Category: Covid-19 Vaccine

Senate Bill 295, filed by Smithfield Senator Lindsey Tichenor, is being billed as a medical freedom measure.

In a statement, Tichenor argues Kentucky citizens were "forced to make compromising health decisions in order to retain their employment, gain access to medical treatment, or to enroll in schools during the response to the pandemic." The bill would block compulsory COVID or mRNA-based vaccinations in those instances.

The lawmaker goes on to call the vaccines "ineffective" and "dangerous."

SB 295 represents a pivotal step in addressing the complexities surrounding vaccination mandates and underscores the importance of preserving individual liberties in the face of public health challenges, Tichenor wrote.

The largest study to date of COVID vaccine safety looked at nearly 100 million vaccinated people across eight countries. The World Health Organization's Global Vaccine Data Network examined 13 medical conditions, including myocarditis, convulsion, and Guillain-Barr syndrome and found elevated risks associated with the vaccines.

Even with the findings, however, researchers concluded the risks from COVID-19 itself remain much higher than the risks of adverse events.

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Kentucky bill bars COVID vaccination mandates in certain situations, citing risk of adverse events - WUKY

(Precision Vaccinations News)

The US Food and Drug Administration (FDA) announced in a post on X that on May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

On February 26, 2024, the FDA confirmed that changes to the vaccine composition may be necessary based on the currently circulating strains of the virus that causes COVID-19.

After receiving any recommendations from the VRBPAC regarding the 2024-2025 formula update, the FDA plans to take appropriate regulatory actions on updated COVID-19 vaccines so that manufacturers can make them available by September 2024.

The FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.

Background material and the link to the online teleconference and/or video conference meeting will be available on theAdvisory Committee calendar no later than twobusiness days before the VRBPAC meeting.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time.

Contact Information:Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, FDA, 202-657-8533 or[emailprotected].

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US FDA to Review COVID-19 Vaccine Formulas on May 16, 2024 - Precision Vaccinations

As the world navigates through the lingering mist of the COVID-19 pandemic, a groundbreaking study has emerged, casting a new light on the voyage we've embarked upon with mass vaccination. This exploration, encompassing the health data of approximately 46 million souls, reveals a compelling narrative about the vaccines designed to shield us from the virus's wrath. It's a tale of protection against severe illness and an unexpected champion of heart health, despite unveiling a slight uptick in certain medical conditions.

The study in question unfurls a tapestry of data illustrating that vaccines not only arm us against COVID-19 but also fortify our defenses against heart attacks, strokes, and other menacing blood clot-related conditions for a span extending at least six months post-administration. This revelation is particularly poignant, considering the virus itself can set the stage for serious cardiovascular complications. The essence of this discovery lies not merely in the numbers but in the lives potentially saved by this dual protection.

Yet, no journey is without its perils. The study acknowledges a slight increase in the risk of certain conditions, including Guillain-Barr syndrome, Bell's palsy, convulsions, myocarditis, and pericarditis, attributed to the vaccines from Moderna, Pfizer-BioNTech, and AstraZeneca. Myocarditis cases, for instance, showed a notable increase following the second dose of Moderna's vaccine. However, the narrative takes a turn when considering these adverse effects remain significantly rarer compared to the risks posed by the virus itself. The dialogue surrounding vaccine safety is nuanced, emphasizing that while the journey is not devoid of risk, the path of vaccination leads to a greater safeguard against the tempestuous seas of COVID-19.

In the wake of these findings, the medical community and public health officials remain steadfast in their support for vaccination. The Global COVID Vaccine Safety project, backed by esteemed institutions, steers this ship with a clear message: the benefits of COVID-19 vaccination far outweigh the potential risks. This stance is not born out of complacency but from a rigorous examination of the data at hand. As we venture further into this uncharted territory, the potential for refining vaccine formulations and administration strategies illuminates the horizon, promising smoother seas ahead for global health.

In essence, the study underscores the critical importance of vaccination in our collective battle against COVID-19. It serves as a reminder of the vaccines' role not just as a shield against the virus but as a beacon of hope for preventing the heart-related storms that the virus can provoke. As we continue to sail through these turbulent times, the key to navigating safely lies in heeding the science, understanding the risks, and embracing the protective embrace of vaccination.

