UofL Health marks 3-years after first staff members receive COVID-19 vaccine
Updated: 5:19 PM EST Dec 14, 2023
It's been three years since the first people in Kentucky received the COVID-19 vaccine.On Dec. 14, 2020, UofL Health's Chief Medical Officer Jason Smith and four of his colleagues received their first dose of the Pfizer vaccine. At that time, the hospital system was treating hundreds of patients for the coronavirus.The arrival of the vaccine demonstrated the best of medicine and our commonwealths collaborative spirit, Smith said. For the first time, we had a tool to minimize the spread of COVID-19 in a significant way.Since then, UofL Health has administered more than 170,000 doses of the vaccine, including first, second, third and fourth shots. UofL Health currently has 30 patients who have COVID-19, four of whom are in the intensive care unit.
It's been three years since the first people in Kentucky received the COVID-19 vaccine.
On Dec. 14, 2020, UofL Health's Chief Medical Officer Jason Smith and four of his colleagues received their first dose of the Pfizer vaccine.
At that time, the hospital system was treating hundreds of patients for the coronavirus.
The arrival of the vaccine demonstrated the best of medicine and our commonwealths collaborative spirit, Smith said. For the first time, we had a tool to minimize the spread of COVID-19 in a significant way.
Since then, UofL Health has administered more than 170,000 doses of the vaccine, including first, second, third and fourth shots.
UofL Health currently has 30 patients who have COVID-19, four of whom are in the intensive care unit.
The type of COVID-19 vaccine and the time interval between vaccination and PET/CT scans are key factors in minimizing false interpretations in cancer patients, according to research published December 9 in Scientific Reports.
The study is the first to examine systemic response changes in patients in correlation to time after COVID-19 vaccination using three different vaccines, and may help minimize dilemmas for clinicians, wrote first author Tina Nazerani-Zemann, MD, of the Medical University of Graz in Austria, and colleagues.
Different vaccines cause different system metabolic changes. The knowledge of vaccine type, the time interval between vaccination and PET/CT scan is essential, especially in therapy evaluation, the group noted.
Previous studies have shown that COVID-19 vaccines can cause axillary lymphadenopathy and that this may mimic activity typically associated with metastasis in oncologic patients, the authors explained.
As the vaccination program continues, we encountered increased F-18 FDG-activity not only in axillary lymph nodes ipsilateral to the injection site but also in other organs, the authors noted.
To further elucidate cancer patient reactions to COVID-19 vaccines, the authors aimed to show any systemic metabolic changes after vaccination with three different vaccines in relation to time.
The group collected data on 220 eligible vaccinated cancer patients (127 with the Pfizer-BioNTech vaccine, 61 with the Moderna, and 32 with AstraZeneca vaccines) who underwent F-18 FDG-PET/CT scans. Of these, 71 patients also underwent a pre-vaccination scan. Most of the patients (n=175 did not receive any therapy related to their diagnosis at the time of the PET/CT scan.
The researchers evaluated the exams from day 1 to day 135 after different vaccinations and compared the standardized uptake value (SUVmax) ratio of tracer activity of axillary lymph node to reference organs in all patients, with differences in tracer activity dynamics explored based on the three different vaccines.
A 73-year-old woman with a suspicious lung nodule was referred to our division for F-18 FDG PET/CT exam. She was vaccinated four days before PET/CT. The lung nodule did not show any pathological FDG uptake; however, high tracer activity was detected on her right arm, where she was injected, and multiple hypermetabolic lymph nodes in the right axilla (arrows). Moreover, PET/CT showed high tracer activity in the liver (black arrows), spleen (triangular arrows), and bone marrow (small triangular arrows) as the result of systemic immune response after vaccination. The tracer defect in the liver was due to the known cyst. (A) fusion scan, (B) PET, (C) maximum intensity projection. Image courtesy of Scientific Reports.
SUVmax of ipsilateral lymph node activity was slightly higher (mean, 3.00) in patients who received the Moderna vaccine than the BioNTech/ Pfizer-BioNTech (mean, 2.69) and AstraZeneca (mean, 2.61), according to the findings.
This FDG activity in axillary lymph nodes showed a steady decrease in all patients after Pfizer-BioNTech vaccinations. Ten days after vaccination, the FDG uptake was at its highest activity, and 70 days after vaccination, the FDG activity was not different from the background activity of the tracer in the axillary region, the researchers reported.
This result also applies to other two vaccines, the group wrote.
However, the authors highlighted several differences in terms of the timing of this activity. The highest peak of activity occurred in the fourth week for Moderna vaccinations and at the 10th day for AstraZeneca vaccinations.
