Pfizer to seek authorization for Covid-19 vaccine for children ages 2 to 11 in September

Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergenc...

Posted: May 4, 2021 1:32 PM

Pfizer expects to file for full US Food and Drug Administration approval for its Covid-19 vaccine for people ages 16 to 85 this month, and will seek emergency use authorization for its vaccine for children ages 2 to 11 in September, the company said during an earnings call on Tuesday.

The company's vaccine safety and efficacy study in children age 6 months to 11 years old is still going.

"We expect to have definitive readouts and submit for an EUA for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September," Pfizer CEO Albert Bourla said, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.

Pfizer has already applied for emergency use authorization for its coronavirus vaccine for teens and children ages 12 to 15. The FDA is poised to authorize Pfizer's coronavirus vaccine in that age group by early next week, a federal government official told CNN on Monday.

Bourla also said on Tuesday that Phase 2 safety data from Pfizer's ongoing study in pregnant women is expected by late July or early August.

Pfizer to seek approval for vaccine this month

Pfizer expects to seek full US Food and Drug Administration approval of its Covid-19 vaccine for 16-to-85-year-olds by the end of May, Bourla said.

"While we are currently distributing our vaccine in the US under an Emergency Use Authorization (EUA), we expect to submit this month a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) seeking full approval for our Covid-19 vaccine for individuals 16 years of age and older," Bourla said.

Progressing from authorized to approved allows vaccine makers to market and directly distribute their vaccines. It could also have an impact on vaccine mandates -- and perhaps help sway skeptics hesitant to get the vaccines now.

Some organizations say they expect to require the Covid-19 vaccine, but have opted not to while it's authorized and not yet fully approved.

"People, when they hear it's still emergency use, they still have a little concern about how far you can go with it," Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's Jim Sciutto last week.

The three Covid-19 vaccines distributed in the United States -- made by Pfizer/BioNTech, Moderna and Johnson & Johnson -- are authorized, but not approved. Emergency use authorization is what its name suggests -- a medical product, such as a vaccine, that gets special FDA authorization to be used during an emergency.

There's high demand for Pfizer's vaccine -- Bourla said Tuesday the company has been contracted to deliver 1.6 billion doses of its Covid-19 vaccine globally this year, and the company expects to produce at least 3 billion doses of the vaccine in 2022.

A move to ease vaccine distribution

Pfizer also said Tuesday it has submitted information to the FDA that may allow its Covid-19 vaccine to be stored at standard refrigerator temperatures. Such a change could help simplify distribution of the vaccine.

Bourla said the company submitted new data to the FDA on Friday, and it may "soon" have an emergency use authorization to allow standard refrigeration for up to four weeks.

Currently, Pfizer's vaccine is authorized to be stored at ultra-cold temperatures, between -80 and -60 degrees Celsius, or in cold storage, between -25 and -15 degrees Celsius, for a maximum of two weeks, which can complicate distribution of the vaccine.

According to Bourla, new data could allow the vaccine to be stored at standard temperatures, between 2 and 8 degrees Celsius, for up to four weeks.

Bourla said Pfizer is working on additional formulations that could further extend the storage time of the vaccine in both standard and ultra-cold refrigerators.

Oregon Coronavirus Cases

Data is updated nightly.

Cases: 205154

Reported Deaths: 2730
CountyCasesDeaths
Multnomah40141612
Washington26650247
Marion23258322
Clackamas18773234
Lane13777158
Jackson11420146
Deschutes994080
Umatilla851786
Linn551779
Klamath475377
Yamhill475079
Polk393755
Douglas379780
Malheur359763
Josephine353272
Benton324022
Jefferson235738
Coos215737
Columbia188829
Union148824
Wasco143429
Lincoln141221
Crook127623
Hood River121533
Morrow115216
Clatsop10318
Baker99315
Curry68510
Tillamook6604
Grant5487
Lake4667
Harney4239
Wallowa1945
Gilliam751
Sherman661
Wheeler351
Unassigned00

California Coronavirus Cases

Data is updated nightly.

