Skip to content
Search

Latest Stories

'Need more data', says India on AstraZeneca vaccine approval

Pramod Thomas
By Pramod ThomasDec 10, 2020
Pramod Thomas
See Full Bio

INDIA's drugs regulator has said that it had sought more data to make a decision on emergency authorisation for AstraZeneca's Covid-19 vaccine candidate and one developed locally by Bharat Biotech and the government.

India, which is the world's biggest vaccine-maker, has said it may authorise some shots in the coming weeks, and experts at the country's Central Drugs Standard Control Organization (CDSCO) met under an "accelerated approval process" to discuss the applications that were made only this week.

The regulator said it had asked the Serum Institute of India, which is the local manufacturer of the AstraZeneca vaccine, to present updated safety data from its ongoing third-stage trial in the country.

It has also asked for immunogenicity data from clinical trials in the UK and India, and for the British authorities' assessment of its emergency-use request there.

Bharat Biotech will also have to provide safety and efficacy data from its vaccine candidate's ongoing Phase III clinical trials in India for further consideration. The company had only presented data from the initial trials.

The Serum Institute did not respond to requests for comment. Bharat Biotech declined to comment.

The CDSCO said Pfizer Inc, which was the first company to seek emergency use authorisation in India through an application on Saturday(5), had sought more time to make a presentation before it.

The regulator also recommended Phase I/II trials for a vaccine candidate developed by Gennova Biopharmaceuticals Ltd, based in the western Indian city of Pune. It will be the ninth vaccine candidate that the country could manufacture.

A source with direct knowledge of the matter told Reuters that a decision on emergency use would be taken "in toto" and it was too early to say whether the vaccines being considered would be rejected or accepted.

India has reported nearly 10 million Covid-19 infections, putting it behind the US globally in overall cases.

serum instituteindia covid-19astrazeneca vaccine

Related News

Surinder Arora
Business

Billionaire Surinder Arora bids for Heathrow expansion with shorter, low-cost runway plan

Elon Musk Publicly Corrects Grok AI Misinformation
Business

Elon Musk corrects Grok chatbot after it claims he ‘took’ Stephen Miller’s wife

Post Office Horizon
UK

£1bn paid to postmasters in Horizon scandal, says UK government

Apple Research Exposes AI Model Weaknesses
Business

Apple study reveals major flaws in billion-dollar AI models

More For You

What Makes the 'Nimbus' Covid Variant Symptoms Different?

Experts warn that nimbus may be more efficient at infecting human cells than earlier variants

iStock

Doctors warn of new covid symptom as nimbus variant spreads across the UK

A new covid variant, known as nimbus (scientifically NB.1.8.1), is causing concern among health experts as cases rise globally. The variant, a descendant of omicron, has been detected in several countries, including China, Singapore, Hong Kong, and the UK. While its symptoms are largely similar to previous covid strains, doctors have identified a distinctive new symptom: a razor blade sore throat, characterised by an intense stabbing pain when swallowing.

Experts warn that nimbus may be more efficient at infecting human cells than earlier variants, which could lead to increased transmission rates. Although there is no current evidence to suggest that it causes more severe illness than its predecessors, the rapid spread has raised concerns, particularly among vulnerable groups.

Keep ReadingShow less
Norma

The family’s tribute underlined the joy she brought to viewers

Instagram/ jessandnorma

Beloved TikTok nan Norma of Jess and Norma dies aged 91

Norma, the 91-year-old grandmother who became a social media sensation as part of the popular TikTok duo Jess and Norma, has died. Her family confirmed her passing on 5 June, announcing the news on social media on Monday.

The pair, known for their heart-warming and humorous videos, built a large online following over the years. Their TikTok account, Jess and Norma, attracted more than 2.7 million followers, with many of their clips going viral.

Keep ReadingShow less
Sands Extends Special Father’s Day Support to Bereaved Fathers

The charity is encouraging individuals to honour a bereaved father with a special online dedication

iStock

This Father’s Day, Sands charity offers vital support to bereaved fathers

As Father’s Day approaches, the UK’s leading pregnancy and baby loss charity, Sands, is extending vital support to grieving fathers and their families. With Sunday, 15 June, likely to be a challenging day for many, the charity is making special efforts to ensure bereaved dads do not feel alone.

Sands has announced extended hours for its confidential Freephone Helpline (0808 164 3332), which will be open from 10 am to 12 pm on Father’s Day. This service offers a safe, non-judgmental space for those affected by pregnancy or baby loss to talk and seek support. Support is also available via email (helpline@sands.org.uk) and through the charity’s online community atwww.sands.community.

Keep ReadingShow less
Sadhvi Bhagawati Saraswati to Celebrate 25 Years of Monastic Life on June 11

Sadhviji, a renowned spiritual teacher and author

Parmarth Niketan

Sadhvi Bhagawati Saraswati to celebrate 25 years of monastic life on June 11

Parmarth Niketan will mark the 25th sanyas anniversary of Pujya Sadhvi Bhagawati Saraswatiji on 11 June, honouring her quarter-century of spiritual service and dedication since she took monastic vows in 2000.

The ceremony will be held on the sacred Shri Rama Katha stage at Parmarth Niketan in Rishikesh and will feature blessings from several prominent spiritual leaders. Among those attending are Pujya Swami Chidanand Saraswatiji, Pujya Swami Ramdevji, mahamandaleshwars Rajendra Dasji, Ravindra Puriji and Harichetnanandji, as well as Pujya Sadhvi Ritambharaji, Pujya Acharya Balkrishanji, Dr Chinmaya Pandyaji and others.

Keep ReadingShow less
NHS Issues Emergency Appeal for 200,000 Blood Donors as Supplies Dwindle

NHS Blood and Transplant (NHSBT) is aiming to boost the number of active donors to one million to meet growing demand

iStock

NHS appeals for 200,000 more donors as blood stocks fall dangerously low

The NHS has launched an urgent appeal for more people to come forward for blood donation, warning that a shortage of over 200,000 donors in England could pose a risk to public safety. NHS Blood and Transplant (NHSBT) is aiming to boost the number of active donors to one million to meet growing demand.

Blood supplies under pressure

Currently, fewer than 800,000 people – just 2% of England’s population – give blood regularly. This small group kept the NHS running last year, but officials say more support is needed. A severe drop in supply last year led to an amber alert, and NHSBT warns that without more blood donations, the situation could escalate to a red alert, meaning hospitals may not have enough blood for patients in critical need.

Keep ReadingShow less
© Copyright 2025 Garavi Gujarat Publications Ltd & Asian Media Group USA Inc