Finally, the researchers noted that there was no significant changes of FDG tracer activity in other reference regions (the mediastinum, spleen, and bone marrow) between the three vaccinations.
Ultimately, numerous studies suggest increased activity in local sites and ipsilateral axillary lymph nodes in F-18 FDG PET/CT scans after COVID-19 vaccination, yet correctly interpreting these changes remains a challenge, the authors noted.
Our study underscores the significance of changes in 2-[F-18] FDG PET/CT scans in lymph nodes and reference organs after vaccination and highlights the importance of this information in the interpretation of PET/CT in vaccinated patients, the group concluded.
The full study is available here.
Dec. 14 (UPI) -- Healthcare providers throughout the United States are in for a rough winter if immunization rates against COVID-19 and other respiratory illnesses do not increase, the CDC warns.
The Centers for Disease Control and Prevention on Thursday warned healthcare providers of an "urgent need" to increase vaccination rates against COVID-19, influenza and respiratory syncytial virus (RSV).
According to the CDC, low vaccination rates and an ongoing increase of national and international cases could lead to an increased strain on the capacity of healthcare organizations in the coming weeks.
In the past four weeks, hospitalizations among all age groups increased 200% for influenza, 51% for COVID-19 and 60% for RSV, according to the CDC.
"Influenza, COVID-19 and RSV can result in severe disease, especially among unvaccinated persons," the organization said in a statement. "Infants, older adults, pregnant people and people with certain underlying medical conditions remain at increased risk of severe COVID-19 and influenza disease. Infants and older adults remain at highest risk of severe RSV disease; it is the leading cause of infant hospitalization in the United States."
COVID-19 vaccination rates are low this winter, with the CDC reporting 17.2% of adults having received the latest booster, along with 7.7% of children under 18 and 9.6% of pregnant people, as of Dec. 2.
Seasonal flu vaccination coverage is low across all age groups as well. As ofNov. 2 the CDC reported 7.4 million fewer doses administered to adults compared to the same time last year.
The CDC said key reasons for low vaccine uptake this year include lack of provider recommendation, concerns about unknown side effects, occurrences of mild side effects and lack of time or forgetting to get vaccinated.
The organization urged health care providers to administer influenza, COVID-19, and RSV immunizations now to patients, if recommended, and to use all available tools to increase immunization rates.
The CDC also recommended people take everyday preventive measures such as washing hands, covering coughs and sneezes, wearing a mask, and staying home when sick.
China has detected seven infections of the Covid subvariant JN.1, news agency Reuters has reported, citing the country's national disease control and prevention administration on Friday.
The authorities said the prevalence level of JN.1 is currently "very low" in the country, but added that it cannot rule out the possibility of it becoming the dominant strain in China due to factors including imported cases.
According to the US Centers for Disease Control and Prevention (CDC), JN.1, a variant of the virus that causes COVID-19, is a closely related offshoot of the variant BA.2.86.
As per the CDC, there is only a single change between JN.1 and BA.2.86 in the spike protein.
JN.1 was first detected in the United States in September 2023.
As of December 8, the public health agency of the United States projects that the variant JN.1 makes up between 1529% of the total cases in the United States.
(The) CDC projects that JN.1 will continue to increase as a proportion of SARS-CoV-2 genomic sequences. It is currently the fastest-growing variant in the United States, the public health agency of the US said.
According to a report in The Times of India, the new coronavirus variant was first detected in Kerala on December 13.
The latest data from the Indian SARS-CoV-2 Genomics Consortium (INSACOG) also confirmed its presence in Kerala.
National Indian Medical Association COVID Task Force's co-chairman Dr Rajeev Jayadevan said that JN.1 may be a contributing factor to the recent surge in India's Covid cases, which currently stands at 1,296.
As per the CDC, It is not currently known whether the JN.1 variant of coronavirus produces different symptoms from other variants. In general, the symptoms of COVID-19 tend to be similar across variants.
The types of symptoms and how severe they are usually depend more on a persons immunity and overall health rather than which variant causes the infection, the CDC said.
While the severity of JN.1 is yet to be figured, the US CDC has said that thecontinued growth of JN.1 suggests that it is either more transmissible or better at evading our immune systems.
At this time, there is no evidence that JN.1 presents an increased risk to public health relative to other currently circulating variants, it said. There is no indication of increased severity from JN.1 at this time. Updated COVID-19 vaccines are expected to increase protection against JN.1, as they do for other variants.
Follow the latest breaking news and developments from India and around the world with Hindustan Times' newsdesk. From politics and policies to the economy and the environment, from local issues to national events and global affairs, we've got you covered....view detail
Not enough Americans are being vaccinated against Covid, the flu and RSV to stem rising numbers of the respiratory illnesses, the Centers for Disease Control and Prevention said Thursday.
