Category: Covid-19 Vaccine

A self-amplifying mRNA vaccine one in which the delivered RNA multiplies inside the body has shown promising results against Covid-19 in ongoing phase 1/2/3 trials. The vaccine, ARCT-154, has been developed by Arcturus Therapeutics Holdings, based in San Diego, California, and its trials are in progress in Vietnam. It offered 95% protection against severe Covid-19 and death, and 55% against Covid infection, Arcturus said in a press release.

WHAT IT MEANS: An mRNA vaccine, such as those from Pfizer/BioNTech and Moderna, use messenger RNA that encodes the spike protein of the coronavirus. In other words, the mRNA directs the cell to produce copies of the spike protein, so that the immune system will recognise the spike if and when actual infection takes place, and mount a response.

A self-amplifying mRNA vaccine is an improvement on the traditional RNA platform. It encodes four extra proteins in addition to the vaccine antigen, and these enable amplification of the original strand of RNA once inside the cell. The basic advantage is that it requires a smaller dose.

THE TRIAL: It enrolled over 19,000 adult subjects in Vietnam, including individuals at higher risk of severe complications of Covid-19 disease. The Phase 3 placebo-controlled vaccine efficacy portion of this study enrolled over 16,000 participants. An analysis between 7 days and 56 days after completion of a two-dose vaccination series demonstrated 55% vaccine efficacy for protection against Covid-19, the release said. These cases were detected during an outbreak in Vietnam when the Delta and Omicron variants were dominant.

The analysis of severe Covid-19 disease (including deaths) included 43 severe cases. Forty-one cases occurred in the placebo group and two in the vaccinated group, demonstrating vaccine efficacy of 95%, the release said. Nine deaths were reported in the placebo group, and one in the vaccinated group, whom the company described as an older age group participant who was also at increased risk of severe Covid-19.

ADVERSE EVENTS: The incidence of unsolicited adverse events in the two groups are comparable, the release said. No cases of myocarditis or pericarditis were reported; however, the company conceded that the study is not large enough to reliably observe these events given their extremely rare frequency of occurrence.

Adverse events collected in diaries of study participants (solicited adverse events) for seven days following each vaccination demonstrate that the majority of these events were mild or moderate in severity, it said. The majority of solicited adverse events resolved within the 7-day window of observation.

IMPLICATIONS: The Pfizer/BioNTech and Moderna vaccines against Covid-19 are the only two mRNA vaccines available so far. The new vaccine may come with significant advantages: easier storage, along with lower cost because its self-amplifying design allows for smaller doses, Science magazine said.

However, the magazine noted, much of the world has already been vaccinated, and the Arcturus vaccine may be making its debut too late, at least for primary vaccination.

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Explained: How self-replicating mRNA Covid-19 vaccines work, and what trial results show - The Indian Express

Evusheld is a therapeutic that is given before exposure to COVID-19 to individuals who may not mount an adequate immune response to COVID-19 vaccination. It is given as a pre-exposure prophylaxis to people who have a compromised immune system and who are at high risk for COVID-19. Evusheld can help protect immunocompromised people by lowering the risk of hospitalization, severe illness, and death. It is recommended that administration of Evusheld occur before exposure to COVID-19. Persons with immune compromised conditions should speak to a provider right away about eligibility.

What is Evusheld?

The U.S. Food & Drug Administration (FDA) issued an emergency use authorization for Evusheld, a monoclonal antibody preventative treatment that has shown to be 77% effective in lowering risk of developing COVID-19 for up to 6 months.

Evusheld is a preventative treatment, which helps prevent COVID-19 in people who have not yet been exposed to the virus. Evusheld uses two monoclonal antibodies, tixagevimab and cilgavimab, that are laboratory produced molecules engineered to serve as substitute antibodies to restore, enhance, or mimic the immune response to pathogens. Evusheld may only be prescribed to a patient by a physician or authorized provider, as it is administered intramuscularly (IM) by two consecutive injections of 300mg of tixagevimab and 300mg of cilgavimab.

Eligibility for Evusheld

The Emergency Use Authorization allows AstraZenecas Evusheld to be used as a pre-exposure prophylaxis for prevention of COVID-19 in adults and individuals that:

Talk to a health care provider to determine whether, based on individual circumstances, someone is eligible to receive Evusheld, and when it should be administered. For best results, do not wait to confirm eligibility.

Evusheld Providers in Nevada

Currently, Nevada has 20 locations in the state that provide Evusheld in the following cities: Reno, Carson City, Fallon, McDermitt, Winnemucca, Elko, Caliente, Las Vegas, Gardnerville, Yerington.

