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Source: Yahoo Finance
OpenOrphan (ORPH.L), parent company of clinical trial platform hVIVO, announced Monday the U.K.’s Medicine and Healthcare Products Regulatory Agency (MHRA) approved the Phase 1 study of the vaccine by U.S. biotech Codagenix, which is also collaborating with the Serum Institute of India — the world’s largest vaccine manufacturer.
The vaccine uses a weakened form of the coronavirus and will be tested on 48 healthy young adults, who will then be intentionally infected with the virus in order to test the vaccine’s efficacy.
The controversial trial method is said, by advocates, to be a quicker and safe method of testing a vaccine.
Codagenix chief medical officer Sybil Tasker said in a statement, “We believe COVI-VAC, a needle-free, single dose vaccine is well-suited to address potential gaps in supplying the global community, as there is likely to be significant unmet need even after the initial roll-out of first-generation COVID-19 vaccines.”
Categories: Vaccine
NEW YORK and PUNE, India, Dec. 14, 2020 /PRNewswire/ — Codagenix, Inc., and the Serum Institute of India Pvt. Ltd. (SIIPL) today announced that a Phase 1 clinical trial of COVI-VAC received regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) and has commenced in London, UK. COVI-VAC is a single-dose intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19, that was shown to be safe and efficacious in preclinical animal studies. COVI-VAC was developed with Codagenix’s Synthetic Attenuated Virus Engineering (SAVE) platform that uses synthetic biology to re-code the genes of viruses into safe and stable vaccines. COVI-VAC is designed to deliver a safe, live attenuated version of SARS-CoV-2 that may induce a more robust immune response and long-lasting cellular immunity against SARS-CoV-2 compared to other vaccines against the virus.
COVI-VAC has the potential to address several key logistical challenges to immunization against SARS-CoV-2 at a global scale. As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe, nor ultra-low temperature freezers. COVI-VAC can be manufactured at large scale and supports ease of administration in a mass vaccination campaign.
https://www.prnewswire.com/news-releases/codagenix-and-serum-institute-of-india-announce-commencement-of-first-in-human-trial-of-covi-vac-a-single-dose-intranasal-live-attenuated-vaccine-for-covid-19-301191756.html
Dec 14 (Reuters) – Codagenix Inc and India’s Serum Institute said on Monday they have received regulatory approval in the United Kingdom to begin an early-stage trial of their single-dose, intranasal COVID-19 vaccine.
The companies said 48 volunteers will be enrolled at three dose levels and expect to begin dosing the trial participants in the first week of January.
UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved the trial for the vaccine, COVI-VAC, after positive safety data in animal studies.
The vaccine candidate uses Codagenix’s Synthetic Attenuated Virus Engineering (SAVE) platform, which works by re-coding genes of viruses into safe and stable vaccines.
COVI-VAC will not need a needle and syringe or ultra-cold storage, the companies said, potentially addressing logistical issues likely faced by other vaccine-makers.
Serum Institute of India, the world’s largest vaccine producer by volume, has also partnered with British drugmaker AstraZeneca to conduct trials of its vaccine in India and produce the vaccine candidate if it secures approval.
https://finance.yahoo.com/news/codagenix-serum-institute-begin-uk-142030444.html?.tsrc=fin-srch