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F.D.A. Panel Recommends Covid Shots for Children 5 to 11

WASHINGTON — An expert committee advising the Food and Drug Administration on Tuesday recommended that regulators authorize Pfizer-BioNTech’s …

F.D.A. Panel Recommends Covid Shots for Children 5 to 11

WASHINGTON — An expert committee advising the Food and Drug Administration on Tuesday recommended that regulators authorize Pfizer-BioNTech’s coronavirus vaccine for 5- to 11-year-olds, bringing about 28 million children a major step closer to becoming eligible for shots.

If the F.D.A. follows the panel’s advice in the coming days, as is expected, the Biden administration will have expanded vaccine access to all but the youngest Americans, while providing booster shots for many as well.

Biden administration officials see the pediatric dose as crucial to keeping schools open and restoring a sense of normalcy to family and work life as the pandemic hurtles toward the end of its second year. The administration wants to be seen as doing everything possible to combat the virus and build upon positive trends, as the Delta variant ebbs and the daily drumbeat of infections and deaths fades.

Younger children would start getting their shots at a time when coronavirus cases are dropping sharply. But public demand for a pediatric vaccine has been high, and some panel members said that even though young children are less likely to get severely ill from Covid-19, parents and doctors alike are anxious to protect them.

Dr. Jay Portnoy, a medical director at Children’s Mercy Hospital in Kansas City, Mo., said he had seen critically ill children in the intensive care unit and “terrified” parents. “I’m looking forward to being able to actually do something to prevent that,” he said.

The vote was 17-0 in favor, with one abstention. Federal regulators and scientists made a strong push, arguing that 8,300 children between 5 and 11 had been hospitalized with Covid-19 and nearly 100 had died over the course of the pandemic.

Covid-19 is “the eighth-highest killer of kids in this age group over the past year,” said Dr. Amanda Cohn, a top C.D.C. vaccine official. “Use of this vaccine will prevent deaths, will prevent I.C.U. admissions and will prevent significant long-term adverse outcomes in children.”

Data from Pfizer showed that the vaccine had a 90.7 percent efficacy rate in preventing symptomatic Covid-19 in a clinical trial of 5- to 11-year-olds. Still, many advisory committee members expressed concern about limited safety data, turning repeatedly to the risk of myocarditis, a rare condition involving inflammation of the heart muscle, in young vaccine recipients. Myocarditis and pericarditis, inflammation of the lining around the heart, have been tied to the Pfizer-BioNTech and Moderna vaccines, particularly in younger men.

The Pfizer dose for younger children would be one-third of the strength given to people 12 and older, with two shots given three weeks apart. Experts have said that could diminish the risk of the heart-related side effects.

If F.D.A. regulators follow the committee’s advice, as they typically do, an authorization could come within days. The Centers for Disease Control and Prevention’s own panel of outside experts is scheduled to meet Tuesday and Wednesday, and is also expected to endorse a pediatric dose. The C.D.C., which sets vaccine policy, would likely then quickly recommend the rollout of shots.

During a long debate before the vote, some committee members questioned whether every child in the age group really needed the vaccine or whether it should be limited to those at high risk of severe Covid-19 — an easily identifiable group, with underlying conditions such as obesity or other risk factors.

Dr. James E.K. Hildreth, the president and chief executive of Meharry Medical College, said that since many children between 5 and 11 may already have some immunity after contracting the virus, the need to vaccinate broadly in the age group might be less urgent.

“It just seems to me that in some ways we’re vaccinating children to protect the adults, and it should be the other way around,” he said. “I do believe that children at highest risk do need to be vaccinated. But vaccinating all of the children to achieve that just seems a bit much for me.”

Dr. Hildreth also bemoaned the fact that Pfizer’s pediatric trial included few children from minority groups, who are at greater risk of bad outcomes from Covid-19.

While some committee members said they wished to recommend the vaccine for a more narrow group of children, they were asked to decide simply whether the benefits of a pediatric shot outweigh the risks. “We decided to go for it with a lot of heavy conscience,” said Dr. Eric Rubin, an infectious diseases expert at the Harvard T.H. Chan School of Public Health.

