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Pfizer is making a vaccine specifically targeting the Delta variant, but the company’s CEO Albert Bourla said Monday he doesn’t think it will be needed because the current vaccine is so effective.
“We are making right now a specialized vaccine for Delta,” Bourla told NBC Nightly News. “I’m almost certain that we will not need it.”
That’s because Pfizer’s current Covid-19 vaccine is already working well against the variant, he noted.
Michigan is the latest state to fully vaccinate at least half of its residents against Covid-19, according to data published Monday by the US Centers for Disease Control and Prevention.
Here’s latest CDC data on vaccination efforts in the US:
If most eligible people get vaccinated, the US could have control over Covid-19 entering the Spring of 2022, Dr. Anthony Fauci said Monday.
Fauci said he misspoke earlier in the day, when he told NPR it would be the fall of 2022.
“If we can get through this winter and get really the majority – overwhelming majority – of the 90 million people who have not been vaccinated, vaccinated, I hope we can start to get some good control in the spring of 2022,” Fauci told CNN’s Anderson Cooper.
Fauci said that includes vaccinating people who have contracted and recovered from Covid-19, who could stand to gain “an enormous increase in the degree of protection” from the vaccine.
“As we get into the spring, we could start getting back to a degree of normality, namely reassuming the things that we were hoping we could do – restaurants, theaters, that kind of thing,” he said.
Fauci, director of the National Institute of Allergy and Infectious Diseases, noted that the spring 2022 timeframe is a hope, but not a guarantee.
Fauci said it’s not yet clear what percentage of the population needs to be vaccinated for the US to gain control over the virus.
“You know how you’re going to know? Just get as many people vaccinated as you possibly can, and when you get control, that’ll be the number,” Fauci said.
Update: This story has been updated to include Fauci’s latest remarks to CNN on when he hopes the US could get control of Covid-19 if everyone gets vaccinated. He said he hopes it could happen in the spring of 2022. Earlier, Fauci told NPR it would be the fall of 2022.
The University of Michigan is requiring all enrolled students to be vaccinated for Covid-19 now that the Pfizer Covid-19 vaccine was approved by the US Food and Drug Administration, University President Joan Gabel and Jakub Tolar, the dean of the medical school, announced in a letter to students, faculty and staff on Monday.
In earlier communications from the university, students were told once the Covid-19 vaccine had been approved by the FDA, it would be required, the letter states.
Faculty and staff will be “expected” to attest to their vaccination status starting Tuesday, the letter adds.
White House press secretary Jen Psaki indicated on Monday that the Biden administration expects to roll out more Covid-19 vaccine mandates within the federal government following the FDA’s recent approval of the Pfizer-BioNTech Covid-19 vaccine.
Asked if the full approval announcement will lead to any additional vaccine mandates from the Biden administration beyond what has been announced, Psaki said during the press briefing, “I expect there will be more, sure, as we’ve said all along.”
In a follow-up question about whether the President will expand its federal vaccine requirement and mandate it so there’s no longer an opt-out option, Psaki said, “I think you’re looking more at agency-to-agency or different factions of the government at this point. But I expect there will be more on that front.”
Some more background: Last month, Biden announced all federal employees must attest to being vaccinated against Covid-19 or face strict protocols including regular testing, masking, limits on official travel and other mitigation measures.
Contractors working for the federal government will also be subject to the new rules.
Pentagon press secretary John Kirby said during a Pentagon briefing on Monday the Department of Defense would move forward with requiring all US military service members to be vaccinated now that the Pfizer/BioNTech vaccine has full FDA approval.
CNN’s Kate Sullivan contributed reporting to this post.
Nashville, Tennessee, public schools reported 395 students and 67 teachers tested positive for Covid-19 in the last week, according to the district’s Covid-19 dashboard.
The rising case count comes after 207 students and 52 employees tested positive in the first four days school was open within the district.
In addition, 2,879 students and 143 employees were quarantined or in isolation from August 16 through August 22, according to the Metro Nashville Public Schools Covid-19 dashboard.
Since Aug. 10 when most Nashville schools opened, at least 3,859 students and 238 employees have had to quarantine.
A total of 602 students have tested positive for Covid-19 in the first two weeks of school, according to the Metro Nashville Public Schools Covid-19 dashboard.
In the same time period, 119 employees have tested positive for Covid-19 with 67 of them coming in the last week, according to the data.
Before school began, the Metro Nashville Board of Education voted to introduce a mask mandate for all 80,000 students in the district as well as all teachers. It is not clear whether the virus spread in school, and the case total likely reflects spread within the community before in-person instruction began.
