Category: Covid-19 Vaccine

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A combined flu and Covid vaccine from Moderna provokes a higher immune response than separate single jabs, according to new data from the firm.

The results raise hopes the new vaccine could be approved by regulators this year or next, with the possibility of being rolled out on the NHS.

A spokesman for Moderna said they hoped the jab would be available for the 2025 or 2026 flu season.

At the moment, Modernas Spikevax vaccine for Covid-19 is used in the NHS booster programmes, alongside Pfizer/BioNTechs Comirnaty.

A newer version of Spikevax has been created and tested by Moderna, which includes a dose of flu vaccine.

The combination means people would only need one jab rather than two, as at the moment, to give them protection against Covid-19 and flu.

Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses

Stephane Bancel, chief executive of Moderna

This is the first time final phase 3 data for a combined vaccine has been published by any firm.

The findings from Moderna showed that the mRNA-1083 vaccine met its goals and led to higher immune responses against flu and Covid than other single vaccines currently in use, including the current Spikevax.

Stephane Bancel, chief executive of Moderna, said: Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses.

Moderna is the only company with a positive phase 3 flu and Covid combination vaccine.

Building on the momentum of positive phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.

The mRNA-1083 jab matched or bettered current flu jabs and was better than the existing Spikevax at making the body produce antibodies probably because it had been designed to fight more recent variants circulating around the world, Mr Bancel told the BBC.

The randomised controlled trial involved two groups of about 4,000 people each, with the first group aged 65 and over testing the new jab compared with a flu vaccine, Fluzone, and the current Spikevax jab.

The second group included adults aged 50 to 64 and included use of the flu jab Fluarix.

Dr Philip Cruz, UK medical director at Moderna, said: The phase three trial results for mRNA-1083, Modernas combination vaccine targeting influenza and Covid-19, have met the primary endpoints, showing a higher immune response in adults over 50 compared to existing flu and Covid vaccines.

These findings are consistent across all tested influenza strains (H1N1, H3N2 and B/Victoria) and the Sars-CoV-2 variant in both the 65 and older cohort and the 50 to 64 age group.

For the adult population aged 65 years and older, our combination vaccine has elicited stronger immune responses against Sars-CoV-2 and key influenza strains compared to the active comparators used in the study.

We are pleased to see mRNA-1083 has successfully met primary end goals.

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Combined flu and Covid vaccine from Moderna shows positive trial results - The Independent

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The FDA tells Covid-19 vaccine makers to update shot to target the variant currently in circulation - The Albany Herald

Although Covid cases remain low in the U.S., vaccine experts are already looking toward the winter, with eyes on preventing a seasonal surge.

A Food and Drug Administration advisory panel on Wednesday unanimously recommended that the Covid vaccines for the fall be updated to target the highly contagious JN.1 variant or one of its descendants.

JN.1 emerged in the U.S. in late August and by January became the dominant strain in circulation.

Various offshoots of JN.1 soon followed, including the so-called FLiRT variants, KP.1.1 and KP.2. In mid-May, KP.2 overtook JN.1 as the dominant strain in the U.S., and it now accounts for over 1 in 4 new cases, according to the Centers for Disease Control and Prevention.

Natalie Thornburg, a research microbiologist at the CDC, said at Wednesdays meeting that the coronavirus appears to be adopting a consistent pattern: a dominant parent strain takes hold in early winter, and by spring, a handful of descendants emerge. Thats also what happened with the XBB strain last year, she said, which dominated in the winter but gave rise to offshoots in the spring.

The panels recommendation didnt specify whether to include the parent JN.1 strain or one of its descendants, but most panel members expressed a preference for JN.1.

"The trunk of the tree is probably our best bet for now," said panel member Dr. Bruce Gellin, the chief of global public health strategy at the Rockefeller Foundation, in a discussion following the vote.

Dr. Peter Marks, the FDA's top vaccine regulator, urged the committee to consider one of the more recent strains, such as KP.2.

We are paying an incredibly high premium for mRNA vaccines to be able to have the freshest vaccines, Marks said, a reference to the speed with which new mRNA-based vaccine shots can be developed and produced.

