Category: Corona Virus Vaccine

For Evans Jutta Kofi Attivor, each dot on the Google map represents an opportunity.

As Municipal Director of Health Service for Nkwanta South municipality of Ghana, Evans is working on catching up children who missed routine immunization during the COVID-19 pandemic in the Nkwanta South of Oti region, located in northeast Ghana. "Each dot represents the geolocation of a child who has missed vaccination, and was followed up through defaulter-tracing," he says.

Last summer, Evans joined the second cohort of theCOVID-19 Recovery for Routine Immunization Programs Fellowshipoffered by the Sabin Vaccine Institute and the World Health Organization. He attended Phase I of the Fellowship, a five-week live engagement series, and then submitted a strategic proposal on his project,Reducing missed opportunities for vaccination: A COVID-19 immunization recovery project in four sub-municipalities in Nkwanta South.

He was accepted to become one of the 60 individual or team Fellows chosen for Phase II, the mentorship program of the Fellowship. Supported with micro-grant funding to help bring his vaccination project to life, Evans and his team are using Google maps in the first round of the immunization project in the rural region.

He started the recovery effort in late 2023, with 12 Community Health Planning and Services (CHPS) facilities from four sub-municipalities out of 30 total. He hopes the project will eventually involve all 30, and possibly become a regional and even a national immunization tracking effort. "We have supervisors, unit heads and sub-municipal leaders from the four implementing sub-municipalities at monthly joint meetings, so all are aware of what's going on and we can reproduce these activities later," he says.

To start, the team focused on planning, partner development and resource mobilization, making certain that every facility had all supplies necessary, assuring that the cold chain structure was in place, and training completed for health care workers. Since 2020, his team has been using an immunization follow-up tool called Nkwanta South Municipal Home Visit/Follow-up Reporting Tool that was designed and deployed on the KoboCollect app. For the Fellowship project, a new app was designed to aid monitoring and data collection, which all supervisors downloaded onto their phones to help capture real-time data in the field. This new tool is designed to record vaccination dates and services provided during supervision as well as to make reporting by the supervisors easy and convenient. "It's part of making certain that we get valid reports," says Evans.

Evans Attivor

"The catch-up campaign includes both static (facility-based) and outreach activities," he adds. "We want to be able to compare our numbers from the field with what the facilities submit and make certain that we can follow up on any discrepancies, to find out exactly what happened and address them."

The main strategy they are using, defaulter tracing, allows the various teams to identify missed children per the vaccination records in the Nutrition and Child Health Registers. In one CHPS zone, the project successfully traced and immunized 81.4% of missed children. Those missed were due to Ill health, vaccine not opened to avoid wastage and child vaccinated but not recorded. Reasons why children defaulted initially included that the child was not available when the vaccination team visited, the shortage of vaccine and breakdown of the motorbike used to transport vaccines. "We work in difficult terrain," he says.

Attivor notes that some of the challenges to service delivery have included transportation and competing activities that sometimes interfere with field work. "We are, however, finding ways to execute all planned activities as well as track our progress," he added.

Midway through the implementation of his Fellowship project, five (41.7%) of the facilities have achieved or exceeded their goals and another four (33.3%) are making good progress. For the three outliers, "We know this is within our reach. We will revisit the data and liaise with the national and regional office to resolve the challenges."

As part of the Fellowship, Evans has been able to check in monthly with his mentor, Katrina Kretsinger, a global immunization expert from WHO. "The monthly meeting with my mentor, which I refer to as the M4 activity Mentee-Mentor Monthly Meeting has given me the chance to discuss opportunities and innovative ideas. I must say that Katrina has really provided me [with] technical advice, motivation and guidance."

Supervisors and facility in-charges after monthly review meeting held on Feb 19, 2024

Evans notes the commitment of his team of municipal and sub-municipal supervisors and the facility in-charges to continue tracing all missed children through home visits. They are also planning to continue conducting monthly reviews, data validation meetings and follow-up to address all issues of population discrepancy.

The Fellowship project, with its monthly group check-ins, training and results, has had a positive impact on everyone, says Evans. "The team is so excited about this project, and some say they are learning so much from it."

This article was originally published by the Sabin Vaccine Institute on 21 February 2024.

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Reaching Every Child with the COVID-19 Recovery Fellowship in Ghana - Gavi, the Vaccine Alliance

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A research team at Freie Universitt Berlin has conducted a comprehensive comparison of the efficacy of a mucosal, replication-competent but fully attenuated virus vaccine, sCPD9-FCS, with the monovalent mRNA vaccine BNT162b2 in preventing the transmission of SARS-CoV-2 variants.

The study, titled "An Intranasal Live-Attenuated SARS-CoV-2 Vaccine Limits Virus Transmission," is published in Nature Communications. The research addresses a critical challenge facing current vaccination strategiesnamely, the limited ability of intramuscularly administered vaccines to induce robust mucosal immune responses in the upper respiratory tract, the primary site of infection and virus shedding.

