Dr. Fauci Chilling Warning to Moderna & J&J Vaccinated Peoples

ABCNews notes that the nation’mandating the Covid-19 vaccines for air travel.
ABCNews notes that the nation’mandating the Covid-19 vaccines for air travel.

Dr. Anthony Fauci said on Sunday that data concerning people who have received Moderna Vaccine or Johnson & Johnson’s COVID-19 vaccinations could be expected soon as new recommendations surrounding the Pfizer vaccine and third-dose booster shots emerge.

“We are definitely paying strong attention to both the J&J Vaccinated people, and those who received a Moderna Vaccine. And the actual data that we’ll get that third shot for the Moderna and second shot for the J&J is literally a couple to a few weeks away,” Fauci, who serves as President Biden’s chief medical adviser, said on NBC’s “Meet the Press.”

“We’re working on that right now to get the data to the [Food and Drug Administration], so they can examine it and make a determination about the boosters for those people,” Fauci added. 

Though Fauci acknowledged that people who have received Moderna or Johnson & Johnson vaccines may be “understandably feeling left out,” he made efforts to assure them that they would soon be included in conversations surrounding booster shots.

“They’re not being left behind by any means,” he said.

Last week, a federal advisory panel recommended that the Food and Drug Administration (FDA) authorize a third-round booster of Pfizer and BioNTech’s shot for vaccinated people in certain higher-risk groups. The recommendation applies to people over age 65 and others who are at increased risk for COVID-19. 

This recommendation is far less than President Biden’s previously announced plan to provide booster shots to all Americans eight months after their second shot.

At the time of that announcement, the Biden administration emphasized that the plan was still pending FDA approval. 

During the interview, host Jake Tapper asked Fauci about the people who are going to ignore the FDA Advisory Committee recommendation and get Pfizer boosters anyway. 

“We are strongly recommending that people do not do that, that they abide by the recommendation,” Fauci said. “I mean, obviously, people are going to do that. It is not recommended. We recommend that people wait until you get to the point where you fall into the category where it’s recommended.”

When Tapper asked if there’s any risk involved with boosting outside of the FDA’s recommendations or if anything “bad will happen” to people who do so, Fauci said,

“You know, there’s always a theoretical risk because the studies have not been done to look at the safety and the immunogenicity of doing that right now for everyone. But, I mean, people who get J&J will be coming in asking to get Pfizer and Moderna, etc.

Theoretically, if you look at things, it is very unlikely that there’s going to be a risk there. But, scientifically, you don’t want to go by unlikely. You want to have some scientific proof. And that’s the reason why, right now, we recommend that people go by the guidelines according to the FDA approval and the [Centers for Disease Control and Prevention] CDC recommendations.”

Previously, during an interview with MSNBC’s Andrea Mitchell on Aug. 19, Fauci was asked about the risk of choosing to get a booster before the FDA had made its ruling and before the eight-month timeframe President Joe Biden previously mentioned.

He explained that going in for an additional dose too early “might defeat the purpose” of the booster if it’s not administered at the recommended interval.

“I wouldn’t say [it’s] dangerous, but one of the things that we’ve learned from an immunological standpoint is that if you get a prime and a boost three to four weeks later, you get the maximum effect of a late boost if you give the immune system a chance to mature over a several month period,” Fauci explained.

Dr. Anthony Fauci, says people shouldn’t get Covid-19 vaccine boosters without FDA approval: “You want to have some scientific proof. That’s the reason why right now we recommend that people go by the guidelines according to the FDA approval and the CDC recommendations.” #CNNSOTU pic.twitter.com/4AzfsMNfpy— CNN Politics (@CNNPolitics) September 19, 2021

During an appearance on Face the Nation earlier this month, Fauci said, “We were hoping that we would get both the candidates, both products, Moderna and Pfizer rolled out by the week of the 20th.” However, he said it was “conceivable that we will only have one of them out,” referring to logistical challenges with Moderna’s paperwork.

While Pfizer got their data in in time for the Sept. 17 FDA meeting, Moderna did not. In early September, Moderna completed their documentation for a 50-mg booster on top of the initial two 100-mg shot regimen, noting that in a clinical trial, that dosage raised antibody levels against the now-dominant Delta variant by more than 40-fold.

The company completed their paperwork on Sept. 3, but it wasn’t enough time to be considered at the latest FDA meeting.

Since some non-Pfizer recipients won’t be able to get a booster of their same vaccine at the eight-month mark, people are wondering if they should boost with Pfizer instead. On Face the Nation, reporter Weijia Jiang asked Fauci, “If I had the Moderna vaccine and I’m hearing that Pfizer is going to be available come September 20th, is it OK for me to mix and match?”

“No, that’s a good question,” Fauci responded. “We are doing studies right now, which are just what you said, they are mix and match studies. Namely, we’re lining up Pfizer against Pfizer, Pfizer for Moderna and vice versa.

Hopefully, within a reasonable period of time, measured in a couple of weeks, we will have that data. But right now, we are suggesting and hopefully, it will work out that way, that if you got Pfizer, you will then boost with Pfizer. If you get Moderna, you’ll be boosting with Moderna.”

