cooperate with an investigation.

The Ohio State Medical Board recently voted to restore Sherri Tenpennys license after she agreed to pay a $3,000 fine and cooperate with investigators.

Tenpenny, an osteopathic doctor, has been licensed in Ohio since 1984. She drew national attention in 2021 when she testified before a state legislative panel in support of a measure that would block vaccine requirements and mask mandates.

During her remarks, Tenpenny claimed that COVID-19 vaccines made their recipients magnetic, interface with cell towers and interfered with womens menstrual cycles.

Roughly 350 complaints were soon filed about Tenpenny with the medical board, which regulates physicians and can discipline them for making false or deceptive medical statements. A probe was launched but Tenpenny refused to meet with investigators, answer written questions or comply with a subpoena ordering her to sit for a deposition.

Tenpenny's license was suspended in August 2023 on procedural grounds for failing to cooperate with the investigation. Her attorney had told the board she wouldnt participate in an illegal fishing expedition."

The board voted 7-2 last month to restore her license, with proponents saying she had met the requirements for reinstatement.

Standing strong and steadfast!" she wrote. Thank you all for your unwavering love and support but most importantly for your prayers during these challenging times.

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Doctor with controversial COVID vaccine views has her medical license reinstated - ABC6OnYourSide.com

New vaccine could protect against coronaviruses which have yet to emerge – The Independent

May 9, 2024

Sign up for our free Health Check email to receive exclusive analysis on the week in health Get our free Health Check email

A new vaccine could be effective against coronaviruses which have yet to emerge, with hopes it could be used to battle future pandemics, research suggests.

Scientists at the University of Cambridge, the University of Oxford, and Caltech in the US are developing a novel approach called proactive vaccinology, which aims to train the bodys immune system to recognise several different coronaviruses.

The vaccine used antigens a substance that triggers an immune response in the body found in eight different coronaviruses, including those circulating in bats. This trains the immune system to go after the parts of the antigens that are shared across the viruses and other similar ones, including those not included in the vaccine.

The vaccine, for instance, does not include the Sars-CoV-1 virus, which led to the 2003 SARs outbreak, but can produce an immune response to it.

Usually vaccines, such as those used for the Covid-19 outbreaks, work by using a single antigen to train the immune system to target a specific and single virus.

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

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

The results have been published in the journalNature Nanotechnology.

Professor Mark Howarth in the University of Cambridges Department of Pharmacology, senior author of the report said: We dont have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now.

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

The study has shown the new vaccine, called Quartet Nanocage, raised a broad immune system response in mice, including those that had already been immunised against Sars-CoV-2 which caused the 2020 pandemic.

According to the study, the vaccine is simpler in design than others that are being developed, and may be used for developing vaccines for other health issues. The study should enter Phase 1 clinical trials by early 2025.

The research was funded by the Biotechnology and Biological Sciences Research Council.

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New vaccine could protect against coronaviruses which have yet to emerge - The Independent

COVID ‘FLiRT’ variants spreading. Chicago experts urge vaccination. – Chicago Tribune

May 9, 2024

A new family of COVID variants nicknamed FLiRT is spreading across the country, as vaccination rates in Chicago as well as nationwide remain concerningly low for some public health experts.

While symptoms and severity seem to be about the same as previous COVID strains, the new FLiRT variants appear to be more transmissible, said infectious disease expert Dr. Robert Murphy.

A new, more contagious variant is out there, said Murphy, executive director of Northwestern Universitys Institute for Global Health and a professor of infectious diseases at the Feinberg School of Medicine. COVID-19 is still with us, and compared to flu and RSV, COVID-19 can cause significant problems off-season.

Murphy urged the public to get up to date on COVID shots, particularly individuals who are at higher risk for severe complications from the virus. While much of the population has some immunity from vaccination or previous COVID infections, Murphy noted that with COVID-19, immunity wanes over time.

One FLiRT variant, KP.2, is estimated to account for roughly a quarter of recent COVID cases, according to Centers for Disease Control and Prevention data from late April.

