American Academy of Pediatrics – 蜜桃影视 America's Education News Source Tue, 07 Apr 2026 19:05:50 +0000 en-US hourly 1 https://wordpress.org/?v=6.7.2 /wp-content/uploads/2022/05/cropped-74_favicon-32x32.png American Academy of Pediatrics – 蜜桃影视 32 32 A Seasoned Pediatrician on What the Latest Vaccine Victory Means for Kids /article/a-seasoned-pediatrician-on-what-the-latest-vaccine-victory-means-for-kids/ Tue, 07 Apr 2026 16:30:00 +0000 /?post_type=article&p=1030810 Following a year of chaos around childhood vaccines, the medical community finally got a win in mid-March when a judge temporarily stayed a number of controversial decisions made by a federal vaccine advisory committee and essentially halted its ability to meet at all.

The ruling came about nine months after the American Academy of Pediatrics and other groups filed a lawsuit against longtime vaccine skeptic, Health and Human Services Secretary Robert Kennedy Jr.,  and the department he leads, which includes the Centers for Disease Control and Prevention.  In it, the plaintiffs argued that Kennedy Jr.鈥檚 advisory committee appointments 鈥 and the panel鈥檚 subsequent votes to roll back childhood vaccine recommendations 鈥 were unlawful.

David Hill, a pediatrician who has been practicing for over 30 years, serves as a spokesperson for the AAP. He recently told 蜜桃影视 that while he and his colleagues are 鈥渧ery happy鈥 with this latest development, 鈥渨e’re also all still holding our breaths.鈥

鈥淭his is one moment in a lengthy process,鈥 he added. 鈥淚t is an encouraging moment, but I don’t think any of us are under the impression that this is over yet.鈥

Most of Hill鈥檚 work centers around hospitalized children and newborn care, which means he is often the first pediatrician a family meets and the one parents talk to about vaccinating their kids. He recently started practicing in Seattle after spending years working in North Carolina, where he served a widely diverse group of patients.

The families he works with, he said, have 鈥渧astly different socioeconomic backgrounds and value systems and understandings of health,鈥 which has given him a unique perspective into on-the-ground impacts of shifting vaccine policies.

While not new to public discourse, vaccine skepticism has significantly swelled and gained greater footing since Kennedy Jr. took the helm of the nation鈥檚 health care system last February. Following his appointment, he swiftly fired all 17 members of the Advisory Committee on Immunization Practices, also known as ACIP, replacing them with hastily hand-picked advisors who largely shared his views on vaccines. 

The committee has since voted to overturn a recommendation that all newborns receive the hepatitis B vaccine; change policies surrounding the measles, mumps, rubella and varicella (chickenpox) combination vaccine; and roll back recommendations around 2025鈥檚 COVID- 19 booster. Then, this January, officials announced a plan to overhaul the U.S. childhood vaccine schedule, significantly reducing the number of shots routinely recommended for all kids 鈥 all amid already falling vaccine rates, measles outbreaks and The AAP and other groups were also cut off from their long-standing liaison roles. 

It was in response to all of these decisions that the AAP, a trusted source of information for pediatricians and families for nearly a century, began boycotting ACIP meetings, released a competing vaccination schedule, filed their lawsuit and effectively severed ties with the committee.

March鈥檚 preliminary injunction halts the changes to the pediatric immunization schedule, and stays Kennedy Jr. ‘s 13 appointments to the committee, essentially rendering it unable to meet. All votes made by the now-stayed ACIP appointments are also overturned 鈥 at least temporarily. 

When asked to comment, HHS spokesperson Andrew Nixon said this week that the department looked forward to the judge’s decision being overturned, but would not say whether it had filed an appeal.

蜜桃影视鈥檚 Amanda Geduld recently spoke with Hill about his organization鈥檚 lawsuit and how childhood vaccine sentiments have shifted over the past three decades. The impacts he鈥檚 seen in his own practice are particularly illuminating.

This interview has been edited for length and clarity. 

What is the most common question that parents ask you about vaccinating their newborns? Is there one vaccine they’re particularly concerned about?

I have the most experience in my current role with the first hepatitis B vaccine, but I think it is a fantastic model for the questions that we get about other vaccines. For example, I recently admitted a child at the hospital with an infection and breathing difficulty at age 2 who had not yet been vaccinated against Haemophilus influenza B (Hib) and pneumococcal pneumonia. 

