FDA Says Suggestion To Halve Moderna Vaccine ‘Not Rooted’ In Available Science

The Food and Drug Administration late Monday shot down an idea floated by a top Trump administration vaccine official who proposed halving doses of the Moderna vaccine. The FDA said that the proposal to stretch the Moderna vaccine was “premature and not rooted solidly in the available science.”

“We want to remind the public about the importance of receiving COVID-19 vaccines according to how they’ve been authorized by the FDA in order to safely receive the level of protection observed in the large randomized trials supporting their effectiveness,” the agency said in a statement posted to its website on Monday night. 

The statement came after Moncef Slaoui, the chief science adviser for Operation Warp Speed, said on Sunday that federal officials and Moderna were discussing the possibility of cutting each of Moderna’s required two doses in half — going against the vaccine’s stated requirements for use and giving each recipient the equivalent of a single dose.

Slaoui suggested on Sunday that Moderna’s clinical trial data revealed that people between the ages of 18 and 55 who received two 50-microgram doses showed an “identical immune response” to the two required 100-microgram doses.

But the FDA’s statement a day later criticized Slaoui’s assertion as too hasty given a lack of available evidence to justify hollowing out the doses.

“We have been following the discussions and news reports about reducing the number of doses, extending the length of time between doses, changing the dose (half-dose), or mixing and matching vaccines in order to immunize more people against COVID-19,” the statement said.

The FDA insisted that any changes to the vaccine regimen would require research in additional clinical trials before being approved or adopted noting that sudden ad hoc adjustments “run a significant risk of placing public health at risk, undermining the historic vaccination efforts to protect the population from COVID-19.” 

The statement noted that clinical trial recipients of the Moderna or Pfizer-BioNTech vaccine who did not receive two doses at the proper time “were generally only followed for a short period of time,” making it inadvisable to draw conclusions about the depth or duration of protection from a single dose of the vaccines.

Dr. Anthony Fauci said on Monday that the sudden switch could also “confuse the public” amid an effort to The  top infectious diseases expert said during an interview with The New York Times that the effort to spread the doses was misdirected after reports that states have not yet vaccinated people with existing doses of the approved coronavirus vaccines.

“At the present time we are not dealing with a shortage of doses — we are dealing with the need to increase our efficiency in getting people vaccinated,” Fauci said.

Hawley Struggles To Explain End Goal Of Objecting To Electoral College Certification

Sen. Josh Hawley (R-MO) fumbled on Monday night when asked what exactly he hopes to achieve by disrupting the congressional proceedings on Wednesday that will cement President-elect Joe Biden as the winner of the 2020 election, given that his objection has no chance of overturning Biden’s victory.

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EXCLUSIVE: Trump Bypasses Top Career Prosecutor To Name New Acting US Attorney In Atlanta

Following the abrupt Monday resignation of Byung Jin “BJay” Pak, the U.S. attorney in Atlanta, President Trump is bypassing his first assistant, a career prosecutor, to name a new acting leader from outside the office.

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Into Georgia

The Georgia elections are upon us and I confess I simply have no idea what the outcomes are going to be. Early voting included encouraging hints for Democrats, particularly in levels of African-American voting. But trying to disentangle the meaning of early voting before you see same day voting is generally a fool’s game. The polls have been almost literally tied throughout. Though the averages of the final polls show one or two point leads for both Democrats, as we’ve learned, in our current politics, Republicans routinely outperform polls by very small but real margins. Especially when Trump is on the ballot. Is Trump on the ballot? Literally, no, but he’s certainly trying to pretend like he is.

Mail Delays Threaten Late Arrival Of Runoff Ballots In Atlanta

Mail delays in Atlanta are threatening to disenfranchise thousands of voters who mailed ballots in the all-important Senate runoffs in Georgia this week, NBCLX reported late Monday.

The publication said that delays in the state’s capital are well below US Postal Service standards, even though Postmaster Louis DeJoy had promised to address the mail slowdown months ago in preparation for November’s general election.

DeJoy came under fire over the summer for changes to the mail service that appeared to exacerbate sluggish delivery times, just as the voters prepared to send the highest number of ballots cast by mail in the nation’s history in November. According to NBCLX, the most recent USPS filings in federal court show that mail delivery has gotten worse since then — with 76% of ballots in the Atlanta processing on-time, as of Dec. 21. The slowdown means that close to a quarter of ballots have been delayed for a region that covers the northern half of the Peach State.

The slow mail delivery also suggests that ballots mailed close to the state’s Jan. 1 deadline for mailing absentee ballots may not make it to elections offices before the Jan. 5 deadline for absentee ballots to be received to count. The election will likely be close and is set to determine which party controls the Senate. 

The state reported more than 38,000 mail ballots received by local elections officials over the weekend.

The USPS’ Gulf Atlantic region covering the southern half of Georgia performed well above Atlanta, but on-time performance for first-class mail dropped across both regions, taking a nosedive from 87% in Atlanta in mid-November to just 60% in mid-December, NBCLX pointed out. 

The USPS had agreed to treat all ballots as Priority Express mail, which usually gets delivered within one day.

But an increase in mail last month amid the holidays appeared to further complicate those efforts.

A USPS spokesperson told NBCLX that a deluge of December mail had affected “scores of all products,” but maintained that “Election Mail and ballots have always been prioritized and are performing well above other product lines.”

Harris On GOPers’ Planned Attack On Election Certification: ‘We’re Going To Be Inaugurated. Period.’

Vice President-elect Kamala Harris signaled on Monday night that she was unfazed by her soon-to-be former GOP Senate colleagues’ crusade to overturn her and President-elect Joe Biden’s electoral victory on Wednesday.

Continue reading “Harris On GOPers’ Planned Attack On Election Certification: ‘We’re Going To Be Inaugurated. Period.’”

Trump Threatens Pence On Electoral College Certification At Last Georgia Rally

President Donald Trump stayed about as on-message as he’s shown himself capable of being at his last rally in Dalton, Georgia, on Monday night, hours before Election Day polls open for the double-barrel senatorial runoffs. That meant lots of tangents.

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Loeffler Plans To Object To Biden’s Electoral Victory Day After GA Runoff

Sen. Kelly Loeffler (R-GA) on Monday announced her plan to object to the Electoral College certification process this week that will ratify President-elect Joe Biden’s victory. The joint session of Congress is scheduled a day after the Georgia runoff elections on Tuesday that will determine the balance of the Senate. Continue reading “Loeffler Plans To Object To Biden’s Electoral Victory Day After GA Runoff”

Proud Boys Leader Arrested After Burning Of Church’s Black Lives Matter Banner

The leader of the right-wing street gang the Proud Boys, Enrique Tarrio, was arrested Monday in Washington, D.C., the Metropolitan Police Department confirmed to TPM.

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