India has already gone through a rather dangerous wave of disinfodemia concerning the country’s vaccines. Now, after a lot of time and conviction, people are gaining confidence and getting vaccinated, but the news from the United States may change the situation a bit, causing a negative impact on Indians. The news in question is the fact that the United States recently decided not to grant an Emergency Use Authorization (EUA) for Bharat biotech’s COVID-19 vaccine, Covaxin.

Does this news mean that Covaxin is not safe? Or is there something wrong with the vaccine? Well, before we jump to any hasty conclusions, let’s read it in detail to find out what’s really going on behind the scenes.

Why did the US not grant EUA to India Covaxine?

The United States has decided not to give EUA to the vaccine developed by Bharat Biotech, Covaxin. The decision was made even before the EUA’s application was filed and was communicated to the company’s US partner, Ocugen. But why did the US decide not to give EUA approval to Covaxin? The reason being the country’s success against the COVID-19 virus in terms of the vaccination campaign. In addition, the United States is in a considerably stable position, which means that it no longer needs to engage in emergency approvals and therefore may take time to do due diligence before giving the seal of approval every time.

The country invested $ 18 billion in developing various vaccines for its people last year, as part of the Operation Warp Speed ​​initiative. He has already given EUA to the Pfizer-BioNtech and Moderna-NIAID vaccines as well as to the jabs against the Johnson & Johnson viral vectors. According to Bharat Biotech, the country has vaccinated a significant part of the population and, if it continued at this rate, it would ensure economic efficiency.

Therefore, now that the country is not suffering from a shortage of vaccine supply, the United States Food and Drugs Administration (FDA) has proposed the strategy to give sufficient priority to reviewing applications. USA. The FDA regulator said in May that it would refuse to review and process EUA’s application for various vaccines in situations where the FDA cannot verify any of the following: conduct of clinical trials, integrity trial data, and whether the standards of vaccine production facilities meet established manufacturing standards.

The FDA further said it should further prioritize EUA requests for various vaccines, out of concern for the health and well-being of the population. This means that the FDA can deny the request to review and process the request of vaccine manufacturers who did not regularly collaborate with the FDA during the manufacture and clinical trials of their vaccines.

Does this rejection mean that there is something wrong with Bharat Biotech’s Covaxin?

Well, a sigh of relief, because that’s absolutely wrong. Indeed, the FDA, in a recent recommendation, asked Ocugen to seek full authorization for the vaccine, as opposed to the current request for emergency approval. However, for full clearance to supply Covaxin to the United States, the FDA will now need more information and data, likely from more human critical trials, to know that the vaccine is completely safe, triggers an immune response to its population and is of acceptable efficacy. . It further suggests that we do not have to worry and that the rejection was not due to the failure of Covaxin.

But at the same time, there is bad news for Bharat Biotech and Ocugen. This is because full authorization, if requested by Covaxin, would take longer to gain approval due to the listless process, which means there is still a long time to go before Covaxin is used in hospitals. United States, if so. Typically, after all, tests and exams, EUA applications are accepted within a month or two after submission of the appropriate data. However, full authorization could take almost a year to receive approval as there is no urgent new requirement for the vaccine, as reported by Massachusetts-based vaccine expert Dr Davinder Gill. .

Problems reported by other countries with Covaxin-

An inspection of the Bharat Biotech site in Hyderabad took place in March by the Brazilian health authority, ANVISA, and they further rejected the request to issue Covaxin with a Good Manufacturing Practices Certificate due to issues that arose during inspection. According to ANVISA, these shortcomings could potentially affect the quality of vaccines and, in turn, could potentially become a health risk for those who use them.

This did not affect the EUA application of the vaccine in the country, but surely caused a delay in its ability to deliver vaccines to India. But despite this, on June 4, ANVISA approved the importation of Covaxin into their country in limited quantities with more stringent conditions. The reason for this approval is the improvement of the action plan and the quality issues that were previously raised by ANVISA.

What about the effectiveness of Covaxin in India itself?

In India, Covaxin has been tested in phases 1, 2 and 3 of human clinical trials involving nearly 26,000 people. In its first days of January, red flags were raised for its restricted emergency clearance as little data was generated on its effectiveness at that time. Since then, Bharat Biotech has reported in the media that the effectiveness of Covaxin is 78%. However, actual data from the Phase 3 trial which involved nearly 25,000 people has not been released so far.

The company has submitted Covaxin to the Central Drugs Standard Control Organizations (CDSCO) and expects data on its efficacy and safety to arrive in July. Peer review of this statement will take almost 3-4 months, as Covaxin project manager Raches Ella said.

What about Indians who have been vaccinated with Covaxin and who will be traveling to the United States?

The United States requires a negative RT-PCR test report to allow people to board a flight. Even if you are an Indian student who wants to continue your education in the United States, just having received two injections of Covaxin will not stop you from going. Many universities in the United States have also started allowing students to resume their vaccination process once they reach the United States with one of the vaccines approved in the country.

Overall, the US FDA will be reviewing the vaccine as part of a standard approval test which may take some time. Bharat Biotech has also applied for an emergency use license with the World Health Organization (WHO). This license will ease any expected restrictions that may arise in the United States for those who have been vaccinated with Covaxin and this license will arrive between July and September of this year.



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