India's drug regulator has initiated a probe and sought further details from the WHO after the global health body issued an alert that cough syrups manufactured by an Indian firm could potentially be linked to the death of children in Gambia.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Drugs Controller General of India, the apex drug regulator, has included a new clause in the trial approval letters, making these firms also accountable for any possible adverse event.
As per RDIF, Sputnik V has a number of key advantages, including that there are no strong allergies caused by Sputnik V.
Biotechnology major Biocon has got the Drug and Controller General of India approval for marketing its BIOMAb EGFR in the Indian market. This is a proprietary product of Biocon, which will be used in treating head and neck cancers.
A 40-year-old man who was a volunteer in the third phase of the ''Covidshield'' vaccine trial in Chennai has alleged serious side effects, including a virtual neurological breakdown and impairment of cognitive functions.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
So far, no other vaccine has been approved globally for children below 12 years. Sohini Das reports.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be a maximum for 28 days from randomisation.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
Pfizer sought to participate in the Subject Expert Committee consultations towards an emergency use authorisation for its Covid-19 vaccine. However, the company representatives have been unable to participate in the meetings because of extremely short notices of a few hours or less and time-zone limitations.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
Once available, Sputnik V will be the third vaccine to be used in India against coronavirus.
Deshmukh said on Twitter that it was "highly deplorable" that two senior Union ministers endorsed the drug.
Bharat Biotech has completed the Phase 2/3 trials of COVID-19 vaccine, Covaxin for use in children under 18 years of age and is expected to submit the data by next week to the Drugs Controller General of India (DCGI), Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella said
According to sources close to ANI, "Bharat Biotech has informed Union health ministry that it will rectify the issues pointed out by WHO in 15 to 20 days." "World Health Organisation (WHO)'s suspension is not related to safety or efficacy issues but limited only to supply for United Nations agencies."
The company had in December said that the CDSCO had approved a 12-month shelf life for Covaxin, which was nine months earlier, Sohini Das reports.
He explained, "Children between the age of 12 and 18 years, particularly those in the age group of 15 to 18 years, are very much like adults. Our research within the country also says that almost two-thirds of the deaths below 18 years which occurred due to COVID in India are within this age group. So, this decision was mainly taken to protect the adolescents."
Poonawalla wished the country and Prime Minister Narendra Modi success for the vaccination programme.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
If things go according to plan, the vaccine would be available in the market by the end of this year.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
If I follow US standards, I will have to shut almost all drug facilities: G N Singh
According to officials, an additional dose of vaccine is different from a booster dose.
Since India is one of the largest vaccine producers in the world, it is the country's 'moral responsibility' to fast-track vaccine development process to break the chain of coronavirus transmission, ICMR Director General Dr Balram Bhargava said referring to the two vaccine candidates developed indigenously.
Avigan comes in a complete therapy pack of 122 tablets with a two-year shelf life.
India achieved this coverage in 130 days as against the USA's feat in 124 days.
Two weeks after the vaccination programme started, about 37 per cent of the targeted 10 million healthcare professionals had received the first shot. This slow rate may prompt the government to allow vaccines in the private market sooner, to use up the doses before they expire, Sohini Das reports.
Vaccine development is a long process to ensure safety and efficacy through different stages and involves regulatory supervision every step of the way. Ruchika Chitravanshi takes you through this carefully drawn journey of vaccine development.
In an address to the nation amid increasing Covid cases through the Omicron variant of the virus, he said the precaution dose will also be available for citizens above 60 years of age and with comorbidities on the advice of their doctor from January 10 next year as well.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
In a video issued by the Health Ministry, Dr Randeep Guleria, Director of the All India Institute of Medical Sciences (AIIMS) answered commonly asked questions regarding the dosage of the vaccine saying that two doses of the vaccine will have to be taken 28 days apart and protective levels of antibodies generally would develop two weeks after the second dose.
The parties intend to start the production of Sputnik V in the beginning of 2021, it added. Currently, Phase III clinical trials are approved and are ongoing in Belarus, the United Arab Emirates, Venezuela and other countries, as well as Phase II-III in India, RDIF said.
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