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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

Published

3 years ago

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FDA rejects emergency use authorization for Bharat Biotech’s Covaxin jab

This is a consequence of the US FDA asking the company to launch an additional trial so that the company can file for a Biologics Licence Application (BLA), which is a full approval. “The FDA provided feedback to Ocugen regarding the Master File the Company had previously submitted and recommended that Ocugen pursue a BLA submission instead of an EUA application for its vaccine candidate and requested additional information and data,” said a statement from Ocugen to NYSE. Adding that the company is in discussions with the FDA on the additional documents required to clear its application. “While this will extend our timelines, we are committed to bringing Covaxin to the US,” said Shankar Musuniri, chief executive of Ocugen.

This development comes at a time when Bharat Biotech is under criticism in India for not sharing data from its phase 3 clinical trials almost six months after the company’s vaccine was included in India’s immunization programme.

The company has been betting on being able to launch its vaccine in regulated markets as it looks to gain validation at a time where authorization of a covid vaccine from WHO or a regulator such as USFDA or the European Union is needed to cross borders. At present, several countries do not recognize the Bharat Biotech vaccine, and those who have received two doses of the vaccine are considered “unvaccinated” in some countries.

News Source : First Post 

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Haryana

Delhi Weather and AQI Today: Warm start at 22.05 °C, check weather forecast for October 22, 2024

Published

2 weeks ago

on

October 22, 2024

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Delhi Weather and AQI Today: Warm start at 22.05 °C, check weather forecast for October 22, 2024

Check the weather forecast and air quality updates for Delhi on October 22, 2024 here.

The temperature in Delhi today, on October 22, 2024, is 32.93 °C. The day’s forecast indicates a minimum and maximum temperature of 22.05 °C and 35.04 °C, respectively. The relative humidity is 26% and the wind speed is 26 km/h. The sun rose at 06:26 AM and will set at 05:44 PM.

Tomorrow, on Wednesday, October 23, 2024, Delhi is predicted to experience a minimum and maximum temperature of 27.42 °C and 34.91 °C, respectively. Tomorrow humidity levels will be at 20%.

With temperatures ranging between 22.05 °C and 35.04 °C, prepare for a hot day and plan outdoor activities accordingly. If you are sensitive to heat, take note of the weather forecast and consider appropriate attire and activities suitable for the prevailing weather.

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The AQI in Delhi today stands at 334.0, falling in the very poor category. Everyone should be cautious. Children and people with respiratory diseases, such as asthma, should stay indoors and others should also limit their outdoor activities. Usage of masks and air purifying devices is advised. Being aware of the AQI helps one make informed decisions regarding one’s overall well-being while planning the day’s activities.

Weather and AQI predictions in Delhi for next 7 days:

DateTemperatureSky
October 23, 202432.93 °CSky is clear
October 24, 202432.69 °CSky is clear
October 25, 202432.5 °CSky is clear
October 26, 202432.07 °CSky is clear
October 27, 202430.69 °CSky is clear
October 28, 202431.29 °CSky is clear
October 29, 202432.09 °CSky is clear

Weather in other cities on October 22, 2024

CityTemperatureSky
Mumbai28.35 °CLight rain
Kolkata28.84 °CSky is clear
Chennai28.94 °CLight rain
Bengaluru25.53 °CModerate rain
Hyderabad27.75 °CModerate rain
Ahmedabad31.9 °CSky is clear
Delhi32.93 °CSky is clear

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