And we had to think about this child very differently, because these are complications of viral illnesses that used to be absolutely horrendous 鈥 with meningitis, aggressive pneumonia, severe ear infections, infections of the bone around the ear or behind the ear. And really, because of the effectiveness of the vaccines against these illnesses, we have been lulled into not worrying about them very much anymore. And so we had to make sure that the team was aware that this was a possibility 鈥 these complications with this baby. 

But most often I’m talking about hepatitis B, and usually I’m the one who begins with the questions, and I say, 鈥淗ey, I noticed that your child has not had the hepatitis B vaccine we usually give. Do you mind sharing with me your thoughts about that?鈥

How have those conversations shifted, if at all, over the past three decades that you鈥檝e been practicing medicine?

Well, they used to be vanishingly rare. And not a 鈥渘ever鈥 event, but a rare enough event that if it occurred, it was remarkable. It might be the first thing I would tell my wife when I came home that evening, or something I would comment to my colleagues about when I went into the office. 鈥淵ou’ll never believe this, but we had a patient turn down [the] hepatitis B vaccine today.鈥

And that is because there was a widely shared understanding that this was an important intervention to keep children healthy for the rest of their lives, and that it was an extraordinarily low-risk intervention with a very high degree of reward. 

And it wasn’t a never event. It’s always been there, but it was remarkable. It was unusual, and the script has flipped to the extent now that when I’m first reviewing a newborn’s chart before I go into the room, I actually breathe a sigh of relief when I see that they have gotten their vaccine, because a really significant proportion of my patients 鈥 especially just in the last five or six months 鈥 have decided that they are going to delay it or maybe not get it at all.

How much of that do you attribute to this current administration and to Robert F. Kennedy Jr.鈥檚 leadership of HHS?

I think that there’s a very apropos chicken-and-egg question here. The wellness industry has put an enormous amount of money and effort into undermining confidence in traditional medicine, and that, of course, allows them to expand their market. It’s a market which is extraordinarily profitable. 

But if patients have trust in traditional medicine, then they’re less likely to purchase those products or to go to those providers. So there has been a decades-long effort 鈥 in terms of marketing, in terms of influence 鈥 that has been well funded and extraordinarily successful. 

It certainly did not start with the election of Donald J. Trump, either the first time or the second time. It definitely was accelerated by the success of a number of proponents of these efforts to achieve power within the United States government, to achieve federal power. 

And as much as people distrust the government, they really do listen to what the government says. So when the message coming from the Centers for Disease Control and Prevention or from the Department of Health and Human Services, are messages undermining confidence in traditional medicine 鈥 whether we like it or not 鈥 that really does have a bearing on the decisions that people make.

Last July, the AAP sued HHS and Kennedy Jr. over vaccine policies. Then, in March, a judge issued a stay, which essentially means that a lot of the votes that ACIP made are overturned 鈥 at least for now. One of those involves the Hep B vaccine birth dose. Can you talk a little bit about the initial decision that was made by ACIP to delay that birth dose, and how you saw that impacting patients on the ground?

I think the really good news for those of us in public health and those of us striving for child health is that the initial decisions made by the ACIP 鈥 the ones that were recently stayed by the court 鈥 had not yet come to affect what vaccines were available to children. And so the stay has also not changed that, because payers were still paying for the vaccines, suppliers were still supplying them, manufacturers were still making them, hospitals and offices were still stocking them. 

So I think it’s very good news that we had not yet seen our worst case scenario of some of these vaccines becoming unavailable or unaffordable. We, on the ground, are very happy to see a court agreeing with our professional opinion that there was no scientific basis for making these changes, and yet I think we’re also all still holding our breaths, because this is not done. There will be appeals. This is one moment in a lengthy process. It is an encouraging moment, but I don’t think any of us are under the impression that this is over yet.

You mentioned that the judge鈥檚 ruling luckily came before some of the worst case scenarios were able to play out. But are you aware of any pediatricians on the ground who had started shifting any of their practices based on ACIP votes?

I am not. I am quite involved in the American Academy of Pediatrics, and listen to a lot of lines of communication. And I think we were all trained to follow the best evidence. And the American Academy of Pediatrics, and scores of other medical organizations, endorsed an evidence-based vaccine schedule that was very similar to the prior vaccine schedule, and that is, as far as I know, what all of my colleagues were referring to.

If the judge had not issued this preliminary injunction, do you think providers on the ground ultimately would have shifted their practices to match the new ACIP guidelines? Or would they have stuck to the evidence-based practices regardless?

