Category: Covid-19 Vaccine

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HIV patients have been less vaccinated with the full initial regimen against COVID-19 – News-Medical.Net

February 7, 2024

In December, the journalVaccinespublished an analysis of COVID-19 vaccination coverage among people with HIV in Catalonia between December 2020 and July 2022. Thearticle, resulting from a study funded by the Fundaci La Marat de TV3 and led by theCentre for Epidemiological Studies on HIV/AIDS and STI of Catalonia (CEEISCAT), a group from the Germans Trias i Pujol Research Institute (IGTP), in collaboration with researchers from thePISCIS Cohortgroup, evaluates the primary, monovalent, and booster doses. This research aims to develop concrete action plans tailored to specific profiles to facilitate and promote vaccination.

The study included a sample of over 200,000 individuals, 18,330 of whom have HIV and were vaccinated against COVID-19. The researchers observed a lower rate of complete primary vaccination schedule in people living with HIV (78.2%) compared to those without this condition (81.8%), with the difference being more pronounced among migrant populations. However, people living with HIV received more booster doses than the rest.

The authors identified several factors that may contribute to the lower complete vaccination rates: having a previous diagnosis of SARS-CoV-2, the status of HIV infection, being a migrant, or having a complicated socioeconomic situation. These factors reflect barriers to vaccine access and healthcare.

The analysis has helped identify patterns and contexts that encourage vaccination against SARS-CoV-2 among people living with HIV, as well as determining the need to improve vaccine access and address the hesitancy of vulnerable populations in taking the doses, highlighting their efficacy and safety.

The same group of researchers has publishedanother articlein theOpen Forum Infectious Diseasesjournal, this time focusing on migrant individuals with HIV. The findings indicate that these individuals (over 3,000 in the sample) have undergone fewer SARS-CoV-2 tests, yet they have a similar cumulative diagnosis rate as local natives. Their vaccination rate, both in terms of the complete schedule and booster doses, is lower compared to those born in Catalonia. In contrast, there were more hospitalisations and admissions to the Intensive Care Unit (ICU) among migrants, even with similar durations of stays and mortality rates. Moreover, having two or more comorbidities in migrant individuals has been associated as a risk factor for severe COVID-19.

The study suggests possible impediments that could justify these results, such as economic inequalities, lack of information, structural discrimination, language barriers, or distrust in the healthcare system. With this data, strategies are expected to be developed to reach the migrant population and promote vaccination, as it is crucial for protecting the individual and curbing future epidemics at a social level.

Source:

Journal reference:

Nomah, D. K., et al. (2023). Comparative Analysis of Primary and Monovalent Booster SARS-CoV-2 Vaccination Coverage in Adults with and without HIV in Catalonia, Spain.Vaccines. doi.org/10.3390/vaccines12010044.

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HIV patients have been less vaccinated with the full initial regimen against COVID-19 - News-Medical.Net

Maternal mRNA COVID-19 Vaccination Safety Study: Reassuring Evidence for Newborns – Medriva

February 7, 2024

A recent large-scale cohort study conducted in Sweden and Norway has provided reassuring evidence about the safety of maternal mRNA COVID-19 vaccines for newborns. The study found that newborns whose mothers received at least one mRNA COVID-19 vaccine during pregnancy did not have worse outcomes than those whose mothers were unvaccinated during pregnancy. These findings add to the growing body of evidence supporting the safety of COVID-19 vaccinations during pregnancy, offering hope and assurance to expectant mothers worldwide.

The study analyzed data from 196,470 newborns, of whom 48% had mothers who received one or more doses of an mRNA COVID-19 vaccine during pregnancy. The unadjusted mortality rates for vaccine-exposed neonates were about half of those for unexposed neonates. This difference remained significant even after adjusting for factors such as maternal age, BMI, education, smoking status, and gestational age. Furthermore, there were no cases of neonatal pericarditis, myocarditis, or other inflammatory neonatal diseases among infants after maternal vaccination during pregnancy.

In addition to these encouraging findings, the study also revealed a lower risk of two serious complications nontraumatic intracranial hemorrhage and hypoxic-ischemic encephalopathy in infants born to vaccinated mothers. This suggests that maternal vaccination could potentially offer some protection against these conditions, although the mechanisms behind this are not yet fully understood.