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Navigating the Waters of COVID-19 Vaccination: A Heartfelt Perspective on Risks and Rewards - Medriva

Moderna (MRNA) shares surged in early trading on Thursday after posting better-than-expected fourth-quarter results. The biotech company reported a surprise profit in the quarter, with CEO Stphane Bancel telling Yahoo Finance Live that "last year was a transition year" for the company.

Oppenheimer & Co. Biotechnology Analyst Hartaj Singh argues that investors should focus less on the Covid-19 business and more on the company's pipeline, given that this should be "a trough year" for Covid-19 vaccine revenues. Singh believes that over the next 6 to 9 months, there will be "a relentless discussion" around the company's pipeline, which he says is "great" given that he thinks "this should be a five-product company in 2026."

Watch the video above to hear why Singh says Moderna is the "kind of stock you want to own."

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

Editor's note: This article was written by Stephanie Mikulich.

- Shares of Moderna up just about 6.5% this morning after reporting better than expected sales when it comes to the estimates that we got here from the street. Now, all of this coming despite the fact that sales for its COVID-19 vaccine pulled back just about 43% from a year ago.

Yahoo Finance spoke with Moderna CEO, Stphane Bancel, about the decline in COVID vaccines. And here's what he had to say.

STPHANE BANCEL: I think we can do much better as a company and also working with public health leaders to increase vaccination rates. Americans need to know, if you are 65 and above, you have five times more chance to get hospitalized because of COVID than because of flu. And as you know, many more people take a flu shot than a COVID shot, so we have to do better there.

- All right, for more on these results, we want to bring in Hartaj Singh, he's Oppenheimer's biotechnology analyst. Hartaj, it's great to see you here. So I'd love to get your reaction to what we just heard from Stphane Bancel and also just putting this in perspective for us. Because over the last couple of quarters, we've talked about the fact, the risk of the decline in the uptake here of COVID-19 vaccines, what that risk or challenge them poses here to Moderna. Are we starting to see that narrative shift just a bit as we get more positive results on RSV? And also some of the excitement surrounding its cancer immunotherapy.

Story continues

HARTAJ SINGH: No, thank you, Seana. And I really appreciate you all having me as always. You know, look, here's the thing, this has been a story around COVID-19 vaccines, the sales, and the underlying trends. When we upgraded earlier this year, we basically said that, look, this is a story that this year will change from COVID-19 vaccine trends and COVID-19 vaccine revenues to basically a pipeline story and with the company being potentially a five product company in 2026.

And I think today what you saw was they reported COVID-19 vaccine revenues that were in line with what we were expecting. This probably should be the trough year. On the call, the company reiterated their guidance for the full year of 2024. And especially I think in January and February, it didn't seem like there was any big change to vaccination trends one way or another. That should give us pause that this should be a trough year for COVID-19 vaccine or COVID vaccine revenues.

The second part to your point that more and more, the conversation is coming up on their pipeline. On conference calls, investor calls, 70%, 80%, 90% of the questions used to be on COVID-19 vaccine revenues. Now, people are talking about flu. Phase two will read out this year. The combination flu and COVID-19. A phase three will read out later this year. CMV cytomegalovirus, this is for pregnant women. That will hopefully read out later this year. And cancer vaccines, rare diseases, those are trials that are initiating.

So you can already see suddenly the change happening where we're going from discussing COVID-19 revenues and vaccination trends relentlessly like Stphane was talking about to now really talking about the pipeline.

- Well, the shares right now down by about 41%, investors waiting for that pipeline story to really ring through to some of the financial results. So where are we in the mRNA platform, messenger RNA as a platform and iterating on top of what they already have to really bring some of these new solutions, treatments to market?

HARTAJ SINGH: Yeah, but so the mRNA platform is a really good question, and it matters in a way. So as a biotech analyst, what does a platform mean to me?

A platform means that the company has an approach with either a type of a molecule. For Regeneron with antibodies. Gilead, infectious diseases. Vertex, they're agnostic but they go after understanding disease pathology. With Moderna, it's the mRNA. And what does that mean? What that means is you should be able to shorten development times, increase the probability of success for your development candidates that follow the first approval, in which in this case, it was the COVID-19 vaccine revenues. Sorry, vaccines.

