The FDA’s Approval Process for Emergency Vaccines and Their Impact

The current Emergency Use Authorizations (EUAs) for COVID-19 vaccines have given the CDC and FDA significant oversight, particularly regarding vaccine distribution and usage. However, as the EUAs expire and the vaccines gain full approval, it opens the door for more flexibility in both medical and commercial use. One such example is the possibility of a third booster dose to maintain immunity, typically given six to twelve months after the primary series. This article delves into the timeline and potential impacts of transitioning from EUAs to full approval, examining the FDA’s process and the broader implications for public health and vaccine acceptance.

Timeline for Full FDA Approval

At present, the FDA is considering the transition from emergency use authorizations to full approval. There are differences and benefits in both stages. EUAs are intended to provide rapid access to life-saving treatments during public health emergencies, but full approval opens new opportunities for wider usage. The FDA must thoroughly evaluate the efficacy and safety of the vaccines, and the process can take several months.

My estimation is that the FDA will receive the necessary data and start the application process mid-January 2022. A review period of two to three months is anticipated. However, the FDA has a history of being meticulous and slow in its processes, so it might take longer.

In the United States, since vaccines are already available under EUA, the question of availability isn't moot. However, stock market players are eager to see the FDA issue full approval early as it can drive significant changes in the market dynamics and sentiment.

Pfizer and Moderna’s Timeline

Pfizer and Moderna likely applied for full certification in August, based on the timeframes for their initial submissions. The others may have also applied, but there's no publicly available information on their specific timelines. The expectation is that full FDA approval for these vaccines will likely follow in a few months, reflecting the agency's usual pace of 'with all deliberate speed.'

Full approval is expected to have little impact on vaccine acceptance. People who support vaccination will continue to get the shots, regardless of FDA approval status. Conversely, those who oppose vaccines will likely find another reason or excuse, much like the 'whack-a-mole' game of addressing vaccine objections.

The FDA’s Role and Legacy

The European Medicines Agency (EMA) has already fully approved the vaccines, ensuring their safety and efficacy. The FDA is expected to follow suit, but the process can be slow due to the rigorous standards and detailed procedures required. There is a risk that dragging the approval process out will make the FDA irrelevant, especially with over 200 million doses already administered.

Some argue that even if full approval were granted, it wouldn't change public sentiment significantly. The number of COVID-19 deaths prevented is a moot point, as there is no evidence that the new vaccines prevent infection or spread. In fact, several individuals have contracted the virus after receiving multiple doses of the 'vaccines.' This suggests that the current vaccines may not be as effective as advertised.

Furthermore, the vaccines are not proven to prevent infection or transmission, and numerous adverse effects have been reported. Consequently, it is highly unlikely that the FDA will approve such vaccines in the future. These shots are considered hazardous, harmful, and ineffective for their intended purpose.

Conclusion

In conclusion, while the FDA is likely to grant full approval to the emergency vaccines in the coming months, the process is expected to be slow and methodical. The broader impact of this approval may be limited, as it doesn't align with the current understanding and reported data on the vaccines' effectiveness. As such, the vaccine landscape and public health efforts may not see significant changes due to this approval.