The results of this study carry significant implications for healthcare professionals, public health authorities, and expectant mothers. Healthcare professionals can use these findings to counsel pregnant women about the safety and potential benefits of receiving a COVID-19 vaccine during pregnancy. This is particularly important given the heightened vulnerability of pregnant women to severe COVID-19 and the potential for adverse pregnancy outcomes associated with COVID-19 infection.

For public health authorities, these findings could help inform policy decisions and vaccination recommendations. And for pregnant women, this study provides further reassurance of the safety of mRNA COVID-19 vaccines not just for themselves, but also for their unborn children.

This study represents a significant step forward in our understanding of the impact of maternal mRNA COVID-19 vaccination on newborn health. It provides compelling evidence that these vaccines are safe for newborns and could potentially lower their risk of certain serious complications. As we continue to battle the COVID-19 pandemic, these findings underscore the importance of vaccination as a key strategy to protect not just ourselves, but also our future generations.

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Maternal mRNA COVID-19 Vaccination Safety Study: Reassuring Evidence for Newborns - Medriva

Alternating arms could make COVID vaccination more effective – The Lund Report

February 7, 2024

New OHSU study of nearly 1,000 vaccine recipients found unexpected gains when patients switched between right and left

Alternating arms between COVID shots can make the vaccine up to four times more effective, according to new research.

Researchers at Oregon Health & Science University in Portland studied how antibodies responded in the blood of 947 people who received two vaccinations against COVID-19 early in the pandemic.

Published last month,the studyfound antibodies responded more vigorously and thoroughly when people received a shot in one arm and a subsequent shot in another arm.

Three weeks after the second shot, researchers found heightened immunity to the original SARS-CoV-2 strain, and an even stronger immune response to the Omicron variant that emerged roughly a year after the second shot. The effect lasted more than 13 months.

The researchers hypothesize that spreading the immune responses between lymph nodes explains the difference.

By switching arms, you basically have memory formation in two locations instead of one, Dr. Marcel Curlin, the lead researcher and medical director of OHSU Occupational Health, said in a press release Feb. 6.

Particippants in the study included OHSU employees who agreed to enroll in research while getting vaccinated. They were randomized to get the second dose in either the same or the opposite arm as the first dose.

Some participants wondered if it made a difference if they alternated arms, Curlin said in the press release. Historically, clinicians thought arm choice didnt matter.

"This question hasnt really been extensively studied, so we decided to check it out," Curlin said. "It turned out to be one of the more significant things weve found."

Curlin and his team matched 54 pairs for age, gender and time between vaccinations and exposures. Half received two doses in just one arm. The other half alternated arms.

Researchers didnt see much of a difference at first. After three weeks, however, they measured significantly greater numbers of antibodies attacking the virus in blood samples. The rates progressively increased over four weeks by as much as four times.

Most people have been exposed to COVID at this point, Curlin said.

However, he added, the study could have ripple effects far beyond the pandemic. "Its probably not limited to just COVID vaccines," he said. "We may be seeing an important immunologic function."

Researchers who coauthored the study included Sedigheh Fazli, Archana Thomas, Abram Estrada, David Xthona Lee, Steven Kazmierczak, Mark Slifka, Bill Messer, Hiro Ross and David Montefiori.

The study was supported by the M.J. Murdock Charitable Trust and OHSU Foundation as well as the National Institutes of Health.

Curlin and his colleagues want further research to determine whether switching arms improves responses for other vaccines -- especially among children.

Personally, Curlin said, he's convinced. "Im going to switch up my arms," he said.

The difference doesn't have to be huge to be important, given the number of people receiving vaccines, he said. "Any incremental improvement might save a lot of lives."

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Alternating arms could make COVID vaccination more effective - The Lund Report

Understanding the Impact of COVID-19 on Our Immune System – Medriva

February 7, 2024

Understanding the Impact of COVID-19 on Our Immune System

The COVID-19 pandemic has significantly tested our immune systems. Novel in nature, the coronavirus has placed a high demand on our bodies to develop immunity. This immunity can either be acquired through infection or more preferably, through vaccination. However, the journey doesnt end there; the emergence of new variants continues to challenge our immune systems.

