FDA Authorizes New COVID-19 Vaccine Without Clinical Data

Epoch Times ^ | 09/03/2024 | Zachary Steiber

[SeekAndFind]

The U.S. Food and Drug Administration (FDA) has authorized a new COVID-19 vaccine from Novavax, giving Americans an alternative to shots from Moderna and Pfizer.

Novavax’s protein-based vaccine will be available soon after regulators granted emergency authorization to the Maryland-based company for the product.

FDA officials said that animal testing data supported the decision.

“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,” Dr. Peter Marks, who directs the FDA’s Center for Biologics Evaluation and Research, said in an Aug. 30 statement.

The FDA cleared vaccines from Moderna and Pfizer that are built on messenger ribonucleic acid technology (mRNA) earlier in the month.

Critics say that the agency should not be making an assertion about safety and effectiveness in the absence of clinical trial data.

“The assertion rings hollow when FDA has not required manufacturers of the mRNA biological [products] to provide scientific evidence to the public that safety and effectiveness has been demonstrated,” Barbara Loe Fisher, co-founder and president of the National Vaccine Information Center, told The Epoch Times previously via email.

Novavax President and CEO John C. Jacobs said in a statement that the company’s vaccine showed “robust cross-reactivity against JN.1 lineage viruses” in animals.

JN.1 was displaced in the spring by KP.3 and other variants, according to sequencing performed by the U.S. Centers for Disease Control and Prevention.

The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks ending Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August.

The Pfizer and Moderna vaccines target KP.3.

FDA officials initially advised manufacturers to target JN.1 but later recommended they target KP.3.

Because Novavax’s vaccine is built on different technology, it takes longer to manufacture than the mRNA shots. Company officials told FDA advisers over the summer that they were planning to continue manufacturing a JN.1-based vaccine and believed it would perform well against KP.3 and other strains from the JN.1 lineage.

The authorization is for people aged 12 and older. People who have never received a vaccine can get two doses of Novavax’s vaccine about three weeks apart. People who have received a vaccine before can get a single dose.

The Moderna and Pfizer vaccines are available for individuals who are at least 6 months old.

The CDC is recommending vaccination for all people aged 6 months and older.

The United States ended the COVID-19 public health emergency in 2023 but extended the emergency declaration under the Public Readiness and Emergency Preparedness Act until the end of 2024. The FDA issued the emergency authorization under that authority.

COVID-19 levels have plummeted since early 2022, although data from wastewater and other sources have indicated a recent uptick.

Twenty-eight states are reporting high levels of COVID-19 and two states are reporting very high levels, based on wastewater, according to the CDC. Hospitalizations and deaths attributed to COVID-19 have also been climbing, although the numbers are far lower than the highs recorded in 2021 and 2022.

[null and void]

ummmmmmm NO!

[delta7]

Are these people just plain stupid? As usual, once respected institutions have all become a laughing stock under senile Joe.

Hey Joe, no one trusts you or your brain dead administration- best you and your pals give it up and leave quickly and quietly.

[null and void]

Just in time for a new election cycle.
Watch for purebloods being denied access to polling places...

The government wants to disarm us after 248 yrs 'cuz they plan to do are doing things we would shoot them for!

At no point in history has any government ever wanted its people to be defenseless for any good reason

The biggest killer of mankind

Nut-job Conspiracy Theory AND/OR Spoiler Alert Ping

To get onto The Nut-job Conspiracy Theory AND/OR Spoiler Alert Ping List you must threaten to report me to the Mods if I don't add you to the list...

"Technology is dominated by two types of people: those who understand what they do not manage, and those who manage what they do not understand." ~ Putt's Law

[null and void]

Are these people just plain stupid?

Nope. They know exactly what they are doing.

Follow that to your logical conclusion...

[Sicon]

Data?! We don’t need no steenking data!

[joe fonebone]

Still trying to find where in that pesky constitution thingie, that the fed was granted the power to regulate food and drugs...

[grey_whiskers]

[Harpotoo]

The lgbtqxyz’s already have no real legacy so I don’t care if the deep state wants to put them out of their misery;-)

[Political Junkie Too]

“Today’s authorization provides an additional COVID-19 vaccine option that meets the FDA’s standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization,”

Why is there still an EUA on this?

Where's the emergency? Isn't it time to lift the emergency and get the FDA back to regular order?

-PJ

[fella]

A replacement label on stuff that’s past its use by date doesn’t make it new just more deadly.

[Bigg Red]

Nope!

[SaveFerris]

[FDA officials said that animal testing data supported the decision.]

Because there wasn't enough Population Reduction^TM last time around.

When do the Nuremberg II trials start for Fauci and his co-conspirators?

[vpintheak]

This is what passes for science in the medical field these days huh? Corruption and graft. Pretty sick.

[metmom]

There is no emergency.

How can an EUA be issued?????

[metmom]

The CDC estimates that KP.3 and the closely related KP.3.1.1 caused about four in 10 cases in the two weeks ending Aug. 3. The agency estimated that KP.3.1.1 became the dominant strain by the end of August.

They're GUESSING!!!!!! They don't even know!!!

This whole vaccine is based on guesswork for something that may not even be happening!!!

[Yaelle]

For what? The illness is not that bad, good vitamin D levels prevent a worst case, and the Covid vaccines are so risky the benefit is nil.

[If You Want It Fixed - Fix It]

More guy generals in skirts?

[Secret Agent Man]

“Not enough of you have died yet from clots or turbo cancers. This will do it.”

[OHPatriot]

Science, what a Joke!! Read this again, “Twenty-eight states are reporting high levels of COVID-19 and two states are reporting very high levels, based on wastewater, according to the CDC.”

So in other words CDC is basing this on “Sh!t Science.” CDC is testing Sh!t to support their crappy science theory.

Testing, WE are the CDC and WE are the Science. /SPIT