Follow this link to find Evusheld near you. COVID-19 Therapeutics Locator

Free State Sponsored Services

The State of Nevada has funding to provide COVID-19 therapeutic services to Nevadans. There are state sponsored services for Nevadans free of charge ranging from fixed site clinics, mobile or home-health services, and telehealth visits for oral antivirals and other therapies. Currently, the free therapies available include: Evusheld, Sotrovimab, Paxlovid, Molnupiravir, and soon Bebtelovimab.

Clark County

In Clark County, there is a fixed site, as well as home-health infusion options.

Northern and Rural

To learn more about statewide assistance regarding free Evusheld, please call 1-800-401-0946 or visit nevadacovidtreatment.com. The NorthernNevada Covid Treatment telehealth services are applicable to all Nevadans (including urban and rural counties). If you are eligible, you will be scheduled for a telehealth visit to assess if and how therapeutics may be used.

Adverse effects of Evusheld

As with all medications, you may experience some common side effects with most being mild to moderate. Headache, fatigue, and cough were among the most common side effects during clinical trials. Overall, side effects occurred in less than 3% of individuals.

Evusheld Effectiveness

Multiple studies have been performed on adults who were not vaccinated against COVID-19 and at elevated risk because of age, comorbidity, history of severe or adverse reaction to any US Food and Drug Administration-licensed vaccine, or residential/occupational status. Protection against severe illness, moderate illness, and COVID-19 symptoms were found to be effective up to 6.5 months after injections. There were no severe or critical COVID-19 events in the group that received Evusheld. Evusheld is not a substitute for vaccination, however, this preventative treatment may provide additional protection for people with severely compromised immune systems who may not mount an adequate immune response to COVID-19 vaccination. There also are people with a history of adverse reactions to vaccines for whom the COVID-19 vaccine is not recommended.

This monoclonal antibody treatment is still relatively new under emergency use authorization (EUA) and is recommended only for those at high risk for severe disease.

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Evusheld Pre-Exposure Preventative Treatment for COVID-19 - Nevada Health Response - Nevada Health Response

Policymaking aside, clinical trial findings involving the immunocompromised can bring about benefits at the individual level. This is what will happen with Ubuntu, says Ivy Fikelephi Kaunda, who works with Caprisa to help recruit participants for clinical trials. Based outside the east coast city of Durban, Kaunda spends much of her time engaging on healthcare issues with residents in the surrounding townships, where over the course of the Covid-19 pandemic, she says she has encountered resistance when encouraging people to take the vaccine. "The ones who are HIV positive will turn and say 'Oh, this is not for us, because we are HIV-positive'." This fear is rooted in the fact that people living with HIV often feel like they are left out, she explains, because they are routinely told that regular treatments are not suitable for them.

But according to Kaunda, this changed with the launch of the Ubuntu trial. When, during her community rounds to recruit participants, Kaunda was able to explain that the trial was tailor-made for people living with HIV, she noticed increasing enthusiasm for the study. Now "when you go to the community people are saying 'I'm part of Ubuntu'... People understand that we also have something for them, and they'll say 'I was part of this change'."

Kaunda speculates that feeling represented by the trial might ultimately encourage more HIV-positive people to get the vaccine which could be a positive stimulus for vaccination rates.

There's another benefit to the trial, which may play out in the longer term: knowing the precise effectiveness of a vaccine can lay a foundation for improved general healthcare, Bekker believes. "It becomes great advocacy to say to people that the vaccine works, but it's better if your immune system is fully constituted therefore it's another reason to get tested and to take your [antiretroviral drugs]," she says. "So it's sort of a secondary public health outcome that is ideal in many ways."

Back at the health centre in Masiphumelele, the circle of women fan themselves with wads of paper consent forms that they need to fill in before the vaccinations can begin. In the centre of the ring, a nurse explains the process, which could take most of the day and will stretch over lunch, which is cooking fragrantly in the nearby kitchen. Their willingness to devote hours of their time could perhaps be taken as an indication that, at the very least, the trial's focus on inclusion is paying off.

"In a world where we recognise that people are marginalised, stigmatised, left behind in clinical research," says Bekker, "we should do our bit to say we don't want to leave people behind."

