Vaccines against SARS CoV 2 and the vaccination campaign in Italy

The SARS COV 2 pandemic has created an unprecedented need to manufacture and distribute a safe and effective vaccine to immunize an exceptionally large number of individuals planning diversified vaccination approaches quickly. A few weeks have passed since the sequencing of the viral genome for the design of the first vaccines and a few months for the implementation of the efficacy and safety studies. The article analyzes the types of vaccines available by examining their characteristics, efficacy and safety, also examining some debated issues such as the thrombotic risk of viral vector vaccines. The second part deals with the issue of the vaccination campaign in our country. KEY WORDS vaccination; COVID-19; spike protein; efficacy; safety.

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Coronavirus Disease 2019 Vaccination during Pregnancy

JOURNAL OF THE KOREAN SOCIETY OF MATERNAL AND CHILD HEALTH ◽

10.21896/jksmch.2021.25.4.231 ◽

2021 ◽

Vol 25 (4) ◽

pp. 231-238

Author(s):

Seong Hyeon Lee ◽

Ki Hoon Ahn

Keyword(s):

Pregnant Women ◽

Viral Vector ◽

Absolute Risk ◽

Academic Community ◽

Efficacy And Safety ◽

Female Reproduction ◽

Mortality And Morbidity ◽

Messenger Ribonucleic Acid ◽

Vaccination Recommendations ◽

Safety Studies

Several vaccines have been developed to combat the coronavirus disease 2019 (COVID-19), including messenger Ribonucleic acid (mRNA, Pfizer-BioNtech, and Moderna) and viral vector (AstraZeneca and Janssen) types. Unfortunately, reports of COVID-19 exposure during pregnancy are scarce, as pregnancy and breastfeeding were among the exclusion criteria in the efficacy and safety studies of major COVID-19 vaccines. The U.S. Centers for Disease Control and Prevention recently included pregnancy as a risk factor for severe COVID-19 infection, although the absolute risk is low. Previous experience in pregnant women with mRNA vaccines is lacking despite such vaccines not using live viruses, being unable to cause disease, not interacting with an individual's DNA, and being unable to cause genetic mutations. In addition, previous studies in animals have not revealed any safety issues with such vaccine types for female reproduction or fetal development. Vaccine-induced antibody titers were equivalent in pregnant and lactating women versus non-pregnant women. Given the data on increased mortality and morbidity associated with COVID-19 during pregnancy, it may be unethical to withhold vaccinations based on a theoretical risk and a lack of clinical research in this population. Additionally, a careful review of the vaccination recommendations for pregnant women by the academic community and government through additional efficacy and safety studies tailored to the situation in Korea is needed.

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COVID-19 Vaccine Acceptance in Azuay Province, Ecuador: A Cross-Sectional Online Survey

Vaccines ◽

10.3390/vaccines9060678 ◽

2021 ◽

Vol 9 (6) ◽

pp. 678

Author(s):

Julio Jaramillo-Monge ◽

Michael Obimpeh ◽

Bernardo Vega ◽

David Acurio ◽

Annelies Boven ◽

...

Keyword(s):

Rural Areas ◽

Online Survey ◽

Vaccination Campaign ◽

Postgraduate Education ◽

Effective Vaccine ◽

Cross Sectional ◽

Lower Education Level ◽

Vaccination Acceptance ◽

History Of ◽

High Level

We investigated the COVID-19 vaccination acceptance level in Azuay province, Ecuador through an online survey from 12th to 26th February (before the start of the COVID-19 vaccination campaign in Ecuador). Overall, 1219 respondents participated in the survey. The mean age was 32 ± 13 years; 693 participants (57%) were female. In total, 1109 (91%) of the participants indicated they were willing to be vaccinated with a COVID-19 vaccine, if the vaccine is at least 95% effective; 835 (68.5%) if it is 90% effective and 493 (40.5%) if it is 70% effective; 676 (55.5%) participants indicated they feared side effects and 237 (19.4%) thought the vaccine was not effective. Older age, having had a postgraduate education, a history of a negative COVID-19 test, a high level of worry of contracting COVID-19, believing that COVID-19 infection can be prevented with a vaccine and understanding there is currently an effective vaccine against COVID-19 were associated with higher vaccination acceptance. A vaccination education campaign will be needed to increase the knowledge of Ecuadorians about the COVID-19 vaccine and to increase their trust in the vaccine. People with a lower education level and living in rural areas may need to be targeted during such a campaign.

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Synthesis and immunological evaluation of synthetic peptide based anti-SARS-CoV-2 vaccine candidates

Chemical Communications ◽

10.1039/d0cc08265a ◽

2021 ◽

Author(s):

Qingyu Zhao ◽

Yanan Gao ◽

Min Xiao ◽

Xuefei Huang ◽

Xuanjun Wu

Keyword(s):

Synthetic Peptide ◽

Spike Protein ◽

Effective Vaccine ◽

The Novel ◽

Vaccine Candidates ◽

Peptide Epitopes ◽

Novel Coronavirus ◽

Immunological Evaluation

For prevention of the coronavirus disease 2019 caused by the novel coronavirus SARS-CoV-2, an effective vaccine is critical. Herein, several potential peptide epitopes from the spike protein of SARS-CoV-2 have...

