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, as the country is deep into a worsening health crisis.
The statement also comes a day after an FDA panel recommended the agency grant an emergency use authorization for the Pfizer-BioNTech coronavirus vaccine.
“Just a little bit ago, the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” HHS Secretary Alex Azar told ABC’s George Stephanopoulos.
HHS confirmed to CNN that Azar was referencing a tweet posted Friday morning that links to a news release Friday 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.
Azar said that “in the next couple of days, probably,” as they work to negotiate with Pfizer and get information the doctors need to prescribe it appropriately, “we should be seeing the authorization of this first vaccine.”
Azar said that they will work with Pfizer to get it shipped out and “so we could be seeing people get vaccinated Monday, Tuesday of next week.”
“So, it’s very close. It’s really just the last dotting of I’s and crossing of T’s,” Azar added.
Once a vaccine is authorized, Operation Warp Speed — the federal government’s initiative to develop a vaccine — can start shipping and 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 advisory committee will meet Friday and is expected to vote Sunday on whether to recommend the vaccine.
While the green light for a Covid-19 vaccine will offer a light at the end of the tunnel, 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 gatherings that could drive infection numbers even higher. The US is now averaging more than 210,000 new cases daily.
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. 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.
And deaths also are soaring: Wednesday saw the highest Covid-19 death toll the US has ever reported in one day, at 3,124. More than 2,700 deaths were reported Thursday.
“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 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,” Fauci told CNN Thursday.
“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.
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.
“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.
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.