When will an antidote against Covid-19 finally become widely available? The answer to this question may eventually be found this month as a handful of coronavirus vaccine candidates near the end of late stage clinical trials. At least two vaccine frontrunners — Pfizer and Moderna Inc — are set to release late-stage and Phase 2 results this month.
While experts have said vaccines were likely to reach the general public in the March-April 2021, drugmakers have been more ambitious with their calculations, with some firms like Moderna Inc eyeing the emergency-use authorisation route to launch their shots by year end. In fact, Pfizer may also file for US FDA approval of its vaccine this month itself, Bloomberg reported.
There are 182 vaccine candidates in pre-clinical or clinical trials across the world. Of these, 36 are in clinical trials and nine in final states of human trials. In India, where two vaccines are in phase II trials and the one by Oxford in phase III, the Union Health Ministry has said it was expecting supplies to be available from January next year.
US biotechnology company Moderna, whose mRNA-1273 vaccine is undergoing phase-3 clinical trials in the United States on 30,000 participants, has said it might seek emergency-use authorisation (EUA) after November 25 once it had enough safety data. During public health emergencies, drug regulators allow the emergency-use authorisation of unapproved medical products or treatments.
“November 25 is the time we will have enough safety data to be able to put into an emergency-use authorization file that we would send to the FDA,” Moderna CEO Stephane Bancel told Forbes. However, he said approval wouldn’t be expected until the late first quarter or early second quarter of 2021.
Recently, results of phase 1 trials of the mRNA-1273 vaccine showed that it was well-tolerated and generated a strong immune response in older adults (participants over 55 years of age).
The study, published in the New England Journal of Medicine, found that the immune response to the vaccine seen in older volunteers was comparable to that seen in younger age groups. Moreover, the blood of vaccinated volunteers contained robust binding and neutralising antibodies against SARS-CoV-2.
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