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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 8:31 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.

California Coronavirus Cases

Data is updated nightly.

Cases: 3554629

Reported Deaths: 51395
CountyCasesDeaths
Los Angeles118754221106
Riverside2891853749
San Bernardino2853342673
Orange2603483889
San Diego2589823260
Santa Clara1098411765
Kern102627811
Fresno947941412
Sacramento929441464
Alameda800881224
Ventura77238834
San Joaquin665691082
Contra Costa62164674
Stanislaus55775944
Tulare47784746
Monterey42138327
San Mateo38763515
San Francisco34061398
Santa Barbara31763407
Solano29968164
Merced28915395
Sonoma27954298
Imperial26843589
Kings21951218
Placer19713231
San Luis Obispo19612227
Madera15390209
Santa Cruz14588183
Marin13136197
Yolo12760185
Shasta10944174
Butte10915160
El Dorado9095100
Napa897668
Sutter884597
San Benito574359
Yuba573336
Lassen560119
Tehama508152
Tuolumne394659
Nevada393274
Mendocino379643
Amador344441
Humboldt316033
Lake313440
Glenn221023
Colusa212813
Calaveras190547
Siskiyou174014
Inyo128736
Mono12114
Del Norte9875
Plumas6536
Modoc4524
Mariposa3947
Trinity3675
Sierra990
Alpine810
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After plenty of morning clouds, we had plentiful sunshine this afternoon with weaker wind and warmer highs. The clear sky and light wind will lead to a chillier start Friday morning, and we'll have a breezy and mild Friday before more changes arrive.
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