You know, I have great confidence that my colleagues would have continued to follow the evidence wherever it leads. I think the fear would have been that some other barriers to following that evidence might have arisen 鈥 in terms of reimbursement, manufacturing, liability 鈥 that would have made it more difficult for us to do what we know is right for children.

I would imagine that the majority of parents across the country are not keeping super close tabs on this lawsuit or tuning into ACIP meetings, but they are reading the headlines, and they’re seeing these rulings go back and forth and practices being implemented and then rolled back. I’m wondering what impact that back-and-forth messaging is having on parents. Is that leading to confusion?

Oh, I know that it is leading to massive confusion. When you look at a marketing campaign, as this has been, people don’t have to be convinced that a message like this is correct, they just have to have some doubt. And so the fact that these conflicting announcements or decisions are sowing doubt is really enough to dramatically change the landscape that we are looking at at this point in terms of communicating with parents, in terms of following the best practices for public health and in terms of protecting children.

So what is your big takeaway of the judge鈥檚 latest ruling then? What impact will this stay have for parents and providers on the ground?

I think the most important shift that I’ve seen 鈥 and as a professional medical communicator, it is a shift that I welcome 鈥 is that pediatricians and health care providers as a whole, and scientists and public health officials are coming to terms with a new understanding of how critical our communication is. And it is across the board revolutionizing the way that we communicate, both individually and in public.

Can you talk a little bit about how that communication is revolutionizing, specifically when you鈥檙e talking to patients and parents of patients?

Yeah, absolutely. My dad is still a practicing pediatrician at age 84, and throughout his career he could count on the fact that he was the doctor being enough for most people. He walks in the room in a white coat with years of experience and an absolutely spectacular education at the best institutions the country has to offer, and has a wall of diplomas behind him, and people will be like, 鈥淥K, you know a thing.鈥 It’s just like when I walk onto my airplane and I see the pilot with all the gold bars on his epaulet. I’m like, 鈥淥h, this guy probably knows how to fly an airplane. I’m going to take my seat.鈥

The relationship between doctors and patients and doctors and the public has changed in a way that I don’t think is going to change back. No matter what happens, we can’t just sit down in the chair and say, 鈥淗ey, I’m the doctor. Here’s what you need to do. Trust me, I studied, I know some stuff.鈥 Patients are really demanding 鈥 and appropriately so 鈥 that we show first that we care and that we can listen and that their value system, their understanding, their goals for their child’s health are the most important thing in that room 鈥 that we are servants who can bring our knowledge to bear to further this family’s goals for their child. 鈥 

My mentor for many years, Dr. Tom Blackstone in Wilmington, North Carolina, used to sit me down early in my career and say, 鈥淒avey, they don’t care how much you know until they know how much you care.鈥 And those are the very wise words of someone who’s been doing this for a long time, and I think those are words we all have to live by.

I love that 鈥 that鈥檚 a beautiful sentiment. Well you talked about how there have been shifts in medicine you don鈥檛 necessarily foresee going back. I鈥檓 going to ask you to look into a crystal ball here, if you will, and tell me if you foresee this moment as a shift in policy moving forward. 

In other words, might this be a time the administration moves away from the attacks on vaccine policy and perhaps more towards other elements of the MAHA movement, like nutrition? Or is this stay merely a brief pause before the vaccine battle continues?

I would tend more toward the brief pause, and I would be thrilled if MAHA acted aggressively on some of their (other) priorities. There is more common ground between the stated priorities of the MAHA movement and the priorities of pediatricians. We would love to see kids get more fresh, healthy food in their diets. We would love to see aggressive measures taken to reduce pollutants in the water, in the air, in farming practices. We would love to see efforts toward increasing family activity and generating safe green spaces for exercise and play really put at the forefront of policy.聽

I think, in a very sincere way, there are a ton of common goals that pediatricians and the MAHA movement share. I am disappointed that on many of these fronts, it appears that this administration is actually taking steps backwards rather than forwards. Taking steps to allow greater degrees of pollution that we know harm children; taking steps to allow greater use of chemicals in farming; taking steps to decrease the availability of fresh, healthy food in schools, for example. 

And people have done this 鈥 there are forums where pediatricians and MAHA advocates sit down and find that they agree on a lot. So I think we would love to see any of those priorities move to the forefront of the movement. 鈥 The attack on vaccines, unfortunately, is very much an attack on public health, and so I think we are still waiting to see what the next steps are going to be before we relax.

