Category: Covid-19 Vaccine

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COVID-19 antibodies are significantly reduced by 6 months post-vaccination among patients with immune-mediated inflammatory diseases, according to data published in The Journal of Rheumatology.

However, individuals with diseases such as rheumatoid arthritis and systemic lupus erythematosus continued to see positive impacts to immunogenicity with fourth and fifth doses of COVID-19 vaccines, the researchers wrote.

Currently, individuals with immune-mediated inflammatory diseases (IMIDs) may be unsure about the value of COVID vaccination beyond the primary series, study author Sasha Bernatsky, MD, PhD, of McGill University, in Montreal, told Healio. This is particularly concerning since immunosuppressant therapy may put individuals at higher risk for SARS-CoV-2 transmission.

On the other hand, social vaccine fatigue has caused many individuals to decline additional COVID boosters after the primary series, she added. Since COVID-19 infection is a potentially fatal and vaccine-preventable co-morbidity, it is vital that individuals with IMIDs have access to relevant information that will help them decide when to get their next COVID vaccination.

To examine how time since last vaccination impacts serologic responses to COVID-19 vaccination and infection in patients with IMIDs, Bernatsky and colleagues conducted a study of 1,823 adults (mean age, 53.2 years) with various relevant conditions. The cohort was recruited from eight cities across Canada beginning in early 2021. Dried blood spots or sera, as well as self-reported data, were collected at enrollment, then 2 to 4 weeks, and subsequently 3, 6 and 12 months, post-vaccination. Participants either collected dried blood spots at home and mailed them for analysis, or had sera analyzed at local centers, depending on their location.

Sasha Bernatsky

Samples underwent automated enzyme-linked immunosorbent assays to measure log-transformed anti-receptor-binding-domain (RBD) titers and anti-nucleocapsid IgG. The effects of each covariate on anti-RBD titers were expressed as exponentiated beta coefficients.

According to the researchers, log-transformed anti-RBD titers were positively associated with female sex, number of vaccine doses, self-reported COVID-19 infections between 2021 and 2023, and negatively associated with use of prednisone, anti-TNF agents and rituximab (Rituxan, Genentech) either the originator or biosimilars. Titers were also negatively associated with time since last vaccination, especially beyond 210 days (exponentiated coefficient = 0.88; 95% CI, 0.8-0.95).

Vaccine doses four and five were associated with positive effects on anti-RBD serology, the researchers wrote.

Our data suggest that these individuals should continue to consider additional doses when more than 6 months has elapsed since last vaccination or infection, Bernatsky and colleagues wrote.

Bernatsky said she was a bit surprised that rituximab demonstrated such strong effects (adjusted exponentiated coefficient = 0.23; 95% CI, 0.1-0.53) on lowering post-vaccination immune response, despite the cohort containing only 44 patients on rituximab.

However, this is a fairly robust finding across studies, so it is something we need to pay attention to, she told Healio.

These findings may help individuals personalize vaccination decisions, including consideration of additional vaccination when more than 6 months have elapsed since last COVID vaccination/infection, she added.

Bernatsky highlighted further research to be done in this area.

The intricate relationships between all these variables age, sex, race/ethnicity, number and timing of vaccination, type of vaccinations, past medical history and the details of medications received need to be carefully modelled for us to truly understand if we can personalize vaccine decisions, she said. That is, can we offer strategies tailored to each patients needs?

According to Bernatsky, the current analyses considered medication exposures only at the time the subject enrolled in our study.

We would like to undertake more detailed analyses of past medications and doses in order to identify those with higher or lower immune system responses to vaccination, she said. The ultimate goal is to prevent COVID-related infections, hospitalizations and deaths.

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Disclosures: This study was supported by funding from the Vaccine Surveillance Reference Group and COVID-19 Immunity Task Force of the Public Health Agency of Canada. The views expressed here do not necessarily represent the views of the Public Health Agency of Canada.

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COVID-19 vaccine response drops significantly after 6 months in patients with IMIDs - Healio

Vaccines are vital to global health, saving millions of lives each year. The COVID-19 pandemic underscored their importance, with more than 20 million lives saved in the first year of vaccine deployment alone. This achievement was fueled by an unprecedented acceleration in innovation, with multiple COVID-19 vaccine candidates developed and launched within roughly one year, a process that has historically taken a decade on average.

This level of activity was dramatically different from what we saw in our 2019 analysis, which revealed signs that the vaccine innovation engine had begun to sputter. While the two decades preceding the pandemic saw strong growth in the vaccine industrywith pipelines doubling and annual growth rates of 12 to 15 percentwe identified four indicators of stagnation in 2019: slowing revenue growth (only 5 percent across the industry over the previous five years), a flattening development pipeline, higher attrition rates for vaccines compared with other biologics, and limited progress targeting disease areas of high unmet need, particularly those endemic to low- and middle-income countries (LMICs).

At that time, we highlighted opportunities to reinvigorate vaccine innovation across six major vaccine archetypes (Exhibit 1) by addressing commercial and technical obstacles and advocated for a comprehensive and shared approach among the relevant stakeholders, including manufacturers, governments, academia, research centers, and the private sector. Some of these strategies proved instrumental to the rapid development of the COVID-19 vaccines.

Now, roughly three years after the surge of innovation spurred by the pandemic, the vaccine industry faces another critical juncture. Despite accelerated vaccine innovation for certain diseases, progress remains uneven, and significant unmet needs persist. This article explores how the pandemic transformed the business case for vaccines. It proposes five actions the vaccine ecosystem can take to harness the pandemic-driven momentum to accelerate vaccine innovation more broadly and to tackle global health challenges more effectively.

The rapid development of COVID-19 vaccines was propelled by multiple factors, including enhanced funding, operational efficiency, technological advancements, and regulatory flexibility. The COVID-19 innovation model has spurred advancements in other areas, particularly in respiratory diseases, which saw ten launches in the United States alone from 2020 to 2023 (up from three between 2016 and 2019). In the past several years, multiple vaccines targeting diseases that primarily affect LMICs, such as dengue and chikungunya, have also been approved by the US Food and Drug Administration (FDA). The vaccine development pipeline has also seen a rise in Phase III candidates (Exhibit 2), which include two meningitis vaccines, a possible human cytomegalovirus (CMV) vaccine, and a promising vaccine against invasive pneumococcal disease in adults.

The overall vaccine development timeline is also compressing (Exhibit 3). Although not as rapid as the unprecedented COVID-19 timeline, which was roughly one year, respiratory syncytial virus (RSV) vaccines have been developed within a three- to five-year time frame (the start of clinical development through regulatory approval), a pace significantly quicker than historical norms. Other vaccine types that are also moving relatively quickly through the clinical phases include Modernas messenger ribonucleic acid (mRNA) combination vaccine candidate for RSV and seasonal influenza, which is on a three- to four-year projected development timeline.

