Category: Vaccine

Some experts have criticised Pfizer for not informing pregnant women in its trial of maternal respiratory syncytial virus vaccine that trials of a similar vaccine were halted over a potential risk of preterm birth. Others think that notification would have been premature and caused unnecessary anxiety. Hristio Boytchev reports

A debate has broken out over whether Pfizer should have told pregnant women participating in its trial of maternal respiratory syncytial virus (RSV) vaccination that a trial of a similar vaccine was halted over a safety signal around preterm birth, The BMJ can report. Both GSK and Pfizer were developing recombinant RSV F protein vaccines to inoculate pregnant women and protect their babies against RSV, a major cause of infant death globally.

GSK halted its phase 3 vaccine trial on 28 February 2022 after a safety signal emerged: a possible increased risk of preterm births and neonatal deaths. In the vaccine arm, 6.81% of births were preterm (95% confidence interval 5.99% to 7.69%) compared with 4.95% (3.97% to 6.07%) in the placebo arm. For neonatal deaths, the percentage was 0.37% (0.20% to 0.64%) in the vaccine versus 0.17% (0.04% to 0.50%) in the placebo arm.12 No clear explanation has been found for the increase in preterm births, and experts think that it might be unrelated to the vaccine. GSK told The BMJ that the imbalance was observed primarily in low and middle income countries and not consistently after a peak in late 2021,3 and that it was still investigating the cause of the preterm births but was no longer developing its vaccine.

Pfizer was studying preterm births as an adverse event of special interest in its own phase 3 trial, and a numerical (not statistically significant) imbalance in preterm births has recently emerged in phase 3 data: 5.7% (4.9% to 6.5%) in the vaccine versus 4.7% (4.1% to 5.5%) in the placebo arm, although there are not enough data to understand if there is truly an increased risk or what the cause is.45

After GSKs trial was halted, opinion was split among clinical trial ethicists and some vaccine researchers over whether Pfizer should have informed all women participating in its trial about the potential risk or updated its consent forms. Some think that only women who had not yet been vaccinated needed to be informed, whereas others think that because there is currently neither convincing evidence nor an explanation for the increased preterm risk, informing expectant mothers would have only caused unnecessary anxiety.

Charles Weijer, bioethics professor at Western University in London, Canada, told The BMJ that informing pregnant women in Pfizers trial about GSKs results would have allowed women who had not yet received the jab to consider whether they still wanted to get it and women who had already received it to seek additional medical advice and follow-up. Any failure to provide new and potentially important safety information data to trial participants is ethically problematic, Weijer said.

The independent Data and Safety Monitoring Board (DSMB), which reviews and evaluates study data to protect participants safety and monitor the studys progress, should normally have considered GSKs results and decided if they merited attention, said Stephen Evans, emeritus professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine. For Pfizer, the DSMB should have regularly assessed the benefit-harm balance, both on the data in the trial and whether the GSK results affected that balance. They should not base their decision simply on whether a particular result is statistically significant. These are difficult decisions, and it is why DSMBs are independent of the company, he told The BMJ.

The DSMB for the Pfizer trial didnt answer The BMJs questions about whether it had considered the GSK results, and two trial investigators told The BMJ that they hadnt received any communication from the DSMB regarding the results. Pfizer has also been criticised for a passage in some of its trial consent forms, seen by The BMJ, saying that its vaccine candidate was risk-free for the baby; a research ethics expert described this assurance as misleading and irresponsible. Pfizer did not respond to The BMJs questions on the issue of informed consent.

GSK told The BMJ that immediately after making the decision to halt its trials over the safety signal, it informed the health authorities and researchers involved in the trial. It also updated its consent forms. Over a year after GSKs trial was halted, The BMJ reported in May 2023 that experts had called for further analysis of Pfizers phase 3 trial data after the slight numerical increase in preterm births was seen.6 The imbalance was discussed a week later by the US Food and Drug Administrations vaccines and related biological products advisory committee.7 Ahead of the meeting, the FDA published an analysis showing that there was no increase in preterm births in high income countries, but there was a numerical increase in upper middle income countries, driven particularly by South Africa.5

The committee ultimately advised that Pfizers maternal RSV candidate was safe, although four of 14 members voted that the data presented by Pfizer were not adequate to support safety after a detailed discussion on the preterm births. Committee member Paul Offit, professor of paediatrics at the Childrens Hospital of Philadelphia, said in a meeting that Pfizers and GSKs vaccines were almost identical and so was concerned by GSKs results. Hana El Sahly, professor of molecular virology and microbiology at Baylor College of Medicine and committee chairwoman, said that the signal of increased preterm births connected to the Pfizer vaccine was significant in the phase 2, in the phase 3, and in a very similar product, adding that failing to design the Pfizer phase 3 study to deliver clarity was a big missed opportunity.8

Regulators have taken different approaches when approving Pfizers vaccine, which is called Abrysvo. The FDA approved it with conditions, including only giving it to women who are 32-36 weeks pregnant. Available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo, said a warning included in the prescribing information.9 To avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age. The FDA is requiring Pfizer to conduct postmarketing studies to assess the signal of serious risk of preterm birth.

