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(CNN) – Pfizer and BioNTech’s covid-19 vaccines will begin shipping across the United States soon after the Food and Drug Administration (FDA) cleared the vaccine for emergency use on Friday, a milestone in the pandemic.
“I think we should take a moment and consider that we are having this event of large numbers of victims every day here in the US, but now we have this vaccine developed in record time that, over time, can really save us and save our country and save the world from this terrible pandemic, ”Dr. Leana Wen told CNN’s Chris Cuomo moments after authorization.
“This is really a monumental moment for us,” he added.
The FDA clearance came on one of the worst days of the pandemic in the US, with a record number of new cases, deaths and patients with COVID-19 in hospitals across the country.
The emergency use authorization (US) is a “significant milestone” in the fight against the pandemic, FDA Commissioner Dr. Stephen Hahn said in a statement on Friday. He said it comes after an “open and transparent review process that included input from independent scientists and public health experts and a thorough evaluation by the agency’s career scientists.”
A USA is not a total approval. Pfizer will need to submit a separate application for its vaccine to be fully licensed by the FDA.
But the US “promises to alter the course of this pandemic in the United States,” said Dr. Peter Marks, director of the FDA’s Center for Biological Evaluation and Research.
Two key steps remain before vaccines can begin. The US Centers for Disease Control and Prevention’s (CDC) vaccine advisory committee, which is scheduled to meet Saturday morning, is due to vote to recommend the vaccine. Subsequently, the agency must accept that recommendation.
Then the vaccination can begin. But it will be months before most Americans are vaccinated. CDC advisers have recommended that healthcare workers and residents of long-term care facilities be first in line.
Of course, the Pfizer and BioNTech vaccine is just one of those in development. Health and Human Services Secretary Alex Azar told ABC News on Friday that about 20 million Americans should be vaccinated by the end of the month, 50 million by the end of January, and at least 100 million people should be vaccinated by the end of the month. February.
Officials “remain confident,” he added, that there will be enough doses for any American who wants to get vaccinated before the summer.
Meanwhile, the United States, devastated by the rampant spread of the virus, is projected to face brutal days ahead, and precautions such as wearing face masks and social distancing will remain crucial.
Overloaded hospitals in the US
The US reported more than 231,700 new COVID-19 infections on Friday, the most ever recorded. The average number of daily cases for the past week was 210,764, another record in the pandemic, according to a CNN analysis of Johns Hopkins data.
Some communities have already begun to feel the impacts of Thanksgiving gatherings and trips, which officials predicted would lead to even more infections and another spike. And that increase could be followed by another increase tied to the upcoming Christmas holidays, some officials have said.
On what is at least the sixth day in a row, the US also reported another record number of COVID-19 patients in hospitals across the country: More than 108,000 nationwide, according to the COVID Tracking Project.
Hospitals in almost every corner of the country have felt the impact. Data from the Department of Health shows that more than 85% of hospitals nationwide had more COVID-19 patients last week than a month ago and, overall, approximately one in five hospitalized patients was confirmed to have COVID-19. -19 last week, almost double the previous month.
In the nation’s 10 largest cities, the proportion of hospital patients who had the virus ranged from 9% in New York to 23% in Chicago. Meanwhile, in El Paso, Texas, more than 50% of patients in city hospitals had COVID-19 between November 27 and December 3. That’s almost double the national average for that period.
In Mississippi, the state’s top health official said Friday that ICUs are full and “many hospitalizations (are) on the way.” Elective surgeries that require hospitalization should be delayed starting Tuesday, state health official Dr. Thomas Dobbs said on Twitter.
“The pressure on ICUs is worse than the sudden increase in summer. Twenty-six hospitals on diversion for critically ill patients, ”Dobbs wrote a day earlier.
‘Catastrophic and unprecedented suffering’
The increase in hospitalized patients with covid-19 across the country has been followed by an increase in the number of deaths. More than 3,300 deaths were reported in the US on Friday, marking the deadliest day since the start of the pandemic. The country’s previous record was set on Wednesday, with more than 3,100 deaths.
As of Friday, the average number of daily deaths for the previous seven days was 2,359, the highest since the pandemic began.
The next three months will be “really tough,” the CDC director warned, even with a vaccine available soon.
“Over the next 60 to 90 days, we will have more deaths per day than on September 11,” Dr. Robert Redfield said Thursday. “This will be a truly regrettable loss of life, like what we have had so far.”
And it is a reality that the authorization of a vaccine will have no impact, he added.
In California, Los Angeles County Public Health Director Dr. Barbara Ferrer issued a grim warning over the next several weeks, after announcing that the county has doubled its number of new cases in about 10 days.
“The problem right now is what we call the Thanksgiving surge,” Ferrer said. “We had a raise and now we have a raise as well as a raise, and it’s really hard for us to calculate exactly what we’re going to see in the next few weeks.
The county, he said, is in “uncharted territory,” with numbers of cases and hospitalizations that “we have not experienced and, frankly, we do not anticipate.”
“We are on a very dangerous path to seeing unprecedented and catastrophic suffering and death here in Los Angeles County if we cannot stop the increase,” Ferrer said.
FAA urges airports to be ready for vaccine flights
Meanwhile, the Federal Aviation Administration (FAA) urged airports across the country to be ready for flights that will carry the covid-19 vaccine, even if some airports are not scheduled to receive shipments.
The agency told CNN on Thursday that it would order air traffic controllers to give priority clearance to flights carrying the vaccine.
States will receive shipments of the covid-19 vaccine from Pfizer once a week to begin after distribution begins, Operation Warp Speed senior adviser Moncef Slaoui said Friday.
“The plan is to send vaccines once a week and inform governors a week in advance of the number of doses they will receive,” Slaoui told CNN. “Those vaccines… are intended to be used in their entirety in the population during that one-week period because the same states will receive an identical number of doses, in the case of the Pfizer vaccine, three weeks later to administer as a second dose to recipients of the first dose, “he said.
The number of vaccines will increase “week after week,” he added, as manufacturing increases.
And if the Moderna vaccine is authorized, he said, “it would be a fairly significant increase in vaccines to be distributed.” FDA vaccine advisers will meet next week to discuss an EUA for Moderna’s vaccine.
CNN’s Shelby Lin Erdman, Pete Muntean, Alta Spells, Haley Brink, Greg Wallace, Kay Jones, Deidre McPhillips, and Andrea Diaz contributed to this report.
