The first COVID-19 vaccines in the US will be from the unique platform. An expert explains how they work.
In the coming days, the US Food and Drug Administration (FDA) will likely approve the first vaccine indicated for the prevention of coronavirus 2019 (COVID-19) in the US.
Pfizer and BioNTech’s candidate BNT162b2, which just this week shared phase 3 data results, will reviewed by the Vaccines and Related Biologic Products Advisory Committee (VRBPAC) and will possibly be approved for emergency use authorization (EUA) shortly thereafter.
It could be joined by Moderna’s vaccine, mRNA-1273, as early as next week, when the small-company vaccine candidate undergoes a similar final stage of regulatory consideration after again, more promising efficacy results.
What’s interesting about these candidates is what they share in common with each other, and with very few other regulated vaccines in the US. They are messenger RNA (mRNA) platform vaccines—which, to many scientists, is a mark of met innovation decades in the making, and to many vaccine skeptics, a concerning factor in what’s already been an extremely expedited process of vaccine development to treat a global pandemic.
In an interview with Contagion prior to FDA regulatory decision, William Schaffner, MD, professor of Preventive Medicine at Vanderbilt University Medical Center, fielded broad questions surrounding the functionality, safety, and brief history of mRNA vaccines.
As he noted, though this is a product being received in a condensed, high-stakes time frame, mRNA technology has actually been a long time coming in vaccinology.
“When we say we have worked very quickly to develop these vaccines, you have to understand that they have 10-15 years of scientific foundation by which these vaccines have been built,” he explained.
Schaffner also touched on the two-dose administration and immune-building schedule of the observed COVID-19 vaccines, and again set high expectations for real-world outcomes with mRNAs.
“It’s really 21st century science, and so far, all the data would indicate it has been marvelously effective,” he said.