SARS-CoV-2

Vaxxas Announces Interim Results from Phase I Clinical Study of First Needle-Free COVID-19 Vaccine Delivered Using Proprietary High-Density Microarray Patch (HD-MAP)

Retrieved on: 
Monday, June 5, 2023
COVID-19, Research, Infectious Diseases, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, NDV-HXP-S, University of Queensland, COVID-19 vaccine, Safety, Vaccination, Omicron, University, SARS-CoV-2, Vaccine

Vaxxas , a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced positive interim results from a Phase I human clinical trial with the first needle-free COVID-19 vaccine candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.

Key Points: 
  • Vaxxas , a clinical-stage biotechnology company commercializing a novel vaccination platform, today announced positive interim results from a Phase I human clinical trial with the first needle-free COVID-19 vaccine candidate delivered using Vaxxas’ proprietary high-density microarray patch (HD-MAP) technology.
  • The HD-MAP COVID-19 vaccine patches were well tolerated, with no serious or severe adverse events.
  • “We are very encouraged by the compelling early data and rapid progress of our needle-free COVID-19 vaccine candidate,” said Vaxxas Chief Executive Officer David L. Hoey.
  • The Phase I clinical study was fully enrolled and all participants have now completed the final step in the study.

EverGlade Consulting Funding Alert: Effect of Fiscal Responsibility Act on Project Next Gen BARDA Funding

Retrieved on: 
Monday, June 5, 2023
ASPR, Biomedical Advanced Research and Development Authority, USG, Defense, SARS-CoV-2, COVID-19, Management consulting, BAA, AOI, DTRA, ARPA, CDC, Development, Tax Equity and Fiscal Responsibility Act of 1982, DARPA, Public health, Organic acid, Federation, Therapy, BARDA, NIH, News, Fiscal, Pharmaceutical industry

CHARLESTON, S.C., June 5, 2023 /PRNewswire/ -- The Fiscal Responsibility Act of 2023 aims to reduce USG spending by $2.1 trillion, with an additional $1.5 trillion in mandated savings over the next two years. The bill reclaims $28 billion of unutilized COVID-19 funds and cuts an additional $400 million from the CDC's "Global Health Fund," which channels taxpayer funds to China. Collectively, these cuts represent the largest rollback of federal spending in American history.

Key Points: 
  • In a bit of good news for contractors, BARDA and ASPR funding, specifically Project Next Gen and the newly formed IBx team remain largely intact.
  • Funding for Project Next Generation Vaccines & Therapeutics remains largely intact and is expected to continue with its anticipated obligations.
  • "Given the success of Project Warp Speed, it is no surprise that Project Next Gen received bipartisan support in this negotiation," stated EverGlade Consulting Founder, Eric Jia-Sobota.
  • EverGlade Consulting is a national consulting firm helping clients navigate the federal landscape.

I need a flu shot and a COVID booster. Can I get them at the same time?

Retrieved on: 
Friday, June 2, 2023
Vaccine, Infection, Human, Australian Technical Advisory Group on Immunisation, Vaccination, Immunization, Pharmacy, SARS-CoV-2, Aborigine, Fever, Influenza A virus, Working group, World, GP, Woman, COVID, Myalgia, Population, Time, Swelling, Lymph, Risk, Influenza, Ageing, WHO, Headache, Safety, Virus, World Health Organization, Pharmaceutical industry

Yes, you can get your flu vaccine and COVID booster safely at the same time, saving you a trip to the GP, nurse or pharmacy.

Key Points: 
  • Yes, you can get your flu vaccine and COVID booster safely at the same time, saving you a trip to the GP, nurse or pharmacy.
  • When COVID vaccines were first rolled out, a gap was recommended between COVID and flu vaccines.
  • This is because we didn’t have adequate data of the individual and long-term effects of the new COVID vaccines.
  • It suggests getting an influenza vaccine and any dose of any approved COVID vaccine at the same time is a practical option.

GT Molecular Announces Entry into the Cancer Molecular Assay Market with two PCR Multiplex Panels for the EGFR and KRAS Genes

Retrieved on: 
Thursday, June 1, 2023
KRAS, DNA, Nucleic acid thermodynamics, Bio-Rad Laboratories, SARS-CoV-2, Mutation, TKI, VAF, Plasma, RSV, RUO, Data analysis, EGFR, Cancer, Exon, PCR, Vaccine

FORT COLLINS, Colo., June 1, 2023 /PRNewswire/ --

Key Points: 
  • The first two RUO panels are for the EGFR activating mutations and the KRAS G12C target which are common in human cancers.
  • These assay kits are designed and optimized for the Bio-Rad QX200™ and QX600™ Droplet Digital™ PCR Systems.
  • GT-Plex™ EGFR Panel targets over 30 actionable mutations in the EGFR gene and spans exons 18 through 21 in one kit.
  • Designed and optimized for the Bio-Rad QX200™ and QX600™ Droplet Digital™ PCR Systems including all necessary controls and data analysis guidance.

