Category: Covid-19 Vaccine

The remarkable effectiveness of mRNA vaccines against SARS-CoV-2 has generated much interest in synthetic mRNA therapeutics for treating and preventing disease. But some basic science questions have remained about whether the modified nucleotides used in the vaccines faithfully produce the protein products that they are designed to make.

The synthetic mRNAs used in the COVID-19 vaccines incorporate the modified nucleotide N1-methylpseudouridine to improve stability and reduce unwanted immune responses. Both features are necessary for the vaccine to work properly. Still, incorporating this non-standard nucleotide introduces the possibility that the cellular machinery could misread the genomic information the mRNA encodes leading to errors during protein translation that might have unintended effects down the line.

Not to worry, as it turns out. A new study from Washington University in St. Louis finds that the N1-methylpseudouridine used in the COVID-19 mRNA vaccines is translated faithfully. The research, published in Cell Reports, was led by scientists in the laboratory of Hani Zaher, associate professor of biology in Arts & Sciences.

Cellular mRNAs dont typically have N1-methylpseudouridine, said Kyusik Kim, a graduate student in the molecular cell biology program, first author of the study. We found that the presence of N1-methylpseudouridine in mRNAs doesnt seem to lead to increases in the number of mistakes during translation.

If thats the case, Kim said, then we can continue to use them in therapeutics and we wont have to worry as much about them making the wrong protein.

The translation of the genetic code into functional protein is a feat accomplished in all domains of life by the ribosome. The Zaher lab conducts research that expands our understanding of the mechanisms that govern translational fidelity on the ribosome and the impact of these mechanisms on cellular fitness.

In this particular study, the Zaher lab researchers used multiple experimental systems to study the effects of N1-methylpseudouridine on translation. They found that N1-methylpseudouridine is read accurately by the ribosome. They also found that mRNAs containing N1-methylpseudouridine did not appear to make miscoded proteins more frequently than mRNAs containing unmodified nucleotides.

Theres been a huge explosion in interest in the use of therapeutic mRNAs for many different diseases, Kim said. This paper adds more confidence that therapeutic mRNAs arent going to make proteins they werent intended to make.

Kim et al., N1-methylpseudouridine found within COVID-19 mRNA vaccines produces faithful protein products, Cell Reports (2022), https://doi.org/10.1016/j.celrep.2022.111300

Funding: This work was supported by a grant from the National Institutes of Health (NIH) (R01GM141474).

The authors thank the Alvin J. Siteman Cancer Center at Washington University School of Medicine and Barnes-Jewish Hospital and the Institute of Clinical and Translational Sciences (ICTS) at Washington University in St. Louis for the use of the Genome Technology Access Center, which provided sequencing services for this study.

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Modified nucleotides used in COVID-19 vaccines work as designed - The Source - Washington University in St. Louis - Washington University in St. Louis

A new and different COVID-19 vaccine is now available on the Central Coast.

Novavax is the fourth coronavirus vaccine approved for emergency use in the U.S. Its now available at health clinics in San Luis Obispo County.

All vaccines work in a similar way in that they want the body to create neutralizing antibodies, said Dr. Scott Robertson, President and CEO of Pacific Central Coast Health Centers.

The ones that were familiar with the Moderna and the Pfizer they really provide instructions to the cells of the body to make something that looks like the virus so that it can mount an immune response, said San Luis Obispo County Public Health Officer Dr. Penny Borenstein.

Public health officials say that Novavax is a more traditional vaccine and is different from messenger RNA shots offered by Pfizer and Moderna.

This one, the Novavax, is more traditional in the way its made, said Dr. Borenstein. It actually has a protein-like substance in the vaccine that is the same protein thats on the virus itself.

Novavax is a two-shot vaccine and doses can be taken three to eight weeks apart. Currently, there is no booster available.

When you look at the data and the outcomes in terms of preventing infection and preventing serious or complex illness due to COVID-19, it really seems to be just as effective as the messenger RNA vaccines, said Dr. Robertson.

Health experts say that vaccination rates have dropped across the Central Coast over the past several months.

I think a lot of that has to do with the changing nature of COVID-19. We are seeing few people hospitalized despite the fact that theres been a tremendous prevalence over the last six weeks in all of our communities, added Dr. Robertson.

SLO Countys Public Health Officer says that Novavax has been made available, in part, due to ongoing concerns among some people over messenger RNA shots.

