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Ocugen (OCGN) Down 23% With FDA Denial of COVID Vaccine EUA
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Ocugen (OCGN - Free Report) announced that the FDA has declined to issue an emergency use authorization (EUA) to its COVID-19 vaccine Covaxin. OCGN had previously submitted a request seeking an EUA for using Covaxin in pediatric population aged from two to 18 years for active immunization to prevent COVID-19 caused by SARS-CoV-2.
Ocugen does not mention the reason for the FDA’s denial. OCGN stated that it will continue to work with the FDA to deduce the regulatory pathway forward for vaccination of pediatric individuals with Covaxin.
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).
Shares of Ocugen declined 23.1% on Mar 4 following the regulatory update on Covaxin EUA. The stock has declined 70.7% in the past year compared with the industry’s decrease of 34.2%.
Image Source: Zacks Investment Research
In December, Ocugen’s partner Bharat Biotech posted positive results from a phase II/III study, evaluating Covaxin in the pediatric age group across India.
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. The Bharat Biotech’s Covaxin is already approved in India. It demonstrated 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization) and 70% efficacy against asymptomatic COVID-19 infection in clinical study when evaluated in adults.
Ocugen is planning to initiate a phase II/III immuno-bridging and broadening clinical study, shortly, to support its biologics license application for the approval of Covaxin to immunize adults. The company is seeking full approval for use of Covaxin in adults following discussion with the FDA.
Bharat Biotech reported positive data from the live virus neutralization assay evaluating a booster dose of Covaxin in January. Data showed that administration of the booster dose following six months of the initial two-dose regimen of the vaccine led to robust neutralizing antibody responses against the two popular COVID-19 variants of concern, namely Omicron and Delta.
The neutralizing activity of sera from individuals who received the booster dose of Covaxin was comparable to the neutralizing activity of sera from individuals who received a booster of the FDA-approved mRNA-based COVID-19 vaccines, namely Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) Comirnaty, and Moderna’s (MRNA - Free Report) mRNA-1273.
Pfizer and BioNTech lead the race for successful developing a COVID-19 vaccine, which is approved as a two-dose series to prevent COVID-19 in individuals aged 16 years and older in the United States. The booster dose of Pfizer and BioNTech’s COVID-19 vaccine is also authorized for use in adults in the United States.
Moderna comes second with its mRNA-1273, which is authorized for use in adults and adolescents. Moderna’s COVID-19 booster is also authorized for use in adults.
The combined sales of Pfizer, BioNTech and Moderna’s COVID-19 vaccines constituted a major chunk of the total COVID-19 vaccine sales in 2021 and these vaccines are likely to maintain their lead in 2022 as well.
Image: Bigstock
Ocugen (OCGN) Down 23% With FDA Denial of COVID Vaccine EUA
Ocugen (OCGN - Free Report) announced that the FDA has declined to issue an emergency use authorization (EUA) to its COVID-19 vaccine Covaxin. OCGN had previously submitted a request seeking an EUA for using Covaxin in pediatric population aged from two to 18 years for active immunization to prevent COVID-19 caused by SARS-CoV-2.
Ocugen does not mention the reason for the FDA’s denial. OCGN stated that it will continue to work with the FDA to deduce the regulatory pathway forward for vaccination of pediatric individuals with Covaxin.
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).
Shares of Ocugen declined 23.1% on Mar 4 following the regulatory update on Covaxin EUA. The stock has declined 70.7% in the past year compared with the industry’s decrease of 34.2%.
Image Source: Zacks Investment Research
In December, Ocugen’s partner Bharat Biotech posted positive results from a phase II/III study, evaluating Covaxin in the pediatric age group across India.
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. The Bharat Biotech’s Covaxin is already approved in India. It demonstrated 78% overall efficacy against COVID-19 disease, 100% efficacy against severe COVID-19 disease (including hospitalization) and 70% efficacy against asymptomatic COVID-19 infection in clinical study when evaluated in adults.
Ocugen is planning to initiate a phase II/III immuno-bridging and broadening clinical study, shortly, to support its biologics license application for the approval of Covaxin to immunize adults. The company is seeking full approval for use of Covaxin in adults following discussion with the FDA.
Bharat Biotech reported positive data from the live virus neutralization assay evaluating a booster dose of Covaxin in January. Data showed that administration of the booster dose following six months of the initial two-dose regimen of the vaccine led to robust neutralizing antibody responses against the two popular COVID-19 variants of concern, namely Omicron and Delta.
The neutralizing activity of sera from individuals who received the booster dose of Covaxin was comparable to the neutralizing activity of sera from individuals who received a booster of the FDA-approved mRNA-based COVID-19 vaccines, namely Pfizer (PFE - Free Report) and BioNTech’s (BNTX - Free Report) Comirnaty, and Moderna’s (MRNA - Free Report) mRNA-1273.
Pfizer and BioNTech lead the race for successful developing a COVID-19 vaccine, which is approved as a two-dose series to prevent COVID-19 in individuals aged 16 years and older in the United States. The booster dose of Pfizer and BioNTech’s COVID-19 vaccine is also authorized for use in adults in the United States.
Moderna comes second with its mRNA-1273, which is authorized for use in adults and adolescents. Moderna’s COVID-19 booster is also authorized for use in adults.
The combined sales of Pfizer, BioNTech and Moderna’s COVID-19 vaccines constituted a major chunk of the total COVID-19 vaccine sales in 2021 and these vaccines are likely to maintain their lead in 2022 as well.
Ocugen, Inc. Price
Ocugen, Inc. price | Ocugen, Inc. Quote
Zacks Rank
Ocugen currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.