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Pharmacogenetics in drug development

Philosophical Transactions of the Royal Society B Biological Sciences ◽

10.1098/rstb.2005.1688 ◽

2005 ◽

Vol 360 (1460) ◽

pp. 1579-1588 ◽

Cited By ~ 11

Author(s):

Alun D McCarthy ◽

James L Kennedy ◽

Lefkos T Middleton

Keyword(s):

Pharmaceutical Companies ◽

Efficacy And Safety ◽

Plasma Drug ◽

Dose Selection ◽

Drug Discovery And Development ◽

Safety Issues ◽

Drug Choice ◽

Probability Of Success ◽

Safety Studies ◽

Appropriate Therapy

Over the last two decades, identification of polymorphisms that influence human diseases has begun to have an impact on the provision of medical care. The promise of genetics lies in its ability to provide insights into an individual's susceptibility to disease, the likely nature of the disease and the most appropriate therapy. For much of its history, pharmacogenetics (PGx—the use of genetic information to impact drug choice) has been limited to comparatively simple phenotypes such as plasma drug levels. Progress in genetics technologies has broadened the scope of PGx efficacy and safety studies that can be implemented, impacting on a broad spectrum of drug discovery and development activities. Recent PGx data show the ability of this approach to generate information that can be applied to dose selection, efficacy determination and safety issues. This in turn will lead to significant opportunities to affect both the approach to clinical development and the probability of success—the latter being an important aspect for pharmaceutical companies and for the patients who will benefit from these new medicines.

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Nanovaccine: A hope to triumph the battle against novel Coronavirus disease 2019 (COVID-19)

Recent Patents on Nanotechnology ◽

10.2174/1872210515666210720130736 ◽

2021 ◽

Vol 15 ◽

Author(s):

Anurag Singh ◽

Anand Maurya ◽

Gaurav Mishra ◽

Rajendra Awasthi ◽

Kamal Dua ◽

...

Keyword(s):

Subunit Vaccine ◽

Goblet Cells ◽

Spike Protein ◽

Effective Vaccine ◽

The Novel ◽

Infection Site ◽

Peptide Vaccines ◽

Ciliated Cells ◽

Novel Coronavirus ◽

Major Target

Background: The novel coronavirus 2019 (COVID-19) infection has caused the global emergence of coronavirus in humans during the last 12 months. Till May 11, 2021, the confirmed global COVID-19 cases and deaths reached 158551526 and 3296855, respectively. Methods: Goblet cells and ciliated cells in the nose act as the initial infection site of SARS-CoV-2. Thus, mucus immunity is important to protect from infection. The outburst of SARS-CoV-2 infection can be halted only when an effective vaccine will be developed. Results: Globally, over 100 different vaccines are under investigation, including DNA vaccines, RNA vaccines, inactivated virus vaccines, adenovirus-based vaccines, recombinant/ subunit protein vaccines, peptide vaccines, and virus-like particles etc. Inactivated virus vaccines and mRNA, and adenovirus-based vaccines have moved fast into clinical trials. Conclusion: : Vaccines containing spike protein of SARS-CoV as subunit could effectively prevent binding of coronavirus to the host cell and membrane fusion. Thus, spike protein can be used as a major target for subunit vaccine preparation.

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COMPARATIVE IMMUNOGENICITY OF BNT162b2 mRNA VACCINE WITH NATURAL COVID-19 INFECTION

10.1101/2021.06.15.21258669 ◽

2021 ◽

Author(s):

Mina Psichogiou ◽

Andreas Karabinis ◽

Garyphallia Poulakou ◽

Anastasia Antoniadou ◽

Anastasia Kotanidou ◽

...

Keyword(s):