The AAP has always been a highly trusted organization and leading authority on children’s health, but I would imagine that role has been pretty seriously magnified over the past year or so with this shift in leadership. Can you talk a little bit about what that feels like from inside the organization and how that’s impacted some of your public-facing actions?

Past administrations have certainly cooperated in more concert with the American Academy of Pediatrics, regardless of whether the leadership was Republican or Democratic. We are a nonpartisan organization, and we have enjoyed close working relationships with pretty much every administration. I believe it is unprecedented since we began working with the ACIP to terminate that relationship. So that certainly would appear to be a flash point. 

However, as a pediatrician of a certain age, I also recall that this is very much in continuity with the American Academy of Pediatrics taking positions in favor of child health that were at times quite unpopular with the public. We were out there early talking about tobacco-free spaces and tobacco-free homes. Those of us who are old enough to remember when people smoked in restaurants and airports and pretty much anywhere they wanted to also recall that there was a tremendous backlash on that. 

When the American Academy of Pediatrics came out in favor of taking lead out of gasoline and paint that was dramatically unpopular. The fuel industry and the paint industry, the builders, really protested quite loudly against that. Even car seats, bike helmets, things that we all take for granted as public safety measures 鈥 like who would not have their baby in a car seat right now? 鈥 were incredibly controversial when they began, and the American Academy of Pediatrics always stood up for child health and safety first and understood that if children’s health was benefited, eventually the public would understand. 鈥

So to some extent, we are just following in the footsteps of those who came before us, and I certainly hope that when I’m not working anymore, there will be another generation to continue in that path, because it’s the right path.

Is there anything I haven’t asked about 鈥 having to do with this current administration and vaccine policy 鈥 that you think is important for readers to understand, given the news of the past couple of weeks?

I think first of all, that the public is wise enough to see where these attacks on vaccines could lead, and to make good decisions regarding child health moving forward. I don’t think we’re going to be having the same conversation in 10 years, or even five years, because as we see measles sweep through certain states, we’re also seeing people in those states recognize what a danger it is. And part of what we’re seeing is parents asking if they can have their babies vaccinated against measles at six months of age, which they can, it just doesn’t keep them from needing the next two vaccines. 

I think that the public is really very intelligent, and that people are already waking up to what these changes mean for public health, and I think for the most part, they don’t like it. One truism that I’ve witnessed as a pediatrician throughout my career is that parents love their children. They want the best for their children. Everybody holds their baby, imagining what that little being is going to turn into, how they’re going to grow, what they’re going to accomplish, and knowing that, I know that societally, we are going to ultimately make good choices, because that’s what it means to love our children.

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CDC COVID Youth Vaccination Figures Clash with Locally Reported Rates /article/exclusive-analysis-cdc-covid-youth-vaccination-figures-clash-sometimes-by-double-digits-with-locally-reported-rates/ Thu, 21 Oct 2021 11:15:00 +0000 /?post_type=article&p=579463 As schools work to mitigate COVID spread in classrooms and get a handle on how many teens have been immunized, they may not be able to rely on vaccination data published by the Centers for Disease Control and Prevention.

In many cases, CDC numbers clash with locally reported vaccination rates, an analysis from 蜜桃影视 reveals, including multiple instances of double-digit gaps between local and federal counts. In some counties, the agency鈥檚 data indicate that the share of 12- to 17-year-olds who have received at least one vaccine dose is impossibly high 鈥 101 percent in Miami-Dade County, Florida, and 104 percent in San Francisco County, California, for example.


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The lack of clarity takes on heightened significance as the country another swath of the K-12 population, with coronavirus shots for children ages 5 to 11 currently under review by the U.S. Food and Drug Administration and expected as soon as early November.

Inaccuracies in CDC data could have implications for the nationwide understanding of vaccine uptake among young people. The youth COVID immunization rate calculated by the , for example, is based on CDC numbers.