Other regulators and national advisory committees, however, such as the European Medicines Agency and the UKs Joint Committee on Vaccination and Immunisation, did not consider a warning around the possible risk of preterm birth or restricting the use of the vaccine to the later weeks of pregnancy necessary in their regions. The Pfizer vaccine is not yet authorised in the UK, and the details of authorisation are not yet clear.

As Pfizer didnt respond to the questions about whether it had informed expectant mothers in its trial about GSKs results, The BMJ contacted governmental health authorities in all 18 countries where Pfizer had trial sites, as well as more than 80 trial investigators, and none answered saying that it had. Some confirmed that Pfizer continued to enrol and vaccinate women for months after the news of the potential risk of preterm birth in GSKs vaccine trial was made public.

Clinical trial ethicists and some other experts think that Pfizer should have made pregnant women in its trial aware of the potential preterm risk; some trial investigators and health authorities disagree. Once the results of the GSK trial on premature births became public, RSV vaccine studies in pregnant women should be updated to include this possible preterm risk, Klaus berla told The BMJ. berla is director of the Institute of Clinical and Molecular Virology of the University Hospital Erlangen and a member of the RSV working group of the standing committee on vaccination, which develops national recommendations for the use of licensed vaccines in Germany.

The renewal of informed consent is a must, added Rose Bernabe, professor of research ethics and research integrity at the University of Oslo. She pointed to guidelines from the Council for International Organizations of Medical Sciences, which state: Researchers must renew the informed consent . . . if new information becomes available that could affect the willingness of participants to continue.10 The internationally recognised Guideline for Good Clinical Practice contains a similar passage.11 In its trial publication, Pfizer said that it followed these guidelines.12

One trial investigator, speaking to The BMJ on the condition of anonymity because they had signed a confidentiality agreement with the company, said that early in 2022 they questioned Pfizer about the potential risk of preterm birth given the similarity between Pfizers and GSKs products and wanted to know whether Pfizer trial participants could be reassured. All I got from Pfizer was that their data hadnt shown any increase in risk, no answer to my question, the researcher said. Nothing was communicated regarding whether the DSMB had discussed the matter, they said. A trial investigator from South Africa, also speaking on the condition of anonymity, agreed that participants should have been informed.

But other trial investigators disagree. Beate Kampmann, director of the Centre for Global Health at Charite University Hospital Berlin, one of the lead authors of Pfizers phase 3 trial publication, and who was responsible for a trial site in the Gambia, told The BMJ that GSKs results werent relevant to her trial participants as most participants were already in follow-up. She said that the Pfizer vaccine was not the same as the GSK product and that the trials DSMB did not raise any concerns. This was a very location specific and also transient finding, which remains poorly understood, she added. She said that The BMJs questions on informed consent and possible side effects in the trial amounted to getting hung up on issues which are not borne out by the analysis and are distorting the benefits this vaccine can bring.

Kampmann did not clarify whether the DSMB had discussed the GSK results, and the DSMBs chair, Flor Munoz, associate professor of paediatrics at Baylor College of Medicine, refused to tell The BMJ whether the board had reviewed GSKs results, citing confidentiality agreements.

As the risk was uncertain and the cause of the increase in preterm births still not understood, amending the consent forms was not warranted, said Joop van Gerven, chair of the Dutch Central Committee on Research Involving Human Subjects (CCMO), a national ethics body responsible for the trial. This would have caused too much uncertainty (without any clinical consequences) for the large number of patients who had already received the vaccine, he told The BMJ. The Spanish health ministry shared this view.

Pfizer did not disclose in patient consent forms for its phase 3 trial that it was studying preterm birth as an adverse event of special interest, documents from the US, Canada,13 the Netherlands, Finland, and New Zealand, obtained by The BMJ, show. In addition, some Pfizer trial consent forms seen by The BMJ contain contradictory statements, warning of possible life threatening effects of the vaccine on the baby while also carrying a passage saying that only the expectant mother is at risk from adverse effects. The consent forms stated: The risks associated with the study vaccine (RSVpreF or placebo) may be experienced by you, but not your baby, since your baby will not receive the study vaccine or placebo directly.

Knowing what we know now, the statement in question is irresponsible and, given the benefit of hindsight, is actually factually incorrect, said Bernabe of the University of Oslo. The statement gives the false sense of security that the fetus or neonate will not be exposed to any risk or inconvenience. Considering the gravity of the risk that this irresponsible statement veils, this misleading statement should be a ground for questioning the validity of the consent process.

The Dutch national research ethics body, CCMO, admitted that the passage could potentially cause confusion. Following The BMJs queries, the Dutch authority alerted Pfizer to possible reader confusion and recommended the passage be adapted, van Gerven, of the CCMO, told The BMJ. However, as it has since emerged that no new participants will be included in the study, making an adjustment . . . is no longer an issue, he said.

Provenance and peer review: Commissioned; externally peer reviewed.

This feature has been funded by the BMJ Investigations Unit. For details see bmj.com/investigations.

Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med 2023;388:1451-1464.

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Concerns over informed consent for pregnant women in Pfizer's ... - The BMJ

14 November 2023

A new study by researchers from the International Agency for Research on Cancer (IARC) shows that a new quadrivalent human papillomavirus (HPV) vaccine, which targets HPV types 6, 11, 16, and 18, is safe and effective in provoking an immune response against these HPV types. The study was published in the journal Lancet Oncology.