If you go back to the R&D slides from last year, you'll see that that's exactly what they're doing. As they're developing products in RSV, in flu, in combo vaccines, in cancer vaccines, in rare diseases, they're shortening the development times and they're increasing their probability of success.

So we're already seeing that this is a company that's beating historical estimates. And that's the kind of stock you want to own if you're a kind of a mid to long-term holder because that means that every product will just get on market faster with a higher degree of certainty.

- Right. Cutting down some of the R&D costs as well along the way here. So for investors that are looking around that time horizon, how far out should they be looking?

HARTAJ SINGH: Look, the first six to nine months here is really just going to be all about the pipeline. We're not going to see COVID-19 sales until-- the insights there until about the second quarter call in late July or even the third quarter call in late October.

So really, the discussion about next six to nine months are going to be all centered around the pipeline, which I think is great because people are now going to start getting comfortable with the idea that they should have a flu vaccines approved next year, RSV approved this year, a combination vaccine flu and COVID-19 approved next year. Cytomegalovirus vaccine possibly approved next year. The readout is good later this year.

So what we're going to see now is a relentless discussion next six to nine months around the pipeline and these projects. So we should start seeing it very quickly. And our upgrade stated in January, a couple of months ago, that this should be a five-product company in 2026. And the update today underlined our conviction there.

- Oppenheimer analyst, Hartaj Singh. Hartaj, thanks so much for taking the time here today to break down the Moderna results. Certainly appreciate it.

HARTAJ SINGH: Thank you for having me.

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Moderna rises on Q4 results: Focus on the pipeline, analyst says - Yahoo Finance

Key points:

Moderna reported a surprise profit in the fourth quarter of 2024, with earnings of 55 cents a share, a decrease from $3.61 a share in the same quarter a year ago. The company's net income exceeded expectations, despite a decline in sales of its Covid-19 vaccine, Spikevax. Revenue for the quarter was $2.81 billion, down from $5.08 billion in the year-ago quarter, but above projections for $2.51 billion.

The company's Covid-19 vaccine netted $800 million in U.S. sales and another $2 billion in international markets. The quarter also included the recognition of $600 million in deferred revenue related to Gavi, the Vaccine Alliance, an international organization created to improve vaccine access for children in poor countries.

Moderna's cost-cutting efforts and deferred payments contributed to the surprise profit. The company also set out a commercial roadmap for its vaccines in Europe and its experimental respiratory syncytial virus (RSV) shot. Moderna expects a U.S. approval decision for its RSV vaccine by May 12 and plans to launch the RSV shot in Germany and Australia this year.

Data posted earlier this month showed the RSV vaccine was 63% effective at preventing RSV-related respiratory symptoms after 8.6 months, down from 84% at 3.3 months. Moderna also expects data from late-stage trials of its next generation COVID shot and its cytomegalovirus and COVID-flu combination vaccines this year.

Despite the decrease in earnings and revenue, Moderna reaffirmed its 2024 forecast of $4 billion in sales, the lowest figure for annual revenue since its COVID vaccine got U.S. emergency authorization in late 2020.

Excerpt from:

Moderna's Unexpected Q4 Profit TradingView News - TradingView

Population and clinical data

Inclusion criteria were: having received at least one dose of a COVID-19 vaccine that was being administered in Sweden during the study period (Comirnaty, Spikevax, Vaxzevria), being diagnosed with a condition or event that was attributed to the vaccine, being 18 years or older at time of recruitment, and having the capability to provide informed consent. Causality assessment for AEFIs were performed according to WHO criteria, as described previously11. The vaccines are detailed as follows: Comirnaty is the proprietary name for the Pfizer-BioNTech mRNA vaccine, also known as BNT162b2. Spikevax is the proprietary name for the Moderna mRNA vaccine, also known as mRNA-1273. Vaxzevria is the proprietary name for the Oxford-AstraZeneca adenoviral-vector vaccine, also known as Covishield, ChAdOx1 nCoV-19, and AZD1222. Anonymous blood donor (BD) samples had been collected for research use before the COVID-19 pandemic at Uppsala University Hospital. APS1 patient samples were collected as part of an ongoing registry (Swedish Addisons Disease Registry; ethics approval number: 2008/296-31/2).

