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Ocugen Partner, Bharat Biotech, Announces Data From COVAXIN™ (BBV152), COVID-19 Candidate Vaccine, in Children 2 – 18 YEARS
On December 30, 2021, Ocugen, Inc. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of the candidate vaccine, COVAXIN™ (BBV152), in children, aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv. Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. Those results demonstrated a greater than 93% reduction in severe disease. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021.
“These data represent the first positive vaccine data in children as young as two years of age and come at an important time as COVID-19 infections are seeing a spike across the globe,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. “The results suggest that COVAXIN™, which is made on the same platform used in traditional polio pediatric vaccines for decades, when administered in a two-dose series to children between 2-18, may offer an option that is safe while delivering a robust immune response.”
In the study, immunogenicity against key COVID-19 proteins was measured using a geometric mean titer (GMT), a test that measures the number of antibodies in the blood in response to the presence of the virus. GMT was measured across three age groups and demonstrated strong immune response after the second dose. There were no serious adverse events such as myocarditis, pericarditis, or blood clots, reported in any of the three age groups.
This immunobridging trial was intended to determine if COVAXIN™ generates the same protective immunity in children as it does in adults. To be considered equivalent, pediatric participants needed to achieve comparable GMT’s to those generated by adults in a large phase 3 clinical trial. At Day 56, across all ages, the mean SARS-CoV-2 antibody GMT was more than 30% higher in children aged 2-18 than the mean GMT from Phase 3 clinical trial involving 25,800 adult subjects aged 18+. These data demonstrate children 2-18 generate antibody response comparable to adults fully vaccinated with COVAXIN™ (BBV152).
The study also showed increased antibody titers against 3 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 4-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.
Participants were not reported to have experienced any severe adverse events. The majority of adverse events noted (49%, n=374) were mild (e.g., injection site pain) and a small proportion (19%, n=6) were moderate (e.g., fever, headache). Mild to moderate adverse events resolved within 24 hours.
The data were also submitted to the Drugs Controller General of India (DCGI) to support a pediatric indication as recommended by an independent committee, known as the Subject Expert Committee (SEC), that advises the Indian regulatory agency. Bharat Biotech intends to submit data from the full Phase 3 trial to a peer-reviewed scientific publication soon.
The seven-month Phase 2/3 open label, multicenter, study enrolled 525 children ages 2 years to 18 from 6 clinical trial sites across India. Conducted between May and July 2021, it was designed to evaluate the safety, reactogenicity and immunogenicity of COVAXIN™ (BBV152) on a two-dose schedule (28 days apart) in three age groups: ages 12-18, ages 6-12, and ages 2-6. Children with prior infection of SARS-CoV-2 were not excluded from the trial.
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ (BBV152) is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.
With more than 125 million doses having been administered to adults outside the U.S., COVAXIN™ (BBV152) is currently authorized under emergency use in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The World Health Organization (WHO) recently added COVAXIN™ (BBV152) to its list of vaccines authorized for emergency use. And, as many as 110 countries have agreed to mutual recognition of Covid-19 vaccination certificates with India that includes vaccination using COVAXIN™ (BBV152). The trade name, COVAXIN™, has not been evaluated by the FDA.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets.
Dr. Malone Twitter Account Suspended After COVAXIN Tweet Like
Rumors are circulating that Dr. Malone’s Twitter account was suspended after liking this post on COVAXIN:
Why we are classifying this as a rumor: Because Dr. Malone was banned from Twitter, it is unclear if he liked the tweet about COVAXIN because of the drug itself, or instead liked the post because of the idea that people should have the option to choose what is right for them.
📽 Bharat Biotech’s US Partner For Covaxin, Ocugen, Faces Class Action Lawsuit| United States| Vaccine[embedyt] https://www.youtube.com/watch?v=lcmxuvdPsUw[/embedyt]
📈 Ocugen Stock Technical Analysis
Both the long and short-term trends are negative. It is better to avoid buying stocks with negative trends. OCGN is currently trading in the lower part of its 52-week range, which is not a good signal considering the S&P500 Index is trading near new highs. Prices have been falling strongly lately, it is better to avoid new long positions here.
There is resistance at 10.30 from a horizontal line in the daily time frame.
OCGN has a bad technical rating, but it does show a decent setup pattern. Prices have been consolidating lately. There is very little resistance above the current price. Click here to sign up for email alerts on technical changes in OCGN stock.