It may be an option for people who have been holding out for something that theyre more comfortable with, said Dr. Borenstein. I expect that demand will be modest because I think most of the people who have wanted to get vaccinated have already done so.

Novavax was authorized for emergency use this week in children between the ages of 12 and 17.

The new vaccine is available by appointment and special request. Anyone interested can call San Luis Obispo County Public Health at (805) 781-5500 for assistance.

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New COVID-19 vaccine now available on the Central Coast - KSBY News

This week, Pfizer asked the FDA to authorize its updated vaccine for people 12 and older. The shots include defenses against the omicron variant.

CLEVELAND Earlier this year, the FDA asked Pfizer and Moderna to create the next generation of COVID-19 vaccines that included defenses against the omicron variant. They did just that, starting clinical trials and releasing early data showing it gave a modest boost.

Except by then, omicron's subvariants took center stage.

The FDA then asked for a new vaccine including original COVID and omicron subvariants BA.4 and 5, but this time, they wanted these shots available by September. Both Pfizer and Moderna did what was asked, except their current data is coming from animal models, and human trials are just starting.

Some experts are concerned by the lack of human data, but last yearn the FDA released guidance that said modified vaccines targeting new variants could be authorized without the need for lengthy trials. A similar policy explains why different flu vaccines are produced each year without human testing.

So why the warp speed? Well, those under age 50 still aren't permitted to get their second booster shot. Their infection protection, even if they had COVID, is waning.

We're heading into cold and flu season, and as kids head back to school and we head indoors to avoid cold weather, it's likely we'll see a bump in COVID cases. Even though the original shots still work at preventing severe disease and death, they're not strong enough to prevent a wicked COVID cold, and BA. 5 is the most contagious of all the variants.

So if updated COVID shots can be given earlier, it may hold off another COVID infection wave.

"It's going to be really important that people this fall and winter get the new shot," White House Coronavirus Response Coordinator. Dr. Ashish Jha said. "It's designed for the virus that's out there, and again, based on everything we have seen so far, all the data suggests it should be highly effective against the new variants."

The FDA says it will review the safety and effectiveness of the shots before granting emergency use approval. However, it's unclear if the independent vaccine advisory board will be part of the review.

Once approval is given, Pfizer says it can begin shipping immediately. The U.S. Government secured 105 million doses of updated Pfizer vaccine and 66 million doses of Moderna's shots.

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The journey towards updated COVID-19 vaccines: How does the process work? - WKYC.com

The West Virginia Department of Health and Human Resources (DHHR) reports as of August 24, 2022, there are currently 2,627 active COVID-19 cases statewide. There have been four deaths reported since the last report, with a total of 7,257 deaths attributed to COVID-19.

DHHR has confirmed the deaths of a 90-year old male from Marion County, a 79-year old male from Taylor County, a 79-year old male from Cabell County, and an 80-year old female from Logan County.

Each death of a West Virginian is a loss if felt by all, said Bill J. Crouch, DHHR Cabinet Secretary. As we extend our deepest sympathies to the loved ones, we encourage all residents to recognize the continued need for COVID vaccines and boosters.

CURRENT ACTIVE CASES PER COUNTY: Barbour (32), Berkeley (162), Boone (42), Braxton (14), Brooke (17), Cabell (97), Calhoun (7), Clay (3), Doddridge (3), Fayette (82), Gilmer (19), Grant (24), Greenbrier (55), Hampshire (30), Hancock (41), Hardy (38), Harrison (97), Jackson (17), Jefferson (61), Kanawha (210), Lewis (29), Lincoln (49), Logan (69), Marion (102), Marshall (46), Mason (60), McDowell (41), Mercer (123), Mineral (64), Mingo (23), Monongalia (149), Monroe (28), Morgan (23), Nicholas (49), Ohio (45), Pendleton (5), Pleasants (0), Pocahontas (17), Preston (39), Putnam (72), Raleigh (118), Randolph (42), Ritchie (12), Roane (13), Summers (17), Taylor (28), Tucker (4), Tyler (4), Upshur (54), Wayne (41), Webster (10), Wetzel (24), Wirt (3), Wood (120), Wyoming (53). To find the cumulative cases per county, please visit coronavirus.wv.gov and look on the Cumulative Summary tab which is sortable by county.

West Virginians ages 6 months and older are recommended to get vaccinated against the virus that causes COVID-19. Those 5 years and older should receive a booster shot when due. Second booster shots for those age 50 and over who are 4 months or greater from their first booster are recommended, as well as for younger individuals over 12 years old with serious and chronic health conditions that lead to being considered moderately to severely immunocompromised.

