FDA's vaccine advisers to discuss rules for authorizing Covid-19 shots for kids

Vaccine advisers to the US Food and Drug Administration will meet Thursday to discuss what information the agency should ask for in considering the go-ahead...

Posted: Jun 9, 2021 4:45 PM
Updated: Jun 9, 2021 4:47 PM

Vaccine advisers to the US Food and Drug Administration will meet Thursday to discuss what information the agency should ask for in considering the go-ahead for vaccinating children under 12 -- including how many children need to be enrolled in clinical trials and how much safety data will be needed.

Members of the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) will not be asked to discuss specific vaccines or to vote on any issues, but instead will weigh in on what specific extra information companies will have to provide in seeking authorization or approval for children.

Pfizer's Covid-19 vaccine is currently authorized for people 12 and older in the US. Pfizer said Tuesday it would begin testing its vaccine in children as young as 5 using smaller doses than what is authorized for people 12 and older. The company said its Phase 2/3 trial will enroll up to 4,500 children in the United States, Finland, Poland and Spain.

Pfizer and its partner BioNTech also plan to start testing the vaccine in babies as young as 6 months in the coming weeks. But no approval or authorization is expected for younger children before the new school year starts at the end of summer.

Data about Moderna's Covid-19 vaccine for children as young as 5 will likely be available in September or October, Moderna told CNN, and the company plans to apply soon for FDA authorization for use of its vaccine in youths as young as 12.

The rollout has been quick in the younger age group; more than 3.5 million people ages 12 to 15 have already received at least one dose of the vaccine. Half of those 12 and older have now been fully vaccinated, according to data published Tuesday by the US Centers for Disease Control and Prevention.

But the FDA says it will be seeking more deliberate study for authorizing use of the vaccines in kids 11 and under.

Pfizer has applied for full approval, called a biologics license application or BLA, for its vaccine in people 12 and older. Moderna is expected to. So the committee members will be asked to consider what would be needed both for emergency use authorization in children, and full approval. The FDA has broken the younger children into three groups: 6 to 11, 2 to 6 and six months to 2 years.

"What I think we're going to do with that meeting is we're going to decide what the parameters are for approval -- either through emergency use authorization or for licensure -- for much younger age groups," VRBPAC committee member Dr. Paul Offit, director of the Vaccine Education Center at the Children's Hospital of Philadelphia, told CNN's Jake Tapper last week.

"Do we want a two-month follow up? Do we want a six-month follow up? What level of efficacy are we looking for?" Offit added. "It's those sort of parameters we'll be discussing."

In briefing documents released ahead of Thursday's meeting, the FDA said it's usually acceptable to use what are called immunobridging studies to justify approval or emergency authorization of vaccines in children.

These look for evidence of immunity based on what's seen in adults who have volunteered in clinical trials.

In the case of coronavirus vaccines, the FDA said, it would accept data on neutralizing antibodies -- the virus-attacking immune system proteins that are generated by vaccination. So instead of vaccinating a group of children and waiting to see if any become infected, companies could instead run blood tests to see if the vaccines generated an immune response.

Because Covid-19 has not caused the same level of serious disease in children as it has in adults, the FDA said companies will have to make a strong case for authorizing their use in children.

FDA usually asks for safety data in between 500 and 3,000 children in considering a new pediatric vaccine. "Since Covid-19 vaccines represent a new class of vaccines, with many of the lead candidates based on new platform technologies, an appropriate overall pediatric safety database would approach the upper end of this range," it said in the briefing documents.

"Emergency use authorization of a COVID-19 vaccine for use in pediatric populations would require a determination that the known and potential benefits of the vaccine outweigh the known and potential risks specifically in the age groups being considered for emergency use authorization," the FDA added.

"Therefore, clear and compelling evidence to support the safety of the vaccine would be expected to justify its authorization for emergency use in millions of healthy children."

Experts will be asked to consider the possibility of a phenomenon called vaccine-enhanced disease -- when vaccinated people get sicker when infected than unvaccinated people do. This happened in 2017 with a dengue vaccine used in the Philippines. So far, there's been no evidence coronavirus vaccines can cause this, the FDA noted.

