Category: Corona Virus Vaccine

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Investigating the trend of demographic changes, mortality, clinical and paraclinical findings of patients hospitalized in … – BMC Infectious…

May 15, 2024

The present study was conducted with the aim of comparing the trend of demographic changes, mortality, clinical and paraclinical findings of patients admitted to the corona ward, before and after the start of general vaccination of COVID-19. The most important findings of the present study indicate that before the start of general vaccination for COVID-19, the majority of patients were hospitalized in the Corona Intensive Care Unit (59.3%), aged between 51 and 65 years (47.3%), hospitalized for more than 3 days (54%), required intubation (49.3%), had SPO2<93% (60.7%), and exhibited common symptoms such as cough, shortness of breath, and loss of consciousness. Paraclinical findings included positive CRP, decreased lymphocytes, and ground glass opacity (GGO). After the start of general vaccination for COVID-19, most patients were hospitalized in the general care department of Corona (68%), aged between 36 and 50 years (47.3%), hospitalized for less than three days (66%), required intubation (20%), had SPO293% (77.3%), and exhibited common symptoms such as weakness, headache, and body pain. Paraclinical findings were within the normal range.

The findings of the present study showed that before the general vaccination of COVID-19, most of the patients hospitalized in corona wards were in the age range of 5165 years. However, after the start of general vaccination against COVID-19, most of the patients hospitalized in corona wards were in the age range of 3650 years.

In line with this finding of the present study, the results of the studies A. Christie et al. (2021) [19], M. L. Salomo et al. (2022) [20] as well as Emre zgen et al. (2023) [21] showed that general vaccination of COVID-19 was associated with a change in the age range of patients hospitalized in corona wards. So that after the start of general vaccination of COVID-19, most of the patients hospitalized in corona wards were in the age group of less than 50 years.

But the results of the study K. Dooling et al. (2021) [22] as well as the results of the study by H. Rossman et al. (2021) [23] are not in line with this finding of the present study. So that the results of their studies showed that the general vaccination of COVID-19 is not related to the change in the age range of hospitalized patients. Also, most of the patients admitted to the Corona wards were elderly people over 60 years old. This discrepancy in research findings can be related to the different geographical environment in the studies as well as the type and number of hospitalized patients.

The findings of the present study showed that most of the patients were hospitalized in the Corona Intensive Care Department before the general vaccination of COVID-19. After the start of the general vaccination of COVID-19, most of the patients were hospitalized in the normal care department of Corona. The results of the study of M. Moffa et al. (2022) [24] as well as the results of the study M. Fogolari et al. (2022) [25] is in line with this finding of the present study. The results of their studies showed that after the start of general vaccination of COVID-19, most of the patients were hospitalized in the general care departments for corona patients. So that the number of patients hospitalized in the special corona wards has decreased.

But the results of the study of M. zsoy et al. (2023) [26] as well as the results of the study of B. Ngo et al. (2021) [27] is not in line with this finding of the present study. So that the results of their study showed that there is no connection between the start of general vaccination of COVID-19 and the type of inpatient department of corona patients. This discrepancy in research findings can be related to the different geographical environment in the studies as well as the type and number of hospitalized patients.

The findings of the present study showed that before the general vaccination of COVID-19, most of the patients were hospitalized for more than 3 days in the care units for corona patients. Also, the findings showed that after the start of general vaccination for COVID-19, most of the patients were hospitalized in the care units for corona patients for less than three days.

In line with this finding of the current research, the results of the study of M. Tenforde et al. (2021) [28] and the results of the study by Aakashneel Bhattacharya et al. (2021) [29] showed that the start of general vaccination of COVID-19 is related to the number of days of hospitalization of patients in corona wards. so that after the start of the general vaccination of COVID-19, the number of days of hospitalization of patients in corona wards has decreased.

However, the results of the study of G. Suleyman et al. (2022) [30] and the results of the study of Anshuman Srivastava et al. (2022) [31] are not in line with this finding of the present study. So that the results of their study showed that there is no relationship between the start of general vaccination for COVID-19 and the number of days of hospitalization of patients in the care departments for corona patients.

The findings of the present study showed that the number of patients requiring intubation had decreased after the start of general vaccination against COVID-19. In line with this finding of the present study, the results of the study by C. Bezzio et al. (2020) [32] as well as the results of the study by Cristiane de Freitas Paganoti et al. (2022) [33] showed that the start of general vaccination of COVID-19 has been associated with a decrease in the need for intubation and also a decrease in the need for hospitalization in special corona wards.

The findings of the present study showed that the percentage of oxygen saturation (SPO2) in most patients was less than 93% before the start of the general vaccination of COVID-19 and more than 93% after the start of the general vaccination of COVID-19. In line with this finding of the present study, the results of Linzy Houchen-Wolloff et al. (2021) [34] as well as the results of the study of Ulfa Husnul Fata et al. (2022) [35] showed that the start of general vaccination of COVID-19 was associated with an increase in the percentage of oxygen saturation in patients hospitalized in corona wards.