Visit the WV COVID-19 Vaccination Due Date Calculator, a free, online tool that helps individuals figure out when they may be due for a COVID-19 shot, making it easier to stay up-to-date on COVID-19 vaccination. To learn more about COVID-19 vaccines, or to find a vaccine site near you, visit vaccinate.wv.gov or call 1-833-734-0965.

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COVID-19 Daily Update 8-24-2022 - West Virginia Department of Health and Human Resources

The Social Science Research Council is providing USD 7.2 million to 12 teams advancing ambitious, applied social and behavioral science to combat the growing global threat posed by low Covid-19 vaccination rates and public health mis- and disinformation

NEW YORK, Aug. 23, 2022 /PRNewswire/ -- The Social Science Research Council (SSRC) announced it will provide an initial USD 7.2 million in direct research funds to 12 teams working in 17 countries in order to better understand how health mis- and disinformation spreads, how to combat it, and how to build stronger information systems, while increasing Covid-19 vaccination rates. Through the Mercury Projectenabled by The Rockefeller Foundation, Robert Wood Johnson Foundation, Craig Newmark Philanthropies, and the Alfred P. Sloan Foundation with a total of USD 10.25 million so farthe SSRC is supportinga first cohort of social and behavioral scientists from around the world to generate much-needed new research on locally tailored solutions in Bolivia, Brazil, Cte D'Ivoire, Ghana, Haiti, India, Kenya, Malawi, Mexico, Nigeria, Rwanda, Senegal, Sierra Leone, South Africa, Tanzania, United States, and Zimbabwe.

Following the characterization of inaccurate health information by the U.S. Surgeon Generalas an "urgent threat," and by the World Health Organization as an "infodemic," the SSRC issued a call for proposals to counter the growing global threats posed by public health mis- and disinformation and low Covid-19 vaccination rates, and received nearly 200 submissions from around the world.

"With Covid-19 prevalent and rapidly evolving everywhere, there is a pressing need to identify interventions with the potential to increase vaccination take-up. Vaccines are only effective if they become vaccinations; vaccines are a scientific marvel but their potential is unfulfilled if they are left on the shelf," said Anna Harvey, President of SSRC. "The large volume of high-quality proposals submitted to the Mercury Project underscores just how eager the social and behavioral science community is to evaluate interventions to increase vaccination demand and build healthier information environments."

Researchers in the Mercury Project's first cohort are affiliated with research institutions and implementing partners around the world:

"This initial cohort's ideas exemplify the creativity and vision behind the Mercury Project," said Dr. Bruce Gellin, Chief of Global Public Health Strategy at The Rockefeller Foundation. "They go far beyond quick fixes, with the goal of identifying robust, cost-effective, and meaningful solutions that can be widely adopted and scaled. We hope that more, better, and science-based knowledge about what we need to do will lead to increased uptake of reliable informationand serve as a powerful counter to the effects of misinformation and disinformation on vaccine demand."

Funded projects will provide evidence about what worksand doesn'tin specific places and for specific groups to increase Covid-19 vaccination take-up, including what is feasible on the ground and has the potential to be cost-effective at scale. Each of the 12 teams will have access to findings from the other teams while exploring interventions including, but not limited to:

The complete list of grantees, and descriptions of each project, are at https://www.ssrc.org/mercury-project-grantees.

"The viral, vaccine, and information environments are all rapidly evolvingbut that doesn't mean it is impossible to make progress towards more effective and equitable responses," said Heather Lanthorn, Program Director at the Mercury Project. "By funding projects on the ground around the world, this work will help us understand what works where, and why, and identify new ways to harness the power of connection and communication to advance public health goals."

The three-year Mercury Project, which launched in November 2021 with USD 7.5 million in seed funding from The Rockefeller Foundation and additional support from the Robert Wood Johnson Foundation, Craig Newmark Philanthropies, and the Alfred P. Sloan Foundation, applies the principles of large-scale, team-based science to the problem of vaccination demand. SSRC carefully selected interdisciplinary, interinstitutional, and international teamswith over 80 participating researchersto create a network that can work in coordination to tackle the global problems of Covid-19 vaccine misinformation and low vaccination take-up.

