Prime Minsiter urges people to not drop caution even after being vaccinated
Prime Minister Narendra Modi launched India’s vaccination drive against the novel coronavirus disease (COVID-19) January 16, 2021. Several vaccination sites were connected virtually while he addressed the people on camera.
A hundred recipients each were scheduled for 3,006 session sites across states and Union territories for the first day.
Ten million healthcare workers and 20 million frontline workers, including personnel of in civic bodies, police and fire departments, anganwadis, etc will be included in this initial phase. Vaccination in two doses (around four weeks apart) is expected to stretch over five months in this phase.
The central government has procured:
Modi did not emulate some of his global peers in taking the jab himself: He had put forth the view at a recent meeting with chief ministers that politicians should not jump the queue.
On Saturday he reiterated that healthcare workers deserved the first opportunity to be vaccinated as they were at the highest risk. He thanked the scientific community for developing vaccines in record time and underscored the affordability and logistical ease of handling of those developed in India.
The PM also urged citizens to keep wearing masks and following distancing norms even after being vaccinated.
Modi rejected doubts about the effectiveness of vaccines as “propaganda”. He called both Indian vaccines “prabhavi” and “surakshit”. The Hindi words can be broadly translated to ‘effective' and ‘safe'.
Questions over the hurried processing of emergency authorization for the vaccines, especially Covaxin, in the run-up to the new year, however, remain unanswered.
The consent form that potential beneficiaries have to sign before being administered Covaxin states:
“In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against Covid-19. However, the clinical efficacy of Covaxin is yet to be established and it is still being studies in phase 3 clinical trial."
The first phase yields data on safety and the second on immunogenicity (whether a vaccine candidate can trigger an immune response). These stages typically involve relatively fewer subjects: 755 in case of Covaxin.
To overcome this, several other candidates released ‘interim efficacy’ data from the final phase, conducted on tens of thousands people, to obtain emergency use approval.
Comirnaty by Pfizer-BioNTech, approved in the United States, showed 95 per cent efficacy in interim results. Interim, because the results of trials on only 37, 706 participants among a total 43,548, were available (by October 9). They had been under observation for two months after being given the second dose of the vaccine.
The interim data from the third phase of Covaxin’s trial, conducted on 25,800 people, is not yet available.
Since Covaxin has been approved under what the country’s drug regulator described as ‘clinical trial mode’ recipients need to sign an informed consent form. They will also be given a form to fill details of any adverse event following immunisation for seven days of receiving each round.
The form states that Bharat Biotech would pay for the consequences of any serious adverse event with a proven causality link.
Government officials have also stated that Covaxin-recipients will be monitored closely and actively.
There, however, has been no communication from the government on adverse effects reported at a Covaxin trial site in Bhopal.
Earlier in the month, All-India Institute of Medical Sciences Director Randeep Guleria had called Covaxin a “back-up”.
VK Paul, chief of India’s COVID-19 vaccine group, however, told news agency Reuters that “both vaccines (Covishield and Covaxin) are equally important.”
For Covishield, neither is a consent form required nor any sheet to note down adverse events.
Vaccination remains optional but recipients can’t chose between the two available vaccines.
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