The findings of the present study showed that the mortality rate in patients hospitalized in the care units for Corona patients decreased after the start of general vaccination for COVID-19. The results of the study by R. Kempker et al. (2022) [36] and the results of the study by P. Moreno-Nunez et al. (2022) [37] are in line with this finding of the present study. The results of their study showed that the start of general vaccination for COVID-19 was associated with a decrease in mortality in patients hospitalized in COVID-19 wards.

The findings of the present study showed that before the general vaccination of COVID-19, cough, dyspnea, and loss of consciousness were among the common symptoms of patients hospitalized in corona wards. However, after the start of the general vaccination of COVID-19, general weakness, headache, and body pain were among the common symptoms of patients hospitalized in corona wards. The results of the study of Zunaira Khan et al. (2022) [38] are in line with this finding of the present study, as the results of their study showed that: after the start of the general vaccination of COVID-19, general weakness, headache, and acute myelopathy were among the common symptoms of patients hospitalized in corona wards.

Also, the results of the study by L. Bonifcio et al. (2022) [39] are in line with this finding of the present study. The results of their study showed that: before the general vaccination of COVID-19, common symptoms like cough, dyspnea, and loss of consciousness were common, but after the vaccination, general weakness, headache, and muscle weakness emerged.

The findings of the present study showed that the laboratory results of most of the patients hospitalized in the care units for corona patients before the start of general vaccination of COVID-19 included positive CRP and a decrease in lymphocytes. However, after the start of the general vaccination of COVID-19, the laboratory findings of most of the patients hospitalized in the care units for corona patients were normal.

The results of the study of H. Fu et al. (2020) [40] are in line with this finding of the present study, in such a way that the results of their study showed that: after the start of general vaccination, CRP levels decreased significantly and lymphocyte counts increased in COVID-19 patients. Also, the results of the study of H. Akbari et al. (2020) [41] are in line with this finding of the present study. The results of their study showed that: before the start of general vaccination, most COVID-19 patients had a decrease in lymphocytes and an increase in CRP, but after the start of vaccination, these results reversed.

The findings of the present study showed that the radiology results of most of the patients hospitalized in the care departments of Corona patients before the start of general vaccination of COVID-19 were ground glass opacity (GGO). However, after the start of general vaccination against COVID-19, the radiology results of most of the patients hospitalized in the care units for corona patients were normal.

The results of the study of Mamatha Reddy D. Cozzi et al. (2021) [42] are in line with this finding of the present study in such a way that the results of their study showed that: before the start of general vaccination against COVID-19, most hospitalized patients had ground-glass opacities (GGO) on CT, but after the vaccination, GGO results decreased. Also, the results of the study of Jufriadif Naam et al. [43] (2021) are in line with this finding of the present study in such a way that the results of their study showed that: before the start of general vaccination against COVID-19, most hospitalized patients had radiology results showing ground glass opacity (GGO) in their thorax.

Among the limitations of the study were the short study period and the small number of samples under investigation. It is suggested to conduct future studies over a longer period of time and with a larger sample size. Another limitation of the current study was the newness of the MCMC system, which was associated with limitations such as not recording a number of variables. Therefore, access to all demographic, clinical, and paraclinical variables of the patients was not possible.

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Investigating the trend of demographic changes, mortality, clinical and paraclinical findings of patients hospitalized in ... - BMC Infectious...

Novavax shares more than double on Sanofi’s $1.4 billion investment for combo vaccine – Morningstar

May 15, 2024

By Louis Goss

Struggling Novavax struck a $1.4 billion deal with Sanofi on Friday to commercialize its existing COVID-19 vaccine and develop a combined jab to protect against both the coronavirus and influenza - causing its share price to more than double.

The agreement saw Novavax lift the going concern notice it issued in 2023, when the Gaithersburg, Maryland company warned that plunging COVID-19 vaccines sales could push it into bankruptcy.

Novavax (NVAX) shares surged 137% on the news, having lost 50% of their value in the 12 months prior to the announcement of the Sanofi deal. Shares of the French pharmaceutical group (FR:SAN) rose 1%, down 5% over the previous 12 months.

Under the deal, Sanofi agreed to pay $500 million upfront, alongside a further $700 million in launch, development and regulatory milestone payments, to sell Novavax's standalone COVID-19 vaccine worldwide, and develop and sell a new combined influenza/COVID vaccine.

Novavax will also be entitled to a further $200 million in additional launch and sales milestone payments, alongside mid-double digit royalties on vaccines developed by Sanofi using its Matrix-M adjuvant technology, which helps vaccines stimulate an immune response.