The agency issued a health alert to doctors across the country, warning that low vaccination rates amid "ongoing increases in national and international respiratory disease activity" could strain U.S. health care systems in the coming weeks, and called on doctors to encourage their patients to get the shots immediately to protect them for the remainder of the season.
"In the past 4 weeks, hospitalizations among all age groups increased by200% for influenza,51% for Covid-19, and60% for RSV," the CDC said in its health alert. "Currently, the highest respiratory disease activity in the United States is occurring across the southern half of the country, with increasing activity in northern states."
As of Dec. 8, just 17.2% of adults had received the updated Covid shot, according to the CDC. About 40% of children and adults have gotten this year's flu shot. And 15.9% of older adults eligible for the RSV vaccine have received it.
The warning comes as illnesses are increasing among children including an apparent uptick in a rare Covid-related complication called MIS-C, the CDC said. Cases had appeared to drop in recent years.
But from September to mid-December, the CDC received 30 such reports in kids, reflecting a "relative increase" compared with previous months.
RSV is also surging as a key drug in helping to keep babies safe from the virus has been in short supply.
Doctors should not hoard the few doses they have of the drug, called Beyfortus, the CDC said, and instead give all they can now, rather than wait for the situation to possibly worsen later this season. The CDC recommends Beyfortus for babies and toddlers up to 19 months old.
On Thursday, the Biden administration announced that it had worked with drug companies to release an additional 230,000 doses of the drug, expected in January.
The flu is also affecting children: So far this season, 12 children have died, the CDC has reported.
Emergency room visits for cases of pneumonia in children have also increased since September, the CDC said, though the number of those illnesses is what would normally be expected during cold and flu season, and is no more severe than usual.
According to the CDC, everyone 6 months and older should get the flu and Covid vaccines. Some people, depending on their previous vaccination status or health, might need two shots this season.
Research shows that it is safe to get both shots at the same time.
New this year, people age 60 and older have access to a vaccine to help prevent RSV. The vaccine is also recommended for women in a specific window of pregnancy: 32 through 36 weeks gestation.
People can find where Covid and flu vaccines are available near them at Vaccines.gov.
Erika Edwards is a health and medical news writer and reporter for NBC News and "TODAY."
A vaccine shows promising results in treating the most deadly form of skin cancer, Moderna and Merck announced on Thursday.
Those with severe melanomas who received the vaccine and Merck's cancer drug Keytruda were 49% less likely to die or have their cancer come back after three years than those who were given only Keytruda, the biotech companies said in a news release.
The findings are based on an ongoing randomized trial involving 157 patients with high-risk stage III/IV melanoma who first had surgery to completely remove cancerous growths. Patients received one milligram of the mRNA vaccine every three weeks for nine doses, and 200 milligrams of Keytruda every three weeks for about a year versus Keytruda alone for approximately a year.
The companies have begun Phase 3 trials of mRNA-4157 with Keytruda for people with stage III and IV melanoma. The Food and Drug Administration earlier this year designated the treatment as a breakthrough therapy in order to expedite the development and review of drugs meant to treat life-threatening diseases.
click to expand
"We look forward to sharing these data with people impacted by the disease and the broader scientific community," Kyle Holen, M.D., Moderna's senior vice president and head of development, therapeutics and oncology, stated.
The results are a vindication of sorts for Moderna's strategy to develop new uses for messenger RNA technology used in its COVID-19 vaccine. Cambridge, Massachusetts-based Moderna said in November it anticipates a steep decline in revenue next year, fueling worries about its capacity to finance multiple product launches planned for 2024 and 2025.
Skin cancer is the most common form of cancer, with melanoma accounting for only about 1% of skin cancer cases in the U.S. That said, it causes a large majority of skin cancer deaths, according to the American Cancer Society. It estimates about 97,610 new melanomas will be diagnosed in the U.S. this year, resulting in 7,990 deaths.
Moderna's stock has cratered this year, falling 50%. On Thursday, its shares shot up 12% in mid-day trading to $87.93.
Rahway, New Jersey-based Merck shares treaded water, down 0.2% at $106.16.
Kate Gibson is a reporter for CBS MoneyWatch in New York.
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When we gave the vaccine directly to the lung, we saw a dramatic improvement in ... immunity and protection in the lung itself and in the nose, leading to near complete protection against infection, said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and the senior author on the paper. Current vaccines raise antibodies in the blood, he said, but have a minimal effect in raising antibody and T-cell responses in the nose and the lungs where it really matters if you want to block infection.
The results, Barouch argues, provide a powerful proof of concept for the idea that future boosters should be delivered using a device similar to an asthma inhaler.
