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WHO may declare a final decision on EUL approval for Bharat Biotech's Covaxin next week

Our Bureau, New Delhi
Wednesday, October 6, 2021, 09:30 Hrs  [IST]

World Health Organisation (WHO) will be holding a meeting next week to come to a final decision on whether to grant Emergency Use Listing approval to Bharat Biotech's Covid-19 vaccine Covaxin.

On Tuesday, the Organisation said, "WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin".

Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on September 27, it said.

"WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week," it added.

The Emergency Use Listing process is done by WHO and the Technical Advisory Group of independent experts - is centred on determining if a manufactured product, such as a vaccine, is quality-assured, safe and effective.

Bharat Biotech, last month, said that the clinical trial data was fully complied and available in June 2021 and all data submitted for Emergency Use Listing (EUL) Application to WHO in early July.

“As a responsible manufacturers with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” said the company in its Twitter page. Experts have been pegging the approval to be in place in the end of September itself.

An update from WHO in the second half of August, showed that the SARS-CoV-2 Vaccine, inactivated (Vero Cell)/Covaxin, has completed the EOI acceptance and pre submission meeting stages and the rolling data started on July 6, 2021.

The NITI Aayog member for Health, Dr V K Paul, has recently said in an interview with a news agency that there are positive developments related to the approval of the indigenous vaccine by WHO and chances are that a positive decision could come within the end of September.

It may be noted that the approval of Covaxin by the Indian drug regulator in early 2021 was criticised by many, alleging that the decision was taken in the absence of adequate necessary data.

Covaxin, the two doses (Day 0 and 28) for people above 18 years of age, administered through intramuscular route, was approved by the CDSCO on January 3, 2021, along with Serum Institute of India Pvt Ltd’s Covishield, another two dose vaccine to be administered among population on or above 18 years of age.

India has so far approved eight vaccines, including Johnson & Johnson’s single dose vaccine to be manufactured by Biological E Ltd (approved on August 18, 2021) and imported by Johnson & Johnson from other sites (approved on August 7, 2021), both to be administered in population on or above 18 years.

Besides, Dr Reddys’s Laboratories was approved to import Russian vaccine Sputnik-V, through an order in April 12, 2021, and Cipla for import of Moderna’s mRNA vaccine, approved on June 29, 2021. Panacea Biotec Ltd was also approved to deal with Sputnik-V, through an order on July 2, 2021. Cadila was the eighth firm to get its approval for its recombinant DNA vaccine with three doses (Day 0, 28 and 56), but this time for those on or above 12 years old. This is also an intradermal vaccine.

 

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