That means it has outpaced the previously most common strain, JN.1, which spurred much of the winter respiratory seasons spike in COVID cases and hospitalizations nationwide, coinciding with a spate of flu and RSV infections around the same time.

The JN.1 variant is estimated to account for about 22% of recent COVID cases across the country, according to CDC data from late April.

Another FLiRT variant, KP.1.1, comprises over 7% of COVID cases nationwide, the CDC data shows. The name FLiRT is an acronym using the technical names for the mutations that caused the family of variants.

Hannah Barbian, a virologist at the Regional Innovative Public Health Laboratory at Rush University Medical Center, has been tracking various COVID variants in Chicago. She said her laboratory has detected the KP.2 variant in Chicago but not KP.1.1, though she believes that variant will likely be detected soon as well.

In general, lineages that emerge in the U.S., we detect them in Chicago, she said.

Barbian added that new COVID variants arent unexpected.

In this case, theyre only slightly different from variants that were most prevalent before, she said.

But some public health experts expressed concern that the new variants have emerged amid low uptake of the updated COVID vaccine locally as well as across the country.

It is concerning that vaccination rates are so low. Because the best way to be protected is vaccination, said Dr. Stephanie Black, interim deputy commissioner of the disease control bureau for the Chicago Department of Public Health. Its helpful to have the most updated vaccine.

She added that a new updated COVID vaccine will likely to be available in the fall.

Sixteen percent of Chicago residents are up to date on COVID vaccination, according to the Department of Public Health statistics, which are based on Illinois Comprehensive Automated Immunization Registry Exchange data.

The numbers are higher for older residents, with 34% of those aged 65 to 74 and almost 39% of those 75 and up having received an up-to-date booster shot.

City officials, though, say the number of residents vaccinated might be higher based on National Immunization Survey data.

Nationwide, about 23% of adults and 14% of children were reported to be up to date on COVID vaccines as of late April, according to the CDC, based on data from the National Immunization Survey.

For people who have fragile immune systems, they should take precautions around large crowds and places where they can be exposed, said Dr. Elizabeth McNally, director of the Northwestern University Feinberg School of Medicine Center for Genetic Medicine. For older people, its generally a good idea to stay up to date on vaccinations since immunity does wane with age.

In February, the CDC recommended that Americans 65 and up get another dose of the updated vaccine that became available in September, if at least four months had passed since their most recent shot.

McNally said its hard to know the impact of new variants since there is not a great deal of testing going on these days.

But she noted that there doesnt appear to be an increase in COVID hospitalizations, nor has she seen uptick in infections in her patients, who tend to be quite sick at baseline and contact me when they are exposed or sick.

COVID hospitalizations and deaths are on the decline in Chicago and nationwide, according to the city health department and CDC. The Chicago regions current COVID-19 hospital admission level is low, as is most of the United States, according to the CDC.

While vaccination rates have tapered off, McNally noted that this is on the backdrop of a great deal more immunity from repeated exposures from natural infection and vaccination, compared with the early stages of the COVID pandemic.

This translates to quicker recoveries and less prolonged illness when people do get COVID, she said.In 2020, we were dealing a virus for which humanity had little immunity.That is, thankfully, very different now.

eleventis@chicagotribune.com

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COVID 'FLiRT' variants spreading. Chicago experts urge vaccination. - Chicago Tribune

Adult RSV Shots Given to More Than 30 Babies by Mistake – Medpage Today

May 9, 2024

Nearly three dozen babies and young children have received respiratory syncytial virus (RSV) vaccines, which are only approved for adults, according to a brief CDC report.

Data from the Vaccine Adverse Event Reporting System (VAERS) revealed 27 reports of the Pfizer RSV vaccine (Abrysvo) and seven reports of the GSK RSV vaccine (Arexvy) being mistakenly administered to children under the age of 2 between Aug. 21, 2023 and March 18, 2024, Pedro Moro, MD, MPH, of the CDC in Atlanta, and colleagues detailed in Pediatrics.

"While rare, vaccine administration errors are known to occur and may increase after a new vaccine or product is introduced," Moro told MedPage Today in an email.

Thirty-one of the children who received the vaccines were infants under 8 months of age. In 21 of the cases, the vaccines were given in family medicine practices.

