POLITICAL PRESSURE VS SCIENCE
BY NATHANIEL WEIXEL - 10/22/20
© Getty Images
The Food and Drug Administration (FDA) has granted full approval to the antiviral drug remdesivir to treat COVID-19, manufacturer Gilead announced Thursday.
FDA initially granted emergency use authorization for remdesivir in May, which allowed doctors and hospitals to use the drug to treat hospitalized patients without a full approval.
It showed modest results in reducing the hospitalizations of patients with severe cases of COVID-19. Remdesivir is administered in a hospital setting through an IV.
The approval is based on three randomized controlled trials, including one sponsored by the National Institutes of Health.
That study, published in the New England Journal of Medicine earlier this month, showed that hospitalized patients receiving remdesivir recovered five days faster on average, and in patients with severe disease, seven days faster, compared to a placebo.
The study also found remdesivir also reduces the likelihood of patients requiring new or more intensive oxygen support. While it was not a primary endpoint for the study, there was evidence remdesivir may reduce the likelihood of death.
Remdesivir is now the only FDA-approved treatment for COVID-19, and is available in more than 50 countries.
“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Daniel O’Day, Gilead's chairman and CEO.
The approval comes a week after a large-scale World Health Organization trial found remsdesivir had no substantial impact on the survival of COVID-19 patients or the length of their hospital stays.
However, Gilead said the WHO trial design "prioritized access" to remdesivir and other investigational treatments "over the ability to draw definitive conclusions, due to the variability in the implementation of the study, standard of care controls and patient populations across trial sites."
The majority of patients treated with remdesivir receive a five-day treatment course using six vials of the intravenous drug.
Gilead currently charges private insurers $3,120 per patient for a five-day course of the treatment.
Other developed countries and direct purchasers in the U.S. government, including the Veterans Affairs hospitals, will pay $2,340 for a five-day course of the drug.
The approval comes a week after a large-scale World Health Organization trial found remsdesivir had no substantial impact on the survival of COVID-19 patients or the length of their hospital stay
BY NATHANIEL WEIXEL - 10/22/20
© Getty Images
The Food and Drug Administration (FDA) has granted full approval to the antiviral drug remdesivir to treat COVID-19, manufacturer Gilead announced Thursday.
FDA initially granted emergency use authorization for remdesivir in May, which allowed doctors and hospitals to use the drug to treat hospitalized patients without a full approval.
It showed modest results in reducing the hospitalizations of patients with severe cases of COVID-19. Remdesivir is administered in a hospital setting through an IV.
The approval is based on three randomized controlled trials, including one sponsored by the National Institutes of Health.
That study, published in the New England Journal of Medicine earlier this month, showed that hospitalized patients receiving remdesivir recovered five days faster on average, and in patients with severe disease, seven days faster, compared to a placebo.
The study also found remdesivir also reduces the likelihood of patients requiring new or more intensive oxygen support. While it was not a primary endpoint for the study, there was evidence remdesivir may reduce the likelihood of death.
Remdesivir is now the only FDA-approved treatment for COVID-19, and is available in more than 50 countries.
“It is incredible to be in the position today, less than one year since the earliest case reports of the disease now known as COVID-19, of having an FDA-approved treatment in the U.S. that is available for all appropriate patients in need,” said Daniel O’Day, Gilead's chairman and CEO.
The approval comes a week after a large-scale World Health Organization trial found remsdesivir had no substantial impact on the survival of COVID-19 patients or the length of their hospital stays.
However, Gilead said the WHO trial design "prioritized access" to remdesivir and other investigational treatments "over the ability to draw definitive conclusions, due to the variability in the implementation of the study, standard of care controls and patient populations across trial sites."
The majority of patients treated with remdesivir receive a five-day treatment course using six vials of the intravenous drug.
Gilead currently charges private insurers $3,120 per patient for a five-day course of the treatment.
Other developed countries and direct purchasers in the U.S. government, including the Veterans Affairs hospitals, will pay $2,340 for a five-day course of the drug.
FDA advisers grapple with COVID vaccine questions
BY NATHANIEL WEIXEL - 10/22/2020
© Getty Images
Members of an expert panel advising the Food and Drug Administration (FDA) on coronavirus vaccines on Thursday argued against ending clinical trials even after the first vaccine becomes available.
