U.S. health regulators okay with Pfizer’s Covid-19 pill

The US Food and Drug Administration (FDA) yesterday approved Pfizer’s Covid pills for high-risk people over the age of 12. This is a major pandemic milestone that will make treatment accessible to millions of people.
“Today’s approval introduces the first treatment for Covid-19 in the form of tablets that are taken orally. This is a major step forward in the fight against this pandemic,” FDA scientists said. Patrizia Cavazzoni said.
Pfizer’s treatment, called Paxlovid, is a combination of two tablets taken over a five-day period that is safe in 2,200 clinical trials and has been shown to reduce the risk of hospitalization and death for at-risk people by 88%. it was done.
As a rare move, the FDA did not convene a regular panel of independent experts to review the detailed data surrounding Pfizer’s tablets prior to approval.
Pfizer’s treatment was previously approved by the European Union. The United States has already paid for 10 million courses.
Authorization is driven by Omicron, the most infectious subspecies ever seen, when cases are proliferating across the United States.
Highly mutated variants can better avoid the immunity conferred by previous infections, and health officials urge the public to be boosted with mRNA vaccines to restore higher levels of protection. I am.
Unlike vaccines, Covid pills do not target the evolving peplomer of the coronavirus used to invade cells. Theoretically, it should provide more diverse evidence, and Pfizer states that preliminary studies support that hypothesis.
Approval of another Covid pill developed by Merck is still awaiting. It has also been taken over 5 days and has been shown to reduce the same results by 30% among high-risk people.
Independent experts voted in favor of the treatment by a small margin, but expressed concerns about its safety, including potential fetal harm and possible DNA damage.
The two treatments work differently in the body, and Pfizer tablets are not considered to have the same level of concern.
Merck’s treatment has been greened by the United Kingdom and Denmark.