ALL NEWS

Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine

May 7, 2021, 7:07 AM | Updated: May 24, 2021, 2:17 pm
Pfizer/BioNTech is seeking full FDA approval for their Covid-19 vaccine.
Mandatory Credit:	Patrick ...
Pfizer/BioNTech is seeking full FDA approval for their Covid-19 vaccine. Mandatory Credit: Patrick T. Fallon/AFP/Getty Images

    (CNN) — Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the first Covid-19 vaccine in the United States to be assessed for full approval from the FDA.

Pfizer’s mRNA two-shot vaccine is currently being used in the US under emergency use authorization (EUA) from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date.

“We are proud of the tremendous progress we’ve made since December in delivering vaccines to millions of Americans, in collaboration with the U.S. Government,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a statement. “We look forward to working with the FDA to complete this rolling submission and support their review, with the goal of securing full regulatory approval of the vaccine in the coming months.”

To apply for full FDA approval Pfizer/BioNTech submitted a Biologics License Application, known as a BLA. The FDA requires vaccine manufacturers submit data on manufacturing processes, facilities and additional information that demonstrates that the vaccine can be produced reliably and consistently. They are also required to submit all pre-clinical and clinical trial data.

Pfizer/BioNTech will submit that information to the FDA over the next few weeks on a rolling basis. Once all the required information is submitted, a goal date will be set for a decision by the FDA. Pfizer/BioNTech has requested priority review, which asks the FDA to take action within 6 months, compared to the 10 months designated under standard review.

The application to the FDA is only intended for adults 16 and older. Pfizer/BioNTech is simultaneously applying to expand its EUA to include children ages 12 to 15. The companies then plan to submit an additional BLA to cover this younger age group once the essential data has been collected six months after administering second doses.

EUA vs. approval

The vaccine, named BNT162b2, was the first Covid-19 vaccine to be awarded FDA emergency use authorization in December.

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. For an EUA to be issued for a vaccine, the FDA says there must be adequate manufacturing information to ensure quality and consistency, and the known and potential benefits of the vaccine must outweigh its known and potential risks.

Due to the seriousness of the pandemic, vaccine makers originally applied for EUAs because the authorization process takes less time than what would be required for full approval. As a condition of the EUA, the companies were expected to work toward full approval from the FDA.

Progressing from authorization to approval could have an impact on vaccine mandates, as some organizations and schools have said they intend to require vaccination against Covid-19, but only once a vaccine is approved by the FDA. It could also have an impact on vaccine hesitancy; a Kaiser Family Foundation survey released this week says about 15% of American adults say they’ll “wait and see” to get a Covid-19 vaccine, and some cite the lack of full approval as a reason to delay.

Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for six months.

Recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech is currently testing booster and variant-specific vaccines.

The-CNN-Wire
™ & © 2021 Cable News Network, Inc., a WarnerMedia Company. All rights reserved.


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.
  • Get vaccinated.

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

 

Today’s Top Stories

All News

After six years leading USU, and an overall 32 year career with the school, President Noelle E. Coc...
Simone Seikaly

USU President Noelle E. Cockett will step down

USU President Noelle E. Cockett has been part of the college's community for 32 years.
3 months ago
A national survey finds Utah the third safest state when it comes to drunk driving fatalities....
Simone Seikaly

Utah one of the leading states for low levels of drunk driving

SALT LAKE CITY — Forbes Advisor has ranked American states to determine which have the highest number of drunk drivers involved in fatal crashes. Their results put Utah third in the nation for the lowest rate of drunk driving. The District of Columbia and New Jersey each ranked higher than Utah when considering this data. […]
3 months ago
free transit rides...
Elizabeth Weiler

Free public transit rides come to Heber Valley

HEBER CITY, Utah — In the summer of 2022, Wasatch County Council approved a sales tax which is now providing funding for free public transit rides throughout Heber Valley.  Wasatch County and High Valley Transit entered a three-year, $3 million agreement to offer public bus transit services between Wasatch and Summit Counties, along with micro-transit […]
3 months ago
carbon monoxide poisoning...
Ali Litzinger

Carbon monoxide poisoning on the rise in winter months

SALT LAKE CITY — Winter is approaching and officials want people to know the signs of carbon monoxide poisoning. Last year, nearly 200 Utahns were treated for carbon monoxide poisoning.  The flame in a gas appliance should generally be blue, with some orange. If the flame is mostly yellow, it’s giving off excess carbon monoxide.  […]
3 months ago
nichole olsen was shot and killed outside a nightclub in dowtown salt lake city over the weekend....
Elizabeth Weiler

Man arrested for murder in weekend shooting outside nightclub in Salt Lake

SALT LAKE CITY — A Southern Utah man has been arrested and booked into jail in connection with the shooting death of a Salt Lake City woman over the weekend. Nichole Olsen, 29, was shot and killed outside a nightclub near 300 S. West Temple in Salt Lake City around 2 a.m. Sunday. Police have […]
3 months ago
A “for sale” sign is displayed outside of a house in Layton. 
Photo: Shafkat Anowar, Deseret Ne...
Adam Small

Salt Lake seeing highest drop in home sales, national report finds

Utah's home sales are dropping fast according to a new national report. Prices have dropped by 48% in the last 12 months.
3 months ago

Sponsored Articles

Happy joyful smiling casual satisfied woman learning and communicates in sign language online using...
Sorenson

The best tools for Deaf and hard-of-hearing workplace success

Here are some of the best resources to make your workplace work better for Deaf and hard-of-hearing employees.
Team supporters celebrating at a tailgate party...
Macey's

8 Delicious Tailgate Foods That Require Zero Prep Work

In a hurry? These 8 tailgate foods take zero prep work, so you can fuel up and get back to what matters most: getting hyped for your favorite
christmas decorations candles in glass jars with fir on a old wooden table...
Western Nut Company

12 Mason Jar Gift Ideas for the 12 Days of Christmas [with recipes!]

There are so many clever mason jar gift ideas to give something thoughtful to your neighbors or friends. Read our 12 ideas to make your own!
wide shot of Bear Lake with a person on a stand up paddle board...

Pack your bags! Extended stays at Bear Lake await you

Work from here! Read our tips to prepare for your extended stay, whether at Bear Lake or somewhere else nearby.
young boy with hearing aid...
Sorenson

Accommodations for students who are deaf and hard of hearing

These different types of accommodations for students who are deaf and hard of hearing can help them succeed in school.
Young woman receiving laser treatment...
Form Derm Spa

How facial plastic surgery and skincare are joining forces

Facial plastic surgery is not only about looking good but about feeling good too. The medical team at Form Spa are trained to help you reach your aesthetic outcomes through surgery and through skincare and dermatology, too.
Pfizer/BioNTech seek full FDA approval for their Covid-19 vaccine