Regular convenings, both virtual and in-person, will ensure that grantee research projects are both informed by and inform health and technology decision-makers around the world.The first convening will occur in late August at The Rockefeller Foundation's Bellagio Center in Italy, where thousands of scientists, policymakers, authors, and artists have turned innovative ideas into action since 1959. Grantee teams will share their research designs with each other and with global health policy leaders, and will build a shared research framework to guide evaluations of interventions to increase Covid-19 vaccination demand and create healthier information environments. A second cohort of research teams will receive funding from the National Science Foundation.

More information about the Mercury Project can be found on the Social Science Research Council website.

About the Social Science Research Council

The Social Science Research Council, an independent and international nonprofit, mobilizes necessary knowledge for the public good by supporting social and behavioral science worldwide, generating new research across disciplines and linking researchers with decision-makers.For more information, sign up for our newsletter at ssrc.org and follow us on Twitter @ssrc_org and LinkedIn at linkedin.com/company/social-science-research-council.

About The Rockefeller Foundation

The Rockefeller Foundation is a pioneering philanthropy built on collaborative partnerships at the frontiers of science, technology, and innovation to enable individuals, families, and communities to flourish. We work to promote the well-being of humanity and make opportunity universal. Our focus is on scaling renewable energy for all, stimulating economic mobility, and ensuring equitable access to healthy and nutritious food. For more information, sign up for our newsletter at rockefellerfoundation.org and follow us on Twitter @RockefellerFdn.

SOURCE The Rockefeller Foundation

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Mercury Project to Boost Covid-19 Vaccination Rates and Counter Public Health Mis- and Disinformation in 17 Countries Worldwide - PR Newswire

DAYTON, Ohio (WDTN) Dayton Childrens Hospital saw an increased interest in the COVID-19 vaccine before school started, and health officials want to see that momentum continue even with kids back in school.

Dayton Childrens Chief Medical Officer Dr. Adam Mezoff said the push during the summer was to make sure kids would be fully vaccinated before they returned to school.

While the initial roll out there was a small but steady interest, there was there was a definite increase over the last, say, 4 to 6 weeks, Mezoff said.

In Ohio, nearly 28% of all 5 to 11-year-olds and 50% of 12 to 17-year-olds have started at least one dose of the COVID-19 vaccine. 1,348 covid-19 cases and 11 hospitalizations for children 17 and under were reported last week, according to the Ohio Department of Health.

Mezoff said just because kids are already back in the classroom now, its not too late to get them their first dose.

Part of the the benefit isnt just trying not to get sick, which unfortunately it may or may not be that as effective as wed like in doing that,Mezoff said. But still, the biggest part of the benefit is to try and prevent you from getting seriously ill.

Mezoff said while the COVID-19 vaccine isnt required to go to school, its especially important now that the CDC has lessened quarantine requirements if a student is exposed to the virus.

Part of that acknowledges that this is now endemic, meaning that its its with us, so how do we push forward live with this but still be sensitive to the fact that we can get sick and it may be a preventable illness, Mezoff said.

Health officials told 2NEWS the data for routine childrens vaccines is reported by school districts to the Ohio Department of Health and wont be available until October.

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Dayton Childrens saw uptick in COVID-19 vaccine interest before start of school - WDTN.com

The COVID-19 vaccines have helped Massachusetts avoid excess mortality, or deaths exceeding the expected number at any given time of year, during two surges in the pandemic, according to a study published Monday by researchers at Brigham and Womens Hospital, and Harvard and Yale universities.

This is good news, and it suggests that, in our highly vaccinated state, we are benefitting from a high level of immunity, which likely helped to protect individuals at highest risk, Dr. Jeremy Faust, a Brigham and Womens emergency medicine physician and an author of the study, said in a statement.

The study appeared Monday in The Lancet Infectious Diseases medical journal.

But we need to remain vigilant, Faust said. As new variants emerge or immunity wanes, we may see a rise in excess mortality once more.

During the pandemic, Massachusetts has seen periods without excess mortality, corresponding to times of low prevalence of the virus, the study found. But there also were two periods when researchers observed no excess mortality despite substantial outbreaks of COVID-19. One such period came between late February 2021 and June 2021, while the second occurred between late February 2022 and June 2022.

The uncoupling of excess mortality and new COVID-19 cases, in the absence of decreases in the mean age of infected individuals ... suggests that in our highly vaccinated state, current levels of immunity are considerable, leaving many, if not most, individuals at high risk with substantial protection against the most severe outcomes of SARS-CoV-2 infection, the study said.

