When will coronavirus vaccine come in hindi | Emergency approval of covid 19 vaccine means what ?
Union Health Minister Harsh Vardhan on Sunday said that the emergency authorization of COVID-19 vaccination is being considered particularly for senior citizens & people working in high-risk settings.
“This shall be done after a consensus has been reached”, he said, according to an official statement.
While addressing his social media followers on the ‘Sunday Samvad’ platform, the minister said that even if no date has been fixed for the vaccine launch, it may be ready by the first quarter of 2021.
He said that NITI Aayog is drawing up a detailed strategy on how to immunize the majority of the population.
“Issues like vaccine security, cost, equity, cold-chain requirements, production timelines etc., are also been discussed intensely”, he said.
He assured the vaccine will be first made available to those who need it the most, irrespective of their paying capacity.
To allay fears regarding the safety aspect of the vaccines, he said he will be happy to take the first dosage of vaccine if some people have a trust deficit.
Elaborating on the vaccine candidates and their development in India, he said that Department of Bio-Technology (DBT), as well as Indian Council of Medical Research (ICMR), have been pro-active in responding to the emerging situation to support the advancement of vaccine candidates.
India is actively partnering with Coalition for Epidemic Preparedness Innovations (CEPI) and trials at different phases are ongoing with respect to several vaccines in Indian laboratories (private or public) and hospitals, the minister said.
He also noted that a safe and effective vaccine will help in establishing immunity to COVID-19 at a much faster pace as compared to the natural infection.
“It is hoped that a consensus will emerge in next few months over the desired level of protective herd immunity in any community,” he said.
India’s COVID-19 case tally on Monday crossed 48 lakh mark with a spike of 92,071 new cases and 1,136 deaths reported in the last 24 hours.
Regardless, questions around how exactly vaccine trials need to be ‘shortened’, and a safe vaccine be made available to the vulnerable population—and eventually, to all—albeit without compromising safety, remain, not just in India, but across the world. Vaccines take long—trials proceed sequentially in Phase 1, 2, 3 and 4—and typically take years before a safe and effective product can be made available for public use. Public health emergencies such as COVID-19 require a different approach, though, to shorten these timelines, while ensuring all safeguards.
To tackle that challenge, Dinda, Tripathi and John propose a first-of-its-kind plan, where each phase incorporates parallel processes. For instance, phase 1 of human trials would not mean stopping animal studies, rather those studies would continue even after the vaccine candidate has moved on to human trials. Similarly, elements of phase 3 would be incorporated in phase 2, and phase 4 processes would be incorporated in phase 3, to further shorten the time frame.
“To optimise time in a public health emergency such as the current one, several or all of the clinical evaluation, production planning, distribution strategy and safety evaluation steps of the vaccine development continuum could be conducted in “parallel, rather than in a sequential manner,” the authors propose.
During the Phase 2 trials, for instance, aside of the regular safety, immunogenicity and efficacy studies, a limited efficacy and safety trial among a small number of volunteers with appropriate controls would be done, as is done in a conventional Phase 3 trial. “This telescoped design will enable an earlier submission of safety and efficacy data, allowing for potential regulatory approval for an EUA for the candidate vaccine,” they say.
Regulatory approvals for the manufacturer for early rollout of the vaccine, and in parallel, robust data systems and a data safety monitoring board would need to be put in place for this phase, so that post-administration follow up data are clearly tracked and safety issues flagged up early, they add.
During Phase 3 trials, by which time the vaccine would have already been rolled out post-EUA issuance by the regulator, evaluations would continue. “Use of emergency use authorized candidate vaccines will be subject to regulatory oversight, rigorous safety and adverse event monitoring and also to revoking of approval on the basis of serious adverse effects,” the plan reads.
Thank You
#emergencyapproval
#covid19
#coronavaccine
#covidvaccine
#drugdaddy
*********************************************************
Follow Us On Our Social Media Links:
Instagram : DrugDaddy
@drugdaddysg :
Facebook Page : DrugDaddy
@DrugDaddy :
