Louisiana lawmakers say COVID vaccines aren’t fully approved. Experts say that’s ‘complete nonsense’ – The Advocate

When Louisiana lawmakers passed legislation back in June barring schools and universities from enforcing COVID vaccine requirements, they agreed that the protections would only be needed for a limited period of time.

By that point, more than 3 million vaccine doses had been administered in Louisiana and data proved the jabs both safe and effective against COVID-19.

But vaccine skeptics in the statehouse didn’t trust the nation’s scientists. They claimed that because the vaccines had been approved under emergency-use authorization, they hadn’t been fully vetted, ignoring the rigorous clinical trials that had demonstrated their effectiveness.

Republican state lawmakers decided legislation banning certain COVID vaccine requirements was necessary – at least until the U.S. Food and Drug Administration granted the vaccines full approval.

So, when federal regulators fully authorized the Pfizer-BioNTech vaccine for people aged 16 and up at the end of August, those doubts should have been settled.

Despite improvements in recent weeks Gov. John Bel Edwards said Tuesday he is extending his indoor mask mandate until Oct. 27 and said COVID-1…

Not so.

Instead, some lawmakers latched on to a farfetched conspiracy theory that’s become increasingly popular among anti-vaccine activists: that the FDA didn’t really fully authorize the Pfizer vaccine.

In a meandering letter sent to Gov. John Bel Edwards on Wednesday, published on Louisiana House of Representatives letterhead, ten GOP legislators demanded the state Health Department buck the FDA and declare that no vaccines with full approval are available in Louisiana.

Much of their argument is incomprehensible. But it boils down to the incorrect notion that doses of the Pfizer vaccine manufactured prior to the full FDA approval aren’t fully authorized.

The letter is “complete nonsense” and misunderstands the FDA approval process, said Nathan Cortez, a law professor at Southern Methodist University in Dallas.

When the FDA granted full approval for the two-dose Pfizer regiment, the product received a new trade name, Comirnaty – but its formulation remained the same and the FDA said it could be used interchangeably with existing stock of the Pfizer vaccine.

“No serious person would argue that the decision renders the vaccine to be a completely different vaccine,” Cortez said. “This letter deserves all the mockery and derision it gets.”

A spokesperson for the governor, Christina Stephens, said Edwards hasn’t read the letter and doesn’t intend to.

“This letter is ridiculous,” Stephens said. “It’s rife with disinformation, which is particularly dangerous to share during a pandemic and could result in immense and irreparable harm to families across this state.”

State Superintendent of Education Cade Brumley’s plan to let students exposed to the coronavirus remain in the classroom sparked pushback Thur…

The letter is the latest effort by a vocal cohort of state lawmakers to sow doubts about the COVID vaccines and comes as Louisiana recovers from its fourth surge of the deadly virus, which pushed hospital capacity to the brink and killed thousands of Louisiana residents.

More than 12,300 people across Louisiana have died of the coronavirus disease, and another 1,600 deaths are considered likely from COVID-19, according to Health Department data. The vast majority of those deaths were among people unvaccinated against COVID.

Lawmakers who signed the letter figured that if they could prove the vaccines available weren’t fully authorized, the sort of mandates that have been put in place for students and employees at universities and hospitals would be deemed illegal.

But that, too, is wrong, according to Edward Richards, a professor at LSU’s School of Law. Though most employers and some universities waited for full FDA approval before issuing vaccine requirements, nothing barred them from enacting those mandates while the product was under emergency-use authorization.

State Rep. Kathy Edmonston, a Gonzales Republican who authored the legislation in the last legislative session targeting vaccine mandates, said she and her colleagues worked together to research the arguments presented in the letter, going so far as to include footnotes citing their sources.

But much of their arguments don’t pan out under scrutiny.

At one point, they cherry-pick a quote from an FDA document saying: “There is no data available on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the vaccine series.”

The lawmakers present the excerpt as a proof that the brand name version of the Pfizer vaccine can’t be used interchangeably with doses previously approved under emergency-use. But Cortez, the SMU law professor, said they “completely misunderstand” the quotation.

“FDA is warning that there is no data whether someone who received a first shot of the Pfizer vaccine would benefit from a second shot of the Moderna vaccine, for example,” Cortez said.

None of the lawmakers behind the letter have a background in science or medicine, and in interviews, some of the signatories demonstrated clear misunderstandings of the FDA’s regulatory process.

State Rep. Valerie Hodges, a Denham Springs Republican, claimed the vaccines had just recently been approved for clinical trials. That’s not true. Tens of thousands of people have participated in clinical trials for the COVID vaccines stretching back to 2020, and the FDA didn’t grant its emergency-use authorizations until reviewing that data.

It’s not the first time lawmakers, backed by anti-vaccine activists, have gotten their facts mixed up. House Bill 498, passed by the Legislature in June, would have temporarily barred certain government vaccine requirements until the FDA secretary approved its full use. 

But the FDA doesn’t have a secretary. It has a commissioner. And approval is granted by the FDA, not a singular commissioner. Edwards vetoed the bill, citing its flawed language. 

Throughout my life, our family gatherings were basically cops and pastors of all political stripes and religious philosophies sitting together…

The lawmakers printed their latest note on generic Louisiana House of Representatives letterhead, causing some readers to believe its contents represented the views and beliefs of the entire lower chamber.

It’s the third time in recent months that vaccine skeptics in the House have used the generic letterhead to promote opinions that challenged the scientific consensus around COVID.

After the latest letter was published, House Speaker Clay Schexnayder, a Gonzales Republican, emailed members saying that going forward, no members would be allowed to use the Louisiana House of Representatives letterhead.

The lawmakers that signed their name to the letter include: Reps Beryl Amedee, R-Houma; Raymond Crews, R-Bossier City; Kathy Edmonston, R-Gonzales; Larry Frieman, R-Abita Springs; Valerie Hodges, R-Denham Springs; Dodie Horton, R-Haughton; Sherman Mack, R-Albany; Danny McCormick, R-Oil City; Chuck Owen, R-Rosepine; and Rodney Schamerhorn, R-Hornbeck.

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