Cases: 3803094

Reported Deaths: 63204
CountyCasesDeaths
Los Angeles124643624433
Riverside3013294620
San Bernardino2990144788
San Diego2813133770
Orange2727455103
Santa Clara1199462177
Kern1106171400
Sacramento1073951723
Fresno1027951720
Alameda893401285
Ventura815721028
San Joaquin744191432
Contra Costa70358810
Stanislaus632661068
Tulare49758849
Monterey43804420
San Mateo42611581
San Francisco37197555
Santa Barbara34577460
Solano33625266
Merced32272474
Sonoma30688323
Imperial28800741
Placer23383299
Kings23170247
San Luis Obispo21411261
Madera16590245
Santa Cruz16206208
Marin14184229
Yolo14120212
Shasta12599232
Butte12586194
El Dorado10351116
Napa999580
Sutter9628112
Yuba646150
San Benito610263
Lassen577524
Tehama571663
Nevada488375
Humboldt443446
Mendocino428250
Tuolumne419970
Amador372147
Lake355645
Glenn242527
Siskiyou239037
Colusa227918
Calaveras220156
Del Norte14528
Inyo143438
Mono12954
Plumas7356
Modoc5344
Mariposa4647
Trinity4175
Sierra1130
Alpine890
Unassigned370
Medford
Partly Cloudy
73° wxIcon
Hi: 71° Lo: 52°
Feels Like: 73°
Brookings
Clear
62° wxIcon
Hi: 69° Lo: 49°
Feels Like: 62°
Crater Lake
Partly Cloudy
73° wxIcon
Hi: 48° Lo: 36°
Feels Like: 73°
Grants Pass
Partly Cloudy
73° wxIcon
Hi: 73° Lo: 44°
Feels Like: 73°
Klamath Falls
Clear
65° wxIcon
Hi: 63° Lo: 43°
Feels Like: 65°

Tonight: Today was our first dry day in a while, although we can't rule out a stray shower or thunderstorm popping up in extreme northern portions of Lake or Klamath counties. Models are hinting that most of this should stay to our north, towards the Bend area. Any lingering clouds today will quickly dissipate by the evening. However, it could prove to be a breezy night in portions of Siskiyou County. Low temperatures will drop down to the upper 30s to low 40s in Northern California, the Klamath Basin, and in the Cascades. Along the coast and in the Rogue Valley, lows will be in the upper 40s to low 50s.

Tomorrow: Our Wednesday will be substantially warmer compared to our Tuesday. Relief from the heat in the form of cloud cover will be absent. High temperatures will be in the upper 80s to low 90s in the Rogue Valley and in Northern California. Highs will be in the mid 80s in the Klamath Basin, mid 70s in the Cascades, and in the upper 60s to low 70s along the coast. The breezy conditions in Siskiyou County from tonight will carry over into Wednesday, and gusts could reach 25 mph in some coastal communities as well. 

Extended: Thursday will be even hotter than Wednesday, and it'll just be a continuation of the stale weather pattern we're about to be in. Skies should remain clear for the forseeable future, and blistering heat looks to be in store for the weekend. We could be talking about high temperature in the upper 90s to triple digits in the Rogue Valley and Siskiyou County. Highs could be in the 90s in the Klamath Basin, in the 80s in the Cascades, and in the 70s along the coast.

Most of the beneficial rain that fell over the weekend was concentrated over the coast, meaning that drought conditions probably didn't improve much in the Rogue Valley and points eastward. As we stay dry and hot throughout the rest of the week, we'll be watching for the return of favorable fire conditions, especially in Lake County. The good news is that winds appear to be light towards the end of the week, which should limit the wildfire threat to some degree.

A FREEZE WARNING has been issued for our westside valleys in Jackson, Josephine and Curry Counties until 8 AM Wednesday. Low temperatures in these areas will fall down to near and even below freezing overnight. The coldest temperatures will be in the Applegate and Illinois Valley where temperatures could dip into the upper 20s. With widespread frost and possible freezing temperatures, be sure to protect and cover any sensitive plants.
Tonight: The clear and warm day will give way to a clear and mild evening. Temperatures for inland areas this evening will stay solidly in the 50s and 60s through the 8 P.M. hour, meaning this will be a near picture perfect evening for a barbecue or Wednesday evening walk. Overnight low temperatures will also stay more mild than recently, falling into the mid to upper 30s in our westside valleys with mid to upper 20s east of the Cascades. The coast will see temperatures staying in the 40s through the overnight hours. 
Extended: Beyond Wednesday, we'll see a very gradual and slow cooling trend through the rest of the workweek, but temperatures will remain above average. Easter Weekend will start off dry, but clouds will increase and by Easter Sunday, we could be looking at some chances for rain for at least parts of our region. We'll be keeping a close eye on this system and your holiday weekend forecast. It's possible wet weather could continue into next week with cooler temperatures.

Stay updated on the StormWatch 12 forecast on-air and online.

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