Covaxin: Political pressure to expedite the regulatory clearance of Covaxin is denied by Bharat Biotech and MoHFW
According to the sources Bharat Biotech, a vaccine maker has refuted the news floating in media accusations that because of political pressure caused covaxin’s regulatory approval has been hurried. The Government of India also refused all these false news and misguiding.
On Thursday the company stated the allegations were made are all rumors spread by some people and other companies that have no knowledge of vaccines or any vaccinology. The Bharat Biotech also stated there was only internal pressure to generate a safe vaccine for COVID-19, In order to produce the safest vaccine for people in India and around the world.
Bharat Biotech stated that we reject all false news spread by some people or any organizations are only rumors, they don’t have any medical or scientific background in vaccination. We are very clear that they all pitched into the spread of stories during the pandemic. They don’t have any knowledge or the ability to understand the process of international processes of developing the product and licensing.
According to some media sources, the corporation bypassed some steps in order to develop a regional vaccine under any “Political Pressure”, the regulator “vetted” its changes to the trial method, and the speed of the clinical trials for the vaccine was a factor.
The Vaccination company claimed that covaxin is one of the most widely investigated vaccines nowadays. We are sure that there is no covid-19 vaccine in India, examined in 20 pre-clinical studies, spanning 3 challenge trails and 9 human medical trials. we hope these investigations have proved that covaxin is completely safe and really very effective. We are really very happy that we have delivered almost a hundred million doses worldwide. Its proven Covaxin is found to be completely safe, with few recognized adverse events and no occurrences of myocarditis or thrombocytopenia related to the vaccine being identified.
One of the biggest examinations for Covaxin is a phase I entirely globally. The investigations to go forward to the phase III examination will be based on data on the outcomes of successful animal challenge trials. The main aim of the phase II examination was to discover whether the 3 MCG dose would be more practical than the 6 MCG dose, which has increased our production capabilities. It was clear to go ahead with 6 MCG doses during phase III clinical examinations in the Public Health Interest.
Ebola and Monkeypox vaccines got approval from the Stringent Regulatory Agencies in all advanced countries based on phase I, and Phase II clinical data only and without phase III data. If we get approval from regulators in India, There would be a commotion, but some people and companies went into silence, showing their dishonesty, the company stated in a statement.
Nearly 1,000 officials in the whole of India were busy developing, testing, manufacturing, and distributing Covaxin in Bharat Biotech. Our officials engaged works showed results in a universal Covid-19 vaccine for elders and kids alike, which will be supervised thoroughly as booster doses. We the Bharat Biotech are really very happy and proud of its work to create a novel Covid -19 vaccine globally.
The Ministry of Health and Family Welfare claims that both the Indian government and the national regulator are clear on this. When licensing Covid-19 vaccines for emergency use authorization, CDSCO used a scientific approach and established standards. The CDSCO’s Subject Expert Committee (SEC) met on January 1 and 2, 2021, and after careful consideration, provided recommendations regarding the request for restricted emergency approval of Bharat Biotech’s Covid -19 virus vaccine.