The researchers compared the efficacy and safety of the new quadrivalent HPV vaccine, given in two doses to girls and boys aged 914 years, with those of a comparable vaccine, given in three doses to women aged 1526 years. The results showed that the new quadrivalent HPV vaccine was as effective and as safe for the younger population as the comparable vaccine.

Access to this new, effective vaccine could help meet the global demand for HPV vaccines and boost coverage for both girls and boys globally.

Sharma H, Parekh S, Pujari P, Shewale S, Desai S, Bhatla N, et al. Immunogenicity and safety of a new quadrivalent HPV vaccine in girls and boys aged 914 years versus an established quadrivalent HPV vaccine in women aged 1526 years in India: a randomised, active-controlled, multicentre, phase 2/3 trial Lancet Oncol, Published online 7 November 2023; https://doi.org/10.1016/S1470-2045(23)00480-1

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Immunogenicity and safety of a new quadrivalent HPV vaccine in ... - IARC

Kuehne+Nagel announced that it has executed a unique operation in September 2023, similar to what is called a milk run, to deliver 150 pallets of flu vaccines directly to over 40 Veterans Affairs (VA) hospitals across the United States within less than five days, with the expertise of its road logistics team.

It was an average Monday afternoon in September at our North American headquarters in Jersey City, NJ, when Tomas Salomoni, Ed Penafiel, and Tony Camacho, of Kuehne+Nagels Road Logistics team received a call from a long-time, well-known, pharmaceutical customer that needed special support, reads the release.

For this, the K+N team used a multi-stop lane, according to the geography/distance to optimize equipment utilization and reduce the overall cost.

By early Wednesday morning, within 36 hours of the initial customer call, the Road Logistics team had arranged for three different carriers to pick up over 150 pallets of vaccines from 14 locations across Georgia, Nevada, and Pennsylvania. The vaccines were transported in 14 temperature-controlled trucks to ensure their safekeeping during the journey.

By Friday afternoon, Kuehne+Nagel had made 42 deliveries across 20 states, providing flu shots to over half a million military veterans and their families across the United States.

It reads, Thanks to the extraordinary teamwork and expertise of the Road Logistics team here at Kuehne+Nagel, this seemingly impossible task was accomplished, and many VA hospitals were able to receive the flu vaccines they needed.

As Veterans Day is upon us, we are especially proud of the teamwork and collaboration to achieve this complex and challenging solution for our customer in support of these everyday heroes, said Joachim Goller, regional road logistics manager, Kuehne+Nagel North America. As more than 15 percent of the population in the United States are veterans, and these VA hospitals serve the entire country, we could not be prouder to have stepped up, and supported this important effort, which we know will make a difference in the lives of veterans and their families. This successful delivery proudly coincides with Veterans Day, so a huge shout out to the Road Logistics team for stepping up, taking on this extremely complex operation and making this happen in support of our veterans.

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K+N US team moves flu vaccine for half a million veterans, families - STAT Times

Prince Edward Island

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Posted: November 17, 2023

Charlottetown-based pharmaceutical company BioVectra isgetting ready to open up new facilities in P.E.I. and Nova Scotia as part of a $90-million expansion.

The new facilities include one of Canada's first mRNA vaccine biomanufacturingcentres in Charlottetown. There is also a new biologicsfermentation suite in Windsor, N.S., and development laboratories in both provinces.

The P.E.I. and federal governments helped fund the expansion.

"It's a day of celebration. It's a day of pride for all of us,"said CEO Oliver Technow.

"Our aim is to be able to supply all Canadians with mRNA therapeutics when they need them."

CBCNews was given an early tour of the vaccine and biomanufacturing centre. It's a large additionwhich is attachedtoexisting buildings near the Charlottetown Airport.

BioVectrasays the facility will be unlike any other in the country.

The new centre includes high-tech equipment. That includes two large robotic "filling isolators" worth $4 million each that fill up vaccine vials and cap themwithout any human hands touching the product until it's sealed.

The machines can fill 100 vials at a time, all within minutes.

Bryan Lowery is vice-presidentof the manufacturing centre. He said the machines willallowmedicationsto stay under sterile conditions.

"It's acomputerized robotic system with two or three motorized arms on the inside of the unit itself," Lowery said. "They actually do all the movements ... that normally a human would be doing."

Lowery said these are the first robotic filling units he's seen after working in the industry for more than a decade.

"It's, I believe, the direction the industry is going," he said.

The centre also has a large production fermenter which helps grow cells that will eventually be used formedicinalingredients in therapies.

There are also extensivepurification suite areasto ensure steriledrug products.

Lowery said it's exciting to have breakthrough technology on-site.

"It's a huge step forward for the company," he said.

Technowsaid a big part of what the company does is to partner with others in the biotech and pharmaceutical industry to help themproduce their products in large quantities.

He said that when the COVID-19 pandemic hit, Canada was caught in a situation where it had to rely on other jurisdictions for vaccines.

"Now, we are the first company in Canada that can actually respond to a future health crisis," he said. "We have the manufacturing domestically to supply these therapies and medicines to Canadians when the time comes."

The CEO said themRNAplatformis a very efficient and safe way to improve people's health.

He said BioVectra is not just looking at vaccines needed for future pandemics, but alsofor products used to treatsevere conditions likecancer, and neurological and cardiovascular diseases.