The paper is just the latest to suggest that it might be possible to block infections and build up a protective force field of immune cells in the nose and lungs by changing how we deliver vaccines. Last month, Chinese researchers published the results of a study in which researchers administered an inhaled vaccine to 11,000 people, demonstrating that the approach was both safe and more effective than an intramuscular shot, Barouch said. The vaccine is currently being rolled out on a large scale in China.
The idea of administering vaccines as nasal sprays also shows promise. In a paper recently posted to the open access preprint site BioRxiv, a team of researchers led by Dr. Robert Seder, chief of the cellular immunology section at the National Institute of Allergy and Infectious Diseases, showed they could boost the ability of monkeys to fight off infection by delivering a booster directly to the nose or lungs using both an FDA approved nose sprayer, or an FDA approved nebulizer.
After delivering the booster, Seders team waited five months before exposing the monkeys to the XBB strain, among the most highly transmissible variants. The immune response, he said, shut the virus down, far outperforming the animals boosted using an intramuscular injection. The study, he said, is under review at a peer-reviewed journal.
Dr. Peter Hotez, a vaccine expert who is dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said he welcomes more research into inhalers and nasal sprays, in part because they could increase booster uptake among those who are scared of needles.
But he disputed the idea that current boosters cant block infection. He pointed to early studies of the initial vaccines that found a significant number of virus-fighting immune cells present in the nose and throat. This small army of antibodies, he said, was able to prevent infection. But as the virus mutated and shape-shifted, the ability of those antibodies to elicit an effective immune attack waned.
Theres got to be a good match between the virus and the vaccine and if its not there, it doesnt matter what delivery system youre going to use, youre not going to stop asymptomatic infection, he said.
Seder disagrees with Hotezs suggestion that there is little advantage to applying the booster directly to the airways. When a booster is delivered through intramuscular injection, he agrees, some antibodies will eventually reach the lungs and nose. But the amount of antibodies present in the airwaves will be far higher if the booster is delivered directly to those areas of the body and since the proportion of those antibodies able to recognize the virus often wanes as it shapeshifts, those extra antibodies are needed.
Seders and Barouchs studies used either the Johnson & Johnson vaccine or similar ones based on an adenovirus. Using the approach with the existing mRNA vaccines would require new formulations stable enough to survive in the new environment, Barouch says. Seder said his group is actively working on the problem, as are a number of others.
Sprayed or inhaled vaccines are also among the areas of focus of Project NextGen, a $5 billion federal effort that aims to accelerate and streamline the development of next generation vaccines and treatments.
But a timeline for human trials remains unclear. Seder notes that mucosal vaccines will need to be tested extensively for safety. He added that the Indian company Bharat Biotech has administered a vaccine similar to the one used in the NIH study to large numbers of people in South Asia, though it did so by placing drops directly into the nose, rather than using the FDA-approved sprayer used in his study. Ocugen, Inc., a Pennsylvania-based biotechnology company, has licensed the technology used in the NIH trial, and a spokesperson said the company hopes to begin human safety trials next year.
Adam Piore can be reached at adam.piore@globe.com.
SciCheck Digest
Data from around the world support the general safety of the COVID-19 vaccines. Some people online, however, incorrectly claim that illegally obtained data from New Zealand show the vaccines have killed 13 million people worldwide. Experts say the analysis is bogus.
How safe are the COVID-19 vaccines?
More thanhalf a billion doses of COVID-19 vaccines have now been administered in the U.S. and only a few, very rare, safety concerns have emerged. The vast majority of people experience only minor, temporary side effects such as pain at the injection site, fatigue, headache, or muscle pain or no side effects at all. As the Centers for Disease Control and Prevention has said, these vaccines have undergone and will continue to undergo the most intensive safety monitoring in U.S. history.
A small number of severe allergic reactions known as anaphylaxis, which are expected with any vaccine, have occurred with the authorized and approved COVID-19 vaccines. Fortunately, these reactions are rare, typically occur within minutes of inoculation and can be treated. Approximately 5 per million people vaccinated have experienced anaphylaxis after a COVID-19 vaccine, accordingto the CDC.
To make sure serious allergic reactions can be identified and treated, all people receiving a vaccine should be observed for 15 minutes after getting a shot, and anyone who has experienced anaphylaxis or had any kind of immediate allergic reaction to any vaccine or injection in the past should be monitored for a half hour. People who have had a serious allergic reaction to a previous dose or one of the vaccine ingredients should not be immunized. Also, those who shouldnt receive one type of COVID-19 vaccine should be monitored for 30 minutes after receiving a different type of vaccine.
