The latest on the Covid-19 pandemic in the US

By Melissa Macaya, Melissa Mahtani, Mike Hayes and Meg Wagner, CNN

Updated 7:55 p.m. ET, September 20, 2021

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9:33 a.m. ET, September 20, 2021

Pfizer's Covid-19 vaccine for children could be available by end of October, official says

From CNN’s Naomi Thomas

Vials of the Pfizer Covid-19 vaccine are seen at a vaccination clinic in Winter Springs, Florida, on September 11. (Paul Hennessy/SOPA Images/LightRocket via Getty Images)

Dr. Scott Gottlieb, former commissioner of the US Food and Drug Administration and a board member at Pfizer, said on CNBC’s Squawk Box Monday that a vaccine for children could be available as early as the end of October.

“Pfizer could be in a position to file very quickly,” Gottlieb said, when asked when the vaccine could be available for children. “The data came a little earlier than some were expecting, and depending on how long the FDA takes to review the application, whether it’s a four week review or a six week review, you could have a vaccine available to children as early as probably by the end of October, perhaps it slips a little bit into November.”

He also added that it is a 10 microgram dose, “so it’s effectively the same vaccine that’s available for adults and children over the age of 12, just in a lower dose.”

Gottlieb's comments come after Pfizer said on Monday a Phase 2/3 trial showed its Covid-19 vaccine was safe and generated a "robust" antibody response in children ages 5 to 11.

These are the first such results released for this age group for a US Covid-19 vaccine, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the FDA for emergency use authorization soon.

8:47 a.m. ET, September 20, 2021

Vaccinating children 5 to 11 could protect another 9% of US population from Covid-19

From CNN’s Deidre McPhillips

If the Pfizer/BioNTech Covid-19 vaccine is authorized for children ages five to 11, more than 28 million additional people will be eligible to be vaccinated against Covid-19, according to a CNN analysis of data from the US Census Bureau.

Currently, about 85% of the US population is eligible to receive a Covid-19 vaccine. But the five to 11 age group represents about 9% of the total United States population, which would bump it up to 94%.

According to the latest data from the US Centers for Disease Control and Prevention, 63.8% of the total US population has received at least one dose of Covid-19 vaccine and 54.6% of the population is fully vaccinated.

But adolescents are the least vaccinated group. About 57% of adolescents age 12 to 17 have received at least one dose and 46% are fully vaccinated, according to a CNN analysis of CDC data. Children 16 and up were included in the initial emergency use authorization of the Pfizer/BioNTech vaccine and children ages 12 to 15 were added in May, more than four months ago.

Covid-19 cases among children have increased 240% since July and recently hit a record high, according to the American Academy of Pediatrics. As of Sept. 9, nearly 5.3 million children have tested positive for Covid-19.

In a news release Monday, Pfizer said that trial data shows that its Covid-19 vaccine for children ages 5 to 11 is safe and generated a “robust” antibody response. They plan to submit to the US Food and Drug Administration for emergency use authorization soon.

9:31 a.m. ET, September 20, 2021

46% of US adolescents are now fully vaccinated against Covid-19, CNN analysis finds

From CNN's Jacqueline Howard

A 16-year-old rolls up their sleeve to receive a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic in Los Angeles in May. (Patrick T. Fallon/AFP via Getty Images)

The percentage of adolescents who are fully vaccinated against Covid-19 is inching toward the halfway point. About 46% of all 12- to 17-year-olds in the United States are now fully vaccinated — an increase from earlier this month.

Out of the roughly 25 million 12- to 17-year-olds total in the United States, more than 11 million are fully vaccinated against Covid-19 as of Monday morning, according to a CNN analysis of data from the US Centers for Disease Control and Prevention.

More than 14 million adolescents have completed at least one dose of vaccine as of Monday morning, the CDC data shows. That number corresponds to about 57% of all 12- to 17-year-olds in the United States.

The latest data shows an increase in vaccinations among adolescents compared with earlier this month. On Sept. 9, about 10.8 million or 43% of all adolescents ages 12 to 17 were fully vaccinated against Covid-19.

Vaccine makers are also working toward a Covid-19 shot for younger children. A Phase 2/3 trial of Pfizer and BioNTech's two-dose coronavirus vaccine for children ages 5 to 11 showed it is safe and generated a "robust" antibody response, Pfizer released in a news release on Monday.

8:22 a.m. ET, September 20, 2021

Pfizer says its Covid-19 vaccine is safe for 5- to 11-year-olds

From CNN's Amanda Sealy

A Phase 2/3 trial of Pfizer/BioNTech’s two-dose Covid-19 vaccine for children ages 5 to 11 showed it is safe and generated a “robust” antibody response, Pfizer said in a news release on Monday.

These are the first such results released for a US Covid-19 vaccine in this age group, and the data has not yet been peer-reviewed or published. Pfizer said it plans to submit to the US Food and Drug Administration for emergency use authorization soon.

The trial, which included 2,268 participants ages 5 to 11, used a two-dose regimen of the vaccine administered 21 days apart. This trial used a 10 microgram dose – smaller than the 30 microgram dose that has been administered to people 12 and older.

“The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age,” Pfizer said.

Participants’ immune responses were measured by looking at neutralizing antibody levels in their blood and comparing those levels to a control group of 16- to 25-year-olds who were given a two-dose regimen with the larger 30 microgram dose. Pfizer said the levels compared well with older people who received the larger dose, demonstrating a “strong immune response in this cohort of children one month after the second dose.”

“Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age,” the company said. A Pfizer spokesperson also confirmed that were no instances of myocarditis, a type of heart inflammation that has been linked with mRNA vaccines.

Pfizer said these data will be included in a “near-term submission” for EUA and the companies will continue to accumulate the data needed to file for full FDA approval for people ages 5 to 11. The vaccine is currently approved for people age 16 and older. It is authorized for emergency use for people ages 12 to 15.

Pfizer said it is expecting trial data for children as young as six months “as soon as the fourth quarter of this year.”

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency," Albert Bourla, chair and chief executive officer of Pfizer, said in the statement.