What is Pfizer-BioNTech vaccine labelled as BNT162b2 to tame the COVID-19 pandemic?
Amid the Coronavirus-blighted year, the world is hoping for a vaccine. Now, with the Pfizer and BioNTech's announcement of concluding the phase 3 study of the COVID-19 vaccine on which they have been collaborating, the fulfilment seems to be in sight.
On 18 November 2020, two pharmaceutical firms, Pfizer and BioNTech reported that the vaccine on which they were collaborating is more than 90% effective in preventing symptomatic cases of the ongoing COVID-19 pandemic. This is an astounding result for a first-generation vaccine as many haven't hoped for efficacy above 70%.
As soon as this news broke, Pfizer's share rose by 15% and those of BioNTech's by 24% in America's stock market.
The head of CEPI, Richard Hatchett stated that the results were hugely positive and encouraging and has increased the probability that many of the other vaccines that are being pursued would also be successful. He further added that one COVID-19 vaccine would not be enough as the Pfizer-BioNTech vaccine (labelled BNT162b2) needs to be kept ultracold and thus the global distribution would be difficult. Also, the governments around the world are hoping for a vaccine that could be kept closer to room temperature and requires a single dose.
Pfizer-BioNTech or BNT162b2 vaccine
The Pfizer-BioNTech or BNT162b2 vaccine depends on messenger RNA or mRNA technology. In this, the genetic material from the virus is injected into the body which in turn uses this material to create a protein normally observed on the surface of COVID-19 virus particles, stimulating the immune system.
Interim analysis of vaccine
The vaccine is being tested on an ethnically diverse group of 43,000 individuals and is currently under trial. As per Pfizer, no serious safety concerns have arisen in the trials underway, although further efficacy data are being collected.
The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. Of the 10 people who had severe COVID-19, one received the vaccine.
The analysis also noted that the vaccine efficacy was consistent across all age groups, gender, race and ethnicity. The efficacy in individuals above 65 years of age was more than 94%.
The results which are announced are based on an interim analysis, conducted by an independent data-monitoring group. The firms intend to submit their data for review in a scientific journal.
It is to be noted that the efficacy percentage may change after the accumulation of additional data.
When will the vaccine be available?
According to several media reports, these pharma firms may secure emergency US and European authorisation for their mRNA-based COVID-19 vaccine before the end of this year. Ugur Sahin, BioNTech Chief Executive, expects to get a nod from the US Food and Drug Administration for emergency use by the mid-December and conditional approval in the EU by the second half of December.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively," said Ugur Sahin.
Although there's a hope for a vaccine, several questions remain unanswered. First, the extent to which the vaccine will work in elderly people; second, which is the most vulnerable group; third, which group may not respond to the vaccine; fourth, will it prevent infectiousness in people; and last but not the least, its efficacy in the long run.
Also, two more vaccines, AstraZeneca and Moderna are under clinical trials. Thus, it can be said that the arrival of vaccines to tame the ongoing COVID-19 pandemic is within the reach, marking the beginning of the end of the pandemic.