AP

Pfizer seeking emergency use of its COVID-19 vaccine in US

Nov 20, 2020, 5:35 AM

Pfizer emergency use...

FILE - In this Nov. 9, 2020, file photo, pedestrians walk past Pfizer world headquarters in New York. Pfizer said Friday, Nov. 20, 2020, it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic -- but not until after a long, hard winter. (AP Photo/Bebeto Matthews, File)

(AP Photo/Bebeto Matthews, File)

Pfizer said Friday it is asking U.S. regulators to allow emergency use of its COVID-19 vaccine, starting the clock on a process that could bring limited first shots as early as next month and eventually an end to the pandemic — but not until after a long, hard winter.

The action comes days after Pfizer Inc. and its German partner BioNTech announced that its vaccine appears 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study.

The companies said that protection plus a good safety record means the vaccine should qualify for emergency use authorization, something the Food and Drug Administration can grant before the final testing is fully complete. In addition to Friday’s FDA submission, they have already started “rolling” applications in Europe and the U.K. and intend to submit similar information soon.

“Our work to deliver a safe and effective vaccine has never been more urgent,” Pfizer CEO Albert Bourla said in a statement.

With the coronavirus surging around the U.S. and the world, the pressure is on for regulators to make a speedy decision.

“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer’s announcement, adding that it’s too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we’re waiting for that help to come.”

Friday’s filing would set off a chain of events as the FDA and its independent advisers debate if the shots are ready. If so, still another government group will have to decide how the initial limited supplies are rationed out to anxiously awaiting Americans.

How much vaccine is available and when is a moving target, but initial supplies will be scarce and rationed. About 25 million doses of the Pfizer vaccine may become available in December, 30 million in January and 35 million more in February and March, according to information presented to the National Academy of Medicine this week. Recipients will need two doses, three weeks apart.

Not far behind is competitor Moderna Inc.’s COVID-19 vaccine. Its early data suggests the shots are as strong as Pfizer’s, and that company expects to also seek emergency authorization within weeks.

Here’s what happens next:

MAKING THE DATA PUBLIC

The public’s first chance to see how strong the evidence really is will come in early December at a public meeting of the FDA’s scientific advisers.

So far, what’s known is based only on statements from Pfizer and BioNTech. Of 170 infections detected to date, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot. On the safety side, the companies cites results from 38,000 study participants who’ve been tracked for two months after their second dose. That’s a milestone FDA set because historically, vaccine side effects don’t crop up later than that.

“We’ll drill down on these data,” said FDA adviser Dr. Paul Offit of the Children’s Hospital of Philadelphia.

Think of it like science on trial. A few days before the meeting, the FDA will release its own internal analysis. That sets the stage for the advisers’ daylong debate about any signs of safety concerns and how the new vaccine technology works before rendering a verdict.

They’ll recommend not just whether FDA should allow broader use of the vaccine generally but if so, for whom. For example, is there enough proof the vaccine works as well for older, sicker adults as for younger, healthier people?

There’s still no guarantee. “We don’t know what that vote’s going to be,” said former FDA vaccine chief Norman Baylor.

EMERGENCY USE ISN’T THE SAME AS FULL APPROVAL

If there’s an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.

That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.

There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?

That’s why the 44,000-person study needs to keep running — something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.

And at least for now, pregnant women won’t qualify because they weren’t studied. Pfizer only recently began testing the vaccine in children as young as 12.

A decision on Pfizer’s vaccine won’t affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.

MANUFACTURING

Brewing vaccine is more complex than typical drug manufacturing, yet the millionth dose to roll out of Pfizer’s Kalamazoo, Michigan, factory must be the same purity and potency as every dose before and after.

That means the FDA decision isn’t just based on study data, but on its determination that the vaccine is being made correctly.

The Pfizer-BioNTech vaccine — and Moderna’s shots — are made with brand-new technology. They don’t contain the actual coronavirus. Instead, they’re made with a piece of genetic code for the “spike” protein that studs the virus.

