Pfizer Inc. (NYSE:PFE) is upbeat that its COVID-19 vaccine candidate will demonstrate early evidence of effectiveness in clinical trials that have commenced.
Pfizer to show by the end of October that Its COVID-19 vaccine works
The company indicated that it will be able to show by the end of October whether the coronavirus vaccine they are developing with Germany-based BioNTech SE is effective and safe. Pfizer said that if results from the trial show that the vaccine is effective, they will then move to seek regulatory approval but have not indicated what data will be used.
With the US going to polls in November, President Donald Trump is optimistic of a vaccine being available soon. Trump expects a vaccine to be available before the November 3 vote, which raised questions about political interference. There are concerns from scientists questioning whether there will be adequate evidence for drugmakers to achieve success by November.
Pfizer has enrolled 29,000 participants in the trial to demonstrate the effectiveness of the vaccine
Pfizer’s trial’s clinical protocols show how the company will make the vaccine meet safety and efficacy standards set by the US FDA. Usually, drugmakers submit clinical trial protocols to the FDA for reviews with an independent expert panel called Data and Safety Monitoring Board overseeing the review. Pfizer’s protocol calls for first vaccine performance assessment after 32 subjects in trial become infected with COVOID-19. Around 29,000 people have been enrolled in the study commenced in July, with some receiving the vaccine and others a placebo.
According to the FDA, a COVID-19 vaccine has to show to be at least 50% effective compared to a placebo group in a large scale study before approval. But according to researchers, a smaller infection sample in a clinical trial can change the calculation on the standard is met.
Interestingly Pfizer’s mRNA vaccine has to show to be around 76.9% effective to demonstrate that it can work based on the 32 infections. This means that not more than six cases should be reported among the population that received the vaccine.