Pfizer seeks full FDA approval of Paxlovid as questions about its benefits grow

Dive Brief:

• Pfizer announced on Thursday it has asked the Food and Drug Administration for a standard approval of its COVID-19 pill Paxlovid.
• Paxlovid was initially cleared for emergency use in the U.S. last year. Converting its initial nod to a full approval could broaden its use in the U.S., however, as it would allow Pfizer to sell the drug outside of government-directed channels.
• Pfizer had delivered 12 million treatment courses as of the end of May and has predicted it will make at least $22 billion in sales from the pill this year.

Dive Insight:

After a slow start, the use of, and demand for Paxlovid has substantially increased amid newer surges in infections.  

To keep up with the demand, Pfizer recently announced plans to invest $120 million in a drug manufacturing facility in Michigan to boost production of its COVID-19 pill. 

A standard FDA approval would bolster those ambitions. Currently, the pill is only available under an emergency authorization, a special regulatory tool the regulator uses to speed medicines to market during a public health crisis. An emergency clearance only lasts as long as the health emergency is ongoing, though, and limits Pfizer to selling its product directly to the government. If Paxlovid is approved, Pfizer can distribute the drug more widely.

But greater use could also highlight Paxlovid’s emerging weaknesses. While Paxlovid has proven strongly effective at reducing severe ramifications in unvaccinated individuals at high risk of developing severe COVID-19, it has mixed results in vaccinated or lower-risk patients. There’s also the risk of COVID-19 rebound, where symptoms can briefly return even after Paxlovid treatment.   

Another concern is the potential emergence of new variants that might escape treatment. Pfizer has said its pill has shown a consistent ability to reduce levels of virus caused by infections with omicron and delta. Emerging laboratory studies show that some circulating variants have mutations that may slip by Paxlovid, though. 

The high number of mutations within omicron rendered multiple antibody drugs ineffective.  

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