There is evidence that the Pfizer/BioNTech and Moderna mRNA vaccines may rarely cause inflammation of the heart muscle (myocarditis) or of the surrounding lining (pericarditis), particularly in male adolescents and young adults.
Based on data collected through August 2021, the reporting rates of either condition in the U.S. are highest in males 16 to 17 years old after the second dose (105.9 cases per million doses of the Pfizer/BioNTech vaccine), followed by 12- to 15-year-old males (70.7 cases per million). The rate for 18- to 24-year-old males was 52.4 cases and 56.3 cases per million doses of Pfizer/BioNTech and Moderna vaccines, respectively.
Health officials have emphasized that vaccine-related myocarditis and pericarditis cases are rare and the benefits of vaccination still outweigh the risks. Early evidence suggests these myocarditis cases are less severe than typical ones. The CDC has also noted that most patients who were treated responded well to medicine and rest and felt better quickly.
The Johnson & Johnson vaccine has been linked to anincreased risk of rare blood clots combined with low levels of blood platelets, especially in women ages 30to 49. Early symptoms of the condition, which is known as thrombosis with thrombocytopenia syndrome, or TTS, can appear as late as three weeks after vaccination andincludesevere or persistent headaches or blurred vision, leg swelling, and easy bruising or tiny blood spots under the skin outside of the injection site.
According to the CDC, TTS has occurred in around 4 people per million doses administered. As of early April,the syndrome has been confirmed in 60 cases, including nine deaths, after more than 18.6 million doses of the J&J vaccine. Although TTS remains rare, because of the availability of mRNA vaccines, which are not associated with this serious side effect, the FDA on May 5 limited authorized use of the J&J vaccine to adults who either couldnt get one of the other authorized or approved COVID-19 vaccines because of medical or access reasons, or only wanted a J&J vaccine for protection against the disease. Several months earlier, on Dec. 16, 2021,the CDC had recommended the Pfizer/BioNTech and Moderna shots over J&Js.
The J&J vaccine has also been linked to an increased risk of Guillain-Barr Syndrome, a rare disorder in which the immune system attacks nerve cells.Most peoplewho develop GBS fully recover, although some have permanent nerve damage and the condition can be fatal.
Safety surveillance data suggest that compared with the mRNA vaccines, which have not been linked to GBS, the J&J vaccine is associated with 15.5 additional GBS cases per million doses of vaccine in the three weeks following vaccination. Most reported cases following J&J vaccination have occurred in men 50 years old and older.
Link to this
Numerous studies have found the COVID-19 vaccines are quite safe, with only a few rare serious side effects. Theres nothing to support the notion that the COVID-19 vaccines are killing large numbers of people, as some people online have claimed for years. Despite the lack of evidence, the claims remain popular,revivedperiodicallybyvariouspseudoscientific analyses.
Most recently, Steve Kirsch, a tech entrepreneur who has become amajorsourceof COVID-19 vaccine misinformation, hasclaimedthat leaked data from the New Zealand government prove that the vaccines have killed on average 1 person for every 1,000 doses or when extrapolated to the entire world, about 13 million people.
There is no possible way that this data is consistent with a safe vaccine, Kirschwrotein his Substack.
Experts say this is wrong. Even if the underlying data are accurate, they cant be used to make causal claims about the vaccines,Jeffrey S. Morris, director of the division of biostatistics at the University of Pennsylvanias Perelman School of Medicine, told us. On top of that, he said, Kirschs methods areflawedand based on invalid assumptions and his interpretations run counter to existing evidence.
His methodology is extremely ad hoc and arbitrary and wrong in very specific ways, Morris said of Kirsch.
Kirsch debuted his claims in a Nov. 30presentationat the Massachusetts Institute of Technology, his alma mater, where he had been invited to speak by a student group. He also shared them in a Substack post, which has beensharedon social media. Others havepicked uphis claimsor circulated related claims about the New Zealand data online.
Adatabase administratoremployed by Te Whatu Ora, or Health New Zealand, illegally gave Kirsch the underlying data he uses in his analysis. On Nov. 30, the workerappeared in a videowith Liz Gunn, a New Zealander known for spreading conspiracy theories and her opposition to the COVID-19 vaccine, discussing the vaccine database information and making claims similar to Kirschs.
Soon after, the employee, a man named Barry Young, wasarrested and chargedfor his role in the data breach, according to the New Zealand Herald. Te Whatu Orasaidin a statement that there is no evidence whatsoever that vaccination is responsible for excess mortality in New Zealand, adding that Young has no clinical background or expert vaccine knowledge and that [w]hat he is claiming is completely wrong and ill-informed and his comments demonstrate this.