That messenger RNA, or mRNA, instructs the body to make some harmless spike protein, training immune cells to recognize it if the real virus eventually comes along.

GETTING INTO PEOPLE’S ARMS

Another government group — advisers to the Centers for Disease Control and Prevention — decides who is first in line for scarce doses. Health and Human Services Secretary Alex Azar said he hopes that decision can be made at the same time as FDA’s.

The Trump administration’s Operation Warp Speed has worked with states to line up how many doses they’d need to cover the populations offered vaccine first.

Pfizer will ship those supplies as ordered by the states — only after FDA gives the OK.

Company projections of how much it will ship each month are just predictions, Baylor warned.

“It’s not like a pizza,” he said. Manufacturing is so complex that “you don’t necessarily end up with what you thought.”

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.


How To Prevent the Spread of COVID-19 Coronavirus

COVID-19 coronaviruses transmitted from person to person. It is a virus that is similar to the common cold and the flu. So, to prevent it from spreading:

  • Wash hands frequently and thoroughly, with soap and water, for at least 20 seconds.
  • Wear a mask.
  • Don’t touch your face.
  • Keep children and those with compromised immune systems away from someone who is coughing or sneezing (in this instance, at least six feet)
  • If there is an outbreak near you, practice social distancing (stay at home, instead of going to the movies, sports events, or other activities.)
  • Get a flu shot.

Local resources

KSL Coronavirus Q&A

Utah’s Coronavirus Information

Utah State Board of Education

Utah Hospital Association

The Church of Jesus Christ of Latter-day Saints

Utah Coronavirus Information Line – 1-800-456-7707

National Resources

Centers for Disease Control and Prevention

Commonly asked questions, World Health Organization

Cases in the United States

 

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

AP

WASHINGTON, DC - JANUARY 4: A view of the U.S. Supreme Court on Thursday morning January 4, 2024 in...

MARK SHERMAN

Supreme Court again confronts the issue of abortion, this time over access to widely used pill

Two years after the Supreme Court overturned Roe v. Wade and cleared the way for bans or severe restrictions on abortion in many Republican-led states, abortion opponents on Tuesday will ask the high court to ratify a ruling from a conservative federal appeals court that would limit access to the medication mifepristone, which was used in nearly two-thirds of all abortions in the United States last year.

2 days ago

File - The Instagram logo is seen on a cell phone in Boston, USA, Oct. 14, 2022. Instagram has star...

Associated Press

New Instagram feature limits display of political content

Instagram has started an automatic clamp down on the amount of political content appearing in its users' feeds.

3 days ago

ghost army Congressional gold medal ceremony...

JAMIE STENGLE Associated Press

Ghost Army members who staged secret WWII battlefield deceptions awarded Congressional Gold Medal

Three of the seven known surviving members attended the ceremony at the U.S. Capitol.

7 days ago

Brigham Young Cougars center Aly Khalifa (50) shoots against the UCF Knights at the Marriott Center...

DAVE SKRETTA AP Basketball Writer

BYU’s Aly Khalifa heads into March Madness without food or water while observing Ramadan

It is a fast Khalifa is embarking on willingly, yet one that carries with it unusual challenges during the NCAA Tournament.

7 days ago

A JetBlue airplane is seen, March 16, 2017, at John F. Kennedy International Airport in New York....

The Associated Press 

JetBlue will drop some cities and reduce LA flights to focus on more profitable routes

JetBlue Airways will end service at several cities and reduce flying out of Los Angeles in a move to focus on stronger markets.

8 days ago

Two shades of purple tulips combine with a spring garden of emerging red-leafed lettuce. (Netherlan...

Mike Corder

AI robots are spotting sick tulips in Dutch bulb fields

As part of efforts to tackle the virus, there are 45 robots patrolling tulip fields across the Netherlands as the weather warms up.

8 days ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

Pfizer seeking emergency use of its COVID-19 vaccine in US