COVID-19 vaccines could be partly to blame for the rise in excess deaths since the pandemic, scientists have suggested.
Researchers from The Netherlands analyzed data from 47 Western countries and discovered there had been more than three million excess deaths since 2020, with the trend continuing despite the rollout of vaccines and containment measures.
They said the unprecedented figures raised serious concerns and called on governments to fully investigate the underlying causes, including possible vaccine harms.
Writing in the BMJ Public Health, the authors from Vrije Universiteit, Amsterdam, said: Although COVID-19 vaccines were provided to guard civilians from suffering morbidity and mortality by the COVID-19 virus, suspected adverse events have been documented as well.
Both medical professionals and citizens have reported serious injuries and deaths following vaccination to various official databases in the Western World.
They added: During the pandemic, it was emphasised by politicians and the media on a daily basis that every COVID-19 death mattered and every life deserved protection through containment measures and COVID-19 vaccines. In the aftermath of the pandemic, the same morale should apply.
The study found that across Europe, the U.S. and Australia there had been more than one million excess deaths in 2020, at the height of the pandemic, but also 1.2 million in 2021 and 800,000 and 2022 after measures were implemented.
Researchers said the figure included deaths from COVID-19, but also the indirect effects of the health strategies to address the virus spread and infection.
They warned that side effects linked to the COVID vaccine have included ischemic stroke, acute coronary syndrome and brain hemorrhage, cardiovascular diseases, coagulation, hemorrhages, gastrointestinal events and blood clotting.
German researchers have pointed out that the onset of excess mortality in early 2021 in the country coincided with the rollout of vaccines, which the team said warranted further investigation.
However, more recent data regarding side-effects has not been made available to the public, with countries keeping their own individual databases of harms, which rely on self-reporting by the public and doctors, the experts warned.
Researchers said that it was likely that the impact of containment measures, restricted healthcare and socioeconomic upheaval during the pandemic had contributed to deaths, although accepted that was difficult to prove.
Gordon Wishart, chief medical officer at Check4Cancer, and visiting professor of cancer surgery at Anglia Ruskin University, warned repeatedly that delaying cancer diagnosis would lead to deaths.
It was predicted early in the lockdown period that limited access to healthcare for non-COVID conditions would lead to delays in the diagnosis and treatment of time-critical conditions such as cancer, cardiac disease, diabetes and dementia and that this would lead to excess deaths from these conditions, he said.
NHS England data shows that per 100,000 people the cancer incidence was 521 in the pre-lockdown year, then fell to 456 in 2020/2021 suggesting around 45,000 cancers were missed in the first pandemic year.
The incidence rate rose to 540 per 100,000 the following year suggesting many cancers were diagnosed late, when treatment would be less effective.
Speaking about the potential for vaccine harm, Wishart added: The authors are correct to point out that many vaccine-related serious adverse events may have been unreported, and point to the fact that the simultaneous onset of excess mortality and COVID vaccination in Germany is worthy of further investigation on its own. The paper provides more questions than answers, but it is hard to disagree with their conclusion that further analysis is required to understand the underlying causes of excess mortality to better prepare for the future management of pandemic crises.
YAHOO NEWS
University of Georgia-based startup CyanVac LLC received federal funding to support a comparative Phase 2b clinical trial of CVXGA, the companys intranasal vaccine candidates designed to protect against COVID-19.
As part of the award from Project NextGen, a federal initiative based in the U.S. Department of Health and Human Services (HHS), CyanVac will sponsor a randomized, double-blind Phase 2b study with 10,000 participants to compare the efficacy and safety of the intranasal vaccine against an FDA-approved mRNA-based COVID-19 vaccine.
The new vaccine is based on a viral delivery platform developed by He containing modified strains of parainfluenza virus 5, which causes kennel cough in dogs but is harmless to humans.
CyanVac was founded by Biao He, Regents Entrepreneur,Fred C. Davison Distinguished University Chair in Veterinary Medicine and a faculty member in UGAs College of Veterinary Medicine (CVM). He served on a White House panel to advise on the future of COVID-19 vaccines and was named both UGA Inventor and Entrepreneur of the Year.
