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The US denied the approval of Covaxin- find the what and why.

India has already been through a rather dangerous wave of misinfodemic concerning the country’s vaccines. Now, after a lot of time and belief, people are gaining confidence and getting vaccinated but the new news coming from the US may change the situation a little, leading to a bad impact on Indians. The news in question is the fact that the United States recently decided not to give Emergency Use Authorization(EUA) to 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 conclusions, let’s read in detail to find out what actually is going on behind the scenes.

Why did the US not give EUA to India’s Covaxin?

The United States decided not to give EUA to Bharat biotech’s developed vaccine, Covaxin. The decision was taken even before the EUA application was submitted and was communicated to the company’s American partner, Ocugen. But why US decided not to give EUA approval to Covaxin? The reason being the success of the country against the COVID-19 virus in terms of the vaccination drive. Further, the United States is in a considerably stable position, implying that they no longer need to engage in emergency approvals and can thus take time for due diligence before giving the approval stamp to any jab. 

The country invested $18 billion in the development of various vaccines for its population last year, under the Operation Warp Speed initiative. It has already given EUAs to the Pfizer-BioNtech and Moderna-NIAID vaccines as well as Johnson & Johnson’s viral vector jabs. According to Bharat biotech, the country has vaccinated a significant amount of the population and, if continued at the rate, would ensure achieving economic efficiency.

Covaxin 1

Therefore, now that the country does not suffer from a shortage of supply of vaccines, the US Food and Drugs Administration (FDA) has come up with the strategy to give enough priority to review EUA requests. The regulator of FDA said in May that they will decline to review and process the EUA request of various vaccines in the situations where the FDA can’t verify any one of the following- the conduct of the clinical trials, the integrity of data of trials, and if the standards of vaccine production facilities meet the manufacturing standards set in place. 

FDA further said that they would need to further prioritize the EUA requests of various vaccines, in concern with the people’s health and well being. This means that FDA may decline the request to review and process the request of those vaccine makers who had not engaged regularly with the FDA during the manufacturing and clinical trials of their vaccines.

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

Well, a sigh of relief, because this is absolutely untrue. In effect, the FDA, in a recent recommendation, asked Ocugen to apply for full authorization of the vaccine, as opposed to the current application for emergency approval. However, for full authorization for the supply of Covaxin in the US, FDA will now require more information and data, likely from more human critical trials to know that the vaccine is completely safe, prompts an immune response to its population, and is acceptably effective. This further suggests that we don’t need to worry and the rejection was not due to the failure of Covaxin.

But along with this, there is a piece of bad news for Bharat Biotech and Ocugen. This roots from the fact that a full authorization, if sought by Covaxin, would take a longer time to get approval due to the listless process, meaning that there’s still a lot of time before Covaxin gets used in the States, if it does.  Generally, after all, tests and reviews, EUA applications are accepted within a month or two after proper data being submitted. However, the full authorization might require almost up to a year to receive approval as there is no new urgent requirement of the vaccine, as reported by the Massachusetts-based vaccine expert, Dr. Davinder Gill.

Issues flagged by other countries about Covaxin-

An inspection of Bharat Biotech’s site in Hyderabad took place in March by the Brazilian health authority, ANVISA and they further rejected the application of giving Covaxin a certificate of good manufacturing practices due to the issues which came up during the inspection. According to ANVISA, these shortcomings had the potential to affect the quality of vaccines and in turn, could possibly become a health risk for those who use them.

This did not affect the EUA application of the vaccine in the country but surely led to a delay in its ability to supply vaccines in India. But despite this, on June 4, ANVISA approved the import of Covaxin in their country in limited quantities with stricter conditions. The reason behind this approval is the improvement in the action plan and quality-related issues that were raised earlier by ANVISA.

 

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What about the efficacy of Covaxin in India itself?

In India, Covaxin has been tested in phase one, two and three of human clinical trials involving nearly 26,000 people. In its initial days of January, red flags were raised for its restricted emergency permission as not much data was generated about its efficacy at that time. From then till now, Bharat Biotech has stated in media reports that the efficacy of Covaxin is78%. However, actual data from the phase 3 trial which involved almost 25,000 people have not been released till now.

The company has submitted the Covaxin to Central Drugs Standard Control Organisations(CDSCO) and is expecting the data about its efficacy and safety to come within July. Peer review of this statement will take nearly 3-4 months, as said by Raches Ella, Covaxin’s project lead.

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

The United States requires a negative report of RT-PCR test to allow people to board a flight. Even if you are an Indian student who wishes to go to the United States for further studies, having received two jabs of the Covaxin won’t stop you from going there. Many universities in the US have also started to allow the students to restart their immunization process once they reach the US with any of the vaccines approved in the country.

All and all, US FDA will be going to review the vaccine under a standard approval test which may take some time. Bharat Biotech has also applied application for an Emergency Use License from World Health Organisation(WHO). This license will ease up the expected restrictions that could arise in the US for those who have been vaccinated with Covaxin and this license will come up between July and September this year.

Simerleen Kaur

Talk to me about economics, trade, and all things India.

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