Dr. Paul Offit, a panel member who heads the Vaccine Education Center at Children’s Hospital of Philadelphia, said it was “nerve-racking” to make public health decisions affecting millions of children based on studies involving just a few thousand participants.

But he said: “The question is, when do you know enough? And I think we certainly know that there are many children between 5 and 11 years of age who are susceptible to this disease who could very well be sick and or hospitalized, or die from it.”

Dr. Peter Marks, who heads the agency’s division that oversees vaccine approvals, told the committee that nearly two million in that age group have been infected, and that a third of those hospitalized have needed intensive care.

Committee members said they hoped a pediatric dose would not only keep elementary schoolers out of the hospital, but would reduce transmission of the virus and cases of long Covid.

Dr. Fiona Havers, a viral disease specialist at the C.D.C., told the panel that more than 2,000 schools had been forced to close between early August and October because of outbreaks, affecting more than a million students.

Children have higher levels than adults of the neutralizing antibodies that are essential for preventing infection, she said, but are at least as likely as adults to be infected, she said. She said there appear to be many more cases of child infection than are publicly recorded.

Covid-19 hospitalization rates in the 5 to 11 age group are three times as high for Black, Hispanic and Native American children as for white children, Dr. Havers added.

The C.D.C. also presented data on blood samples from young children indicating that 42 percent had coronavirus antibodies, raising questions about whether many had been infected with no symptoms and developed natural immunity. Dr. Havers cautioned that the children tested were already under clinical care and may not represent the general pediatric population.

“We saw the highest hospitalization rates in the 5- to 11-year age group in September, during the Delta wave,” she said. “There’s clearly a lot of susceptible children still out there that are vulnerable to severe disease.”

It is unclear how many parents would quickly vaccinate their elementary schoolers if given the chance. Polling has showed that roughly a third are eager to do so right away, while a third prefer to wait. Since federal regulators cleared Pfizer shots for adolescents ages 12 to 15 in May, 46 percent have been fully vaccinated, compared with about 69 percent of adults.

Many panel members said the data on safety and efficacy was compelling enough for government to offer shots and give parents a choice.

But Dr. Michael G. Kurilla, an official at the National Institutes of Health who abstained from the vote, said the government was embracing a “one-size-fits-all” approach.

“I think for many children who have experienced Covid already, they’re probably more than adequately protected. One dose may be sufficient,” he said. “I think for the high-risk children, it’s very different.”

The vote took place in a highly charged atmosphere. As of early Tuesday, nearly 140,000 public comments had been formally submitted to the agency on the issue. By contrast, only 66 comments were submitted before the panel recommended boosters for adult recipients of the Moderna and Johnson & Johnson vaccines.

Over the weekend, panel members were deluged with messages in an organized email campaign urging them to vote against recommending authorization. The C.D.C. warned members of its own expert panel Tuesday afternoon that they might be targeted by a similar “misinformation campaign.”

Dr. Marks said that while the public had “strong feelings” about authorization, the committee was only being asked whether to allow shots, not whether to mandate them.

But Dr. H. Cody Meissner, a panelist and chief of the pediatric infectious diseases division at Tufts Children’s Hospital, said he feared that state-level mandates would follow too quickly, before sufficient safety data could be gathered. And others questioned how well the government tracks adverse side effects, despite assurances that any worrisome patterns would be detected.

F.D.A. scientists said the benefits of staving off Covid-19 with a pediatric dose generally outweighed the risks of the most worrisome side effects. Even in a scenario where the risk of infection was low, as in June, the vaccine’s benefits may be greater because those hospitalized with Covid-19 tend to be sicker, and for longer, than those with myocarditis triggered by the vaccine, they said.

