FDA authorizes first Covid-19 vaccine for younger kids

By Adrienne Vogt, Aditi Sangal, Meg Wagner and Melissa Macaya, CNN

Updated 5:58 p.m. ET, October 29, 2021
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4:24 p.m. ET, October 29, 2021

Pfizer says Covid-19 vaccine for kids ages 5 to 11 can have "profound effect" on children and schools

From CNN's Nadia Kounang

Dr. William Gruber, Pfizer’s senior vice president of vaccine clinical research and development, called Friday “a great day” for the health of children after the US Food and Drug Administration authorized the company’s Covid-19 vaccine for children ages 5 to 11, saying the vaccine could have “a profound effect” on their lives and schools.

“The ability to vaccinate children frees them up to attend school with reduced risk of outbreaks that limit in-person learning,” Gruber told CNN. “I think for many children, school is a safe space, as well as obviously the important role that it plays in their education … for many children it's actually a place where they get a meal. So this has really a profound effect beyond the important prevention of Covid-19.” 

He added that the benefit of the vaccine wasn’t just to protect children themselves but those around them at home and in public.

“That is the benefit of preventing potential transmission, both in the school room settings: other children and their teachers and other providers in the school,” Gruber said. “And then of course, there's the potential that if a child acquires infection in the schoolroom setting, they can bring it home to vulnerable loved ones, parents, grandparents, siblings, other individuals with underlying diseases that look into greater risk.” 

Some context: Shots can’t be administered until the US Centers for Disease Control and Prevention signs off – its vaccine advisers will meet Tuesday to consider whether to recommend the vaccine.

Gruber said vaccinating younger children was an important step toward ending the pandemic.

“We're looking for more and more good chapters that take us to the end of the book, and in position where we can say Covid-19 is behind us at least as a pandemic illness," he said.

Pfizer is continuing its Covid-19 vaccines studies in children as young as six months.

“We have work ongoing to extend the vaccines in even younger children and we hope to begin to provide some of that data by the end of this year and into next year,” he said, adding that it anticipates authorization for the youngest children to come sometime next year.

3:22 p.m. ET, October 29, 2021

FDA authorizes Pfizer's Covid-19 vaccine for children ages 5 to 11

From CNN's Maggie Fox

Doses of the Pfizer Covid-19 vaccine for children, in Puurs, Belgium.
Doses of the Pfizer Covid-19 vaccine for children, in Puurs, Belgium. (Pfizer/AP)

The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children ages 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children. 

On Tuesday, the FDA’s vaccine advisers voted 17-0, with one abstention, to recommend EUA for the vaccine, which is formulated at one-third the dose of the vaccine used for people 12 and older.  

Pfizer says a clinical trial showed its vaccine provides more than 90% protection against symptomatic disease among children, even at one-third the dose, and the company hopes the lower dose will reduce the risk of any side effects.

What happens next: The question now goes to the US Centers for Disease Control and Prevention. The CDC’s vaccine advisers, the Advisory Committee on Immunization Practices, meet Nov. 2 to discuss whether to recommend use of the vaccine among US children. Then the CDC director, Dr. Rochelle Walensky, makes the final decision on use of the vaccine. 

The White House says it has a plan already in place for distributing vaccines to children. Vaccines could be administered as soon as the CDC signs off.

Pfizer’s Covid-19 vaccine was previously authorized for children ages 12 to 15. The vaccine is approved for people age 16 and older.

4:01 p.m. ET, October 29, 2021

Vaccination protects against coronavirus infection more strongly than previous infection, CDC study finds

From CNN's Maggie Fox

A pharmacist fills a syringe with the Pfizer Covid-19 vaccine on October 1, in San Rafael, California.
A pharmacist fills a syringe with the Pfizer Covid-19 vaccine on October 1, in San Rafael, California. (Justin Sullivan/Getty Images)

Vaccination protects people against coronavirus infection much better than previous infection, a team of researchers led by the US Centers for Disease Control and Prevention reported Friday. 

The team said their findings should help settle debates over whether people who have been infected should bother getting vaccinated. They should, the researchers said.

