From Stat

Here Come the Tortoises: In the Race for a Covid-19 Vaccine, Slow Starters Could Still Win Out

September 24, 2020

The race is not always to the swift, as the cocky hare learned in Aesop’s classic fable, “The Hare and the Tortoise.” Those handicapping the so-called competition to develop Covid-19 vaccines would do well to keep an eye on the slower runners in this pursuit.

Corporate giants Sanofi and Merck, which got a relatively late start in developing Covid-19 vaccines, may seem far behind the frontrunners. But experts say they also have such deep experience developing and testing vaccine candidates, and producing vaccine at commercial scale, that both could well close the gap considerably in the months ahead.

The race is not always to the swift, as the cocky hare learned in Aesop’s classic fable, “The Hare and the Tortoise.” Those handicapping the so-called competition to develop Covid-19 vaccines would do well to keep an eye on the slower runners in this pursuit.

Corporate giants Sanofi and Merck, which got a relatively late start in developing Covid-19 vaccines, may seem far behind the frontrunners. But experts say they also have such deep experience developing and testing vaccine candidates, and producing vaccine at commercial scale, that both could well close the gap considerably in the months ahead.

Each is developing two vaccines, in partnership with others….

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Lilly’s Covid-19 Antibody Helps Some Patients Rid Their Systems of Virus Sooner in Early Analysis

September 16, 2020

Adrug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.

The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.

Adrug being developed by Eli Lilly helped sick patients rid their systems of the virus that causes Covid-19 sooner and may have prevented them from landing in the hospital, according to newly released data.

The drug is what is known as a monoclonal antibody, which experts view as being among the most likely technologies to help treat Covid-19. It’s a manufactured version of the antibodies that the body uses as part of its response to a virus.

“This is a good start,” said Eric Topol, the director and founder of the Scripps Research Translational Institute. “A lot is pinned not only on Lilly but on the whole family of these [monoclonal antibodies], because even though they’re expensive and they’re not going to make a gajillion doses, they could make a big difference in the whole landscape of the pandemic….”

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Experts See a Chance for a Covid-19 Vaccine Approval This Fall — If It’s Done Right

September 2, 2020

There is growing concern that the Food and Drug Administration, under political pressure, could approve a Covid-19 vaccine before it has robust safety and efficacy data.

The consequences of such a decision could be significant, particularly if the vaccine is ultimately shown to be less effective than early data suggest. But an approval before the completion of large, Phase 3 trials does not have to be problematic. Experts aren’t ruling out the possibility that a vaccine could be cleared this fall if it is very effective.

There is growing concern that the Food and Drug Administration, under political pressure, could approve a Covid-19 vaccine before it has robust safety and efficacy data.

The consequences of such a decision could be significant, particularly if the vaccine is ultimately shown to be less effective than early data suggest. But an approval before the completion of large, Phase 3 trials does not have to be problematic. Experts aren’t ruling out the possibility that a vaccine could be cleared this fall if it is very effective.

“There are mechanisms by which products that have a good amount of data can be made available in a controlled way,” said Natalie Dean, an assistant professor of biostatistics at the University of Florida who specializes in vaccine study design….

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New Covid-19 Testing Guidelines, Crafted at the White House, Alarm Public Health Experts

August 27, 2020

Public health experts reacted with alarm Wednesday to new Covid-19 testing guidelines issued by the Centers for Disease Control and Prevention, guidance that they said will make it harder to find and isolate people spreading the SARS-2 virus early and will undermine efforts to control transmission.

The guidance recommends against testing people who have been in contact with confirmed Covid-19 cases but who don’t yet have symptoms — even though such people can be infectious. It was crafted not by the CDC but by the White House coronavirus task force, and the nation’s best-known infectious disease expert, Anthony Fauci, didn’t sign off on it….

Public health experts reacted with alarm Wednesday to new Covid-19 testing guidelines issued by the Centers for Disease Control and Prevention, guidance that they said will make it harder to find and isolate people spreading the SARS-2 virus early and will undermine efforts to control transmission.

The guidance recommends against testing people who have been in contact with confirmed Covid-19 cases but who don’t yet have symptoms — even though such people can be infectious. It was crafted not by the CDC but by the White House coronavirus task force, and the nation’s best-known infectious disease expert, Anthony Fauci, didn’t sign off on it….

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Stunning FDA Rejection Signals Potential New Hurdles for Gene Therapies

August 20, 2020

The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder hemophilia has reverberated through the biotech industry, potentially complicating the path to market for these one-time treatments.

In deciding not to approve Roctavian, a BioMarin Pharmaceutical gene therapy for hemophilia A, the FDA demanded two additional years of data to strengthen the case that its benefits are durable. That contrasts with the agency’s perceived leniency in approving previous one-time therapies for rare diseases, and it could affect the plans of other gene therapy companies hoping to win FDA approval based on early signs of promise….

The Food and Drug Administration’s unexpected rejection of a gene therapy for the bleeding disorder hemophilia has reverberated through the biotech industry, potentially complicating the path to market for these one-time treatments.

In deciding not to approve Roctavian, a BioMarin Pharmaceutical gene therapy for hemophilia A, the FDA demanded two additional years of data to strengthen the case that its benefits are durable. That contrasts with the agency’s perceived leniency in approving previous one-time therapies for rare diseases, and it could affect the plans of other gene therapy companies hoping to win FDA approval based on early signs of promise….

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