Basic demographic data, elapsed time from vaccination until AEFI onset, and other clinical characteristics were collected from medical records and standardized questionnaires. Patients were classified according to AEFI diagnoses into the following groups: coagulation, neurological, allergic, cardiac, major adverse cardiac events (MACE), cytopenia, systemic disease, infection, vascular, and other. Exact diagnoses included in each group are detailed in Supplementary Table 1.

Venous blood samples of patients with AEFIs (n=290) were collected into EDTA-containing tubes. All samples were centrifuged to obtain plasma (1500g, 10min, 4C), aliquoted, and sent for storage at 70C. De-identified samples were received at or transferred to the Medical Biochemistry and Microbiology Department of Uppsala University for analyses.

The screening of type I IFN autoantibodies was performed via an established bead-based anti-IgG assay that has been used previously with demonstration of reproducible results13. The large multiplex assay analysis plan was created to examine autoantibodies against 96 designated bead IDs (antigens, including technical controls) in a grand total of 2112 samples. Antibodies against IFN- (IFNA1, 2, 4, 5, 6, 7, 8, 10, 14, 16, 17 and 21), IFN- (IFNB), IFN- (IFNE), IFN- (IFNK), and IFN- (IFNW) were measured in the study population for the specific purpose of the presented hypothesis. As part of the large multiplex assay, all samples underwent measurement of anti-human immunoglobulin G and antibodies against the primary proteins of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), including Spike (S protein), receptor binding domain (RBD), and nucleocapsid (N protein). Antibody levels against the Epstein-Barr virus nuclear antigen 1 (EBNA1) were also measured to assess the detection reliability and reproducibility of measurements.

Samples (1 ul) were diluted with a 2-step process: 1:25 in phosphate-buffered saline (PBS) and then a further 1:10 in a solution containing 0.05% Tween-20, 3% BSA and 5% non-fat milk in PBS. Magnetic beads (MagPlex, Luminex Corp.) were coupled with commercially-available type I IFNs (and other proteins examined) at a concentration of 3 ug per 1.5 10^6 beads. For coupling, the AnteoTech Activation Kit for Multiplex Microspheres was used (Catalog code: A-LMPAKMM-10). The diluted samples (250 ul total volume) were incubated with 5l of the bead solution for two hours at room temperature with slight agitation achieved by a shaker set to 650rpm. Following the incubation, beads were magnetized before washing with 0.05% Tween-20 in PBS (3X), and then resuspended in 50 microliters of 0.2% paraformaldehyde for 10min. After another 3X wash process, a 30-min incubation with the secondary antibody (Invitrogen, H10104 lot#2384336) was performed. Measurement was carried out with a FlexMap 3D instrument (Luminex Corp) and results were recorded in AUs.

The initial multiplex screening (bead-based assay, Luminex) results were confirmed via optimized ELISA methods for several IFNs that were selected due to the presence of at least one sample with elevated response in the bead-based screening. That is, ELISA re-analysis was performed for a certain IFN if at least one elevated response had been observed in either the AEFI or the BD group for said IFN (defined as >1500 AUs, based on Bastard et al.14). According to this criterion, we performed confirmatory testing for IFNA2 (number of samples with elevated response = 1), IFNA6 (n=7), IFNA8 (n=2), and IFNK (n=1). For each antigen, the highest 8 samples (including those with elevated response) were included in the analyses (total n=32). Starting sample dilution was 1:10 and was increased based on optimization goals described in the Supplementary Methods (1:20, 1:40, 1:80, 1:100, 1:160, 1:320, 1:1000, 1:2000, 1:5000, 1:10000, 1:20000, 1:25000, 1:50000, and 1:100000). In addition to the tested samples, we included three patients with APS1 as positive controls, one sample known to have high cross-reactivity (or non-specific binding), and three known-negative BDs during the course of each ELISA optimization (Supplementary Fig. 1).

