Category: Vaccine

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.

Te Whatu Ora/Health New Zealand. Email to FactCheck.org. 12 Dec 2023.

Briefing on the Governments response to COVID-19. New Zealand Parliament. 26 Aug 2021.

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Flawed Analysis of New Zealand Data Doesnt Show COVID-19 Vaccines Killed Millions - FactCheck.org

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.

Read more:

Future COVID vaccines should be inhaled, suggests new study by Boston scientists - The Boston Globe

The U.S. Food and Drug Administration fought back on Friday against what it calls the proliferation of misinformation by Floridas Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.

In a letter earlier this month to the FDA, Ladapo had questioned the agencys drug approval and raised alarms about what he sees as the risk of potential cancer posed by COVID mRNA vaccines. Ladapo,the leader of Floridas health department, said he believed the drug delivery system used by mRNA vaccines could be an efficient vehicle for delivering contaminant DNA into human cells.

But a top researcher with the FDA released a public response to Ladapo on Friday saying the Surgeon Generals scientific assertion regarding the cancer risk is implausible.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said the premise asserted by Ladapo that DNA contaminant could cause cancer in vaccine recipients is not scientifically accurate because there is no way that minute amounts of DNA fragments could find their way into the nucleus of human cells where DNA resides.

He added that this type of disinformation results in vaccine hesitancy.

Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19, Marks wrote. Indeed, only 11% of Floridians have received an updated COVID booster, despite the states large population of elderly who are most at risk for poor outcomes. Even more, only about a third of the states vulnerable long-term care population has had the updated shot, according to the Centers for Disease Control and Prevention.

We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines, Marks wrote in the response to Ladapo. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.

(Article continues after the letter.)

In his Dec. 6 letter, Ladapo had pressed the FDA and CDC to answer three questions by Dec. 13: Was the risk of DNA integration evaluated by drug manufacturers and provided to the federal agencies; did FDA standards take the COVID vaccines delivery system into account; and was a risk evaluated of integration with reproductive cells beyond the local injection site?

Dr. Kawsar Talaat, an associate professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, says those three concerns have no scientific basis.

Her research expertise is in conducting clinical trials for a variety of vaccines to determine their safety and efficacy. The COVID vaccine enters the outer part of cell and the RNA works there. It wouldnt be possible for the DNA to integrate into the chromosomes since they are not even in same compartment, she said. Even if they were, the mechanism that allows that to happen is not included in the vaccine.

Talaat said Ladapo overlooks how much research on the mRNA COVID-19 vaccines has taken place.

There has not been a vaccine released into the population that has been under more scrutiny than the mRNA COVID vaccines, she said. There has not been any evidence thus far that there are any problems with integration with any DNA, or cancer as a result of the vaccines.

Talaat said she just had a 40-year-old friend with a health condition die of COVID-19.

These questions (raised by Ladapo) are designed to scare people rather than investigate true science, she said. What we do know is that COVID continues to kill thousands of people every month in the U.S. I think he is doing a disservice to the people of Florida by trying to scare them into not getting a vaccine that can be lifesaving.

(Article continues after the letter.)

Ladapo did not respond by the end of the business day on Friday to the Sun Sentinels request for comment about the FDA letter.

This isnt Ladapos first tussle with the FDA. In March, he was publicly rebuked by the FDA and CDC over his vaccine advice. Those agencies told him to stop disproportionately focusing public attention on the few instances of adverse effects from the COVID vaccine. Ladapo previously has painted the COVID vaccines as dangerous and claimed there have been no clinical trials on the effects of the new booster on human beings, a statement that the manufacturers say is false.

Sun Sentinel health reporter Cindy Goodman can be reached at cgoodman@sunsentinel.com.

See original here:

Florida's Surgeon General told the FDA that COVID vaccines aren't safe. The FDA calls that misinformation. - South Florida Sun Sentinel

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.

Continue reading here:

As winter virus activity picks up, CDC warns of urgent need' to boost vaccine coverage - NBC Southern California

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 http://www.nih.gov.

NIHTurning Discovery Into Health

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NIH research identifies opportunities to improve future HIV vaccine candidates - National Institutes of Health (.gov)

(Adds vaccination details and background in paragraphs 5 to 7)

Dec 14 (Reuters) -

The U.S. Centers for Disease Control and Prevention (CDC) on Thursday issued an alert urging healthcare providers to increase immunization coverage for influenza, COVID-19 and respiratory syncytial virus (RSV).