Seventy-seven percent of Massachusetts residents are considered fully vaccinated against COVID-19, according to a weekly state report updated Aug. 17.

More than 3.1 million first booster doses have been administered statewide, along with 684,168 second boosters.

There have been 20,025 confirmed deaths from COVID-19 in Massachusetts since the start of the pandemic, according to state data.

Travis Andersen can be reached at travis.andersen@globe.com. Follow him on Twitter @TAGlobe.

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High levels of immunity with COVID-19 vaccines have helped avoid excess mortality in Mass., study says - The Boston Globe

Newly updated Covid booster shots designed to target omicron's BA.5 subvariant should be available within in the next three weeks. That begs an important question: Who's going to be eligible to get them?

The short answer: anyone ages 12 and up who has completed a primary vaccination series, a Centers for Disease Control and Prevention spokesperson tells CNBC Make It. It's unlikely to matter whether you've received any other booster doses or not before, the spokesperson says but if you're unvaccinated, you won't be eligible for the updated formula until you complete a primary series with the existing Covid vaccines.

The longer answer is somewhat more complex, because it depends on which booster shots get approved and when.

Pfizer's "bivalent" shot, which targets both the original Covid strain and omicron's BA.5 subvariant, is expected to be authorized first. The CDC says it'll likely come with a wide eligibility swath: the full group of vaccinated Americans ages 12 and up.

Moderna's bivalent shot is expected to follow suit later, most likely in October. It'll come with a somewhat narrower range of eligibility, at least at first: vaccinated people ages 18 and older. For both shots, younger pediatric age groups could become eligible later, the CDC says.

Those projections are tentative, at least for now. A person familiar with the matter told NBC News on Wednesday that it'll hinge on how much supply Pfizer and Moderna are able to manufacture and roll out by next month. If that supply is limited, the shots could first be available to those most at risk, such as the elderly and immunocompromised.

Federal health officials believe the shots will provide the best level of protection against the highly transmissible BA.5 subvariant to date, especially in the fall and winter when a large wave of Covid infections is projected to hit the U.S.

"It's going to be really important that people this fall and winter get the new shot. It's designed for the virus that's out there," Dr. Ashish Jha, the White House's Covid response coordinator, said at avirtual eventhosted by the U.S. Chamber of Commerce Foundation on Tuesday.

If you're eligible for a second booster dose but haven't received it yet, Jha's advice is to get it now rather than holding off in anticipation of the updated boosters.That advice could apply to a lot of people: Among adults 50 and over who are eligible for a second booster shot, only 33.2% have gotten it, according to the latest CDC data.

"My general feeling is, no reason to wait, go get it, even if we're only a few weeks away," Jha said at the Chamber event. He added that people who get boosted now will still be able to get the BA.5 shot in a few months, when their immunity from the booster wanes.

Dr. Anthony Fauci, President Biden's chief medical advisor, has also emphasized that all Americans should get vaccinated and boosted now if they aren't up to date, noting that the country's approved vaccinesstill work exceptionally well at preventing severe illness, hospitalization and death.

"If [people] don't get vaccinated or they don't get boosted, they're going to get into trouble," FaucitoldLos Angeles radio station KNX News 97.1s "KNX In Depth" earlier this month.

As for the BA.5 shot, experts are split over whether you should get it as soon as you're eligible or wait to get it until cases rise in the fall or winter, in an attempt to maximize your immunity boost over those crucial months.

Andy Slavitt, a former senior advisor on Biden's Covid response team, wrote in Twitter thread on Friday that some experts including Fauci and Robert Wachter, chair of the department of medicine at the University of California, San Francisco support the former approach.

"The other view is one no one wants to be on record for," Slavitt wrote. "It's that since we don't know the duration of the boost, why not wait until October?"

"For lower risk people who want to have 4 months of coverage (a reasonable minimal expectation), some may choose to wait," Slavitt added.

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BA.5 boosters could be here in the next 3 weeks, says Dr. Jha: 'These are substantial upgrades in our vaccines'

Dr. Fauci: BA.5-specific booster shots are the country's 'best guess' for dealing with Covid this fall

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Omicron-specific Covid booster shots are just weeks away. Here's who willand won'tbe eligible - CNBC

Vaccinated people are more likely than the unvaccinated in recent months to be a COVID-19 case, hospitalization, or death in 25 states, according to an Epoch Times investigation.