The researchers compared the efficacy of the live attenuated vaccine (LAV) sCPD9-FCS and a monovalent mRNA vaccine in preventing the spread of two SARS-CoV-2 variants: the ancestral B.1 and the omicron BA.5 in Syrian hamsters. They investigated the performance of the vaccines in two different scenarios.

In the first scenario, they evaluated the protective efficacy of the two vaccines by exposing vaccinated Syrian hamsters to infected antagonists. Here, the LAV vaccine completely blocked infection, while the mRNA vaccine offered no significant protection against infection.

In the second scenario, the transmission of the challenge virus from vaccinated and subsequently infected hamsters to unsuspecting contacts was investigated. In this scenario, transmission was blocked or strongly suppressed by the LAV vaccine but not by the mRNA vaccine. These results clearly showed that the LAV sCPD9-FCS significantly outperformed the mRNA vaccine in preventing virus transmission in both scenarios.

Freie Universitt Berlin virologist Dr. Jakob Trimpert, one of the lead authors of the study, said, "Our results provide compelling evidence for the benefits of locally administered live attenuated vaccines over intramuscularly administered mRNA vaccines. This is a significant advance in improving our ability to prevent infection and reduce virus transmission, particularly in the context of emerging SARS-CoV-2 variants."

According to the team, the COVID-19 pandemic has posed unprecedented challenges to research and society, and the continued spread of SARS-CoV-2 underscores the need for innovative vaccination strategies. The LAV sCPD9-FCS, which was developed by de-optimizing codon pairs, offers a promising solution as it induces strong mucosal immunity in the respiratory tract and systemic immunity against a range of SARS-CoV-2 antigens.

"Our study has addressed the shortcomings of existing vaccines and underscored the potential of intranasally administered vaccines to create a more effective barrier against infection, prevent virus replication and attenuate transmission," said Dr. Dusan Kunec, research group leader at the Institute of Virology at Freie Universitt Berlin, co-author and lead researcher of the study.

Rocketvax founders Dr. Vladimir and Dr. Natasa Cmiljanovic said, "The impressive preclinical results consistently confirm the advantages of our lead SARS-CoV-2 live vaccine candidate sCPD9-FCS, administered intranasally, over intramuscularly administered mRNA vaccines, prompting us to accelerate its further development and translation into clinical settings for its further validation."

According to the research team, the results of the study have significant implications for the future of COVID-19 vaccination strategies. The superiority of sCPD9-FCS in preventing transmission points to a promising avenue for further research and development of intranasal vaccines that offer a potential solution to the challenges posed by emerging variants.

This study provides compelling evidence for the superiority of the intranasally administered live attenuated vaccine sCPD9-FCS in preventing SARS-CoV-2 transmission. The study underscores the importance of exploring alternative vaccination approaches to address the evolving landscape of the COVID-19 pandemic.

More information: Julia M. Adler et al, An intranasal live-attenuated SARS-CoV-2 vaccine limits virus transmission, Nature Communications (2024). DOI: 10.1038/s41467-024-45348-2

Journal information: Nature Communications

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Researchers examine the benefits of COVID-19 nasal spray vaccination - Medical Xpress

After four years of the first covid-19 case in Brazil, it isnt still possible to identify a pattern for the diseases behavior. With vaccination, the infection and death rates dwindled dramatically, as well as the seriousness of the disease for most of the population.

Continua aps publicidade

Even so, the high rate of transmissibility of the virus and the unpredictability of mutations impose a kind of "precarious equilibrium" on the current epidemiological situation.

Antonio Augusto Moura da Silva, an epidemiologist and professor of the Graduate Program in Collective Health at the Federal University of Maranho (UFMA, in Portuguese), states that, as the population acquires immunity against the virus, a pandemic may evolve to an endemic, that is, when a disease becomes recurring in a region, but without a significant number of cases or deaths.

The question that emerges is whether we have already reached this balance, that is, whether the situation has evolved into what we call an endemic. Currently, its difficult to determine whether or not it was reached. We cant affirm it. However, every state of equilibrium for all infectious diseases is always very fragile and can be disrupted by anything new," says the professor.

::Brazil intends to eliminate measles and risks of other diseases with vaccination campaign ::

Moura da Silva says that, although Brazil has not reached this stage, evidence indicates the country is walking "in this direction. However, any balance is precarious, especially if the virus develops a more aggressive mutation. A lethal mutation is a possibility. Mutations are random events, and we can't predict which way they will go," he explains.

This analysis has the same conclusion as Paulo Lotufo, a professor of Internal Medicine at the University of So Paulo Medical School, to whom there isnt yet a total comprehension of the diseases behavior.

He believes that, when dealing with the peaks of COVID-19 cases, its interesting to compare them to those of influenza. While the influenza season follows a well-defined time pattern, COVID still did not show this clarity, making it difficult to predict how things will develop. The vaccine, although its contribution to decreasing serious cases and deaths, doesnt provide for a broad comprehension of covid-19 peaks of cases, he states.

The current perception is that, as seen in other diseases, there will be more vulnerable individuals, such as those with heat conditions. This dynamic is similar to that of influenza, but the pandemic continues to uncover particularities yet to be totally understood and recorded given the complexity constantly evolving.

