Covid Vaccine Next Week? Non-US Approval and FDA
(Thursday, December 3, 2020]
With UK approving the Pfizer Covid vaccine this week, there is increased pressure on FDA to be the next regulatory agency to do the same, which could be as early as next week. Historically, European and US regulators have routinely raced to be the first to approve well publicized new treatments. Covid vaccines fit that bill and MHRA did win that race this time. FDA is locked into previous commitments to not cut any corners in its review of the clinical trial data, and transparent public discussion via advisory committee meetings, a process that takes time. The MHRA made its decision based on the same data currently being reviewed by FDA. Typically, FDA claims to not be influenced by approvals by non-US regulators. In fact, one of the most revered story of FDA’s astute review process is that of FDA not approving Thalidomide despite the European approval, which, in turn, protected the US patients. However, this is not a typical case. Aside the political pressure to make a quick decision while maintaining statutory standards for review and complete transparency, any decision by FDA is under the watchful eye of the media for any missteps, and the public, looking for relief from the pandemic. And this decision by MHRA followed by Pfizer’s announcement that it is rapidly starting to vaccinate people in the UK, has created an immense pressure on FDA to make a quicker favorable decision. And unless there is some hidden adverse event overlooked by all and found by FDA, the vaccine’s emergency authorization is all but guaranteed. Both Pfizer and Moderna submitted applications for approval first in Europe and then in the US, for exactly this reason. Approval by a European regulator would have a higher appeal with the US public than say an approval in Russia or China. Also, European approval would facilitate approval by regulators in other countries, if not necessarily the US. Either way, filing outside the US was a smart and strategic plan that would pay returns in the US. Both companies are seeking emergency authorizations and not full approval of their vaccines. However, in this case, this authorization will, for all practical intents and purposes, be equivalent to a full approval as both vaccines will be likely used on all of the population.