"Will we regret not having been a little bit closer?" he added.

The FDA is expected to make a final decision soon on which strain it will advise drugmakers to target. That will kickstart production of the updated shots, which will be distributed as part of a fall vaccination campaign.

Pfizer said Wednesday it can have updated Covid shots available immediately upon approval from the FDA; Moderna said it can have shots available to distribute as early as mid-August.

Novavax said its on track to have an updated vaccine that targets JN.1 available in August. However, should the FDA select a different strain, the company said it will not have an updated shot for that specific strain available for the fall vaccination campaign. Novavax uses a protein-based vaccine, which takes longer to manufacture than the mRNA-based vaccines made by Pfizer and Moderna.

All three drugmakers presented data Wednesday showing that a JN.1 vaccine should generate higher levels of antibodies against circulating strains of the virus compared to the current vaccine, which is targeted against XBB.1.5, a subvariant thats no longer in circulation. Once the updated vaccine is available, the older vaccine will be discontinued.

Covid hospitalizations remain at their lowest levels since the start of the pandemic in 2020, though there are some indications that cases may be starting to creep upward.

CDC data showsthat, as of May 25, the weekly test positivity ratewas4.2%,up from 3.4% the week prior. In comparison, in early 2022, when the omicron variant began to rapidly spread, the weekly test positivity rate was around 30%.Thornburg said that virtually all Americans have developed some form of immunity to Covid, either through infection, vaccination or a combination of both.

Were sitting at about just below 100% seroprevalence, she said, referring to the number of people in a population who have been exposed to a virus.

Later this month, a CDC advisory group will make recommendations for who should get the vaccine in the fall.

Berkeley Lovelace Jr. is a health and medical reporter for NBC News. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. He previously covered the biotech and pharmaceutical industry with CNBC.

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FDA panel recommends updating the Covid vaccines for the fall to target JN.1 strain - NBC News

WASHINGTON (AP) Government advisers Wednesday said its time to update the recipe for the COVID-19 vaccines Americans will receive in the fall -- targeting a version of the ever-evolving coronavirus called JN.1.

While COVID-19 cases currently are low, more surges are inevitable and manufacturers need time to brew shots for fall. Moderna, Pfizer and Novavax all have tested doses updated to match the JN.1 variant that became dominant last winter.

But just a few months later, numerous offshoots of JN.1 already are on the rise, prompting Moderna and Pfizer to also test a slightly different vaccine formula targeting whats now the most common U.S. subtype, called KP.2.

That made for a tough choice as the Food and Drug Administration decides the final recipe. FDAs advisers voted Wednesday that the next vaccine should come from the JN.1 lineage or family. Then FDA vaccine chief Dr. Peter Marks challenged them to be more specific about exactly which variant to target, wondering if KP.2 was a better option.

If this evolves further in the fall, will we regret not having been a little bit closer? Marks said, likening the choice to how he always picks the freshest milk with the longest expiration date in the grocery store.

But KP.2 isnt likely to still be the biggest threat by fall, the panel responded. Having to make the choice now, they preferred the parent JN.1 variant itself rather than trying to predict which of its descendants was most likely to increase in the coming months.

Having a vaccine thats the trunk of the tree rather than the branches makes sense to me, because it would offer some cross-protection to other subvariants that emerge, said one adviser, Dr. Melinda Wharton of the Centers for Disease Control and Prevention.

Health officials have told Americans to expect a yearly update to COVID-19 vaccines, just like they get a new flu shot each fall designed to match as best as possible the currently spreading strains. Even though just about everyone has either been infected or had at least one round of COVID-19 vaccinations, the coronavirus keeps churning out new varieties that can dodge prior immunity - and protection also wanes over time.

Last falls COVID-19 vaccine targeted a completely different section of the coronavirus family tree, and CDC data shows only about 22.5% of adults and 14% of children received it. But even though public concern about COVID-19 has waned, it remains deadlier than the flu, according to a recent analysis of Veterans Affairs hospitalizations this past winter.

