STREAMING NOW: Watch Now

Moderna applies for FDA authorization for its Covid-19 vaccine

Pharmaceutical company Moderna applied on Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.The company asked th...

Posted: Nov 30, 2020 4:51 AM
Updated: Nov 30, 2020 5:30 PM

Pharmaceutical company Moderna applied on Monday to the US Food and Drug Administration for authorization of its Covid-19 vaccine.

The company asked the FDA to review an expanded data set showing the vaccine is 94.1% effective at preventing Covid-19 and 100% effective at preventing severe cases of the disease.

'This is striking,' said Dr. Paul Offit, a member of the FDA's vaccine advisory committee. 'These are amazing data.'

Moderna's chief medical officer said he became emotional when he saw the data Saturday night.

'It was the first time I allowed myself to cry,' Dr. Tal Zaks said. 'We have a full expectation to change the course of this pandemic.'

Moderna is the second company to apply to the FDA for emergency use authorization for a coronavirus vaccine. Pfizer applied on November 20 with data showing similarly high efficacy.

The FDA will meet with its advisory committee in December to review Pfizer's and Moderna's applications.

The first vaccinations in the United States are expected to take place 'towards the latter part of December,' according to Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

Moderna said it also planned to apply for authorization from the European Medicines Agency on Monday.

Moderna's new data

On Monday, Moderna released updated efficacy data for its Phase 3 clinical trial.

Starting in July, Moderna gave either its vaccine or a placebo -- a shot of saline that does nothing -- to some 30,000 people in the United States. With high rates of coronavirus throughout the country over the next following months, many of those study subjects developed Covid-19.

But there was a big difference between the group that got the vaccine and the group that got the placebo.

Among the approximately 15,000 people who received the vaccine, 11 developed Covid-19.

Among the approximately 15,000 people who received the placebo, 185 developed Covid-19.

That amounts to a 94.1% efficacy for Moderna's vaccine.

None of the 11 people who received the vaccine became severely ill, but 30 of the 185 who received the placebo became severely ill, and one of them died.

The vaccine had similar efficacy rates for elderly people and for people in racial minority groups, Zaks said.

In Pfizer's Phase 3 clinical trial, the vaccine proved to be 95% effective, and one study participant who received the vaccine developed a severe case of Covid-19.

While the two vaccines are not identical, both Pfizer and Moderna use messenger RNA to elicit an immune response in the human body. The vaccines are given in two doses a few weeks apart, and can cause side effects, such as a fever or body aches for a few days.

Next steps

The FDA is scheduled to meet with its Vaccines and Related Biological Products Advisory Committee on December 10 to review Pfizer's application and on December 17 to review Moderna's application.

Offit, who is a member of that panel, said it will be important to look and see why some people still got Covid-19 even after being vaccinated.

'Were they more likely to be older? Were they more likely to be African-American or obese or have underlying medical problems like diabetes?' said Offit, a vaccine expert at the University of Pennsylvania.

If the FDA grants the vaccine emergency use authorization -- and it's expected that it will -- within a day or two, an advisory committee to the US Centers for Disease Control and Prevention will make a recommendation about who should get the shots first. That group will likely include health care workers and nursing home residents.

After the CDC issues those recommendations, shots can go into arms.

Zaks said as the pandemic rages on, he looks forward to seeing the vaccines in action.

By the end of 2020, Moderna expects to have approximately 20 million doses of its vaccine available in the United States, and it's on track to manufacture 500 million to 1 billion doses globally next year, according to the company's press release Monday.

'The magnitude of this achievement and the implications of what it means to what's ahead of us in the context of what's going on around us is -- it's just overwhelming emotionally,' Zaks said.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 154878

Reported Deaths: 2206
CountyCasesDeaths
Multnomah31824528
Washington21099212
Marion18373285
Clackamas13328175
Lane10200126
Jackson8315111
Umatilla763982
Deschutes593459
Yamhill376764
Linn357756
Malheur334458
Polk303942
Klamath278455
Douglas244754
Josephine232849
Benton232516
Jefferson195128
Coos144019
Union128119
Columbia124821
Wasco122026
Lincoln112820
Hood River106429
Morrow104614
Clatsop7756
Crook77518
Baker6507
Curry4246
Tillamook4142
Lake3746
Harney2736
Grant2221
Wallowa1424
Gilliam531
Sherman530
Wheeler221
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3559311

Reported Deaths: 51794
CountyCasesDeaths
Los Angeles118923221241
Riverside2894503767
San Bernardino2860772783
Orange2607213982
San Diego2589823260
Santa Clara1102371777
Kern102627811
Fresno950151422
Sacramento929611464
Alameda802791241
Ventura77395834
San Joaquin665691082
Contra Costa62164674
Stanislaus55887946
Tulare47784746
Monterey42138327
San Mateo38872515
San Francisco34138398
Santa Barbara31763407
Solano30024164
Merced28915395
Sonoma28004298
Imperial26855589
Kings21951218
Placer19763232
San Luis Obispo19612227
Madera15414209
Santa Cruz14588183
Marin13136197
Yolo12787185
Shasta10969174
Butte10922160
El Dorado9095100
Napa899869
Sutter884597
San Benito575259
Yuba573336
Lassen560119
Tehama508152
Tuolumne394659
Nevada394074
Mendocino379643
Amador344841
Humboldt318033
Lake314140
Glenn221923
Colusa212813
Calaveras190547
Siskiyou174014
Inyo128736
Mono12114
Del Norte9875
Plumas6536
Modoc4524
Mariposa3957
Trinity3675
Sierra990
Alpine810
Unassigned00
Medford
Cloudy
41° wxIcon
Hi: 48° Lo: 36°
Feels Like: 37°
Brookings
Partly Cloudy
42° wxIcon
Hi: 52° Lo: 33°
Feels Like: 42°
Medford
Cloudy
41° wxIcon
Hi: 28° Lo: 13°
Feels Like: 37°
Medford
Cloudy
41° wxIcon
Hi: 49° Lo: 35°
Feels Like: 37°
Klamath Falls
Partly Cloudy
31° wxIcon
Hi: 38° Lo: 25°
Feels Like: 26°
Drying out and warming up
KDRV Radar
KDRV Fire Danger
KDRV Weather Cam

Community Events