鈥淥ur method is to clearly state the source of our data,鈥 Suk-fong Tang, senior database analyst for the AAP, told 蜜桃影视. But due to time limitations and the vast quantity of information, she said, 鈥渋t is not possible at this time to validate everything that we use.鈥

鈥淲e work with [CDC] data with the faith that the data really captures the large trends,鈥 the AAP expert continued. 鈥淚t may not be, you know, accurate down to the single-digit counts.鈥

While the CDC does not publish youth immunization data directly, it releases vaccination rates and raw counts for those over 12 and those over 18 by county. Using those numbers, 蜜桃影视 calculated the rate of inoculation for 12- to 17-year-olds via a method that Tang confirmed produced a 鈥渉ighly similar鈥 youth vaccination figure as the AAP. (Click to see the math.) Those rates frequently deviated from local reports, indicating possible flaws in the federal agency鈥檚 vaccination counts, population counts, or both.

For example, CDC data downloaded by 蜜桃影视 Sept. 30 indicate that in Queens County, New York, 86 percent of teens have received at least one vaccine dose, while NYC Health said the county鈥檚 figure was actually 74 percent. In an especially extreme case, federal data for Coconino County, Arizona, indicate a 93 percent one-dose vaccination rate for 12- to 17-year-olds, while Coconino Health and Human Services reported a 57 percent rate.

Coconino County officials explained the gap in an email to 蜜桃影视, saying they use a 鈥渕ore enhanced data cleaning process鈥 than the state or the CDC.

Other areas such as Fairfax County, Virginia; Marin County, California; and Howard County, Maryland, reported youth vaccination rates that closely aligned with federal counts, differing by under 5 percentage points.

The CDC did not respond to the discrepancies identified by 蜜桃影视, and did not provide comment when asked for the reasons behind them, despite over a half-dozen requests made over more than a two-week span. The agency did send a link to information on its vaccination data reporting protocols, which that their population counts are based on the Census Bureau鈥檚 2019 estimates, meaning that their percentages could be inaccurate if individuals moved counties in the last two years.聽

Population shifts may not completely account for the discrepancies. Outside experts also said issues such as or delays in reporting data upstream to the federal government could contribute to inaccuracies.聽

鈥楩lying blind鈥

Data woes have plagued the CDC throughout the pandemic, said Ali Mokdad, who, after years monitoring vaccine coverage at the federal agency, is now a professor of epidemiology at the University of Washington.聽

鈥淲e鈥檙e flying blind,鈥 he said, pointing out that U.S. decisions around Pfizer booster shots were based on data from Israel and Qatar, where vaccination numbers are collected in a more standardized fashion, due to a dearth of reliable U.S. data.聽

From the CDC鈥檚 decision to for breakthrough infections to their for vaccinated individuals, the agency has come under fire at multiple points throughout the pandemic.聽

In past months, the epidemiology professor said, many Americans received by crossing state lines or lying about their vaccination status thanks to lax immunization tracking. 鈥淲e don鈥檛 know [exactly how many people are] vaccinated or not, and what types of vaccines they have received and when.鈥

That can become a life-or-death problem, said Mokdad. 鈥淲hen you know how many people are vaccinated, you know what immunity you have in your community,鈥 he explained. 鈥淸But if you don鈥檛] know how many people are vaccinated 鈥 you can’t get a handle on how many people are susceptible in your own community and then that will sustain a surge.鈥

In instances where local vaccination numbers are above CDC counts, it鈥檚 possible that states have been slow to report their most recent immunization data, Emily Pond, a researcher for the Johns Hopkins University , told 蜜桃影视 鈥 she calls that glitch 鈥渄ata lag.鈥 Where the CDC count is higher, Pond explained, federal overseers may have access to vaccination counts that local departments of health do not, such as coronavirus immunizations that occurred at army bases or on tribal lands through the Indian Health Service.

In Navajo County, Arizona, for example, Assistant County Manager Bryan Layton said via email, 鈥淲e openly acknowledge the inherent challenges of tracking and reporting case data and vaccine rates in a rural county that is home to 3 different sovereign tribal entities: the White Mountain Apache Tribe, the Hopi, and the Navajo Nation 鈥. The Navajo Nation 鈥 uses a series of service areas that do not necessarily conform to county or state jurisdictions.鈥

Still, local reports in Navajo County say of residents under 20 years old have received at least one dose of the vaccine, compared to CDC numbers that put the rate for 12- to 17-year-olds at 98 percent 鈥 a gap that likely can鈥檛 be fully explained by Indian Health Service data absent at the local level.