Pfizer officials described safety data on about 4,500 children ages 5 to 11 divided into two cohorts of roughly equal size. The first group was followed for about two months, the second for about two and a half weeks. None of the children involved in Pfizer’s clinical trial developed myocarditis or pericarditis, but that was expected given the small size of the clinical trial and the rarity of those conditions.

Federal health officials have said that cases of the heart conditions tend to be mild and resolve quickly, and that younger people can also develop myocarditis from the virus itself.

Pfizer tried to reassure the panel that pharmacists and other providers would be able to handle children’s shots. They would be color coded to reduce the risk of a mix-up, company officials said.

Apoorva Mandavilli contributed reporting from New York and Carl Zimmer from New Haven, Conn.

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escortBahçelievler Escortbostancı escortBağdat Caddesi Escortataşehir escortBağcılar Escortcevizli escortatalar escortmaltepe escortAvrupa Yakası Escortkartal escortmaltepe escortAvcılar EscortAtaşehir Escortümraniye escortAnkara escortUlus escortTunalı escortTandoğan escortSıhhiye escortRus escortMamak escortMamak escortGölbaşı escortcialiscinsel sağlık ürünleribayan azdırıcı fiyatkadın azdırıcı damlasertleştirici ilaçlarcialis fiyatviagra fiyatpenis büyütücükamagra jelgeciktirici spreycialis 20 mgcialis 100 mgviagra 30 luen iyi penis sertleştirici ilaçsertleştirici haplarhasta yataklarıkent switch fiyatKeno Club Sigaraparliament aqua bluemarlboro double fusionGauloises Sigarakent switchdjarum blackLeader SigaraAnadolu yakası escortAtaşehir escortBostancı escortErenköy Escortavrupa yakası escortAtaköy EscortAvcılar EscortBahçeşehir Escortözel escortlaranal escortçıtır escortelit escortAnadolu Yakası escortAtaşehir escortbağdat caddesi escortBostancı escortGöztepe Escortİstanbul 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EscortÜmraniye Escortbağdat caddesi escortgöztepe escortistanbul escortkartal escortkurtköy escortmaltepe escortpendik escorttuzla escortüsküdar escortataköy escortavcılar escort bayanavrupa yakası escortbahçeşehir escortbakırköy escortbeşiktaş escortbeylikdüzü escorterenköy escortetiler escortgöztepe escortikitelli escortkartal escortkurtköy escortmaltepe escortmecidiyeköy escortpendik escortşirinevler escortşişli escortsoğanlık escortataşehir escortkaynarca escortümraniye escortgebze escorttuzla escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortavrupa yakası escortsex hikayeleriadana escortadıyaman escortafyon escortağrı escortaksaray escortamasya escortankara escortantalya escortantep escortardahan escortartvin escortaydın escortbalıkesir escortbartın escortbatman escortbayburt escortbilecik escortbingol escortbitlis escortbolu escortburdur escortbursa escortçanakkale escortçankırı escortçorum escortdenizli escortdiyarbakır escortdüzce escortedirne escortelazığ escorterzincan escorterzurum escorteskişehir escortgiresun escortgümüşhane escorthakkari escorthatay escortığdır escortısparta escortistanbul escortizmir escortizmit escortkarabük escortkaraman escortkars escortkastamonu escortkayseri escortkıbrıs