*This article was supported with funding from the European Journalism Centre, through the Global Health Security Call. This programme is supported by the Bill & Melinda Gates Foundation

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How effective are Covid-19 vaccines for people with HIV? - BBC

Note:The Pfizer vaccine is approved by the U.S. Food and Drug Administration (FDA) for use in persons aged 16 and older, and is authorized under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in persons aged 5 to 15. The Moderna and Johnson & Johnson vaccines are authorized under an EUA for use in persons aged 18 and older. The emergency use of these products is only authorized for the duration of the COVID-19 emergency declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the Food Drug & Cosmetic Act unless the declaration is terminated or authorization revoked sooner.

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COVID-19 Vaccine - Michigan (.gov)

In a recent study posted to the medRxiv* pre-print server, researchers investigated the association between genetic predisposition to venous thromboembolism (VTE) and increased risk of thrombosis post coronavirus disease 2019 (COVID-19) vaccination.

Venous thromboembolism (VTE) involves deep vein thrombosis and pulmonary embolism and predominantly affects older individuals. VTE affects nearly 10 million people globally every year and leads to considerable morbidity and mortality. Although studies have shown that COVID-19 vaccination is linked to a higher risk of VTE, it is not clear if a genetic predisposition to VTE plays a role in the increased risk of thrombosis post-vaccination.

In the current study, the researchers used UK Biobank (UKBB) data containing information related to in-depth genotyping data and associated vaccination and health outcomes to generate a polygenic risk score (PRS). They used 299 genetic variants identified in a previous study on large genome-wide association.

The UK Biobank is a prospective cohort with more than 500,000 individuals from England (89%), Scotland (4%), and Wales (7%) between 2006 and 2010. The age of these individuals at baseline enrolment was in the range of 40 to 69 years. The Biobank data comprised comprehensive information about demographics, lifestyle factors, socioeconomics, medical history, and physical metrics collected using questionnaires and standardized measurements.

The team prospectively evaluated associations between incident VTE and PRS post first and second doses of COVID-19 vaccination. They performed sensitivity analyses stratified based on vaccine type (mRNA or adenovirus vaccine) and used two historical cohorts that were unvaccinated. The hazard ratios (HR) for PRS-VTE associations were estimated using Cox models.

In the vaccinated cohorts, all UKBB participants from England who had received at least one dose of ChAdOx1 or BNT162b2 COVID-19 vaccines between December 2, 2020, and September 31, 2021, were included. The team followed up the eligible participants from the vaccination date to outcome, death, or the end of the follow-up period at 28 and 90 days, whichever happened first. Participants from Scotland or Wales were not included in this cohort because of the lack of vaccination records at the time of this study.

A total of 359,310 individuals received a single COVID-19 vaccine dose, of which 44.6% or 160,327 were males, and the mean age was 69.05 years on the vaccination date. On 28- and 90-day follow up after first-dose vaccination, 88 and 299 patients developed VTE, respectively, which was equivalent to a 0.88 and 0.92 incidence rate per 100,000 person-days. This association between VTE and PRS slightly decreased after the second dose vaccination in the 28- and 90-days follow-up period.

The results showed that the PRS was significantly associated with an increased risk of VTE. The team found similar associations in the two vaccine dose cohort and the historical unvaccinated cohorts after stratification by vaccine type. Of the 221,875 vaccine recipients whose vaccine-type information was available, 172 83,816 received BNT162b2 and 138,059 received ChAdOx1. Similar PRS-VTE associations were observed across each vaccine dose and follow-up period. HR ranged between 1.24 and 1.63 in the ChAdOx1 cohort and between 1.20 and 1.38 in the BNT162b2 cohort.

Interestingly, the VTE incidence rates in the BNT162b2 cohort were nearly twice as high as the incidence rates in the ChAdOx1 cohort. This was expected because the BNT162b2 vaccine was approved first in the UK and was prioritized among the older, more vulnerable populations.

The study results support several conclusions. First, the data showed that genetic susceptibility to VTE is a risk factor for VTE following COVID-19 vaccination. Second, this genetic susceptibility was independent of conventional risk factors including obesity, old age, and comorbidity, as evidenced by the lack of associations between the baseline characteristics and PRS.

Third, data from the historical comparison arm suggests that clinically significant interactions are unlikely between the genetic background of individuals and COVID-19 vaccination. This has specific implications for hereditary VTE patients with predisposing traits who are vaccine-hesitant due to concerns related to vaccine safety signals. Fourth, using the genetic score, the team found that 5% of the participants had an over two-fold higher VTE risk, which is of great public health relevance as it can inform intervention policies in the vaccinated population.

