Bharat Biotech’s Covaxin is the COVID-19 CLOVID-19 vaccine in India. While the delay in the publication of Phase 3 test data invites criticism, the Government said it is satisfied with the data published so far.
Bharat Bharat Biotech, based in Hyderabad, will publish its phase clinical trial data Soon, the company has recently said in the midst of delay criticism in the publication of the findings that were supposed to be outside in June. The Food and Drug Administration of the United States has also refused to grant the authorization of emergency use to Indian vaccine, which has also invited a recoil of several quarters. However, the company has said that it is completely committed to maintaining transparency. And the denial of the FDA is not considered a setback, since the US UU is not giving the approval of emergency use to any vaccine now, since the COVID-19 situation in the US. UU is relatively under control . In addition, the company will continue its full license, which does not occur any vaccine produced in India in the US. UU
Clinical trials in the United States.
Bharat Biotech will carry out clinical trials of Covaxin, the COVID-19 vaccine developed by the company in association with the Indian Council of Medical Research, in the United States, since its US partner UU. Acugen has said that he will now apply for a Full license in the us. To obtain this, Bharat Biotech, through its US partner. UU will have to follow the process of requesting a biological license for which the clinical trial will be required. Therefore, vaccines will now be tested in the participants of the United States. It is not yet known if it will be a large-scale study or a small bridge studio. The company will not lower the authorization route for emergency use again after being denied by the Food and Drug Administration.
Research papers in Covaxin
The company said there are enough data on the effectiveness of the vaccine. There are nine research studies on the safety and effectiveness of covaxin in five magazines reviewed equally worldwide, he said. It is the first and only product that will publish the data of human clinical trials in India. It is the only product to have data on emerging variants.
USA in Canada.
The US partner of Bharat Biotech has said that it will seek an application for emergency use approval in Canada. The company has already ensured the exclusive right to market Covaxin in Canada
How many countries are Covaxin administering?
Covaxin is being administered in six countries currently, while the US has been obtained in 13 countries.
If Covaxin gets a full license in the United States, it will be a great leap, the company said that no vaccine was made from India, has received the US license or USFDA’s full license.
Covaxin in India
The Government has said that it is satisfied with the data provided by India’s general drug controller and the FDA decision will not have an impact on India’s continuous vaccination unit. While the company is increasing its production, its judgment to children aged 12 to 18 is happening.