We are very excited about this opportunity to test a novel intranasal COVID vaccine whose technology platform has been developed at UGA, said He, who is based in UGAs Department of Infectious Diseases. The name of our vaccineCVXGAis a tribute to UGA and CVM whose support over the years made this possible.
Project NextGens goal is to advance new, innovative vaccines and therapeutics that provide longer lasting and more durable protection against COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the HHS Biomedical Advanced Research and Development Authority (BARDA) to accelerate product and technology development.
The Phase 2b study, which will begin this fall, will be carried out by BARDAs Clinical Studies Network, focusing on evaluating the vaccine in a subset of participants who are at a higher risk of severe disease.
South Africa is trying to source Mpox vaccines from the United Nations World Health Organisation (WHO) member countries, the Department of Health said.
Updating the media on the situation on Wednesday, Health Minister Dr Joe Phaahla told a media briefing in Pretoria there was no registered treatment for the infectious disease in South Africa and that the WHO member countries in question have stockpiles that exceed their needs.
He also said the global vaccine alliance, GAVI, had been approached.
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These vaccines will be stored and distributed from our provincial depots, said Phaahla.
Additional intervention is being considered as National Advisory Group for Immunisation (NAGI), a technical working group for Mpox vaccines, has been appointed and is considering Mpox vaccine for both pre and post-exposure administration for high-risk groups, including but not limited to sex workers, men-who-have-sex-with-men (MSM), healthcare workers and laboratory workers.
This week, South Africa recorded its first Mpox death at Tembisa Hospital in Gauteng. Three of South Africas five reported cases have been in Durban, and the other two are in Gauteng.
The disease is caused by the monkeypox virus (MPXV), an orthopoxvirus (a group of large, complex, double-stranded DNA viruses that replicate in the cytoplasm of the host cell) that transmits from person to person through close contact, and from domesticated and wild animals infected by pathogens in East, Central, and West Africa.
Phaahla said the multi-country Mpox outbreak was characterised by sustained human-to-human transmission via direct skin-to-skin and sexual contact. People living with HIV are disproportionately affected.
He said all cases/patients in South Africa were men aged between 30 and 39 years without travel history to the countries currently experiencing an outbreak, which suggests that there is local transmission within the country.
All five cases were classified as severe cases as per the WHO definition, requiring hospitalisation.
The WHO recommends the use of Tecovirimat (known as TPOXX) for treatment of severe cases, such as in individuals with a CD4 (type of white blood cells) count of less than 350. However, the department has obtained Tecovirimat via Section 21 SAPHRA approval on a compassionate use basis for the five known patients with severe disease. Three of the five cases had access to Tecovirimat treatment as advocated by the National Institute of Communicable Diseases (NICD).
With regards to a vaccine, Phaahla said options were being considered as to which population groups should be targeted.
Phaahla added that the stigma of MSM has hindered contact tracing and honesty from those who may be infected by Mpox as patients were not forthcoming with traceable contacts in order to establish where they got the Mpox so their contacts can be tested too.
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He said only one of the patients indicated they had had sexual contact with multiple partners, including males and females.
Co-morbidities have also been identified among MSM cases in other countries.
Vaxart, Inc.
10,000-subject Phase 2b study will evaluate Vaxarts next generation oral pill COVID-19 vaccine against an approved mRNA vaccine comparator
Vaxart anticipates initiating enrollment as early as summer 2024
SOUTH SAN FRANCISCO, Calif., June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) announced today that it received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle (RRPV). The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
The funds will be used to conduct a Phase 2b comparative study evaluating Vaxarts oral pill COVID-19 vaccine candidate against a U.S. Food and Drug Administration (FDA)-approved mRNA vaccine comparator. In preparation for the trial, Vaxart created and manufactured under Good Manufacturing Practice (GMP) standards a next-generation oral COVID-19 vaccine tablet candidate that based on preclinical data is more potent than Vaxarts prior COVID-19 vaccine constructs.
Funding under the award will be provided in two parts with approximately $65.7 million available immediately to continue study start-up activities, and the remainder of approximately $387.2 million provided when Vaxart and BARDA have determined that the study may further proceed and paid over the course of the study. Currently, Vaxart anticipates initiating enrollment as early as summer 2024. An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur as early as the first quarter of 2025.