In Kentucky in June, for example, 67 percent of the deaths were among the vaccinated, according to data obtained by The Epoch Times.

That same month, the vaccinatedmade up 65 percent of COVID-19 cases, 64 percent of COVID-19 hospitalizations, and 66 percent of COVID-19 deaths in Wisconsin.

The numbers are a drastic change from 2021.

Afterthe mass vaccination campaign in the United States gained momentum, virtually every state reported unvaccinated people making up the vast majority of COVID-19 cases, hospitalizations, and deaths.

The numbers began tilting while the Delta virus variant was dominant. They have tilted even more since the Omicron variant displaced Delta, according to the newly collated numbers.

The Epoch Times compiled the data from state health department websites and databases. Some were obtained through records requests and have never before been made public.

The statistics underline how vaccines have increasingly performed worse as newer virus variants emerged, according to some experts.

They are clear evidence that the vaccines are not working to prevent disease and death, Dr. Robert Malone, who helped invent the messenger RNA utilized in the two most widely-administered vaccines, told The Epoch Times.

Others argue the raw numbers dont contribute to analyzing vaccine effectiveness because they must first be adjusted to account for factors such as age.

Unless one is able to correct for age and health status, this number is misleading, and does not lead to the conclusion vaccines are ineffective, Dr. Roger Klein, a policy adviser to The Heartland Institute and a former adviser to the U.S. Centers for Disease Control and Prevention (CDC) and other U.S. health agencies, told The Epoch Times via email.

Some states provide age-adjusted numbers, as recommended by the CDC.

Click the dots in the upper right part of the graph to unveil the full-screen option. Story continues below.

Most states report at least one metric (cases, hospitalizations, deaths) by vaccination status. Some group the partially vaccinated with the unvaccinated when breaking down metrics.

As vaccines have proven increasingly unable to prevent COVID-19 infection in the Omicron era, a growing number of states have followed the CDC in separating those who have received a booster from the fully vaccinated.

Key terms as generally defined:

The term fully vaccinated will be used in this article to refer to anybody who has received a primary series, regardless of whether theyve received a booster. Not fully vaccinated refers to anybody who has not received a primary series. The term vaccinated, meanwhile, will refer to anyone who has received at least one dose of a vaccine.

In 14 states, the percentage of one or more so-called breakthrough metricspost-vaccination cases, hospitalizations, and/or deathsin recent months exceeded the percentage of the population that was vaccinated or fully vaccinated.

In most cases, that was a single metric. But in several, it was multiple, and in one, it was all three.

All data are from 2022. Only percentages were available for some states. Data for June were preferred, followed by data for July. Metrics are only listed if they exceed the percentage of vaccinated.

*vaccinated+fully vaccinated-unclear**excludes partially vaccinated

Some states adjust the data before releasing it, which is meant to eliminate differences that result from one population being different from another. The most common adjustment is for age.

Age adjustment is used to compare populations directly when the age distribution of who most commonly gets the disease, or seriously sick from the disease, is skewed, according tothe Wisconsin Department of Health Services.For COVID-19, older populations are more likely to experience severe illness and death, and are also more likely to be vaccinated, experts say.

While the raw numbers look bad for the vaccinated, after adjusting for age, the rates of COVID-19 hospitalizations and deaths in Wisconsin are higher for the unvaccinated throughout 2022 (cases have been higher in the vaccinated in recent months). Thats similar to most of the other states that report data as rates, some of whichalso provide raw numbers.

Wisconsins raw numbers were obtained through a records request.

Clinical trials and vaccine efficacy studies are the basis for determining vaccine effectiveness,Dr. Ryan Westergaard, chief medical officer for the states Bureau of Communicable Diseases, said during a briefing, adding that the research shows that protection against severe disease and death remains high.

Studiescan help control for biases such as vaccinated people being more likely to get tested at sites, which report data to the state, versus at home, which is not counted,Dr. Leisha Nolen, Utahs state epidemiologist, told The Epoch Times.

The studies show the vaccines arent doing as well at keeping us from getting infected, but they are still keeping people out of the hospital, Nolen told The Epoch Times.

Nolen singled outa study from researchers with the CDC and partner institutions, published in the agencys journal on July 22 (pdf).

Researchers reported datafrom a CDC-funded network of hospitals across 10 states from December 2021 to June 2022. The data showed that two doses of a vaccine, or a primary series, provided 57 to 68 percent protection against hospitalization through 149 days after vaccination, but dropped to as low as 24 percent 150 or more days after vaccination.

