PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROV

[PeteS in CA]

PFIZER AND BIONTECH INITIATE ROLLING SUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR U.S. FDA APPROVAL OF THEIR COVID 19 VACCINE

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-initiate-rolling-submission-biologics

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for approval of their mRNA vaccine to prevent COVID-19 in individuals 16 years of age and older. Data to support the BLA will be submitted by the companies to the FDA on a rolling basis over the coming weeks, with a request for Priority Review. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA will be set once the BLA is complete and formally accepted for review by the agency.

The Pfizer-BioNTech COVID-19 Vaccine is currently available in the U.S. under an Emergency Use Authorization (EUA) granted by the FDA on December 11, 2020. Since then, the companies have delivered more than 170 million doses of the vaccine across the U.S. Submission of a BLA, which requires longer-term follow-up data for acceptance and approval, is the next step in the rigorous FDA review process.
...
Pfizer and BioNTech initiated the BLA by submitting the nonclinical and clinical data needed to support licensure of the COVID-19 vaccine for use in individuals 16 years of age and older. This includes the most recent analyses from the pivotal Phase 3 clinical trial, where the vaccine’s efficacy and favorable safety profile were observed up to six months after the second dose. The companies will submit the required manufacturing and facility data for licensure in the coming weeks to complete the BLA.

Pfizer and BioNTech also have submitted an application to expand the current EUA for their COVID-19 vaccine to include individuals 12 to 15 years of age. The companies intend to submit a supplemental BLA to support licensure of the vaccine in this age group once the required data six months after the second vaccine dose are available.

There are two pieces of news in this.

First, in plain English, BioNTech and Pfizer have initiated the process that if successful will result in full approval of their vaccine.

Second, BioNTech and Pfizer have also applied for an EUA allowing use of their vaccine with youths ages 12-15, and plan 6 months later to initiate the process of including those youths in their BLA.

Speaking speculatively, it seems likely that Moderna will also soon start the BLA process. I hope LIEden's crew aren't stupid enough to try to arm-twist Pfizer and Moderna over their patents: "Nice vaccine you got there, it'd be a shame if you defended your patent and something happened to your BLAs."

[jmyrlefuller]

Another little nugget: once one of the vaccines gets full approval, that opens the door to vaccine mandates. Right now, most states operate under the premise that they cannot mandate use of a vaccine if none of the options are fully approved (EUA does not count).

So there are likely quite a few public health bureaucrats anticipating full approval of the Pfizer shot, and I imagine the Moderna shot a few weeks from now.

[PeteS in CA]

PFIZER AND BIONTECH RECEIVE FIRST U.S. AUTHORIZATION FOR EMERGENCY USE OF COVID-19 VACCINE IN ADOLESCENTS

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-authorization

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the U.S. Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) for their COVID-19 vaccine to include individuals 12 to 15 years of age. This is the first COVID-19 vaccine authorized in the U.S. for use in this age group.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210510006021/en/

“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents before the start of the next school year,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are grateful to all of our clinical trial volunteers and their families, whose courage helped make this milestone possible. Together, we hope to help bring a sense of normalcy back to young people across the country and around the world.”

The FDA based its decision on data from a pivotal Phase 3 clinical trial, which enrolled 2,260 participants aged 12 to 15 years. Topline results from this trial, announced on March 31, 2021, showed a vaccine efficacy of 100% in participants with or without prior SARS-CoV-2 infection and robust antibody responses. In the trial, the vaccine was also generally well tolerated. Participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

[PeteS in CA]

Unsurprisingly, Moderna has also started the process for full - not "just" Emergency Use Authorization - approval by the FDA.

Moderna Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for the Moderna COVID-19 Vaccine

https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-initiation-rolling-submission-biologics

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 1, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.

“We are pleased to announce this important step in the U.S. regulatory process for a Biologics License Application (BLA) of our COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the rolling submission.”

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks with a request for a Priority Review. Once the rolling BLA submission is complete, FDA will notify the Company when it is formally accepted for review.

[PeteS in CA]

Rather than proliferating related/similar threads:

Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States

https://investors.modernatx.com/news-releases/news-release-details/moderna-files-emergency-use-authorization-its-covid-19-vaccine

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jun. 10, 2021-- Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it has requested an emergency use authorization (EUA) for its COVID-19 vaccine in adolescents with the U.S. Food and Drug Administration (FDA).

“We are pleased to announce that we have submitted for an emergency use authorization for our COVID-19 vaccine with the FDA for use in adolescents in the United States,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents. We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population. We remain committed to helping to end the COVID-19 pandemic.”

If this is handled by the FDA in the way it handled the similar Pfizer request, this revision might be approved tomorrow, or the weekend, or Monday.