Moderna, Pfizer and Novavax all said they could have supplies of JN.1-specific shots ready by fall, although they didnt provide amounts. Like it has in previous years, the CDC will make recommendations on who should receive updated shots and when.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Science and Educational Media Group. The AP is solely responsible for all content.

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FDA advisers urge targeting JN.1 strain in recipe for fall's COVID vaccines - The Associated Press

NIAID

Astudy in Texas found higher rates of antimicrobial-resistant (AMR) organisms in areas with higher levels of economic deprivation, researchers reported today in Clinical Infectious Diseases.

Using electronic health records from two large healthcare systems in the Dallas-Fort Worth metropolitan area, a team led by researchers from the University of Texas Southwestern Medical Center collected select patient bacterial culture results from 2015 to 2020. They chose five AMR organisms to represent potential community- and healthcare-associated acquisition, used residential addresses to geocode cultures and link them to socioeconomic index values, and identified geographic clusters of high and low AMR organism prevalence.

Among the 43,677 unique cultures collected, 43.5% were identified as methicillin-resistant Staphylococcus aureus (MRSA), 31% as extended-spectrum beta-lactamase (ESBL)producing organisms, 11.3% as carbapenem-resistant Enterobacterales, 8.2% as vancomycin-resistant Enterococcus, and 5.9% as AmpC beta-lactamase producers. Significant clusters of all five organisms were found in areas with high levels of economic deprivation, as measured by the area deprivation index (ADI), and there was significant spatial autocorrelation between ADI and AMR prevalence.

The strongest correlation was observed for MRSA and AmpC, with 14% and 13%, respectively, of the variability in prevalence rates attributed to their relationship with the ADI values of the neighboring locations.

The study authors say several factors could explain why AMR organisms are more prevalent in areas with greater socioeconomic disparities. For example, people in areas with higher ADI may have poorer sanitation due to utility disruptions or poor plumbing and therefore be more likely to be exposed to bacteria, or may live in overcrowded settings that can contribute to the spread of infection. The practice of sharing "leftover" antibiotics with friends and family could also select for resistant organisms.

While further research is needed to delineate the relationship, they say the findings highlight the importance of addressing these disparities.

"This finding that ADI is associated with higher prevalence of AMR supports the need for tailored, local interventions for small neighborhoods including social programs that increase access to health insurance, along with public health campaigns discussing proper hygiene techniques to prevent the spread of disease within a household," they wrote.

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Study shows no link between stillbirths, COVID-19 vaccines - University of Minnesota Twin Cities

A combination flu and COVID-19 vaccine developed by Moderna generated a higher immune response in a late-stage trial than standalone vaccines, the company said Monday.

A two-in-one shot could improve vaccination rates and reduce the burden on the health care system.

Modernas phase 3 clinical trial studied two groups of about 4,000 people in each.

In one group, consisting of participants ages 65 and older, researchers compared the combo vaccine, called mRNA-1083, to the influenza vaccine Fluzone HD and Spikevax, Modernas COVID shot.

In the second group, of people 50 to 64, scientists compared mRNA-1083 to the flu vaccine Fluarix and Spikevax.

The study found that not only were immune responses from the combo vaccine not inferior to the other shots, they were statistically significantly higher against three flu strains H1N1, H3N2, and B/Victoria as well as COVID-19.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," Modern CEO Stphane Bancel said in a statement.

Pfizer and Novavax are also developing combo flu and COVID shots, but Moderna is the first to report positive phase 3 results.

Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health, Bancel said.

Moderna said it will present its data at an upcoming medical conference and submit the study results for publication, when they will be peer reviewed. It will then engage with regulators.

The vaccine will not be available for this years flu season.

Moderna said the combination shot also appears to be safe. The majority of side effects reported were minor, the most common being injection-site pain, fatigue, muscle aches and headache. The side effects were consistent with the other vaccines monitored in the study, the company said.

Francesca Ceddia, chief medical affairs officer for Moderna, noted in a blog post that, as of last month, flu vaccine uptake in the United States was more than double COVID-19 immunization rates (48.4% vs. 22.4%). Meanwhile, COVID-related hospitalizations are higher than with the flu and more than double among older adults.