We are grateful to BARDA for this funding, which will enable Vaxart to conduct a Phase 2b trial for our COVID-19 oral pill vaccine candidate. This trial will evaluate whether our oral pill vaccine candidate compares favorably against an approved mRNA injectable vaccine, said Dr. James F. Cummings, Vaxarts Chief Medical Officer. We are excited to explore the results of this head-to-head comparison. Previous research showed that our earlier COVID-19 vaccine constructs triggered long-lasting immune responses and induced a cross-reactive immunogenic response against all tested SARS-CoV-2 variants.
Vaccine delivery has relied primarily on injection for more than 150 years. This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination, said Steven Lo, Vaxarts Chief Executive Officer. We believe our oral pill vaccine platform can better meet societal needs not just for COVID-19, which is now in the endemic phase, but for other infectious diseases that present significant endemic and pandemic threats.
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Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. In earlier clinical trials, Vaxart demonstrated its COVID-19 vaccine candidates generated robust cross-reactive mucosal IgA responses, boosted immune responses to existing COVID-19 vaccines, increased neutralizing antibodies against Omicron 4/5, and had a benign tolerability profile.
Funding for this award was received under Project NextGen, a $5 billion initiative by HHS to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19 than the first generation COVID-19 vaccines and medicines. This project has been funded with federal funds from HHS; ASPR; BARDA, under Other Transaction (OT) number 75A50123D00005.
About the COVID-19 Phase 2b Trial
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxarts oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,000 healthy adults 18 years and older in the United States with 5,000 receiving Vaxarts COVID-19 vaccine candidate and 5,000 receiving an approved mRNA comparator. At least 25% of the participants should be at least 65 years old.
The study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxarts COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
An independent Data and Safety Monitoring Board (DSMB) will review safety data of the participants.
Execution of this Phase 2b study will be funded by BARDA through the RRPV.
About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxarts development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxarts first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, receipt of funding from BARDA for the Phase 2b study, results from preclinical and clinical trials and the timing of such trials and results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," anticipate, "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxarts receipt of funding from BARDA for the Phase 2b study (or for any other purpose), Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; Vaxarts expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contacts
VaxartMedia Relations:
Investor Relations:
Mark Herr
Andrew Blazier
Vaxart, Inc.
FINN Partners
mherr@vaxart.com
IR@vaxart.com
(203) 517-8957
The new RSV vaccines approved for older adults may be linked to a slightly increased risk of a rare neurological condition, a recent analysis finds.
However, the Centers for Disease Control and Prevention (CDC) says the benefits of the vaccines outweigh this slight increased risk. Therefore, the agency still recommends that adults 60 years and older get an RSV vaccine in consultation with their doctor. The available vaccines include one called Arexvy and another called Abrysvo.
The recent research published May 30 by CDC scientists in the agency's Morbidity and Mortality Weekly Report is consistent with findings in the clinical trials for the vaccines, according to study leader Anne Hause, an epidemiologist and program lead for V-safe in the CDC's Immunization Safety Office. During clinical trials, researchers observed higher-than-expected rates of Guillain-Barr syndrome, a disorder in which the immune system attacks healthy nerves.
While Guillain-Barr syndrome was noted as a potential concern during the trials, the trials were too small to tease out any possible connection to the shots. Real-world monitoring data involves much larger groups of patients and thus helps confirm the link that trial data hinted at.
Related: Who should get the new RSV vaccines? Here's everything you need to know
Guillain-Barr syndrome causes tingling, numbness and muscle weakness, and it can progress to paralysis. According to the Mayo Clinic, most people recover completely from this illness, but it can take months or years. In severe cases, the condition can affect the muscles that support breathing and be life-threatening.
While Guillain-Barr is fairly rare, RSV, or respiratory syncytial virus, circulates every year and poses a threat to children and older adults, in particular. Among U.S. adults over 65, the seasonal infection kills approximately 6,000 to 10,000 people each year, according to the CDC.
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The two new vaccines, one produced by Pfizer and the other by GSK, were approved for older adults in May 2023. The new CDC report examines the first year of safety data using surveys of patients, as well as the Vaccine Adverse Event Reporting System (VAERS), a database where anyone can submit suspected vaccine reactions.