Te Whatu Ora was alsogranted an injunctionto remove any database information that remains online to protect peoples privacy. In his Substack, Kirsch had posted the data, which he said had been anonymized, andencouragedothersto download it to perform their own analyses. In some cases, people who have done so have had their file hosting accountssuspended.
Kirsch and others have tried to spin the arrest of the database administrator and subsequent removal of the data as evidence of government efforts tohidethe truth. But Morris said Kirsch was downplaying legitimate legal issues.
Its a very serious thing to share identified data, he said, adding that the information given to Kirsch had the birth dates of the individuals, the dates they got their vaccines, the dates they died, which could uniquely identify every single person.
Kirsch has argued that his sharing of the data is not a problem because it was anonymized, but its not necessarily clear yet whether the data contains any identifying information. Morris said he would have performed and presented his own analysis of the data, but did not feel comfortable doing so because of potential legal and privacy concerns.
There are multiple problems with Kirschs analysis that Morris andothershave noted, as well explain in more detail below. And tellingly, even many people who have spread misinformation about the COVID-19 vaccines before and believe the vaccines are killing people have pushed back on Kirschs claims.
But Morris also suggested looking atexcess death graphsfor New Zealand and other countries just to see whether Kirschs claims pass a basic sniff test and they do not.
In much of the world, spikes in excess deaths closely correspond to when countries experienced COVID-19 deaths. There is no evidence that millions of people died from the vaccines.
New Zealand is a little different in that during much of the pandemic, the country actually had a deficit of deaths, likely due to the mitigation measures the island took and the success the nation had in keeping the coronavirus out. Those measures may have also reduced flu deaths and other kinds of deaths.
But there, too, the only real period of excess deaths occurs during the two waves of COVID-19 New Zealand experienced in March and August 2022, a year or so after vaccination began. Some excess deaths in 2022 could also be a kind of catch-up, Morris said, from older people who avoided dying in 2020 and 2021.
Regardless, the pattern is clear, Morris said, and part of what happened in 2022 in New Zealand was a return to a baseline level of death after a couple of years of fewer deaths.
What hes saying is implausible, Morris said of Kirsch.
According to his description, Kirschs analysis consists of what he calls a time-series cohort analysis of record-level data from 4 million out of the 12 million COVID-19 vaccine doses given in New Zealand. These doses, he says, were part of a pay-per-dose program in the country, which he claims were randomly administered.
Kirsch uses the data to plot death rates from any cause over time since vaccination, claiming that if the vaccine is safe, the graph should level off and be flat or decline three weeks after vaccination. If its not, he says, any increase reflects deaths caused by the vaccine. Using this flawed logic, he then calculates a death rate for all ages of 1 death per 1,000 doses, which he applies globally to arrive at his 13 million estimate of the number of people killed by the vaccines, and an estimate of 675,000 for the U.S.
There are numerous problems with this approach. To start, Morris said many of Kirschs assumptions are simply not true.
Theres nothing in the literature that says, oh, these plots should be completely flat. And if theyre not flat, the only explanation can be that the vaccine is causing death, he said. Theres no such thing.
In theory, Morris said, the curve for a safe vaccine would be flat if theres a constant death rate that never varies throughout the year, and if the decision to get vaccinated or additional doses is completely random. But thats not the situation with real data. So in fact, Morris said, there are many reasons why a curve might increase, even if a vaccine is not killing people.
Susan Oliver, an Australian scientist who corrects misinformation, similarly explained in a YouTube video critiquing Kirschs claims that such curves are not expected to be flat for seasonal vaccines. The reason for this is because deaths [due to any reason] dont occur uniformly throughout the year, she said. They follow a seasonal trend with higher deaths in the winter months.
The same could be true during a pandemic if many people are vaccinated around the same time, and then COVID-19 restrictions are lifted and a COVID-19 wave hits, as occurred in New Zealand. Or, as also happened in New Zealand, an abnormally low mortality rate rebounded to a normal level after a period of intense COVID-19 restrictions.
Kirsch has simply claimed that the vaccination records he has represent a random sample of the 12 million doses given in New Zealand. But he provides no evidence that this is true, instead arguing that others have to prove him wrong, incorrectly reversing the burden of proof.
There is little public information about the pay-per-dose program, and Te Whatu Ora told us it could not provide further comment given the ongoing investigation and injunctions. However,it appearsthe pay-per-dose system was for reimbursing providers such as primary care practices, which would have been separate from mass vaccination clinics, for example. It is hardly clear that the populations served by both groups would be identical. And in any case, there remain important differences between the populations that get a different number of doses.