The first line of vaccines was highly effective at restricting COVID-19’s damage

Retrieved on: 
Thursday, June 1, 2023
Vaccine, Immunization, Phase 10, Vaccination, Hospital, SARS-CoV-2, Infection, Impact of the COVID-19 pandemic on hospitals, COVID-19, Research, Public health emergency of international concern, Messenger, Death, Time, Risk, Comment, Public Health Agency of Canada, WHO, World, The Lancet, Public Health Agency, World Health Organization, Disease, Pharmaceutical industry, Propane, Omicron

COVID-19 vaccination was deemed crucial to prevent the continued spread of the disease, protect those infected from experiencing severe effects, counter the rise of new variants, and ultimately end the pandemic.

Key Points: 
  • COVID-19 vaccination was deemed crucial to prevent the continued spread of the disease, protect those infected from experiencing severe effects, counter the rise of new variants, and ultimately end the pandemic.
  • Understanding the effectiveness of vaccines remains crucial.

Primary doses and boosters

    • A total of 5.09 billion people have completed a primary COVID-19 vaccination series (i.e., two doses of a two-dose vaccine or one dose of a one-dose vaccine).
    • First, how well does the primary series of COVID-19 vaccines protect people (against infections, hospitalizations and deaths) four months or more after completing vaccination?
    • Answering these questions will provide invaluable information for policymakers to make evidence-based decisions, such as the timing of administering COVID-19 vaccine booster doses.


    In total, we identified 68 studies that met these criteria, representing 23 countries. We then combined all the data to better understand how the vaccines’ protection changes over time. The results were published in Lancet Respiratory Medicine.

Protection against COVID-19, in general

    • Specifically, vaccines should show at least 70 per cent protection against infections and 90 per cent protection against hospitalizations and deaths.
    • We found that the primary series offered excellent protection against hospitalizations and deaths in the short term, showing over 90 per cent protection against both outcomes within 42 days after vaccination.
    • Protection then fell to around 45 per cent against infections and to around 70 per cent against hospitalizations after four months had passed.

Protection against the Omicron variant

    • Vaccines were generally less effective against the Omicron variant, which emerged in fall 2021, about a year after COVID-19 vaccines were introduced.
    • The primary series’ protection against hospitalization for Omicron infections reached around 70 per cent within the first 42 days, but also dropped over time, reaching closer to 50 per cent after six months.
    • Yet, booster protection also waned over time, falling to about 40 per cent against Omicron infections and 70 per cent against hospitalizations after four months post-booster.
    • With Omicron, boosters are particularly needed to maintain adequate protection, but this protection also needs additional boosting as it wanes over time.

Behaviour-based prevention measures remain necessary

    • That means measures like wearing a mask, washing one’s hands, and staying at home when sick remain essential complements to vaccination.
    • Contrary to vaccines, these measures do not decline in effectiveness over time and are particularly well suited to protect people against infections.
    • Keven Joyal-Desmarais receives funding from the Fonds de recherche du Québec (FRQ) and the Canadian Institutes of Health Research (CIHR).

EQS-News: CureVac Announces Financial Results for the First Quarter of 2023 and Provides Business Update

Retrieved on: 
Thursday, June 1, 2023
Vaccine, BioNTech, Operating cost, Workforce, GSK, Intellectual property, Federal Patent Court (Germany), SARS-CoV-2, COVID-19, Infection, Clinical trial, CureVac, CMO, IP, Messenger, Sale, Glioblastoma, Trial of the century, Research and development, Development, Patent, Patient, Research, CVAC, Safety, Virus, Pfizer, Pharmaceutical industry, Cryptocurrency, Video game, Pfizer–BioNTech COVID-19 vaccine

The increase was mainly driven by €219.8 million in net proceeds raised in a follow-on offering during February 2023.

Key Points: 
  • The increase was mainly driven by €219.8 million in net proceeds raised in a follow-on offering during February 2023.
  • The first quarter of 2022 was positively impacted by €6.8 million related to the reversal of an outstanding CRO provision.
  • Net financial result for the first quarter of 2023, amounted to €3.0 million, or an increase of €2.9 million from €0.1 million for the same period in 2022.
  • Pre-tax loss was €57.4 million for the first quarter of 2023 compared to €15.2 million in the same period of 2022.

