FDA authorizes first Covid-19 vaccine for younger kids

Parents should not wait to get their younger children vaccinated, acting US Food and Drug Administration commissioner Dr. Janet Woodcock said Friday.

The FDA gave emergency use authorization to Pfizer’s Covid-19 vaccine for 5-11 year-olds Friday and Woodcock urged parents to get their children vaccinated right away if the US Centers for Disease Control and Prevention signs off on the EUA next week.

“As a parent, if I had young children in this age group, I would get them vaccinated now. I would not want to take the risk that they would be one of the ones who would develop long Covid, who would develop multi-system inflammatory syndrome or have to be hospitalized from the virus,” Woodcock said at a news conference.

Vaccinations aren’t just about protecting the individual, Woodcock said, they can help protect the community.

“One of the ways we can make that happen is by diminishing transmission through all age groups,” Woodcock said. “So, I think the recommendation would be that we continue to vaccinate children.”

A Kaiser Family Foundation poll found on Thursday that the majority of parents say they do not plan to vaccinate their children ages 5 to 11 right away, and instead plan to wait and see how the vaccine is working for other people or not to vaccinate them at all.

Covid-19 vaccines for the youngest children are still likely a few months off, a top US Food and Drug Administration official said Friday.

The FDA gave emergency use authorization for a one-third dose of Pfizer’s Covid-19 vaccine to children 5-11 on Friday. It will be a while longer before studies are complete for children under 5, Dr. Peter Marks, the director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research, told reporters.

“It has to do with when they were enrolled in the trials and the fact that as we get down to younger children, the benefit/risk gets to be even more of a careful consideration, because the youngest children are affected the least directly in terms of severe Covid-19,” Marks said.

The FDA and the US Centers for Disease Control and Prevention will be keeping a close eye on all children both in clinical trials and in the real world getting these vaccines, Marks said, to make sure there aren’t rare side effects that only become apparent when many people receive them.

“Even with 3,000 children, that’s a large number, but very rare side effects sometimes become known later on and so we want to always be able to pick those up and then inform the public if there’s an issue,” Marks said.

Dr. Janet Woodcock, the acting US Food and Drug Administration commissioner, said Friday that the FDA anticipates that children in the 5 to 11 age group will be able to get vaccinated following next week's meeting of the US Center for Disease Control and Prevention's Advisory Committee on Immunization Practices that will discuss clinical recommendations for this age group.

“As a mother and as a physician I know parents, caregivers, school staff and children who have been waiting for today's authorization vaccinating younger children against Covid-19, bring us closer to returning to a sense of normalcy,” Woodcock said.

The FDA issued an emergency use authorization on Friday for Pfizer’s Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the US for younger children.

“Parents and guardians can rest assured that we conducted [a] comprehensive and rigorous evaluation of the data on the vaccine safety and effectiveness,” Woodcock said.

Pfizer says data from the clinical trial shows the vaccine provides more than 90% protection against symptomatic disease among children of this age group.

While many children have only had mild cases of Covid-19, Woodcock said it was important to understand that more than 1.9 million children 5 to 11-years-old have gotten sick and more than 8,300 of them have been hospitalized through September of this year. Half of those children who were hospitalized did not have underlying health conditions.

“Vaccines are one of our greatest tools in the fight against this pandemic. Making sure younger children in our population now have access to them has been one of our highest priorities,” Woodcock said.

Wyoming Attorney General Bridget Hill has joined a 10-state coalition led by Missouri in filing a lawsuit against the BidenAdministration for imposing a vaccine mandate on federal contractors and federally contracted employees, according to a press statement released by Gov. Mark Gordon’s office Friday.

The lawsuit takes issue with the Biden administration’s use of federal procurement statutes to mandate vaccinations through Executive Order 14042, according to the statement.

“This vaccine mandate for federal contractors is a clear example of the extreme federal overreach that Wyoming must put an end to,” Gordon said in the statement. “Today, as promised, we take action as a broad collation of which General Hill is proud to be a part. We are committed to defend the interests of Wyoming’s people and protect them from further federal intrusion into our lives.”

The coalition alleges, “The Sept. 2, 2021, executive order enacted by the Biden Administration usurps the state’s police powers, violates the Tenth Amendment and federalism, violates the Procurement Act, violates the Administrative Procedures Act, and is an unconstitutional exercise of spending power,” according to the statement.

Joining Wyoming and Missouri in the lawsuit are Alaska, Arkansas, Iowa, Montana, Nebraska, New Hampshire, North Dakota, and South Dakota.

Some context: Florida Gov. Ron DeSantis announced that his state has officially filed a new lawsuit in Tampa against the Biden administration over the President’s same order, scheduled to take effect Dec. 8.

The White House responded to DeSantis’ announcement by saying “vaccine requirements work” and that Biden has the authority to mandate them.

In addition to the regular update of vaccination numbers on Friday, the US Centers for Disease Control and Prevention made updates to the vaccination data for Illinois and Kentucky that have affected the overall numbers, the agency told CNN. 

Updates to old data made by Illinois accounted for 316,351 Covid-19 vaccine doses administered. Data adjustments relating to how pharmacies report vaccination in Kentucky contributed a decrease of 411,224 doses administered. 

To note: As with Covid-19 statistics covering case and death rates, vaccination data is continually updated and occasional backdating and retroactive changes are made, like what is seen in Friday’s update. The numbers contained in this update are the most accurate currently.  

The changes in this update appear to have most affected the number of people newly vaccinated.

The data Friday shows a sharp drop from previous days, and should be taken in the context of current trends and the data changes mentioned above. As with every sharp turn seen in these numbers, it will take a couple days to know whether a change is indicative of a new trend.

Here’s latest data on vaccination efforts in the US, published Friday by the CDC:

• Fully vaccinated: 57.8% of the total US population (all ages), more than 191 million people
• Not vaccinated: 22.2% of the eligible population (12+). 
• Current pace of vaccinations (7-day average): 137,195 people are initiating vaccination each day.
• An average of 259,759 people are becoming fully vaccinated each day. 
• An average of 1,008,247 doses are being administered each day.
• More than 16.7 million people have received an additional dose, or booster.

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.

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.

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.

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.”