The analysis showed that there were five reports of Guillain-Barr syndrome for every million doses of Pfizer RSV vaccine administered, amounting to 17 cases in total. There were 1.5 reports per million doses of GSK RSV vaccine, or 11 cases in total.
These rates were higher than the background rate of Guillain-Barr expected in this population. This background rate was based on the rates in people given mRNA-based COVID vaccines, which were not tied to any uptick in the syndrome.
However, because VAERS is based on voluntary self-reporting, researchers can't confidently tie every case to the RSV vaccinations, Hause emphasized. Because of this uncertainty, "CDC and FDA are conducting additional safety evaluations in other vaccine safety systems," she said.
Guillain-Barr syndrome often appears after an infection with viruses or bacteria, said Maria Pino, a pharmacologist and associate professor at the New York Institute of Technology's medical school who has written about the RSV vaccines. Similar to the new shots, a 1976 swine flu vaccine was also linked with a slightly increased risk of the syndrome.
The precise link between some infections and vaccinations and the autoimmune syndrome is unknown. However, it likely has something to do with the body's natural immune response to these types of triggers going rogue and turning against the wrong target, Pino told Live Science.
Health officials still recommend getting the RSV vaccines because the risk of developing Guillain-Barr is so low compared with the risk posed by an RSV infection, said Dr. Simon Drysdale, a pediatric infectious disease specialist in the Oxford Vaccine Group. For adults over 60 living in high-income countries, their risk of dying from RSV if they're hospitalized with the infection is 7%, Drysdale said, citing 2023 research published in the journal Influenza and Other Respiratory Viruses.
Unlike the flu or COVID-19, there is no antiviral treatment available for RSV. Rather, treatment involves maintaining a person's vitals in the hope the infection subsides on its own.
"You've got a very, very, very small risk of a significant side effect [from vaccination], versus a much higher risk of having a significant outcome from having RSV disease," Drysdale told Live Science.
For patients deciding whether to get an RSV vaccine, the best source of information is always their own doctor, Pino said. During that discussion, doctors and patients can weigh that specific person's risk factors for RSV complications. Those who face a heightened risk include people with compromised immune function, chronic lung disease and chronic heart disease, as well as those ages 75 and older and those living in long-term care facilities, Hause said.
Other risk factors include frequent contact with children, who carry and spread the virus easily, Drysdale said, as well as chronic kidney disease, which is associated with a high risk of hospitalization from RSV.
"For the vast majority of people," Drysdale said, "the benefit is going to significantly outweigh the risk."
This article is for informational purposes only and is not meant to offer medical advice.
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This commitment from Gavi is crucial and will expedite efforts to halt human fatalities caused by dog-mediated rabies, said Dr Jrme Salomon, Assistant Director-General for Universal Health Coverage, Communicable and Noncommunicable Diseases at WHO. WHO will provide technical assistance to countries, not only to support their funding applications to Gavi but to draw up comprehensive plans of action that can deliver real progress towards the Zero by 30 goal.
In more than 150 countries where dog rabies remains a serious public health problem, stocks of human rabies vaccines in public health systems are often extremely limited, especially in marginalised communities. Where human rabies vaccine is available through private facilities, the cost of PEP can impose a catastrophic financial burden on families and communities.
Gavis aim with this program is to contribute to global rabies efforts and save lives by helping countries ensure that human rabies vaccines are available to anyone who needs them and that vulnerable and marginalised communities have equal access to these essential medicines,said Aurlia Nguyen, the Chief Programme Officer at Gavi, the Vaccine Alliance.
Rabies is a viral disease that causes severe inflammation of the brain. In 99% of cases, it is transmitted to humans by a rabid dog. Once the virus reaches the central nervous system and an infected person shows clinical symptoms, rabies infection is near100% fatal.
The deadly nature of rabies and its traumatic symptoms make it one of the worlds most feared diseases. However, rabies infection is preventable by prompt PEP, which consists of thorough wound washing, administration of a course of good quality human rabies vaccine, and immunoglobulins if needed.
Gavi initially agreed to include human rabies vaccines for PEP in its 2021-25 Vaccine Investment Strategy, however the COVID-19 pandemic led to postponement of the program until mid-2023, when the decision to restart was made by Gavis Board.