People who had not been vaccinated and who ended up in the hospital were five times more likely to have Covid-19 than people who had been vaccinated within the past three to six months, they found.

“All eligible persons should be vaccinated against COVID-19 as soon as possible, including unvaccinated persons previously infected with SARS-CoV-2,” the researchers wrote in the CDC’s weekly report, the Morbidity and Mortality Weekly report.

“We now have additional evidence that reaffirms the importance of COVID-19 vaccines, even if you have had prior infection,” CDC Director Dr. Rochelle Walensky said in a statement. 

“This study adds more to the body of knowledge demonstrating the protection of vaccines against severe disease from COVID-19. The best way to stop COVID-19, including the emergence of variants, is with widespread COVID-19 vaccination and with disease prevention actions such as mask wearing, washing hands often, physical distancing, and staying home when sick.” 

About the study: Researchers across the country collected data on 7,000 people treated at 187 hospitals in nine states for Covid-like illnesses between January and September. All were tested for coronavirus. Those who were not vaccinated were 5.49 times as likely to test positive for coronavirus as those who had been vaccinated within the past three to six months – even if they had a recent Covid-19 infection.

The CDC noted that a recent Israeli study found just the opposite—but also noted that the Israeli study looked at people who had been vaccinated six month before or longer. “Understanding infection-induced and vaccine-induced immunity over time is important, particularly for future studies to consider,” they wrote.

“In this study, the benefit of vaccination compared with infection without vaccination appeared to be higher for recipients of Moderna than Pfizer-BioNTech vaccine, which is consistent with a recent study that found higher vaccine effectiveness against COVID-19 hospitalizations for Moderna vaccine recipients than for Pfizer-BioNTech vaccine recipients,” they added.

12:12 p.m. ET, October 29, 2021

Moderna will supply 56.5 million more Covid-19 vaccine doses to low- and middle-income countries in 2022

From CNN's Naomi Thomas

Moderna announced a new agreement with Gavi, the Vaccine Alliance, to supply an additional 56.5 million Covid-19 vaccine doses for delivery in the second quarter of 2022, the company said Friday. 

This option for additional doses increases an agreement from earlier in the year for 60 million doses of Moderna’s vaccine, bringing the total to 116.5 million Covid-19 vaccine doses.

Under the agreement, 92 low- and middle-income countries are covered, according to a news release. These 92 countries are the Gavi COVAX Advance Market Commitment countries. 

Gavi has the option to procure 233 million additional doses in 2022, the release says. The doses are offered at the lowest price tier. 

“I am grateful to our partners at Gavi and COVAX for their work and collaboration to reach this agreement. This is another important milestone as we work to ensure that people around the world have access to our COVID-19 vaccine,” said Stéphane Bancel, CEO of Moderna, said in the release. “We support COVAX’s mission to ensure broad, affordable and equitable access to COVID-19 vaccines and we remain committed to doing everything that we can to ending this ongoing pandemic with our mRNA COVID-19 vaccine. We have recently offered to COVAX to access more vaccines for Q2 and Q3 2022.”

10:47 a.m. ET, October 29, 2021

Tonight's the deadline for some New York City workers to get vaccinated

From CNN's Dakin Andone

New York City Fire Department members, New York Police Department members and other city workers have until 5 p.m. ET tonight to have proof that they've received at least one dose of vaccine or be placed on unpaid leave.

On Thursday, members of the FDNY opposed to the mandate crowded outside Gracie Mansion, the mayor's official residence, to demonstrate, with some attendees carrying signs that read, "Essential Workers aren't Disposable Heros (sic)," "My Body My Choice," and "#Natural Immunity."

"In 21 years, we've been through the Trade Center, hurricanes, Covid, and just to come out and put this mandate on in such a short period of time, it's just not right," said Julian Eyre, who told CNN he's choosing to retire after 21 years with the fire department rather than get the vaccine.

"I've been working a year and a half with Covid, I haven't gotten sick, I haven't tested positive. I've been healthy the entire time. I don't feel that I need the vaccine to survive," Eyre said, adding he's concerned about health risks stemming from the vaccine.