Cocrystal Pharma Receives HREC Approval to Initiate Phase 1 Study to Evaluate Oral Broad-Spectrum Coronavirus 3CL Protease Inhibitor CDI-988

Retrieved on: 
Wednesday, May 31, 2023
Cocrystal, SARS-CoV-2, Coronavirus, COVID-19, Pharmacokinetics, RNA, Government, Patient, Orthornavirae, CFO, Safety, COCP, Pharmaceutical industry, Vaccine

BOTHELL, Wash., May 31, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces approval from the Australian Human Research Ethics Committee (HREC) to conduct a Phase 1 study with its novel, oral, broad-spectrum 3CL protease inhibitor CDI-988 as a potential treatment for COVID-19.

Key Points: 
  • BOTHELL, Wash., May 31, 2023 (GLOBE NEWSWIRE) -- Cocrystal Pharma, Inc. (Nasdaq: COCP) (Cocrystal or the Company) announces approval from the Australian Human Research Ethics Committee (HREC) to conduct a Phase 1 study with its novel, oral, broad-spectrum 3CL protease inhibitor CDI-988 as a potential treatment for COVID-19.
  • The Phase 1 randomized, double-blind, placebo-controlled, dose-escalating study will assess the safety, tolerability and pharmacokinetics of CDI-988 in healthy volunteers.
  • CDI-988 exhibited superior in vitro potency against SARS-CoV-2 and other coronaviruses, and demonstrated a favorable safety profile and pharmacokinetic properties supportive of daily oral dosing.
  • Cocrystal applied its proprietary drug discovery platform technology to design this investigational drug candidate.

GeoVax Partners With ABL to Advance cGMP Production of Vaccine Candidates

Retrieved on: 
Wednesday, May 31, 2023
Vaccine, GMP, Omicron, Good manufacturing practice, SARS-CoV-2, Biotechnology, COVID-19, Infection, Messenger, Bone marrow, Master service agreement, CDMO, CGMP, Patient, MSA, Immune system, Cancer, Potyvirus, ABL, Pfizer, MVA

ABL, a subsidiary of Institut Mérieux, is a pure-play contract development and manufacturing organization (CDMO) specialized in development and manufacturing of gene therapies, oncolytic viruses and vaccine candidates.

Key Points: 
  • ABL, a subsidiary of Institut Mérieux, is a pure-play contract development and manufacturing organization (CDMO) specialized in development and manufacturing of gene therapies, oncolytic viruses and vaccine candidates.
  • With cGMP facilities located in the U.S. and Europe, ABL is well-positioned to support GeoVax’s global development programs.
  • CM04S1 continues to advance in a second Phase 2 clinical trial as a booster for healthy patients who have previously received the Pfizer or Moderna mRNA vaccine (ClinicalTrials.gov Identifier: NCT04639466 ).
  • Data from these studies will form the basis for comparing vaccine potential in unique patient groups as well as the general population.

IMUNON Presents PlaCCine Preclinical Data at the 2023 Viruses and Cells – Gordon Research Conference

Retrieved on: 
Tuesday, May 30, 2023
Vaccine, Vaccination, SARS-CoV-2, Drug discovery, COVID-19, Virus, Temperature, Gordon Research Conferences, Messenger, Cell, Therapeutic vaccines, Mouse, Regulation of tobacco by the U.S. Food and Drug Administration, IND, Conference, Food, Fatigue

LAWRENCEVILLE, N.J., May 30, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Khursheed Anwer, Ph.D., the company’s Executive Vice President and Chief Science Officer, presented new PlaCCine preclinical data at the 2023 Viruses and Cells – Gordon Research Conference in Barcelona. Dr. Khursheed’s presentation, titled “A Novel DNA Vaccine Approach to Prophylactic and Therapeutic Vaccines,” was delivered on May 25, 2023, and described IMUNON’S PlaCCine technology platform for the development of next-generation vaccines. Dr. Anwer’s presentation is available [here].

Key Points: 
  • LAWRENCEVILLE, N.J., May 30, 2023 (GLOBE NEWSWIRE) -- IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces that Khursheed Anwer, Ph.D., the company’s Executive Vice President and Chief Science Officer, presented new PlaCCine preclinical data at the 2023 Viruses and Cells – Gordon Research Conference in Barcelona.
  • Dr. Khursheed’s presentation, titled “A Novel DNA Vaccine Approach to Prophylactic and Therapeutic Vaccines,” was delivered on May 25, 2023, and described IMUNON’S PlaCCine technology platform for the development of next-generation vaccines.
  • In addition, PlaCCine was stable for at least eight months at refrigerated temperatures and for at least one month at room temperature.
  • Dr. Corinne Le Goff, President and Chief Executive Officer of IMUNON, said, “These preclinical findings underscore the potential of our PlaCCine platform to produce next-generation COVID-19 vaccines that address the limitations of the current commercial products.