Serum India & Bharat Biotech to pursue intranasal Covid-19 vaccine clinical trials

This festive season, charity must take precedence over celebration

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Covid-19
Dr Harsh Vardhan during Sunday Samvaad-6

Dr Harsh Vardhan, union minister of Health and Family Welfare, answered many inquisitive social media interactors on the sixth episode of Sunday Samvaad. Offering his heartfelt wishes for Navaratri, he urged his followers to honor the Prime Minister’s call for Jan Andolan and religiously follow Covid appropriate behavior becoming its ambassador to others. He reiterated his request to everyone to celebrate at home with their loved ones in the traditional way. “This festive season, charity must take precedence over celebration. My own celebrations too shall remain subdued due to the heart-rending impact of Covid-19 on lakhs of corona warriors across the world battling for us.”

Kerala paid the price of negligence during Onam

Vardhan shared his views on the recent spike in Covid-19 cases in Kerala. Noting that between 30 January and 3 May 2020, Kerala had reported just 499 cases and two deaths due to Covid-19. He regretted that Kerala was paying the price of gross negligence during the recent Onam festivities when State-wise unlocking of services, along with an increase in inter and intrastate travel for trade and tourism, led to the spread of Covid-19 cases across various districts. “Epicurve of Kerala changed completely due to Onam festivities across the State, the daily new cases nearly doubled.” The Minister said this ought to serve as a good lesson for all the state governments negligent in planning for the festival season.

On China’s claim that the novel coronavirus broke out simultaneously in several countries last year, Vardhan explained that no evidence could validate the claims on global multiple focal points for the novel coronavirus outbreak. He stated that Wuhan, China remains recognized as the first report worldwide.

Responding on the market being flooded with oximeters made in China, Vardhan observed, “Consumers should look for FDA/CE approved products with ISO/ IEC specifications while purchasing a pulse oximeter from the market or from the online retailers.” However, he made it clear that a dip in oxygen saturation level is not a Covid-19 symptom, as it may happen due to other underlying medical conditions as well.

He also assured that no mutation of coronavirus has been detected in India, which is either more transmission efficient or more pathogenic.

Covid-19 grants to states

The minister shared that the Ministry of Health and Family Welfare has already released the Phase II of the Covid Package to 33 States and Union Territories. The total amount released in the second package amounts to a total of Rs 1352 crore. This Phase II grant has been released in tranches during August, September, and October 2020.

Newspapers are completely safe

He rekindled the joy of having morning tea in a respondent by reassuring him that there is no scientific evidence that proves that novel coronavirus transmission can happen via newspapers. He said that reading newspapers is completely safe even during the Covid-19 pandemic.

Correct modalities of reporting of deaths

Speaking on the discrepancy in the number of Covid-19 deaths across India, Vardhan said that the Ministry of Health & Family Welfare has taken up the issue of correct certification of Covid-19 deaths with all States and UTs on multiple instances and also shared a proper modality of reporting of deaths with them to ensure consistency in reporting of Covid-19 related deaths across India.

No shortage of medical oxygen in the country

The Minister assured that there is no shortage in medical oxygen. The current oxygen production capacity of India is around 6400 MT in a day. According to him, the Government is ready to scale up the production capacity to meet any further increase in demand arising due to the pandemic. The Empowered Group, constituted by MHA, is monitoring the requirement of medical oxygen across India. The Ministry of Health is also monitoring the availability and supply of medical oxygen at the field level through regular video conferencing with State nodal officers for oxygen as well as with principal secretaries or mission directors; 1,02,400 medical oxygen cylinders have been delivered to States and UTs; The National Pharmaceutical Pricing Authority has fixed the price of Liquid Medical Oxygen; Guidelines on ‘Rational use of Oxygen for management of Covid-19’ have also been issued.

No intranasal Covid-19 vaccine under clinical trial

Vardhan remarked that although there are no intranasal Covid-19 vaccines under trial in India at the moment, Serum India and Bharat Biotech are expected to pursue clinical trials of such vaccines in India in the coming months on receipt of regulatory approval. He clarified that the Phase III clinical trial is generally with thousands of participants, sometimes even close to 30,000 to 40,000 participants. A couple of hundred participants may be selected from a specific city or hospital at a given time. Still, in general, the overall Phase III participant pool is much larger.

Mentioning details on the special drive for Adverse Drug Reaction (ADR) reporting and monitoring of drugs used in Covid-19, Vardhan clarified that this special drive is not because of an adverse reaction reported with an existing drug but is part of a proactive Covid-19 preparedness program.

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