To summarize, the study findings show that the genetic determinants of developing VTE following COVID-19 vaccination are similar to those found in historical data. This indicates that post-COVID-19 vaccine VTE has a similar etiology as conventional VTE, at the population level. In addition, the observed associations between PRS and VTE were equivalent for mRNA and adenovirus-based COVID-19 vaccines.

medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.

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Incidence of venous thromboembolism following COVID-19 vaccination - News-Medical.Net

For a study, researchers sought to determine the peripartum consequences of COVID-19 immunization during pregnancy. A birth registry connected with the provincial COVID-19 vaccination database was used in a population-based retrospective cohort research in Ontario, Canada. All births occurred between December 14, 2020, and September 30, 2021. COVID-19 immunization during pregnancy, COVID-19 immunization after pregnancy, and no immunization Postpartum hemorrhage, chorioamnionitis, cesarean birth (including elective and emergency cesarean delivery), neonatal intensive care unit (NICU) admission, and poor infant 5-minute Apgar score (7) Linear and robust Poisson regression were used to calculate adjusted risk differences (aRDs) and risk ratios (aRRs) when comparing the cumulative incidence of outcomes in those who received COVID-19 vaccination during pregnancy to those who were vaccinated after pregnancy and those who had no record of COVID-19 vaccination at any point. To account for confounding, inverse probability of treatment weights were utilized.

About 22,660 (23%) of 97,590 people (mean [SD] age, 31.9 [4.9]) got at least one dose of COVID-19 vaccination during pregnancy (63.% received dose 1 in the third trimester; 99.8% received an mRNA vaccine). When those vaccinated during pregnancy were compared to those vaccinated after pregnancy (n=44,815), there were no significantly increased risks of postpartum hemorrhage (incidence: 3.0% vs 3.0% ; aRD, 0.28 per 100 individuals [95% CI, 0.59 to 0.03]; aRR, 0.91 [95% CI, 0.82-1.02]), chorioamnionitis (0.5% vs 0.5%; aRD, 0.04 per 100 individuals [95% CI, 0.17 to 0.09]; aRR, 0.92 [95% CI, 0.70-1.21]), cesarean delivery (30.8% vs 32.2%; aRD, 2.73 per 100 individuals [95% CI, 3.59 to 1.88]; aRR, 0.92 [95% CI, 0.89-0.95]), NICU admission (11.0% vs 13.3%; aRD, 1.89 per 100 newborns [95% CI, 2.49 to 1.30]; aRR, 0.85 [95% CI, 0.80-0.90]), or low Apgar score (1.8% vs 2.0%; aRD, 0.31 per 100 newborns [95% CI, 0.56 to 0.06]; aRR, 0.84 [95% CI, 0.73-0.97]). When compared to individuals who did not receive COVID-19 vaccination at any point (n = 30,115), the findings were qualitatively similar.

COVID-19 immunization during pregnancy, compared to vaccination after pregnancy and no vaccination, was not related with a higher risk of unfavorable peripartum outcomes in the population-based cohort analysis in Ontario, Canada. The studys analysis should take into account that the immunizations received during pregnancy were mostly mRNA vaccines given in the second and third trimesters.

Reference:jamanetwork.com/journals/jama/fullarticle/2790607

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Association of COVID-19 Vaccination in Pregnancy With Adverse Peripartum Outcomes - Physician's Weekly

GAITHERSBURG, Md., April 22, 2022 /PRNewswire/ -- Novavax. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, has initiated administration of the first booster doses of NVX-CoV2373, the company's protein-based COVID-19 vaccine, in the pediatric expansion of the PREVENT-19 pivotal Phase 3 clinical trial. The study will evaluate the safety and immunogenicity of a third dose of NVX-CoV2373 among trial participants aged 12 through 17.

"We see the ongoing need for alternative vaccine options because we are continuing to monitor spikes in COVID-19," said Gregory M. Glenn, M.D., President, Research and Development, Novavax. "The expansion of our PREVENT-19 booster trial into the pediatric population reinforces our commitment to seek to make our vaccine available to a broader population."

All PREVENT-19 trial participants aged 12 through 17 are now eligible to receive a third booster dose of NVX-CoV2373. The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M adjuvant) and may be administered at least five months after receipt of active vaccine. Post-booster objectives include the assessment of the humoral immune response 28 days after the administration of the booster dose, as well as describing COVID-19 disease. Initial results are expected during the second half of 2022.

Findings from the pediatric expansion of the PREVENT-19 pivotal Phase 3 trial were announced in February.