In a statement, Novavax CEO John C. Jacobs said the deal, which is worth more than double the value of Novavax's $628 million market cap, marks "the beginning of an exciting new chapter" for the biotech.

Novavax has seen its sales collapse over the previous two years, due to plummeting demand for its COVID-19 vaccines. In February 2023, the firm said it had "substantial doubt" about its ability to continue operating.

Analysts at Barclays, led by Emily Field, said Sanofi's interest in Novavax largely relates to the potential boost its COVID-19 vaccine could provide to sales of the French company's own flu vaccine, via creation of a combined jab.

"Given declining uptake of COVID vax timing raises some questions, but angle seems to be protecting incumbent flu business," the Barclays' analysts said.

Novavax, which was started in 1987, first gained regulatory approval for its non-mRNA COVID-19 vaccine in the U.S. in July 2022, almost two years after Pfizer (PFE) obtained approval for its own mRNA-based vaccine in December 2020 at the peak of the pandemic.

At the time, there were hopes the more conventional protein-based vaccine would help persuade vaccine skeptics to get their shots.

In April, activist hedge fund Shah Capital, which owns a 6.7% stake in Novavax, called for an "urgent shakeup" of Novavax's board over claims it had failed to highlight fears surrounding mRNA vaccines to boost sales of its non-mRNA alternative.

In a statement sent to MarketWatch, Shah Capital founder Himanshu H. Shah said: "The deal announced concurs with Shah Capital's prior comments on their superior respiratory vaccine technology platform as well as marketing failings. A step in the right direction for shareholders."

Even with Friday's gains, Novavax's $1.48 billion market cap remains well below its peak at $10.8 billion which it hit in 2021, according to the website CompaniesMarketCap.

-Louis Goss

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

05-10-24 1021ET

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Novavax shares more than double on Sanofi's $1.4 billion investment for combo vaccine - Morningstar

FLiRT, FLip, and other new Covid-19 subvariants: What you need to know – RNZ

May 15, 2024

The Covid family tree is a confusing one. But JN.1 was like a big, strong branch. And now, it is dense with twigs. (Illustration image) Photo: 123RF

If you have caught Covid-19 in Aotearoa New Zealand in 2024, chances are you were infected with Omicron subvariant JN.1.

The subvariant made headlines just before Christmas, and by March accounted for 98 percent of sequenced cases.

But its reign is coming to an end, as one of its descendants has given rise to a new subset of variants, referred to as "FLiRT" or, in some cases, "FLip" (based on the technical names for their mutations).

The Covid family tree is a confusing one. But JN.1 was like a big, strong branch. And now, it is dense with twigs.

We know SARS-CoV-2, the virus which causes Covid, has a propensity for big, evolutionary leaps.

In early 2022, the Omicron variant replaced Delta as the dominant strain. On an individual level, Omicron was less dangerous, but more transmissible.

Omicron subvariants have circulated since then, thanks largely to advantageous spike protein mutations. (The spike proteins, protruding like needles from a pincushion, help the virus infect human cells.)

From Omicron came BA.2.86, nicknamed Pirola, and then JN.1. It did not take long for the fast-spreading JN.1 to out-compete other lineages in New Zealand, as it had overseas.

Environmental Science and Research's (ESR) latest Covid-19 genomics report, from 12 April, noted 98 percent of sequenced cases were JN.1 or a JN.1-derived lineage. The only other subvariant detected in the last fortnight was BA.2.86 - JN.1's parent.

The latest wastewater results also showed almost complete replacement of older lineages by JN.1.

ESR has been tracking FLiRT mutations in its public report for about a month, science leader, genomics and bioinformatics Dr David Winter told RNZ.

"In the last few weeks, emerging lineages have both been rising reasonably quickly as a proportion of all cases, with the fastest growing of these having a growth advantage of about 5 percent per day over JN.1."

This meant the lineage was about 5 percent better each day than JN.1 at infecting people. (This is still below the level expected to have a substantial impact on caseloads.)

While JN.1 was still dominant, JN.1.16, KP.2 and KP.3 were creeping onto surveillance charts.

At the week ending 5 May, the three named variants accounted for just over 20 percent of all Covid viruses sequenced from wastewater.

"It's a contributing pressure to case numbers, but not enough by itself to spur a variant-driven wave," Winter said.

The presence of SARS-CoV-2 in wastewater has spiked since 21 April. Hospital admissions have also increased, with the rolling seven-day average at 27 on 5 May, up from 22 the Sunday prior, and 20 the one prior to that.

Covid-19 modeller Professor Michael Plank said it looked as though FLiRT variants were driving "a bit of growth" in Covid numbers internationally. "There are signs in the latest data that this is probably starting to happen in New Zealand as well."

While the growth rate of these variants was not as large as that of JN.1 around Christmas, the colder weather could give the virus a "helping hand", Plank said.