::Brazil and Cuba strengthen ties at a summit that united the Global South; countries sign a health agreement ::

In this sense, the continuous collection and recording of data is crucial due to the constant transformations, contributing to a more complete and efficient understanding in the management of the health system.

Isaac Schrarstzhaupt, an epidemiologist and data scientist at the Rede Anlise Covid (Covid Analysis Network, in English), also agrees that there is no pattern to the virus's behavior. He affirms further: he doesnt know whether it will be possible to identify some pattern due to the virus's high transmissibility.

Schrarstzhaupt says the SARS-CoV-2 is so infectious that it doesnt depend, for instance, on the seasons, which happens to flu during the winter, when people crowd indoors. In Covid's case, its more related to peoples behavior.

For instance, with people adopting prevention measures less frequently, such as the use of protective face masks, there is an increase in the rate of infection, regardless of whether it is winter or summer. As a result, there is a greater chance of the virus mutating and breaking the current control over the disease. "Mutation is a consequence of this high transmission rate because the virus enters the body, enters cells, begins to replicate, and then mutation occurs. A mutation can make the virus completely useless, or smarter. And then it becomes a new predominant variant."

It is mainly through this explanation that Schrarstzhaupt can't see the establishment of a pattern for the diseases behavior. "For this to happen, the virus would have to lose the capacity to mutate and create so many variants, and the predominant variant that remains would have to be more or less predictable, like influenza. SARS-CoV-2's high mutation rate is what makes me believe its unpredictable, at least not in the medium term," says the data.

Vaccination

In addition to being highly infectious, there is a low COVID-19 vaccination rate, especially among children. Researchers emphasize that the current epidemiological situation is significantly different from the scenario seen before the vaccine. Even so, adherence to the latest doses of the vaccine is lower than desired.

According to the Ministry of Health, from the beginning of COVID-19 vaccination in Brazil, on January 17, 2021, until February 6, 2024, 517 million doses were administered to the general public, 6.7 million of which were to children under five years of age.

Up until now, only 6% of children aged between six months and two years and 6.4% of children aged between three and four years have concluded the monovalent vaccination schedule (bivalent coverage is only for children aged 12 and over). The percentage is well below the target of 90% immunization coverage.

"To reduce cases, the population must adopt protective measures. However, to reduce serious cases and deaths, it's only through vaccination. Data show that the pandemic is nowhere near the emergency phase, but it is still serious and responsible for a large percentage of serious respiratory cases," especially among children and the elderly, says the data researcher.

::Government launches program to eliminate and control malaria, tuberculosis and HIV/Aids ::

In 2024, up to the sixth epidemiological week (February 10-16), there were 4,937 hospitalized cases of Severe Acute Respiratory Syndrome (SARS), with 41% (2,020) of them identified as respiratory viruses. Of these, 64% were due to COVID-19. Regarding deaths, 506 SARS deaths were reported in the same period, with 56% (283) identified as respiratory viruses. Of these, 91% were due to COVID-19. The data is from the Ministry of Health's latest Epidemiological Bulletin.

The Ministry's data shows that the elderly are more infected than children. In terms of deaths, the elderly lead.

What does the Ministry of Health say?

Ethel Maciel, Secretary of Health and Environmental Surveillance at Brazils Ministry of Health, says the current epidemiological situation is "very different" from when the pandemic was considered a Public Health Emergency of International Concern (PHEIC) by the World Health Organization (WHO). "After vaccination, there was very significant control of the disease. So we've gone from 3,000 people dying a day to an average of between 30 and 50 people a day," she explained.

This year, the COVID-19 vaccine became part of the countrys National Immunization Program (PNI, in Portuguese). The Ministry of Health's priority is children aged between six months and five years old and groups with a higher risk of developing severe forms of the disease: the elderly, immunocompromised people, pregnant and postpartum women, health workers, people with comorbidities, Indigenous people, river dwellers and quilombola people; people in long-term care institutions and their workers, people with permanent disabilities, people deprived of their liberty, teens and young people serving socio-educational measures, workers of the prison system, and people living on the streets.

The secretary highlights that "new strains may emerge. However, in the current scenario where the Omicron and its subvariants dominate our vaccines still protect. Our concern lies with those who are falling seriously ill and dying, which are mainly children under the age of two and adults over 70. Therefore, these groups are our current major concern."

"We've already seen a reduction in the number of deaths. Since we have a vaccine and medication, we don't want anyone to die. So one death is already a bad result. But we won't be able to eliminate it overnight. And we never can. We'll always have some remnants. But we're going to work towards an even greater reduction," says Maciel.

Edited by: Rodrigo Duro Coelho

See the article here:

Control over COVID-19 is still unstable in Brazil four years after the first case - Brasil de Fato

Very few nursing home residents are up to date on their COVID-19 vaccination, and for staff, its even lower. New Mexicos numbers are not much better than the country overall.

A KFF analysis shows that New Mexicos nursing facility residents fall just below the national average with a 37% uptake. Staff, on the other hand, have one of the highest rates in the country at just 22%.