"We will work on a number of new products and new indications that hopefully will help eradicate certain diseases that we currently have no therapies for," he said.

"There's a lot of research underway to tackle diseases in the oncology space as well as the neuroscience space."

The company said there is a lot of demand for the facility already.Technow said confidentiality agreements prevent BioVectra from mentioning exact names of companies, but that it'salready been working with more than a hundredinternational companies.

He said the new facilities are a "big deal."

"What we do here, nobody else can do in Canada," Technow said.

The company expectsto hire another 125 peoplein Atlantic Canada with the expansions. That's on top of about 650 positions that exist already.

The facility is close to being ready. BioVectrawill hold a grand opening, and then the buildings will essentially be sealed up, off-limits tothe general public.

The industry is heavily regulated. There are a number of steps to validate equipment and processes.

BioVectrawill likely work on some clinical trials at first,but the company expects to start having the products it manufactures at the new centreused on a wider scale by next summer.

BioVectra has seven facilities in Atlantic Canada, five of which are in Charlottetown.

Laura Meader is a video journalist for CBC P.E.I.

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BioVectra opening new mRNA vaccine manufacturing facility in P.E.I. as part of $90M expansion - CBC.ca

Human papillomavirus (HPV) vaccines are unique in the world of routine immunization due to their timing. Many vaccines are given to young children, but HPV vaccination occurs at adolescence, when pediatric visits are no longer routine. As HPV vaccine delivery strategies to reach this population vary by country, so does program cost.

PATH recently worked with immunization program managers on astudy to assess operational context and estimate ongoing costs of HPV vaccine delivery(excluding the cost of vaccines and supplies) beyond the introduction years. The study generated evidence on delivering a two-dose HPV vaccination schedule insix countries: Ethiopia, Guyana, Rwanda, Senegal, Sri Lanka, and Uganda.

The results, described below and recently published in the journalVaccine, shed light on the operational context and costs per HPV vaccine dose delivered. They point to key opportunities that policymakers may wish to consider for greater cost efficiencies, particularly as programs seek to rebuild and accelerate coverage after the acute phase of the COVID-19 pandemic.

HPV vaccine delivery cost per dose varied widely across the study countries based on operational context (frequency and intensity of program implementation activities in each country) and service volume (number of doses delivered).

All immunization programs conduct ongoing activities, such as program planning and management, social mobilization, crisis management, and vaccine distribution and storage. "For HPV vaccination program activities, varying levels of engagement in these activities were apparent within and across countries, depending on context," said Rose Slavkovsky, MPA, health economics program officer at PATH and one of the study authors. "For example, training and crisis management activities were at lower intensities in Rwanda, the longest-running HPV vaccination program in this study sample. Conversely, sustained levels of social mobilization and program planning were apparent in several study countries."

Varied service delivery intensity also contributed to differences in cost estimates across countries. Service volume was important because a lower number of doses delivered per health facility meant a higher cost per dose. The average number of doses delivered per health facility varied by country, as did the frequency of conducting HPV vaccination sessions and other program activities (fixed time points in Ethiopia versus year-round vaccination in Senegal, for example).

Despite the differences among the study countries, there were a couple notable trends. Activities and expenditures at health facilities contributed the largest proportion of the economic cost per dose (see figure below).

Additionally, the largest proportion of costs were opportunity costs. Separate from financial costs that measure direct expenditures, opportunity costs measure the value of existing resources (sometimes shared with other health programs) used by the HPV vaccination program. Of these, health worker and non-health worker time were the largest cost category across study countries, regardless of operational context. Direct expenditures accounted for a smaller share of the delivery costs.

When more doses are delivered, resources are spread over a larger denominator, contributing to a lower cost per dose. A strategy to increase the number of doses delivered could include concurrently vaccinating multiple cohorts. Additionally, adopting asingle-dose vaccination schedule, endorsed in December 2022 by the World Health Organization as an alternative to the current two-dose schedule evaluated in this study, could reduce the delivery cost per fully vaccinated child.

The study team used data from five of the six study countries to model the potential cost implications of implementing this single-dose schedule. This modeling analysis found that, although the estimated financial costs per dose for HPV vaccine delivery could increase because of the smaller number of doses delivered, the financial costper fully vaccinated childcould decrease by nearly half (excluding the cost of vaccine).

Economic cost, which is the sum of both financial and opportunity costs, also decreases significantly per fully vaccinated child on a single-dose schedule.

Studies such as this one demonstrate how improving our understanding of the operational context and costs of vaccine delivery can help improve or reaffirm current strategies in not just the study countries, but other low- and middle-income countries (LMICs) as well. Cervical cancer is still a leading cause of cancer in women in LMICs, but widespread access to HPV vaccines would dramatically reduce the number of cases.

"The potential impact of more widespread HPV vaccine access on the health of women and girls is profound," said Mercy Mvundura, PhD, health economics technical advisor at PATH and study lead. "Our hope is that these study findings will inform planning and decision-making to revitalize cancer-preventing HPV vaccination programs, especially as health systems recover from COVID-related interruptions."

This article was originally published by PATH on 13 November 2023.