Despite these advances, progress has been uneven across different vaccine archetypes (Exhibit 4). Multiple vaccines were launched in recent years that target residual unmet needs (archetype two) such as malaria, pneumonia, and meningitis, with additional late-stage candidates in the pipeline. However, few vaccine candidates for neglected diseases (archetype five) have progressed to late-stage clinical development. Vaccines for this disease archetype face high levels of commercial uncertainty as well as technical complexity, including difficulty in generating protective immunity.

Vaccines targeting persisting global threats (archetype three), including HIV and the EpsteinBarr virus, face technical challenges in identifying appropriate antigens and generating sufficient immune responses, especially for pathogens with complex life cycles. And although concerns about hospital-acquired antibiotic-resistant infections have piqued interest in nosocomial-associated threats (archetype six), efforts to develop vaccines for them have returned mixed results.

Some projects, such as an E. coli vaccine candidate, have moved into Phase III trials; others, including several C. difficile vaccine attempts, have not been successful. These initiatives also face commercial and logistical challenges, including uncertainties about how to identify the target demographic for vaccination and the optimal timing for vaccine administration.

Addressing disparities and accelerating vaccine development for these unmet needs remain crucial in the ongoing fight against infectious diseases. Overcoming technical challenges and streamlining the development process will be essential to closing the gaps in the vaccine development pipeline and ensuring worldwide equitable access to lifesaving vaccines.

The response to the COVID-19 pandemic strengthened the vaccine business case and led to a remarkable 30 percent increase in vaccine candidates over the past five years.

The development of vaccines targeting infectious diseases has historically been hindered by an unfavorable business case characterized by high capital costs, long regulatory timelines, increased opportunity costs, technical complexity, and commercial uncertainty. However, the response to the COVID-19 pandemic strengthened the vaccine business case and led to a remarkable 30 percent increase in vaccine candidates over the past five years (Exhibit 5). These changes to the business caseswhich demonstrated what is possible when the right stakeholders work together to accelerate innovationincluded the following:

Economic R&D and manufacturing incentives. Unprecedented levels of funding were also appropriated for vaccine R&D, including more than $2 billion each from the US federal government and the global PPP Coalition for Epidemic Preparedness Innovations (CEPI). Canada, Germany, and other public- and private-sector stakeholders worldwide also directly invested in expanding manufacturing capacity to reduce the financial risk of scaling up vaccine production.

Despite a substantial increase in public funding, it is important to note that private funding for infectious disease vaccine R&D still lags behind funding in other areas, with only 3.4 percent of the total venture capital raised for biopharmaceutical companies during the past ten years going to companies with infectious-disease-vaccine programs, compared with 38 percent for oncology programs.

Although the speed, magnitude, and cohesiveness of these responses are far more sustainable during a pandemic than in a steady state (noncrisis-related) vaccine development environment, they have given the industry a model for accelerating innovation.

The vaccine ecosystem now faces another inflection point: Will it revert to a state that is more susceptible to a challenging business case, or will it draw lessons from the pandemic and sustain or even accelerate the vaccine innovation momentum it ignited? The five actions detailed below (and outlined in Exhibit 6) aim to enhance the vaccine development landscape by addressing key drivers such as investment requirements, regulatory hurdles, and market uncertainties.

The COVID-19 pandemic showed how alliances among companies, not for profits, academia, and governments can accelerate R&D and manufacturing. Several of the most quickly approved COVID-19 vaccines represented R&D partnerships among research institutes, academia, and industry, including the National Institutes of Health/Moderna and the University of Oxford/AstraZeneca collaborations.

In addition, broader collaborations such as the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership brought together US federal agencies, innovators, academia, and others to develop a research strategy to accelerate the development of COVID-19 vaccines and therapeutics and coordinate clinical trials. Vaccine manufacturing partnerships and networks also grew significantly during the pandemicmore than 70 percent of the 374 manufacturing and supply chain announcements involved a collaboration among multiple stakeholders.

There are signs that these types of partnerships will continue to grow in the coming years, particularly partnerships focused on rapid production of vaccines for future pandemics, such as the one CEPI is building in the Global South. Maintaining these partnerships beyond the pandemic context could lower capital costs and speed up production. However, new collaboration models are required to ensure rapid technology transfer with minimal risk and resource demands.

The scale of COVID-19 funding is unrealistic for steady-state vaccine development and potentially even unnecessary for more commercially attractive blockbuster vaccines. However, targeted funding commitments can reduce investment risks and promote ongoing innovation, particularly for vaccine candidates aimed at diseases prevalent in LMICs. The ones set up by the Biomedical Advanced Research and Development Authority (BARDA) and Gavi could inspire the design of future funding mechanisms.

Even without the scale of COVID-19 investment, global funders and international institutions can boost the commercial appeal of vaccine development if they offer clear innovation funding incentives. For example, Gavis recently established African Vaccine Manufacturing Accelerator has committed to making $1 billion available to manufacturers at critical moments in the development process to offset their start-up costs and create demand certainty for vaccines that may be needed to prevent future pandemics.

The pandemic demonstrated the potential for high vaccination rates among the adult population. Sustaining such levels will require coordinated efforts across the healthcare ecosystem to improve vaccine access, engage populations that are more vulnerable to certain diseases, and innovate delivery methods.

COVID-19 vaccination rates among adults who received first doses were historically high during the pandemic; conversely, the vaccination rates for subsequent booster doses have been in line with and, in some cases, lower than the rates for other adult vaccines. As of March 2024, fewer than 25 percent of eligible adults in the United States had received an updated 202324 COVID-19 vaccine since September 2023. Despite the US Centers for Disease Control and Preventions recommended immunization schedule for adults, adult immunization rates are consistently lower than those of children and vary significantly by geography and demography. Each year for the past decade, only 30 to 50 percent of mid-adults (18 to 64 years old) have gotten a seasonal influenza vaccine.

To help ensure the public health benefits and stabilize the commercial demand, the public sector, vaccine manufacturers, retail pharmacies, and other stakeholders could take the following coordinated and complementary actions:

The COVID-19 pandemic highlighted the importance of fungible capacity to reduce bottlenecks to widespread vaccine availability. Transitioning toward flexible, multiproduct manufacturing can help ensure readiness for future pandemics and streamline production processes.

The historical model, in which most large vaccine manufacturing facilities specialize in a single product, may no longer be fully fit for purpose, particularly given the need to prepare for future pandemics. One example of fungible manufacturing is at-scale systems that either allow the production of multiple vaccine types on the same platform or can produce the same vaccine on various platforms. Such flexible technology platforms will be critical to avoid building excess capacity. They will also likely be most crucial in the shorter term, particularly in the context of pandemic preparedness.