President Biden spoke today addressing concerns about Covid-19 cases among children. He said that cases among children are “still rare, and severe cases among children are very, very rare.”
He said that it’s “not as reassuring as anyone would like it to be” for parents who are concerned about their children and Covid-19. Biden said that parents have “two tools” available to keep their kids safe.
President Biden said the US Food and Drug Administration’s (FDA) approval of the Pfizer vaccine is “an important moment in our fight against the pandemic.”
During remarks from the White House, Biden urged those who were hesitant to receive a vaccine until FDA approval to do so now.
Biden added, “The FDA approval is the gold standard. And as I just said, now it has been granted. Those who have been waiting for full approval should go get your shot now. The vaccination is free, it’s easy, it’s safe, and it’s effective, and it’s convenient.”
President Biden is speaking from the White House following the US Food and Drug Administration’s full approval of the Pfizer-BioNTech’s Covid-19 vaccine.
According to a White House official, Biden will encourage Americans who have been waiting for the vaccine’s full approval to go get vaccinated against Covid-19 and he’ll also reiterate his call for private and public sector leaders to adopt strong vaccination requirements.
The Pfizer/BioNTech Covid-19 vaccine is the first coronavirus vaccine to be fully approved by the FDA — the Moderna and Johnson & Johnson Covid-19 vaccines remain under emergency use authorization — and the announcement is expected to open the door to more vaccine mandates.
Last month, Biden announced all federal employees must attest to being vaccinated against Covid-19 or face strict protocols including regular testing, masking, limits on official travel and other mitigation measures. Contractors working for the federal government will also be subject to the new rules.
Read more about Biden’s remarks here.
The deadline for United Airlines employees to get vaccinated or lose their job has been bumped up now that the Pfizer/BioNTech vaccine has been granted full FDA approval.
United Airlines confirmed on Monday that all of its 67,000 employees in the US will need to be fully vaccinated by Sept. 27 or face getting fired.
United’s mandate originally spelled out that workers must get vaccinated by Oct. 25 or five weeks from FDA approval of any vaccine, whichever came first.
The carrier is the only major US airline to mandate its workers get vaccinated.
Following United’s announcement earlier this month, CEOs of Southwest Airlines, Delta Air Lines and American Airlines all said that they were not changing their policies and insisted that many of their employees were already vaccinated even without a mandate. Alaska Airlines said it was considering an employee mandate if a vaccine became fully FDA approved.
New York City Mayor Bill de Blasio said today that the “mandate” for all NYC Department of Education employees to get the Covid-19 vaccine “will take place on September 27.”
Starting this week, de Blasio’s administration will begin bargaining with labor unions over the specific impacts of the new vaccine mandate and will be working with the unions to determine elements of implementation.
The mayor noted that he’s not worried about teacher resignations stemming from the vaccine mandate, saying he feels “confident that this is going to work, we’re going to see a lot of our teachers and other school staff get vaccinated as a result of this mandate.”
The mayor also said he’s not concerned about teacher shortages because “a lot of teachers and other professionals yearn to work in the NYC public school system for a lot of reasons, including the way we compensate.”
New York City Department of Education Chancellor Meisha Porter chimed in support of the mayor’s sentiments, saying that city’s public school system teachers have showed throughout the pandemic. “This is next way to get our babies back in class and to keep them protected and safe,” she said.
De Blasio added that he’s looking forward to getting authorization approved to be able vaccinate children between the ages of 5 and 11 as soon as a few months from now.
“We’re seeing a great response from our young people and our parents,” he said, adding that his administration is currently focused on vaccinating NYC children ages 12 and up over the next weeks.
There are currently no Covid-19 vaccines authorized for individuals under the age of 12. Pfizer has said it expects to have vaccine trial data on children ages 5 to 11 by the end of September, and the company could apply to have its vaccine authorized for those younger ages shortly after. The company also has said data for even younger children, ages 2 to 5, could be available shortly after.
Moderna and Johnson & Johnson are also working on studies in children.
CNN’s Jacqueline Howard contributed reporting to this post.
President Biden on Monday will encourage Americans who have been waiting for full approval from the US Food and Drug Administration to go get vaccinated against Covid-19 today, a White House official tells CNN.
The President will mark the key milestone of Pfizer/BioNTech’s Covid-19 vaccine receiving full FDA approval in remarks on Monday afternoon at the White House, and will reiterate his call for private and public sector leaders to adopt strong vaccination requirements, the official said.