The health regulator said that low vaccination rates, coupled with ongoing increases in respiratory disease activity, could lead to more severe disease and increased healthcare capacity strain in the coming weeks.

Healthcare providers should recommend antiviral medications for influenza and COVID-19 for all eligible patients, especially older adults and people with certain underlying medical condition, the CDC said.

In the past four weeks, hospitalizations among all age groups increased by 200% for influenza, 51% for COVID-19, and 60% for RSV, according to CDC data.

There were 7.4 million fewer influenza vaccine doses administered to adults in pharmacies and physician offices compared with the 20222023 influenza season.

Nearly 16% of U.S. adults aged 60 years and higher were reported to have taken an RSV vaccine and 36% of U.S. adults aged 65 years and higher took a COVID-19 shot for the 2023-2024 period.

Pfizer has COVID and RSV vaccines that are approved in the United States, while Moderna and Novavax have updated COVID shots that are approved in the country. (Reporting by Christy Santhosh; Editing by Maju Samuel)

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UPDATE 2-US CDC says there's urgent need to increase respiratory vaccine coverage - Yahoo Finance

Moderna-Merck Vaccine Halves Melanoma Recurrence Risk

Moderna and Merck announced on Thursday that a vaccine is showing promising results in treating melanoma, according to CBS News. To test the efficacy of the vaccine, they conducted an ongoing randomized trial in 157 patients with high-risk stage III and IV melanoma who first had surgery to completely remove cancerous growths. Compared with those who only received Keytruda (pembrolizumab), those who received both the vaccine and Keytruda were 49% less likely to die or have their cancer recur in 3 years. The companies have begun phase 3 trials of mRNA-4157 with Keytruda for those with stage III and IV melanoma; the FDA designated the treatment as a breakthrough therapy earlier this year to expedite its development and review since it is used to treat a life-threatening disease.

Biden Administration to Impose Inflation Penalties on Drugmakers

The White House announced on Thursday that the Biden administration will implement inflation penalties on dozens of drugmakers to reduce out-of-pocket costs for Medicare recipients, according to CNBC. This is a result of President Joe Bidens Inflation Reduction Act (IRA), which includes a provision to penalize drugmakers for charging prices that rise faster than inflation for patients with Medicare coverage. The White House explained that the prices of 64 drugs this year increased faster than inflation, with 48 of these drugs doing so during the last quarter of 2023; the 48 drugs may be subject to inflation rebates in the first quarter of 2024 due to the IRA.

Urgent Need to Increase Respiratory Vaccine Coverage, CDC Says

The CDC issued an alert on Thursday urging health care providers to increase immunization coverage for influenza, COVID-19, and respiratory syncytial virus (RSV), according to Reuters. In the past 4 weeks, hospitalizations among all age groups increased by 200% for influenza, 60% for RSV, and 51% for COVID-19. The CDC noted that low vaccination rates, coupled with the ongoing increase in respiratory disease activity, could lead to more severe disease and increased health care capacity strain in the coming weeks. To prevent this, the CDC is suggesting that health care providers recommend antiviral medications for influenza and COVID-19 to all eligible patients.

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What We're Reading: Inflation Penalties; Melanoma Vaccine; Respiratory Vaccine Coverage - AJMC.com Managed Markets Network

The U.S. Food and Drug Administration fought back on Friday against what it calls the proliferation of misinformation by Floridas Surgeon General Joseph Ladapo about the safety of COVID-19 vaccines.

In a letter earlier this month to the FDA, Ladapo had questioned the agencys drug approval and raised alarms about what he sees as the risk of potential cancer posed by COVID-19 mRNA vaccines. Ladapo, the leader of Floridas health department, said he believed the drug delivery system used by mRNA vaccines could be an efficient vehicle for delivering contaminant DNA into human cells.

But a top researcher with the FDA released a public response to Ladapo on Friday saying the Surgeon Generals scientific assertion regarding the cancer risk is implausible.

Dr. Peter Marks, director of the Center for Biologics Evaluation and Research for the FDA, said the premise asserted by Ladapo that DNA contaminant could cause cancer in vaccine recipients is not scientifically accurate because there is no way that minute amounts of DNA fragments could find their way into the nucleus of human cells where DNA resides.