In an effort to mitigate the anticipated staffing problems, the fire department is planning to cancel vacations and enact mandatory overtime. The city's medical services also will seek support by enacting mutual aid with private hospitals and volunteer ambulance services, per the source.

Mayor Bill de Blasio on Thursday offered assurances that emergency services will continue to function despite expected staff shortages, though he said he expected a rapid increase in vaccinations as the deadline approached, similar to what took place last month when a vaccine mandate went into effect for teachers and health care workers.

9:22 a.m. ET, October 29, 2021

US government purchases 50 million additional doses of Pfizer's Covid-19 vaccine for children

From CNN Health’s Amanda Sealy

Boxes of Pfizer Covid-19 vaccine doses for children are packaged in Puurs, Belgium.
Boxes of Pfizer Covid-19 vaccine doses for children are packaged in Puurs, Belgium. (Pfizer/AP)

The US government has purchased an additional 50 million doses of Pfizer and BioNTech’s Covid-19 vaccine for younger children, Pfizer said in a news release on Thursday.

These additional doses are to “continue to support preparedness for pediatric vaccinations including securing vaccines for children under 5 years of age, should they receive regulatory authorization,” said the release.

The US Food and Drug Administration is currently considering whether to authorize the Pfizer/BioNTech Covid-19 vaccine for children ages 5 to 11. Pfizer said initial data from studies of two younger groups – those age 2 to younger than 5, then those age 6 months to younger than 2 – “are expected as soon as fourth quarter 2021 or early first quarter 2022.”

These additional doses are expected to be delivered by April 30, 2022, and bring the total number of Pfizer doses purchased to 600 million. This is the total number of doses the United States is able to acquire under the agreement with Pfizer in July 2020.

“From the very beginning, it has been our goal to provide access to a highly effective vaccine to as many people as possible. This supply agreement will help to offer a vaccine to all children younger than 12 years of age in the United States,” Ugur Sahin, CEO and co-founder of BioNTech, said in the release.

In a separate agreement, Pfizer agreed to provide 1 billion doses to the US government that would go to low- and lower-middle-income countries.

Deliveries of those doses began in August 2021; all the doses are expected to be delivered by the end of September 2022.

8:21 a.m. ET, October 29, 2021

FDA advisers voted to recommend Covid-19 vaccines for children 5 to 11. Here's what happens next.

From CNN's Maggie Fox

Vaccine advisers to the US Food and Drug Administration voted 17-0 with one abstention Tuesday to recommend emergency use authorization of Pfizer’s Covid-19 vaccine in children 5 to 11.

Members of the FDA’s Vaccines and Related Biological Products Advisory Committee agreed that the benefits of vaccinating younger children appeared to outweigh the risks, but some members appeared troubled about voting to vaccinate a large population of younger children based on studies of a few thousand. 

“It is reassuring to me that we are giving a lower dose,” said Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. Pfizer has cut its vaccine to one-third of the adult dose for the children under 12. 

“I am just worried that if we say yes, then the states are going to mandate administration of this vaccine for children to go to school and I do not agree with that,” said Dr. Cody Meissner, a professor of pediatrics at Tufts University School of Medicine. “I think that would be an error at this time.”

But Dr. Amanda Cohn of the US Centers for Disease Control and Prevention reminded the committee that children have died of Covid-19. According to CDC, more than 700 children 18 and under have died of Covid-19. “We don’t want children dying of Covid,�� she said. “And we don’t want children in the ICU.”

The FDA had said that, under most of the scenarios it projected, the benefits of vaccinating younger children would outweigh any risks and Pfizer said clinical trials showed the vaccine was more than 90% effective in preventing symptomatic infection in children.  

What happens next: The FDA will take the committee’s vote into consideration and then make the final decision about whether to authorize it.  Then, the US Centers for Disease Control and Prevention's independent advisory committee meets Nov. 2 and 3, and will vote on whether to recommend the vaccine for this age group.

Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee's recommendation.

Once Walensky signs off, younger children could start getting Covid-19 shots immediately.

The US federal government has a plan in place for delivering the smaller-sized vaccines to pediatricians’ offices, pharmacies and other venues across the country.