Priya Chidambaram, a senior policy analyst with KFF, said national numbers are on the decline.

That is lower than the share that received those same vaccines last year and much lower than the share that received their vaccines when they first became available in 2021, she said.

The numbers arent as low for non-profit facilities as they are for government-run ones.

We found that states that have more non-profit facilities in them have, overall, a higher vaccination rate, Chidambaram said.

The report also noted that states that voted for President Biden in 2020 had higher vaccinatino rates. Other factors included whether facilities had programs to keep residents up to date on vaccines.

KFF also found that over one-fifth of all U.S. COVID-19 deaths have occurred in long-term facilities.

About 90% of nursing home residents received the initial vaccine in 2021.

Even though COVID-19 poses a higher risk for older adults, about 72% of nursing home residentsreceived the flu vaccine as of December.

This coverage is made possible by the W.K. Kellogg Foundation and KUNM listeners.

Read more from the original source:

COVID-19 vaccination rates in nursing facilities are on the decline for residents and staff alike - KUNM

(NewsNation) A new study discovered possible links between COVID-19 vaccines and possible neurological, blood and heart-related conditions.

The new study, published in the journal Vaccine, is the largest of its kind since the pandemic began and could reignite the debate over the risks and benefits of the vaccine.

Over the past three years, more than 13.5 billion doses of COVID-19 vaccines have been administered around the world. The World Health Organization recently announced vaccination has saved at least 1.5 million lives in Europe alone.

The study links vaccines to slight increases in neurological, blood and heart-related conditions such as myocarditis, pericarditis and Guillain-Barr syndrome.

Researchers stressed that an association between the vaccine and adverse side effects does not prove the vaccine caused them and that side effects were rare.

Of the more than 99 million people studied, researchers observed 190 cases of Guillain-Barr Syndrome, which is typically developed after a viral infection but has also been linked to vaccines in rare cases, and 69 cases of hematological conditions.

COVID-19 itself can also cause side effects that affect the heart, including myocarditis.

Those who have experienced side effects include 24-year-old George Watts Jr. of New York, a healthy college student who died of vaccine-related myocarditis two years ago. The condition is listed as a possible side effect of the Pfizer vaccine.

There has been partisan fighting for years, with Republicans objecting to vaccine mandates and saying the vaccine was rushed to market, while Democrats pushed for mandates in the name of public health for Americans overall.

Since the pandemic began in March 2020, nearly seven million people have died globally from COVID-19, including more than one million Americans.

See the rest here:

New study links COVID-19 vaccine to possible health issues - NewsNation Now

A New York man pleaded guilty in Newark federal court Monday for his role in a kickback scheme involving COVID-19 testing, U.S. District Attorney Philip Sellinger announced on Tuesday.

David Weathers, 61, of Bronx, pleaded guilty to his involvement in soliciting kickbacks for the referral of COVID-19 test samples before U.S. District Judge Brian Martinotti, authorities said.

Weathers and co-conspirators solicited kickbacks in exchange for providing COVID-19 test samples to Metpath Laboratories, a clinical laboratory in Parsippany, that conducted testing to detect COVID-19 in samples obtained from individual patients, according to court documents.

Metpath paid kickbacks for the referrals of COVID-19 test samples while billing Medicare and other health care programs for the tests leading to a loss of more than $3.5 million for federal programs, authorities said.

The defendant in this case has admitted to seeking payments for sending COVID-19 tests to a particular lab for processing, Sellinger said in the release. There is no place in our healthcare system for illegal payments made in an attempt to influence medical decisions. My office will continue to prosecute those who attempt to corrupt the health care system.

Weathers faces up to five years in prison and a fine when he is sentenced, scheduled for July 10. Weathers was represented by Jeffery Greco.

Thank you for relying on us to provide the local news you can trust. Please consider supporting NJ.com with a voluntary subscription.

Deion Johnson may be reached at djohnson@njadvancemedia.com. Follow him on Instagram at @DeionRJohnson or X @DeionRJohhnson

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Man involved in COVID-19 testing kickback scheme pleads guilty - NJ.com

Study design and participants

We conducted a prospective cohort study of adults receiving pandemic COVID-19 vaccine (BNT162b2, Pfizer BioNTech) at Eidsvg general practice and Haukeland University Hospital in Bergen, Norway. All participants received the first two doses of BNT162b2 vaccine at a 3-week interval in JanuaryFebruary 2021, and the third dose of BNT162b2 vaccine 1011 months later in NovemberDecember 2021. No vaccinee had tested rt-PCR positive for SARS-CoV-2 or had any COVID-19 symptom before receiving the 1st dose mRNA vaccine.

The COVID-19 patients were participants of a larger case-ascertained study conducted in Bergen, Norway. All patients tested rt-PCR positive for SARS-CoV-2 from nasopharyngeal swabs during March and April 2020. None of the infected patients received any COVID-19 vaccine within 12 months post diagnosis.

