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.
Serum Institute already has two deals of 100 million each to supply the Oxford-AstraZeneca and the Novavax vaccine to Gavi-Covax at $3 per dose.
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'Safety is my first priority.' 'I need to ensure that any drug or vaccine that our citizens get is first safe.'
The Covishield maker's forte throughout the past half a century has been a combination of affordable vaccines and high volumes. Its tetanus, diphtheria and measles vaccines are known throughout the world, reports Sohini Das.
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'We are hoping by March, the government allows us to export and give it to the private market.'
'The government should put the whole road map together for the vaccine and decide how industry can support...' 'They should allow the private sector to vaccinate.'
The expert committee sought more information from Serum Institute regarding the Oxford-AstraZeneca vaccine.
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.
The health and family welfare ministry spent 70 per cent of its allocation till October. The ministry may need additional funds for the vaccination drive which is expected to be kicked off from January.
Each of the larger states may need less than Rs 10,000 crore each to finance the exercise.
At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.
The new wing will be known as the corporate finance investigation department, which will be headed by one of Sebi's executive directors. This department will have information technology solutions experts, particularly to detect the menace of frauds.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
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.
In the first phase, most of the outdated regulations in the state and central Acts will be removed. Further, compliances with regard to annual inspections, licence renewal, and storage of multiple data will be eased.
India's first mRNA platform-based vaccine will remain stable at 2-8 degrees Celsius while Pfizer-BioNTech's vaccine needs minus 70 degrees Celsius and Moderna vaccine can remain stable for six months at minus 20 degrees Celsius, reports Sohini Das.
'Our client is suffering due to the ill-effects of the vaccine. He has to be compensated for his suffering. Further, a detailed investigation has to be done on the Covishield vaccine and its side-effects,' says the volunteer's advocate.
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