Quantcast

Why Aren’t The Vaccines Approved?

"The difference between emergency authorization and full approval matters." The F.D.A. is encouraging people to get a Covid-19 shot — but hasn’t formally approved those vaccines.

The F.D.A. is encouraging people to get a Covid-19 shot — but hasn’t formally approved those vaccines.

New York Times – It is the most discordant part of the U.S. government’s response to Covid-19.

Even as President Biden, the C.D.C. and virtually the entire scientific community are urging — pleading with, even — Americans to get vaccinated, the government has not formally approved any vaccine.

The Food and Drug Administration has instead given only “emergency use authorization” to the shots from Moderna, Pfizer and Johnson & Johnson.That’s a temporary form of approval that allows people to receive shots while the agency continues to study their effectiveness and safety.

The difference between emergency authorization and full approval matters. Right now, the military, schools and other organizations cannot easily require vaccinations. The “lack of F.D.A. licensure leave schools, colleges, businesses in a legal quandary,” Dr. Jerome Adams, a former surgeon general, recently wrote. Adams argued that lives were at stake and that the issue should be receiving more media coverage than it has.

“The F.D.A.’s leaders have failed to understand how most Americans really think about the vaccines.”

...article continued below
- Advertisement -

The situation also feeds uncertainty and skepticism among some Americans who have not yet gotten a shot. Those skeptics, as Matthew Yglesias of Substack wrote yesterday, are effectively taking the F.D.A. at its word. The F.D.A. leaders’ official position is that “they don’t have enough safety data yet,” Yglesias noted.

The strangest part of all this is that the F.D.A.’s official position does not reflect its leaders’ actual views: They agree with the C.D.C. and other scientists that Americans should be getting vaccinated as soon as possible.

Dr. Janet Woodcock, the F.D.A.’s acting commissioner, has said that the F.D.A. “conducted a rigorous and thorough review” of the vaccines before allowing them to be given to people and that the Pfizer vaccine “meets F.D.A.’s high standards for safety and effectiveness.”

She also said, “Getting more of our population vaccinated is critical to moving forward and past this pandemic.”

Hurry up and wait

Why, then, hasn’t the F.D.A. taken the final step of formal approval?

...article continued below
- Advertisement -

It is following a version of its traditional, cautious process for vaccine approval. That process has historically had some big advantages, reducing the chances that Americans end up taking a faulty drug. To move much more quickly would risk undermining the public’s confidence in the F.D.A. and, by extension, the medicines it approves, Dr. Peter Marks, who oversees the process, has argued.

But I think the F.D.A.’s leaders have failed to understand how most Americans really think about the vaccines. It is different from the way that scientists and epidemiologists do. It’s less technical and based more on an accumulation of the publicly known facts.

READ MORE (subscription may be required.)

 

- Advertisement -

TRENDING

Biden Admin. Awards $150K To Florida District That Resisted DeSantis

WASHINGTON — The Biden administration said on Thursday that it was reimbursing a Florida school district that lost state money for imposing a mask...

Ivermectin: What The Evidence Says

Daily Briefing, September 21, 2021 ADVISORY BOARD – Ivermectin is an anti-parasite drug discovered in 1975. It was initially introduced as a drug for livestock,...

CDC Backs COVID Booster For Millions

AP – The Centers for Disease Control and Prevention on Thursday endorsed booster shots for millions of older or otherwise vulnerable Americans, opening a...

Doctors Charged In Massive Fraud Including False Covid Claims

NBC NEWS – The Department of Justice has announced criminal charges against 42 medical professionals, including 23 doctors, and nearly 100 other people for...

Middle-School Mom Rips School Board Over Anal Sex Reference

FOX NEWS – A Texas school district has removed a book from schools after an irate mother read aloud an excerpt about anal sex...

State Cops Sue Governor To Block Vaccine Mandate

FOX NEWS – The union that represents about 1,800 Massachusetts State Police troopers went before a judge Wednesday asking for a delay in the...

Vaccine Effectiveness “Appears To Wane Over Time”

(CNN) The protection provided by Covid-19 vaccines appears to wane over time, especially for people 65 and older, a US Centers for Disease Control...

Frozen Shrimp From India? Throw It Back [Check Labels Now]

FOOD SAFETY NEWS – Officials say a Salmonella Weltevreden outbreak linked to imported, cooked, frozen shrimp is over, but they are concerned some consumers...

“Biden’s Failure During A National Health Crisis” – Kaiser

KAISER HEALTH NEWS – President Joe Biden’s failure to name someone to lead the Food and Drug Administration, more than 10 months after the...

Rising Covid Death Count “A Real Failure Of Society”

For health workers, the deaths, combined with misinformation and disbelief about the virus, have been "heart-wrenching, soul-crushing."
- Advertisement -