"It's possible we'll see a wave that is similar in size to the summer one, but still much smaller than the waves we had in 2022 and 2023."

About the new names? Not really, said epidemiologist Michael Baker.

"It's still the same virus. Don't get caught up in the clever names," he said.

The takeaway was that this was how the virus would behave in the human population for the foreseeable future, he added. "The virus only cares - not that it has consciousness - about one thing: making more copies of itself."

It is obvious at this point the virus is going to "keep creating waves".

"There's not much evidence it's getting more dangerous or more infectious necessarily. The driver [of mutations] is evading existing immunity, meaning it becomes more infectious at a population level. But it's not changed how it's transmitted in the air."

It is impossible to say whether the new subvariants cause different symptoms from prior ones.

"The greatest variability isn't between lineages, it's between people," Baker said. "It's more about your state of immunity when you get infected. I don't think it's helpful to try to assign different symptoms to different lineages."

A Covid wave ends when the susceptible population decreases, making it harder for the virus to find a host. People get immunity from either prior exposure to the virus, or vaccination.

"Obviously, it's preferable to get immunity from vaccination, which is why people need to keep getting boosters, particularly if they're at-risk," Baker said.

As we head into winter, more people will be getting sick in general, thanks to other common coronaviruses and influenza.

Covid would remain an additional burden on the health system, Baker said. Covid patients in hospitals must be managed more intensely, and pose a risk to other, at-risk patients.

"A lot of people are acquiring Covid in hospital, and people are dying with Covid in hospital when they didn't go in with it."

Long Covid - when the effects of the disease last longer than 12 weeks - remained one of Baker's biggest concerns.

Free Covid rapid antigen tests (RATs) were available to collect until at least 30 June, 2024.

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FLiRT, FLip, and other new Covid-19 subvariants: What you need to know - RNZ

Neale Hanvey: We must follow the science and that includes Covid vaccines – The National

May 13, 2024

This has manifested in various ways but has almost always been accompanied by vilification of those raising the alarm and the monstering of those most affected.

Such behaviours are evident in the handling of the Post Office Horizon scandal, the victims of malpractice in gender medicine, women attacked for defending sex-based rights and the victims of Covid-19 vaccine injury.

While I have been on the receiving end of such attacks, I remain resolute in my position. This is not because I am pig-headed, a dinosaur or a conspiracy theorist, its because I draw on my professional experience and critical thinking skills to analyse, evaluateand interpret information in a logical and systematic manner.

No more clearly can this be demonstrated than by a recent attempt from an unnamed SNP source who contacted the Dundee Courier advising it that the questions I have been raising in Parliament on behalf of vaccine-injured constituents constituted apparent support for conspiracy theories.

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The sad reality is this was an ill-informed political smear rather than an accusation of substance, and when I represented the factual basis of my concerns to the journalist who initially seemed very eager to participate in the smear the story was dropped.

Investigating clinical injury is something I have done many times. Thankfully such injuries are often transient and a full recovery is achieved. In most cases they are down to human error as opposed to negligence but addressing concerns thoroughly and diligently is essential to reassure the injured party and minimise any repeated risk.

On rare occasions, the impact can be far more serious, with the consequences devastating or even fatal. In either case, the need to investigate without an agenda is paramount as there is nothing to be gained by trying to protect any individual, organisation, corporate or political interest for risk to be understood, managed and mitigated.

Since I started looking into vaccine injury, I have established that there are serious questions to be answered but to date there has been little political appetite to do so north or south of the Border.

Politicians, clinicians and industry each carry a duty of honesty and candour, and they must not dismiss emerging clinical evidence. Whether we like it or not, this issue must be addressed openly and urgently.

After decades of direct involvement in the management and delivery of numerous clinical trials, my starting point is a matter of unavoidable fact.

Any agent has the potential to cause harm or injury to the subject. The responsibility to identify, reportand address such risks are the foundation of good clinical practice and are central to any clinical trial protocol.

Good Clinical Practice (GCP) guidelines are the standards on which good science is based. GCP is not about having a nice bedside manner or knowing which treatment to prescribe it is a set of internationally recognised ethical and scientific quality requirements that must be followed when designing, conducting, recordingand reporting on clinical trials that involve people.

The rights, safetyand wellbeing of the trial subjects are the most important considerations and should prevail over interests of science and society, including commercial or political interests.

Clinical trials should always be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, GCP and applicable regulatory requirements.

And this matters because there are allegations that the big pharmaceutical companies responsible for developing the mRNA-based Covid vaccines have deliberately hidden evidence of significant complications in their published trial data.

I spoke to one woman who was severely injured during the initial trials but who discovered all record of her case was removed from trial data. If substantiated, this is a breach of every principle of GCP and the Declaration of Helsinki.