The neutralization properties of equivocal responses (n=4) detected in the multiplex autoantibody assay were analyzed via cell culture experiments modified from previously-reported methods23. The experimental design involved (i) cell plating, (ii) co-transfection with Firefly (type I IFN-stimulable) and Renilla luciferase (constitutive expression) genes, (iii) stimulation with IFNA2 & addition of samples, and (iv) detection via a dual luciferase reporter assay. On day 1, HEK293T cells were seeded at 45000 cells/well in a 96-well plate (clear, flat-bottom, cell culture) with a final volume of 90 ul growth media per well (Gibco DMEM GlutaMAX + 10% fetal bovine serum + 100 units of penicillin-streptomycin). Transfection was performed with the Firefly pGL4.45[luc2P/ISRE/Hygro] and Renilla pRL-SV40 internal control luciferase vectors (Promega; #E414A and #E2231, respectively). The transfection solution was created in OptiMEM media with a 3:1 (ul:ug) ratio between the X-tremeGENE9 transfection reagent (Sigma-Aldrich; 6365787001) and total DNA (inter-vector ratio: 2:1 between Firefly and Renilla). The solution was incubated for 15min and added to the wells (10l). On day 2, following overnight incubation, stimulation was performed with a final concentration of 10ng/ml IFNA2 in wells (MedChemExpress; HY-P7022), except for non-stimulation controls. Immediately after stimulation, plasma samples were added into the wells to create a final plasma dilution of 1:10 in media, except for non-plasma controls. The plasma samples tested for neutralization included APS1 samples, AEFI samples with equivocal positivity (n=4), and BD samples. On day 3, following 24h of incubation, the Dual-Luciferase Reporter Assay System (Promega; #E1960) was used for analysis as described by the manufacturer (cell lysis, transfer of lysates to white opaque plates, and measurement with sequential addition of substrate and inhibitory/activating solutions). To perform quantification, we employed a plate reader that had luminescence quantification capabilities with magenta (Firefly) and green (Renilla) filters (Tecan, Magellan). The Firefly:Renilla ratio was used to assess neutralization. Technical controls confirmed experimental success, APS1 samples showed strong neutralization (ratios of <0.050), and BDs showed similar results to non-plasma controlsindicating non-neutralization (Supplementary Fig. 1).

To obtain descriptive data and perform statistical analyses, we utilized the SPSS software (version 25.0; IBM, NY, USA). Continuous data were summarized in the form of meanstandard deviation. Categorical data were summarized with absolute (n) and relative frequency (%). Normality of distribution in continuous variables was checked via evaluation of Q-Q plots or histograms. When required, the lack of normal distribution was confirmed via the Shapiro-Wilk or the Kolmogorov-Smirnov (Lilliefors correction) tests. The Kruskal-Wallis test was used to compare continuous variables among diagnosis subgroups (and the BD group), and post hoc adjustments were performed with the Bonferroni correction. In the comparison of groups formed according to the presence/absence of elevated response (>1500 AUs), analyses for continuous data were performed with the MannWhitney U test and we used appropriate Chi-square tests for categorical data. For data visualization in the form of scatterplots and the heatmap, we respectively used the ggplot2 and pheatmap packages installed on RStudio software (Cherry Blossom release, 2023.03.1-Build 446)24. All code used to analyze data are available upon reasonable request from the corresponding authors. Dimensionality reduction was performed via principal component analysis (PCA) with use of the prcomp and factoextra packages in RStudio. The APS1 group was excluded from PCA. All type I IFN values were standardized with the calculation of Z-scores. Antibody levels for IgG, EBNA1 and SARS-CoV-2-related proteins were not included in the PCA in order to be able to detect the potential effects of IFNs since smaller effects (and subgroups) could have been masked by variables with far greater impact (Supplementary Fig. 3).

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

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No link between type I interferon autoantibody positivity and adverse reactions to COVID-19 vaccines | npj Vaccines - Nature.com

Since 2022, member states of the World Health Organization (WHO) have been negotiating a new treaty provisionally termed the Pandemic Agreement. If adopted, it would transform how the world handles pandemic prevention, preparedness and response. Opinions differ on what negotiators should prioritize. But no issue has captivated public attention as much as vaccine equity or done more to bring countries to the negotiating table.

During the COVID-19 pandemic, scientists began to design vaccine candidates only a few hours after the first SARS-CoV-2 genome sequence was shared. By the end of 2020, mass vaccination had begun in the United States and Europe. High-income countries promised to share vaccines through the voluntary WHO COVID-19 Vaccines Global Access (COVAX) programme, but failed to meet their commitments. When South Africa and India appealed to the World Trade Organization for an emergency waiver of intellectual-property rights related to COVID-19 vaccines, so that every country could start their own manufacturing, high-income countries blocked the proposal for months. The refusal of wealthier nations to cooperate had cost between 200,000 and 1.3 million lives by the end of 2021 in low- and middle-income countries1,2. Today, nearly one-third of the worlds population has still not received a single dose, and the death toll resulting from vaccine nationalism continues to grow.