However, the expense of flexible capacity will require new incentives and significant investment on behalf of funders and manufacturers. We are seeing some promising signs of innovation. For example, Sanofis Evolutive Vaccine Facilities platform is designed around a central unit housing several fully digital production modules, making it possible to produce three to four vaccines simultaneously. This modularity can make it possible to prioritize the production of a specific vaccine more quickly.

The COVID-19 pandemic highlighted the benefits of cooperation, communication, and collaboration between innovators and regulators, which could be integrated into regular practice for other diseases. For example, at a 2023 US Senate hearing, the FDA commissioner discussed a program from the Center for Biologics Evaluation and Research (CBER) devoted to emerging pathogens. The program would, among other things, expedite reviews, provide guidance to developers, leverage real-world data for product assessment, and support advanced manufacturing.

Initiatives launched before the pandemic can offer inspiration for the design of new vaccine-focused mechanisms. For example, the European Unions PRIME initiative, launched in 2016, offers enhanced support for the development of therapies addressing unmet needs, including early contact with the European Medicines Agency and expedited scientific advice during development. The FDAs Oncology Center of Excellence Real-Time Oncology Review (RTOR) program, launched in 2018, enables faster reviews by allowing submission of top-line efficacy and safety results for drug candidates likely to demonstrate substantial improvements or candidates with straightforward study designs. This allows for earlier identification of issues that may arise during development and helps regulators and innovators align on trial design.

Global regulatory cooperation can also accelerate vaccine innovation and streamline administrative processes. During the pandemic, forums such as the International Coalition of Medicines Regulatory Authorities formed COVID-19 working groups that rapidly accelerated vaccine development by establishing governing protocols, agreeing on approaches to adapt vaccines to address variants, and improving regulatory agility. Also, the WHO-backed African Vaccine Regulatory Forum introduced an emergency joint review process that led to an accelerated review turnaround. Working groups for other diseases could promote consistent standards and requirements, encouraging innovation and bolstering clinical trial efficiencies. Expanding regulatory measures such as accepting electronic files and conducting virtual inspections could also promote vaccine innovation.

In the meantime, innovators can consider assessing and improving the level of their submission excellence, or their ability to quickly prepare high-quality regulatory submissions, which can help boost the odds of first-cycle approval.

The COVID-19 pandemic ignited a revolution in vaccine development. Unprecedented speed and scale brought lifesaving vaccines to the world in record time. However, without concerted effort, the urgency that fueled innovation during the crisis could easily dissipate. The five actions outlined in this article provide a road map for sustaining the innovation surge and accelerating the development of lifesaving vaccines for the worlds most pressing health challenges. With collective action and unwavering commitment, stakeholders in the vaccine ecosystem can harness the lessons of the pandemic to spur transformative change and help secure a healthier future for all.

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Beyond the pandemic: The next chapter of innovation in vaccines - McKinsey

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As the saying goes "There is no such thing as normal" and this has been especially true after the pandemic.

Before the emergence of the omicron COVID-19 variant, countries like the U.K. had high vaccination coverage along with widespread exposure to COVID-19 in the population.

This combination of vaccine and infection-derived immunity is termed hybrid immunity and is different to vaccine immunity or infection immunity alone.

In contrast, other countries, including Australia, New Zealand and those in the Western Pacific, had a very different pandemic experience. These countries and regions had low prior exposure and differing levels of vaccination.

The widespread waves of COVID-19 that followed the emergence of the omicron variant in late 2021 completely changed the immune landscape.

Omicron sharply increased COVID-19 exposures across the world, including in the Western Pacific Region which previously had low exposure.

Now, there is a complex global situation where populations in different countries have unique hybrid immunity landscapes, born from a wide range of vaccination history and exposure history combinations.

In 2023, we needed to consider what hybrid immunity meant for booster vaccinations. And what different types of hybrid immunity meant for future vaccination strategies.

Because while countries were "returning to normal," SARS-CoV-2 hadn't gone away. We needed a systematic way to make population-level recommendations and support government decision-making on a global scale.

We gain hybrid immunity from a combination of COVID-19 vaccinations and past infections. When a population goes through various COVID-19 waves and cycles of vaccination, the population acquires a complex hybrid immune landscapeand this is the current state in countries around the world.

Hybrid immunity can prevent future infection and reduce the severity of outcomes. We were particularly interested in what this means for future waves of COVID-19 and the implications on future vaccine strategies.

Given competing health priorities and resource constraints, governments and policymakers need to assess their future vaccination policies. After all, if a population already has high immunity derived from infection, are vaccinations still required?

Our modeling helps us answer this question, finding that yes, vaccinations are still important on the population level, but they will likely be used in a different way in future.

Our model is an "agent-based model," where we simulate thousands of "individuals," each with their own vaccination and infection histories.

With a focus on the Western Pacific Region, we configured the model to a range of exemplar populations in the region, accounting for prior immunity and vaccination coverage (ranging from high to low), and population age structure (older versus younger age demographics).

Then, by running the model "into the future," under various scenarios regarding COVID-19 variants and vaccine coverage, we tested what could happen, given different historical settings (hybrid-immunity levels) and the future emergence of new variants.

The strongest benefit of COVID-19 vaccines is their protection against severe outcomes, including hospitalization. In contrast, they have limited efficacy against transmission between infected and non-infected people.

Our results suggest that populations with low vaccination coverage and high past infection rates should still consider vaccination if public health measures are not enforced or social mixing is not reduced, with particular emphasis on protecting those at higher risk, such as older age groups.

Modeling can help us understand ongoing COVID-19 waves, including the likely impact of responsive vaccine interventions, and how vaccinations will continue to play a key role in keeping people healthy and safe.

Using this work as a springboard, we extended it in response to a request for data modeling from the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE) Working Group on COVID-19.

We evaluated the cost-effectiveness of vaccination strategies across a range of settings considering (largely) unvaccinated low- and middle-income countries (LMICs) and well-vaccinated countries.

These results fed into the global policy decisions through the WHO's SAGE Group and their Immunization and Vaccine-related Implementation Research Advisory Committee (IVIR-AC).

In particular, our modeling informed WHO's revised (March 2023) recommendations for COVID-19 booster vaccination to achieve equitable health outcomes.

COVID-19 continues to circulate in the global population. However, competing health priorities and resource constraints mean governments and policymakers must carefully consider if, when, and who to vaccinate.

Complex and diverse immune landscapes and global needs make it difficult to guide broad policy on vaccine decision-making.