The convenience that a combination vaccine could offer patients may help fill this gap while simplifying and routinizing vaccination against both diseases, which could help improve compliance with public health recommendations, Ceddia wrote.

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Moderna reveals promising study results on combo flu-COVID vaccine - Spectrum News NY1

Moderna said on Monday that its combination vaccine that targets COVID-19 and the flu was more effective than their current separate vaccines for both viruses, according to new late-stage clinical trial data.

The pharmaceutical giant is the first company to release Phase 3 clinical trial data on a combination flu-COVID vaccine, leading the industry over rivals such as Novavax and Pfizer.

Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses, Moderna CEO Stephane Bancel said.

Modernas mRNA vaccine, called mRNA 1083, comprises two different experimental formulas: one for seasonal influenza and another designed for recent variants of COVID-19.

The clinical trial is examining mRNA 1083 in 8,000 patients and is comparing the combination shot to the standard flu and COVID-19 shots already on the market. Patients between the ages of 50 and 64, as well as those over 65, are being studied in two different cohort groups.

So far, the combination vaccine is producing significantly higher immune responses against three strains of influenza and COVID-19.

Moderna reported that the safety of the combination shot is reasonable, with the most common side effects being mild to moderate injection site pain, muscle pain, and headache.

Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine, Bancel said. Building on the momentum of positive Phase 3 data across our respiratory portfolio, we continue to address significant unmet medical needs and advance public health.

Stock prices for both Moderna and Pfizer plummeted following the decreasing uptake of mRNA COVID-19 vaccines as the pandemic receded. Moderna, however, seems to be making a recovery following its successful approval for a new RSV vaccine as well as its progress in developing a bird flu vaccine.

The pharmaceutical company is also working on a combination vaccine to combat both influenza and RSV, as well as a tripartite vaccine to target COVID-19, the flu, and RSV.

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Moderna combo flu and COVID-19 vaccine more effective than single shots - Washington Examiner

(Precision Vaccinations News)

Moderna, Inc. today announced that its Phase 3 clinical trial of mRNA-1083, an investigational combination vaccine against influenza and COVID-19, has met its primary endpoints, eliciting a higher immune response than the licensed comparator vaccines used in the trial.

mRNA-1083 met its primary endpoints, eliciting higher immune responses against influenza and SARS-CoV-2 viruses than licensed flu and COVID vaccines in adults 50 and older, including an enhanced influenza vaccine in adults 65 and older.

"Combination vaccines have the potential to reduce the burden of respiratory viruses on health systems and pharmacies, as well as offer people more convenient vaccination options that could improve compliance and provide stronger protection from seasonal illnesses," said Stphane Bancel, Chief Executive Officer of Moderna, in a press release on June 10, 2024.

"Moderna is the only company with a positive Phase 3 flu and COVID combination vaccine."

Moderna plans to present the Phase 3 clinical data for mRNA-1083 at an upcoming medical conference, submit them for publication, andengageregulators on the next steps.

mRNA-1083 comprises components of mRNA-1010, Moderna's vaccine candidate for seasonal influenza, and mRNA-1283, Moderna's next-generation COVID-19 vaccine candidate. Moderna says each investigational vaccine hasindependentlydemonstratedpositive Phase 3 clinical trial results.

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Influenza and COVID-19 Combo Vaccine Candidate Posts Positive Phase 3 Data - Precision Vaccinations

SINGAPORE: The Ministry of Health (MOH) on Monday (Jun 3) rejected "egregious and false claims" cited by the People's Power Party, which had called for a suspension of COVID-19 vaccination.

The opposition party's Facebook post on May 29 cited "studies and analyses by prominent medical experts", which claimed that COVID-19 vaccines caused high incidences of severe side effects, MOH said.

It also attempted to draw associations between high vaccination rates and excess deaths, the ministry said in a media statement on Monday.

The People's Power Party claimed that Singapore has been experiencing "unusual and exceptionally high excess deaths" since 2021 when COVID-19 vaccination was introduced as compared to pre-vaccination years.