He added that this type of disinformation results in vaccine hesitancy.

Given the dramatic reduction in the risk of death, hospitalization and serious illness afforded by the vaccines, lower vaccine uptake is contributing to the continued death and serious illness toll of COVID-19, Marks wrote. Indeed, only 11% of Floridians have received an updated COVID-19 booster, despite the states large population of elderly who are most at risk for poor outcomes. Even more, only about a third of the states vulnerable long-term care population has had the updated shot, according to the Centers for Disease Control and Prevention.

We would like to make clear that based on a thorough assessment of the entire manufacturing process, FDA is confident in the quality, safety, and effectiveness of the COVID-19 vaccines, Marks wrote in the response to Ladapo. Additionally, with over a billion doses of the mRNA vaccines administered, no safety concerns related to residual DNA have been identified.

In his Dec. 6 letter, Ladapo had pressed the FDA and CDC to answer three questions by Dec. 13: Was the risk of DNA integration evaluated by drug manufacturers and provided to the federal agencies; did FDA standards take the COVID-19 vaccines delivery system into account; and was a risk evaluated of integration with reproductive cells beyond the local injection site?

Dr. Kawsar Talaat, an associate professor in the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, says those three concerns have no scientific basis.

Her research expertise is in conducting clinical trials for a variety of vaccines to determine their safety and efficacy. The COVID vaccine enters the outer part of cell and the RNA works there. It wouldnt be possible for the DNA to integrate into the chromosomes since they are not even in same compartment, she said. Even if they were, the mechanism that allows that to happen is not included in the vaccine.

Talaat said Ladapo overlooks how much research on the mRNA COVID-19 vaccines has taken place.

There has not been a vaccine released into the population that has been under more scrutiny than the mRNA COVID vaccines, she said. There has not been any evidence thus far that there are any problems with integration with any DNA, or cancer as a result of the vaccines.

Talaat said she just had a 40-year-old friend with a health condition die of COVID-19.

These questions (raised by Ladapo) are designed to scare people rather than investigate true science, she said. What we do know is that COVID continues to kill thousands of people every month in the U.S. I think he is doing a disservice to the people of Florida by trying to scare them into not getting a vaccine that can be lifesaving.

Ladapo did not respond by the end of the business day on Friday to the South Florida Sun Sentinels request for comment about the FDA letter.

This isnt Ladapos first tussle with the FDA. In March, he was publicly rebuked by the FDA and CDC over his vaccine advice. Those agencies told him to stop disproportionately focusing public attention on the few instances of adverse effects from the COVID-19 vaccine. Ladapo previously has painted the COVID vaccines as dangerous and claimed there have been no clinical trials on the effects of the new booster on human beings, a statement that the manufacturers say is false.

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Florida's surgeon general told the FDA that COVID-19 vaccines aren't safe. The FDA calls that misinformation - Yahoo News

A breast cancer tumor, credit NASA/Goddard Space Flight Center.T

A drug that targets the deadliest form of breast cancer has recently been found to elicit no side effects, and triggered an immune response in 75% of patients.

Conducted at the Cleveland Clinic with funding from the Pentagon, the vaccine was administered to 16 women in three separate doses. The form of the vaccine that went through trials is meant to stop the return of this aggressive form of cancer in those who have already been treated.

Further research will tool it to attack tumors in women who have yet to undergo treatment.

mRNA vaccines for cancer tumors are really where this technology comes into its own. Using a piece of the tumor to train immune cells like bloodhounds to search them out is far more effective than using it to train a single component of a constantly mutating virus, as was done to try and combat COVID-19.

It could be available in five years, estimates ABCs medical correspondent Dr. Jennifer Ashton, who didnt participate in the research.

According to Anixa Biosciences, the firm behind this vaccine, the drug will target a lactation protein, known as -lactalbumin, that is present in the majority of triple-negative breast cancer patients.

The data from our Phase 1 trial to date has exceeded our expectations, and we are pleased with our progress. This vaccine is designed to direct the immune system to destroy TNBC cancer cells through a mechanism that has never previously been utilized for cancer vaccine development, stated Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences.

OTHER CANCER DEVELOPMENT: Scientists Develop Personalized Anti-Cancer Vaccine That Works in Mice

This year, GNN reported on another cancer vaccine with immense promise; this one for melanoma, which is predicted to be the second-most common type of cancer in the US by 2040.