According to a web page on the Centers for Disease Control and Prevention (CDC) website, the 2023-2024 monovalent XBB 1.5 COVID-19 vaccine has been shown to provide approximately 54% increased protection against symptomatic SARS-CoV-2 infection compared to no vaccination. This highlights the crucial role of vaccination in reducing the risk of infection and its potential in controlling the pandemic.

As the virus mutates and evolves, variants of concern (VoCs) such as Omicron have emerged, posing an additional challenge to our immune responses. However, advances in vaccine development are proving instrumental in tackling this issue. A research article published in ScienceDirect discusses the development of a polyvalent RNA vaccine, LION/RepRNA Polyvalent, composed of mRNA from five VoCs. This vaccine has been successful in inducing neutralizing antibodies in mice previously immunized with LION/RepRNA D614G and reduced the imprinted phenotype associated with low neutralization capacity of Omicron B.1.1.529 pseudoviruses.

Aside from protecting against the virus, COVID-19 vaccination has other potential benefits. An article published in Nature highlights that COVID-19 vaccination may help mitigate the dysregulation of IL-1 and IL-18, as well as gastrointestinal symptoms in individuals with post-COVID-19 condition. It also emphasizes the safety and efficacy of mRNA-based COVID-19 vaccines in generating strong antibody responses without causing cytokine dysregulation or worsening symptoms.

An interesting study on the Infectious Disease Advisor website found that hybrid immunity from COVID-19 vaccination and prior infection among pregnant individuals provides more durable protection among infants compared to prior infection alone. Conducted at the University of Washington, the study showed that maternal vaccination before delivery was the strongest predictor of maternally-derived antibody persistence through 6 months of age. This reinforces the importance of vaccination not only for individual protection, but also for the protection it offers to others, especially vulnerable populations such as infants.

In conclusion, the COVID-19 pandemic has underscored the vital role of vaccination in our global health response. Vaccines not only reduce the risk of infection, but they also aid in controlling the spread of variants, provide potential health benefits to recipients, and even offer extended protection to vulnerable populations. With the potential for a yearly vaccination schedule similar to the flu vaccine, its clear that vaccines will continue to play an integral role in our battle against COVID-19.

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Understanding the Impact of COVID-19 on Our Immune System - Medriva

Science Update: Preterm infants protected by maternal COVID-19 vaccination, NIH-funded study suggests – National Institute of Child Health and Human…

February 7, 2024

Preterm infants born to people who have been vaccinated for COVID-19 had roughly the same levels of antibodies to the spike protein of SARS-CoV-2 as term infants born to vaccinated people, according to a study funded by the National Institutes of Health (NIH). Moreover, in all infants, antibodies to the spike protein were higher among those born to individuals who had received three or more vaccine doses before delivery, compared to those who had only two prior vaccine doses. The findings may help allay concerns that fewer antibodies might pass to preterm infants than term infants.

The study was conducted by Alisa Kachikis, M.D., M.S., of the University of Washington, and colleagues. It appears in JAMA Network Open. NIH funding was provided by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Office of Research on Womens Health, the National Institute of Allergy and Infectious Diseases, and the National Center for Advancing Translational Sciences.

Pregnant individuals who are vaccinated against COVID-19 have lower rates of severe COVID-19 illness and pregnancy complications than unvaccinated pregnant people. COVID-19 vaccines protect against the disease by stimulating production of antibodies to the spike protein, which SARS-CoV-2 uses to infect cells. Previous research has shown that anti-spike antibodies pass from pregnant individuals through the placenta to the fetus and may protect infants from severe COVID-19 illness. However, little is known about how well anti-spike antibodies are transferred to preterm infants.

For the current study, researchers compared levels of anti-spike antibodies in 1) the blood of pregnant individuals with no history of COVID-19 infection who received mRNA vaccines and then gave birth and 2) the umbilical cord blood of these infants, who were born at term and preterm. The team also compared anti-spike antibody levels from those who had been vaccinated twice before delivery (including before pregnancy) and those who were vaccinated three or more times before delivery.

