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Pfizer will submit full data on Covid treatment pill to the FDA in a few days, CEO says

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Paxlovid, a Pfizer’s coronavirus disease (COVID-19) pill, is seen manufactured in Ascoli, Italy, in this undated handout photo obtained by Reuters on November 16, 2021.

Pfizer | Handout | via Reuters

Pfizer will submit full data on its Covid treatment pill to the Food and Drug Administration in the coming days, CEO Albert Bourla told CNBC on Wednesday.

Bourla said he’s confident the full results from the clinical trials will show that the oral antiviral pill, Paxlovid, reduces hospitalization and death by 89% as interim data showed in November. Paxlovid is taken in combination with a popular HIV drug, ritonavir.

“We will have the full set in a few days,” Bourla told CNBC’s “Squawk Box.” “And we will submit them. I feel comfortable the data that we will submit will mimic at large what we saw in the first part of the study. When we unblind the data I don’t expect we will have a difference.”

Pfizer submitted its application to the FDA last month for emergency approval of the treatment. Bourla told CNBC the FDA has a “very high sense of urgency” and he believes they will make a decision this month.

The pill would be available to the public soon after its approved by the FDA, Bourla said. “We have already shipped product into the U.S, so product will be available this month if it’s approved,” the CEO told CNBC.

President Joe Biden said last month the U.S. has bought 10 million courses of Paxlovid and delivery will start at the end of the year.

Bourla previously told CNBC he doesn’t expect omicron to impact the efficacy of the pill because it works differently than the vaccines. Paxlovid fights the virus by inhibiting an enzyme it needs to replicate, whereas the vaccines target the the spike protein the virus uses to invade human cells.

The spike protein has mutated significantly across virus variants, making it more transmissible and in some cases more severe. The vaccines that target the spike potentially need updates depending on the type of mutation that occurs.

However, Bourla told The Wall Street Journal on Tuesday that it’s very difficult for the virus to mutate in a way where it doesn’t need the enzyme, called a protease, that Pfizer’s pill targets.

“It’s very difficult for the virus to create a strain that can live without this protease,” Bourla said. “It’s not impossible. It’s very difficult.”

The FDA’s advisory panel narrowly endorsed Merck and Ridgeback Therapeutics’ oral antiviral pill, molnupiravir, late last month. Panel members were divided and worried about unanswered questions regarding molnupiravir’s safety and efficacy.

Interim results from Merck showed the pill was 50% effective at preventing hospitalization and death, but fuller data found the drug is just 30% effective.

Several members of the FDA advisory panel said the agency should consider withdrawing emergency authorization for Merck’s pill if another treatment becomes available. The FDA has not yet made a final decision on molnupiravir.



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