Our flexible framework can consider different country contexts by inputting different age distributions, vaccination schedules, contact matrices and other key parameters to help determine the relative benefits of potential vaccine programs in different populations.

This information helps support individual countries in deciding what part vaccines will play in protecting populations against emerging variants of concern.

Here is the original post:

How a simulation is informing COVID-19 vaccine policy after our 'return to normal' - Medical Xpress

In an interview, Kazumasa Nagayama, President of Moderna Japan underscored the significance of facilitating COVID-19 vaccination opportunities. He spoke with The Sankei Shimbun on May 13. Nagayama emphasized, "It is crucial for us to provide opportunities for receiving COVID-19 vaccinations." He strongly reaffirmed the company's commitment to ensuring vaccine supply despite the change in national priority.

Based in Tokyo, Moderna Japan develops vaccines using Messenger RNA (mRNA) technology.The government downgraded COVID-19 to a Level 5 common infectious disease in May 2023. From the autumn and winter of 2024, vaccinations, too, transition to normal treatment in terms of cost-sharing.

Since April 2024, COVID-19 vaccines have been accessible as voluntary self-funded vaccinations. However, routine vaccination campaigns targeting the elderly and other demographics are scheduled to start in the autumn and winter, with partial coverage of costs by individuals.

President Nagayama highlighted, "Moderna is currently the only supplier of vaccines for this spring and summer (2024)." He also underlined the importance of vaccinations as infections continue. Nagayama noted that "COVID-19 infections, including hospitalization rates, have shown no signs of decline, and the severity of post-infection effects such as cognitive decline has worsened."

He also disclosed that Moderna is "preparing vaccines to counter mutant strains for the forthcoming autumn and winter vaccination drives."

Moreover, Moderna is in the process of developing a "next-generation vaccine" for COVID-19 This is intended for co-administration with the influenza vaccine, with the aim of bolstering effectiveness and minimizing side effects.

Encouraging results from final-stage clinical trials conducted on a global scale have shown significant immune responses. Results have been particularly hopeful among individuals aged 65 and above. President Nagayama affirmed, "The vaccine will be readily available even within Japan's routine vaccination framework."

(Read the report in Japanese.)

Author: Yohei Ushijima

See the original post:

INTERVIEW: Moderna Japan's Kazumasa Nagayama on COVID-19 Vaccines and New Initiatives - JAPAN Forward

When people find out that, in 2021, I very nearly died from Delta-COVID pneumonia surviving only because of the care I received over 13 days in a hospital COVID ward they always ask if I had received the COVID vaccine. When I tell them no, they invariably ask if I regret not getting vaccinated.

My answer is an emphatic NO I dont regret it at all. Never have. And because of what were learning about the dangerous side-effects of the COVID vaccine, I never will.

I have been evaluated by a pulmonologist who tells me I have no residual effect from COVID in my lungs. He says Im completely recovered . Nor have I had so much as even a cold since them. I appear to be a living example of What doesnt kill you makes you stronger!

Mrs. Beatty (an RN, BSN), likewise nearly died of COVID pneumonia. We were both hospitalized at the same time. She does not have any regrets whatsoever about not being vaccinated either.

Why, you ask? Well, compare our unvaccinated experience, recovering from COVID, with those who were vaccinated and have suffered long-term debilitating side effects.

The New York Times which touted vaccination at the time now reports there is evidence of far more serious side effects of the vaccine than previously reported.

For example:

Within minutes of getting the Johnson & Johnson Covid-19 vaccine, Michelle Zimmerman felt pain racing from her left arm up to her ear and down to her fingertips. Within days, she was unbearably sensitive to light and struggled to remember simple facts.

She was 37, with a Ph.D. in neuroscience, and until then could ride her bicycle 20 miles, teach a dance class and give a lecture on artificial intelligence, all in the same day. Now, more than three years later, she lives with her parents. Eventually diagnosed with brain damage, she cannot work, drive or even stand for long periods of time.

A woman with a PhD in neuroscience says her life has been effectively ruined by the COVID vaccine. It seems she would be taken seriously. But apparently not.

Dr. Janet Woodcock, a longtime leader of the Food and Drug Administration, who retired in February, said she believed that some recipients had experienced uncommon but serious and life-changing reactions beyond those described by federal agencies.

I feel bad for those people, said Dr. Woodcock, who became the F.D.A.s acting commissioner in January 2021 as the vaccines were rolling out. I believe their suffering should be acknowledged, that they have real problems, and they should be taken seriously.

Michelle Zimmerman is not alone among health care professionals who believe receiving the COVID vaccine had serious side effects they werent warned about.

Shaun Barcavage, 54, a nurse practitioner in New York City who has worked on clinical trials for H.I.V. and Covid, said that ever since his first Covid shot, merely standing up sent his heart racing a symptom suggestive of postural orthostatic tachycardia syndrome, a neurological disorder that some studies have linked to both Covid and, much less often, vaccination.

He also experienced stinging pain in his eyes, mouth and genitals, which has abated, and tinnitus, which has not.

The same government that used threats of withholding federal funding to coerce private health-care providers to require vaccination of their employees, is now apparently ignoring pleas for help from health care workers suffering from vaccine side-effects.

I cant get the government to help me, Mr. Barcavage said of his fruitless pleas to federal agencies and elected representatives. I am told Im not real. Im told Im rare. Im told Im coincidence.

In fact, it appears the government does not even want to hear about adverse side effects even when reported by health care professionals.

Renee France, 49, a physical therapist in Seattle, developed Bells palsy a form of facial paralysis, usually temporary and a dramatic rash that neatly bisected her face. Bells palsy is a known side effect of other vaccines, and it has been linked to Covid vaccination in some studies.

But Dr. France said doctors were dismissive of any connection to the Covid vaccines. The rash, a bout of shingles, debilitated her for three weeks, so Dr. France reported it to federal databases twice. I thought for sure someone would reach out, but no one ever did, she said.

When a neuroscientist, a nurse practitioner, and a physical therapist report they suffered severe immediate, and long-term, effects following vaccination a rational person would assume they know of what they speak.

But since we are talking about the government, rational doesnt come in to play. Especially if that government was complicit in causing the problem.

I wrote here before about the governments duplicity in approving the COVID vaccine (that by clinical definition never was actually a vaccine) and how the government colluded in suppressing information about vaccine adverse effects, in which I quoted an excerpt from a article written by two esteemed physicians:

The large clustering of certain adverse events immediately after vaccination is concerning, and the silence around these potential signals of harm reflects the politics surrounding COVID-19 vaccines.

Those who most strenuously advocated vaccination, particularly those who attempted to shame and ostracize the un-vaccinated, will now tell you doing so saved countless lives. There is just one problem with that post hoc justification they cant prove it.

