Novavax says Covid-19 vaccine shows 90.4% overall efficacy in US/Mexico Phase 3 trial

The American biotechnology company Novavax announced on Monday that its coronavirus vaccine candidate was found to have an overall efficacy of 90.4% in a Phase 3 trial conducted across the United States and Mexico.

Posted: Jun 14, 2021 8:29 AM
Updated: Jun 14, 2021 12:53 PM

The American biotechnology company Novavax announced on Monday that its coronavirus vaccine candidate was found to have an overall efficacy of 90.4% in a Phase 3 trial conducted across the United States and Mexico.

Additional analyses of the trial are ongoing, according to the company, and will be submitted to peer-reviewed journals for publication.

The trial results appear consistent with the efficacy and safety profile the vaccine previously showed in a Phase 3 trial conducted in the United Kingdom, Dr. Gregory Glenn, president of research and development for Novavax, told CNN.

"Different continent, different population, different viruses floating around, and yet, we still see really good efficacy," Glenn said. "This is what you want to have."

The study launched in December and enrolled 29,960 adults across 113 sites in the United States and six sites in Mexico. Some of the participants were given a placebo and some were administered two doses of the Novavax vaccine 21 days apart.

The company said the vaccine was "generally well-tolerated" and common side effects included pain at the injection site, lasting less than three days, and fatigue, headache and muscle pain, lasting less than two days.

There were 77 Covid-19 cases that emerged among participants during the study, according to Novavax. Sixty-three of the cases were in people in the placebo group and 14 in the vaccine group.

The company noted that all cases in the vaccine group were mild. There were 10 moderate and four severe cases in the placebo group, demonstrating a vaccine efficacy of 100% against moderate or severe disease, according to Novavax.

Most cases were in "high-risk" people, such as those older than 65, with certain comorbidities or having frequent exposure to Covid-19. The company announced the vaccine's efficacy was 91% in "high-risk" populations.

Novavax researchers also took a close look at sequencing data for 54 of the 77 Covid-19 cases in the study. Based on their sequencing of those cases, the company announced that the "vaccine efficacy was 93.2%" against variants of concern or of interest.

A final analysis of Novavax's UK Phase 3 trial results, announced in March, showed that the vaccine had an overall efficacy of 89.7% -- and its efficacy was 96.4% against the original coronavirus strain and 86.3% against the B.1.1.7 variant first identified in the UK.

Novavax's coronavirus vaccine, called NVX-CoV2373, differs from the three vaccines already in use in the United States. The vaccine relies on what is called recombinant nanoparticle technology and Novavax's adjuvant, called Matrix-M, to stimulate an immune response.

The two mRNA vaccines that were authorized last year in the United States -- from Pfizer/BioNTech and Moderna -- both use genetic material to stimulate an immune response. Johnson & Johnson's single-shot vaccine, which was authorized in February, uses a weakened common cold virus as a vector to carry the genetic instructions.

Novavax said on Monday it plans to apply in the US for emergency use authorization of its vaccine in the third quarter of this year and is "on track" to manufacture about 100 million doses per month by the end of the third quarter.

Indiana Coronavirus Cases

Data is updated nightly.

Cases: 926604

Reported Deaths: 15083
CountyCasesDeaths
Marion1262201958
Lake626901087
Allen52772747
Hamilton43283445
St. Joseph41475584
Elkhart33129488
Vanderburgh29927439
Tippecanoe26589247
Johnson23267415
Hendricks21902340
Porter21473341
Clark17150224
Madison17065379
Vigo15815273
Monroe14298190
LaPorte14108237
Delaware13771219
Howard13635262
Kosciusko11232134
Hancock10637160
Warrick10523176
Bartholomew10341167
Floyd10200202
Wayne9690218
Grant8939196
Morgan8734158
Boone8299109
Dubois7596123
Henry7469128
Dearborn745187
Noble7294101
Marshall7237128
Cass7097117
Lawrence6862150
Shelby6457107
Jackson643981
Gibson6036106
Harrison595585
Huntington591891
Montgomery5706102
DeKalb563591
Knox537599
Miami531983
Clinton527164
Putnam525367
Whitley516251
Steuben486367
Wabash477492
Jasper471961
Jefferson461991
Ripley444175
Adams439365
Daviess4064106
Scott394963
White386257
Clay382356
Greene380189
Wells379683
Decatur379595
Fayette367176
Posey354941
Jennings346356
Washington325847
LaGrange315774
Spencer313034
Fountain309753
Randolph305487
Sullivan299447
Owen279161
Starke272761
Orange272659
Fulton268851
Jay250634
Perry247451
Carroll241127
Franklin233637
Vermillion229750
Rush228930
Parke215220
Tipton206754
Pike202538
Blackford165634
Pulaski158751
Crawford142818
Newton140742
Benton139816
Brown132646
Martin126916
Switzerland123510
Warren113416
Union93511
Ohio77211
Unassigned0468

Ohio Coronavirus Cases

Data is updated nightly.

Cases: 1342777

Reported Deaths: 21471
CountyCasesDeaths
Franklin1502191556
Cuyahoga1327732318
Hamilton962791318
Montgomery659161136
Summit555141045
Lucas50248862
Butler46732653
Stark40741974
Lorain31004529
Warren29609328
Mahoning26462637
Clermont25206287
Lake24339416
Delaware22014143
Licking20180241
Fairfield20139221
Greene19955268
Trumbull19500508
Medina19478286
Clark17565325
Richland15949231
Portage15851228
Wood15438208
Allen13875256
Miami13549249
Muskingum12261149
Wayne11647237
Columbiana11344239
Tuscarawas10657265
Marion10509148
Pickaway10301128
Scioto10082126
Erie9618171
Ross9209174
Lawrence8516116
Hancock8298141
Ashtabula8180185
Geauga8066155
Belmont7966184
Jefferson7324168
Huron7253127
Union717849
Washington7037119
Athens681064
Sandusky6734133
Darke6559136
Knox6475121
Seneca6237137
Ashland5808112
Auglaize580488
Shelby5654101
Mercer552190
Brown551068
Defiance5361100
Madison535170
Crawford5299114
Highland527581
Fulton520082
Clinton515980
Logan503182
Preble4902110
Putnam4778106
Guernsey454661
Williams448281
Champaign436264
Perry432152
Ottawa431184
Jackson413260
Pike378941
Morrow369150
Fayette367652
Coshocton359466
Hardin350069
Adams348069
Gallia338054
Holmes3197108
Henry318868
Van Wert307170
Hocking291669
Wyandot276158
Carroll256752
Paulding236442
Meigs205242
Monroe185049
Noble164840
Morgan159228
Harrison151940
Vinton133918
Unassigned05
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