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Former FDA Chief Says Major New Development Signals the 'End of the Pandemic'

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A Pfizer board member on Friday predicted that the end of the COVID-19 pandemic might come before the end of the year and said it is dependent on whether his company’s new therapeutic is approved for emergency use by the Food and Drug Administration.

Dr. Scott Gottlieb, the former head of the FDA and a current Pfizer board member, appeared on CNBC’s “Squawk Box” to talk about the oral COVID treatment Paxlovid.

The medication, according to Gottlieb, could bring about an end to the pandemic, which would occur before President Joe Biden’s vaccine mandate goes into effect on Jan. 4.

The Pfizer executive said he is so certain the company’s therapeutic works that he doesn’t think the Occupational Safety and Health Administration will need to fine companies that employ unvaccinated workers.

“I think the bottom line is the end of the pandemic, at least as it relates to the United States, is in sight right now,” Gottlieb told CNBC.

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“These mandates that are going to be put in place by Jan. 4 really are coming on the tail end of this pandemic,” he added. “By Jan. 4, this pandemic may well be over, at least as it relates to the United States after we get through this delta wave of infection. And we’ll be in a more endemic phase of this virus.”

He also told the network that Paxlovid might become a substitute for vaccinations for many people.

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“When you have therapeutics that are this effective, that can be a backstop for people for whom vaccines don’t work, people who have breakthrough infections – there’s pills being studied in that setting,” he said. “It really is a backstop against death and disease from this infection.”

Pfizer is expected to submit an authorization request for the medication by Thanksgiving. In clinical trials, the medicine was reportedly so successful that trials were halted. The new drug was reported to be especially successful when it was combined with medication given to people with HIV.

Reuters reported the drug in trials cut down the risk of hospitalization or death in patients with COVID by 89 percent — showing more promise than Merck & Co. antiviral drug molnupiravir.

Pfizer said in a news release Friday that no deaths were reported during a 28-day study.

“PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19,” the company said. “In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo.”

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“Pfizer plans to submit the data as part of its ongoing rolling submission to the U.S. FDA for Emergency Use Authorization (EUA) as soon as possible,” the company added.

Pfizer CEO Albert Bourla also issued a statement.

“Today’s news is a real game-changer in the global efforts to halt the devastation of this pandemic. These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” he said.

“Given the continued global impact of COVID-19, we have remained laser-focused on the science and fulfilling our responsibility to help healthcare systems and institutions around the world while ensuring equitable and broad access to people everywhere.”

Pfizer shares were up nearly 8 percent Friday morning.

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Johnathan "Kipp" Jones has worked as a reporter, an editor and a producer in radio, television and digital media. He is a proud husband and father.
Johnathan "Kipp" Jones has worked as an editor and producer in radio and television. He is a proud husband and father.




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