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OBSERVATION: Biologics can take a long time to develop but COVID vaccines have been in development for almost 50 years and novel approaches were used to develop these vaccines. Vaccines typically take 10 to 15 years to develop, test and release to the public. The coronavirus vaccines, however, took less than a year.
Valneva SE, who developed the worlds first FDA-approved chikungunya vaccine , has now unveiled promising Phase III data for its single-shot chikungunya vaccine, IXCHIQ, in adolescents aged 12 to 17. IXCHIQ is the only licensed chikungunya vaccine in the US for adults aged 18 and older at increased risk of exposure to the virus.
German pharmaceutical firm Merck has extended its partnership with Moderna to jointly develop and sell mRNA-4157/V940, an investigational personalised cancer vaccine (PCV). They subsequently expanded the collaboration to include the development of antigen mRNA cancer vaccines in 2018.
Intranasal delivery of ChAdOx1 nCoV-19 failed to induce either a consistent mucosal antibody response or a strong systemic immuneresponse, according to results from a Phase 1 clinicaltrial released today.
France-based biotech company Osivax has thrown its hat into the influenza ring by dosing the first subject with its vaccine candidate OVX836. The Phase IIa trial (NCT05734040) in Australia will see a potential 500 volunteers given OVX836 in combination with quadrivalent influenza vaccines (QIVs).
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted conditional authorisation for Moderna ’s Covid-19 booster vaccine, mRNA-1273.214 (Spikevax Bivalent Original/Omicron), for use in adults aged 18 years and above. It comprises mRNA-1273 (Spikevax) and a vaccine candidate that acts on the SARS-CoV-2 virus’ BA.1
A trial of Russia’s Sputnik V coronavirus vaccine has shown the jab produces an immuneresponse, although the study was too small to produce conclusive findings, particularly on safety. The vaccine also produced a T-cell response within 28 days, a secondary outcome.
A new HIV vaccine from Scripps Research has shown a significantly improved ability to neutralize the virus in preclinical tests, and it will soon be studied in healthy people who volunteer to participate in clinicaltrials.
HDT Bio has received Emergency Use Approval from Indian regulators for its Covid-19 vaccine, Gemcovac. The vaccine leverages self-amplifying RNA (saRNA), which can replicate itself after administration and could be effective at very low doses. HDT Bio CEO Steve Reed said: “Our saRNA vaccine is a game-changer.
The US Food and Drug Administration (FDA) has granted approval for Merck's (MSD outside the US and Canada) pneumococcal 15-valent conjugate vaccine, Vaxneuvance, for use in children aged six weeks to 17 years. The post US FDA grants approval for Merck’s pneumococcal vaccine for children appeared first on Pharmaceutical Technology.
GlaxoSmithKline (GSK) has signed an agreement with the Government of Canada for pandemic and seasonal influenza vaccines to aid in protecting adults and children in the country. The company intends to supply both vaccines from its 230,000ft² Sainte-Foy facility in Quebec. .
from the US National Institutes of Health (NIH) unit National Institute of Allergy and Infectious Diseases (NIAID) to develop a prophylactic intranasal vaccine against Neisseria gonorrhoeae (NG). Leveraging its outer membrane vesicles (OMV) platform technology, Intravacc will develop the vaccine.
Moderna has joined forces with non-profit organisation IAVI on a third phase 1 trial of its candidate HIV vaccine in Africa, where the burden of the virus is still being keenly felt. One candidate – mRNA-1644 – has already shown its potential in an earlier phase 1 trial (IAVI G001) run in the US.
The Japanese Ministry of Health, Labour and Welfare (MHLW) has accepted GlaxoSmithKline’s (GSK) regulatory application for recombinant, adjuvanted Zoster vaccine, Shingrix, for preventing shingles (herpes zoster) in at-risk adults of the age 18 years and above.
Canadian clinical-stage biotech company Symvivo Corporation has developed an oral COVID-19 vaccine that entered clinicaltrials this week. The first healthy volunteer was dosed with the vaccine in Australia as part of the bacTRL-Spike COVID-19 Phase I clinicaltrial.
Sanofi and GSK announced a delay on Friday in their adjuvanted recombinant protein-based COVID-19 vaccine program to improve immuneresponse in the elderly, saying clinicaltrials showed an insufficient immuneresponse in older people.
Health Canada has granted expanded authorisation for Novavax ’s Covid-19 vaccine (Recombinant protein, Adjuvanted) [Nuvaxovid; NVX-CoV2373] as a homologous booster for usage in adults aged 18 and above. The vaccine is indicated for active immunisation to prevent the disease.
The Korean Ministry of Food and Drug Safety (KMFDS) has granted expanded approval to Novavax partner SK bioscience for the Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), for use as a booster dose in adults aged 18 and above. Nuvaxovid is a protein-based vaccine created from the genetic sequence of the initial SARS-CoV-2 virus strain.
Co-administration of Novavaxâs COVID-19 vaccine candidate and an approved influenza vaccine induced robust immuneresponses, according to data from a clinicaltrial. âThe findings suggest simultaneous vaccination may be a viable immunization strategy,â says the company.
The US Food and Drug Administration (FDA) released a statement this week about dosing schedules for COVID-19 vaccines, saying that any dose changes would be premature. The FDA therefore continues to recommend the two-dose regimens that both the BioNTech/Pfizer and Moderna vaccines require.
