FDA intends to 'proceed towards an authorization' of Covid-19 vaccine'
(CNN)The FDA has informed Pfizer it intends "to proceed towards an authorization" of the manufacturer's Covid-19 vaccine, the US Health and Human Services Secretary told ABC on Friday morning, as the country is deep into a worsening health crisis.
The statement comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.
Other key steps remain, but if those hurdles are cleared, the first vaccinations in the US could happen as early as Monday or Tuesday, HHS Secretary Alex Azar told ABC's George Stephanopoulos.
"Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine," Azar told ABC.
HHS confirmed to CNN that Azar was referencing a tweet posted Friday morning that links to a news release from Drs. Stephen Hahn and Peter Marks of the US Food and Drug Administration. The release said the FDA told Pfizer it will "rapidly work toward finalization and issuance of an emergency use authorization."
Key players in the vaccine decision process have been told to expect the FDA to issue the emergency authorization Saturday, according to a federal government source close to the situation.
The source cautioned that anything is possible, and the FDA decision could still come Friday.
Once the FDA authorizes the vaccine, Operation Warp Speed -- the federal government's initiative to develop a vaccine -- can start distributing the vaccine to states. But vaccinations won't begin until after a Centers for Disease Control and Prevention committee recommends the vaccine, and the CDC accepts that recommendation.
That CDC advisory committee will meet Friday and is expected to vote Sunday on whether to recommend the vaccine.
Azar said the FDA would work with Pfizer to get the vaccine shipped "so we could be seeing people get vaccinated Monday, Tuesday of next week."
Governors are prioritizing who would get the vaccines first in their states. Healthcare workers and the most vulnerable, including residents of long-term care facilities, are expected to be first in line.
While a green light for a Covid-19 vaccine will offer hope, leading experts have warned the worst days of the pandemic are still ahead for the US. More case surges are likely to take shape as a result of Thanksgiving travels, and future holiday gatherings could drive numbers even higher, they say.
https://www.cnn.com/2020/12/11/health/us-coronavirus-friday/index.html
(CNN)The FDA has informed Pfizer it intends "to proceed towards an authorization" of the manufacturer's Covid-19 vaccine, the US Health and Human Services Secretary told ABC on Friday morning, as the country is deep into a worsening health crisis.
The statement comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.
Other key steps remain, but if those hurdles are cleared, the first vaccinations in the US could happen as early as Monday or Tuesday, HHS Secretary Alex Azar told ABC's George Stephanopoulos.
"Just a little bit ago, the FDA informed Pfizer that they do intend to proceed toward an authorization for their vaccine," Azar told ABC.
HHS confirmed to CNN that Azar was referencing a tweet posted Friday morning that links to a news release from Drs. Stephen Hahn and Peter Marks of the US Food and Drug Administration. The release said the FDA told Pfizer it will "rapidly work toward finalization and issuance of an emergency use authorization."
Key players in the vaccine decision process have been told to expect the FDA to issue the emergency authorization Saturday, according to a federal government source close to the situation.
The source cautioned that anything is possible, and the FDA decision could still come Friday.
Once the FDA authorizes the vaccine, Operation Warp Speed -- the federal government's initiative to develop a vaccine -- can start distributing the vaccine to states. But vaccinations won't begin until after a Centers for Disease Control and Prevention committee recommends the vaccine, and the CDC accepts that recommendation.
That CDC advisory committee will meet Friday and is expected to vote Sunday on whether to recommend the vaccine.
Azar said the FDA would work with Pfizer to get the vaccine shipped "so we could be seeing people get vaccinated Monday, Tuesday of next week."
Governors are prioritizing who would get the vaccines first in their states. Healthcare workers and the most vulnerable, including residents of long-term care facilities, are expected to be first in line.
While a green light for a Covid-19 vaccine will offer hope, leading experts have warned the worst days of the pandemic are still ahead for the US. More case surges are likely to take shape as a result of Thanksgiving travels, and future holiday gatherings could drive numbers even higher, they say.
https://www.cnn.com/2020/12/11/health/us-coronavirus-friday/index.html
