COVID-19 Vaccine Approval Dates Unknown

There are currently two COVID-19 vaccines that are awaiting emergency approval from the US FDA which include Pfizer/BioNtech and Moderna. Misbar has found that the FDA plans to discuss approval for the Pfizer vaccine on December 10 and plans to meet again on December 17 to review Moderna’s request for Emergency Use Authorization. However, there has been no mention of how long the process will take for approval to be granted. Such authorization allows a drug to be used as a treatment while studies are still being conducted in determining its safety and effectiveness, with critics stating that such a process is likely to lead to a greater risk of health complications. An emergency authorization significantly speeds up FDA approval, which typically takes six to ten months depending on priority.

General Gustave Perna of the Trump administration’s Operation Warp Speed coronavirus vaccine program stated that the speed of Pfizer’s application for emergency use authorization was “remarkable” and that his team would have vaccines “moving throughout the country” within 24 hours of authorization being issued. Health Secretary, Alex Azar, confirmed that such distribution would be ready within a day of approval. Pfizer plans to have 6.4 million doses ready for delivery by 19 December, According to notes from Mr. Pence's conference call with US governors on Monday. That would be sufficient for three million people as two shots are required per person in order for the vaccine to be effective. Both Pfizer and Moderna are estimated to produce enough vaccines by the following week for another 10 million people, and by the end of the month, the companies are projected to have produced enough vaccines for 30 million people.

According to a statement by Pfizer, the pharmaceutical company has already initiated rolling submissions across the globe including in Australia, Canada, Europe, Japan, and the U.K. Plans to submit applications will occur immediately to other regulatory agencies around the world. Furthermore, the company “expects to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021”, with the distribution of the vaccine set to be ready within hours after authorization.

The UK became the first nation to approve the Pfizer/BioNtech vaccine on Wednesday and is expected to begin rolling it out next week. According to Scotland’s First Minister, Nicola Sturgeon. Pfizer and BioNtech have submitted their application to the European Health Authorities and are expected to receive approval from the US and UK on December 29.

Misbar's team found that the date of approval is still unknown and can't be determined. There have been several varying dates claimed by users for vaccine approval and distribution. The Trump administration, FDA, and both Pfizer and Moderna have confirmed the timeline of authorization and roll-out in the US.