The mRNA vaccines produced by Pfizer and Moderna are faster to develop as they do not require companies to produce protein or weakened pathogen for the vaccine.
Traditional vaccines typically use a weakened version of the pathogen or a protein piece of it, but because these are grown in eggs or cells, developing and manufacturing vaccines takes a long time. By contrast, by using just the genetic material that makes the Spike glycoprotein – the protein on the surface of the coronavirus that is essential for infecting human cells – the design and manufacture of the vaccine is simplified.
The genetic material mRNA is easy to make in a laboratory. Manufacturing an mRNA vaccine rather than a protein vaccine can save months, if not years.
Another factor that accelerated vaccine development was the swift and efficient recruitment of patients for clinical trials.
How is safety assured when vaccine development is so fast?
Safety is the first and foremost goal for a vaccine.
In my opinion, safety is not compromised by the speed of vaccine development and emergency use authorization. The reason that vaccines may be approved so quickly is that the large clinical trials to assess vaccine efficacy and safety are happening at the same time as the large-scale manufacturing preparation, funded by the federal government’s Operation Warp Speed program.
Typically, large-scale manufacturing begins only once the vaccine has been tested in clinical trials. In the case of COVID-19, the U.S. government wanted to be ready to begin distributing the vaccine the moment the results of the phase 3 trials were known and the safety data had been analyzed.
To this end, the pharmaceutical companies launched at-risk manufacturing – which means that the manufactured vaccine doses would be thrown away if the vaccine was ineffective or unsafe – during the FDA-mandated two-month safety waiting period.
The upside is that if the vaccine is safe and effective, it can be distributed immediately, and vaccination can begin.
EUA stands for emergency use authorization.
Under EUA, the FDA is requiring that a COVID-19 vaccine be at least 50% effective at preventing symptomatic illness.
It is also requiring a median of two months of follow-up after completion of the vaccination for half of the vaccine recipients (for most of the vaccines this is two doses). This two-month period is to allow detection of an adverse event from the vaccine.William Petri, Professor of Medicine, University of Virginia
This article is republished from The Conversation under a Creative Commons license. Read the original article.
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