The study was approved by the regional ethics committee (Regional Committee for Medical Research Ethics, Western Norway (REK Vest number 118664) and Northern Norway (REK Nord number 218629)) and is registered in the National Institute for Health database Clinical trials.gov (NCT04706390). All participants provided written informed consent before inclusion in the study.

Electronic case report forms (eCRF) were used to collect demographics, comorbidities, infection history (rt-PCR test results and presence of COVID-19 symptoms), vaccination data and side reactions.

The vaccine used in the study was a monovalent COVID-19 mRNA vaccine BNT162b2 embedded in lipid nanoparticles contained 30g of a purified single-stranded, 5-capped messenger RNA (mRNA), encoding the viral spike protein of SARS-CoV-2 from the founder Wuhan-Hu1 strain (pre-alpha). The vaccine was supplied as a multidose vial reconstituted in sodium chloride 9mg/mL (0.9%) containing 0.45ml per dose, 5 doses per vial, and administered by intramuscular injection.

Serum samples were collected pre-, post 1st (day 21) and 2nd doses (2 months), and pre- (9 months) and post 3rd (12 months) vaccination from all COVID-19 vaccinees, and during the acute (08 days post diagnosis), convalescent phase (1676 days post diagnosis) and 12 months (334387 days post diagnosis) after infection from all COVID-19 patients. Sera were separated, aliquoted and stored at 80C until use.

The hCoV-19/Norway/Bergen-01/2020 (GISAID accession ID EPI_ISL_541970, termed as Bergen-1 hereafter) virus was isolated in-house from an rt-PCR-confirmed patient in March 2020 and propagated in Vero cells in a certified Biosafety Level-3 Laboratory.

The human coronavirus (HCoV) strain NL63 (GenBank: AY567487) was obtained from BEI Resources (Cat. NR-470) and propagated in LLC-MK2 cells (ATCC CCL-7) in biosafety level-2 laboratory. The HCoV strain OC43 (GenBank: AY585228) was obtained from BEI Resources (Cat. NR-52725) and propagated in HCT-8 cells (ATCC CCL-244) in biosafety level-2 laboratory.

The full-length spike proteins from SARS-CoV-2 Wuhan-1 isolate (GenBank: QHD43416), HCoV 229E strain (GenBank: A0G74783), NL63 strain (GenBank: AFV53148), HKU1 strain (UniProtKB/Swiss-Prot: Q0ZME7), and OC43 strain (GenBank: AIL49484) were produced in-house in Expi293F cells (Thermo Fisher Scientific) using the constructs provided by Prof. Barney Graham. The S1 and S2 domains of spike protein from SARS-CoV-2 Wuhan-Hu-1 isolate were obtained commercially (Sino Biological Cat. 40591-V08H and 40590-V08B, respectively).

To quantify the SARS-CoV-2 and HCoV spike specific binding IgG, Maxi Sorp 96-well plates (Thermo Fisher) were coated with in-house prepared full-length spike proteins (Wuhan-Hu-1 spike 0.05g/well; 229E, HKU1 and OC43 spikes 0.1g/well; NL63 spike 0.3g/well) or commercial spike proteins (Wuhan-Hu-1 S1 and S2 domains, 0.05g/well) at 4C overnight. Sera were 5-fold serially diluted from 1:100 and tested in duplicates. Biotin labelled anti-human IgG (1:1000, Sigma-Aldrich Cat. B-1140); horseradish peroxidase (HRP) labelled streptavidin (1:1400, Southern Biotech Cat. 7105-05) were added followed by o-Phenylenediamine dihydrochloride (OPD, 0.05mg/well, Sigma-Aldrich Cat. P-8287). The chromogenic reaction was stopped by sulfuric acid. Optical density (OP) values were read at 490nm using a synergy H1 plate reader (BioTek). Immunoglobulin concentrations were interpolated as binding antibody unit (BAU)/ml from the standard curve with purified human IgG (Sigma-Aldrich Cat. I-4506).

To measure serum neutralizing antibody titres, the microneutralization assay was performed in a certified Biosafety Level 3 Laboratory against the infectious hCoV-19/Norway/Bergen-01/2020 (GISAID accession ID. EPI_ISL_541970). Briefly, sera were heat inactivated at 56C for 60min, analysed in serial dilutions (duplicated, starting from 1:20), and mixed with 100 50% tissue culture infectious doses (TCID50) viruses in 96-well plates (ThermoFisher). After one hour incubation, the sera-virus mixtures were added to Vero cells and further incubated at 37C for 24h. Cells were fixed and permeabilized with methanol (Sigma-Aldrich) and 0.6% H2O2 (Sigma-Aldrich) and incubated with rabbit monoclonal IgG against SARS-CoV-2 NP (1:2000, Sino Biological Cat. 40143-R019). Cells were further incubated with biotinylated goat anti-rabbit IgG (H+L) (1:2500, Southern Biotech Cat. 4050-08), and Streptavidin-HRP (1:1400, Southern Biotech Cat. 7105-05). The reactions were developed with OPD (0.05mg/well, Sigma-Aldrich Cat. P-8287). The neutralizing (IC50) titer was determined as the reciprocal of the serum dilution giving 50% inhibition of virus infectivity. Negative samples were assigned a value of 10 for calculation purpose.