“President Biden will deliver remarks to highlight the vaccination progress we have made in seven months, including over 170 million fully vaccinated Americans, and acknowledge another key milestone in our fight against the virus — FDA’s full approval of the Pfizer vaccine,” the official told CNN.
To issue full licensure to the Pfizer/BioNTech Covid-19 vaccine, the US Food and Drug Administration worked around the clock and conducted its own analyses of the vaccine in addition to the companies’ analyses, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said during a briefing call on Monday.
The FDA completed the full approval process “in about 40%” of the time it would normally take for an approval application submission of this magnitude, Marks said.
“We also did benefit-risk assessments based on real-world data that has emerged since the vaccine has now been used in hundreds of millions of people globally. And so that actually takes a lot of work,” Marks said, adding that the agency also inspected facilities that make the product.
Even though the US Food and Drug Administration approved the Pfizer/BioNtech Covid-19 vaccine on Monday for people 16 and older, the agency emphasizes that this does not mean the vaccine can be used “off-label” in children younger than 12, saying it “it would not be appropriate.”
Off-label refers to an approved product being used in a way or in a patient that it wasn’t necessarily approved for. The Pfizer/BioNTech Covid-19 vaccine is still available to people as young as 12 under emergency use authorization or EUA, but it is not currently approved nor authorized for children younger than 12.
“So that would be a great concern that people would vaccinate children because we don’t have the proper dose and we don’t have the safety data, nor do we have all the efficacy data, as well,” Woodcock said. “We are not recommending that children younger than age 12 be vaccinated with this vaccine. It would not be appropriate.”
The US Food and Drug Administration’s full approval of the Pfizer/BioNTech Covid-19 vaccine on Monday means that the American public can be “confident” in the vaccine, Acting FDA Commissioner Dr. Janet Woodcock said during a briefing call on Monday.
Woodcock called the approval “a pivotal moment” for the United States’ fight against the coronavirus pandemic.
“Health care providers can continue to use the vaccine on their shelves,” Woodcock added. “The FDA-approved vaccine and the EUA-authorized vaccine have the same formulation and can be used interchangeably to provide the Covid-19 vaccine series.”
Pentagon press secretary John Kirby said that the US military will now require all service members to be vaccinated from Covid-19 following the FDA approval of the Pfizer vaccine.
Speaking at a press conference this morning, Kirby said that the Department of Defense is “prepared to issue updated guidance requiring all service members to be vaccinated,” adding that a “timeline for vaccination completion will be provided in the coming days” by DOD.
Some context: Previously, US Defense Secretary Lloyd Austin said that it was his intent to mandate the Covid-19 vaccine for the military upon FDA licensure or by mid-September to seek a waiver from the President.
New York City Mayor Bill de Blasio announced a Covid-19 vaccine mandate for all education department staff on Monday for all public schools across the city without a testing alternative, becoming the largest school system in the US to do so.
All school staff are required to provide proof of vaccination of at least one dose of the Covid-19 vaccine by Sept. 27, the mayor said.
The New York City Department of Education (DOE) now becomes the largest public school system in the US to mandate Covid-19 vaccines for its employees.
The NYC DOE serves 1.1 million students in over 1,800 schools and employs at least 143,000 people within the education system.
Now that the Pfizer/BioNTech Covid-19 vaccine has received full approval from the US Food and Drug Administration, the companies are able to market and advertise the vaccine.
A spokesperson for Pfizer told CNN Monday that the company hopes to increase confidence in the Covid-19 vaccines.
They also said the company plans to market and advertise its vaccine under the brand name Comirnaty.
Michigan Gov. Gretchen Whitmer says the “MI Shot To Win Sweepstakes” helped increase the state’s vaccination rates among residents ages 16 and over from 61% to 63%. The state’s vaccination rate for the group is now 65%, according to a news release from her office.
The Covid-19 vaccine initiative “helped Michigan reverse that trend during a critical period of time before the more infectious Delta variant became the dominant strain of COVID-19,” according to the release.
Michigan has fully vaccinated 55.1% of its eligible population, according to it’s Covid-19 dashboard.
After the US Food and Drug Administration granted full approval to Pfizer/BioNTech’s Covid-19 vaccine, Dr. Anthony Fauci told CNN he believes the approval will boost confidence in the safety and efficacy of the vaccine.
Fauci said he believes the full FDA approval could encourage as many as “20-30%” of unvaccinated people to get vaccinated.
Secondly, Fauci said he believes the full FDA approval will lead to a wave of businesses, universities and large organizations implementing vaccine requirements, which could have a significant effect on vaccinations in the US.
