US FDA approves first Covid-19 vaccine

By Melissa Macaya, Mike Hayes, Meg Wagner and Veronica Rocha, CNN

Updated 0316 GMT (1116 HKT) August 24, 2021
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11:42 a.m. ET, August 23, 2021

Pentagon: US military will make Covid-19 vaccines mandatory following FDA approval of Pfizer's shot

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.

"We're going to move forward, making that vaccine mandatory. We're preparing the guidance to the force right now. And the actual completion date of it, in other words, how fast we want to see it get done, we're working through that guidance right now."

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. 

11:13 a.m. ET, August 23, 2021

New York City mayor announces Covid-19 vaccine mandate for all education department employees

From CNN’s Artemis Moshtaghian

NYC Media
NYC Media

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.

10:52 a.m. ET, August 23, 2021

Pfizer working on plans to market and advertise its newly approved Covid-19 vaccine

From CNN’s Amanda Sealy

A pharmacy technician loads a syringe with Pfizer's COVID-19 vaccine, Tuesday, March 2, 2021 at a mass vaccination site at the Portland Expo in Portland, Maine. 
A pharmacy technician loads a syringe with Pfizer's COVID-19 vaccine, Tuesday, March 2, 2021 at a mass vaccination site at the Portland Expo in Portland, Maine.  Robert F. Bukaty/AP

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.

10:30 a.m. ET, August 23, 2021

Michigan's vaccination rate saw an increase in July thanks to sweepstakes, governor says

From CNN's Melissa Alonso

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.

"Over that same July time span, more than 2.4 million Michiganders signed up to win cash prizes and over 106,000 Michiganders entered to win scholarships," the release said.

Michigan has fully vaccinated 55.1% of its eligible population, according to it's Covid-19 dashboard. 

10:23 a.m. ET, August 23, 2021

Fauci on Pfizer vaccine approval: "No one can argue now with the effectiveness and the safety"

From CNN’s Jeremy Diamond

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.

"No one can argue now with the effectiveness and the safety of these vaccines because the FDA did precisely what they should have been doing," Fauci said in a phone interview, stressing the independence of the process. "They took the very great care in analyzing all of the information."

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.

10:47 a.m. ET, August 23, 2021

President Biden will speak this afternoon after FDA grants full approval of Pfizer vaccine

From CNN's Betsy Klein

President Joe Biden speaking from the East Room of the White House in Washington, Wednesday, Aug 18, 2021, on the COVID-19 response and vaccination program.
President Joe Biden speaking from the East Room of the White House in Washington, Wednesday, Aug 18, 2021, on the COVID-19 response and vaccination program. Susan Walsh/AP

President Joe Biden will speak on Covid-19 response and vaccines at 1:30 p.m. ET in the South Court Auditorium, per the White House.

The remarks come hours after the US Food and Drug Administration has granted full approval to Pfizer’s Covid-19 vaccine.

10:37 a.m. ET, August 23, 2021

US children younger than 12 still can't get vaccinated 

From CNN's Jen Christensen

A 13-year-old newly vaccinated against COVID-19 shows his bandage at a pop-up vaccination site on June 5, 2021 in the Queens borough in New York City. 
A 13-year-old newly vaccinated against COVID-19 shows his bandage at a pop-up vaccination site on June 5, 2021 in the Queens borough in New York City.  Scott Heins/Getty Images

While the US Food and Drug Administration granted full approval to the Pfizer/BioNTech Covid-19 vaccine today for people age 16 and older, the agency still has its hands full looking to authorize first doses for younger children. 

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.

As schools across the country begin to open their doors, parents and pediatricians are growing impatient for a Covid-19 vaccine for younger children

Last month, the FDA asked Pfizer and Moderna to double the number of children ages 5 to 11 in clinical trials. The FDA also asked for six months of follow-up safety data, instead of the two months it asked for with adults.

The American Academy of Pediatrics said it understands parents' anxiety and impatience. AAP President Dr. Lee Savio Beers stressed there needs to be more urgency around the authorization of the Covid-19 vaccine for young children in the United States.