Of the 220 participants, 184 delivered full-term infants and 36 delivered preterm, while 121 had been vaccinated twice and 99 had been vaccinated three or more times. For those receiving 2 vaccine doses, the average concentration of anti-spike antibodies was 674. The average concentration was 8,159 among those who received 3 or more doses. For cord blood samples, the average was 1,000 after 2 doses and 9,992 after 3 or more doses. The researchers did not find a significant difference in umbilical cord antibody levels between infants delivered at term and preterm.

The findings provide assurance that preterm infants receive similar levels of maternal antibody protection as term infants after maternal COVID-19 vaccination. In addition, compared to receiving two doses of a vaccine, receiving 3 or more doses resulted in 10 times the level of anti-spike antibodies in umbilical cord blood. The authors concluded that policies should be considered for the administration and timing of COVID-19 vaccines for those at risk of preterm delivery.

Given that the two-dose vaccine series is no longer available and the current recommendation is for a single vaccine dose, additional research is needed to determine the ideal number of doses for pregnant individuals with and without a history of COVID-19 infection.

Kachikis, A, et al. Timing of maternal COVID-19 vaccine and antibody concentrations in infants born preterm. JAMA Network Open. 2024.

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Science Update: Preterm infants protected by maternal COVID-19 vaccination, NIH-funded study suggests - National Institute of Child Health and Human...

Company accused of selling COVID-19 vaccines to rich gets $2M from Florida for Holocaust education – gulflive.com

February 7, 2024

A company that paid a $1.75 million settlement for allegedly selling COVID-19 vaccines to the wealthy, instead of administering them to the senior home residents in its care, was recently awarded $2 million by the state of Florida to develop an educational program for the states public schools.

It is unclear why the state is doing business with MorseLife Health System after it, according to the U.S. Department of Justice, purportedly targeted ineligible people for donations of $25,000 and more in exchange for vaccines meant for the most vulnerable in December 2020.

This specific vaccination program was designed to protect some of the nations most vulnerable individuals at a critical time when the COVID-19 pandemic was devastating that population, Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Departments Civil Division, said in 2022 after the settlement was reached. The department will hold accountable those who misused vital pandemic relief programs for their own financial gain.

In a news release late last month, a nonprofit program developed by MorseLife Health System, a not-for-profit company that provides senior living residences and services in Palm Beach County, declared it was entrusted by Florida with a budget of just over $2 million for statewide Holocaust education across 67 districts.

The program was created in partnership with Next Generations of Holocaust Survivors, a nonprofit organization founded in 2004.

But Barbara Goldstein, the executive director of the Holocaust Education Resource Council, is concerned and says the announcement is misleading.

First, as a long-standing member of the Holocaust Education Task Force, whose core mission to promote Holocaust education in the state of Florida, Goldstein wanted to know why the task force wasnt consulted or included in any decision to enlist MorseLife.

According to documentation obtained by GulfLive.com, The Holocaust Learning Experience developed by MorseLife Health System submitted a project proposal to provide the service on Nov. 17, 2023, in paperwork signed by MorseLife CEO Keith A. Myers.

It was approved less than one month later on Dec. 13, 2023, with an allotted budget of $2,050,000.

This is the same organization that, in June 2022, agreed to pay the U.S. government $1.75 million as part of a settlement to resolve its potential liabilities under the False Claims Act for purportedly diverting a portion of its vaccine allotment, intended for vulnerable populations, to billionaires and millionaires for donations.

In December 2020, 40% of COVID-19 related deaths occurred in long-term health care facilities. With a limited vaccine supply, the Centers for Disease Control and Prevention launched a program prioritizing vaccines for residents and staff of these facilities, through on-site clinics.

MorseLife signed up for the program and scheduled a clinic at its senior living facility in West Palm Beach for Dec. 31, 2020.

In text messages obtained by the Justice Department, in anticipation of the upcoming vaccination clinic, the CEO of MorseLife Health Systems told the organizations fundraising arm, the MorseLife Foundation, Go after the billionaires first, adding, Hell, were taking care of their life.

While the DOJ did not name the CEO, he is identified on the organizations website as Keith A. Myers.

Myers stated he was disappointed with foundation members for not asking for bigger donations referring to them in the text message as, little boys and girls in the foundation only asking for $25,000.