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What can we learn from HPV vaccine delivery costs? - Gavi, the Vaccine Alliance

The Joint Committee on Vaccination and Immunisation (JCVI) has advised the UK government that meningococcal B (MenB) vaccines should be routinely offered to prevent gonorrhoea by targeting the people at greatest risk.1

Evidence indicates that, even with a modest vaccine effectiveness against gonorrhoea of 32.7-42.0%, rolling out the 4CMenB vaccine to groups with the highest risk could prevent many cases, said the committee. Because infection with the Neisseria gonorrhoeae bacterium does not protect against future infection, many people are commonly reinfected.

Andrew Pollard, JCVI chair, said that

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Routinely offer MenB jabs to prevent gonorrhoea, UK vaccine ... - The BMJ

For 10 days after the first dose, Jamie was fine. He went home and went about his normal life. Then, on the morning of May 3, his and the familys life fell apart. Kate recalls what happened next. Jamie complained of tiredness and Kate let him sleep in, taking the boys downstairs for breakfast. An hour later, he vomited, recalls Kate. The noise of his retching was unlike anything she had ever heard. It sounded different. I came upstairs to check on him. At this point his speech was impaired. I thought he was having a stroke. He just wasnt speaking a language and he didnt know where he was or who I was.

An ambulance was called, taking Jamie to the local hospital where physicians there diagnosed a suspected case of Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT). Their quick thinking helped to save Jamies life. The hospital knew it was too small and did not have the expertise to treat Jamie and, as he threatened to slip away, another ambulance took him to Coventry hospital.

His condition continued to deteriorate. Despite the Covid restrictions in place at the time, Jamies father was summoned to his bedside along with Kate, who was keeping vigil. By this time he was non-communicative and didnt know who I was, says Kate.

The situation was now desperate. Coventry hospital summoned an air ambulance to get Jamie to Birmingham for an emergency operation at the one hospital in the region with the expertise to carry it out. But a storm prevented the helicopter from flying and Jamie was rushed there by road instead. Queen Elizabeth Hospital in Birmingham was the third hospital to treat Jamie in the course of just one day. Doctors there would keep him alive.

Jamie was in surgery for three hours for what was a catastrophic bleed on the brain. An MRI scan showed the damage to an area of the brain 97mm by 47mm, almost four inches by almost two inches. It is equivalent to about the area of a credit card. That now is dead tissue, says Kate.

The reason this was so complicated to treat and the reason Jamie is lucky to be alive is this had never happened before. It [VITT] didnt exist. It is why she knows the vaccine was responsible for Jamies near death; why it was the cause of the bleed on the brain. The vaccine had caused both a massive clot at the entrance to the brain and a bleed on the inside. Treating the clot risked worsening the bleed, says Kate.

Jamie underwent a craniotomy, removing part of his skull to reduce the swelling. For the next four weeks and five days he was in a coma on a ventilator and with a tracheotomy put in his throat. Through the whole terrifying time, Kate was largely refused permission to see her husband because of strict Covid regulations inside the intensive care unit. Their children, at the time aged four and eight months, did not see their father for four months. Only the previous month, Downing Street staffers had been enjoying illegal parties inside the seat of power, including one on the eve of the Duke of Edinburghs funeral.

Kate saw her husband when the hospital was fairly sure he was dying. Three times I was called in to say goodbye; three times I was called in because they thought he wasnt going to make it, says Kate. But the boys didnt see him for 122 days. For them their dad just disappeared. He couldnt communicate and he couldnt Facetime. He was just gone. That was so hard.

Kate was persistent and in the end negotiated with the hospital authorities that she could visit Jamie for an hour each week. I was luckier than others, she says with an optimism born out of extreme hardship. Jamie is a medical miracle. If you see the damage on the MRI scan you can understand that.

Kate admits it is both hard and sad to talk about what happened to Jamie. She does a lot of talking for him. I still get goosebumps. He was my perfect partner, he was the perfect date. The hardest thing for Jamie now is he is not able to be that same dad and husband. We have two boys who are energetic. They love playing football and climbing trees and Jamie cant do that anymore. He remembers that he could. He has that constant internal battle with himself, knowing what life was like before and knowing his limitations and understanding he cant do anything about that because of the size of the bleed.

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'We were told the vaccine was safe - but what happened has been life-changing' - The Telegraph

A BMJ investigation has raised concerns that the VAERS system isnt operating as intended and that signals are being missed. Jennifer Block reports

Three weeks after receiving a second dose of a covid vaccine, Robert Sullivan collapsed at home on his treadmill. An anaesthesiologist in Maryland, USA, he was a particularly fit 49 year old: the week before falling ill, hed been happily skiing at altitude in Colorado.

Sullivan was given a diagnosis of sudden onset pulmonary hypertension, which is generally progressive, can be fatal, and in most cases cant be cured. The condition is rare, especially in middle aged men. Sullivan decided to file a report in the Vaccine Adverse Event Reporting System (VAERS), which collects reports of symptoms, diagnoses, hospital admissions, and deaths after vaccination for the purpose of capturing post-market safety signals.

But the submission process was a glitchy race against the clock. The format is cumbersome and it times you out, he tells The BMJ. For his troubles, Sullivan received a confirmation by email and a temporary e-report number. He learnt from his doctors office that a VAERS representative had requested medical records. Then he didnt hear back for a year.