"It's really important to make sure that we are approaching authorization of the Covid vaccine for our youngest children with the same urgency that we did in adults," Beers told CNN's Wolf Blitzer earlier this month. "It really is a very urgent situation."

The AAP argued the FDA should authorize the vaccines for kids ages 5 to 11 based on the initial trial data already available. Two months of safety data should also be enough, it said.

US Surgeon General Dr. Vivek Murthy said earlier thins month the FDA will "move fast" to evaluate data from vaccine companies once it's ready, and it's possible a Covid-19 vaccine will be available for kids under the age of 12 before the end of 2021.

Read more about where things stand here.

9:56 a.m. ET, August 23, 2021

FDA grants full approval to Pfizer's Covid-19 vaccine

From CNN's Jacquelien Howard

Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic on April 9, 2021 in Los Angeles, California. 
Vials containing doses of the Pfizer COVID-19 vaccine are viewed at a clinic on April 9, 2021 in Los Angeles, California.  Mario Tama/Getty Images

The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.

The Pfizer/BioNTech vaccine has been authorized for emergency use in the United States since mid-December for people age 16 and older. In May, the authorization was extended to those 12 and older.

Out of more than 170 million people in the United States fully vaccinated against Covid-19, more than 92 million have received the Pfizer/BioNTech vaccine.

Albert Bourla, the chair and chief executive officer of Pfizer, said the decision reaffirms the vaccine's safety.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans," Bourla said.
8:49 a.m. ET, August 23, 2021

Covid-19 hospitalizations in unvaccinated cost US health system $2.3 billion in June and July, analysis shows

From CNN's Naomi Thomas

Clinicians work while caring for COVID-19 patients in the improvised COVID-19 unit at Providence Holy Cross Medical Center in the Mission Hills neighborhood on July 30, 2021 in Los Angeles, California. 
Clinicians work while caring for COVID-19 patients in the improvised COVID-19 unit at Providence Holy Cross Medical Center in the Mission Hills neighborhood on July 30, 2021 in Los Angeles, California.  Mario Tama/Getty Images

Covid-19 hospitalizations in unvaccinated people cost the US health system $2.3 billion in June and July alone, a number which is likely an understatement, according to an analysis from the Kaiser Family Foundation published Friday.

KFF looked at various sources, including CMS data and analyses of private claims, to find that the average cost of a Covid-19 hospitalization was around $20,000.

They used Health and Human Services and US Centers for Disease Control and Prevention data to find the number of preventable Covid-19 hospitalizations in the US in the months of June, 37,000 preventable hospitalizations, and July, 76,000 preventable hospitalizations. 

“If each of these preventable hospitalizations cost roughly $20,000, on average, that would mean these largely avoidable hospitalizations have already cost the U.S. health system billions of dollars since the beginning of June,” the analysis says.

For this estimate, they looked at those who were hospitalized primarily due to Covid-19 and adjusted that number to reflect the fact that even if unvaccinated adults had got the vaccine, it would not prevent 100% of hospitalizations. Then they multiplied the number of preventable hospitalizations by the cost of each hospitalization, using a typical cost of $20,000.

“Based on our estimates, described below, we find preventable Covid-19 cost the U.S. health system $2.3 billion in June and July 2021,” the analysis says.

However, the analysis noted that “this ballpark figure is likely an understatement of the cost burden on the health system from treatment of Covid-19 among unvaccinated adults.” KFF gives a few reasons for this, including that cases, hospitalizations and deaths have continued to increase into August, outpatient treatment costs were not included in the analysis and neither were costs from the unvaccinated spreading the virus to those who have taken the measures to protect themselves.

The cost of treating the unvaccinated is borne not only by patients but also society more broadly, KFF says, including taxpayer-funded public programs and private insurance premiums.

Patients only pay a small share of the cost of hospitalization directly themselves, the analysis says. Insurers are also prohibited from charging higher premiums to unvaccinated people by the Affordable Care Act and other laws, although employers could impose higher costs through wellness programs.

Private insurers have also begun to reinstate cost-sharing for Covid-19 hospitalizations, KFF says, and adults can largely avoid these costs, as well as severe illness, by getting a vaccine, which is free.