Go for the 25,000 Ill go for the billions; Im a little disappointed in the foundations mentality; I have delivered you 350 of the richest people in the country and youre still thinking $25,000 gift, he wrote. Do not be weak be strong you have the opportunity to take advantage of everyone who needs the shot.

In all, the DOJ alleged that 567 of the 976 people vaccinated at MorseLifes clinic on Dec. 31, 2020, were ineligible to participate in the program.

The settlement today exemplifies my office and its law enforcement partners strong commitment to combatting all forms of health care fraud-related schemes, especially those that exploit government resources designed to assist individuals who were acutely affected by the COVID-19 global pandemic, U.S. Attorney Juan Antonio Gonzalez for the Southern District of Florida, said in a news release issued at the time of the settlement. We will not relent in holding accountable those in South Florida who exploit health care programs intended to assist vulnerable populations during the COVID-19 pandemic.

The integration of Holocaust lessons into K-12 public schools has been mandated since the passage of the Holocaust Education Bill by the Florida Legislature in 1994. In the 2023-2024 legislative session, Florida allotted funding of about $27 million across approximately 47 Jewish community organizations to provide a variety of services, and Goldstein said there are dozens of Holocaust organizations throughout the state that provide teachers with free resources for their Holocaust curriculum, including books, downloadable lesson plans, videos and speakers.

In 1998, the Florida Department of Education commissioned the Holocaust Documentation & Education Center to write the first statewide resource manuals on Holocaust studies for grades K-12. In addition to being available for download online, they also were distributed to all private, public and parochial schools in the state of Florida.

Theyre not the only Holocaust educators in Florida, Goldstein said, referring to MorseLife.

And, she said, its been a joint effort with all the various organizations collaborating and communicating, except she says, for one outlier: MorseLifes Holocaust Learning Experience.

Despite Goldsteins request for the organization to share its lesson plan, she claims she was denied on the grounds that it was private.

Everybody is alarmed about this, Goldstein said. Because all of the other Holocaust education centers share everything; we work together.

Gulf Live reached out to Florida Commissioner of Education Manny Diaz Jr. and MorseLife Health Systems CEO Myers for comment, but they did not immediately respond. Florida Holocaust Education Task Force Chair Michael Igel declined to comment.

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Company accused of selling COVID-19 vaccines to rich gets $2M from Florida for Holocaust education - gulflive.com

More Evidence COVID Shot in Pregnancy Is Safe, Healthy for Babies – HealthDay

February 7, 2024

TUESDAY, Feb. 6, 2024 (HealthDay News) -- The COVID-19 vaccine given to pregnant women does no harm to their unborn babies, and can actually lower the risk of serious complications in newborns, a new study finds.

Babies born to women who received the COVID vaccine had half the death rate of those born to unvaccinated moms, according to findings published Feb. 6 in the Journal of the American Medical Association.

Newborns of vaccinated mothers also had lower rates of two brain-related complications, cerebral hemorrhages and brain oxygen deprivation, the researchers said.

We found no increased risks, said lead researcher Dr. Mikael Norman, a professor of pediatrics and neonatology at Karolinska Institute in Sweden. If anything, infants to vaccinated women had lower risks for some severe outcomes.

For the study, researchers tracked the health of nearly 200,000 newborns in Sweden and Norway -- 98% of all babies born in those countries between June 2021 and January 2023.

About half (48%) of their moms had received one or more doses of an mRNA COVID vaccine.

The babies were studied for 15 different complications and conditions typically suffered by newborns. They were tracked for at least one month, or as long as they were kept in the hospital following birth.

Infants of vaccinated mothers had the same risk for most complications, and lower risk for the two brain-related conditions. They also had a dramatically lower death rate.

The incidence of other bleedings, blood clots or inflammation in various organ systems did not differ between the groups, Norman said

Researchers could not explain the vaccines benefit to newborns.

A direct vaccine effect is unlikely, Norman said. Previous studies have shown that the vaccine does not cross the placenta and that it cannot be found in umbilical cord blood.

Based on these results, expecting mothers should strongly consider getting the COVID vaccine, Norman said.

COVID-19 is still present in society and is probably something we will have to deal with for a long time, Norman said. It is therefore very important for the one hundred thousand women who become pregnant every year in Sweden, and the 130 million in the world, to know that vaccination with mRNA-vaccines against COVID-19 is safe for their babies.