escortkilis escortkırıkkale escortkırklareli escortkırşehir escortkocaeli escortkonya escortkütahya escortmalatya escortmanisa escortmaraş escortmardin escortmersin escortmuğla escortmuş escortnevşehir escortniğde escortordu escortosmaniye escortrize escortsakarya escortsamsun escortsiirt escortsinop escortşırnak escortsivas escorttekirdağ escorttokat escorttrabzon escorttunceli escortzonguldak escorturfa escortuşak escortvan escortyalova escortyozgat escorterkeklerde sertleşmeye iyi gelen ilaçlarsertleştirici hap eczane fiyatlarıvega 100 mg hapfuck googledolandırıcı hesap satışıbacklink alToscanello Blu Anice AnasonToscanello CappuccinoToscanello Cioccolato ÇikolataToscanello GrappaToscanello LimoncelloToscanello MacchiatoToscanello Rosso CaffeToscanello RubinoToscanello VanilyaToscanello PuroToscanello Cappuccino Puroweb postegropostegro girişAvrupa yakası escortAksaray escortAtaköy escortAtaşehir escortAvcılar escortBahçelievler escortBahçeşehir escortBakırköy escortBaşakşehir escortBeşiktaş escortBeylikdüzü escortBostancı escortBüyükçekmece escortEsenyurt escortEtiler escortFatih escortHalkalı escortKadıköy escortKartal escortKüçükçekmece escortMaltepe escortMecidiyeköy escortMerter escortPendik escortRus escortŞirinevler escortŞişli escortTaksim escortTopkapı escortümraniye escortZeytinburnu escortgaziantep escortalanya escorttekirdağ escortşanlıurfa escortşanlıurfa escortsamsun escortbolu escortbodrum escortbeylikdüzü escortyozgat escortyalova escortvan escortuşak escorturfa escorttrabzon escorttokat escorttokat escortsivas escorturfa escortsakarya escortsakarya escortrize escortniğde escortniğde escortmuğla escortmuğla escortmarmaris escortmardin escortmardin escortmaraş escortmanisa escortmanisa escortkütahya escortkocaeli escortkocaeli escortkıbrıs escortkastamonu escortkars escortısparta escortgümüşhane escortgiresun escortgaziantep escortzonguldak escortzonguldak escortyozgat escortyalova escortvan escorttrabzon escorttekirdağ escortsivas escortsamsun escortordu escortmersin escortmaraş escortmalatya escortkütahya escortkuşadası escortkonya escortkayseri escortkastamonu escortısparta escorthatay escortgiresun escorteskişehir escorterzurum escorttekirdağ escortdiyarbakır escortçorum escortçeşme escortburdur escortbolu escortmalatya escortdenizli escortbodrum escortbalıkesir escortafyon escortbalıkesir escortaydın escortartvin escortantep escortantalya escortağrı escortadana escorterzurum escorterzincan escorterzincan escortedirne escortdüzce escortdüzce escortdidim escortdidim escortdenizli escortçorum escortçeşme escortçanakkale escortbursa escortburdur escortbolu escortbodrum escortrize escortordu escortmersin escortkonya escortantalya escortaydın escortartvin escortalanya escortalanya escortağrı escortafyon escortadana escortzonguldak escortyozgat escortyalova escortvan escortuşak escorturfa escorttrabzon escorttekirdağ escortsivas escortsinop escortsinop escortsinop escortsamsun escortsakarya escortordu escortniğde escortnevşehir escortnevşehir escortnevşehir escortmuğla escortmarmaris escortmardin escortmaraş escortkütahya escortkuşadası escortkonya escortkocaeli escortkıbrıs escortkayseri escortkastamonu escortkars escortısparta escorthatay escortgümüşhane