That lives were supposedly saved is pure speculation. There is no scientific data to support it.

From back whenCOVID was sweeping through the population and I declined vaccination, right up to now, whenever asked why I refused my answer is the same. My every instinct, based on life experience with government, and my medical training, told me the COVID vaccine was a dangerous experiment using us as beta-test subjects.

The New York Times article documents just a few examples of how that testing was harmful, and how the government refuses to acknowledge that it was wrong.

I wonder how many of those who criticized, shamed and ostracized others who didnt get vaccinated will now admit they were wrong? Probably none. Here is what I wrote about them back in the fall of 2021:

I dont participate in any social media. Im only indirectly aware of what goes on in that playpen. Ive been shown comments saying anyone not vaccinated deserves to get COVID. That unvaccinated people should be denied hospital COVID treatment to make room for vaccinated people who need it. (Wait What? You mean vaccination doesnt keep you from getting COVID?)

Some even said the unvaccinated deserved to die from COVID. From what dark pit of the soul and emotional emptiness does that level of hatred germinate?

It may be no more complicated than a pathological obsession with COVID filling an emotional void. Experience, though, cautions me that its likely far more sinister. History teaches where that can lead.

To some, my life already has no value because I have a different viewpoint about COVID than theirs. Why else would they believe I deserve to die because Im not vaccinated? That sounds like, to them, this pandemic is a convenient short-cut to the gas chambers

Gary Beatty

Gary Beatty lives between Florida and Pagosa Springs. He retired after 30 years as a prosecutor for the State of Florida, has a doctorate in law, is Board Certified in Criminal Trial law by the Florida Supreme Court, and is now a law professor.

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A DIFFERENT POINT OF VIEW: Reports of COVID Vaccine Side-effects - Pagosa Daily Post

New Delhi: A study conducted by a group of researchers at the Banaras Hindu University (BHU) on safety of Covaxin said that close to one-third of their studys participants developed adverse events of special interest (AESIs).

This study was published on May 13 and it made it to various newspapers and other publications on May 16 as it was shared by one of its authors on social media.

These newspaper reports on Covaxin came out after a controversy around Covishield erupted earlier this month based on some misinterpretations after AstraZeneca admitted to a rare side effect in a UK court.

The headline that most publications tend to pick up from this Covaxin study is one sentence from the paper: Close to one-third of individuals developed AESIs.

Some of these reports even go on to say that the vaccine, like Covishield, was not safe, referring to many misinterpreted conclusions about the controversy.

A screenshot of the collage of news items on the Covaxin study; taken at 8:05 pm on May 17.

At the outset, AESIs are adverse events, or the side effects, as the name suggests, of special interest. These are not necessarily all AEFIs (adverse effects following immunisation). In fact AESIs may be referred to as a subset of AEFIs.

AEFIs are a bigger basket that would record all adverse effects, including minor ones, and not just those of special interest.

While the Covaxin paper did say that one-third (33%) of the studys participants developed AESIs. Only 1% of all participants developed serious AESIs.

A total of 926 Covaxin recipients took part in the study 635 adolescents and 291 adults. They were interviewed by researchers between January 2022 and August 2023 via telephone. The researchers tried to understand any health issues post-vaccination in this period.

As for the study, one of the major adverse effects it highlighted was respiratory infections, or what are called viral upper respiratory tract infections in scientific jargon.

It said about half of the enrolled participants developed these respiratory infections.

Dr Aviral Vatsa, who is a general practitioner and scientist working with the National Health Service-Scotland and who was not involved in the study, sounded a note of caution against making interpretations from the study.

[The] participants who reported viral upper respiratory tract infections were not routinely tested for COVID-19. This means some cases of COVID-19 might have been missed, potentially skewing the results, he told The Wire.

In fact, this is something the paper also mentions.

The paper says many of those who were reported to have a respiratory infection after vaccination might have got COVID-19 itself and not any other infection.

Reporting a COVID-19 infection could have been missed because testing rates went down by the end of the third wave, when this study was being conducted.

Had a COVID-19 test been done on individuals following a respiratory infection, it would have become clear whether what they had post-vaccination was a COVID-19 infection or any other respiratory infection, as Vatsa says.

This is significant because the occurrence of a COVID-19 infection was commonplace at the time when the study was being done. Even a COVID-19 infection after vaccination was not uncommon.

For context, none of the COVID-19 vaccines were designed to prevent an infection per se, but to prevent the severe form of the disease and hospitalisation.

Getting a COVID-19 infection was common; with or without vaccination.

So the interpretation that a COVID-19 vaccine led to different types of respiratory infections, as it was reported in several newspaper reports might not be entirely true.

Some of those respiratory infections could have been a COVID-19 infection.

A screenshot of the collage of news items on the Covaxin study; taken at 8.05 pm on May 17.

Typhoid and other serious AESIs

Another important AESI highlighted was the development of typhoid after the COVID-19 vaccination.

[But] there are concerns about the accuracy of diagnosing post-vaccination typhoid due to possible false positives, which could affect the attribution of adverse events, Vatsa said.

Adding to Vatsas concerns, the paper also said there were possibilities that a patient reporting positive for a typhoid infection might actually be a COVID-19 case, because of what is known as cross-reactivity of typhoid and COVID-19 antibodies for the same test.

Therefore, the association of typhoid fever with Covaxin needed to be interpreted cautiously, the paper warns.

Among the most serious side effects observed was Guillain-Barre Syndrome (GBS), a disorder in which the immune system starts attacking the bodys nerves and can lead to paralysis.

Of all the 1% of participants who reported serious side effects, only one participant or 0.1% of the total developed GBS.

But even one is important here due to the impact it can have on ones life.

Nonetheless, the paper itself clarifies that there was only probable association between the vaccine and GBS.

More importantly, it adds that the concerned person had a history of GBS 15 years before the study.

Hence [s/he] might have been more vulnerable to develop the syndrome [after a COVID-19 infection or vaccination], it added.

Writing an opinion piece on Covishield in the light of the recent controversy in the Indian Express, virologist Shahid Jameel referred to a multi-country observational study on the Pfizer, Moderna and AstraZeneca COVID-19 vaccines causing GBS. It was published in April this year, Jameel wrote.

It showed that these vaccines increase the incidence of [GBS] within 42 days of receiving the vaccine. About 200 cases were found among 99 million people who were studied a risk of one in 5,00,000.

It must be noted here that the vaccines that Jameel referred to were different from Covaxin, but the GBS data in their case was brought out after studying as many as 99 million people receiving those vaccines.

In fact, this paper on Covaxin also says that the observed rates of serious AESIs such as stroke and GBS will need confirmation from vaccine-specific, larger multi-centre studies.

