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Former FDA Executive on COVID-19 and Convalescent Plasma

By Jacob Wolinsky. Originally published at ValueWalk.

convalescent plasma Former FDA Associate Commissioner

Former FDA Associate Commissioner on COVID-19, Vaccines and Convalescent Plasma Authorization: Margin of Error and Distribution; AstraZeneca, Moderna, Pfizer


Q2 2020 hedge fund letters, conferences and more

Fauci: ‘About 40%-45% of Infections Are Asymptomatic’

Prof. Peter Pitts on Cheddar TV

Former FDA Associate Commissioner Says FDA Made Right Move to Authorize Convalescent Plasma

Topics

COVID-19 vaccines: What’s coming and when?

Some 170 Covid-19 vaccines are in development around the world, according to the WHO, each one promising to protect people from the deadly coronavirus and allow them to go back to work and school.

Now, a handful are starting or nearing the final stage of testing. Depending on the results, some companies say their vaccines could be greenlighted for use as soon as this year.

How does a vaccine get approved?

The FDA says the advisory committee typically has scientists, physicians, biostatisticians and a consumer representative who review the data. “The independence of these bodies is incredibly important,” Peter Pitts told CBS News on Friday, noting that he oversaw appointing experts to advisory committees while at the FDA. The agency almost always follows the panel’s advice, he said.

What is the margin for error?

“When it comes to vaccines, there is no margin for error,” Pitts said. “There is no replacing lost public confidence.”

On vaccine distribution

“We haven’t really reached a crisis where we need to vaccinate the whole population at the same time,” Pitts recently told Gray TV

Pitts says a number of organizational issues need to be ironed out, like cold storage as the states prepare to unfurl their distribution plans. He also says specifically who makes the decisions on distribution is a thorny question.

AstraZeneca resumes vaccine trial as Gilead drug gets a boost from Lilly

AstraZeneca (AZN) has resumed its Phase 3 vaccine trial in the U.K., marking the end to a brief but abrupt interruptionto the global frontrunner in the vaccine race.

Other frontrunners like Moderna (MRNA) and Pfizer (PFE) are also moving along in the final stage of trials, with Pfizer expecting to enter regulatory review next month and distribute its vaccine by the end of the year. On Monday, the race got a new competitor in the form of Vaxart (VXRT), which received regulatory approval for human trials for its vaccine candidate — and sent the stock up around 50% intraday.

Fauci: ‘About 40%-45% of Infections Are Asymptomatic’

Asymptomatic carriers can account for a large proportion — up to 50% — of virus transmissions, Dr. Anthony Fauci told a virtual crowd of critical care clinicians gathered by the Society of Critical Care Medicine (SCCM) on Friday.

Such transmissions have made response strategies, such as contact tracing, extremely difficult, he said.


Peter Pitts

Former FDA Associate Commissioner

President of the Center for Medicine in the Public Interest

Visiting Professor at the University of Paris School of Medicine

Author of Common Sense Healthcare Policy for Common Sense Americans, Cognito Press, Aug 22, 2019

Named one of the 300 “most powerful people in American healthcare,” by Modern Healthcare Magazine

The post Former FDA Executive on COVID-19 and Convalescent Plasma appeared first on ValueWalk.

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