Cadila Healthcare Ltd has posted a net profit of Rs 172.91 million for the quarter ended December 31, 2002 as compared to Rs 147.03 million for the quarter ended December 31, 2001.
This government's approval for use of the antiviral drug comes at a time when India's daily COVID tally is crossing the 3-lakh mark.
As the Omicron variant of Sars-CoV-2 takes centrestage, vaccine makers in India are of the view that scaling up the existing vaccines to make them more effective is possible.
Union Health Minister Mansukh Mandaviya on Tuesday told Bharatiya Janata Party MPs that Covid vaccination for children is likely to start soon, sources said.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
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
While Bharat Biotech's Covaxin is in trials among children already, Serum Institute of India will begin Novavax vaccine trials on children from July, whereas the Pfizer vaccine has been approved for adolescents in the United States; and Cadila Healthcare's ZyCoV-D has done trials on 12 year-olds and above already, reports Sohini Das.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
The government has also given permission to 20 plants to produce the antiviral drug.
Zydus Cadila COVID-19 vaccine for children above 12 years is expected to be available by August as its trials are likely to be completed by July-end, said Dr N K Arora, Chairman, National Technical Advisory Group on Immunisation (NTAGI).
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
Cadila, Biocon developing rapid antibody testing kits; Eris, Mylan, Gland importing. There are two kinds of testing for the novel coronavirus - the real-time polymerase chain reaction test kit that uses throat or nasal swabs and provides results in a few hours, and the other is antibody-based rapid testing kit that use blood samples and provides results in a few minutes.
Modi on Saturday will embark on a three-city tour to take stock of the COVID-19 vaccine development work.
Ahmedabad was the first stop in the PM's three city tour today, to personally review the vaccine development and manufacturing process in the country.
Companies such as Cadila Healthcare, Lupin, and Natco, which sell generic versions of flu medication in the US market, are likely to benefit.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
Government institutions and pharma industry are examining if a 'cocktail' approach to making a multi-variant Covid-19 vaccine works against multiple strains of the ever-mutating virus, reports Sohini Das.
Responding to another question, Choubey said that the phase-I of clinical trials have revealed excellent safety of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd, and now their immunogenicity testing is in progress. Their phase II clinical trials are ongoing.
The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- will be participating in the meeting.
A senior health official said the probe will find out how the teenager was given the shot even though the government is yet to roll out any anti-COVID 19 vaccination programme for minors.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
The Central Drugs Standard Control Organisation said while the rights, safety, and well-being of trial subjects were of paramount importance, protocol amendment, deviation or modification might be necessary in some cases owing to unavoidable circumstances.
The primary objective was to get the adult vaccine as children rarely have a severe form of the disease. Once schools reopen, the demand for vaccines for children under 12 may soar.
To address the shortage of COVID-19 jabs in the country, the government is exploring the possibility of boosting production of vaccines, including identifying manufacturing sites for indigenously developed Covaxin outside India, sources said.
Cautioning that the country is passing through a phase when there are festivals and potential gatherings, he said this is a critical phase as the virus can spread again.
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.
While there has been no commitment from the government on the procurement of vaccines, initial volumes, or distribution plans, there is a likelihood that the low interest loans may be made available to these players only when the time to scale up manufacturing arises.
There was speculation that a one-time special Covid-19 cess would be imposed and that it would raise an estimated Rs 18,000 crore.
Zydus plans to initiate the clinical trials of ZyCoV-D in July 2020 across multiple sites in India. In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
Efforts are being ramped up for massive production of vaccines and make them available in the shortest possible time, a top government official said on Wednesday, stressing that India currently has a promising pipeline of four-five Covid-19 vaccine candidates, while three have already been approved for emergency use.
The teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddys Laboratories Ltd Hyderabad.
Phase-I clinical trials have revealed "excellent safety" of the two candidate vaccines indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research and Cadila Healthcare Ltd and their immunogenicity testing is now in progress, minister of state for health Ashwini Choubey informed the Rajya Sabha on Tuesday.
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
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
'Antibodies remain in the blood for at least seven to nine months.'
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