More information

The U.S. Centers for Disease Control and Prevention have more about COVID vaccines in pregnancy.

SOURCE: Karolinska Institute, news release, Feb. 6, 2024

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More Evidence COVID Shot in Pregnancy Is Safe, Healthy for Babies - HealthDay

Trust in Medical Profession Influences Vaccine Uptake – Study Reveals – Medriva

February 7, 2024

Trust in Medical Profession Influences Vaccine Uptake

A new study spearheaded by researchers at the NYU School of Global Public Health has shed light on the central role of trust in the medical profession in determining whether Americans choose to get vaccinated against COVID-19. Published in Preventive Medicine Reports, the study reveals that even among those who were initially hesitant or disinclined towards getting a COVID-19 vaccine, trust in the medical profession played a pivotal role in their decision to get vaccinated. Conversely, trust in public officials did not seem to influence vaccination behaviours to the same extent.

The study involved a detailed analysis of data from 1,967 U.S. adults who were surveyed on two separate occasions. The findings highlight the extent to which the COVID-19 vaccines have been politicized, and underscore the need for increased engagement of the medical profession in communicating the benefits of vaccination in the event of future pandemics.

The study also delved into the differences in trust levels among various demographics. It revealed that trust in the vaccine varied significantly among different demographic groups. This was particularly evident among Black and Hispanic individuals, among whom lower levels of trust were reported. The study further discovered that factors such as political affiliation and exposure to information about vaccines on social media also had a significant impact on trust in the vaccine.

One of the most striking findings of the study was the clear politicization of the COVID-19 vaccines. Individuals identifying as Republicans and Independents were found to be less likely than Democrats to opt for vaccination or to seek booster shots. This revelation underscores the need to separate public health issues from politics, in order to ensure that decisions regarding health and wellbeing are based on accurate and unbiased information.

The findings of the study emphasize the importance of engaging the medical profession in communicating the benefits of vaccines, particularly in the face of future pandicemics. This engagement is crucial not only in promoting vaccination, but also in building trust in the vaccine among different demographic groups. Given the significant influence of the medical profession on vaccination behaviors, it is clear that their involvement is key in ensuring widespread vaccination and mitigating the impact of future pandemics.

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Trust in Medical Profession Influences Vaccine Uptake - Study Reveals - Medriva

Oregon Governor is Immune From Liability in COVID Vaccine Suit – Law.com

February 7, 2024

DuBose Miller, LLC 01/23/2024 Daily Report

TO: ALL MEMBERS OF THE BAR AND ALL CITIZENS OF THE CITY OF ATLANTA The Atlanta Judicial Commission is now accepting nominations for the position of Municipal Court Judge for the City of Atlanta Municipal Court. Members of the bar may nominate themselves or others, and the public is invited to submit nominations. Nominations in writing must be received by February 10, 2024, and should be addressed to: The Atlanta Judicial Commission c/o Von A. DuBose, Esq. 75 14th Street, NE, Suite 2110, Atlanta, GA 30309 A nominee must be at least 25 years of age, a resident of the City of Atlanta for one year prior to appointment and shall have been admitted to practice law in the State of Georgia for at least five years. The Commission will send an application and letter outlining its schedules and procedures to each nominee. The list of nominees is public information and is available upon request. The Commission welcomes communications from organizations or persons familiar with the specific qualifications, experience and ability of any nominee but discourages general endorsement letter-writing campaigns in support of a nominee. A copy of any communication regarding a nominee should be sent to all members of the Commission. FOR THE COMMISSION Von A. DuBose, Esq. Chair Members of The Commission Von A. DuBose, Esq. 75 14th Street NE, Suite 2110 Atlanta, Georgia 30309 [emailprotected] (404) 720 -8111 William A. Morrison, Esq. 50 Hurt Plaza, Suite 1110 Atlanta, Georgia 30303 [emailprotected] (404) 290-4628 Seth David Kirschenbaum, Esq. 918 Ponce De Leon Ave NE Atlanta, Georgia 30306 [emailprotected] (404) 471-3177 David Coleman [emailprotected] (404) 626-1726 Cheryl Turner, Esq. 83 Richmond Street Atlanta, Georgia 30312 [emailprotected] Jeffery E. Tompkins, Esq. 3355 Main Street Atlanta, Georgia 30337 [emailprotected] (404) 688-4503 Steven K. Weiner, Esq. 730 Peachtree Street, NE, Suite 600 Atlanta, Georgia 30308 [emailprotected] (404) 525-0992 Jan Bryson [emailprotected] (404) 944-0034