A virus neutralizing assay against the HCoV NL63 strain was developed. Serum samples were heat inactivated and 2-fold serially diluted (starting from 1:10) in DMEM supplemented with 2% heat-inactivated fetal bovine serum, 1% non-essential amino acid (Sigma-Aldrich) and 1.5g/L sodium bicarbonate (NaHCO3), then incubated with 100 TCID50 NL63 virus at 3334C for 60min. The mixture was then added into 96-well plates (ThermoFisher) pre-seeded with LLC-MK2 cells (7000 cells/well). The virus neutralization (VN) endpoint titer against NL63 virus was determined as the highest sera dilution giving 100% inhibition of cytopathic effect on LLC-MK2 cells 7 days after infection. Negative samples were assigned a value of 5 for calculation purpose.

When testing for virus neutralizing antibodies against the HCoV OC43 strain, serum samples were heat inactivated and 2-fold serially diluted (starting from 1:10) in RPMI-1640 supplemented with 2% heat-inactivated horse serum, then incubated with 100 TCID50 OC43 virus at 3334C for 60min. The mixture was then added into 96-well plates (ThermoFisher) pre-seeded with HCT-8 cells (15,000 cells/well). After 13 days incubation, 100l/well supernatant were mixed with 50l human O erythrocytes (0.7% v/v). The VN endpoint titer against OC43 virus was determined as the highest sera dilution giving 100% inhibition of hemagglutination. Negative samples were assigned a value of 5 for calculation purpose.

The spike protein amino acid sequences from HCoVs and SARS-CoV-2 used in ELISA and micro-/virus neutralization assays were obtained from NCBI database. Phylogenetic analyses were performed at ngPhylogeny.fr35 using MAFFT (Multiple Alignment using Fast Fourier Transform, default settings), BMGE (Block Mapping and Gathering with Entropy, default settings), and PhyML (Phylogeny software based on the Maximum-likelihood, default settings).

Biological replicates were used in all experiments. Antibody titers and fold-inductions were Ln transformed prior to all statistical analyses. RM one-way or two-way ANOVA with the Geisser-Greenhouse correction and Turkeys multiple comparisons were performed among time points within the same vaccinee or patient group. To compare adult and elderly vaccinees the unpaired t test was performed at each time point. The one-way ANOVA and Bunnetts multiple comparisons were used to compare between COVID-19 patients and vaccinees at different time points. All statistical analyses were performed with GraphPad Prism 9.

Further information on research design is available in the Nature Research Reporting Summary linked to this article.

See original here:

Impact of ageing on homologous and human-coronavirus-reactive antibodies after SARS-CoV-2 vaccination or ... - Nature.com

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A global study of over 99 million people across eight countries has identified two new harmful but very rare side effects of Covid-19 vaccines, an advance that could lead to better health monitoring of immunised people.

Researchers part of an international collaboration called the Global Vaccine Data Network (GVDN) hosted at the University of Auckland assessed 13 neurological, blood, and heart-related medical conditions to see if there was a greater risk of them in patients after receiving a Covid-19 vaccine.

The study assessed deidentified data of millions of people who received a Covid-19 vaccine, and examined if there is a greater risk of developing a medical condition in various periods after getting a vaccine compared with before the vaccine became available.

It found that some patients had heart inflammation conditions like myocarditis and pericarditis after they took mRNA vaccines, and some had muscle-weakening Guillain-Barr syndrome and a type of blood clot in the brain after taking viral vector vaccines.

Researchers also found signs of inflammation of part of the spinal cord (transverse myelitis) after taking viral vector vaccines as well as inflammation and swelling in the brain and spinal cord also known as acute disseminated encephalomyelitis after some people took viral vector and mRNA vaccines.

CDC easing covid isolation guidance

However, the chances of having a neurological event after infection with the novel coronavirus were up to 617-fold higher than following Covid-19 vaccination, suggesting that the benefits of vaccination substantially outweigh the risks, scientists say.

This multi-country analysis confirmed pre-established safety signals for myocarditis, pericarditis, Guillain-Barr syndrome, and cerebral venous sinus thrombosis, scientists wrote, adding that other potential safety signals requiring further studies were also identified

The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals. Single sites or regions are unlikely to have a large enough population to detect very rare signals, study co-author Kristna Faksov said in a statement.

Researchers are conducting further studies to build upon the current understanding of Covid-19 vaccines to better unravel their safety using big data.

By making the data dashboards publicly available, we are able to support greater transparency, and stronger communications to the health sector and public, Helen Petousis-Harris, another author of the study, said.

While the study identified rare safety signals following Covid-19 vaccination, scientists say further investigation is warranted to confirm associations and assess clinical significance of these findings.

Read more:

Two new rare Covid vaccine side effects revealed by global study - The Independent

The largest global vaccine safety study has linked COVID-19 vaccines with small increases in health conditions involving the brain, blood, and heart.

The international team of researchers emphasizes that the chances of getting any of these conditions are still very low. It's important to note that extensive research shows COVID-19 vaccines protect against serious illness, death, and long COVID symptoms.

