The coronavirus pandemic remains relevant, and so does the vaccine race to annihilate this disease. In a resounding announcement, two US and German pharmaceutical companies said they had developed a vaccine that was 90% effective.
A vaccine that far exceeds the requirements of the American authorities
The American pharmaceutical giant Pfizer and the German biotechnology company BioNTech declared in a Press release that their coronavirus vaccine was over 90% effective. This announcement is based on data analyzed by an external, independent committee tasked with verifying the results of the Phase 3 vaccine trials – the last step before submission for a commercial license. The study found that 94 participants who received the two-dose vaccine were protected against disease 28 days after their first inoculation. These individuals were chosen from the 43,538 study participants.
It should be noted that these analyzes relate only to the first results of clinical trials, and not to the final results. Either way, this remains hugely promising news in the progress towards finding a solution to stop the Covid-19 pandemic. So far, the two companies have provided little information about their experimental vaccine. Aside from recent claims on how effective the product is, BHT162b2 is known to be an mRNA-based vaccine, and that it did not cause any major problems with test participants.
When the final test results are obtained – and if they are conclusive – Pfizer and BioNTech intend to apply for marketing authorization for the vaccine with the US regulatory body, the Food and Drug Administration (FDA). It should be noted that the current results for this vaccine far exceed the criteria of the FDA for the approval of a vaccine for Covid-19. The body requires an efficiency of at least 50% in placebo-controlled trials for the vaccine to be validated. For their part, scientists hope that the future vaccine will be at least 75% effective, CNBC reported.
A vaccine that could be deployed before the end of the year
It is important to know that studies for the third phase of testing the vaccine are still ongoing, and the percentage of effectiveness is still subject to change. Additional safety and safety testing will also need to be performed. In addition, the complete data will still need to be peer reviewed before it can be submitted to the FDA. Participants will also be followed for a full two years after receiving their second and last dose of the vaccine to test for long-term effects. However, the vaccine can be validated before these two years of follow-up.
The results so far have been promising, and the two companies hope to be able to start large-scale distribution of the vaccine before the end of the year. If the FDA grants emergency use clearance for the vaccine, Pfizer and BioNTech believe they can manufacture enough doses to immunize 15-20 million people by the end of this year, taking into account that two doses per person will be required. It is very likely that hospital staff will be the first to receive the vaccine, reported The Guardian. The two companies also plan to produce an additional 1.3 billion doses in 2021.