While, Bharat Biotech’s US partner for ‘COVAXIN’, Ocugen is looking forward to seek the Emergency Use Authorisation (EUA) approval of United States’ Food and Drug Administration, the Philippines FDA has already granted EUA for the usage of Indian COVAXIN in the country last month.
Ocugen’s wait to seek FDA approval
Ocugen is all set to seek FDA’s Emergency-Use Authorisation for the usage of COVAXIN in the US market.
Chairman of the Board, CEO and and co-founder of Ocugen, Shankar Musunuri said that the Ocugen team is actively preparing the Emergency-Use Authorization application and has submitted a thorough drug master file with the FDA.
Earlier, the White House chief medical adviser Anthony Fauci said that the Covaxin is capable enough to neutralise the B1617 variant of COVID-19. Following his statement, many health experts gave their positive feedback over this Indian vaccine.
On Monday, a study by ICMR-National Institute of Virology, Ocugen, outlined the fact that Covaxin “demonstrated potential effectiveness against the Brazil variant of SARS-CoV-2”.
It further added, “As previously disclosed, a study conducted by ICMR also suggested that Covaxin was effective against the UK variant, as well as the Indian double-mutant variant.”
Earlier in February 2021, the US-based Ocugen and India’s Bharat Biotech had signed an agreement which said that the former together with the latter would develop, supply and commercialise Covaxin in the US market.
Under this pact, the Bharat Biotech would initially provide the vaccine shots for usage in the United States as per Ocugen’s receipt of EUA. Not only will the Ocugen have US rights to vaccine but will also be accountable for medical development, administrative approval which includes EUA and commercialisation of this vaccine in the US market.
Philippines granted EUA approval to India’s Covaxin
On 19th April, India’s Bharat Biotech was given Emergency Use Authorisation (EUA) approval for its highly efficacious ‘COVAXIN’ by the Food and Drug Administration (FDA) of Philippines. Also, it gave EUA approval to Janssen vaccines of Johnson and Johnson company.
Country’s vaccine czar Secretary Carlito Galvez in the presence of President Rodrigo Duterte, declared in a briefing that the FDA had granted EUA for the usage of Janssen shots and thanked the FDA for its approval.
Indian Ambassador to Philippines, Shambu Kumaran tweeted:
In a response to the Indian envoy, the Foreign Affairs Secretary Teodoro Locsin Jr., said in a tweet, “Thank you, Philippines? You have nothing to thank us for. We thank you, we owe you the lives of our loved ones who would otherwise die because of pure idiots,” further adding, “Thank you, India”.
In its research and study, the FDA has reportedly found Covaxin to be around 92% and 95% efficacious over its different races and survey population, respectively.
Also, the Sinovac and AstraZeneca COVID-19 vaccine shots were made available in the market by the Philippines Govt after it undertook the mass vaccination drive in March 2021.
As far as the Indian market is concerned, the demand for Covaxin jabs is escalating. Bharat Biotech in collaboration with Global healthcare provider IHH Healthcare, will supply Covaxin to the three locations of Gleneagles Global Hospitals in India.
On Tuesday, IHH declared, “Three of the IHH Healthcare institutions in India – BGS Gleneagles Global Hospitals, Kengeri, Bengaluru; Gleneagles Global Health City, Chennai; and Gleneagles Global Hospitals, Hyderabad, will foray into this initiative and also widen the vaccination drive for the younger population.”
This partnership between them is aimed at widening the immunisation program across several communities in Hyderabad, Chennai and Bengaluru and other cities which fall under this network.
The Third-Phase of inoculation drive which began on 1st May, aims at vaccinating the Indians between the age of 18-44 years. The Indian Govt outlined that it is going to accelerate and liberalise the 3rd Phase of inoculation drive in all the parts of the country.
As far as Covaxin is concerned, it was developed and rolled out by Bharat Biotech in India on 16th January 2021. The vaccine has shown 78% efficacy against most of the COVID-19 variants in India. Here, 78% efficacy doesn’t mean that 78 out of 100 people will not contract COVID-19, instead it means that each immunised person will have 78% chance of not getting infected by the virus.