Across just under 100 million COVID-19-vaccinated people in eight countries, potential links called safety signals were identified by comparing observed rates of 13 specific conditions following vaccination to what we'd expect to see based on prior rates, or 'background risk' of the conditions the rates that these conditions are expected to occur in the absence of COVID-19 vaccines.

"The risk up to 42 days after vaccination was generally similar to the background risk for the majority of outcomes," the authors write in their published paper.

The authors say their multi-country analysis confirmed pre-established links between COVID-19 vaccinations and low risks of myocarditis, pericarditis, Guillain-Barr syndrome, and cerebral venous sinus thrombosis. But the enormous size of the study also meant there was a higher chance of them spotting rarer safety signals that prior studies may have missed.

Since the World Health Organization declared the COVID-19 pandemic on March 11, 2020, nearly 7 million people have died from the disease, including more than 1 million in the US. Over 13.5 billion doses of COVID-19 vaccines have been given, with at least 70.6 percent of the world's population having received at least one dose.

Vaccine rollouts usually identify common and moderate side effects, after excluding dangerous ones during clinical trials. But even in huge clinical trials, extremely rare side effects can go undetected.

"This unparalleled scenario underscores the pressing need for comprehensive vaccine safety monitoring, as very rare adverse events associated with COVID-19 vaccines may only come to light after administration to millions of individuals," the authors write.

Their study sought safety signals observed within the 42 days after receiving viral-vector vaccines (such as AstraZeneca) or mRNA vaccines (such as Pfizer-BioNTech). Health datasets from before the COVID-19 vaccines were used to determine the rates of these conditions that were expected in the general population prior to vaccine rollout, and the observed rates were derived from the same dataset after vaccination.

In the wake of viral-vector vaccines, the team discovered a statistically significant rise in cases of Guillain-Barre syndrome; a rare immune system disorder that affects nerves. Within the group that had these vaccines, 66 cases were expected, and 190 were observed. This increase was not seen after mRNA vaccines.

Following a first dose of the AstraZeneca vaccine, there was a 3.2 times greater-than-expected risk of cerebral venous sinus thrombosis (a type of blood clot in the brain) observed in 69 events, compared to an expected 21. The risks were 1.49 times higher after the Pfizer vaccine's first dose, and 1.25 times higher after second doses.

In March 2021, some countries in Europe suspended the AstraZeneca COVID-19 vaccine after observed versus expected analysis identified thrombosis with thrombocytopenia syndrome as a safety signal.

The analysis found a higher risk of heart inflammation called myocarditis after mRNA vaccines, with observed rates highest after a second dose of Moderna's vaccine. These vaccines instruct cells to produce a protein that resembles the SARS-CoV-2 virus, giving the immune system a preview and prompting it to create antibodies to protect the body.

In rare cases, this immune response can result in heart muscle inflammation. Though COVID-19 vaccine-induced instances have mostly been mild, 28 deaths have occurred.

After a first dose of mRNA vaccines, the risk for pericarditis inflammation of tissue surrounding the heart was 1.7 times higher than expected, and it became 2.6 times higher after a fourth dose.

Potential safety signals were found for transverse myelitis (inflammation of part of the spinal cord) after viral-vector vaccines, and for acute disseminated encephalomyelitis (inflammation and swelling in the brain and spinal cord) after both types of vaccines.

Compared to an expected two cases, seven cases of acute disseminated encephalomyelitis were observed after mRNA vaccines.

"The size of the population in this study increased the possibility of identifying rare potential vaccine safety signals," says first author Kristna Faksov, an epidemiologist at the Department of Epidemiology Research in Denmark.

"Single sites or regions are unlikely to have a large enough population to detect very rare signals."

Vaccines have saved countless lives by preventing the spread of the COVID-19 pandemic, and there is strong evidence that they are safe in the majority of cases and effective. A recent study found that if everyone in the UK was fully vaccinated, about 7,180 out of 40,393 severe outcomes (including deaths) from COVID-19 could have been avoided.

"We have a number of studies underway to build upon our understanding of vaccines and how we understand vaccine safety using big data," says Steven Black, an infectious disease scientist at the Global Vaccine Data Network (GVDN).

Anyone can view the methodology and complete results of this analysis on the GVDN's interactive data dashboards.

The study has been published in the journal Vaccine.

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Largest COVID Vaccine Study Ever Reveals The Actual Health Risks You Face - ScienceAlert

Even while the COVID-19 vaccines have been hailed as one of the greatest achievements in modern science, they have been swirled in misinformation perpetuated by anti-vaccine figures and organizations who question their efficacy and robust safety record. The shots have even been wrongly blamed for high-profile health events, like when LeBron "Bronny" James Jr. suffered a cardiac arrest during practice. While research has shown that a COVID-19 infection is linked to an increased risk in myocarditis, which is inflammation of the heart muscle, how and if that translates to causation from vaccines has been widely taken out of context.