What has been established clinically is that mRNA technology doesnt replicate at the site of administration as was originally suggested. It travels to distant tissue and replicates spike protein in all tissue and organs. This is problematic for a variety of reasons.

According to the esteemed University of London Professor of Oncology, and principal of the Institute for Cancer Vaccines and Immunotherapy, Professor Angus Dalgleish, this has precipitated serious and sometimes fatal consequences.

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He and other clinical academics have been arguing for some time that the vaccine has induced a coagulation condition called Thrombotic Thrombocytopenia Syndrome (TTS) which leads to both blood clot formation and a reduction in available platelet cells needed for normal blood clot formation.

This can lead to stroke, pulmonary emboli (lung clots) and heart attacks, all of which can be life-limiting or fatal. Another antibody that Dalgleish has linked to the spike protein exerts an effect on myelin and is associated with paralysing Guillain-Barre Syndrome (GBS) and Transverse Myelitis, a swelling of the spinal cord.

In a speech in the Commons last month, I cited multiple clinical studies and reviews raising further serious concerns about mRNA vaccines including their impact on cardiac inflammatory markers, cancer relapse, excess mortalityand the abandonment of ethical practice in the rush to find a vaccine during a once-in-a-century pandemic.

I have also uncovered that the Medicines and Healthcare products Regulatory Agency (MHRA) has received 489,004 Covid-19 vaccine suspected adverse drug reaction reports, 2734 of which are associated with a fatal outcome. The true number is unknown, due to limited public awareness, under-reporting and most worryingly a refusal from the Office of National Statistics (ONS) and UK Government to open Record Level Data (RLD) to clinical academic scrutiny.

The need for an urgent rethink has been given fresh impetuous following AstraZenecas admission that the AZ vaccine can, in very rare cases, cause TTS. This admission runs counter to previous comments in 2023 that AZ would not accept that TTS is caused by the vaccine and comes after a 100 million class action lawsuit was filed in the UK on behalf of 50 victims claiming the vaccine was responsible for severe injuries and deaths.

This is an important development for victims because the governments own Vaccine Damage Payment Scheme is totally inadequate.

I raised this specific point during the recent debate and I am pleased to see that Health Secretary Victoria Atkins (above) has since ordered a review of the scheme as Covid vaccine claims soar.

The bottom line is that dogma, hyperbole and adherence to false received wisdom wont cut it. We must investigate the impact of mRNA as a technology without agenda.

As I said at the start of this column, there is nothing to be gained by trying to protect any individual, organisation, corporate or political interest for risk is to be understood, managed and mitigated.

Questions being raised on this issue must be answered with full access to ONS record level data for clinical academics as a minimum. If we are to tackle the problem, we must first understand the extent of it.

None of these clinical experts are quacks or conspiracy theorists.

As the Government said so often during the pandemic, we must follow the science.

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Neale Hanvey: We must follow the science and that includes Covid vaccines - The National

Researchers hopeful new vaccine works against new coronaviruses | interest.co.nz – Interest.co.nz

May 11, 2024

The rapid development of vaccines that protect against COVID was a remarkable scientific achievement that saved millions of lives. The vaccines have demonstrated substantial success in reducing death and serious illness after COVID infection.

Despite this success, the effects of the pandemic have been devastating, and it is critical to consider how to protect against future pandemic threats. As well as SARS-CoV-2 (the virus that causes COVID), previously unknown coronaviruses have been responsible for the deadly outbreaks of SARS (2003) and MERS (2012 outbreak with ongoing cases). Meanwhile, several circulating bat coronaviruses have been identified as having the potential to infect humans which could cause future outbreaks.

My colleagues and I have recently shown, in mice, that a single, relatively simple vaccine can protect against a range of coronaviruses even ones that are yet to be identified. This is a step towards our goal of what is known as proactive vaccinology, where vaccines are developed against pandemic threats before they can infect humans.

Interview with the author, Rory Hills.

Conventional vaccines use a single antigen (part of a virus that triggers an immune response) that typically protects against that virus and that virus alone. They tend not to protect against diverse known viruses, or viruses that have not yet been discovered.

In previous research, we have shown the success of mosaic nanoparticles at raising immune responses to different coronaviruses. These mosaic nanoparticles use a type of protein superglue technology that irreversibly links two different proteins together.

This superglue is used to decorate a single nanoparticle with multiple receptor-binding domains a key part of a virus located on the spike protein that come from different viruses. The vaccine is focused on a sub-group of coronaviruses called sarbecoviruses that includes the viruses that cause COVID, SARS and several bat viruses that have the potential to infect humans.

As a virus evolves, some parts of it change while other parts remain the same. Our vaccine incorporates evolutionarily related receptor-binding domains (RBDs), so a single vaccine trains the immune system to respond to the parts of the virus that remain unchanged. This protects against the viruses that are represented in the vaccine and, critically, also protects against related viruses that are not included in the vaccine.