"It is more worrying that such high excess deaths situation is not unique to Singapore as other highly COVID-19-vaccinated countries and region are also encountering similar problems," said the opposition party in its Facebook post.

MOH categorically rejects these egregious and false claims, said the Health Ministry, adding that people must"draw the right conclusions and follow the scientific evidence on the safety and effectiveness of COVID-19 vaccines".

"The primary reason whySingapore recorded one of the lowest excess death rates in the world during the pandemic, is because the majority of Singaporeans took the vaccines," said MOH.

The ministry also said that contrary to the claims that vaccination has led to excess deaths, multiple studies have shown that that COVID-19 vaccination reduces the risk of death as compared to the unvaccinated during the period of the pandemic.

This includes countries that predominantly use the mRNA vaccines, it added.

In fact, 19.8 million deaths from COVID-19 were prevented globally within the first 12 months that vaccines became available (from December 2020 to December 2021), said MOH.

The Health Ministry added that excess deaths in Singapore during the pandemic were attributable to deaths of people infected with COVID-19 or those with a recent infection. Of those who died, there was an "over-representation" of people who were not fully vaccinated.

The high level of vaccine protection in our society averted many COVID-related deaths, protected our healthcare system from being overwhelmed, and allowed us to preserve lives and livelihoods, said the ministry.

The normalcy in our daily lives today is in large part due to the protection that COVID-19 vaccines provide.

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MOH rejects 'egregious and false claims' by People's Power Party about COVID-19 vaccines - CNA

Covid-19 infection can also cause complications related to the heart and brain.

MOH said people need to draw the right conclusions and follow the scientific evidence.

Several examples given by the PPP were either not written by the authors they cited, or their work had been debunked, said the MOH.

For example, the PPP cited Dr Peter McCullough, who claimed that the risks of myocarditis outweigh the benefits of vaccination.

MOH said his article, A Systematic Review Of Autopsy Findings In Deaths After Covid-19 Vaccination, was removed by Preprints With The Lancet.

The reason given was the studys conclusions are not supported by the study methodology.

The Lancet journal said preprints are early-stage research papers that have not been peer-reviewed.

Regarding the claim made by Dr Geert Vanden Bosshe, a virologist from Belgium, that mass vaccinations expedited the evolution of the Sars-CoV-2 virus, which causes Covid-19, MOH said that viruses naturally mutate as they replicate, and that there is no evidence that the mRNA vaccines contributed to evolution.

Three others mentioned by the PPP Dr Robert Malone, Dr Aseem Malhotra and Professor Angus Dalgleish did not author the articles which the PPP had quoted them as saying.

In mid-May, Health Minister Ong Ye Kung warned that Singapore was facing an upsurge in Covid-19, which he expected to peak towards the end of June.

At that time, about 250 people were hospitalised for Covid-19 each day.

This has since gone up to an average of 371 a day, an MOH spokesman told The Straits Times, although the number requiring intensive care remains low.

More people are also being diagnosed with Covid-19. There were 24,800 cases in the week of May 19-25, up from 21,900the previous week.

Looking back at the pandemic, which raged globally for more than two years from 2020, the ministry said: The high level of vaccine protection in our society averted many Covid-related deaths, protected our healthcare system from being overwhelmed, and allowed us to preserve lives and livelihoods.

The normalcy in our daily lives today is in large part due to the protection that Covid-19 vaccines provide.

On May 18, the MOH said that about 80 per cent of people here who have completed their initial or additional vaccine doses have not received a dose within the past year.

The recommendation is for people who are 60 years and older, or who are medically vulnerable, to be vaccinated annually.

The Covid-19 vaccine remains free for all eligible residents at 250 Healthier SG clinics and at five joint testing and vaccination centres, and selected polyclinics.

Urging people, especially those at higher risk of severe illness if infected, to stay up to date with their Covid-19 vaccines, the spokesman said the ministry is closely tracking the KP.1 and KP.2 wave, and is ready to implement additional measures to preserve our healthcare capacity if necessary.

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MOH rejects call by People's Power Party to temporarily suspend Covid-19 vaccination - The Straits Times