Saturday, 04 December 2021

Covaxin got Approval from WHO

Covaxin got Approval from WHO

On Wednesday, the World Health Organization granted Covaxin an emergency use listing, or EUL, which means other countries will finally recognize the 'made-in-India vaccine, and Indians who received the shot need not self-quarantine or face restrictions when traveling abroad.

Covaxin has been cleared for use for all age groups over 18 plus two doses spacing four weeks. However, no advice has been made for use on children, and available data on pregnant women is inadequate to assess safety or efficacy, WHO said.

The global health body said.

"The Technical Advisory Group an liberated panel that provides the WHO with vaccine recommendations has determined Covaxin meets requirement for protection against COVID-19 and the benefit of the vaccine far outweighs risks (and) the vaccine can be used,"

It said.

"Available details on vaccination of pregnant women with Covaxin are not sufficient to assess vaccine efficacy or safety in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,"

The WHO confirmed Covaxin was "78 percent effective against COVID-19 of any seriousness, 14 or more days after second dose, and is extremely suitable for low and middle-income countries due to easy storage requirements".

Bharat Biotech said the grant of the EUL was

"a very significant step towards make sure global access to India's widely administered, efficacious and safe (vaccine)."

Dr. Krishna Ella, Bharat Biotech Managing Director, and Chairman said.

"As an organisation we have steady on maintaining strict safety and quality standards that meet accuate assessment and scientific standards established by WHO and EUL authorisation for Covaxin will enable us to contribute to accelerating the fair access of COVID-19 vaccines..."

The EUL comes after a rigorous and lengthy review period - Bharat Biotech provided the first batch of data in July - that involves assurances about the vaccine's safety, efficacy, and stability, as well as checks of production facilities.

Covaxin got Approval from WHO 1unsplash image

Read More: Covaxin gets approval for children aged 2-18 years

The delay left millions in limbo; in particular, it was a huge problem for Indian students studying abroad in Canada, the US, the UK, and Australia.

The WHO had said it

"understands many people are waiting for Covaxin to be included in the COVID-19 Emergency Use Listing."

But had also stressed, "we cannot cut corners before recommending a product for emergency use... we must evaluate thoroughly to make it is safe and effective".

The WHO also underlined its trust in the Indian vaccine industry. In its defense, it referred to the 30 days it took for a EUL for Serum Institute's Covishield (the AstraZeneca-Oxford University shot).

"... this is not about moving fast with one or another vaccine. We really trust the Indian industry."

The approval is also likely to clear the way for India to commit vaccine supplies to COVAX - the global vaccine-sharing effort co-led by the WHO, which aims to provide vaccines to poorer countries.

Last month news agency Reuters reported the government was delaying a deal on that point while the World Health Organization deliberated on approval for Covaxin.

Covaxin is one of a few 'made-in-India vaccines and, with Covishield, is the mainstay of the country's drive against the coronavirus; as of this evening, over 12.14 crore people have been given the jab.

Apart from Covishield and Covaxin, the WHO has approved vaccines produced by American pharma giants Pfizer, Johnson & Johnson, Moderna, and China's Sinopharm.

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