Additionally, while Kirsch is aware of whats called the healthy vaccinee effect a phenomenon in which, especially at first, vaccinated people will have an artificially lower rate of death than the overall population because very sick people would not be getting vaccinated Morris said Kirsch arbitrarily decided that it ends after exactly three weeks. Theres no basis for that, he said.
Kirsch then uses the rate of death at three weeks as the baseline for death and counts all deaths above that as excess deaths caused by the vaccines. Again, Morris said its invalid to just assume that all excess deaths would be vaccine-caused but also, the baseline may be completely incorrect.
Morris suspects that this is the case, noting that while Kirschs main analysis misleadingly focuses on all ages and all doses, when the rising death rates only exist for older people, one would really need to break the data down by age and by dose, and then use actuarial data for each age group to get some idea of an accurate baseline. The baseline Kirsch uses is much too low, he said.
The entire increase in deaths could simply be a recovery back to the actual baseline. He hasnt ruled that out at all, Morris said of Kirsch.
This gets at another fundamental problem with Kirschs analysis: the lack of an unvaccinated group. Kirsch claims this isnt needed for his type of analysis, but as Morris told us, Kirsch has no idea how the death rates in vaccinated or unvaccinated people compare.
When you dont even have the unvaccinated, then you have no calibration point because its possible that whatever youre looking at in the vaccinated, its possible that their death rate is lower than the unvaccinated across the board, Morris said. So if thats the case, how can you argue that the vaccine is killing people on the basis of this data?
Indeed, while Kirsch presents his analysis as iron-clad proof that the vaccines have killed millions of people, its incorrect to even say that this data could provide that degree of certainty.
The data that he got, even if its fully legitimate and accurate, cannot be used to answer the question that he wants to answer about causal effects of vaccines on death, Morris said.
Kirsch also hypes the data, misleadingly claiming that [n]o State or country has ever released record-level public health data on any vaccine and casting his analysis as special.
Morris said that in fact, while no one else uses the term record-level data, such information has been used in numerous COVID-19 vaccination studies around the world, which have turned up no evidence of mass vaccine-related death.
But unlike in Kirschs case, those researchers have a legal right to use the data, and the raw data are not shared because of privacy reasons. In addition, Morris said, that data usually include information on confounders, or other variables that might be associated with an outcome of interest such as death precisely the data that would help make a causal connection, but something that is lacking in Kirschs dataset.
Clarification, Dec. 15: We updated the story to clarify Morris comment about not performing his own analysis of the New Zealand data.
Editors note: SciChecks articles providing accurate health information and correcting health misinformation are made possible by a grant from the Robert Wood Johnson Foundation. The foundation has no control over FactCheck.orgs editorial decisions, and the views expressed in our articles do not necessarily reflect the views of the foundation.
Morris, Jeffrey S. Director, Biostatistics Division and Professor of Public Health and Preventative Medicine at the University of Pennsylvania, Perelman School of Medicine. Zoom interview with FactCheck.org. 8 Dec 2023.
UPDATE: Unauthorised data breach and attempt to spread misinformation. Statement. Te Whatu Ora/Health New Zealand. 8 Dec 2023.
Plummer, Benjamin and Lincoln Tan. Police arrest man in connection with alleged Te Whatu Ora mass privacy breach of Covid vaccination data. New Zealand Herald. 3 Dec 2023.
Griffiths, Ethan. Te Whatu Ora employee charged with Covid-19 vaccination data breach granted bail. New Zealand Herald. 3 Dec 2023.
Reminder of vaccine safety and effectiveness following release of misinformation. Statement. Te Whatu Ora/Health New Zealand. 1 Dec 2023.
Investigation ongoing into release of data and spread of misinformation. Statement. Te Whatu Ora/Health New Zealand. 3 Dec 2023.
Gorski, David. Steve Kirschs mother of all revelations about the deadliness of COVID-19 vaccines goes poof. Science-Based Medicine. 4 Dec 2023.
Steve Kirschs claim that New Zealand data shows COVID-19 vaccines killed millions is based on a flawed analysis. Health Feedback. 8 Dec 2023.
First batch of COVID-19 vaccine arrives in NZ. Press release. New Zealand government. 15 Feb 2021.
Back to the Science. Record level stupidity Steve Kirsch and the New Zealand data. YouTube video. 13 Dec 2023.
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Briefing on the Governments response to COVID-19. New Zealand Parliament. 26 Aug 2021.
Media Advisory
Thursday, December 14, 2023
Study suggests greater CD8+ T-cell activity may increase HIV immunity
An effective HIV vaccine may need to prompt strong responses from immune cells called CD8+ T cells to protect people from acquiring HIV, according to a new study from researchers at the National Instituteof Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and colleagues. The study findings, appearing in Science, draw comparisons between the immune system activity of past HIV vaccine study participants and people with HIV who naturally keep the virus from replicating even in the absence of antiretroviral therapy (ART). The latter individuals are often called long-term non-progressors or elite controllers (LTNPs/ECs).