Also read: Report on Rare Adverse Side Effects of Covishield Causes Panic. But Should It?

Other disorders

The paper reported many general and skin disorders post Covaxin vaccination.

More than 10% of adolescents (out of 635 studied) complained of skin conditions, mainly in the form of alopecia (hair loss), and a similar percentage had general disorders such as weakness.

While the majority of those with general disorders had recovered, skin disorders were present in the majority of those who had them during the final follow-up and persisted with a median time of 8.5 months, the paper said.

Close to 5% of adolescents and adults complained of nervous system disorders such as headaches, which persisted in the majority of those who had them for around nine months at the final follow-up.

Eye disorders were reported in 3.6% of adolescents. As many as 5% of adolescent female individuals complained of new-onset menstrual abnormalities.

Hypothyroidism was reported by around 0.6% of adolescents and adults each.

Deaths after vaccination

This BHU study also reported four deaths after vaccination. Three of them had prior history of diabetes and/or hypertension. Out of these, two died due to stroke post-vaccination and the cause of the third persons death was not known.

The fourth had developed mucormycosis a serious bacterial infection after having a COVID-19 infection.

The paper concludes about these deaths: Three of these fatalities shared a possible association with the vaccine while the [cause] the fourth was unclassifiable.

Other observations

As a generic observation, Vatsa said many of the impacts that have been recorded in this paper as post-COVID-19 vaccination outcomes are incidentally also part of the umbrella called Long COVID.

It represents a set of diseases that one may develop after one has got rid of the COVID-19 virus due to the long term impact of its infection.

How do we know that what we are seeing [in this paper] is not due to [the] long term impacts of a COVID-19 infection?, he asked.

Vatsa also said that since the interviews of the participants which stretched over the period of one year were done telephonically, there was a risk of recall bias that is, one cant say if the participants were accurately able to share the side effects with the researchers.

The study accepts this as one of its limitations. But it says that to reduce this bias, only those issues that were present in participants for at least one month during the course of the study were considered persistent AESIs.

Vatsas other generic observations about the study included the fact that it had a small sample size a majority of which were adolescents raising questions about the replicability of the studys results over a larger adult population; and its limited geographical scope it was conducted in northern India leading to concerns whether the results could be generalised for the rest of the country.

Vatsa also raised concerns about absence of a control group that is, a comparison of the incidence of these post-vaccination disorders among people who were not vaccinated.

But such a comparison might not have been possible because a large majority of the Indian population had been vaccinated by the time the study was launched, and it would hence have been difficult to have a control group in the study.

The researchers who had conducted the Covaxin study also conducted a similar study on Covishield, the other vaccine administered in India.

That study had a predominantly adult-based population. It found nearly 14% of participants developed AESIs after taking Covishield, as against 33% in the Covaxin study. The incidence of the general disorders was also low in Covishields case.

Bharat Biotechs response

In response to the study, Covaxin maker Bharat Biotech issued a statement raising a few points the subjects AESI safety profile prior to their participation in the study; the comparison of the safety profiles of non-vaccinated subjects during the course of the study; the comparison of the safety profiles of subjects who received other vaccines during the course of the study and the following up of all study participants during the course of the study instead of only a subset.

It also claimed that several studies have been executed on the safety of Covaxin, and published in peer reviewed journals, demonstrating an excellent safety track record.

When The Wire mailed these points to Upinder Kaur, the BHU studys corresponding author, she refused to react.

I would not like to respond to the same. As we are scientists, our work is to bring information to the public domain after due peer-review. People can interpret all data as per their own expertise, she replied.

The researchers said that since a majority of AESIs persisted for about a year, long-term surveillance of vaccinated individuals was warranted.

It must also be mentioned here that Covaxin was rolled out by the government in what it termed clinical trial mode even without waiting for the interim results of its phase-3 trial.

This attracted sharp criticism from vaccinologists.

Eleven months after the vaccines rollout, the phase-3 results were published, which concluded that the vaccine was safe.

Original post:

BHU's Covaxin Safety Study: Cautious Interpretation of Results Needed - The Wire

Quick Take

As per a social media user, Covaxin COVID vaccine can cause death after two years of vaccination. The user also claims that the Covaxin has caused the deaths of crores of people. We did the fact check and it came out to be false.

The claim

An X user has shared a post which claims Covaxin COVID vaccine has caused the death of crores of people across India.

No, Covaxin COVID vaccine cannot cause death two years after vaccination. As of the latest available information, there is no conclusive evidence linking Covaxin, developed by Bharat Biotech, to an increased risk of heart attacks or death occurring two years post-vaccination. Vaccines, including Covaxin, undergo rigorous testing for safety and efficacy before approval and continued monitoring even after approval.

Some adverse events following vaccination can occur. But, these are generally observed within a short period after vaccination, and long-term severe side effects are extremely rare. Covaxin was approved for emergency use by the WHO, after a complete risk-benefit analysis. Moreover, vaccines are the most important tool in the fight against any disease. We must also remember we were combating a pandemic at that time. As we have stated it earlier, vaccines have saved lives and have helped in controlling the spread of disease.

It's important to consider that heart attacks and other cardiovascular events can occur due to a variety of factors, such as underlying health conditions, lifestyle, and genetic predispositions. These events happening two years post-vaccination are unlikely to be directly related to the vaccine itself.

Yes, Covaxin COVID vaccine underwent extensive clinical trials. In June 2020, the Ministry of Health and Family Welfare in India gave permission to start Phase I and II human trials for Covaxin after preclinical studies showed it was safe and produced a strong immune response in animals. Bharat Biotech conducted Phase I and Phase II trials involving approximately 1,000 participants. These trials demonstrated promising safety and immunogenicity results and were published in internationalpeer-reviewed scientific journals. Following these initial phases, the Phase III clinical trials for Covaxin began in mid-November, targeting the recruitment of 26,000 volunteers across multiple sites in India. This was the largest Phase III efficacy trial ever conducted for any vaccine in India, marking India's first and only Phase III efficacy study for a COVID-19 vaccine. The trials ensure the vaccine's safety and efficacy before approval and widespread distribution.

Covaxin has received several significant regulatory approvals to ensure safety:

The World Health Organization (WHO) stopped Covaxin supply for UN programs. This was because Bharat Biotech's main manufacturing facility in Hyderabad didn't fully follow good manufacturing practices (GMP). This happened because the facility had to focus entirely on making Covaxin due to the COVID-19 emergency. During this time, certain equipment needed for strict quality control wasn't available due to the pandemic. Bharat Biotech emphasised that Covaxin's quality was never compromised.

