Pfizer’s Covid Pill is approved for ages 12+ in the US

The United States authorized this Wednesday (22) the use of the pill against Covid-19 from Pfizer for people in the risk group over 12 years old, at a time when the number of cases of the omicron variant in the country does not stop go up, threatening the holiday season.

Paxlovid, which comprises two types of pills, received emergency use authorization from the Food and Drug Administration (FDA) after a clinical trial showed that its use reduces the risk of hospitalization and death for people. at risk by 88%.

“Today’s action is a testament to the power of science and the result of American innovation and ingenuity,” President Joe Biden said in a statement, vowing to invoke a law that would help Pfizer rapidly increase production of the drug.

The United States has already agreed to buy 10 million treatments worth approximately 5.3 billion dollars. The first 265,000 will be delivered in January and the rest by the middle of next year, White House coordinator for the pandemic, Jeff Zients, said in a statement.

“Today’s authorization features the first treatment against Covid-19 in pill form, taken orally,” FDA scientist Patrizia Cavazzoni said in a statement.

“This approval provides a new tool to fight Covid-19 at a critical time in the pandemic, when new variants are emerging,” said the FDA official.

The body emphasized that the treatment should complement and not replace vaccines, which continue to be the first-line tool in combating the coronavirus.

But pills that can be sold in pharmacies should be much easier to access than treatments with synthetic antibodies, which require infusions administered by drip in hospitals or specialized centers.

The use of Pfizer’s treatment had already been authorized last week in the European Union, awaiting formal approval and as an emergency measure given the increase in omicron cases.

omicron wave

The authorization comes at a time when Covid-19 spreads in the United States, driven by the omicron variant, the most infectious to date, and when access to detection tests has become a challenge due to long lines.

Companies like Amazon, Walgreens and CVS have limited the number of home tests that customers can purchase.

Biden’s administration has promised to distribute 500 million tests starting next month, though experts believe that number is too small and the measure comes too late.

Infections in the United States number about 150,000 a day, of which 7,800 require hospitalizations and 1,200 result in death, according to data from the Centers for Disease Control and Prevention (CDC).

The omicron variant accounts for 90% of all cases in some regions of the country, CDC Director Rochelle Walensky told reporters.

This variant, which contains multiple mutations, is better able to evade the immunity conferred by a previous infection or vaccines, and health officials are urging the public to take a booster dose of messenger RNA (mRNA) vaccines for added protection.

Unlike vaccines, the anti-covid pill does not act on the ‘spike’ protein of the coronavirus, which is constantly evolving and is used by the virus to invade cells. Thus, theoretically, it would be better able to face new variants. According to Pfizer, preliminary laboratory studies support this hypothesis.

Paxlovid is a combination of a new molecule, nirmatrelvir, and ritonavir, the antiviral against HIV, which are taken in separate pills.

Nirmatrelvir blocks the action of an enzyme the virus needs to replicate, while ritonavir slows down the breakdown of nirmatrelvir so that it stays in the body longer and at higher levels.

Synthetic antibody treatments developed by Eli Lilly and Regeneron are not effective against omicrons, scientist Anthony Fauci told reporters, but an antibody treatment from GlaxoSmithKline (GSK) and a prophylactic antibody drug from AstraZeneca still provide protection.

The United States bought a million cycles of the GSK treatment, which should be ready in January, as well as half a million doses of AstraZeneca’s drug, which can be given preventively to immunosuppressed people who don’t respond as well to vaccines.

Authorization is still awaited for another pill against the disease, developed by MSD pharmaceutical (known as Merck in the United States and Canada) and which is also administered for five days.

Independent experts voted in favor of this treatment by a narrow margin, but expressed concerns about its safety, such as the potential harm to fetuses in pregnant women and possible damage to the DNA strand.

The two treatments work differently within the body and the Pfizer pill is not believed to pose the same level of risk.