The US Food and Drug Administration requires a series of protocols that are different from those necessary for the emergency authorization of inoculants.
Thirty percent of non-vaccinated American adults say they are waiting to be vaccinated for the COVID-19 vaccine, which is currently licensed for emergency use and is officially licensed by the US Food and Drug Administration (FDA). Approved. However, according to US media, this could happen in the next few days with a vaccine from Pfizer / Biotech Laboratory, which could give a new impetus to the vaccination campaign in the US.
So what needs to happen for the FDA to move from emergency use authorization to complete approval of COVID vaccines?
The authorization for emergency use, but streamlining the regulatory process to make the vaccine available to the public faster, must also meet a rigorous process by the FDA to ensure the safety and efficacy of the vaccine. The difference with full or final approval is that more time has passed for the latter, and more data will be available for review.
For both emergency use authorization and full approval of COVID-19 vaccines, the FDA first requires safety studies in a small number of people. In that instance, researchers document the possible adverse events or side effects that the vaccine may cause. Researchers also determine the safest and most effective dose of the vaccine.
Once the vaccine is determined to be safe and an optimal dose is identified, the researchers will create more extensive studies to determine how well it works in a controlled setting where some people receive the vaccine while others receive a placebo.
The number of people who participated in the initial safety studies of the COVID-19 vaccine was similar to that of the safety studies of other commonly used vaccines, including vaccines against tetanus, diphtheria, whooping cough, and meningitis. More than 43,000 adults participated in the early stages of the Pfizer / Biotech Clinical Trial, more than 30,400 in Moderna and more than 44,000 in Johnson & Johnson. Half of the participants in each study received the vaccine, while the other half received placebo.
Following safety studies, the paths to emergency clearance and full approval diverge, according to FDA protocols.
The FDA requires that at least half of the original study participants be followed for at least two months after vaccination for emergency use authorization. This is because the vast majority of vaccine-related side effects occur immediately after vaccination.
On the other hand, full FDA approval requires that participants in the original study be followed for at least six months. Researchers analyzed data from the same study participants but collected it over a more extended period. All adverse events are reviewed, and the manufacturer must also provide more detailed manufacturing plans and processes and a higher level of supervision and inspections.
Both Pfizer and Moderna began the process to obtain rapid FDA approval, designed to speed up the review. This allows companies to submit parts of their application for approval to the FDA for thought as they are completed.
Full FDA approval is likely to apply only to those age groups who were originally tested for emergency use. This means that the vaccine will be approved first for people 16 years of age and older for Pfizer and 18 years of age and older for Moderna.