When HIV enters the body, the virus begins to damage the immune system by inserting itself into CD4+ T cells, which are white blood cells that help coordinate the immune response to pathogens. In most people, HIV continues to replicate and damage more and more CD4+ T cells unless controlled by ART. Among LTNPs/ECs, the immune system appears to promptly recognize CD4+ cells with HIV and activate other immune cells called CD8+ T cells. CD8+ T cells destroy CD4+ cells with HIV, enabling the suppression of HIV in a persons blood.
The aim of an effective HIV vaccine is to provide durable protective immunity to HIV, or if initial defenses are bypassed, to help control HIV in the body long term, as happens with LTNPs/ECs. Although several preventive HIV vaccine candidates have been designed to stimulate CD8+ T-cell activity, they did not prevent HIV acquisition or control viral replication in clinical trials. Understanding and addressing this lack of effect is a scientific priority of HIV vaccine research.
Scientists in the HIV-Specific Immunity Section of NIAIDs Laboratory of Immunoregulation and colleagues designed their study to better understand which CD8+ T-cell functions were lacking in previous HIV vaccine recipients. They compared laboratory samples from previous HIV vaccine study participants with samples from LTNPs/ECs. They found that both HIV vaccine recipients and LTNPs/ECs generated large numbers of CD8+ T cells that recognized HIV. However, unlike the CD8+ T cells of LTNPs/ECs, HIV vaccine recipients CD8+ T cells failed to deliver the proteins necessary to destroy HIV-infected CD4+ T cells with HIV.
Further tests suggested this dampened response was due to reduced sensitivity to HIV of vaccine recipients T-cell receptorsthe part of a CD8+ T cell that detects a CD4+ T cell with HIV. This reduced T-cell receptor sensitivity suggests the vaccine candidates from several prior studies did not sufficiently stimulate the maturation of CD8+ T cells to recognize, reach, and destroy all CD4+ T cells with HIV in a persons body.
According to the authors, the study suggests that future HIV vaccine candidates may be more successful if they include additional doses or persist longer in the body to further stimulate the immune system. They also write that the potential of an HIV vaccine might be better judged by measuring how it affects CD8+ T-cell function and sensitivity in addition to just assessing the number of CD8+ T cells generated, which has been the usual practice.
These findings build on decades of research by the HIV-Specific Immunity Section of NIAIDs Laboratory of Immunoregulation to better understand the immune response to HIV. The insights from this work may help guide future preventive and therapeutic HIV vaccine design and development, as well as HIV immunotherapy approaches.
Editorial note: While the terms elite controller and long-term non-progressor are used in scientific settings, the HIV research community is working to identify person-first language as a possible alternative to these phrases.
SA Migueles et al. HIV Vaccines Induce CD8+ T Cells with Low Antigen Receptor Sensitivity. Science DOI: 10.1126/science.adg0514 (2023).
Mark Connors, M.D., chief of the HIV-Specific Immunity Section of NIAIDs Laboratory of Immunoregulation, is available to discuss this research.
To schedule interviews, please contact NIAID News & Science Writing Branch at 301-402-1663 or via e-mail at NIAIDNews@niaid.nih.gov.
NIAID conducts and supports research at NIH, throughout the United States, and worldwide to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIHTurning Discovery Into Health
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L.L. Bean has just added a third shift at its factory in Brunswick, Maine, in an attempt to keep up with demand for its iconic boot.
Orders have quadrupled in the past few years as the boots have become more popular among a younger, more urban crowd.
The company says it saw the trend coming and tried to prepare, but orders outpaced projections. They expect to sell 450,000 pairs of boots in 2014.
People hoping to have the boots in time for Christmas are likely going to be disappointed. The bootsare back ordered through February and even March.
"I've been told it's a good problem to have but I"m disappointed that customers not getting what they want as quickly as they want," said Senior Manufacturing Manager Royce Haines.
Customers like, Mary Clifford, tried to order boots on line, but they were back ordered until January.
"I was very surprised this is what they are known for and at Christmas time you can't get them when you need them," said Clifford.
People who do have boots are trying to capitalize on the shortage and are selling them on Ebay at a much higher cost.
L.L. Bean says it has hired dozens of new boot makers, but it takes up to six months to train someone to make a boot.
The company has also spent a million dollars on new equipment to try and keep pace with demand.
Some customers are having luck at the retail stores. They have a separate inventory, and while sizes are limited, those stores have boots on the shelves.