"Healthcare facilities that provide preventive care for children and adults might store and administer Pfizer and GSK RSV vaccines, other routine vaccines, and nirsevimab [Beyfortus]," Moro and colleagues wrote in the report. "Thus, the potential exists for Pfizer or GSK RSV vaccines to be administered in error to infants and young children."

Eric Simes, MD, a pediatric infectious diseases expert at Children's Hospital Colorado in Aurora, told MedPage Today that he was "not surprised" by the vaccine errors. "Mistakes will happen, especially with COVID vaccines being given to [both] adults and children, with pneumococcal vaccines being first given to children and now to adults, etc."

Simes said that he did not personally know of any cases where the RSV vaccines had been administered to children, but emphasized that "adult RSV vaccines should absolutely not be given to children."

The Pfizer vaccine is approved for use in pregnant individuals at 32 through 36 weeks gestational age, to prevent serious RSV cases in infants, and both the Pfizer vaccine and GSK vaccine are approved and recommended for adults 60 years of age and older.

Twenty-seven of the reports noted no adverse health events associated with the erroneous vaccines, but the remaining seven described at least one adverse event. One of those events occurred in an infant with a history of congenital heart disease who received the GSK RSV vaccine in combination with routine childhood vaccinations. That child required hospitalization for cardiorespiratory arrest within 24 hours after vaccine receipt. The remaining six reports described injection site reactions or systemic reactions, such as irritability, after receiving the RSV vaccines.

"Administration errors are preventable with proper education and training," the authors of the report emphasized. They suggested several strategies to prevent vaccine administration errors, including only ordering products that are approved for the patient population a facility serves, electronic health record alerts or warnings, close attention to labeling, and best practices for vaccine storage.

"To prevent mix-ups, CDC reached out to clinicians to educate them about the proper administration of the RSV vaccines," Moro said. "Education and additional vigilance will reduce the likelihood of errors."

The CDC and FDA will continue to monitor VAERS for vaccine administration errors, and clinicians are encouraged to report errors to VAERS.

The report was published several months after a notice was sent to healthcare providers that the CDC and FDA had received reports of 25 cases of the RSV vaccines being administered in error to young children in outpatient settings. At that time, there were also 128 reports of the GSK RSV vaccine being administered in error to pregnant people in outpatient settings and pharmacies. However, the CDC noted that, overall, these were a small number of cases relative to an estimated 1 million infants protected from RSV either through vaccination of pregnant individuals or infant receipt of nirsevimab -- a monoclonal antibody recommended for all infants under 8 months of age entering their first RSV season or born during it.

In instances when an RSV vaccine is given in error to children, no special monitoring is needed, according to the CDC. However, because the efficacy of the adult RSV vaccines in infants and young children has not been evaluated, children who receive an RSV vaccine in error should receive nirsevimab to prevent severe RSV disease, if otherwise eligible.

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

Moro and other study co-authors reported no potential conflicts of interest.

Simes reported consulting for GSK and has received grants for research and consulting from Pfizer.

Primary Source

Pediatrics

Source Reference: Moro PL, et al "Incorrect administration of adult RSV vaccines to young children" Pediatrics 2024: DOI: 0.1542/peds.2024-066174.

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Adult RSV Shots Given to More Than 30 Babies by Mistake - Medpage Today

New vaccine offers broad protection against coronaviruses that havent even emerged yet: Study – Hindustan Times

May 9, 2024

The rapid development of vaccines that protect against COVID was a remarkable scientific achievement that saved millions of lives. The vaccines have demonstrated substantial success in reducing death and serious illness after COVID infection. Despite this success, the effects of the pandemic have been devastating, and it is critical to consider how to protect against future pandemic threats. As well as SARS-CoV-2 (the virus that causes COVID), previously unknown coronaviruses have been responsible for the deadly outbreaks of SARS (2003) and MERS (2012 outbreak with ongoing cases).

Meanwhile, several circulating bat coronaviruses have been identified as having the potential to infect humans which could cause future outbreaks. My colleagues and I have recently shown, in mice, that a single, relatively simple vaccine can protect against a range of coronaviruses even ones that are yet to be identified. This is a step towards our goal of what is known as proactive vaccinology, where vaccines are developed against pandemic threats before they can infect humans.