Despite this success with mosaic nanoparticles, the vaccine was complex, making it difficult to produce on a large scale.

In a collaboration between the universities of Oxford, Cambridge and Caltech, we have now developed a simpler vaccine that still provides this broad protection. We achieved this by genetically fusing RBDs from four different sarbecoviruses to form a single protein that we call a quartet. We then use a type of protein glue to attach these quartets to a protein nanocage to make the vaccine.

When mice were immunised with these nanocage vaccines, they produced antibodies that neutralised a range of sarbecoviruses, including sarbecoviruses not present in the vaccine. This show the potential to protect against related viruses that may not have been discovered at the time that the vaccine was produced.

Along with this streamlined production and assembly process, our new vaccine elicited immune responses in mice that at least matched, and in many cases exceeded, those raised by our original mosaic nanoparticles vaccine.

Given the large fraction of the world vaccinated or previously infected with SARS-CoV-2, there was a worry that an existing response to SARS-CoV-2 would limit the potential to protect against other coronaviruses.

However, we have shown that our vaccine is able to raise a broad anti-sarbecovirus immune response even in mice that had previously been immunised against SARS-CoV-2.

Our next step is to test this vaccine in humans. We are also applying this technology to protect against other groups of viruses that can infect humans. All of this brings us closer to our vision of developing a library of vaccines against viruses with pandemic potential before they have had the opportunity to cross over into humans.

Rory Hills, PhD Candidate, Biochemistry, University of Oxford

This article is republished from The Conversation under a Creative Commons license. Read the original article.

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Researchers hopeful new vaccine works against new coronaviruses | interest.co.nz - Interest.co.nz

Researchers new vaccine technology shows efficacy against broad range of coronaviruses – PMLiVE

May 11, 2024

Researchers from the University of Cambridge, the University of Oxford and Caltech have collaboratively developed a new vaccine technology that has proven to provide protection against a wide range of coronaviruses, including those that have not yet emerged.

Published in Nature Nanotechnology and funded by the Biotechnology and Biological Sciences Research Council, the new proactive vaccinology approach aims to build a vaccine before the disease-causing pathogen emerges in preparation for future outbreaks.

Most conventional vaccines involve a single antigen to train the immune system to target a single specific virus, potentially not protecting against a diverse range of existing coronaviruses or against newly emerging pathogens.

Building on previous work conducted by the University of Oxford and Caltech, the novel all-in-one Quartet Nanocage vaccine works to train the bodys immune system to recognise specific regions of eight types of coronaviruses, including SARS-CoV-1, SARS-CoV-2 and several others circulating in bats that have the potential to cause a human pandemic.

For example, despite not including the SARS-CoV-1 coronavirus, the vaccine still induces an immune response to that virus.

Based on a nanoparticle structure a ball of proteins bound together by strong interactions the vaccine demonstrated an increased broad immune response in mice that were pre-immunised with SARS-CoV-2.

We dont have to wait for new coronaviruses to emerge, said professor Mark Howarth, department of pharmacology, University of Cambridge.

He continued: We know enough about coronaviruses and different immune responses to them that we can get going with building protective vaccines against unknown coronaviruses now.

Much simpler in design compared to other vaccines, the technology has the potential for use in vaccine development to protect against many other health challenges and the vaccine is intended to enter phase 1 clinical trials in early 2025.

Rory Hills, graduate researcher, department of pharmacology, University of Cambridge, said: Our focus [was] to create a vaccine that will protect us against the next coronavirus pandemic and have it ready before the pandemic has even started.

Weve created a vaccine that provides protection against a broad range of different coronaviruses including ones we dont even know about yet.

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Researchers new vaccine technology shows efficacy against broad range of coronaviruses - PMLiVE

New vaccine effective against coronaviruses that haven’t even emerged yet – Science Daily

May 11, 2024

Researchers have developed a new vaccine technology that has been shown in mice to provide protection against a broad range of coronaviruses with potential for future disease outbreaks -- including ones we don't even know about.

This is a new approach to vaccine development called 'proactive vaccinology', where scientists build a vaccine before the disease-causing pathogen even emerges.

The new vaccine works by training the body's immune system to recognise specific regions of eight different coronaviruses, including SARS-CoV-1, SARS-CoV-2, and several that are currently circulating in bats and have potential to jump to humans and cause a pandemic.

Key to its effectiveness is that the specific virus regions the vaccine targets also appear in many related coronaviruses. By training the immune system to attack these regions, it gives protection against other coronaviruses not represented in the vaccine -- including ones that haven't even been identified yet.

For example, the new vaccine does not include the SARS-CoV-1 coronavirus, which caused the 2003 SARS outbreak, yet it still induces an immune response to that virus.