Gavis investment is hugely important and underpins a key pillar of the global strategy to stop people dying from this terrible disease, said Professor Lucille Blumberg, Chair of United Against Rabies. But to stop human rabies deaths completely, we urgently need better data and surveillance, dog populations must be vaccinated, and people must be educated about what to do if bitten, and how to avoid being bitten in the first place. Stopping human deaths from rabies is within our reach, but it will take multiple sectors working together to achieve it.
All Gavi-eligible countries can apply for support to invest in human rabies vaccines for PEP. Funding will be available for vaccine procurement and associated supplies. Rabies immunoglobulins (RIG) and dog vaccines are not covered by this program. Countries are not required to have a national rabies control plan in place to apply for the first round of multiyear funding, but a national plan will be mandatory for all subsequent applications.
Funding applications will be accepted by Gavi in 2024 by 15 July and by 23 September 2024, with subsequent funding windows open three times every year.
Its summer 2024, but the COVID-19 pandemic is still hanging around. And while the virus continues to evolve, its doing so in more predictable ways.
There are new variants in town, a reformulated vaccine on the horizon and fresh preventive treatments to help protect the most vulnerable people from getting severely ill from COVID. At-risk groups are now the main focus of the U.S. strategy against COVID instead of the sweeping, one-size-fits-all approach taken in the early days of the pandemic which means there may be less for an average, healthy person to do. But awareness is the key to staying healthy, experts say, so its more important than ever to know just how at-risk you are.
Heres what to know about COVID this summer.
A variant of the COVID virus known as KP.3 is now responsible for about a quarter of the cases in the U.S., which is more than any other form, according to the latest data from the Centers for Disease Control and Prevention. KP.3 recently overtook its close relative, KP.2, but both belong to a group known as the FLiRT variants. All these cousins are descendants of omicron, the more easily spread variant of the disease that swept the globe beginning in late 2021.
However, the FLiRT variants are different enough from the last omicron variant that protection is not going to be very durable either from the current vaccine, which was based on that variant, XBB.1.5, Dr. Amesh Adalja, an infectious disease specialist at the Johns Hopkins University Center for Health Security, tells Yahoo Life. This is the new normal. New variants will continuously appear and have the ability to infect a population that has a lot of prior immunity; thats what we should expect now and forever.
But the good news is that the newly dominant variants dont appear more likely to cause severe illness, hospitalization or death, says Adalja.
The symptoms are all essentially the same no matter what variant you get, Adalja says. Everybody talks about these changing symptoms, says Dr. David Smith, head of the University of California, San Diegos division of infectious diseases. But in reality, it's the good old cough, fever, sore throat, feeling badly or malaisethe same old things from the very beginning of the pandemic. The New York Times also reports patients feeling generally blah. According to the CDC, common symptoms include:
The CDC advises that everyone ages 5 and older should get one dose of one of the current COVID vaccines made by either Pfizer, Moderna or Novavax. Younger children, adults 65 and older and immunocompromised people may need multiple doses, the agency says.
However, with a new round of vaccines expected to be available this fall, experts advice is a little more complicated. If they havent gotten a dose of the current vaccine, most people can probably hold off, says Adalja. If you get it now, it may blunt the effect of the new vaccine in the fall. The FDA has requested that vaccine makers update their shots for the fall to be effective against the JN.1 lineage, of which the FLiRT variants are descendants.
For most people, Adalja says whether to get a shot this summer varies case by case, and advises considering:
How long its been since your last vaccination
How high your risks of severe COVID are
What category of risk you belong to (e.g., older people, people with excess weight, people with chronic health conditions, immunosuppressed people)
How long its been since your last COVID infection
Whether you are pregnant
Smith says that anyone 65 and older should get a dose of the current shot if they havent already. The summer wave is coming, and the vaccine does offer quite a bit of protection against the [FliRT] variants, he tells Yahoo Life. People who are otherwise relatively healthy and not older can decide for themselves. But if you dont, theres a pretty good chance that youll get infected in the summer wave.
Most likely, yes, and cases have already started to tick up. The rate of positive COVID tests rose to 4.5% during the week ending June 1, compared to a 3.8% positivity rate the prior two weeks, according to CDC data. And emergency room visits for COVID rose by 16.2% for the week ending June 1. But hospitalizations and deaths have remained stable.
