FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People

[PeteS in CA]

FDA Advisory Committee Recommends Emergency Use Authorization of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

https://ir.novavax.com/2022-06-07-FDA-Advisory-Committee-Recommends-Emergency-Use-Authorization-of-Novavax-COVID-19-Vaccine-for-People-Aged-18-Years-and-Older

GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

Anti-Covid-Vaxxers may very soon have a 4th Covid vaccine - utilizing a third vaccine technology - to demonize.

[PeteS in CA]

US regulators OK new COVID-19 shot option from Novavax

https://www.msn.com/en-us/health/medical/us-regulators-ok-new-covid-19-shot-option-from-novavax/ar-AAZxVXr

The U.S. is getting another COVID-19 vaccine choice as the Food and Drug Administration on Wednesday cleared Novavax shots for adults.
...
For now, the FDA authorized Novavax's initial two-dose series for people 18 and older.

“I encourage anyone who is eligible for, but has not yet received, a COVID-19 vaccine to consider doing so,” FDA Commissioner Dr. Robert Califf said in a statement.

Before shots begin, the Centers for Disease Control and Prevention must recommend how they should be used, a decision expected next week.

[Smokin Joe]

So, what, precisely is the "emergency" this Emergency Use Authorization is supposed to fix?

[libertybele]

So, what, precisely is the "emergency" this Emergency Use Authorization is supposed to fix?

My guess is the new variant BA.5, which none of the vaccines are effective against it (no surprise) .... and it's even transmissible outdoors.  The usual crappola.

[PeteS in CA]

1. It's the same Emergency Use Authorization given Pfizer, Moderna, and J&J. Use of Emergency Use Authorization for a Covid vaccine was, IIRC, authorized in February 2020, and the law creating Emergency Use Authorization was passed during GWB's Administration (possibly 2005).

2. This is not in response to whatever variant is currently circulating, simply because Phase 1/2 (human) testing of this vaccine began in May 2020, a couple of years before Omicron (or whatever) came into circulation, and Novavax had conditional purchase contracts with DoD in June 2020 and with HHS in July 2020. See https://www.gopbriefingroom.com/index.php/topic,412701.0.html for more details. The Novavax vaccine is not some CT-grade "Plan B", Novavax was part of Trump's Operation Warp Speed more or less from the beginning.

[Kamaji]

More political bullshit regarding a virus that is no longer distinguishable from your average seasonal flu virus. 

[jmyrlefuller]

Not sure what this achieves this late in the process, since everyone who would have taken the shot has already done so.

[Smokin Joe]

1. It's the same Emergency Use Authorization given Pfizer, Moderna, and J&J. Use of Emergency Use Authorization for a Covid vaccine was, IIRC, authorized in February 2020, and the law creating Emergency Use Authorization was passed during GWB's Administration (possibly 2005).

2. This is not in response to whatever variant is currently circulating, simply because Phase 1/2 (human) testing of this vaccine began in May 2020, a couple of years before Omicron (or whatever) came into circulation, and Novavax had conditional purchase contracts with DoD in June 2020 and with HHS in July 2020. See https://www.gopbriefingroom.com/index.php/topic,412701.0.html for more details. The Novavax vaccine is not some CT-grade "Plan B", Novavax was part of Trump's Operation Warp Speed more or less from the beginning.

With all due respect, I asked what the emergency was, not the authorization.

Seems to me, COVID is the least of our worries at the moment.

Do we really need to fast-track another experimental shot?

[PeteS in CA]

With all due respect, I asked what the emergency was, not the authorization.
...

I answered your question with this clause:

Use of Emergency Use Authorization for a Covid vaccine was, IIRC, authorized in February 2020 ...

Checking my recollection, I found this in about 20 seconds - I'm a slow typist - using the DDG search phrase "emergency use authorization to be used for covid vaccines":

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.


Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below.

I'm mildly surprised my memory was correct, down to the month. The current SecHHS has not rescinded that determination.

[mountaineer]

From NBC News: Menstrual changes after Covid vaccines may be far more common than previously known.
A study found that 42% of people with regular menstrual cycles said they bled more heavily than usual after their Covid vaccination.
Just FYI.

[Smokin Joe]

I answered your question with this clause:

Checking my recollection, I found this in about 20 seconds - I'm a slow typist - using the DDG search phrase "emergency use authorization to be used for covid vaccines":

https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization

I'm mildly surprised my memory was correct, down to the month. The current SecHHS has not rescinded that determination.

So, (please correct me if I am wrong) in essence, that determination is what constitutes the emergency, not caseloads, deaths, or any real world data that takes into account developments since it was issued.

As for the current SecHHS, well, there are fundamental doubts I have about that (pronoun quagmire deleted).