"Our focus is to create a vaccine that will protect us against the next coronavirus pandemic, and have it ready before the pandemic has even started," said Rory Hills, a graduate researcher in the University of Cambridge's Department of Pharmacology and first author of the report.

He added: "We've created a vaccine that provides protection against a broad range of different coronaviruses -- including ones we don't even know about yet."

The results are published today in the journal Nature Nanotechnology.

"We don't have to wait for new coronaviruses to emerge. We know enough about coronaviruses, and different immune responses to them, that we can get going with building protective vaccines against unknown coronaviruses now," said Professor Mark Howarth in the University of Cambridge's Department of Pharmacology, senior author of the report.

He added: "Scientists did a great job in quickly producing an extremely effective COVID vaccine during the last pandemic, but the world still had a massive crisis with a huge number of deaths. We need to work out how we can do even better than that in the future, and a powerful component of that is starting to build the vaccines in advance."

The new 'Quartet Nanocage' vaccine is based on a structure called a nanoparticle -- a ball of proteins held together by incredibly strong interactions. Chains of different viral antigens are attached to this nanoparticle using a novel 'protein superglue'. Multiple antigens are included in these chains, which trains the immune system to target specific regions shared across a broad range of coronaviruses.

This study demonstrated that the new vaccine raises a broad immune response, even in mice that were pre-immunised with SARS-CoV-2.

The new vaccine is much simpler in design than other broadly protective vaccines currently in development, which the researchers say should accelerate its route into clinical trials.

The underlying technology they have developed also has potential for use in vaccine development to protect against many other health challenges.

The work involved a collaboration between scientists at the University of Cambridge, the University of Oxford, and Caltech. It improves on previous work, by the Oxford and Caltech groups,to develop a novel all-in-one vaccine against coronavirus threats. The vaccine developed by Oxford and Caltech should enter Phase 1 clinical trials in early 2025, but its complex nature makes it challenging to manufacture which could limit large-scale production.

Conventional vaccines include a single antigen to train the immune system to target a single specific virus. This may not protect against a diverse range of existing coronaviruses, or against pathogens that are newly emerging.

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New vaccine effective against coronaviruses that haven't even emerged yet - Science Daily

Novavax shares soar on license deal with Sanofi at lofty valuation – Yahoo! Voices

May 11, 2024

By Patrick Wingrove and Bhanvi Satija

(Reuters) -Novavax on Friday said it had struck a licensing deal worth at least $1.2 billion with Sanofi for its COVID-19 vaccine in exchange for a stake that valued the U.S. biotech firm at double its current market capitalization.

The Maryland-based drugmaker's stock more than doubled in Friday trading to $8.97 following the deal as the company also removed a warning notice from February last year that raised doubts about it being in business. At their peak in 2021, shares traded at about $332.

Sanofi will take a 4.9% stake in the U.S. drugmaker for $70 million. That values Novavax at about $1.4 billion, nearly double its market capitalization of about $628 million as of Thursday, but a far cry from its peak of $20 billion in 2021.

The deal also entitles Novavax to an upfront cash payment of $500 million and future payments contingent on certain milestones, as well as royalties.

Sanofi, one of the world's largest vaccine makers, will gain a license to co-sell Novavax's vaccine in most countries and use the COVID shot along with its own flu vaccines to develop a combination shot.

"A company like Sanofi, that has pioneered protein recombinant-based vaccines for decades, validating and actually needing what Novavax has as their next pipeline innovation engine is very powerful," said B. Riley Securities analyst Mayank Mamtani.

For Sanofi, the agreement could help bolster its flu vaccine franchise as companies such as Pfizer and Moderna develop rivals, including combination vaccines to be used along with COVID-19 shots.

The French drugmaker made nearly $7.5 billion in sales from its vaccines last year.

Novavax CEO John Jacobs said during a call with analysts that the company expected the deal with Sanofi to be worth further billions of dollars in the future.

"The majority of what we see as the future value of this deal comes from the anticipated royalties that will be ongoing from Sanofi's ability to sell our COVID vaccine and their own combination vaccine or vaccines," he said.

Jacobs said the company would consider similar deals for its other experimental vaccines, which include a standalone influenza shot.

SHORT SELLERS FEEL PAIN

The cash infusion is likely to strengthen the balance sheet of the vaccine maker, whose shares lost more than 98% of their value since the early days of pandemic as it struggled to get its vaccine to the market in a timely manner.

Novavax has become a target for both short sellers who bet that the value of the stock will fall, and an activist shareholder pushing for changes.

About 35.5% of Novavax's publicly available shares are shorted. Friday's rise is squeezing out short sellers, who are buying back stock to exit their position.

The bearish investors had lost roughly $255 million on paper, according to analytics firm S3 partners.