Health Care Workers ◽

Nucleocapsid Protein ◽

Natural Infection ◽

Multivariable Analysis ◽

Severe Infection ◽

Spike Protein ◽

Care Workers ◽

Number Of Individuals ◽

High Immunogenicity ◽

Clinical Subgroup

The mRNA vaccine BNT162b2 has proven highly effective and currently many millions are being vaccinated. There are limited and conflicting data from immunogenicity studies on the effects of age, gender, vaccination side effects (VSE), risk factors for severe COVID-19 (RFS-COV), obesity (BMI) and previous SARS-CoV-2 (Pr-CoV) Moreover, immunogenicity data from COVID-19 patients comparing various disease categories of natural infection i.e. asymptomatic vs mild vs moderate vs severe infection are sparse, and include limited number of individuals. This study included 871 vaccinated health care workers (HCW) and 181 patients with natural infection. Immunogenicity was assessed by a quantative assay measuring anti-SARS-CoV-2 against the RBD domain of the spike protein (anti-RBD) and anti-SARS-CoV-2 against nucleocapsid protein (anti-N). Samples were collected 1-2 weeks after completion of the 2nd dose in the vaccinated HCWs and 15-59 days post symptoms onset in patients with natural infection. The concentration of anti-RBD in vaccinated individuals after multivariable analysis was significantly associated with age, gender, VSE and Pr-CoV. Specifically, anti-RBD median levels (95% CI) were lower by 2,466 (651-5,583), 6,228 (3,254-9,203) and 7,651 (4,479-10,823) AU/ml in 35-44, 45-54, 55-70 yrs respectively, compared with 18-34 yrs group. In females, median levels of anti-RBD were higher by 2,823 (859-4,787) compared with males, in individuals with VSE were higher by 5,024 (3,122-6,926) compared with no VSE, and in HCWs with Pr-CoV were higher by 9,971 (5,158-14,783) AU/ml compared with HCWs without Pr-CoV. Among individuals with natural infection, the median anti-RBD levels were 14.8 times higher in patients with critical COVID-19 infection compared with non-hospitalized individuals. The ratio of anti-RBD in vaccinated individuals versus those with natural infection varied from 1.0 up to 19.4 according to the clinical subgroup of natural infection. This study proves the high immunogenicity of BNT162b2 vaccine although its sustainability remains to be seen. The use of comparative data from natural infection serological panels, expressing the clinical heterogeneity of natural infection may facilitate early decisions for vaccine evaluation in clinical trials.

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HiSpike Method for High-Throughput Cost Effective Sequencing of the SARS-CoV-2 Spike Gene

Frontiers in Medicine ◽

10.3389/fmed.2021.798130 ◽

2022 ◽

Vol 8 ◽

Author(s):

Ephraim Fass ◽

Gal Zizelski Valenci ◽

Mor Rubinstein ◽

Paul J. Freidlin ◽

Shira Rosencwaig ◽

...

Keyword(s):

Real Time ◽

High Throughput ◽

Cost Effective ◽

Developed Countries ◽

Spike Protein ◽

Medical Community ◽

Effective Vaccine ◽

Gene Variants ◽

Spike Gene ◽

Field Samples

The changing nature of the SARS-CoV-2 pandemic poses unprecedented challenges to the world's health systems. Emerging spike gene variants jeopardize global efforts to produce immunity and reduce morbidity and mortality. These challenges require effective real-time genomic surveillance solutions that the medical community can quickly adopt. The SARS-CoV-2 spike protein mediates host receptor recognition and entry into the cell and is susceptible to generation of variants with increased transmissibility and pathogenicity. The spike protein is the primary target of neutralizing antibodies in COVID-19 patients and the most common antigen for induction of effective vaccine immunity. Tight monitoring of spike protein gene variants is key to mitigating COVID-19 spread and generation of vaccine escape mutants. Currently, SARS-CoV-2 sequencing methods are labor intensive and expensive. When sequence demands are high sequencing resources are quickly exhausted. Consequently, most SARS-CoV-2 strains are sequenced in only a few developed countries and rarely in developing regions. This poses the risk that undetected, dangerous variants will emerge. In this work, we present HiSpike, a method for high-throughput cost effective targeted next generation sequencing of the spike gene. This simple three-step method can be completed in < 30 h, can sequence 10-fold more samples compared to conventional methods and at a fraction of their cost. HiSpike has been validated in Israel, and has identified multiple spike variants from real-time field samples including Alpha, Beta, Delta and the emerging Omicron variants. HiSpike provides affordable sequencing options to help laboratories conserve resources for widespread high-throughput, near real-time monitoring of spike gene variants.

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Recent Advances in Clinical Trials of HCV Vaccines

Journal of Applied Virology ◽

10.21092/jav.v3i1.48 ◽

2014 ◽

Vol 3 (1) ◽

pp. 10 ◽

Cited By ~ 2

Author(s):

Yongneng Luo ◽

Limin Jiang ◽

Zi'an Mao

Keyword(s):

Clinical Trials ◽

Viral Vectors ◽

Vaccine Development ◽

Viral Vector ◽

Core Protein ◽

Therapeutic Vaccine ◽

Hcv Infection ◽

Effective Vaccine ◽

Protein Subunit ◽

Preclinical Development

<p> Hepatitis C virus infects nearly 3% of the global population, and spreads to 3-4 million new people annually. HCV infection is a leading cause of liver cirrhosis, hepatocellular carcinoma, and end-stage liver diseases and causes liver-related death in more than 300,000 people each year. Unfortunately, there is currently no vaccine for HCV prevention (prophylactic vaccine) or treatment (therapeutic vaccine). Circulating HCV is genetically diverse, and therefore a broadly effective vaccine must target conserved T- and B-cell epitopes of the virus and induce strong cross-reactive CD4+/CD8+ T-cell and neutralizing antibody responses in preventing or clearing HCV infection. So far, a few of vaccine development approaches are successful and some of the HCV vaccine candidates have reached human clinical trials, including those modalities mainly based on recombinant proteins (envelope proteins and core protein subunit), synthetic peptides, DNA (plasmid) and viral vectors (virosome). Encouraging results were obtained for those HCV vaccine formulations consisting of prime-boost regimen involving a live recombinant viral vector vaccine alone or in combination with DNA or subunit vaccine. Among several other vaccine strategies under preclinical development, the most promising one is virus like particle based vaccine that will be moving into human studies soon.</p>

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