A third dose increased protection to 92 percent against BA.1, one of the subvariants, and 69 percent against BA.2, another subvariant. That protection dropped to 85 percent and 52 percent, respectively, after 120 or more days.

BA.5 is currently the dominant strain in the United States. Emerging data indicate the vaccines do not provide as much shielding against BA.4 and BA.5 as earlier strains.

In 11 other states, the vaccinated made up a majority of at least one metric, but the proportion of vaccinated did not exceed the percentage of vaccinated.

All data are from 2022. Percentages reported near or above 50 percent. Preference was for data in June, followed by data in July. Metrics with unvaccinated comprising a majority are not listed.

*vaccinated+fully vaccinated-unclear**excludes partially vaccinated

Vaccine-provided protectionbegan waningagainst infection and, to a lesser extent,against severe illness in 2021, when the Delta variant was dominant. Since Omicron emerged in December 2021, that trend has quickened.

Omicron and its subvariants, described as more immune-evasive, are better at evading the protection from vaccines and prior infection. The vaccines have bestowed lower levels of initial protection, and the protection drops faster than before, research indicates. Known as natural immunity, the shielding from previous infection has held up betteragainst Omicron, and was superior against Delta, according to studies.

Research on booster effectiveness has largely shown an initial increase in protection, followed by a quick decline. Other research, meanwhile,has indicated that vaccinated people are, at a certain point, more likely than unvaccinated people to get infected, which could relate to a phenomenon called immune imprinting.

Owing to the waning effectiveness, U.S. regulators have already cleared first and second boostersas have many other countriesand are poised to authorize updated vaccines that target Omicron, describing the current formulation as not well-matched to the dominant variant.

Its really not possible to predict what this virus is going to do, and I think it makes sense to be prepared with these boosters, which contain components of a BA.4 and BA.5 as well as the so-called archival Wuhan strain, Dr. Cody Meissner, one of the U.S. Food and Drug Administrations external vaccine advisers, told The Epoch Times.

Some experts like Meissner say most people, including all adults, should still get vaccinated. Others note healthy individuals are at little risk from COVID-19, especially new variants, and say that the more recent data suggest little benefit for many.

That includesdata from other parts of the world, including the United Kingdom, that have recorded the vaccinated as comprising the bulk of COVID-19 metrics.

What were looking at now is a sign of progress of a number of factors, primarily [that] the vaccinated can still catch and spread the COVID-19 virus, Dr. Steven Hatfill, a virologist, told The Epoch Times.

The cost-benefit ratio now especially for the younger age groups has disappeared, he added later.

Of the remaining 25 states, eight reported the unvaccinated as making up more of the COVID-19 cases, hospitalizations, and deaths.

All data are from 2022. Rates are listed when raw numbers were not available. When rates are listed, they are age-adjusted. June is preferred, followed by July.

*counts partially vaccinated with unvaccinated+rates per 100,000**excludes partially vaccinated

The 17 other states reported incomplete or insufficient data. To be included, states needed to report figures for at least one metric broken down by vaccination status, and a breakdown by time. States that would only provide data since the beginning of the pandemic were excluded. Some were still working on filling records requests by press time.

Earlier in the pandemic, when the unvaccinated were making up the bulk of the metrics across the country, U.S. officials and news outlets cited the state-level data as proof the vaccines worked.

The CDC still presents data on its website for COVID-19 cases and deaths by vaccination status. The data,based on statistics from 31 health departments, has repeatedly been offered by the agency as evidence of vaccine effectiveness.

The data is presented as incidence rates. Efforts to obtain the raw numbers have not yet been successful. According to the rates, the unvaccinated were 2.1 times more likely to test positive in June and five times more likely to die from COVID-19in June than the fully vaccinated.

Separately, the CDC presents data on COVID-19 hospitalizations based on a hospital network in 14 states that it funds. But the agency has stopped listing fully vaccinated people. Instead, it lists only the unvaccinated and the boosted.

State officials are advised by the CDC not to report raw numbers by vaccination status, because the percentage of vaccinated people among COVID-19 cases rises with either increasing vaccination coverage or decreasing vaccine effectiveness. Officials are recommended to reportdata as incidence rates or rate ratios, which adjust for differences between the unvaccinated and vaccinated populations such as age. The rates are described as more stable and directly related to vaccine effectiveness.