Global vaccination must be swifter

The Pandemic Agreement could be the last chance to fix this problem before the next COVID-19 arrives. Yet the proposed solution the Pathogen Access and Benefit-Sharing (PABS) System, which was outlined in Article 12 of the latest treaty draft still hangs in the balance. The second-to-last session of the treatys Intergovernmental Negotiating Body is now under way. So far, countries have been unable to agree on this part of the text. As time runs out, we urge WHO member states to agree on a science-for-science mechanism that ensures vaccine equity in the next pandemic.

Across all fields, scientists from the global north have frequently extracted data and samples from the global south without the permission of the people there, without collaborating meaningfully if at all with local scientists, and without providing any benefit to the countries where they conduct their work. In 1993, the Convention on Biological Diversity recognized parties sovereign rights to their genetic resources. Since 2014, under the Nagoya Protocol on Access and Benefit-sharing, countries have developed their own legislation to ensure that they receive benefits (such as financial compensation or scientific collaboration) when scientists and others from outside the country access their genetic resources.

Discussions on access and benefit-sharing in global health began in earnest in 2007, when the Indonesian government refused to share avian influenza samples with the rest of the world, on the grounds that such samples were often used to make vaccines that were never made available in most places3. Sparked by this conflict and the 2009 H1N1 flu pandemic WHO member states developed the 2011 Pandemic Influenza Preparedness (PIP) Framework to streamline the sharing of influenza viruses with pandemic potential, as well as vaccines and other benefits.

After the 2009 H1N1 influenza pandemic, the World Health Organization designed a plan for global sharing of flu viruses and vaccines. The same must be done for all viruses with pandemic potential.Credit: James Hill/Redux/eyevine

Under the PIP Framework, 14 manufacturers have promised that when the next influenza pandemic starts, they will share up to 10% of the vaccines that they make (around 420 million doses) with the WHO. In exchange, these companies have access to a global network of laboratories and their flu samples. The PIP model shows significant promise, but is so far untested and applies only to influenza.

The proposed PABS System in the Pandemic Agreement would take lessons from the PIP Framework and apply an access and benefit-sharing scheme to any pathogen with pandemic potential, such as SARS-CoV-2. Under the PABS System, scientists would share pathogen samples and data through a global network of laboratories and sequence data repositories. In exchange for access to samples and data, manufacturers of vaccines or therapeutics would give at least 20% of their products to the WHO (half for free, and half at affordable prices). The WHO would then distribute these on the basis of public-health risk and needs. Users of the PABS System would also contribute to a capacity-development fund, and be encouraged to explore other kinds of benefit-sharing, such as scientific collaborations and technology transfer.

With regard to physical samples, the Nagoya Protocol and its national implementing legislation can be cumbersome to navigate4. Some scientists are apprehensive about the idea of introducing similar barriers into work with genetic sequence data, especially during outbreaks.

Global pandemic treaty: nations wrestle with how to fairly share virus data

In relation to the Nagoya Protocol, several professional societies, including the American Society for Microbiology, have endorsed a group of US scientists that opposes any restriction or control of access and/or use of any genetic sequences (see go.nature.com/3i5ds). Comments from sessions indicate that such concerns are increasingly being echoed by representatives of global north countries in the current Pandemic Agreement negotiations. Some critics have even argued that the proposals for PABS would block progress towards open science, in favour of a transactional approach5.

As a collective of 290 scientists from 36 countries, we argue that a pandemic treaty cannot succeed unless it ensures that everyone will benefit from pandemic science.

Under the new treaty, should it be adopted with the current vision of the PABS System, countries will still be expected to ensure that their scientists share lifesaving data openly and rapidly. Scientists will still be able to share their data freely outside of PABS platforms, and widely used databases could enter into the PABS System meaning that most researchers would never experience any disruptions to their workflow. The WHO could also establish its own repository or clearinghouse for genetic sequence data and samples, which would potentially provide scientists with more transparent management of these resources and the guarantee of continued access.