VAERS is supposed to be user friendly, responsive, and transparent. However, investigations by The BMJ have uncovered that its not meeting its own standards. Not only have staffing levels failed to keep pace with the unprecedented number of reports since the rollout of covid vaccines but there are signs that the system is overwhelmed, reports arent being followed up, and signals are being missed.

The BMJ has spoken to more than a dozen people, including physicians and a state medical examiner, who have filed VAERS reports of a serious nature on behalf of themselves or patients and were never contacted by clinical reviewers or were contacted months later.

Our investigation has also found that, in stark contrast to the US governments handling of adverse reaction reports on drugs and devices, the publicly accessible VAERS database on vaccines includes only initial reports, while case updates and corrections are kept on a separate, back end system. Officials told The BMJ that this was to protect patient confidentialitybut this means that patients, doctors, and other public users of the database have access only to an incomplete and uncorrected version.

Co-managed by the US Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration, the VAERS reporting system relies on a mixture of voluntary adverse event reports from doctors and patients and mandatory reporting from vaccine manufacturers, which are required by law to report all adverse events they become aware of.

Good pharmacovigilance requires prompt data collection, review by people with clinical expertise, and adequate follow-up, says Marie Lindquist, former director of the Uppsala Monitoring Centre in Sweden, an internationally recognised non-profit pharmacovigilance body. We know that even the best clinical trials wont detect [rare adverse events], she tells The BMJ.

VAERSs standard operating procedure for covid-19 states that reports must be processed quickly, within days of receipt.12 Serious reports trigger the requisition of medical records and at minimum a manual review, while deaths and other adverse events of special interest may undergo a more in-depth clinical review by CDC staff.

However, The BMJ has learnt that in the face of an unprecedented 1.7 million reports since the rollout of covid vaccines, VAERSs staffing was likely not commensurate with the demands of reviewing the serious reports submitted, including reports of death. While other countries have acknowledged deaths that were likely or probably related to mRNA vaccination, the CDCwhich says that it has reviewed nearly 20000 preliminary reports of death using VAERS (far more than other countries)has not acknowledged a single death linked to mRNA vaccines.

Before the pandemic VAERS was receiving nearly 60000 adverse event reports each year. A 2015 CDC article suggests that the agency had the capacity to request records for just a few thousand serious reports each year.3 But in 2021 the total number of reports shot up to a million, and another 660000 have been filed since. Nearly one in five meet the criteria of serious. This surge reflects the unprecedented campaign to vaccinate against covid-19in the US alone some 675 million doses have been administeredand the vast majority of recent reports are related to covid vaccines. The CDC states that, in the event of a significant increase in VAERS reports warranting clinical review, the standard operating procedure requires additional CDC Immunization Safety Office staff to process cases.12

Freedom of Information Act documents seen by The BMJ suggest that Pfizer has around 1000 more full time employees working on vaccine surveillance than the CDC, despite the latters responsibility for handling adverse event reports on all products. The CDC didnt provide The BMJ with specific numbers, instead stating that its staffing reflects the needs of the office at any given time and can range from several dozen to hundreds, including contractors and individuals reassigned from across the agency. The latest confirmed number of staff, as of November 2022at the Immunization Safety Office, which houses VAERSis 70-80 full time equivalent workers.

In comparison, a February 2021 Pfizer analysis of adverse event reports showed that the company had onboarded 600 additional full time employees to handle the volume and planned to employ a total of 1800.4 Pfizer didnt respond to The BMJs requests for information on current staffing.

Interviews with more than a dozen VAERS users by The BMJall of whom were trying to file reports of a serious naturerevealed a patchy and frustrating experience. Some users heard back from clinical reviewers months after making their first report, while others never heard anything. Some of those making reports were told conflicting information about updating their report or were discouraged from making a report altogether.

Those people include Patrick Whelan, a rheumatologist and researcher at the University of California Los Angeles, who in 2022 reported how one of his patients, a 7 year old boy, had a cardiac arrest after covid vaccination. The patient was intubated when Whelan filed a VAERS report, and he expected a prompt follow-up call from a CDC investigator.

I assumed that, since it was a catastrophic event, the safety committee would want to hear about it right away, he says. But, to his knowledge, nobody called or requested medical records. In an email sent to Whelan months later the FDA said that it had followed up soon after receiving his report and had made several requests for medical records. The agency added, Generally speaking, staff might not reach out to providers unless they have specific questions about a case or a VAERS report.

James Gill has been a medical examiner and forensic pathologist for 25 years and is currently chief medical examiner for the state of Connecticut. In June 2021 he made the first VAERS report of his career. It was for a 15 year old boy who died suddenly days after getting a second jabwhat Gill concluded on autopsy was stress cardiomyopathy following second dose of the Pfizer-BioNTech covid-19 vaccine.567

Gill, who has appointments at Yale University and the University of Connecticut, cant recall getting any calls from VAERS after he filled out the online form, and he still has only a temporary e-report number. After he published the case reports in the Archives of Pathology & Laboratory Medicine in February 2022, however, the CDC did respondin the form of a letter to the editor contesting Gills findings.567

In November 2022, React19, an advocacy group of some 30000 people who have experienced prolonged illness after covid vaccination, reviewed 126 VAERS reports among its ranks. In its audit, which was conducted by volunteers inside and outside the organisation, 22% had never been given a permanent VAERS ID number and 12% had disappeared from the system entirelyin other words, one in three of the reports they looked for didnt show up in the publicly searchable database.8

A week after Whelan filed the VAERS report for his young patient in Los Angeles, he had cause to update it. The boys condition didnt improve, and the decision was made to terminate life support. But there was no mechanism for [updating] it, he tells The BMJ. The only option I had was to make a new VAERS report.