Already, early signs of the surge are showing up in wastewater monitoring, with hotspots in areas of the Northeast, South, West and in Hawaii, according to Time. Wastewater monitoring can offer a preview of how many people have COVID (or other infectious diseases) before the test positivity rate begins to shift.
The wave is startingbut who knows if were going to have the big summer waves like weve had every summer since [the COVID pandemic] started, Smith says. Adalja says that, with the arrival of a new variant, the uptick in COVID cases is expected. Its nothing unmanageable in the health care system, but its an increase, he says.
Both experts caution that, anytime youre spending time in crowded places, theres still some risk of contracting COVID, especially amid the FLiRT-fueled summer increase. That doesnt mean everyone has to stay home, simply that you should know your risks and do what you can to mitigate them.
The main behavior we should ingrain in our culture is, if youre sick, stay home, says Smith. The flip side is also true: We have to be more forgiving when someone says I dont feel well and I dont think I should come in [to work] or go to that event. We need to be grateful to that person for taking care of us by not exposing us to COVID or anything else that they might have.
Yes. The CDC still recommends testing if you have symptoms of COVID or know youve been exposed to someone with the virus. If you dont feel right, you need to get a test, says Smith. If your initial home test is negative, the CDC says the best way to be sure you are COVID-free is to take a second test within 48 hours if you have symptoms, and three home tests if you have no symptoms.
However, you'll no longer be able to order free tests from the U.S. government. The program was discontinued as of March 2024. Private insurers are also no longer required to pay for the tests. But some insurers still cover the tests, as do Medicaid and Medicare.
The CDC relaxed its recommendations for quarantining after a positive test in March, and now only suggests that people stay home and away from other people if they have symptoms. If you have been fever-free and without symptoms for at least 24 hours, you dont need to stay home.
Smith recommends that if you do test positive, then you need to talk to a doctor about whether or not you need a treatment. However, he adds that we still dont have great treatments for COVID, with Paxlovid being the only approved medication for COVID. Its not like Tamiflu, where you get better faster, but its really about the prevention of severe disease, says Adalja. The CDC advises that Paxlovid which requires a prescription should be given to people who are at high risk of getting severely ill. Paxlovid needs to be taken within five to seven days of developing symptoms.
But for most people, the agency says you can recover at home, and use over-the-counter medications including acetaminophen or ibuprofen to help manage your symptoms.
FILE - Vials of single doses of the Jynneos vaccine for mpox are seen from a cooler at a vaccinations site on Aug. 29, 2022, in the Brooklyn borough of New York. South African health authorities have reported two deaths from mpox in the space of three days. Health Minister Joe Phaahla says Thursday the two fatalities this week were among six recent confirmed cases of mpox in South Africa, all of them men in their 30s.(AP Photo/Jeenah Moon, File)
CAPE TOWN, South Africa (AP) South African health authorities say two people have died this week after contracting mpox, and it appears there is local transmission of the disease.
The health ministry said Thursday that a 38-year-old man died in the eastern KwaZulu-Natal province on Wednesday, the same day a laboratory test confirmed that he had contracted the virus. Another man died Monday in a hospital near Johannesburg, the ministry said.
Health Minister Joe Phaahla said the two deaths were among six recent confirmed cases of mpox in South Africa, all of them in men in their 30s. Some had multiple sexual partners, including men and women. Genetic tests for the first three cases showed the men had the less severe version of mpox, which spread globally in an outbreak that began in 2022.
In all cases, the men had no travel history to countries currently experiencing an outbreak, which suggests there is local transmission of this infectious disease, Phaahla said.
He said the six men had underlying conditions. The latest man to die had HIV. Mpox is known to be more deadly in people with other health conditions, particularly those that weaken their immune systems.
Mpox, also known as monkeypox, is a rare disease caused by infection with a virus thats in the same family as the one that causes smallpox. It is common to other parts of Africa, where people are often infected through bites from rodents or other small animals.