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Oregon Governor is Immune From Liability in COVID Vaccine Suit - Law.com

Novavax Granted Authorization in United Kingdom for its COVID-19 Vaccine – Contagionlive.com

February 7, 2024

Last week, the United Kingdoms Medicines and Healthcare products Regulatory Agency (MHRA) announced it has granted marketing authorization for Novavaxs NVX-CoV2601 (Nuvaxovid) XBB15 COVID-19 vaccine for prevention of COVID-19 in individuals aged 12 years and older.1

Todays MHRA authorization is recognition of the role our vaccine can have in protecting the British public against COVID-19 this year, Novavax CEO John C. Jacobs, said in a statement last week. We are in ongoing conversations with additional UK partners to identify potential opportunities to offer our protein-based non-mRNA COVID-19 vaccine to all eligible individuals who want one. We believe this is critical to supporting long-term, broad uptake of a seasonal COVID-19 vaccine in the UK.1

According to the company, this authorization was based on non-clinical data showing the updated COVID-19 vaccine induced functional immune responses for XBB15, XBB116 and XBB23 variants. Additional non-clinical data demonstrated the vaccine induced neutralizing antibody responses to subvariants JN1which is the dominant strain in the United StatesBA286, EG51, FL151 and XBB1166 as well as CD4+ polyfunctional cellular (T-cell) responses against EG51 and XBB1166. These data indicate Novavaxs vaccine can stimulate both arms of the immune system and induce a broad response against circulating variants.1

Back in late November, the WHO granted Novavax an emergency use listing (EUL) for the same vaccine. The EUL was also based on non-clinical data.2

Novavax's COVID-19 vaccine, NVX-CoV2601 (Nuvaxovid), is distinct from many other COVID-19 vaccines as it does not utilize the mRNA platform.

The vaccine incorporates a patented saponin-based Matrix-M adjuvant. The Matrix-M adjuvant enhances both the cellular and humoral arms of the immune system.

The NVX-CoV2601 vaccine has practical advantages in terms of storage and shelf life. It can be stored at temperatures between 2 to 8 degrees Celsius, making distribution and administration more straightforward.

The Vaccines Novelty

This vaccine does not use the m-RNA technology, but the companys patented saponin-based Matrix-M adjuvant platform. The vaccine can be stored at 2 to 8 degrees Celsius and has a 12-month shelf life, simplifying delivery, decreasing the carbon footprint and reducing wastage. And as previously mentioned, it has demonstrated efficacy against multiple variants. 2

Contagion spoke to Seth Toback, MD, senior vice president, Medical Affairs, Novavax, at last falls IDWeek about the novelty of the vaccine.

Our vaccine is a protein based vaccine; it's really unique in that it uses the entire full length spike protein. It takes that spike protein and arranges it as a three-dimensional shape, which puts it in a very similar shape to the natural wild type SARS-CoV-2, said Toback. "So when we make antibodies towards that vaccine, the antibodies are more accurately reflecting the wild type virus and gives us a neutralization response. We then take that fully-spiked protein and we add it to our novel adjuvant, which is called matrix Mit enhances both the cellular and humoral arms of the immune system.2

References

1. Novavaxs Updated COVID-19 Vaccine Authorized in the United Kingdom. Novavax press release. January 24, 2024. Accessed January 31, 2024. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom

2. Parkinson J. Novavaxs Updated COVID-19 Vaccine is Granted EUL by WHO. ContagionLive. December 2, 2023. Accessed January 31, 2024 Novavaxs Updated COVID-19 Vaccine is Granted EUL by WHO. https://ir.novavax.com/press-releases/Novavaxs-Updated-COVID-19-Vaccine-Authorized-in-the-United-Kingdom

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Novavax Granted Authorization in United Kingdom for its COVID-19 Vaccine - Contagionlive.com

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