Pfizer, BioNTech seek EUA as COVID-19 vaccine shows over 90% efficacy; here's what's next

As Pfizer-BioNTech COVID-19 vaccine showed more than 90 per cent efficacy in preventing coronavirus, the preliminary results have now paved the way for the companies to seek an emergency-use authorisation from the regulators if further research shows the shot is also safe. While the coronavirus infections recently passed the grim milestone of 50 million cases, American pharmaceutical company Pfizer said on November 9 that the interim analysis of its vaccine produced along with German partner BioNTech group has shown promising results. 

The recent findings are based on an interim analysis conducted after 94 participants contracted coronavirus. According to a Bloomberg report, the trial will continue until 164 cases have occurred. If the data hold up and key safety readout Pfizer expects in about a week also looks good, it could mean the world has a vital new tool to control the pandemic. The recent development could also bode well for the other experimental vaccines, in particular one being developed by Moderna Inc. that uses similar technology. If the study succeeds, there could be two vaccines available in the United States by around year-end. 

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The American pharmaceutical company Pfizer now expects to get two months of safety follow-up data, which is a key metric required by US regulators before an emergency authorisation is granted. The data is expected to be available in the third week in November. If the findings raise no problems, Pfizer could apply for authorisation in the US this very month. Additionally, regulators are also working with BioNTech to “further accelerate the process”. 

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Pfizer, BioNTech on track to 1st COVID vaccine 

Pfizer and BioNTech have said that the so far, the trial’s data monitoring committee has identified no serious safety concerns. While speaking to Bloomberg, BioNTech Chief Executive Officer Ugur Sahin said that the recent development is “really a victory of science”. He also informed that the positive preliminary data mean that the US pharma giant and its German partner are on track to the first vaccine, after signing advance deals with governments worldwide for hundreds of thousands of doses. 

Both the companies have reportedly said that they should be able to produce 1.3 million doses by the end of 2021. They also said, however, only 50 million doses are expected to be available in 2020. According to the media outlet, the shot relies on messenger RNA technology never before used in an approved medicine. Using mRNA, which basically teaches the body’s cell to become vaccine factories, allowed it to be developed much faster than a traditional vaccine. The American drugmaker has not yet provided any further details about the cases included in the analysis from an independent data monitoring board but informed that the initial protection rate might vary by the time the study would end. 

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