escortgiresun escortrize escortgiresun escorteskişehir escorterzincan escortdiyarbakır escortdidim escortburdur escortbeylikdüzü escorttokat escortmersin escortmanisa escortmalatya escortbolu escortbeylikdüzü escortmalatya escortadana escortafyon escorteskişehir escorterzurum escorterzurum escorterzincan escortelazığ escortelazığ escortelazığ escortelazığ escortedirne escortedirne escortdüzce escortdiyarbakır escortdidim escortdenizli escortçorum escortçeşme escortçeşme escortçanakkale escortçanakkale escortçanakkale escortburdur escortbolu escortbodrum escortbodrum escortbalıkesir escortaydın escortartvin escortartvin escortantep escortantep escortalanya escortağrı escortafyon escortadana escortantalya escortalanya escortalanya escortAmazon Prime izleBeIN Connect izleBlutv izleDisney Plus izleexxen izleGain TV izleNetflix izleAmazon prime izleBlutv izleDisney Plus izlebeylikdüzü escorteryaman escortcaptain blackkalpli sigarasertleştirici hap eczane fiyatlarışişme bebeksertleşme sağlayıcı ilaçlar ve isimleriviagra fiyatManchester Double Drive SigaraKing Edward imperial purobetpas girisbetpas yeni adresibetpas kayitbetbabaikimislirestbetsupertotobetsuperbetinbetsatbets10bahsegelonbahishilbetbetparktarafbetromabetbetmatiktimebetdinamobetelitbahisbetboobahigowinxbetpusulabetaresbetmobilbahisnerobetsuperbahisjetbahisbetbooadana escort1xbet kayıt1xbet casino1xbetpenis sertleştirici cinsel haplarescortGaziantep escortDenizli escortAdana escortHatay escortAydın escortİzmir escortAnkara escortAntalya escortBursa escortİstanbul escortKocaeli escortKonya escortMuğla escortMalatya escortKayseri escortMersin escortSamsun escortSinop escortTekirdağ escortEskişehir escortYalova escortRize escortAmasya escortBalıkesir escortÇanakkale escortBolu escortErzincan escortŞırnak escortVan escortYozgat escortZonguldak escortAfyon escortAdıyaman escortBilecik escortAksaray escortAğrı escortBitlis escortSiirt escortÇorum escortBurdur escortDiyarbakır escortEdirne escortDüzce escortErzurum escortKırklareli escortGiresun escortIsparta escortTrabzon escortSivas escortŞanlıurfa escortSakarya escortTokat escortManisa escortOrdu escortOsmaniye escortArdahan escortKaraman escortBatman escortBayburt escortElazığ escortBingöl escortGümüşhane escortHakkari escortUşak escortIğdır escortBartın escortNevşehir escortKastamonu escortMuş escortMaraş escortKırşehir escortMardin escortKırıkkale escortKarabük escortKars escortKilis escortsertleştirici hap eczane520 kalpli sigara elmalı520 kalpli sigaras20 kalpli sigaraİstanbul escort bayanİstanbul escortİstanbul escortsEscort istanbulistanbul escort bayanİstanbul escortEscort istanbulistanbul escortEscort bayanBayan escortescortEscort bayanbayan escortescortAnkara escort bayanEscort ankaraEscort Bayan İstanbulviagraviagra nedirkamagraviagra siparişcialis kullanımıcialis nedirümraniye escortüsküdar escortzeytinburnu escortkadıköy escortkağıthane escortkartal escortmaltepe escortkeçiören escortmanavgat escortalanya escortbodrum escortkuşadası escortdidim escortarnavutköy escortsilifke escortbelek escortşişli escortpendik escortkarşıyaka escortseyhan escortnilüfer escortesenler escortbeylikdüzü escortİstanbul escortİstanbul escort bayanEscort istanbulBayan escortEscort