FDA: COVID-19 Rebound Takes Place Whether Or Whether Paxlovid is Used

FDA documents state that regardless of Paxlovid treatment, a rebound of COVID-19 may be a normal part of the disease’s course.

Prior to a meeting of the agency’s outside experts on Thursday to decide on the medication’s full approval, Food and Drug Administration staff members supported the use of Paxlovid in adults at high risk of severe COVID-19.

In the United States, the therapy has been administered in excess of 8 million times., according to federal data. Some Paxlovid patients experienced a resurgence of COVID-19 symptoms and tested positive for the virus after previously testing negative, such as with President Joe Biden and renowned infectious disease expert Anthony Fauci.

But in documents published online this week, agency officials supported the use of Paxlovid, arguing that “rebound may occur as part of the natural progression and resolution of Regardless of PAXLOVID therapy, COVID-19 disease exists.”

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The rates of COVID-19 symptom rebound were comparable between Paxlovid users and those who took a placebo, according to an analysis cited by FDA staff. According to the documents, the average rate of symptom recurrence was between 10 and 16%.

The FDA’s Antimicrobial Drugs Advisory Committee will discuss the information on Thursday when it convenes to decide whether the treatment’s advantages outweigh its disadvantages. In December 2021, the drug received emergency use approval.

According to Pfizer’s trial of the drug, Paxlovid reduced the risk of hospitalization or death in high-risk, unvaccinated adults by 86%.

The FDA approved Pfizer’s updated COVID-19 booster shot for children under the age of five on Tuesday for emergency use.

“Today’s authorization provides parents and caregivers of children 6 months through 4 years of age who received the three-dose primary series with the monovalent Pfizer-BioNTech COVID-19 Vaccine an opportunity to update their children’s protection by receiving a booster dose with the Pfizer-BioNTech COVID-19 Vaccine, Bivalent,” In a statement, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said. “We strongly advise all eligible people to make sure that they are up to date on their vaccinations with a bivalent COVID-19 vaccine because the best defense against serious illness, hospitalization, and death brought on by COVID-19 across all age groups continues to be vaccination.”

However, only 16% of Americans do. population has rolled up their sleeves to get the updated booster shot, likely setting up the under 5 age group to see low uptake as well.