Yesterday, the FDA approved the use of the Pfizer-biotech vaccine for use in people over 16 years old. The vaccine is the first of the Covid-19 vaccines to be fully approved by the FDA. The vaccine was previously granted Emergency use authorization (EUA), and this still applies to its use in children aged 12 to 15, as well as in third doses to some immunocompromised people.
Acting FDA Commissioner Janet Woodcock, M.D. stated, “The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”
The vaccine will now be marketed as Comirnaty. It is still the exact same vaccine, working by delivering mRNA genetic material to the body, equipping it to fend off Covid-19 in the future. The FDA emphasizes that despite some people’s concerns, “The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material,” -- just like with other mRNA vaccines.
“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”
Want to Learn More?
In addition to keeping you up to date on all things clinical trials, we also act as a digital CRO with a specific focus on patient recruitment and retention. We believe that patient recruitment and study startup (especially study design and study material) are heavily intertwined. After all, study design can make or break clinical trials, and the patient-perspective should be considered when designing studies to ensure that patient targets are met not only on time, but also on budget.
For Citruslabs, patient recruitment starts with study design and ends with trial completion. We recruit patients through our network of health apps, which enables you to connect with thousands of patients in real time. The best part: these patients are already educated and prepared for the clinical trial process.