bayanescorteczanede satılan sertleştirici ilaçlarseoboşalmayı geciktirici haplargeciktirici kremlergeciktirici spreylerpenis büyütücü haplarbayan azdırıcı damlabayan azdırıcı haperken boşalma geciktirici ilaçlarpenis büyütücü çeşitleribayan cinsel istek arttırıcılarcialis fiyatıviagra fiyatlarıbayan cinsel istek arttırıcılarerken boşalmayı geciktirici ilaç çeşitleripenis büyütücü ürün çeşitlerierken boşalmayı geciktirici ilaç çeşitleribayan cinsel istek arttırıcı damlageciktirici sprey çeşitlerien iyi geciktirici kremkadın istek arttırıcı damlaen iyi bayan azdırıcı ilaçcialis fiyatı eczaneviagra eczane fiyatıerken boşalmayı geciktirici haplargeciktirici krem çeşitleripenis büyütücü haplarcinsel gücü arttırıcı ilaçlarbayan azdırıcı ilaçlaren iyi geciktirici ilaç isimleripenis büyütücü kremen iyi bayan cinsel istek arttırıcılarhublaagramtiktok takipçi satın algeciktirici haplargeciktirici kremler çeşitlerikadın azdırıcı çeşitlerigeciktirici ilaç çeşitleripenis büyütücü çeşitlerieczane cialis fiyatıviagra eczane fiyatlarıbayan azdırıcı ilaçlaren iyi geciktiricilerpenis büyütücülerbayan uyarıcılarerken boşalmayı geciktiren ilaçlarpenis büyütücülerviagra eczane satış fiyatlarıeczane cialis fiyatıerken boşalmayı geciktirici ilaçlargeciktirici krem fiyatlarıgeciktirici sprey eczaneen etkili büyütücülerbayan istek arttırıcı çeşitlerien iyi bayan cinsel istek artırıcılarerken boşalmayı geciktirici ilaçpenis büyütücülercialis eczanecialis eczanede kaç tlADIYAMAN ESCORTADANA ESCORTAFYONKARAHİSAR ESCORTAĞRI ESCORTAMASYA ESCORTANKARA ESCORTANTALYA ESCORTARTVİN ESCORTAYDIN ESCORTBALIKESİR ESCORTBİTLİS ESCORTBİNGÖL ESCORTBİLECİK ESCORTBOLU ESCORTBURDUR ESCORTBURSA ESCORTÇANAKKALE ESCORTÇANKIRI ESCORTÇORUM ESCORTDENİZLİ ESCORTDİYARBAKIR ESCORTEDİRNE ESCORTELAZIĞ ESCORTERZİNCAN ESCORTERZURUM ESCORTESKİŞEHİR ESCORTGAZİANTEP ESCORTGİRESUN ESCORTGÜMÜŞHANE ESCORTHATAY ESCORTISPARTA ESCORTMERSİN ESCORTİSTANBUL ESCORTİZMİR ESCORTKARS ESCORTKASTAMONU ESCORTKAYSERİ ESCORTKIRŞEHİR ESCORTKOCAELİ ESCORTKONYA ESCORTKUTAHYA ESCORTMALATYA ESCORTMANİSA ESCORTKAHRAMANMARAŞ ESCORTMARDİN ESCORTMUĞLA ESCORTMUŞ ESCORTNEVŞEHİR ESCORTNİĞDE ESCORTORDU ESCORTRİZE ESCORTSAKARYA ESCORTSAMSUN ESCORTSİNOP ESCORTSİVAS ESCORTTEKİRDAĞ ESCORTTOKAT ESCORTTRABZON ESCORTURFA ESCORTUŞAK ESCORTVAN ESCORTYOZGAT ESCORTZONGULDAK ESCORTAKSARAY ESCORTKARAMAN ESCORTKIRIKKALE ESCORTBATMAN ESCORTBARTIN ESCORTARDAHAN ESCORTIĞDIR ESCORTYALOVA ESCORTKARABÜK ESCORTKİLİS ESCORTOSMANİYE ESCORTDÜZCE ESCORTpostegroinstagram beğeni hilesiAnadolu Yakası Escortavrupa yakası escortinstagram takipci hilesicialis fiyatıcinsel ereksiyon ilaçlarıcialis fiyatlarıviagra fiyatıcialis fiyatı eczaneFlynta 20 Mgkamagra 100 mgOrcafil 20 MgLifta 5 MgHardcis 5 MgLex 20 MgLevitra 20 MgPriligy 30 MgVigaroo 100 MgHardcis 20 MgAfilta 20 MgHardcis 20 Mgdegralifta 20 mgankara escortantalya escortizmir escortmersin escortCinsel sağlık ürünleriCinsel performans ürünleriGeciktirici ürünlerSertleştirici haplarKamagra jelKamagra jel fiyatKamagra jel eczaneVega 100 mgVega 100 mg fiyatViagraViagra fiyatViagra 100 mg fiyatViagra 30 lu fiyatCialisCialis fiyatCialis 20 mg fiyatCialis 100 mg fiyatCialis 30 lu tablet fiyatCialis 5 mg fiyatankara escortantalya escortizmir escort