鈥淚 have a red flag when any [vaccination rate] is above, like, 90 percent,鈥 said Pond. Differences between CDC and local figures, she said, can be rather common.聽

鈥楢 lot of moving parts鈥

To get a better sense of the frequency of discrepancies between local and CDC vaccination rates, 蜜桃影视 queried a random sample of 10 U.S. counties, a small sliver of the over 2,600 in the full dataset and separate from the analysis of the counties with the highest reported rates. Seven returned data for comparison against federal numbers, some using slightly different age boundaries for youth vaccination than 蜜桃影视鈥檚 12- to 17-year-old range.

Out of those seven counties, three had rates that diverged from CDC numbers by more than 5 percentage points. Hood River County, Oregon, reported that 72 percent of youth ages 12 to 17 had received at least one dose of the coronavirus vaccine while the CDC reported an 80 percent figure. Sullivan County, Pennsylvania, reported a 23 percent rate for youth ages 12 to 19 compared to a 30 percent 12- to 17-year-old rate from the CDC. And Schoolcraft County, Michigan, reported that 32 percent of youth ages 12 to 15 and 47 percent of youth ages 16 to 19 had received at least one dose, compared to a 13 percent CDC rate for youth ages 12 to 17. Both Sullivan and Schoolcraft counties have populations under 10,000, meaning small inaccuracies could have an outsized impact on their vaccination percentages.

The inconsistencies don鈥檛 surprise Michael Kurilla, director of the National Center for Advancing Translational Sciences at the National Institutes of Health. The U.S. has a decentralized health care system, he pointed out, meaning that providers can鈥檛 easily share data. For example, someone sick with COVID who leaves the hospital too early and re-admits to another facility could easily be counted as two cases, said Kurilla.

Further, the reporting systems themselves are often antiquated, the NIH expert explained.

鈥淪ome places are still paper based, some are using fax to transmit information,鈥 he told 蜜桃影视, adding 鈥 only half joking 鈥 that it wouldn鈥檛 surprise him if some local health agencies still used floppy disks.

On top of technological woes, the many different settings offering COVID-19 shots can compound reporting challenges, explained Phil Chan, medical director for the Rhode Island Department of Health. It鈥檚 easy to document doses at state-run vaccination clinics, he said, but vaccinations delivered at doctor鈥檚 offices or pharmacies can be harder to track.

鈥淚t鈥檚 a lot of moving parts,鈥 he told 蜜桃影视. 鈥淭he devil鈥檚 really in the details.鈥

Vaccination sites can use this form when they lack internet. (Centers for Disease Control and Prevention)

When those details are mishandled, inaccuracies in the data arise. In mid-September, the CDC adjusted their report of the share of people 12 and older in West Virginia who had received at least one dose of the coronavirus vaccine , after discovering that they had double-counted certain data streams for over three months.

On the flip side, increased data transparency may well translate into increased accuracy. In Maine 鈥 the only U.S. state to publicly report student and staff COVID vaccination data for school districts, according to the University of Washington鈥檚 Center on Reinventing Public Education 鈥 reported by the state for each of its 16 counties align closely with federal numbers.

鈥淲e need to be transparent, you need to show exactly what you do,鈥 said Mokdad, the UW epidemiologist who spent two decades at the CDC.

He wishes his former employer would be more forthcoming about its raw numbers and any possible shortcomings in its data pipeline. In his own COVID research, Mokdad said, he relies on infection counts from the Johns Hopkins tracker, because he finds it more reliable than the federal numbers.

鈥淭here is a big problem at CDC right now,鈥 said the epidemiologist. Mokdad himself was involved in a high-profile incident in 2004 where he co-authored a CDC paper that the number of annual deaths caused by obesity. The health expert said he left the centers in 2008 for unrelated reasons and on good terms with all his co-workers.

鈥淚 criticize CDC because I love CDC,鈥 he said.

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Pfizer Sends Vaccine Data for Kids Ages 5-11 to FDA /pfizer-sends-vaccine-data-for-kids-ages-5-11-to-fda-now-days-away-from-formal-authorization-request-ceo-says/ Tue, 28 Sep 2021 19:37:46 +0000 /?p=578325 Updated, Oct. 1

Pfizer-BioNTech has submitted initial data to the Food and Drug Administration that its COVID-19 vaccine is safe and effective for 5- to 11-year olds, the pharmaceutical company Tuesday.

The development represents another key step toward shots for young children, but Pfizer has yet to formally submit a request to the FDA for authorization to inoculate the roughly Americans under 12 years old, which it must do before the federal agency can fully begin the weeks-long review process.

