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Covid-19 pill gets FDA approval

FDA Officer in Charge Dr. Oscar Gutierrez. Contributed Photo

THE Food and Drug Administration (FDA) has approved for emergency use another pill for Covid-19 patients.

The Paxlovid pill, according to its developer, American drug giant Pfizer, is 89 percent effective in preventing hospitalization or death in high-risk adults.

The emergency use authorization (EUA) was issued to Pfizer on March 10, FDA Officer in Charge Dr. Oscar Gutierrez said. This allows the Department of Health (DoH) and the National Task Force Against Covid-19 to procure supplies of the pill and distribute it free of charge to Covid-19 patients.

The pill has two antiviral compounds, nirmatrelvir and ritonavir, and has to be taken twice daily for five days after diagnosis for Covid-19 for adults ages 18 above.

It is not recommended for women who are pregnant, lactating or those with child-bearing potential

Paxlovid is the second oral Covid-19 drug approved for emergency use in the country. The FDA earlier approved molnupiravir, with eight manufacturers given authority to distribute it in the country.

Among the latest manufacturers to receive an EUA for molnupiravir is Sahar International Trading, which markets it as Molenzavir.

EUAs were also issued for casirivimab and imdevimab, antibody cocktails for patients with mild Covid-19.

Gutierrez said the FDA welcomes the DoH's plan to donate near-expiring vaccine doses to countries such as Myanmar, Cambodia and parts of Africa.

“Magandang desisyon 'yun kung ang Pilipinas ay makapagdonate sa mga bansang nangangailangan (It's a wise decision to donate vaccines to other countries which are in need),” he added.

Gutierrez also said any extension to the shelf life of vaccines must conform to the guidelines on vaccine stability issued by the World Health Organization in 2006.

Manufacturers must have retention samples from every batch number to determine how long their vaccines will remain effective past its printed shelf life.

Gutierrez said the FDA will not approve any shelf life extension if the manufacturers note changes in the quality profile.

Gutierrez said many vaccine batches have had their shelf life extended following testing.

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