The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
The Oxford vaccine, which also has a tie-up with the Serum Institute of India, is expected to win approval in the UK before Thursday, speeding up the provision of the jab to the most vulnerable groups.
An important focus of the dry run will be on management of any possible adverse events following immunisation.
Dr V K Paul, Member (Health) Niti Aayog, who also chairs the national expert group on COVID-19 vaccine administration, said the government attaches 'great importance to this offer of partnership from a very special friend to this nation'.
'Even after vaccines are given, precautions like using a mask and maintaining social distancing have to be taken.'
The new malaria vaccine (RTS.S/ AS01, tentatively brand-named Mosquirix) is the very first one to offer immunity against a parasite -- specifically the plasmodium falciparum parasite, which is the deadliest of the five parasites that cause malaria.
There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Swaminathan said.
The modalities of COVID-19 vaccine delivery, distribution and administration were discussed during the meeting.
Sputnik V is the third vaccine India has given the go-ahead to after 'Covishield', developed by Oxford University and AstraZeneca and 'Covaxin', the indigenous vaccine manufactured by Bharat Biotech. Covishield is manufactured by the Serum Institute of India.
The official expressed hope on the success of the five vaccines that are under different phases of trial in the country.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
The first 100 beneficiaries of such foreign vaccines shall be assessed for seven days for safety outcomes before it is rolled out for further immunisation programme within the country, the Union health ministry said.
In a tweet, Prime Minister Narendra Modi said India is deeply honoured to be a 'long-trusted' partner in meeting the healthcare needs of the global community and that supplies of the vaccines to several countries will commence on Wednesday, and more will follow in the days ahead.
While the vaccine could be available at $3-6 (Rs 225 to Rs 550) per dose, herd immunity might be two years away due to implementation challenges, it said, adding the experience in large scale adult vaccination programmes is thin.
The Medicines and Healthcare Products Regulatory Agency said in its latest Yellow Card monitoring of the coronavirus vaccine programme this week that of the 18.1 million people who had the Oxford vaccine in the UK, 30 people developed blood clots and seven had died as of March 24.
The volunteer said he had also volunteered 10 years ago for clinical trials for a vaccine against the H1N1 (swine flu) virus.
Out of the 447 adverse events following immunisation, only 3 required hospitalisation.
Senior Congress leader Manish Tewari and Union Health Minister Harsh Vardhan sparred on Twitter on Saturday with the Opposition leader raising questions over the emergency use approval given to the indigenously developed vaccine Covaxin and the Bharatiya Janata Party leader hitting back alleging that Tewari was only passionate about spreading rumours.
First a scientist and then a businessman, founder chairman Krishna Ella quit his faculty position at the Medical University of South Carolina in Charleston, United States, in 1996 to return to India.
Will syringe shortage puncture India's Covid vaccine plans?
A dipstick survey covering 30 villages in Rajasthan threw up some worrisome numbers. About 250 children missed their regular vaccination schedule in March alone. These numbers are alarming, since India has around 600,000 villages according to the 2011 census. Sohini Das reports.
The Indian vaccine industry largely feels there are two ways in which vaccine innovation can be spurred - one, get a high price for the product and two, have the government buy a few hundred million doses of the product at a certain price.
As India launches the world's most ambitious and biggest vaccination drive against COVID-19, the country will encounter the formidable challenge of rapidly scaling up distribution of the vaccines to secure immunity for its entire population, two prominent Indian scientists at World Health Organisation have said.
According to the World Health Organisation, 10 candidate vaccines for COVID-19 are in the clinical evaluation and 126 are in the pre-clinical stage.
Gautam Adani, who is diversifying into many businesses, saw a 48 per cent rise in his wealth to Rs 1.40 lakh crore and moved up two places in rankings to being the fourth richest Indian. Hinduja Brothers and HCL's Shiv Nadar were ranked 2nd and 3rd. Wipro's Azim Premji slipped two places to fifth place.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
'Scientific data has proven that masks can reduce COVID-91 transmission by 53 per cent...A booster dose of vaccine, even if it works, is just a temporary fix'
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
'We have 25,000 private hospitals participating in this exercise and if each of these hospitals does 200 vaccinations per day, that makes it 50 lakhs.'
The novel mRNA vaccine candidate, HGCO19, is supported with seed grant under the Ind-CEPI mission of the Department of Biotechnology. The mRNA vaccines do not use the conventional model to produce immune response. Instead, they carry molecular instructions to make the protein in the body through a synthetic RNA of the virus.
"The country wide vaccination exercise is being exponentially expanded to include those above 60 years of age and those above 45 years with co-morbidities, from March 1.
'Whenever you roll out: effectiveness is important, operational logistics are important, side effects are important and vaccine hesitancy is important.'
Pune-based Serum Institute of India will soon become the second company to get manufacturing approval for a vaccine for the H1N1 virus (swine flu) . The company's intra-nasal swine flu vaccine is expected to get regulatory clearance by the month-end, health ministry officials said.
This will boost availability of these items as well as make them cheaper, it said, adding that Modi also directed the revenue department to ensure seamless and quick custom clearance of such equipment.
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
'We will see a kind of disaster which the country has not seen in the last 100 years.'
'Rolling out the vaccine is not a major challenge in India.'
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.
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