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Glaxo (GSK), Medicago COVID-19 Jab Effective Against Variants
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GlaxoSmithKline plc (GSK - Free Report) and privately-held Medicago announced promising top-line data from a global phase III study evaluating their plant-based COVID-19 vaccine candidate.
In the study, vaccine efficacy was demisntrated against all variants seen in the study. Data from the late-stage study demonstrated that vaccination with the candidate achieved an efficacy rate of 71% for against all variants of.
The efficacy rate was 75.3% when the candidate was evaluated in a subset of study participants who had no previous exposure to COVID-19. The vaccine candidate yielded an effectiveness of 75.3% for any severity caused by the Delta variant and the figure was 88.6% against the Gamma variant.
Glaxo and Medicago also stated that there were no cases of severe COVID-19 infection observed in the vaccine arm of the study.
However, the Omicron variant was not circulating during the study duration.
We note that the late-stage study evaluated Medicago’s plant-based, recombinant Coronavirus Virus-Like Particles (CoVLP) in combination with Glaxo’s pandemic adjuvant system across six countries. Two doses of the adjuvanted vaccine or a placebo were administered intramuscularly in more than 24,000 participants 21 days apart.
Glaxo and Medicago stated that a direct comparison with the currently authorized COVID-19 vaccine was not possible as these vaccines were primarily evaluated against the ancestral coronavirus, SARS-CoV-2.
Based on the encouraging late-stage study data, Glaxo and Medicago are planning to seek regulatory approval for their vaccine candidate in Canada soon on a rolling basis. The company has already initiated regulatory procedures to gain authorization/approval for their vaccine candidate in the United States and the United Kingdom. The companies are also in discussion with the World Health Organization for the preparation of a regulatory submission with the global entity.
So far this year, Glaxo’s shares have gained 15.1% compared with the industry’s 12.8% increase.
Image Source: Zacks Investment Research
Glaxo has formed several collaborations to make its pandemic adjuvant technology available to partners, including with Sanofi (SNY - Free Report) and CureVac (CVAC - Free Report) who are making adjuvanted COVID-19 vaccine candidates.
Glaxo entered into a collaboration with CureVac last year to jointly develop multi-valent mRNA vaccines for COVID-19. Glaxo and CureVac are currently developing an mRNA-based COVID-19 vaccine in pre-clinical studies.
In May, Glaxo and Sanofi began a phase III study to evaluate their adjuvanted recombinant-protein COVID-19 vaccine candidate. A booster dose of the vaccine is also being evaluated in a phase II study by Glaxo and Sanofi.
Apart from COVID-19 vaccines, Glaxo is also engaged in developing antibody therapeutics for COVID-19 infection in collaboration with Vir Biotechnology (VIR - Free Report) .
In a separate press release, Glaxo and Vir Biotechnology announced pre-clinical data from pseudo-virus testing, which demonstrated that their COVID-19 therapy, sotrovimab, maintains activity against the full combination of mutations of the spike protein in the Omicron variant. These findings build on the initial preclinical data generated through pseudo-virus testing, provided last week, showing sotrovimab retained in vitro activity against key individual mutations of the Omicron variant, including those found in the binding site of sotrovimab
We note that Glaxo and Vir Biotechnology’s sotrovimab, as an intravenous administration, was granted emergency use authorization for treating mild-to-moderate COVID-19 in adult and pediatric patients in May.
Image: Bigstock
Glaxo (GSK), Medicago COVID-19 Jab Effective Against Variants
GlaxoSmithKline plc (GSK - Free Report) and privately-held Medicago announced promising top-line data from a global phase III study evaluating their plant-based COVID-19 vaccine candidate.
In the study, vaccine efficacy was demisntrated against all variants seen in the study. Data from the late-stage study demonstrated that vaccination with the candidate achieved an efficacy rate of 71% for against all variants of.
The efficacy rate was 75.3% when the candidate was evaluated in a subset of study participants who had no previous exposure to COVID-19. The vaccine candidate yielded an effectiveness of 75.3% for any severity caused by the Delta variant and the figure was 88.6% against the Gamma variant.
Glaxo and Medicago also stated that there were no cases of severe COVID-19 infection observed in the vaccine arm of the study.
However, the Omicron variant was not circulating during the study duration.
We note that the late-stage study evaluated Medicago’s plant-based, recombinant Coronavirus Virus-Like Particles (CoVLP) in combination with Glaxo’s pandemic adjuvant system across six countries. Two doses of the adjuvanted vaccine or a placebo were administered intramuscularly in more than 24,000 participants 21 days apart.
Glaxo and Medicago stated that a direct comparison with the currently authorized COVID-19 vaccine was not possible as these vaccines were primarily evaluated against the ancestral coronavirus, SARS-CoV-2.
Based on the encouraging late-stage study data, Glaxo and Medicago are planning to seek regulatory approval for their vaccine candidate in Canada soon on a rolling basis. The company has already initiated regulatory procedures to gain authorization/approval for their vaccine candidate in the United States and the United Kingdom. The companies are also in discussion with the World Health Organization for the preparation of a regulatory submission with the global entity.
So far this year, Glaxo’s shares have gained 15.1% compared with the industry’s 12.8% increase.
Glaxo has formed several collaborations to make its pandemic adjuvant technology available to partners, including with Sanofi (SNY - Free Report) and CureVac (CVAC - Free Report) who are making adjuvanted COVID-19 vaccine candidates.
Glaxo entered into a collaboration with CureVac last year to jointly develop multi-valent mRNA vaccines for COVID-19. Glaxo and CureVac are currently developing an mRNA-based COVID-19 vaccine in pre-clinical studies.
In May, Glaxo and Sanofi began a phase III study to evaluate their adjuvanted recombinant-protein COVID-19 vaccine candidate. A booster dose of the vaccine is also being evaluated in a phase II study by Glaxo and Sanofi.
Apart from COVID-19 vaccines, Glaxo is also engaged in developing antibody therapeutics for COVID-19 infection in collaboration with Vir Biotechnology (VIR - Free Report) .
In a separate press release, Glaxo and Vir Biotechnology announced pre-clinical data from pseudo-virus testing, which demonstrated that their COVID-19 therapy, sotrovimab, maintains activity against the full combination of mutations of the spike protein in the Omicron variant. These findings build on the initial preclinical data generated through pseudo-virus testing, provided last week, showing sotrovimab retained in vitro activity against key individual mutations of the Omicron variant, including those found in the binding site of sotrovimab
We note that Glaxo and Vir Biotechnology’s sotrovimab, as an intravenous administration, was granted emergency use authorization for treating mild-to-moderate COVID-19 in adult and pediatric patients in May.
GlaxoSmithKline plc Price
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Glaxo currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.