A COVID-19 vaccine candidate, developed by the American drugmaker Pfizer and the German biotech firm BioNTech SE, may be available for emergency use soon. Pfizer Inc has reportedly said that it may file for emergency-use authorisation of the coronavirus vaccine by late November, provided it gets positive efficacy and safety data from ongoing Phase 3 clinical trials.
This is for the first time that a leading Western vaccine developer has provided such a specific timeline to roll-out the eagerly awaited vaccine, reported the Wall Street Journal.
The drug major expects to have data on the vaccine's effectiveness-whether it protects at least a majority of vaccinated people from the disease-later this month. Besides, it expects to have data on the drug's safety by the third week of November, as per the report. Based on this timeline, the vaccine is likely to get US authorisation by the end of this year.
As per the US Food and Drug Administration (FDA) norms, to get authorisation for emergency use of experimental coronavirus vaccine, companies have to submit at least two months of safety data.
Pfizer and BioNTech's vaccine candidate, BNT162b2, is currently being evaluated in a global Phase 3 study ongoing at more than 120 clinical sites worldwide including the United States, Brazil, South Africa and Argentina. To date, the trial has enrolled approximately 37,000 participants with more than 28,000 having received their second vaccination. Preliminary data from the Phase 1 and 2 of the study have demonstrated that the vaccine was well tolerated with mild to moderate adverse events in all age groups.
The company has recently received US FDA nod to enroll participants as young as 12 in its late-stage vaccine trial to understand how it works in a wider age group. Though there are very rare symptoms of severe COVID-19 infections in children, they can pass on the virus to high-risk groups such as the elderly.The vaccine candidate, BNT162b2, is based on BioNTech's proprietary mRNA technology and supported by Pfizer's global vaccine development and manufacturing capabilities. It encodes an optimized SARS-CoV-2 full-length spike glycoprotein (S), which is a target of virus neutralising antibodies.
Besides Pfizer, rivals such as Moderna Inc, AstraZeneca Plc and Johnson & Johnson are also in the race to develop a safe and effective vaccine for the coronavirus. While Moderna, J&J and Novavax Inc are conducting trails on adult candidates only, Pfizer is the only one which is enrolling younger participants.
By Chitranjan Kumar