Three weeks later he met with the FDA in his capacity as a researcher to discuss a forthcoming paper, and without having planned to he mentioned the case and the lack of follow-up. Nair reached out by email the next day, and six weeks later Whelan discussed the case with Nair and a press officer for around 35 minutes.

Today, however, that VAERS report still shows the child as having been admitted to hospital. I made the false assumption that that conversation would result in an adjustment in the publicly reported case, says Whelan. Think of all the people who are using VAERS data as a means to assess whats happening with the vaccinesexcept in this case youd be left with the false impression that the child had had a serious adverse event, rather than seeing that hed died.

The BMJ has found that the FDA and CDC essentially maintain two separate VAERS databases: a public facing database, containing only initial reports; and a private, back end system containing all updates and correctionssuch as a formal diagnosis, recovery, or death.

In December last year Nair explained the situation at a meeting with advocates. He said, Theres two parts to VAERS, the front end system and the back end . . . Anything derived from medical records by law cant be posted on the public facing system. The CDC has told The BMJ that protecting patient confidentiality is a priority.

Interestingly, the FDA Adverse Event Reporting System (FAERS), which collects reports on drugs, does maintain a publicly accessible database that gets updated, as does the agencys Medical Device Reporting systemraising the question of why VAERS cant do the same. Neither the CDC nor the FDA provided an explanation. An FDA spokesperson told The BMJ that patients can submit formal requests under FOIA [Freedom of Information Act] to obtain the full record of their report.

For serious cases, reporters to VAERS are supposed to receive emails prompting them to provide updates. These emails include a code and upload link, but the reporters The BMJ spoke to didnt get confirmation emails, and if they searched for their report in the database it remained unchanged. Similarly, if a reporter successfully treated a diagnosis and the patient improved, or if they confirmed that the cause of the illness was unrelated to a vaccine, this wouldnt be reflected in the public database.

Nair acknowledged in a meeting with advocates that people get frustrated when they look for an updated report, find the original untouched, and feel ignored. He said, They never see it on the front end, because we dont alter that initial report.

Pharmacovigilance has been effective in alerting the public to unusual, acute reactions, even when based on few reports. For example, it took just six VAERS reports of thrombosis with thrombocytopenia syndrome after administration of the Janssen covid vaccine for regulators to issue a pause in April 2021.9

Ralph Edwards, former director of the Uppsala Monitoring Centre and until recently editor in chief of the International Journal of Risk & Safety in Medicine, explains that monitoring systems such as VAERS excel at detecting adverse reactions that occur very soon after vaccination or are known from other vaccines, such as anaphylaxis or Guillain-Barr syndrome. But detecting new and unusual reactions, especially those with latent effects, has been an ongoing challenge in the world of pharmacovigilance.

Edwards tells The BMJ, If something hasnt been heard of before, it tends to be ignored. He explains that regulators may be relying too heavily on epidemiological evidence to acknowledge a signal. VAERS alone is unlikely to capture such long term adverse outcomes unless reports are regularly updated and reviewers are closely following such casesa real catch 22, he says. Youll never get the evidence unless you have the idea to look for it in the first place.

Addressing an October 2021 meeting, Helen said that most doctors were only willing to talk about the FDA recognised vaccine adverse events. She asked the FDA to alert doctors to potential adverse neurological reactions, as had been done with myocarditis. But more than once the FDAs Peter Marks expressed confusion about why it would matter to doctors whether or not regulators acknowledged that a condition might be related to the vaccine. Arent they treating whats in front of them? he asked.

However, Svetlana Blitshteyn, a neurologist and researcher at the University at Buffalo, New York, who has been treating postural orthostatic tachycardia syndrome for around 20 years and has seen the condition present after vaccination, tells The BMJ that if physicians arent educated to look for the condition theyre unlikely to test for it or know how to treat it.

Helen is calling for an end to the negative feedback loop . . . the FDA is not naming additional adverse reactions to the vaccines because the passive surveillance systems arent displaying it. But the passive surveillance systems arent displaying it because physicians are blinded to the adverse reactions in their patients, and thus arent reporting them.

The European Union, for its part, has added hypoaesthesia and paraesthesia (reduced or abnormal sensation in the skin such as numbness, tingling, or burning) to the labelling on mRNA covid vaccinesbased on around 21000 cases reported by August 2021as well as including heavy menstrual bleeding.1011 Japan has also added paraesthesia and hypoaesthesia.

Harlan Krumholz, a cardiologist and researcher at Yale, has been recruiting members of React19 to study their reactions.12 We are working hard to understand the experience, clinical course, and potential mechanisms of the ailments reported by those who have had severe symptoms arise soon after the vaccination, he tells The BMJ. There are so many people whose lives have been changed dramaticallybut what I dont know is how many or why.

This feature has been funded by the BMJ Investigations Unit. For details see bmj.com/investigations

Competing interests: I have read and understood BMJ policy on declaration of interests and have no relevant interests to declare.

