FDA issues updated guidance on adapting Covid-19 vaccines, tests and therapeutics for coronavirus variants

The US Food and Drug Administration has...

Posted: Feb 22, 2021 5:03 PM
Updated: Feb 22, 2021 5:03 PM

The US Food and Drug Administration has issued updated guidance for companies that plan to adapt their Covid-19 medical products -- including vaccines, tests and therapeutics -- to address the emergence of coronavirus variants.

The agency said in an announcement on Monday that it expects that "manufacturing information will remain generally the same" for authorized Covid-19 vaccines that may be updated to target variants. The agency recommended that data from clinical immunogenicity studies be used to support any changes or updates to vaccines.

Such studies would be smaller and could take less time than large-scale clinical trials.

"It's going to be on the order of a few hundred individuals in terms of size and we'd expect that that might take a few months," Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said during a call with reporters on Monday.

"For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient's immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine," the agency noted in its announcement.

According to the FDA guidance, studies to assess the effectiveness of a Covid-19 vaccine's primary shot and booster dose should compare the immune response induced by the modified version of the vaccine to the original vaccine, and researchers should conduct a "booster study" in which the modified vaccine is administered to those who previously received the original vaccine.

"Each of the studies described above may be conducted in a single age group," the guidance said. Those results can then be extrapolated to other age groups for which the original vaccine has been authorized -- and to previously infected people in those age groups.

The agency released separate guidance for Covid-19 tests and therapeutics too.

"The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants," Dr. Janet Woodcock, acting commissioner of the FDA, said in the announcement on Monday.

"We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products," Woodcock said in part. "By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts."

FDA officials said during Monday's call that some of the updated guidance for Covid-19 vaccines is modeled after what is already done for the development of seasonal influenza vaccines.

"We have experience with the fact that viruses change over time and seasonal influenza changes very frequently," Woodcock said during the call.

Marks added, "What we're doing here that's similar is trying to leverage the change with the minimal amount of extra data that we need to facilitate things. We're trying to prepare in advance, like we would for influenza."

Mississippi Coronavirus Cases

Data is updated nightly.

Cases: 291891

Reported Deaths: 6605
CountyCasesDeaths
DeSoto19470226
Hinds18555383
Harrison16385273
Rankin12498260
Jackson12401216
Lee9635160
Madison9353193
Jones7836144
Forrest7055135
Lauderdale6735225
Lowndes5989137
Lamar579379
Lafayette5688113
Washington5124128
Bolivar4567120
Oktibbeha438091
Panola424092
Warren4091113
Pearl River4070127
Pontotoc406066
Marshall397992
Monroe3971125
Union391372
Neshoba3746166
Lincoln343799
Hancock337773
Leflore3346118
Sunflower315785
Tate299172
Pike297792
Scott291367
Alcorn289760
Itawamba288471
Yazoo282662
Tippah275265
Copiah273357
Coahoma272265
Simpson269278
Prentiss267158
Leake250870
Wayne250140
Marion249478
Covington246277
Grenada244576
Adams232374
George229545
Newton222551
Winston220174
Tishomingo210965
Jasper210343
Attala205669
Chickasaw200250
Holmes181470
Clay177348
Stone170729
Tallahatchie169039
Clarke167671
Calhoun155327
Smith151131
Yalobusha141936
Greene126333
Walthall123040
Noxubee122429
Montgomery120537
Perry120133
Lawrence118420
Carroll117123
Amite110632
Webster108629
Jefferson Davis99831
Tunica97923
Claiborne97329
Benton92524
Humphreys91226
Kemper89222
Quitman76614
Franklin75319
Choctaw69316
Wilkinson62226
Jefferson60827
Sharkey48817
Issaquena1676
Unassigned00

Alabama Coronavirus Cases

Cases: 488973

Reported Deaths: 9660
CountyCasesDeaths
Jefferson703321342
Mobile35725716
Madison32088437
Tuscaloosa23913404
Montgomery22369481
Shelby21714209
Baldwin19554263
Lee14827147
Morgan13529243
Etowah13091309
Calhoun13063281
Marshall11197202
Houston10019255
Limestone9303130
Elmore9283179
Cullman8856176
St. Clair8747214
Lauderdale8541209
DeKalb8419173
Talladega7424161
Walker6466240
Jackson6450101
Autauga614384
Blount6058125
Colbert5973118
Coffee522299
Dale4606106
Russell400530
Franklin396575
Covington3918105
Chilton380096
Escambia375970
Tallapoosa3533138
Clarke342348
Dallas3385139
Chambers3382102
Pike292471
Lawrence280685
Marion277492
Winston244563
Marengo243454
Bibb243259
Geneva238168
Pickens223453
Barbour208450
Hale208064
Fayette198755
Butler194865
Henry181741
Cherokee175737
Monroe165538
Randolph161240
Washington155832
Crenshaw143052
Clay142554
Macon140344
Cleburne136139
Lamar130632
Lowndes130148
Wilcox120525
Bullock116033
Conecuh106423
Perry104927
Sumter98231
Greene86732
Coosa86323
Choctaw54723
Out of AL00
Unassigned00
Tupelo
Partly Cloudy
56° wxIcon
Hi: 76° Lo: 41°
Feels Like: 56°
Columbus
Cloudy
56° wxIcon
Hi: 76° Lo: 39°
Feels Like: 56°
Oxford
Partly Cloudy
50° wxIcon
Hi: 70° Lo: 45°
Feels Like: 50°
Starkville
Cloudy
52° wxIcon
Hi: 77° Lo: 43°
Feels Like: 52°
WTVA Radar
WTVA Temperatures
WTVA Severe Weather