FDA Advisers Back Full Approval of Paxlovid

Facts

• Independent advisers to the US Food and Drug Administration (FDA) on Thursday voted 16-1 in support of full approval of Paxlovid — Pfizer’s oral treatment for COVID — for high-risk adults.¹
• The FDA is expected to decide by May whether to grant full approval to the medication, which has been used by millions of Americans since it received emergency use authorization from the FDA in 2021.²
• Paxlovid is for people over 50 years old, or those with medical conditions that could land them in the hospital or put them at risk of dying from COVID, who become infected.³
• Patients have been concerned about a 'rebound effect' related to taking Paxlovid, but FDA data has also shown that people who didn’t take the drug sometimes also suffered from a rebound.⁴
• At this time, remdesivir is the lone antiviral drug with full FDA approval as a COVID treatment. Molnupiravir, another pill, has emergency authorization, but regulators in Europe have recommended against its approval due to safety concerns.⁴
• The FDA advisers also were concerned about adverse reactions that could result from interactions between Paxlovid and other drugs. But those risks could be addressed by taking certain actions, including adjusting the dose of some drugs and monitoring patients closer.³

Sources: ¹Reuters, ²Associated Press, ³CNBC and ⁴New York Times.

Narratives

• Narrative A, as provided by CNN. Paxlovid should be on a clear path to full approval from the FDA, and that status can’t come soon enough. This important tool in the fight against COVID would have prevented thousands of deaths last winter, and it will be useful in the winters ahead. Concerns about COVID rebound and problems with drug interactions have been addressed, so the FDA shouldn’t postpone Paxlovid’s wider availability much longer.
• Narrative B, as provided by Atlantic. Not so fast. The data on who would benefit most from Paxlovid is still lacking, and there are still numerous questions that need to be answered. Doctors are already tentative about prescribing it because of the fear of side effects, in addition to uncertainty over whether it’s safe for people who are pregnant or in vulnerable populations. The FDA will have to solve many of these mysteries before full approval.