Provenance and peer review: Commissioned; externally peer reviewed.

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Is the US's Vaccine Adverse Event Reporting System broken? - The BMJ

The legal action being brought against AstraZeneca over the side-effects of its Covid vaccine challenges the usual narrative surrounding the UKs inoculation programme. The drug was developed in Oxford and hailed as a triumph for British scientific endeavour.

However, scores of people have either died or been left disabled by brain injuries caused by the vaccine. The High Court is to hear two test cases for damages over a new condition known as Vaccine-induced Immune Thrombocytopenia and Thrombosis (VITT).

The vaccines role has been largely acknowledged and sums paid out under the Vaccine Compensation Scheme. But the families say the 120,000 tax-free payment is not enough to compensate for loss of a bread-winner or the ability to work.

The claim maintains that the AstraZeneca vaccine was defective in that it was not as safe as individuals were entitled to expect. However, this should not detract from the signal success of the vaccination programme which is credited with saving millions of lives. Adverse effects, while tragic for some, were extremely rare and not confined to Covid jabs.

People know that there are risks and side effects associated with most medicines, which always need to be balanced against the benefits of taking them. Furthermore, it is important that this does not play into the hands of those who seek to tarnish all vaccines.

One lesson to be learnt it is that young, healthy people should not have been forced, through restrictions on their movements, to be vaccinated against a disease that hardly affected them.

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A lesson learnt on vaccine harms - The Telegraph

The U.S. Food and Drug Administration (FDA) on Thursday announced its approval of Ixchiq, the first chikungunya vaccine.

The vaccine, which is made by Valneva, is approved for anyone age 18 and older who has a risk of being exposed to the virus.

The chikungunya virus is transmitted to people through bites from infected mosquitoes.

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"This virus is in a similar category as dengue or Zika and is carried by the same mosquitoes," noted Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor.

The FDA described chikungunya as an "emerging global health threat," with at least five million cases reported over the past 15 years.

The chikungunya virus is transmitted to people through bites from infected mosquitoes. The FDA called chikungunya an "emerging global health threat." (iStock)

"Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions," said Peter Marks, M.D., PhD, director of the FDAs Center for Biologics Evaluation and Research, in a press release on Thursday.

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"Todays approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options," he also said.

Before the FDAs approval, the vaccines safety was tested in clinical trials that included 3,500 adults.

The Ixchiq vaccine is a single-dose injection that contains a weakened form of the virus. (REUTERS/Emily Elconin/File photo)

Participants most commonly reported headache, muscle pain, fatigue, joint pain, nausea, fever and tenderness at the injection site as side effects.

A small share of recipients (1.6%) experienced adverse reactions, with two of the recipients needing to be hospitalized, per the FDAs release.

In a separate study, the vaccines efficacy was measured based on the immune response data of 266 adult participants.

Almost all of them were shown to have protective antibody levels.

The most common symptoms are fever and joint pain, with some people also experiencing headache, muscle pain, joint swelling or rash, according to the Centers for Disease Control and Prevention (CDC).

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Symptoms usually begin within three to seven days after transmission.

Most people who contract the virus get better within a week.

In rare cases, the virus can cause severe and long-lasting joint pain.

Signage is seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on Aug. 29, 2020. The agency on Thursday announced its approval of Ixchiq, the first chikungunya vaccine. (REUTERS/Andrew Kelly/File Photo)

Those at highest risk for adverse health effects include older adults, newborns who contract the infection at birth, and people with heart disease, diabetes or high blood pressure, per the CDC.

Deaths from the virus are very rare.

Mosquitoes carrying the chikungunya virus are endemic in Africa, Southeast Asia and parts of the Americas, the FDA stated in its release.

Before 2013, cases of the chikungunya virus were primarily documented in Africa, Asia, Europe, and the Indian and Pacific Oceans.

DENGUE FEVER: WHAT YOU NEED TO KNOW ABOUT THE MOSQUITO-BORNE ILLNESS SWEEPING JAMAICA

In late 2013, the first local cases were documented in Caribbean countries, which then led to the virus spreading throughout the Americas, the CDC stated.

For those who have been exposed and have symptoms, a blood test can confirm the presence of chikungunya or other similar viruses.

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People who are infected and experience symptoms should rest, stay hydrated with fluids and take over-the-counter medications, such as acetaminophen or paracetamol, to relieve and reduce fever, according to the CDC.

People who are traveling to countries where the virus is prevalent can reduce their risk by using insect repellent, wearing long-sleeved shirts and pants, and staying indoors or in screened areas.

People who are traveling to countries where the virus is prevalent can reduce their risk by using insect repellent, wearing long-sleeved shirts and pants, and staying indoors or in screened areas. (iStock)

Siegel noted that the vaccine which he deems "safe and effective" contains a live weakened version of the virus vaccine.

"That means it is not intended for [the] immunocompromised, but it is useful for those at risk of severe cases of chikungunya," he told Fox News Digital.

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Added the doctor, "The vaccine is being fast-tracked, which for me means I would give it to those most at risk first, while watching post-marketing studies over next year."

For more Health articles, visit http://www.foxnews.com/health.

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First vaccine for chikungunya virus, an 'emerging global health threat,' gets FDA approval - Fox News