Conventional vaccines use a single antigen (part of a virus that triggers an immune response) that typically protects against that virus and that virus alone. They tend not to protect against diverse known viruses, or viruses that have not yet been discovered. In previous research, we have shown the success of mosaic nanoparticles at raising immune responses to different coronaviruses. These mosaic nanoparticles use a type of protein superglue technology that irreversibly links two different proteins together.

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

As a virus evolves, some parts of it change while other parts remain the same. Our vaccine incorporates evolutionarily related receptor-binding domains (RBDs), so a single vaccine trains the immune system to respond to the parts of the virus that remain unchanged. This protects against the viruses that are represented in the vaccine and, critically, also protects against related viruses that are not included in the vaccine. Despite this success with mosaic nanoparticles, the vaccine was complex, making it difficult to produce on a large scale.

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

When mice were immunised with these nanocage vaccines, they produced antibodies that neutralised a range of sarbecoviruses, including sarbecoviruses not present in the vaccine. This show the potential to protect against related viruses that may not have been discovered at the time that the vaccine was produced. Along with this streamlined production and assembly process, our new vaccine elicited immune responses in mice that at least matched, and in many cases exceeded, those raised by our original mosaic nanoparticles vaccine.

Given the large fraction of the world vaccinated or previously infected with SARS-CoV-2, there was a worry that an existing response to SARS-CoV-2 would limit the potential to protect against other coronaviruses. However, we have shown that our vaccine is able to raise a broad anti-sarbecovirus immune response even in mice that had previously been immunised against SARS-CoV-2.

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

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Original post:

New vaccine offers broad protection against coronaviruses that havent even emerged yet: Study - Hindustan Times

Anixa expands cancer vaccine collaboration with Cleveland Clinic – Pharmaceutical Technology

May 9, 2024

Anixa Biosciences has expanded its partnership with US medical centre Cleveland Clinic to develop additional cancer vaccines.

Cleveland Clinic is undertaking a Phase I clinical trial for triple-negative breast cancer, the most lethal form of the disease.

A vaccine for ovarian cancer, currently in pre-clinical stages, is also being developed by Cleveland in partnership with the National Cancer Institute.

The vaccines aim to immunise against retired proteins expressed in specific cancer forms. The goal is to destroy emerging cancer cells and prevent the formation of tumours.

Developed at Cleveland, the vaccines have been licensed to Anixa Biosciences.

Cleveland Clinic will receive royalties and other commercialisation revenues.

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The new joint development agreement research will be led by Cleveland Clinics department of inflammation and immunity chair, Thaddeus Stappenbeck.

Justin Johnson, a co-inventor of the breast and ovarian cancer vaccines, will also be involved in the research.

Anixa chairman and CEO Dr Amit Kumar stated: Cleveland Clinic is a valued partner to Anixa in the development of both breast and ovarian cancer vaccines.

The progress weve made to date in the breast cancer vaccine programme, including promising preliminary data, drives our confidence in pursuing research and development for additional vaccines and cancer types using the same technology platform.

Assuming the breast cancer clinical studies continue to exhibit positive results, we believe the search for retired protein antigens will be pursued by many cancer researchers. We are seeking to maintain our lead in this potentially game-changing arena of cancer research.

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Anixa expands cancer vaccine collaboration with Cleveland Clinic - Pharmaceutical Technology

Our new vaccine could protect against coronaviruses that haven’t even emerged yet new study – The Conversation Indonesia

May 7, 2024

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

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

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

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

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

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

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

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

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

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

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

Given the large fraction of the world vaccinated or previously infected with SARS-CoV-2, there was a worry that an existing response to SARS-CoV-2 would limit the potential to protect against other coronaviruses. However, we have shown that our vaccine is able to raise a broad anti-sarbecovirus immune response even in mice that had previously been immunised against SARS-CoV-2.

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

More here:

Our new vaccine could protect against coronaviruses that haven't even emerged yet new study - The Conversation Indonesia

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