Financing committed largely by pharmaceutical firms using these platforms (which sometimes directly derive profits from publicly funded science) would, in turn, go towards expanding sequencing capacity and scientific research in low-resource settings. It would also help to support other priorities, such as pandemic prevention6. Whats more, scientists everywhere, but especially in the global south, would benefit from a system that creates opportunities for international collaboration and that ensures that people receive credit for sharing their data.

Access and benefit-sharing could just as easily be called science for science: the PABS System will support more pandemic science, and ensure that scientists contributions result in their communities having access to lifesaving advancements.

Earlier this week, the Intergovernmental Negotiating Body for the Pandemic Agreement reconvened for its penultimate session. If Article 12 is weakened or dismantled, it will be a monumental setback for global health justice and for the global scientific community.

Although todays scientific community has embraced the ideals of open data sharing, the world is no closer to a fair system for sharing vaccines and therapeutics. Intellectual property, not benefit-sharing, is the antithesis of open science. We dream of a world in which such barriers are dismantled for lifesaving medicines. Until that day, the Pandemic Agreement offers the last best chance to avoid repeating the mistakes made during the COVID-19 pandemic.

C.C. has previously received funding support from the Coalition for Epidemic Preparedness Innovations, and has been a consultant for the US Department of State on Global Health issues. D.B. is a member of the Lancet-PPATS Commission on Prevention of Viral Spillover. A.P. has advised multiple countries pro bono on the treaty negotiations and has consulted for the WHO on international law. C.C. and A.P. receive funding support from the Carnegie Corporation of New York and the US National Science Foundation for research related to the Pandemic Agreement. We declare no other competing interests.

Originally posted here:

Save lives in the next pandemic: ensure vaccine equity now - Nature.com

One of the great perplexities of our time is how do we get this country back on the rails if there's so much money to be made peddling ignorance and dangerous nonsense. The Washington Post reports that Covid misinformation

According to the WP, there are connections between these organizations and some of the more energetic Bible-banging enterprises, as well as the libertarian Right. And the people in charge are living the sweet life as well.

They also have connections that reached into the Capitol on January 6, 2021. It's all one big universe of crazy, and now it pays very well.

It's a living, I guess. For these people, anyway.

Charles P Pierce is the author of four books, most recently Idiot America, and has been a working journalist since 1976. He lives near Boston and has three children.

See the rest here:

Washington Post Report: Covid Vaccine Misinformation Groups Generated Big Revenue - Esquire

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ABC is dealing with legal troubles and "religious discrimination claims" from two former employees who worked for the long-running soap opera "General Hospital," according to a report from Wednesday.

The two former crew members "sued the network after they were fired for refusing the COVID-19 vaccination, marking one of the first rulings to clear the way for trial over terminations caused by blanket vaccine mandates widely imposed by studios amid the pandemic," The Hollywood Reporter revealed.

Per an order shared by the outlet, the two former ABC members, James Wahl and his son, Timothy Wahl, ran the construction shop and special effects department for "General Hospital."

LARGEST-EVER COVID VACCINE STUDY LINKS SHOT TO SMALL INCREASE IN HEART AND BRAIN CONDITIONS

ABC is dealing with legal troubles and "religious discrimination claims" from two former employees who worked for the long-running TV show "General Hospital," according to a report from Wednesday. (Getty Images)

Judge Stephen Goorvitch in an order on Tuesday found they "may have had sincerely held religious beliefs that ABC should have accommodated by affording them exemptions and allowing them to follow safety protocols implemented before mandatory vaccination policies were rolled out."

"After ABC instituted a requirement that its employees get vaccinated against COVID-19, Plaintiffs requested religious exemptions, which were denied," the document, filed Tuesday, reveals.

The lawsuit also claims that ABC violated Article 1, Section 1 of the California Constitution, religious discrimination under FEHA [Fair Employment and Housing Act], disability discrimination under FEHA, retaliation under FEHA and "wrongful termination in violation of public policy."

"ABC argued that the Wahls did not have genuine religious beliefs and that, even if they did, it could not have accommodated them without undue hardship," the Hollywood Reporter wrote, adding the entertainment labor union IATSE "waived any rights members had to object to mandatory vaccination policies."