Furthermore, WHO has also mentioned that this does not raise concern over the safety and efficacy of the Covaxin. It remains safe and effective.

Covaxin is an inactivated vaccine developed from the SARS-CoV-2 virus, meaning it uses a virus that has been killed and cannot cause COVID-19. When you receive the Covaxin shot, your immune system recognizes the inactivated virus and produces antibodies against it. These antibodies help your body fight off the virus if you are exposed to it in the future. The vaccine also includes substances called adjuvants, which enhance the immune response and help provide longer-lasting immunity. Covaxin is easy to store, as it only needs refrigeration between 2 to 8C.

Covaxin has been shown to be 77.8% effective against symptomatic COVID-19 according to the final analysis of its Phase III trials. A booster dose six months after the second dose resulted in over 75% of participants having detectable neutralising antibodies, with even higher antibody levels than after the initial two doses. The booster also showed strong responses against the Omicron and Delta variants. Side effects are generally mild, including pain at the injection site and flu-like symptoms. Covaxin has also demonstrated strong safety and efficacy in children compared to adults.

Covaxin may cause mild side effects such as pain, swelling, redness, or itching at the injection site, as well as body ache, weakness, stiffness, nausea, vomiting, fever, malaise, and headache. These effects are typically temporary and resolve on their own.

However, severe side effects or consequences of Covaxin are rare but can include allergic reactions such as anaphylaxis. It's crucial to seek immediate medical attention if you experience symptoms like difficulty in breathing, swelling of the face or throat, rapid heartbeat, or severe dizziness after vaccination. Additionally, while extremely rare, there have been reports of blood clotting disorders associated with Covaxin.

After vaccination, most people experience a sore arm, with more widespread effects like fever and chills usually appearing within 8 to 12 hours. These side effects usually resolve within 48 hours. Since the vaccine cannot cause a COVID-19 infection, experiencing symptoms indicates a healthy immune response. While rare, allergic reactions can occur within the first 15 to 30 minutes after the jab. More common side effects include arm soreness, redness, and swelling at the injection site, with body-wide effects lasting 12 hours or more. Experts advise that these side effects generally cease within 24 to 48 hours after vaccination, although slight fatigue or arm soreness may persist. Comparing 48 hours of side effects to the risk of hospitalisation and death from COVID-19, experts emphasise the benefits of vaccination outweigh potential side effects.

The emergency approval of Covaxin before completing Phase III trials faced criticism from the Indian scientific community. Despite nearly 14 million COVID-19 cases, approval came as cases were dropping. The CDSCO's vague term restricted use in an emergency situation left many puzzled.

Groups like the All India People's Science Network called the approval hasty, while the All India Drug Action Network demanded transparency. Concerns grew after a Phase III trial participant died, with allegations of improper screening at the trial site.

However, 45 doctors, including former AIIMS directors, defended Covaxin, calling it India's gift to humanity and labelling the criticism as irresponsible.

If you have specific concerns about health conditions post-vaccination, it's advisable to consult with a healthcare professional. They can provide personalised medical advice and conduct any necessary evaluations. They can also help differentiate between vaccine-related issues and other potential causes of health problems. We would like to make it clear, one should not trust random and unreliable social media posts for making their healthcare decisions.

Yes, the CDC and other notable organisations have been actively monitoring COVID-19 vaccine-induced myocarditis. They provide transparent, evidence-based information on vaccine safety and participate in the WHO-led Vaccine Safety Net project. The CDC has launched investigations into myocarditis and pericarditis cases. Especially following mRNA vaccinations (Covaxin is an inactivated virus vaccine), with active surveillance in adolescents and young adults.

The CDC actively combats COVID-19 misinformation. To address false information on social media, the CDC uses a multimodal approach. It provides credible, evidence-based information on vaccine safety and adverse effects through its website and collaborates with health organizations. The CDC also uses social media to communicate with the public and dispel myths about COVID-19 vaccines.

We would like to conclude with, The benefits of COVID vaccines far outweigh the associated side effects.

We have debunked several claims regarding the COVID vaccines. Was COVID handling by the Government of India a huge scam?Has Japan's government banned the COVID-19 vaccine?Has the German government admitted there was no Pandemic?Has Japan declared an emergency over the explosion of mRNA cancers'?Are Covishield-vaccinated Indians susceptible to developing TTS?

(This story was originally published byTHIP Media, and republished by NDTV as part of the Shakti Collective.)

Link:

Fact Check: Can Covaxin Lead To Death After 2 Years Of Vaccination? - NDTV

SINGAPORE (The Straits Times/ANN): Singapore is seeing a new Covid-19 wave, with rising cases of infection in the last two weeks, said Health Minister Ong Ye Kung on May 18.

We are at the beginning part of the wave where it is steadily rising, said Mr Ong. So I would say the wave should peak in the next two to four weeks, which means between mid- and end of June.

The Ministry of Health (MOH) said that to protect hospital bed capacity and as a precaution, public hospitals have been asked to reduce their non-urgent elective surgery cases and move suitable patients to facilities like transitional care facilities or back home through Mobile Inpatient Care@Home.

Mr Ong urged those who are at greatest risk of severe disease, including individuals aged 60 years and above, medically vulnerable individuals and residents of aged care facilities, to receive an additional dose of the Covid-19 vaccine if they have not done so in the last 12 months.

MOH said the estimated number of Covid-19 cases in the week of May 5 to May 11 rose to 25,900 cases, compared with 13,700 cases in the previous week. The average daily Covid-19 hospitalisations rose to about 250 from 181 the week before. The average daily intensive care unit (ICU) cases remained low at three cases, compared with two cases in the previous week.

Mr Ong said that if the number of Covid-19 cases doubles one time, Singapore will have 500 patients in its healthcare system, which is what Singapore can handle. However, if the number of cases doubles a second time, there will be 1,000 patients, and that will be a considerable burden on the hospital system, he noted.

One thousand beds is equivalent to one regional hospital, Mr Ong said. So I think the healthcare system has to brace ourselves for what is to come.

There are no plans for any form of social restrictions or any other mandatory type of measures for now, as Covid-19 is treated as an endemic disease in Singapore, he said, adding that imposing additional measures would be a last resort.

Mr Ong said that with Singapore being a transport and communications hub, it will be one of the cities to get a wave of Covid-19 earlier than others.

So Covid-19 is just something that we have to live with. Every year, we should expect one or two waves, he said.

Mr Ong was speaking to the media on the sidelines of the Community in Review 2024 Conference Thriving with Age: Building a World of Active Ageing at the Furama Riverfront.

Globally, the predominant Covid-19 variants are still JN.1 and its sub-lineages, including KP.1 and KP.2. Currently, KP.1 and KP.2 account for over two-thirds of cases in Singapore.