Authorization in the U.S.

NVX-CoV2373 has not yet been authorized for use in the U.S. by the U.S. Food and Drug Administration.

About NVX-CoV2373

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. NVX-CoV2373 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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.

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 NVX-CoV2373 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 NVX-CoV2373 Phase 3 Trials

NVX-CoV2373 is 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 NVX-CoV2373 with Matrix-Madjuvant in 29,960 participants 18 years of age and older 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 7 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, NVX-CoV2373 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).

PREVENT-19 is being conducted with support from the U.S. government, including the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS), and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to$1.75 billionunder a Department of Defense agreement.

Additionally, a trial conducted in the U.K. with 14,039 participants aged 18 years and older 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 7 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-MAdjuvant

Novavax' patented saponin-based Matrix-Madjuvant 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. NVX-CoV2373, the company's COVID-19 vaccine, has received conditional authorization from multiple regulatory authorities globally, including the European Commission and the World Health Organization. The vaccine is also under review by multiple regulatory agencies worldwide. In addition to its COVID-19 vaccine, Novavax is evaluating a COVID-seasonal influenza combination vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and its quadrivalent influenza investigational vaccine candidate previously known as NanoFlu*. 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.com and 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, including the PREVENT-19 booster study in adolescents results expected during the second half of 2022, the ongoing development of NVX-CoV2373, including its COVID-19-influenza 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, the potential impact and reach of Novavax and NVX-CoV2373 in addressing vaccine access, controlling the pandemic, and protecting populations, and the efficacy, safety and intended utilization 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; 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, 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.gov and 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 | 240-268-2022ir@novavax.com

MediaAli Chartan | 240-720-7804Laura Keenan Lindsey | 202-709-7521media@novavax.com

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SOURCE Novavax, Inc.

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Novavax Announces Initiation of COVID-19 Vaccine Booster Study in Adolescents in Phase 3 PREVENT-19 Trial - BioSpace

A vaccine dose that remains in the vial is 0% effective no matter what the clinical trial showed, Dr. Walter Orenstein, a former director at the Center for Disease Control and Preventions immunization program and a professor at the Emory Vaccine Center, said.

Two years after COVID vaccines started going into arms, they are still highly protective in warding off severe disease and hospitalization. Even so, the protection offered by COVID vaccines has been found to wane within a few months. According to the CDC, COVID vaccines are 91% effective in preventing hospitalization during the first two months but drop to 78% after four months. Booster shots were cleared by the FDA to extend the protection, but vaccine experts say the prospect of taking a booster two or more times a year will be challenging.

Its not a feasible strategy, said Dr. Glen Nowak, a UGA professor and expert in public health communications who spent 14 years at the CDC. We havent convinced many people that they should get one additional dose of the vaccine.

Vaccine experts said that any new vaccines that hit the market will need to require less frequent booster shots or tackle multiple viruses at the same time to gain traction among an increasingly shot-resistant country. Scientists said those are tall tasks to accomplish, especially as the coronavirus continues to mutate at a rapid pace.

Todays COVID vaccines are all based on the original version of the coronavirus.

However, the delta and omicron variants led to more breakthrough cases among vaccinated populations, expediting the need for new and improved vaccines.

That first omicron variant reminded everybody that you better keep doing research because this virus changes, Caplan said.

On Tuesday, Moderna announced that an updated version of its vaccine based on one of the coronavirus first mutations, the beta strain, was able to produce more antibodies capable of fighting several variants including omicron than todays booster shots.

Georgians are helping with that research. Dr. Lilly Immergluck, a vaccine trial unit co-director at Morehouse School of Medicine, is leading a clinical trial using updated versions of Modernas vaccine. She said theyre testing six different vaccines based on coronavirus variants, including beta, delta and omicron, to see how effective they are at preventing infection and serious illness over the next year.

Morehouse School of Medicine is among 24 sites across the U.S. participating in the clinical trial, and theyre recruiting participants through early May.

Dr. Baozhong Wang, a professor at Georgia States Institute for Biomedical Sciences, said updated vaccines are within the reach of modern science and can be ready by the end of this year.

The true issue will be determining what strains should be used as templates for updating the coronavirus booster shots a perennial problem for the seasonal influenza vaccine., Wang said in an email.

A new and even more effective vaccine doesnt solve a key obstacle: Not enough people are getting vaccinated.

I dont think (vaccine hesitancy) is going to disappear. Its very entrenched, so thats why I dont think you can vaccinate your way out of COVID, Caplan said.

