FDA intends to ‘proceed towards an authorization’ of Covid-19 vaccine, official says, as cases soar


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.

“Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech Covid-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” the release reads.
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.

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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.

Cases, hospitalizations and deaths already are soaring:

• The US has averaged 210,201 new official Covid-19 cases daily over the past week — the highest average ever recorded for the country, according to Johns Hopkins University data.

• The US on Thursday set another record for the number of Covid-19 patients in hospitals on a given day, at more than 107,200, according to the COVID Tracking Project.

• The county’s average number of deaths reported daily across a week was 2,259 Thursday, just below a pandemic peak reported a day before.

• This week also saw the most coronavirus deaths reported by the US in one day — 3,124, on Wednesday.

“We are in the time frame now that probably for the next 60 to 90 days, we’re going to have more deaths per day than we had in 9/11,” CDC director Dr. Robert Redfield said. “This is going to be a real unfortunate loss of life, as all that we’ve had so far, and the reality is the vaccine approval this week is not going to really impact.”

A CNN analysis of newly released data from the US Department of Health and Human Services showed that at least 200 hospitals across the US were at full capacity last week. And more than 90% of ICU beds were occupied in a third of all hospitals.

A timeline for the future

It’s likely the US won’t see any meaningful, widespread impacts from vaccinations until well into 2021. But just how quickly the country will be able to recover depends on how quickly Americans get vaccinated — and how many people are willing to get the vaccine.

“If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly. Into the summer, and certainly into the fall,” Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, told CNN Thursday.

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“My hope and my projection is that if we get people vaccinated en masse so that we get that large percentage of the population, as we get into the fall, we can get real comfort about people being in schools, safe in school — be that K-12, or college,” he added.

Azar said this week at least 20 million Americans will be able to get Covid-19 vaccines by the end of the month, 50 million by the end of January and at least 100 million should be vaccinated by the end of the first quarter.

“We remain confident that across our portfolio of multiple vaccines, we will have enough doses for any American who wants a vaccine by the end of the second quarter of 2021,” Azar added.

The US is in a crisis

While the country anxiously awaits the first Covid-19 vaccine authorization, local and state leaders across the US are also working to curb the spread of the virus that’s ravaging American communities.

Ohio Gov. Mike DeWine announced Thursday the state is extending its statewide curfew until January 2, saying officials believed the curfew so far, along with face masks, have had an impact.

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In Rhode Island, the governor extended a statewide “pause” on reopening one more week, saying the situation in the state was “getting scary.”

“In this crisis, we continue to lose Rhode Islanders every day and my heart goes out to each and every one of you who are struggling to get through this pandemic,” Gov. Gina Raimondo said. “Let’s stick to staying at home and honoring the pause one more week.”

Raimondo wasn’t the only governor to express concern about Covid-19 trends this week.

New Mexico Gov. Michelle Lujan Grisham called the number of hospitalizations “very frightening,” with more than 900 patients statewide. At least 159 of those were on ventilators.

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“We are getting to a place where it’s really dire,” the governor said.

Meanwhile, Louisiana is on a trajectory toward overwhelming the health care system as a third surge of Covid-19 cases only keeps climbing, the governor said.

“It’s at a trajectory we cannot sustain for much longer if we want to preserve that capacity to deliver lifesaving care,” Gov. John Bel Edwards said.

Number of infections likely underestimated, expert says

But as most states continue to report a significant number of new cases, hospitalizations and deaths, one expert says the reported number of cases and deaths in the US are likely underestimated.

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Aron Hall, chief of the Respiratory Viruses Branch at the CDC, said Thursday more than 15 million cases and more than 285,000 deaths have been associated with the virus.

“However, based on seroprevalence surveys and models, the total estimated number of infections, is likely two to seven times greater than reported cases,” Hall said.

“We do feel, as with hospitalizations and illnesses, that the reported number of deaths is likely an underestimate of the true number of deaths,” he later added.

And even with promising vaccine news, he said there is a continued need for measures like face masks, physical distancing and regular hand washing to help bring an end to the pandemic.

CNN’s Ben Tinker, Deidre McPhillips, Amanda Watts, Hollie Silverman, Melissa Alonso, Jennifer Selva and Andrea Diaz contributed to this report.





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