In this article, Ben Hargreaves looks into the promise of cancer vaccines and how this treatment modality may offer advantages over existing immunotherapies in the oncology sector. One area that is gathering increasing levels of interest is the development of cancer vaccines. A broad front.
A newly published paper in The Lancet shows that an experimental vaccine against Marburg virus (MARV) was safe and induced an immuneresponse in a small, first-in-human clinicaltrial.
Pfizer/BioNTech’s mRNA vaccine against COVID is a technical marvel – but the ultra-cool temperatures required for storage and stability has been tricky to handle. A nasal delivery method will also produce an immuneresponse at the point where the virus enters the body.
Scancell has reported preliminary immunogenicity data from its Phase 1 COVIDITY clinicaltrial: with the plasmid DNA based COVID-19 vaccine candidates inducing immuneresponses when delivered via needle-free tech.
A clinicaltrial testing a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults found that it was safe and stimulated both antibodies and responses from the cellular arm of the immune system. Results are published in Nature Communications.
MBA, managing director at CanSino Biologics Europe, tells us about Convidecia, a single dose SARS-CoV-2 vaccine offered as an injectable and inhalant that allows ease of storage, an alternative option for individuals with needle phobias, and robust elongated CD4 and CD8 cellular response. Morgon, PharmD, LL.M, How it works.
Just a few months after starting clinicaltrials of its nasal spray vaccine for COVID-19, US biotech Altimmune is abandoning the project, saying that it generated weaker than expected immuneresponses in a phase 1 trial. .
WHAT: In adults who had previously received a full regimen of any of three COVID-19 vaccines granted Emergency Use Authorization (EUA) or approved by the Food and Drug Administration (FDA), an additional booster dose of any of these vaccines was safe and prompted an immuneresponse, according to preliminary clinicaltrial results reported in The […]. (..)
Gritstone bio has reported interim results from an ongoing Phase 1 study evaluating the company’s self-amplifying mRNA (samRNA) vaccine as a boost against Covid-19 (CORAL-BOOST). The Phase I CORAL-BOOST dose-escalation trial (NCT05148962) evaluated Gritstone’s samRNA candidate (GRT-R910) in previously vaccinated healthy older adults.
The company said the vaccine produced a strong immuneresponse in children younger than 6, but proved only about 40 percent effective in preventing symptomatic Covid-19.
Sanofi and Translate Bio have started a first clinicaltrial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. The post Sanofi and Translate take first mRNA flu vaccine into clinic appeared first on.
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. The vaccine works by inducing the body's immuneresponse.
Influenza vaccine 2 is under clinical development by Shanghai Institute of Biological Products and currently in Phase I for Pandemic Influenza. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Influenza vaccine 2 LoA Report. The vaccine works by inducing the body's immuneresponse.
Adding to recent announcements from Pfizer and Moderna on the efficacy of their COVID-19 vaccine candidates, AstraZeneca and Oxford revealed today that their vaccine contender is 70 percent effective, and could be as high as 90 percent. Oxford-AstraZeneca COVID-19 Vaccine Induces ImmuneResponses in Early ClinicalTrials.
As the rush for a COVID-19 vaccine continues, healthcare services company Kaiser Permanente has joined in on the clinical testing of Pfizer Inc. and BioNTech’s lead vaccine candidate in a Phase III trial being conducted at sites in California and Oregon.
Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. Pfizer and BioNTech Advance COVID-19 Vaccine Strategy With Study Start of Next-Generation Vaccine Candidate Based on Enhanced Spike Protein Design. deliesschef.
Department of Defense When clinicaltrials were conducted to determine the immunogenicity — the ability to elicit an immuneresponse — for the first two vaccines marshaled against SARS-CoV-2the virus that causes COVID-19, one group was not among those included: people who have received solid organ […].
who had been enrolled in the Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524) Phase 3 clinical study. The study is investigating the efficacy, safety and immunogenicity of an investigational Lyme disease vaccine candidate, VLA15.
The European Commission has placed its first advance order for a coronavirus vaccine, snapping up 300 million doses of AstraZeneca’s ChAdOx1 candidate developed by the University of Oxford, with an option on another 100 million. The EU says its advance purchase order will finance part of the upfront costs of developing the vaccine.
China’s national regulator has approved Sinovac Biotech’s COVID-19 vaccine for use by the general public. This is the second vaccine approved by China’s National Medical Products Administration (NMPA). Both of the vaccines, along with another experimental vaccine from Sinopharm, have been used in China’s vaccination programme.
Moderna has announced that its coronavirus vaccine candidate has shown promise in generating an immuneresponse in elderly patients in an early-stage clinicaltrial. . Each patient was given two 100 microgram doses of the vaccine 28 days apart. Conor Kavanagh. Source link.
The developer of Russia’s COVID-19 vaccine Sputnik V has pledged to make it available for less than $10 per dose – or $20 per two-dose course – on the same day as revealing new clinical data with the shot. Pfizer and Moderna’s vaccines require much lower temperatures to prevent their active ingredients from breaking down.
Moderna revealed the first interim results from a small, Phase I study of its mRNA-based influenza vaccine, which showed that the vaccine had no significant safety concerns and elicited immuneresponses against four strains of the influenza virus. First Trial Results for First mRNA Influenza Vaccine.
The study assessed cynomolgus macaques vaccinated with 12µg of either the first or second-generation vaccine candidate. During challenge with the original SARS-CoV-2 virus, animals vaccinated with CV2CoV were found to be better protected based on highly effective clearance of the virus in the lungs and nasal passages.
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