Category: Covid-19 Vaccine

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.

Follow Hanako Montgomery onTwitterandInstagram.

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

CORPUS CHRISTI, TX Multiple locations are available next week for COVID-19 vaccines and first and second-dose booster shots. Vaccinations for children are available at no cost with parental consent at all City-County Public Health District vaccination clinics.

Vaccines

The CDC recommends Pfizers COVID-19 vaccine be given to children ages 5 and older administered as a two-dose series, three weeks apart. Individuals aged 5 through 17 must have verbal or written parental consent to receive a Pfizer vaccination.

COVID-19 vaccine third doses are available for the following Pfizer and Moderna vaccine recipients who completed their initial series at least 28 days ago and are:

The CDC recommends immunocompromised people who have received one primary Johnson & Johnson vaccine get an additional Pfizer or Moderna vaccine four weeks after their initial dose.

Things to know:

Booster Shots

The Centers for Disease Control and Prevention (CDC) has updated its clinical recommendations to include the following:

First Dose Booster Shots:

Second Dose Booster Shots

Visitwww.cctexas.com/coronavirusandwww.nuecesknows.comfor more information. You can also find updates on city social media channels Facebook@citygovand Twitter@cityofcc.

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No Cost Vaccinations and Booster Shots Available Throughout the City - Corpus Christi

Novavax, fashionably late to the COVID-19 vaccine party, could still reap $5B in 2022: analyst  FiercePharma

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Novavax, fashionably late to the COVID-19 vaccine party, could still reap $5B in 2022: analyst - FiercePharma

A study conducted by the UK Health Security Agency has recently estimated the rate of hospitalization and death due to coronavirus disease 2019 (COVID-19) among unvaccinated persons residing in England. The study finds that a significant number of hospitalizations and deaths may happen if these unvaccinated populations become infected with the omicron variant of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The study is currently available on the medRxiv* preprint server.

About 80% of the adult population in the UK have received at least two doses of the COVID-19 vaccines as of early 2022. In addition, about 67% of the population have received the third booster dose. Despite high vaccine coverage, a small but significant proportion of the UK population remains unvaccinated because of a lack of access or hesitancy to vaccination.

People's hesitancy to receive COVID-19 vaccines is associated with various factors, including uncertainty about vaccine safety and efficacy, disbelief in government policies, and socio-cultural and religious beliefs. In addition, misinformation spread by anti-vaccination campaigns strongly discourages people from receiving COVID-19 vaccines.

In the current study, the scientists estimated the mortality rate in 2021 among unvaccinated people in Englandwho have access to the COVID-19 vaccine but are hesitant to receive it. In addition, they have predicted the rates of hospitalization and mortality in the unvaccinated English population under two hypothetical situations. In one situation, they have assumed that no further vaccination has been done and unvaccinated people have become infected with SARS-CoV-2. In the other situation, they have assumed that most vaccine-resistant people have received full vaccination.

The study has focused on any deaths that occurred within 60 days of COVID-19 diagnosis. The analysis has been done by considering vaccination rates in five age groups, including 15-24 years, 25-44 years, 45-64 years, 65-74 years, and >75 years.

The mortality rate was calculated by considering the time when 90% of the two-dose vaccination administered by December 2021 was achieved. The analysis revealed that about 3500 deaths occurred in 2021 among unvaccinated people who had access to COVID-19 vaccination but refused to receive it because of vaccine hesitancy.

The study further estimated the number of deaths per day per million people in the vaccinated and unvaccinated populations to adjust for the significant size variation between vaccinated and unvaccinated populations. The findings revealed that the death rate is 2-8 times higher in the unvaccinated population compared to that in the vaccinated population.

The prediction analysis was conducted by considering that all of the remaining unvaccinated population in the UK got infected with SARS-CoV-2. The findings revealed that about 29,600 hospitalizations and 11,700 deaths could occur in the future if vaccine-hesitant people remain unvaccinated and contract SARS-CoV-2 infection, especially omicron infection.

Furthermore, the analysis predicted that the number of hospitalizations and deaths could be reduced to 19,500 and 5,300, respectively, if most vaccine-resistant people receive a COVID-19 vaccine.

The study findings highlight that hesitancy to COVID-19 vaccination can significantly increase the rate of COVID-19-related hospitalizations and deaths in England. Importantly, the study predicts that the observed severity of COVID-19 could be reduced significantly if the majority of unvaccinated people, who are resistant to COVID-19 vaccination, agree to receive full vaccination.

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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The impact of COVID-19 vaccine hesitancy and resistance on the population of England - News-Medical.Net