FDA panel endorses lower-dose Moderna COVID shot for booster

Moderna COVID-19 vaccine, Photo Date: 1/14/2021 | Credit: USAF / Aaron Irvin | License Link | Image Source

A panel of U.S. health advisers has endorsed booster shots for Moderna’s COVID-19 vaccine.

Posted: Oct 14, 2021 3:23 PM
Updated: Oct 15, 2021 9:29 AM

U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine at least six months ago should get a half-dose booster to rev up protection against the coronavirus.

The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19.

The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month — and those are the same high-risk groups that FDA's advisers said should get a Moderna booster.

But there's no evidence that it's time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that.

The coronavirus still is mostly a threat to unvaccinated people — while the vaccinated have strong protection against severe illness or death from COVID-19.

“I don’t really see a need for a ‘let it rip’ campaign for everyone," said Dr. Michael Kurilla of the National Institutes of Health.

As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster.

The agency convened its experts to weigh in on who should get boosters and when for those who received the Moderna and Johnson & Johnson shots earlier this year. The panel will discuss J&J on Friday.

The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one.

Many U.S. scientists remain divided about exactly who needs boosters and their purpose — whether they’re needed mostly for people at risk of severe disease or whether they should be used to try to reduce milder infections, too.

The FDA panel wrestled with whether Moderna presented enough evidence backing its low-dose booster.

As the delta variant surged in July and August, a Moderna study found people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago.

Another study of 344 people found a six-month booster shot restored virus-fighting antibodies to levels thought to be protective — and that included large jumps in antibodies able to target the delta variant. But that was a small study, and only about half of those people got the exact series of doses that would be offered under a Moderna booster campaign.

“The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh.

And several advisers worried that boosting with a lower dose might cost people some of the potential benefit of a full-strength third shot.

“That may actually have a tremendous impact on the durability,” Kurilla said.

Moderna said it chose the lower-dose booster because it triggered fewer uncomfortable shot reactions such as fever and achiness but also leaves more vaccine available for the global supply.

One very rare side effect of both the Moderna and Pfizer vaccines is heart inflammation, particularly among young men soon after the second dose — and one lingering question is whether another dose could spark more cases. Moderna's booster study wasn't large enough to spot such a rare risk.

But Israel began offering Pfizer boosters sooner than the U.S. and to more of its population. Thursday, Dr. Sharon Alroy-Preis of Israel's health ministry told the FDA panel that after 3.7 million booster doses administered, there's no sign the extra shot is any riskier.

Because the Moderna vaccine is similar, the FDA's advisers found that data reassuring.

While Pfizer's boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stemming the delta surge.

“There is no question in my mind that the break of the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a lowering of delta cases without widespread booster use.

But FDA's advisers also highlighted one confusing issue: People with severely weakened immune systems already can get a third full dose of the Moderna vaccine soon after the initial vaccinations — so a lingering question is whether they should be eligible for a booster, too, which would be their fourth dose.

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 512632

Reported Deaths: 10262
CountyCasesDeaths
Harrison34853555
DeSoto33162432
Hinds32556641
Jackson24830389
Rankin22442402
Lee16238242
Madison14874283
Jones14086247
Forrest13741259
Lauderdale12249324
Lowndes11286193
Lamar10644140
Pearl River9707244
Lafayette8827143
Hancock7835132
Washington7550169
Oktibbeha7204138
Monroe6989179
Pontotoc6970109
Warren6849178
Panola6746134
Neshoba6726210
Marshall6653141
Bolivar6440151
Union633897
Pike5924156
Alcorn5862107
Lincoln5525136
George510180
Prentiss500884
Tippah490282
Itawamba4829107
Scott477499
Adams4766125
Tate4748116
Leflore4723144
Copiah455895
Yazoo455591
Simpson4543117
Wayne442772
Covington432895
Sunflower4299106
Marion4265112
Coahoma4227109
Leake413790
Newton395581
Tishomingo381793
Grenada3775109
Stone365666
Jasper340166
Attala337790
Winston317792
Chickasaw313367
Clay311878
Clarke301195
Calhoun284449
Holmes271289
Smith268952
Yalobusha243747
Tallahatchie231453
Greene224749
Walthall221366
Lawrence217840
Perry213356
Amite209557
Webster205148
Noxubee188642
Montgomery181557
Carroll174441
Jefferson Davis173643
Tunica163239
Benton152639
Kemper144941
Choctaw136527
Claiborne134238
Humphreys131139
Franklin124929
Quitman107528
Wilkinson105939
Jefferson96834
Sharkey65121
Issaquena1957
Unassigned00

Alabama Coronavirus Cases

Cases: 844594

Reported Deaths: 16115
CountyCasesDeaths
Jefferson1160612006
Mobile741651379
Madison53255732
Shelby38313368
Baldwin38061589
Tuscaloosa35996641
Montgomery34473781
Lee25541263
Calhoun22582518
Morgan22441406
Etowah20009517
Marshall18771316
Houston17723425
St. Clair16863358
Limestone16123218
Cullman16032303
Elmore15902294
Lauderdale14945306
Talladega14186299
DeKalb12957269
Walker12011380
Blount10700192
Autauga10512157
Jackson10151194
Coffee9412192
Colbert9325208
Dale9013191
Tallapoosa7248201
Russell707465
Chilton7015170
Escambia6951143
Covington6926195
Franklin6337108
Chambers5778142
Marion5400130
Dallas5283209
Pike5114109
Clarke484986
Lawrence4826129
Winston4777110
Geneva4640136
Bibb434094
Barbour369180
Butler3433100
Marengo342393
Monroe336666
Randolph334067
Pickens333188
Fayette329885
Henry320566
Hale317989
Cherokee316963
Crenshaw260477
Washington256952
Cleburne254360
Lamar251253
Clay250869
Macon244764
Conecuh192762
Coosa184647
Lowndes178168
Wilcox177438
Bullock152545
Perry141840
Sumter139041
Greene130245
Choctaw93228
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