The US refused emergency use permission (EUA) to Covaxin. In many countries, those who get the vaccine are not counted among the vaccinated people. After these reports, questions are being raised whether the indigenous vaccine Covaxin is bad? Is it weak in keeping us safe from coronavirus? These are questions and answers can influence decisions about getting a vaccine. Let us understand what is the decision of the US regulator? What did he say about Covaxin?
America says that it has had enough doses. Herd immunity has also been achieved to some extent. Because of this country has changed its policy. The rules have been tightened to give emergency approval to the vaccine. It is important to know that the US spent $ 18 billion (Rs 1.30 lakh crore) last year under the Operation Warp Speed Initiative for the development of the vaccine.
Pfizer and Moderna's mRNA vaccine has been given emergency use approval. Johnson & Johnson's viral vector vaccine is also being found there. The US FDA has also been involved in the process of making these vaccines, such as the Indian Council of Medical Research (ICMR), an organization of the Government of India, which has played an active role in the development of the vaccine.
The US FDA has asked the US partner of Bharat Biotech, Ocugen, to apply for full approval. For this, it will need additional information and data. Clinical trials may also have to be done to verify the safety, immune response and acceptable effectiveness of the vaccine.
It only means that it will take time for Covaxin to enter the US vaccine market. Emergency approval is available on a few months of data. But full approval may take a few months or even years as it is not considered urgent. That is, it may take time for Bharat Biotech and Ocugen to make Covaxin available in the US market.
There is no scientific basis to believe so. Both have given good results. If it is about America, then Covishield (the vaccine developed by AstraZeneca) has also not got approval there. Efforts are underway for full approval in the US for Covishield as well. That is, except for the approval of WHO, Covishield and Covaxin are the same for America.
As far as going abroad is concerned, the Indian government is in talks with other countries. Foreign Ministry spokesperson Arindam Bagchi said, 'Bharat Biotech has requested WHO to put Covaxin in the list of emergency use. If there is any problem in any country, then the Ministry of External Affairs is talking to the governments of those countries.
Joint Secretary in the Union Health Ministry, Lav Agarwal, says that talks are going on with the countries which are denying visas to those who got the vaccine. If the WHO puts Covaxin on the list of emergency use, then it can be valid for every country. The government is in talks with the WHO.
Dr Paul says that all the regulators have a decision-making process. We respect the decision of the US regulator. But its decision will have no bearing on our vaccination campaign. Our regulator has enough data regarding its safety.
Difficult, but not impossible. So far, no Indian vaccine manufacturer has received full approval in the US. For this reason, Bharat Biotech has entered into a deal with American company Ocugen. In the US as well as Canada, 45% of the profit on Covaxin will be from Ocugen.
Ocugen says it will no longer seek emergency approval for Covaxin in the US. Rather, it will obtain a Biologics License Application (BLA). If needed, we will also do trials in America. But whether it will be bridging trials on small groups or studies on large groups, it is not clear.
Shankar Musunuri, chairman and CEO of Ocugen, said Covaxin is effective on other strains, including the delta variant. In such a situation, going forward, America is going to need a strong vaccine-like Covaxin.
If you are going to America or anywhere, you have to read the rules there. American policy says that if your RT-PCR report is negative then you can catch the flight. You will not be considered vaccinated even if you have had Covaxin. You will also have to get the vaccine available there. It has no harm.
The road to full approval of Covaxin in the US is not yet closed. At the same time, WHO can issue emergency use approval between July and September on the application of Bharat Biotech. It can be expected that after the approval of WHO, those who have got Covaxin in other countries including America will also be counted among the vaccinated people.
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