There is no vaccine for COVID-19 for the panel to review yet, as clinical trials are still continuing. The FDA has said it expects to reconvene the panel multiple times in the future to examine the evidence every time a vaccine manufacturer applies for emergency authorization or approval.
During the daylong remote meeting, the panel of infectious disease experts and federal scientists offered reassurances that when they do review a COVID-19 vaccine, it will not be rushed to market before it is proven safe.
"Vaccine development can be expedited; however, I want to stress that it cannot, and must not, be rushed," Marion Gruber, director of FDA’s vaccine research office, told the panel.
The clinical trials of major vaccine manufacturers are ramping up, the FDA could see initial results by the end of November. Moderna, for instance, announced Thursday its clinical trial had finished enrolling participants.
Moderna said that more than two-thirds of its trial participants had received their second dose and that the company was working toward FDA's requirement of tracking participants for two months afterwards.
FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include people at highest risk from COVID-19, like older adults, minorities and people with underlying health issues.
FDA has made clear that any vaccine must be at least 50 percent effective.
If and when a vaccine becomes available, its availability will be extremely limited for the first few months, if not longer. Federal officials are grappling with the question of whether to continue clinical trials during the time.
Patients enrolled in the blinded trials will likely want to know if they have been given a placebo. In comments submitted ahead of the meeting, Pfizer said it wants to be able to dose placebo patients with an authorized vaccine if they want it.
The FDA has said it does not consider the emergency approval of a vaccine to be grounds for stopping blinded trials.
During the meeting, FDA's Dorian Fink, a deputy director in the agency's vaccine application division, said it is important to keep the blinded trials going as long as possible.
A vaccine authorized under emergency use is still considered experimental, he said, so more safety and efficacy data will be needed.
Stephanie Schrag, an epidemiologist at the Centers for Disease Control and Prevention, noted there will be limited information available under an emergency authorization, which generally requires less data than full approval.
Schrag said that if the FDA allows emergency use of a vaccine before a trial is over, experts may not have the full picture of how long it can protect people or whether the vaccine will merely prevent serious infection or completely prevent the disease.
BY NATHANIEL WEIXEL - 10/22/2020
© Getty Images
Members of an expert panel advising the Food and Drug Administration (FDA) on coronavirus vaccines on Thursday argued against ending clinical trials even after the first vaccine becomes available.
There is no vaccine for COVID-19 for the panel to review yet, as clinical trials are still continuing. The FDA has said it expects to reconvene the panel multiple times in the future to examine the evidence every time a vaccine manufacturer applies for emergency authorization or approval.
During the daylong remote meeting, the panel of infectious disease experts and federal scientists offered reassurances that when they do review a COVID-19 vaccine, it will not be rushed to market before it is proven safe.
"Vaccine development can be expedited; however, I want to stress that it cannot, and must not, be rushed," Marion Gruber, director of FDA’s vaccine research office, told the panel.
The clinical trials of major vaccine manufacturers are ramping up, the FDA could see initial results by the end of November. Moderna, for instance, announced Thursday its clinical trial had finished enrolling participants.
Moderna said that more than two-thirds of its trial participants had received their second dose and that the company was working toward FDA's requirement of tracking participants for two months afterwards.
FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include people at highest risk from COVID-19, like older adults, minorities and people with underlying health issues.
FDA has made clear that any vaccine must be at least 50 percent effective.
If and when a vaccine becomes available, its availability will be extremely limited for the first few months, if not longer. Federal officials are grappling with the question of whether to continue clinical trials during the time.
Patients enrolled in the blinded trials will likely want to know if they have been given a placebo. In comments submitted ahead of the meeting, Pfizer said it wants to be able to dose placebo patients with an authorized vaccine if they want it.
The FDA has said it does not consider the emergency approval of a vaccine to be grounds for stopping blinded trials.
During the meeting, FDA's Dorian Fink, a deputy director in the agency's vaccine application division, said it is important to keep the blinded trials going as long as possible.
A vaccine authorized under emergency use is still considered experimental, he said, so more safety and efficacy data will be needed.
Stephanie Schrag, an epidemiologist at the Centers for Disease Control and Prevention, noted there will be limited information available under an emergency authorization, which generally requires less data than full approval.
Schrag said that if the FDA allows emergency use of a vaccine before a trial is over, experts may not have the full picture of how long it can protect people or whether the vaccine will merely prevent serious infection or completely prevent the disease.
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