Mpox was not known to spread easily among people until 2022, when authorities detected epidemics in Europe, North America and elsewhere and the World Health Organization declared it a global emergency. That epidemic also marked the first time that mpox was seen to spread via sex; the majority of people affected were gay or bisexual men. The U.N. health agency said last year mpox was no longer an international crisis.
WHO reported last month that there had been 186 mpox deaths worldwide since 2022, with a fatality rate of less than 1%.
South Africa last recorded an mpox case in 2022, Phaahla said. He said South Africa doesnt have any vaccines but was considering obtaining doses and rolling out an immunization campaign.
Phaahla said the outbreak in South Africa is distinct from the ongoing epidemic in Congo, where a more lethal form of the disease might be fueling the countrys biggest-ever outbreak.
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AP Africa news: https://apnews.com/hub/africa
(Precision Vaccinations News)
Researchers recently wrote that combining two monoclonal antibodies for treating chronic herpes simplex 2 (HSV-2) may provide a novel therapeutic option for this expanding disease.
The U.S. CDC says HSV constitutes a significant global health concern due to its wide range of clinical manifestations thatcan affect the skin and mucous membranes, the eyes, and the nervous system.
On May 28, 2024, the Journal of Biomedical Science published results from a study designedto develop a next-generation therapy by combining different antiviral monoclonal antibodies.
This researchshowed that the fully human antibody HDIT102 has the potential for further clinical development as a potent novel HSV therapeutic, particularly in combination with its clinical humanized ancestor antibody HDIT101.
HDIT101 isa humanized IgG that was previously investigated in phase 2 clinical trials.
Both antibodies induced the internalization of gB from the cell surface into acidic endosomes by binding distinct epitopes in domain I of gB and competing for binding.
CryoEM analyses revealed the ability to form heterogenic immune complexes consisting of two HDIT102 and one HDIT101 Fab bound to one gB trimeric molecule.
Both antibodies mediated antibody-dependent phagocytosis by antigen presenting cells which stimulated autologous T-cell activation.
In vivo, the combination of HDIT101 and HDIT102 demonstrated synergistic effects on survival and clinical outcome in immunocompetent BALB/cOlaHsd mice.
In conclusion, these researchers wrote, 'Antibody characteristics to inhibit cell-to-cell spread, to mediate uptake of cell-free virusesby phagocytic cells and concomitantly stimulate T-cell responses may promote cellular immunity and may have benefits in preventing recurrences.'
Antibody therapeutics are available to address a variety of diseases, and the U.S. Food and Drug Administration has approvedmore than 100 products.
Despite years of development,HSV vaccine candidates haveyet to be approved. As of June 10, 2024, several herpes vaccines are conducting clinical research.
Modernasaid on Monday its combination vaccine to protect against both Covid and influenza generated a stronger immune response in adults aged 50 and over when compared to separate shots against the viruses in a late-stage trial.
In the study, the combination using messenger RNA technology generated greater antibodies than currently marketed traditional flu vaccines and Modernas Spikevax mRNA Covid shot, the company said.
The vaccine, called mRNA-1083, elicited a higher immune response against two A strains and one B strain of the flu in older adults when compared with widely used flu shots from GlaxoSmithKlineand Sanofi, according to the company.
The Food and Drug Administration in March recommended drugmakers target those three strains, called H1N1, H3N2, and B/Victoria, when developing their seasonal flu vaccines for 2024.
The latest data was collected from two arms of a larger study that involved around 8,000 people one tested the combination against GSKs Fluarix in adults aged 50 to 64 and another against Sanofis Fluzone HD in people 65 and older. Fluzone is a high-dose vaccine for older people.
Moderna President Stephen Hoge said the drugmaker hopes to launch the combination shot for the autumn respiratory disease season in 2025. If not 2025, then 2026, he said.
The Cambridge, Massachusetts-based company has been banking on new vaccines to make up for vastly lower demand and sales for its Covid shot.
If approved, the combination vaccine would be Modernas third marketed product, having receivedFDA approvalfor its respiratory syncytial virus (RSV) vaccine last month.
Moderna also said the combination was found to be safe and tolerable in the latest study, and that rates of adverse side effects were similar to those of the other vaccines used in the trial.
The most common side effects were injection site pain, fatigue, muscle aches and headache, Moderna said.
The company said it expects to release the full results from the study at an upcoming medical conference.
