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Hahn said he could not talk about a “specific issue” that may involve the AstraZeneca trial.
An AstraZeneca spokesperson told CNN earlier that regulators in Britain, Brazil and South Africa had all decided to resume the trials. “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial,” the spokesperson said.
15 hr 57 min ago
AstraZeneca vaccine trial still on hold in US but FDA’s Hahn won’t reveal why; it’s "confidential”
From CNN Health’s Shelby Lin Erdman and Jen Christensen
A general view of AstraZeneca on August 19, in Sydney, Australia. Lisa Maree Williams/Getty Images
Drugmaker AstraZeneca’s Covid-19 vaccine trial in the United States is still on hold after a participant developed a serious illness, but the Food and Drug Administration commissioner won’t say why.
At the US Pharma and Biotech Summit hosted by the Financial Times Wednesday, US FDA Commissioner Dr. Stephen Hahn was asked why the trial was still on pause in the US, even though it has resumed in Europe. Hahn said he couldn’t answer.
Hahn said he could not talk about a “specific issue” that may involve the AstraZeneca trial.
An AstraZeneca spokesperson told CNN earlier that regulators in Britain, Brazil and South Africa had all decided to resume the trials. “We are continuing to work with the FDA to facilitate review of the information needed to make a decision regarding resumption of the US trial,” the spokesperson said.
Moderna's coronavirus vaccine won't be ready for widespread distribution until spring, CEO predicts
He reportedly predicted the vaccine wouldn't be available to the general public until sometime next spring
Just a day after President Trump said the nation was only “weeks away” from a coronavirus vaccine, the head of Moderna reportedly said his company will not be able to apply for authorization from the Food and Drug Administration (FDA) until late November at the earliest.
“November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA – assuming that the safety data is good, i.e. a vaccine is deemed safe,” Stephane Bancel, Moderna CEO, told the Financial Times on Wednesday.
He then predicted that the company would not be able to release the vaccine to the general public until sometime next spring.
“I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine,” he told the news outlet.
MODERNA SAYS CORONAVIRUS VACCINE BOOSTS IMMUNE SYSTEM RESPONSE IN OLDER ADULTS
The government has already struck a deal with Moderna for 100 million doses of the vaccine as part of Operation Warp Speed, with an option to buy an additional 400 million doses. Bancel has previously conceded that it will take more than one company to supply enough vaccines to combat the coronavirus.
The timeline regarding a coronavirus vaccine was a hot topic of debate on Tuesday night, as Trump and former Vice President Joe Biden sparred safety concerns of a rushed vaccine and over the White House’s response to the ongoing pandemic.
TRACES OF CORONAVIRUS FOUND IN LAKE SUPERIOR WATER, RESEARCHERS SAY
“I’ve spoken to the companies and we can have it a lot sooner… I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to – Moderna, Johnson & Johnson, and others,” Trump said during the debate, regarding a vaccine timeline. “They can go faster than that by a lot.”
On Tuesday, Moderna announced that its vaccine candidate, dubbed mRNA-1273, elicited immune responses in older adults from a Phase 1 study in levels comparable to those seen in younger adults.
“These interim Phase 1 data suggests that mRNA-1273, our vaccine candidate for the prevention of COVID-19, can generate neutralizing antibodies in older and elderly adults at levels comparable to those in younger adults,” Dr. Tal Zaks, chief medical officer of Moderna, said in the announcement. “Given the increased morbidity and mortality of COVID-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273’s protection in this population, which is being evaluated in the Phase 3 COVE study.”
In mid-September, Bancel had reportedly said the company hoped to see results by October, but a dip in the average national cases made it difficult for researchers to compare the vaccine’s success against a placebo.
The U.S. has tallied over 7.2 million cases of novel coronavirus and more than 207,000 deaths.
Fox News' Kayla Rivas contributed to this report.
Moderna's coronavirus vaccine won't be ready for widespread distribution until spring, CEO predicts
The timeline regarding a coronavirus vaccine was a hot topic of Tuesday night's presidential debate.www.foxnews.com
好像加国向这公司订购了疫苗Moderna's coronavirus vaccine won't be ready for widespread distribution until spring, CEO predicts
He reportedly predicted the vaccine wouldn't be available to the general public until sometime next spring
Just a day after President Trump said the nation was only “weeks away” from a coronavirus vaccine, the head of Moderna reportedly said his company will not be able to apply for authorization from the Food and Drug Administration (FDA) until late November at the earliest.
“November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA – assuming that the safety data is good, i.e. a vaccine is deemed safe,” Stephane Bancel, Moderna CEO, told the Financial Times on Wednesday.
He then predicted that the company would not be able to release the vaccine to the general public until sometime next spring.
“I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine,” he told the news outlet.
MODERNA SAYS CORONAVIRUS VACCINE BOOSTS IMMUNE SYSTEM RESPONSE IN OLDER ADULTS
The government has already struck a deal with Moderna for 100 million doses of the vaccine as part of Operation Warp Speed, with an option to buy an additional 400 million doses. Bancel has previously conceded that it will take more than one company to supply enough vaccines to combat the coronavirus.
The timeline regarding a coronavirus vaccine was a hot topic of debate on Tuesday night, as Trump and former Vice President Joe Biden sparred safety concerns of a rushed vaccine and over the White House’s response to the ongoing pandemic.
TRACES OF CORONAVIRUS FOUND IN LAKE SUPERIOR WATER, RESEARCHERS SAY
“I’ve spoken to the companies and we can have it a lot sooner… I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to – Moderna, Johnson & Johnson, and others,” Trump said during the debate, regarding a vaccine timeline. “They can go faster than that by a lot.”
On Tuesday, Moderna announced that its vaccine candidate, dubbed mRNA-1273, elicited immune responses in older adults from a Phase 1 study in levels comparable to those seen in younger adults.
“These interim Phase 1 data suggests that mRNA-1273, our vaccine candidate for the prevention of COVID-19, can generate neutralizing antibodies in older and elderly adults at levels comparable to those in younger adults,” Dr. Tal Zaks, chief medical officer of Moderna, said in the announcement. “Given the increased morbidity and mortality of COVID-19 in older and elderly adults, these data give us optimism in demonstrating mRNA-1273’s protection in this population, which is being evaluated in the Phase 3 COVE study.”
In mid-September, Bancel had reportedly said the company hoped to see results by October, but a dip in the average national cases made it difficult for researchers to compare the vaccine’s success against a placebo.
The U.S. has tallied over 7.2 million cases of novel coronavirus and more than 207,000 deaths.
Fox News' Kayla Rivas contributed to this report.
Moderna's coronavirus vaccine won't be ready for widespread distribution until spring, CEO predicts
The timeline regarding a coronavirus vaccine was a hot topic of Tuesday night's presidential debate.
Other health experts, including Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, have also said they believe a coronavirus shot could be available for the most vulnerable populations, including health care workers, the elderly and those with underlying health conditions, by the end of the year.
Through the COVAX Facility coordinated by Gavi, the Vaccine Alliance, more than 75 ‘high-income’ countries have committed funding to provide at least part of the cost for procuring the vaccine for poorer nations.