Most states only report age-adjusted data or only present raw data in large chunks, such as from the beginning of the pandemic. The Epoch Times reviewed percentages and numbers from states that do report them, and obtained monthly or weekly breakdowns from some states. It also obtained unadjusted data from others that have never been reported before. Some states stopped reporting metrics by vaccination status after inquiries from The Epoch Times. Their reports were saved before they stopped.

Hilary Lin and Angel Yuan contributed to this report.

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Zachary Stieber covers U.S. and world news. He is based in Maryland.

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Meiling Lee is a health reporter for The Epoch Times.

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EXCLUSIVE: Vaccinated Making Up Higher Proportion of COVID-19 Metrics in US - The Epoch Times

GAITHERSBURG, Md., Aug. 17, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a heterologous and homologous booster dose in adults aged 18 and older.

Following the expanded provisional approval decision by Medsafe, New Zealand, people may now choose Nuvaxovid as their first and/or second COVID-19 booster dose(s) after completion of their primary series using any of the authorized COVID-19 vaccines.

"We are pleased to offer another booster choice and the only protein-based COVID-19 vaccine for those aged 18 and older in New Zealand," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As New Zealand endures winter months where thousands of COVID-19 infections are being recorded each day, we believe our vaccine is a strong option, particularly given its broad immune responses to a wide range of circulating variants."

The request for expanded provisional approval for the booster dose is supported by data from Novavax' Phase 2 trial conducted in Australia, from a separate Phase 2 trial conducted in South Africa, and from the UK-sponsored COV-BOOST trial. As part of the Novavax-sponsored Phase 2 trials, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a significant antibody response when used as a heterologous third booster dose.

In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, reflecting the increased immunogenicity seen with a third dose. Medically attended adverse events, potentially immune-mediated medical conditions, and severe adverse events occurred infrequently following the booster dose and were balanced between vaccine and placebo groups.

As a booster for adults, Nuvaxovid is also provisionally registered in Australia and approved in Japan, and is actively under review in other markets.

New Zealand previously granted provisional approvalfor Nuvaxovid in adults aged 18 and older in February 2022. Novavax' sponsor in Australia and New Zealand is Biocelect Pty. Ltd.

Trade Name in the U.S.The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.

Important Safety Information: New Zealand

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, or to request additional information, please visit the following websites:

About the Novavax COVID-19 vaccine (NVX-CoV2373)

The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations.

Novavax has established partnerships for the manufacture, commercialization, and distribution of its COVID-19 vaccine worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.

About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials

The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials.

PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and over in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the trial were published in theNew England Journal of Medicine(NEJM).

The pediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the United States, compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the U.S.Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published inNEJM.

About Matrix-M Adjuvant

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine, has received authorization from multiple regulatory authorities globally, including the FDA, European Commission, and the World Health Organization. The vaccine is currently under review by multiple regulatory agencies worldwide, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a COVID-seasonal influenza combination vaccine candidate in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu*, its quadrivalent influenza investigational vaccine candidate, and is also evaluating an Omicron strain-based vaccine (NVX-CoV2515) as well as a bivalent format Omicron-based / original strain-based vaccine. These vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

For more information, visitwww.novavax.comand connect with us on LinkedIn.

*NanoFlu identifies a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine candidate produced by Novavax. This investigational candidate was evaluated during a controlled phase 3 trial conducted during the 2019-2020 influenza season.

Forward-Looking Statements

Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, including an Omicron strain based vaccine and bivalent Omicron-based / original strain based vaccine, a COVID-seasonal influenza investigational combination vaccine candidate, the scope, timing and outcome of future regulatory filings and actions, including Novavax' plans to supplement existing authorizations with data from the additional manufacturing sites in Novavax' global supply chain, additional worldwide authorizations of NVX-CoV2373 for use in adults and adolescents, and as a booster, the evolving COVID-19 pandemic, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic and protecting populations, the efficacy, safety and intended utilization of NVX-CoV2373, and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; unanticipated challenges or delays in conducting clinical trials; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax' Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.govand http://www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Contacts:

InvestorsErika Schultz | 240-268-2022[emailprotected]

MediaAli Chartan or Giovanna Chandler | 202-709-5563[emailprotected]

SOURCE Novavax, Inc.

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Novavax Nuvaxovid COVID-19 Vaccine Granted Expanded Provisional Approval in New Zealand as a First and Second Booster for Adults - PR Newswire