ALL NEWS

US regulators post positive review of Pfizer vaccine data

Dec 8, 2020, 7:32 AM | Updated: 8:41 am

WASHINGTON (AP) — Documents released by U.S. regulators Tuesday confirmed that Pfizer and BioNTech’s COVID-19 vaccine was strongly protective against COVID-19 — offering the world’s first detailed look at the evidence behind the shots.

The Food and Drug Administration posted its analysis online even as across the Atlantic, Britain on Tuesday began vaccinating its oldest citizens with the Pfizer-BioNTech shots.

But the U.S. judges experimental vaccines in a unique way: On Thursday, the FDA will convene what’s essentially a science court that will debate — in public and live-streamed — just how strong the data backing the shots really is.

A panel of independent scientists will pick apart the FDA’s first-pass review before recommending whether the vaccine appears safe and effective enough for millions of Americans. The FDA, which typically follows the committee’s advice, is expected to issue a decision in the days following the review. If given the green light, the first recipients would be health care workers and nursing home residents according to plans laid out by each state.

Pfizer and its German partner BioNTech previously reported the shots appear 95% effective at preventing mild to severe COVID-19 disease in a large, ongoing study. That’s based on the first 170 infections detected. Only eight of the infections were among volunteers given the real vaccine while the rest had received a dummy shot.

That was measured soon after study participants got their second dose. Still unknown is how long that protection lasts. “We’re looking at the best possible data,” Dr. Paul Offit of Children’s Hospital of Philadelphia and an FDA adviser recently cautioned. “People worry, reasonably, how about six months later?”

The other critical issue: Safety. Pfizer has reported no serious side effects. Some recipients experience flu-like reactions — including fever, fatigue or muscle aches — especially after the required second dose. It’s a sign the immune system is revving up, able to recognize and fight back if the real virus comes along.

Other questions on the FDA advisers’ list:

–How well do the shots protect people at high risk such as those over age 65 or those of any age with additional health problems such as obesity or heart disease?

–Were the shots adequately tested in Black, Hispanic and other communities hard-hit by the pandemic, to know how well the vaccine works in those populations?

–Does the vaccine protect against asymptomatic infection, or could the vaccinated still unknowingly spread the virus?

–What should pregnant women be told about vaccination, since they weren’t tested in Pfizer’s study?

Studies in children as young as 12 are just beginning.

Emergency vaccinations could begin before Pfizer’s 44,000-person study is complete, and answering some of those questions will require keeping that study going. Health authorities are wrestling with how to do so in a way that’s fair to placebo recipients who justifiably would want to get the real vaccine.

That access “is top of mind for many,” Pfizer and BioNTech recently wrote trial participants. The companies said they’re exploring ways to let placebo recipients switch to the vaccine group once they meet eligibility criteria for early access — if they’re health workers, for instance, or when the line opens for other essential workers or people over age 65.

On the safety front, study volunteers will be monitored for two years but even studies of tens of thousands of people can’t spot a complication that only strikes 1 in a million. So the government also is gearing up for unprecedented monitoring of recipients once emergency vaccinations get underway.

___

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.

All News

UTA Frontrunner commuter rail. UTA Plans to address delays by updating cars and adding a new line t...

Curt Gresseth

UTA boss talks about train delays, says improvements coming

Despite frustrating delays, UTA has a 90 percent "on-time" record, says the executive officer.

54 minutes ago

nikki haley shown, she will be in utah next week...

Bridger Beal-Cvetko, KSL.com

Nikki Haley to visit Utah next week ahead of Super Tuesday presidential caucus votes

Nikki Haley plans to hold a rally at the Noorda Center for the Performing Arts on Utah Valley University's campus in Orem on the morning of Feb. 28.

2 hours ago

solar panel shown, solar power in utah is the major focus of a proposed law...

Heather Peterson

Bill focusing on solar power customers in Utah gets favorable recommendation in Senate committee

Right now, Rocky Mountain Power only credits solar power customers in Utah about 5 cents for the power they send back to the grid.

3 hours ago

a woman on her phone...

Lindsay Aerts, KSL TV

Utah Legislature approves candidate signature gathering change

A shift is coming for candidates who have to gather signatures to get on the ballot, an app allowing them to verify a voter's eligibility in real-time.

4 hours ago

a meetinghouse shown, select meeting houses will be used as community centers...

Britt Johnson

Select meetinghouses will serve as community resource centers

The community resource centers are part of the MyHometown Utah initiative, which seeks to support and strengthen local communities.

5 hours ago

kansas city shooting...

NICK INGRAM Associated Press

2 adults are charged with murder in the deadly shooting at Kansas City’s Super Bowl celebration

The new charges come after two juveniles were charged for the Kansas City shooting last week.

6 hours 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.

US regulators post positive review of Pfizer vaccine data