As at May 3, the World Health Organisation has classified KP.2 as a variant under monitoring. There are currently no indications, globally or locally, that KP.1 and KP.2 are more transmissible or cause more severe disease than other circulating variants, MOH said.

However, members of the public are urged to stay updated with vaccination to protect themselves against current and emerging virus strains. MOH said that to date, about 80 per cent of the local population have completed their initial or additional dose, but have not received a dose within the last year.

The ministry added that since Covid-19 vaccination started in 2020 to 2021, the vaccines have consistently been proven to be safe and effective in protecting individuals from severe illness. Billions of doses have been administered globally, and safety monitoring internationally has shown that the vaccine is safe, it said.

There have also been no long-term safety concerns with Covid-19 vaccination, and adverse effects from vaccines, including the mRNA vaccines, have all been observed to occur shortly after vaccination, the ministry added.

Based on local data, keeping updated with vaccination which is receiving an additional dose within the last year has continued to be a key effective measure in preventing severe Covid-19 illness requiring hospitalisation or ICU admission, MOH said.

During the peak month of the JN.1 wave in December 2023, the incidence rate of Covid-19 hospitalisations and ICU admissions among seniors aged 60 years and above was 25 per cent higher in those who had not kept their vaccination updated compared with those who had, it added.

The updated Covid-19 vaccines continue to be free for all eligible residents. Those enrolled in Healthier SG can now receive their vaccination at about 250 participating Healthier SG clinics islandwide.

Over the next few months, MOH will progressively expand the network of Healthier SG clinics offering Covid-19 vaccination to ensure its ready accessibility to the community. The public is advised to book their Covid-19 vaccination appointments via the Health Appointment System at https://book.health.gov.sg/covid or call the clinics directly before making their way there.

To extend its reach into the heartland, particularly for seniors, MOH will deploy additional mobile vaccination teams to selected heartland locations in the coming weeks. The deployment location and schedule are found on https://www.vaccine.gov.sg/locations/mvt

From May 21 to June 29, the five joint testing and vaccination centres (JTVCs) will extend their operating hours on Saturdays and eve of Public Holidays from 9am to 7pm, instead of the usual opening hours from 9am to 1pm. Selected polyclinics will continue to offer vaccination. Appointments for these polyclinics can be made via HealthHub.

MOH will be sending out SMSes to individuals who have not taken any Covid-19 vaccination in the past 12 months, to remind them to keep their vaccination up to date. They can go to https://gowhere.gov.sg/vaccine for the nearest vaccination site and the types of vaccines offered at each site.

The public is also urged to exercise personal and social responsibility, including maintaining good personal hygiene, reducing social interactions when feeling unwell, and wearing masks if medically vulnerable, in crowded areas, or when symptomatic.

With the June holiday season approaching, those travelling overseas are reminded to be vigilant and to adopt relevant travel precautions. MOHs health advisory for travellers is available at http://www.moh.gov.sg/diseases-updates/travel-advisory

The public is also urged to reserve medical treatment at a hospitals Emergency Department for serious or life-threatening emergencies, particularly if their symptoms are mild or if they have no medical vulnerabilities. This will preserve hospital capacity for patients who need acute hospital care and allow those with severe illness to receive timely treatment. - The Straits Times/ANN

Read more from the original source:

Singapore facing new Covid-19 wave; vaccination recommended especially for seniors, says health minister - The Star Online

SINGAPORE: There has been a near doubling of COVID-19 cases in Singapore week-on-week, prompting the Health Ministry to take steps to ensure sufficient capacity at public hospitals.

The estimated number of COVID-19 infections in the week of May 5 to 11 rose to 25,900 a 90 per cent increase compared with the 13,700 cases in the week before that.

The average daily COVID-19 hospitalisations rose to about 250 from 181 the week before, said the Ministry of Health (MOH) on Saturday (May 18). It added that the average daily cases in intensive care remained low at three cases compared to two cases in the previous week.

MOH is closely tracking the trajectory of this wave, the ministry said.

To protect hospital bed capacity and as a precaution, public hospitals have been asked to reduce their non-urgent elective surgery cases, and move suitable patients to care facilities like Transitional Care Facilities or at home through Mobile Inpatient Care@Home.

It also urged people not to seek treatment at a hospitals Emergency Department if their symptoms are mild or if they have no medical vulnerabilities.

The KP.1 and KP.2 strain of the COVID-19 virus currently account for more than two-thirds of cases in Singapore.

The two strains belong to a group of COVID-19 variants scientists have dubbed FLiRT, after the technical names of their mutations. They are all descendants of the JN.1 variant, which spread rapidly around the world several months back.

Earlier this month, the World Health Organization classified KP.2 as a Variant Under Monitoring. It is also the dominant strain in the United States and has been detected in countries like China, Thailand, India, Australia and the United Kingdom.

There are currently no indications, globally or locally, that KP.1 and KP.2 are more transmissible or cause more severe disease than other circulating variants, MOH said on Saturday.

Follow this link:

Singapore's COVID-19 cases nearly double; public hospitals to reduce non-urgent elective surgeries - CNA

Moderna said Friday that the European Patent Office has upheld the validity of one of its key patents, a victory in a continuing dispute with Pfizer and BioNTech over rival COVID-19 vaccines.

Cambridge-based Moderna has been fighting Pfizer and BioNTech in the courts over the partners COVID shot, called Comirnaty. Moderna sued them in 2022 for allegedly copying its messenger RNA technology.

Pfizer and BioNTech, its German business partner, filed a countersuit, alleging that Modernas patent was invalid.

Comirnaty and Modernas vaccine, Spikevax, generated billions of dollars during the pandemic. But revenues have plunged as the health threat receded and there was tepid interest in booster shots.

We are pleased that the European Patent Office decided to maintain the validity of Modernas EP949 patent, one of the key patents currently asserted against Pfizer and BioNTech in various European national courts, Moderna said in a statement to the Globe.

Moderna said it expected that Pfizer-BioNTech will appeal the decision. New York-based Pfizer told Reuters that it was disappointed in the decision and would consider all legal options.

Irrespective of the outcome of this legal matter, we will continue to manufacture and supply the Pfizer-BioNTech COVID-19 vaccine, Pfizer said in a statement to Reuters.

The oral decision was handed down on Thursday, according to the Financial Times, which was the first to report the matter. A written decision is expected to be published in the coming months.

Modernas stock was largely unchanged on Friday, rising 0.17 percent to close at $132.90.

Jonathan Saltzman can be reached at jonathan.saltzman@globe.com.

More here:

Moderna wins a battle in vaccine patent dispute with Pfizer-BioNTech - The Boston Globe