EU Approves Pfizer’s COVID-19 Pill for Adults at Risk of Severe Disease

This image provided by Pfizer in October 2021 shows the company's COVID-19 Paxlovid pills. Pfizer via AP

The European Commission (EC) on Friday authorized the use of Pfizer’s COVID-19 antiviral pill one day after the European Unions’ (EU) drugs regulator backed the treatment for adults who do not require supplemental oxygen and who are at increased risk of severe disease.

Stella Kyriakides, the EU’s commissioner for health and food safety, called it “a key step in bringing the most promising therapeutics to citizens and a strong, second line of defense against the pandemic after vaccination.”

The pill, Paxlovid, was endorsed by the European Medicines Agency (EMA), which issued a statement on Thursday as it granted conditional marketing authorization for the oral antiviral medicine used for treating the CCP (Chinese Communist Party) virus, which causes COVID-19.

“Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating COVID-19,” the EMA said.

The drug was cleared by regulators in the United States and Britain in late December, although authorities noted that supplies would be extremely limited.

Paxlovid is made of two active substances that come as two separate pills taken twice a day together for five days. Britain said last month it already secured more than 2.75 million courses of the drug.

A similar antiviral pill produced by Merck is also expected to soon be authorized. The pills from both Pfizer and Merck are expected to be effective against Omicron because they do not target the spike protein where most of the variant’s worrisome mutations reside.

Merck's antiviral pill against COVID-19 is seen in an undated photograph. Merck via AP

The EMA said its decision was made based on a review of the drug’s use in people who were mostly infected with the Delta variant of the CCP virus, but they believed it would also be helpful against Omicron.

“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants,” the regulator said. It said the drug’s safety profile was “favorable” and that side effects were generally mild.

The Associated Press contributed to this report.

From NTD News