The deal is "a step in the right direction for shareholders", hedge fund Shah Capital, which has been pushing for a shake-up of Novavax's board, said.

Separately, Novavax cut its 2024 sales forecast, excluding contributions from the Sanofi deal, to between $400 million and $600 million from $800 million to $1 billion previously.

It also reported a net loss that narrowed to $148 million in the first quarter from $294 million a year ago.

(Reporting by Patrick Wingrove in New York, Bhanvi Satija, Medha Singh, Shubham Kalia and Sriparna Roy in Bengaluru, and Tassilo Hummel in Paris; Editing by Shinjini Ganguli and Arun Koyyur)

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Novavax shares soar on license deal with Sanofi at lofty valuation - Yahoo! Voices

AstraZeneca withdraws COVID-19 vaccine, citing low demand – DW (English)

May 11, 2024

The pharmaceutical giant AstraZeneca has reportedly withdrawn its COVID-19 vaccine Vaxzevria, also known as Covishield, worldwide,citing commercial reasons for the decision.

"As multiple, variant COVID-19 vaccines have since been developed, there is a surplus of available updated vaccines. This has led to a decline in demand for Vaxzevria, which is no longer being manufactured or supplied," various media outlets quoted the company was quoted as saying.

A document hosted by the EU's European Medicines Agency website confirmedthatVaxzevriawas no longer authorized in the region.

In an email to DW, virologistWolfgang Preiser said"the demand for SARS-CoV-2 vaccines is very low and unlikely to pick up significantly in the foreseeable future, so I understand the reasoning."

AstraZeneca, who developed the vaccine with Oxford University,said it was "incredibly proud of the role Vaxzevria played in ending the global pandemic."

More than three billion doses were supplied globally. Independent studies estimate that more than 6.5 million lives were saved in the first year that itwas used.

The Oxford-AstraZenecavaccine was developed within the first months of the pandemic in 2020. It was first approved in the UK on December 30, 2020, with other countries granting the vaccine conditional marketing authorization later in 2020 due to the urgency of the pandemic.

Vaxzevria was effective against initial ancestral variants of COVID-19 virus the alpha variant but was less effective against newer variants of COVID-19, such as the omicron variant.

Many governments, including in the UK, Germany and Australia, had stopped using the Oxford-AstraZeneca vaccine before its withdrawal from the market.

"We are still distributing COVID-19 vaccines, but none of them are AstraZeneca any more. They were the first manufacturer with which we concluded our arrangement in 2022,"Olly Cann, director of communications at the international organization Gavi, the Vaccine Alliance, told DW.

Along with the Coalition for Epidemic Preparedness Innovationsandthe World Health Organization, Gavi was involved inCOVAX, a effortto guaranteepeople in every country in the world had fair access to COVID vaccination.

Thelatest COVID-19 vaccine advice issuedby the World Health Organisation in April advised that COVID-19 vaccines should target the JN.1 lineage of the virus, which is now the most dominant variant.

However,at the time of writing,Preiser saidrelatively few severe infections were being observed"due to a high level of population immunity stemming from past vaccination,and often also past infection."

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Although the vaccine was found to be safe and effective overall, it carried a very small risk of developingblood clotsas a side effect. The condition is known as "thrombosis with thrombocytopenia syndrome(TTS)."

The rare syndrome occurred in two to three people per 100,000 who were vaccinated with the Vaxzevria vaccine.

While studies found the vaccine did not increase the risk of heart attacks or strokes, it has been under intense scrutinydue to TTS.

"The side effects are real and may have serious consequences for those affected, but as with all interventions, a careful risk-benefit analysis [was]needed. During the pandemic, the balance was definitely in favor of using the vaccine," saidPreiser, who is based atStellenbosch University in South Africa.

In a UK High Court case, AstraZeneca isbeing sued by more than 50 people, who claim to have been affected by side effects.

The BritishTelegraph newspaper, quoted as the first to break the news of Vaxzevria's withdrawal from the market, reportedthat AstraZeneca had admitted in the court case in February 2024 that the vaccine "can, in very rare cases, cause TTS."

AstraZeneca said the decision to withdraw the vaccine was not linked to the court case or any risks associated withTTS.

Edited by: Zulfikar Abbany

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AstraZeneca withdraws COVID-19 vaccine, citing low demand - DW (English)

Novavax rockets on news of COVID-19 vaccine deal with Sanofi – The Pharma Letter

May 11, 2024

French pharma major Sanofi (Euronext: SAN) says that, as part of its commitment to developing a diverse portfolio of best-in-class vaccines, it has entered into a co-exclusive licensing agreement with US biotech Novavax (Nasdaq: NVAX).

Shares of Novavax were up a 127.3% at $10.03 in pre-market trading this morning.

Sanofi is one of the worlds top producers of flu vaccines with sales of 2.7 billion euros ($2.9 billion) last year, but its early

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