But now, a new study, published in the journal Vaccine, examined the potential health effects of the coronavirus vaccines. In its international attempt to separate fact from fiction, scientists have found that there are some links between the vaccines and adverse health effects to be aware of but more research is needed to land on any definitive conclusions.

What we wanted to do was to see if there was any signal to suggest that COVID vaccines might be associated with an increased risk of certain medical events occurring, Helen Petousis-Harris, a co-author of the study and co-director of the Global Vaccine Data Network, told Salon. So what we did was we compared what we would normally expect to see because these events occur all the time what would you normally expect to see, and what are we actually seeing.

Misrepresenting this study doesnt tell the whole story about weighing the risk between being unvaccinated and getting infected with COVID-19.

The study included 99 million people across eight countries and found that the first, second and third doses of Pfizer-BioNTechs and Modernas mRNA vaccines were linked to rare cases of myocarditis. Specifically, people who received a second dose of Moderna vaccine were 6.1 times more likely to have myocarditis. The condition also developed among people who received the Pfizer vaccine while researchers identified that pericarditis had a 6.9-fold increased risk for those who received a third dose of AstraZenecas vaccine.

There was also a 2.5-times increased risk of developing the rare autoimmune disorder called Guillain-Barr syndrome linked to those who received AstraZenecas vaccine. Separate research has found that COVID itself can cause this syndrome at a rate far higher than vaccines.

Petousis-Harris told Salon in general that the researchers werent surprised with the findings, in part because previous research had already pointed to the rare risk associated with vaccination and conditions like myocarditis and pericarditis. But they did pick up something that hadnt been discussed before: a link between AstraZeneca's viral-vector vaccine and acute disseminated encephalomyelitis, a rare condition that causes inflammation and swelling in the brain and spinal cord.

And what that enabled was to take the next step, to a different kind of study, to really ask the question: Is this a problem? she said. Our colleagues in Australia performed a study in 6 million people, which is in the same issue, to look at that, and found that essentially after the viral-vector vaccines, the risk is about less than one extra case per million doses. So very very rare.

Notably, the risk was not observed in the mRNA vaccine design.

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As Salon has previously reported, COVID-19 vaccines changed the course of the pandemic. The mRNA technology, which was novel at the time, allowed for an effective vaccine to be developed in record time. Yet what the scientific community saw as a historic moment for biotechnology turned into a polarizing debate among American lawmakers who fell for conspiracy theories and misinformation surrounding the vaccines marking a pivotal turning point for the anti-vaccine movement. Typically, misinformation about vaccines doesn't appear out of nowhere. There is usually a kernel of truth to it, and the misinformation persists because it lacks context.

Unsurprisingly, this study is already being used to justify long-held concerns about the vaccines. But experts say that doesnt come as a shock and that misrepresenting this study doesnt tell the whole story about weighing the risk between being unvaccinated and getting infected with COVID-19, and getting vaccinated against COVID-19. For example, previous research has found that the risk of myocarditis is seven times higher from getting a coronavirus infection than getting vaccinated.

Glen Pyle, a molecular cardiologist who investigates cardiac injury associated with COVID-19, told Salon via email the most recent study is a great example of the continuous safety monitoring that vaccines are subjected to, and it confirms much of the safety work already done.

For example, with adverse events like myocarditis it shows that these events are very rare, he said. And when we stack these rare risks up against the overwhelming cardiovascular benefits of vaccination, the case for vaccination becomes clear.

Previous research has found that the risk of myocarditis is seven times higher from getting a coronavirus infection than getting vaccinated.

Pyle added that this study highlights the need for public health experts to communicate the risks of vaccination and how common they are in the right context.

For example, myocarditis is a very rare complication that increases primarily in younger males, he said. On the other hand, cardiac arrhythmias are far more common and they increase significantly with infection, but not vaccination in fact, vaccination decreases these risks.

He added there are small but real increases in rare risks after vaccination, compared to large increases in very common risks with COVID-19.

This strengthens the case for vaccination, and why cardiovascular societies throughout the world recommend vaccination, especially for people with cardiovascular conditions. Petousis-Harris said its hard when a study like this is published because risk communication is a complex science on its own.

You have lots of ways you need to communicate this, and I think it's vital to be open and transparent with people, but you also have to work hard at how you are able to present to them, she said. I think it's important to empower our people who are health professionals and vaccinators to be able to confidently have those conversations with people and have the tools that they need to help show people what the risks look like.

She emphasized that any pharmaceutical has risk of side effects.

Probably vaccines are the safest of all pharmaceuticals by a longshot, Petousis-Harris said. One of the challenges is actually expressing how safe they really are. And another challenge is that we have health events happen by chance all the time, and they may or may not be related to a vaccine.

She added that what has become clear is that its been difficult for people to grasp this nuance when it comes to the COVID-19 vaccines.

People are really interpreting anything bad that happens after the vaccine has therefore been caused by the vaccine, Petousis-Harris said. Notably, the study only examines links and associations potential safety signals, its not definitively declaring a cause. Ultimately, if the issue is transparency, this is transparent.

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Major COVID vaccine study finds heart risks are rare and the real threat is being unvaccinated - Salon