Currently, 56% of Georgians are fully vaccinated, but that number has remained stagnant for the past few months. It took from February 7 to April 7 for the state to increase a single percentile.

Given that only 55% of Americans received their flu vaccine this past winter, annual shots might not be a long-term solution for country-wide immunity. Vaccine developers are searching for a one-shot solution to potentially address that issue, but it would be an unprecedented medical discovery. Caplan said the challenge could be similar to that of developing a vaccine for HIV, which has eluded scientists due to the viruss quick mutations.

The ability for people to become reinfected with COVID, just like the flu, means its a completely different situation from developing the vaccines that nearly eradicated measles and polio, Orenstein said.

Many types of vaccines, called mRNA vaccines, target the virus spike protein, which is how viruses enter and infect human cells. The spike protein for measles and polio doesnt change, allowing for vaccines to provide lifelong protection.

The flu and coronaviruses have spike proteins that mutate often, requiring reformulated vaccines and multiple shots.

There are scientific studies underway searching for a pan-coronavirus vaccine, sometimes called a universal vaccine, which would provide long-term protection against COVID and its variants. But those efforts have been attempted with the flu for decades and have yet to yield a miracle shot.

To do better than Mother Nature is a challenge, Orenstein said.

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New COVID-19 vaccines are in the works, but how much will they help? - The Atlanta Journal Constitution

The Department of Health and Human Service is a paid sponsor of The Morning Blend

COVID-19 cases and hospitalizations among children in the U.S. rose to record levels with the spread of the Omicron variant. Though COVID-19 infections in children can range from mild cold-like symptoms to long-term respiratory problems, many parents still have questions about whether a COVID vaccine is an appropriate choice to make for their childs health.

Dr. Ilan Shapiro, Medical Director of Health Education and Wellness, AltaMed talks about the impact of COVID on children and teens. He also address myths and misinformation about vaccines, discuss the anticipated vaccine authorization for children under age 5, and provide insights on a variety of COVID-related topics.

For more information visit: https://www.vaccines.gov/

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Covid-19, vaccines, and children: what doctors want parents to know - KGUN 9 Tucson News

AJapanese QAnon group claimed that inoculating children with COVID-19 vaccinations was a crime. Photo:Yuichi Yamazaki/Getty Images

A leader of a Japanese QAnon group that believes COVID-19 was made up has been arrested for allegedly trespassing into a clinic offering vaccinations for children in Tokyo.

Hiroyuki Kuraoka, a 43-year-old anti-vax activist and former actor, was detained on Wednesday after he entered the facility earlier this month and protested the COVID-19 vaccinations it provided. Kuraoka leads YamatoQ, which describes itself as a Japanese version of the pro-Trump conspiratorial movement QAnon and claims to want to restore the health and safety of young children.

Kuraoka and 11 other members of his group came to the clinic on April 7 and demanded to speak to the clinics director. They reportedly shouted inoculating children with COVID-19 vaccines is a crime and save kids in an hourlong stunt. Police apprehended four members who were standing in the clinics waiting room, in what YamatoQ decried as a clear suppression of citizens activities. The others, including Kuraoka, were allowed to leave.

Anti-vaccination sentiments and activism have persisted in parts of Japan despite a relatively high vaccination rate of 80 percent nationwide, with groups like YamatoQ regularly demonstrating against inoculation and even questioning the very existence of the virus that has killed more than 6 million people worldwide.

Following Kuraokas arrest, his father Jiro Okazaki, an actor known for playing tough guy roles, apologised for his sons actions.

I hope that he will be punished severely by the law to atone for his crime, that he will make amends to everyone who was inconvenienced by this incident, and that he will be rehabilitated and become a person who can be of service to society as soon as possible, he wrote in an online letter.

YamatoQ is one of several Japanese versions of QAnon, a term describing a bunch of conspiracy theories promoting a false reality that the world is run by Satan-worshipping child sex traffickers in government, the media, and powerful businesses. Some disciples of the theory believe former President Trump was waging a global war against those supposedly evil forces.

YamatoQ postulates similar claims that Trump saved many children from Satanists. It also falsely suggests that COVID-19 does not exist and that the vaccine contains a harmful pathogen. Some of the groups videos have been taken down by YouTube for violating community guidelines.

The group is also heading a village revitalization project, in which they hope that YamatoQ members can live and work while growing vegetables and other foods free of pesticides.

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Japanese QAnon Leader Arrested for Entering COVID-19 Vaccination Site to Save Kids - VICE