FLORIDA SURGEON GENERAL CALLS FOR HALT TO COVID-19 VACCINE USAGE AFTER FDA SAID HE SPREAD MISINFORMATION

ABC beat another, similar lawsuit from Ingo Rademacher for "his dismissal from General Hospital for refusing to get the COVID-19 vaccine." (Nick Argo/ABC via Getty Images)

"Ruling against ABC on summary judgment, the court concluded that the studio may have discriminated against the Wahls on the basis of their religion by failing to find a workaround for their refusal to get vaccinated," the outlet reported.

ABC beat another similar lawsuit from Ingo Rademacher after he was fired from "General Hospital" for declining the COVID vaccine.

The star exited the daytime drama in 2021 after refusing to comply with ABC's mandate requiring show employees to be vaccinated against the coronavirus.

Documents were filed by attorney John W. Howard on behalf of the actor at the time, stating that Rademacher applied for a religious exemption to the mandate but was denied. He was also represented by Robert F. Kennedy Jr., who is now running for president as an independent.

"I am entitled to a religious exemption against mandatory vaccination for COVID-19 on the basis of my deeply and sincerely held moral belief that my body is endowed by my creator with natural processes to protect me and that its natural integrity cannot ethically be violated by the administration of artificially created copies of genetic material, foreign to nature and experimental," the actor wrote in an email to Disney's human resources team in 2021, per the suit.

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A Los Angeles judge ruled in ABC's favor in 2023, saying the actor's objections to the vaccine were based on health reasons, not religious beliefs.

ABC did not respond to a request for comment from Fox News Digital.

Fox News' Nate Day contributed to this report.

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A new study has found two Covid vaccine side-effects which can attack the heart, brain and spinal cord.

Researchers at the Global Vaccine Data Network discovered links between mRNA(Pfizer and Moderna) vaccines and myocarditis - inflammation of the heart muscle - and pericarditis - swelling of the thin sac covering the heart.

Experts stress that the new side-effects are "exceptionally rare" and the benefits of Covid vaccines still "vastly outweigh the risks".

The study of more than 99 million people also confirmedGuillain-Barr syndrome, when the immune system attacks the nerves and cerebral venous sinus thrombosis, a type of blood clot in the brain as rare side effects associated with the AstraZeneca vaccine.

The international journal Vaccine, where the new data is published, also established that acute disseminated encephalomyelitis - an inflammation and swelling in the brain and spinal cord - was also linked to the AstraZeneca vaccine.

A new study has found two very rare Covid vaccine side-effects which can attack the heart, brain and spinal cord

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The study involved people from Australia, Argentina, Canada, Denmark, Finland, France, New Zealand and Scotland.

Researchers say the results were based on electronic healthcare data, which compared the rates of 13 brain, blood and heart conditions in people after they received the Pfizer, Moderna or AstraZeneca vaccine with the rate that would be expected of those conditions in the population before the pandemic.

The new discovery of acute disseminated encephalomyelitis triggered researchers to independently confirm the side-effect by carrying out a second study.

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Prof Jim Buttery, co-director of the Global Vaccine Data Network said the second study included a separate dataset of 6.8 million Australians who were injected with the AstraZeneca vaccine.

The Australian study of AstraZeneca-specific data confirmed acute disseminated encephalomyelitis as a side-effect but also helped detect a second new rare side-effect, known as transverse myelitis - spinal cord inflammation.

According to Vaccine, the risk of acute disseminated encephalomyelitis is found in 0.78 cases for every million doses, while transverse myelitis appears in 1.82 cases per million doses.

The risk of myocarditis is even higher with natural Covid infection than it is following a vaccination, Buttery said.

The new discovery of acute disseminated encephalomyelitis triggered researchers to independently confirm the side-effect by carrying out a second study

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The senior research analyst at the Murdoch Childrens Research Institute in Australia added that despite the conditions being serious, patients usually recover from them.

Prof Julie Leask, a vaccine expert at the University of Sydney said it is important to note that a Covid infection increases the risk of some of the rare conditions "much more than a vaccine" does.

She said the studies show that: Our vaccine experts are paying attention to when vaccines lead to serious side-effects, and theyre acting on it.

"Being confident in a system that will detect problems and address them, is a very important part of a robust vaccination program."

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Covid vaccine side-effects: Rare risk of inflammation and swelling in brain and spinal cord discovered - GB News