In a phase 2b trial, 107 participants were treated with both the vaccine and immunotherapy drug pembrolizumab. Their melanoma returned in only 24 patients (22.4%) within two years, compared with 20 out of 50 (40%) who received only pembrolizumab.

WATCH the story from GMA below

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Vaccine Targeting Triple-Negative Breast Cancer Shows Good Response in First Clinical Trial of Patients - Good News Network

Moderna (MRNA) shares have jumped by over 9% on Thursday in relation to positive trial results in Moderna and Merck's (MRK) collaborative skin cancer treatment that utilizes both a vaccine and the drug Keytruda. Additionally, Pfizer (PFE) disappointed investors this week over the pharmaceutical company's 2024 guidance.

Yahoo Finance Health Reporter Anjalee Khemlani details the top stories and biggest drivers behind pharmaceutical stocks Thursday.

For more expert insight and the latest market action, click here to watch this full episode of Yahoo Finance Live.

- Shares of Moderna popping today on positive trial data for a skin cancer treatment. Moderna developing the vaccine alongside Merck, but those shares little changed today. Here with more is Yahoo Finance's, Anjali Khemlani. Anj.

ANJALI KHEMLANI: Hi, Julie. Well, yes. So, of course, Moderna out with this update on its cancer vaccine that it is testing in tandem with Merck's Keytruda, that blockbuster cancer drug. And what they found is that the drug in tandem with the vaccine can reduce the risk of recurrence of melanoma-- late stage melanoma-- by up to 49% after three years. That's a really huge number in terms of the protection that it can give patients.

So that's where the jump is coming from today. Moderna finally getting a little bit of positive news for its stock. We know that it's been a little bit under pressure because of the lack of movement in its pipeline ever since the one vaccine that they do have to their name, which is the COVID-19 vaccine.

So I had a chance to catch up with the CEO earlier today. And we were talking about that and the leadership changes that the company has been through as well. And how he is now going to be looking over commercial progress. And he wants to, in his words, obsess over it. So looks like Moderna is in for some hard times ahead.

- Yeah, and Anj, I want to switch names to another name here. Checking out Pfizer today under some pressure. It's down more than 2%. It looks like that's off this 2024 outlook. What's new there?

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ANJALI KHEMLANI: That's right. First of all, I just want to point out, I never thought I'd have to say these two companies names in the same breath again since COVID. But here we are again. So Pfizer--

- Because they're both facing some similar challenges moving past that era.

ANJALI KHEMLANI: Absolutely. And that is where the pressure on Pfizer comes from. Downgrading its 2024 outlook to be basically flat compared to 2023. And saying that its COVID portfolio is estimated to bring in just $8 billion. That's a lot less than what the Street was looking for and estimating.

But in the call yesterday, Pfizer CEO, Albert Bourla, as well as CFO, Dave Denton, did have to battle a lot of really stern questions from analysts. A lot of doubt and a lot of wariness that has been sort of an overhang on the stock for years.

Even during the pandemic, we had conversations here at Yahoo Finance with Albert Bourla about just that. About how their stock didn't get that boost that a lot of others saw during the pandemic. And he said even earlier this year, in April, saying, quote, "Although I'm not happy, all we can do is to execute on our strategy so that investors will see that this is a good growth opportunity."

And that growth opportunity he's referring to is the two acquisitions last year as well as that huge $43 billion C-Gen which is oncology focused this year. As well as getting 13 launches of new products from the pipeline. So a lot of R&D focus for the company. And still not being rewarded there by the Street.

Lots of doubts, including, for example, in an analyst note from JPM, saying "PFE shares are looking increasingly washed out at current levels, we do not see a clear path for the stock to recover given the ongoing uncertainty about the company's core earnings power."

And basically what they're saying, and what these analysts have been saying, is that even though they have these acquisitions and they have this rich pipeline, there's nothing to really make up for what could be a $17 billion hole from patent expiry at the end of the decade. And so there's no catalyst. There's no blockbuster to take place what they're losing.

And even though there's a lot in the pipeline, there's nothing that's really stand out and enough to really just weigh on-- give up the weight on the stock.

- All right, we'll keep watching. Anjali, thank you so much for that.

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Moderna stock sees boost over skin cancer treatment trials - Yahoo Finance