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Ocugen (OCGN) Up on Bharat Biotech's Data in Pediatric Group
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Shares of Ocugen, Inc. (OCGN - Free Report) gained 10.2% after the company announced that partner Bharat Biotech posted positive results from a study of vaccine Covaxin in the age group (two to 18 years) for COVID-19.
Covaxin (BBV152) is an investigational vaccine candidate product in the United States. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (“ICMR”) - National Institute of Virology (“NIV”).
The seven-month phase II/III open label multicenter study enrolled 525 children aged two to 18 from six clinical trial sites across India.
The participants demonstrated a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv, when given a two-dose regimen administered 28-days apart. The children in this age group showed antibody responses comparable to adult data from a previous phase III study wherein greater than 93% reduction in severe disease was observed.
This immunobridging study was intended to determine if Covaxin generates the same protective immunity in children as it does in adults.
The data from this age group was also the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children two to 18 in November 2021. Ocugen is co-developing Bharat Biotech’s Covaxin for COVID-19 in the United States and Canadian markets.
At day 56, across all ages, the mean SARS-CoV-2 antibody geometric mean titer (GMT) was more than 30% higher in children aged two to 18 than the mean GMT from the phase III study involving 25,800 adult subjects aged 18 and above.
The study also showed increased antibody titers against three viral antigens (Spike – S1, Receptor Binding Domain - RBD and Nucleocapsid - NP), providing a broad immune response to COVID-19. In each case, a more than four-fold increase in neutralizing antibody titers versus baseline (titers measured in the same participants before being vaccinated) was seen in all age groups after the second dose.
The data was also submitted to the regulatory body in India to support a pediatric indication as recommended by an independent committee known as the Subject Expert Committee.
Covaxin is currently authorized for emergency use in 17 countries.
Ocugen also focuses on discovering, developing and commercializing gene therapies to cure blindness.
Shares of Ocugen have surged 163.9% this year against the industry‘s 20.8% decline.
Image Source: Zacks Investment Research
The companies developing vaccines and other antibody treatments have had a spectacular run in the year. Biotech companies are running a race against time and currently evaluating every possible weapon in their arsenal to combat yet another surge in cases owing to the rapidly spreading Omicron variant. Any positive update in this regard has led to a massive surge in the share price of the respective companies and fueled the overall sector. The same trend is expected to continue, with booster doses of the vaccines becoming the need of the hour.
BioNTech SE (BNTX - Free Report) is another company that has scaled the skies on the success of its COVID-19 vaccine, Comirnaty, which it has developed with pharma giant Pfizer (PFE - Free Report) and is based on its proprietary mRNA technology.
Pfizer and BioNTech have led the race in record time for the successful development of this COVID-19 vaccine approved as a two-dose series to prevent COVID-19 in individuals 16 years of age and older in the United States.
Earlier in the week, Novavax (NVAX - Free Report) and its India-based partner Serum Institute of India Pvt. Ltd. announced that the regulatory body in India granted an EUA to the recombinant nanoparticle protein-based COVID-19 vaccine.
Novavax had previously announced initial data from the evaluation of its COVID-19 vaccine NVX-CoV2373 against the Omicron variant
Image: Bigstock
Ocugen (OCGN) Up on Bharat Biotech's Data in Pediatric Group
Shares of Ocugen, Inc. (OCGN - Free Report) gained 10.2% after the company announced that partner Bharat Biotech posted positive results from a study of vaccine Covaxin in the age group (two to 18 years) for COVID-19.
Covaxin (BBV152) is an investigational vaccine candidate product in the United States. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (“ICMR”) - National Institute of Virology (“NIV”).
The seven-month phase II/III open label multicenter study enrolled 525 children aged two to 18 from six clinical trial sites across India.
The participants demonstrated a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv, when given a two-dose regimen administered 28-days apart. The children in this age group showed antibody responses comparable to adult data from a previous phase III study wherein greater than 93% reduction in severe disease was observed.
This immunobridging study was intended to determine if Covaxin generates the same protective immunity in children as it does in adults.
The data from this age group was also the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children two to 18 in November 2021. Ocugen is co-developing Bharat Biotech’s Covaxin for COVID-19 in the United States and Canadian markets.
At day 56, across all ages, the mean SARS-CoV-2 antibody geometric mean titer (GMT) was more than 30% higher in children aged two to 18 than the mean GMT from the phase III study involving 25,800 adult subjects aged 18 and above.
The study also showed increased antibody titers against three viral antigens (Spike – S1, Receptor Binding Domain - RBD and Nucleocapsid - NP), providing a broad immune response to COVID-19. In each case, a more than four-fold increase in neutralizing antibody titers versus baseline (titers measured in the same participants before being vaccinated) was seen in all age groups after the second dose.
The data was also submitted to the regulatory body in India to support a pediatric indication as recommended by an independent committee known as the Subject Expert Committee.
Covaxin is currently authorized for emergency use in 17 countries.
Ocugen also focuses on discovering, developing and commercializing gene therapies to cure blindness.
Shares of Ocugen have surged 163.9% this year against the industry‘s 20.8% decline.
The companies developing vaccines and other antibody treatments have had a spectacular run in the year. Biotech companies are running a race against time and currently evaluating every possible weapon in their arsenal to combat yet another surge in cases owing to the rapidly spreading Omicron variant. Any positive update in this regard has led to a massive surge in the share price of the respective companies and fueled the overall sector. The same trend is expected to continue, with booster doses of the vaccines becoming the need of the hour.
BioNTech SE (BNTX - Free Report) is another company that has scaled the skies on the success of its COVID-19 vaccine, Comirnaty, which it has developed with pharma giant Pfizer (PFE - Free Report) and is based on its proprietary mRNA technology.
Pfizer and BioNTech have led the race in record time for the successful development of this COVID-19 vaccine approved as a two-dose series to prevent COVID-19 in individuals 16 years of age and older in the United States.
Earlier in the week, Novavax (NVAX - Free Report) and its India-based partner Serum Institute of India Pvt. Ltd. announced that the regulatory body in India granted an EUA to the recombinant nanoparticle protein-based COVID-19 vaccine.
Novavax had previously announced initial data from the evaluation of its COVID-19 vaccine NVX-CoV2373 against the Omicron variant
Ocugen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.