Covid-19: Serum Institute to halt trial of Oxford vaccine after DCGI notice

On Tuesday, AstraZeneca had decided to stop trials after a participant fell sick with an unexplained illness.

In a major turn of events, the Indian drug regulator on Wednesday issued a show cause notice to Serum Institute of India (SII), which had earlier said it would proceed with clinical trials of AZD1222, the vaccine candidate developed by the University of Oxford, despite a halt on the same by AstraZeneca in the UK. On Tuesday, the British-Swedish drug major had decided to stop trials after a participant fell sick with an unexplained illness. Reacting to the show cause notice, a Serum spokesperson said:

“We were going by the DCGI’s direction, and so far had not been told to pause trials. If the DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.” Earlier during the day, the company had said that as far as Indian trials were concerned, they would continue as SII had faced “no issues at all”.

Investigators here, however, had expressed concerns during the day. The lead investigator of one of the clinical trial sites in western India had said trials here should have, ideally, been paused as it was the same vaccine being administered to volunteers. The person added that investigators were waiting to hear from the Indian Council of Medical Research (ICMR) and SII on this. In a strongly worded show cause notice to SII, V G Somani, the DCGI, asked the Pune-based firm why the permission granted to it on August 2 should not be suspended till “patient safety is established”…Read More

Dengue - A continuing global threat

Dengue fever is a painful, debilitating mosquito-borne disease caused by dengue viruses. Each year, an estimated 400 million people globally are infected with the virus; about 100 million get progressively sick and 2.5 percent of those patients die. It is the fastest growing mosquito borne infection in the world.

BS| The World health Organisation (WHO) estimates that 40 percent of world’s population is at risk of being infected due to environmental conditions and burden of disease; people of all age groups are at risk. Most people who are infected have mild or no symptoms.

Dr Mohammed Sakeel of Fortis Hospital, Kalyan, said that mild symptoms of dengue may be confused with other illnesses that cause fever and flu-like symptoms. He stated that the most common symptoms are fever, and one or more of the following:

1) Headache

2) Eye pain (typically behind the eyes)

3) Muscle, joint, or bone pain

4) Rashes

5) Nausea and vomiting

6) Unusual bleeding (nose or gum bleed, small red spots under the skin, or unusual bruising)

Severe symptoms of dengue can be labelled as an emergency. Therefore, it is important to recognise the warning signs early.

Warning signs:

Watch for signs and symptoms of severe dengue, which develop 24-48 hours after initial fever goes away. If you or a family member develops any of these warning signs, go to a physician or nearest emergency department immediately:

1) Severe stomach pain or vomiting (at least 3 vomiting episodes within 24 hours)

2) Bleeding from the nose or gums

3) Vomiting blood, or blood in the stool

According to Rasika Parab of Fortis Hospital, Mulund and Rajeshwari Shetty of SL Raheja Hospital, dengue has the most vague myths associated with itself and the rise of social media just adds to the problem.

>Keep Reading :-  Dengue – A continuing global threat<< 

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