Though younger children are not yet cleared for the vaccine, California Gov. Gavin Newsom on Friday ordered COVID shots for all eligible K-12 students in the state, marking the first such statewide move in the nation. The mandate but depends on when vaccines receive full FDA approval for young people ages 12 and up, the Los Angeles Times reports. Currently, Pfizer shots have full FDA approval for use in individuals 16 or older.

鈥淭his is just another vaccine,鈥 Newsom said. Coronavirus shots will be added to 鈥渁 well-established list that currently includes 10 vaccines and well-established rules and regulations that have been advanced by the Legislature for decades.鈥


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Pfizer鈥檚 submission for emergency use authorization among kids under 12 will come , CEO Albert Bourla told ABC News on Sunday.

If Bourla鈥檚 company sticks to that timeline, young kids should have access to COVID shots before the end of next month, said Dr. Anthony Fauci.

“I would imagine in the next few weeks [the FDA] will examine that data and hopefully give the OK so we can start vaccinating children hopefully by the end of October,” the nation鈥檚 top infectious disease expert told MSNBC鈥檚 Morning Joe.

An anonymous source familiar with the authorization process, however, told The Wall Street Journal that if Pfizer delays its submission to the FDA, clearance for young children to receive shots

Dr. Jennifer Shu (Children’s Medical Group, P.C.)

Either way, it’s big news for schools, says Atlanta-based pediatrician Jennifer Shu. Though classrooms have not proven to be the locus of viral spread through the pandemic, circulation of the highly contagious Delta variant this fall has spurred outbreaks forcing some already since buildings opened. In late September, minors made up , the American Academy of Pediatrics reports, though the risk of severe outcomes remains small, doctors say.

鈥淥nce kids ages 5 to 11 are eligible for [the] vaccine, attending school during the pandemic will be safer,鈥 Shu wrote in a message to 蜜桃影视.

The Pfizer data included 2,268 participants ages 5 to 11 who were each given a two-dose regimen of the vaccine 21 days apart. Children were given a 10 microgram dose, smaller than the 30 micrograms administered to older children and adults, which the drug company said was a carefully selected dosage for safety, tolerability and effectiveness.

In an internal review of the results last week, Pfizer reported that one month after the second dose, the shots produced a 鈥渞obust鈥 antibody response, including immunity and side effects comparable to that delivered by the larger dose in 16- to 25-year-old patients.

The FDA said that it will analyze those data as soon as possible, the .

In the Atlanta pediatrician鈥檚 practice, patients are eager to have youngsters inoculated 鈥 though Shu鈥檚 clientele may be the exception, from a nationwide perspective.

鈥淚鈥檓 mostly seeing families that are all in,鈥 she said. 鈥溾嬧婥hildren are telling me they can鈥檛 wait until they can get the vaccine, since they are often the only ones in their family who haven鈥檛 even gotten one dose yet.鈥

Youth ages 12 and up have been eligible for doses since May, but , according to the AAP. By that measure, inoculating those under 12 years old may prove a challenge.

A Kaiser Family Foundation national poll from mid-August found that only of 5- to 11-year olds would want their child to receive the COVID-19 shot right away after it鈥檚 cleared, while another 40 percent said they would 鈥渨ait and see.鈥 That attitude may be changing, however, as of U.S. parents surveyed in a Gallup poll published Tuesday indicated that they would have their children inoculated against COVID-19 if shots were available.

Getting children under 12 vaccinated 鈥渨ill be an uphill battle,鈥 Rebecca Wurtz, professor of health policy at the University of Minnesota, told 蜜桃影视. 鈥淚 think parents are even more protective of their younger kids (than their older children).鈥

In the Kaiser survey, an additional 9 percent of parents said they would get their youngsters vaccinated only if the shots were required. Meanwhile, momentum is building for schools to do just that.

Last week, Oakland Unified School District in California joined Golden State counterparts Los Angeles and Culver City, as well as Hoboken, New Jersey, in in order to attend in-person school.

Los Angeles Unified School District officials chose not to comment when asked by 蜜桃影视 last week whether they would extend their student vaccine requirement to learners ages 5 to 11, should shots be approved for that age group.

Whether or not student vaccination mandates continue to expand, Shu believes the real-world outcomes from COVID shots should encourage parents who may be on the fence.

鈥淢ore than 5.5 billion doses of COVID vaccine have been given worldwide,鈥 she points out. 鈥淚 hope that builds confidence for parents to give it to their children.鈥

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