Like Fauci, the CDC and FDA have not recommended a mix-and-match approach to booster shots either, a conversation that came up earlier with Johnson & Johnson, the one-dose vaccine that saw protection wane earlier than the mRNA vaccines from Pfizer and Moderna.

“There aren’t enough data currently to support getting an mRNA vaccine dose (either Pfizer-BioNTech or Moderna) if someone has previously gotten a J&J/Janssen vaccine,” the CDC advises on its website. “People who got the J&J/Janssen vaccine will likely need a booster dose of the J&J/Janssen vaccine, and more data are expected in the coming weeks.”

As for Johnson & Johnson boosters, the CDC and the U.S. Department of Health and Human Services (HHS) said in a joint statement on Aug. 18: “Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. … With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

On State of the Union, Fauci was optimistic that it “is not going to be very long” until boosters are approved for the other two types of COVID vaccines.

“We fully anticipate that, within a period of a couple to three weeks, that there will be enough information on the data that will be presented to the FDA by J&J and by Moderna that we’ll be able to proceed and get those data analyzed to be able to move with the booster in those categories,” he said. “We don’t believe it’s going to be a considerable period of time.”

In mid-August, President Joe Biden announced that a COVID booster program would begin on Sept. 20. “The plan is for every adult to get a booster shot eight months after you got your second shot,” he said. “This shot will boost your immune response.

It will increase your protection from COVID-19. And it’s the best way to protect ourselves from new variants that could arise.” But new complications with the booster rollout have emerged in recent weeks.

Now, White House chief COVID adviser Anthony Fauci, MD, is warning in a new interview with CBS’s Face the Nation that Moderna recipients may not be able to get a booster right away.

According to Reuters, on Sept. 1, Moderna submitted their initial documentation for a 50-mg booster to complement the initial two 100-mg shot regimen, noting that in a clinical trial, that dosage raised antibody levels against the Delta variant by more than 40-fold.

Then, the company filed the remainder of its paperwork on Sept. 3. “We are pleased to announce that today we completed our submission to the @US_FDA, which we began on Wednesday, for the evaluation of a booster dose of the Moderna COVID-19 vaccine,” the company tweeted.

Before the data was filed, a health official told the Associated Press (AP) on Sept. 3 that the FDA and CDC hadn’t seen enough data to approve a third dose of the Moderna vaccine and are waiting until more information becomes available before doing so. The source told the AP that approval for the third dose of Moderna will likely now come in October at the earliest.

As Fauci said on Face the Nation, Pfizer’s booster shot is expected to make the Sept. 20 deadline because the company began the approval processes earlier.

Their data is to be reviewed by the FDA on Sept. 17. Bloomberg reported on Sept. 3, after Moderna submitted its final booster documentation, that it wasn’t clear whether a separate meeting would need to be scheduled to assess their data. But Fauci’s comments on Sept. 5 hint that’s a distinct possibility.

Luckily, Pfizer has been the most widely distributed vaccine in the U.S., according to the CDC. The country has administered nearly 213 million doses of the Pfizer vaccine compared to 146.7 million of Moderna and 14.5 million of Johnson & Johnson (a much smaller number since it’s a one-dose regimen).

But since Moderna recipients may not be able to get a third shot of Moderna specifically at that recommended eight-month mark, some are wondering if they should boost with Pfizer instead. On Face the Nation, reporter Weijia Jiang asked Fauci, “If I had the Moderna vaccine and I’m hearing that Pfizer is going to be available come September 20th, is it OK for me to mix and match?”

“No, that’s a good question,” Fauci said. “We are doing studies right now, which are just what you said, they are mix and match studies. Namely, we’re lining up Pfizer against Pfizer, Pfizer for Moderna and vice versa. Hopefully within a reasonable period of time, measured in a couple of weeks, we will have that data.

But right now, we are suggesting and hopefully it will work out that way, that if you got Pfizer, you will then boost with Pfizer. If you get Moderna, you’ll be boosting with Moderna. But we are doing the studies to determine if we can do just that—switch one with the other.”

The CDC has also not yet approved a booster dose for the non-mRNA Johnson & Johnson vaccine. “Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks,” the U.S. Department of Health and Human Services (HHS) said in a statement on Aug. 18.

“With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.”

The CDC and FDA have not recommended a mix-and-match approach to booster shots for those with the J&J vaccine. “There aren’t enough data currently to support getting an mRNA vaccine dose (either Pfizer-BioNTech or Moderna) if someone has previously gotten a J&J/Janssen vaccine,” the CDC advises on its website.

“People who got the J&J/Janssen vaccine will likely need a booster dose of the J&J/Janssen vaccine, and more data are expected in the coming weeks.”

Shortly before the announcement about the fall booster program, the CDC recommended that the U.S. begin administering third shots to people with moderately to severely compromised immune systems who were given the Pfizer or Moderna vaccines.

As far as mixing and matching goes in this case, the CDC says: “For people who received either Pfizer-BioNTech or Moderna’s COVID-19 vaccine series, a third dose of the same mRNA vaccine should be used. …

If the mRNA vaccine product given for the first two doses is not available or is unknown, either mRNA COVID-19 vaccine product may be administered.”

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