Doctors will also be asked about the possibility of a condition called multisystem inflammatory syndrome in children or MIS-C, which is seen in some kids who have been infected with coronavirus and which is theoretically possible after vaccination, but hasn't been seen yet.

"Finally, the VRBPAC will be asked to discuss circumstances under which emergency use authorization could be considered for age groups within 6 months to 12 years and, in that context, data needed to support benefits of making COVID-19 vaccines available under emergency use authorization and safety data needed to assess risks," the FDA said.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 319115

Reported Deaths: 7353
CountyCasesDeaths
DeSoto22246264
Hinds20612421
Harrison18342316
Rankin13855282
Jackson13666248
Madison10213224
Lee10050176
Jones8452167
Forrest7810153
Lauderdale7253242
Lowndes6488149
Lamar632288
Lafayette6295120
Washington5412136
Bolivar4833133
Panola4659110
Oktibbeha465898
Pearl River4591146
Marshall4571105
Warren4436121
Pontotoc424573
Union415576
Monroe4154135
Neshoba4059179
Lincoln4007111
Hancock385187
Leflore3514125
Tate342386
Sunflower339391
Pike3366110
Alcorn323272
Scott319274
Yazoo313971
Adams304785
Itawamba304777
Copiah299666
Coahoma298283
Simpson297889
Tippah291168
Prentiss283361
Leake271674
Marion271280
Covington266683
Wayne264442
Grenada264087
George251851
Newton248563
Tishomingo230867
Winston229881
Jasper222048
Attala214973
Chickasaw210459
Holmes190374
Clay187454
Stone187233
Tallahatchie179941
Clarke178980
Calhoun173732
Yalobusha167740
Smith164034
Walthall135147
Greene131633
Lawrence131024
Montgomery128643
Noxubee127934
Perry126638
Amite125942
Carroll122330
Webster115032
Tunica107927
Jefferson Davis107633
Claiborne102930
Benton102225
Humphreys97533
Kemper96628
Franklin84923
Quitman81816
Choctaw79018
Wilkinson69332
Jefferson66228
Sharkey50817
Issaquena1696
Unassigned00

Alabama Coronavirus Cases

Cases: 547323

Reported Deaths: 11266
CountyCasesDeaths
Jefferson808021563
Mobile41925826
Madison35600522
Tuscaloosa26136458
Shelby25554254
Montgomery25067610
Baldwin21774313
Lee16234175
Calhoun14692325
Morgan14614285
Etowah14132361
Marshall12443230
Houston10748287
Elmore10295212
Limestone10180157
St. Clair10146250
Cullman9921200
Lauderdale9582248
DeKalb8955189
Talladega8441184
Walker7318279
Autauga7215113
Blount6925139
Jackson6900113
Colbert6394139
Coffee5616126
Dale4928114
Russell454441
Chilton4461116
Franklin430683
Covington4263122
Tallapoosa4117154
Escambia400280
Chambers3715123
Dallas3604156
Clarke352861
Marion3231106
Pike313978
Lawrence3121100
Winston283372
Bibb267364
Geneva256981
Marengo250565
Pickens236562
Barbour234559
Hale226578
Butler223371
Fayette217162
Henry193843
Cherokee187245
Randolph186844
Monroe179141
Washington170339
Macon163051
Clay159559
Crenshaw155057
Cleburne152543
Lamar145837
Lowndes141953
Wilcox127030
Bullock124242
Conecuh112930
Coosa111129
Perry108726
Sumter105732
Greene93434
Choctaw61725
Out of AL00
Unassigned00
Tupelo
Clear
79° wxIcon
Hi: 94° Lo: 74°
Feels Like: 83°
Columbus
Clear
73° wxIcon
Hi: 91° Lo: 73°
Feels Like: 73°
Oxford
Clear
73° wxIcon
Hi: 92° Lo: 74°
Feels Like: 73°
Starkville
Partly Cloudy
72° wxIcon
Hi: 91° Lo: 73°
Feels Like: 72°
Rain and thunderstorms will continue into this afternoon and evening. However, drier weather is in store for next week.
WTVA Radar
WTVA Temperatures
WTVA Severe Weather