WH: J&J News Should Increase Confidence In CDC And FDA

WILMINGTON, DELAWARE - DECEMBER 08: Jeff Zients, President-elect Joe Biden’s pick to head the White House’s coronavirus response, attends a news conference at the Queen Theater December 08, 2020 in Wilmington, De... WILMINGTON, DELAWARE - DECEMBER 08: Jeff Zients, President-elect Joe Biden’s pick to head the White House’s coronavirus response, attends a news conference at the Queen Theater December 08, 2020 in Wilmington, Delaware. With the novel coronavirus pandemic continuing to ravage the country with daily records for infections and deaths, members of Biden's health team said they will make fighting COVID-19 the priority. (Photo by Chip Somodevilla/Getty Images) MORE LESS
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Americans should have more trust in the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) following the decision to pause administering Johnson & Johnson’s COVID-19 vaccine, White House COVID-19 Response Coordinator Jeff Zients said on Wednesday.

The White House messaging comes amid growing concerns that the news could discourage people from getting vaccinated in the first place.

On Tuesday morning, the FDA and CDC released a joint recommendation advising health care providers to stop administering Johnson & Johnson’s COVID-19 vaccines “out of an abundance of caution,” following an FDA advisory reporting that six women in the U.S. developed a rare blood-clotting disorder that led to the death of one woman and put another in critical condition.

Acting FDA Commissioner Janet Woodcock said the pause was expected to last for just “a matter of days.”

Shortly after the FDA and CDC held a press conference on its recommended pause of J&J vaccine distribution, several states moved to cease its distribution.

During a White House COVID-19 Response Team briefing the next day, Zients assured the media that the Biden administration is on track to fulfill the President’s goal of administering 200 million shots by his 100th day in office, despite the pause on J&J distribution.

Emphasizing the Biden administration’s commitment to “lead with science,” Zients said that the administration has been engaging state and local health officials, governors, community leaders, clinicians and medical experts in the past 24 hours to provide clear information on the rationale behind the pause.

Reiterating the administration’s efforts to build vaccine confidence — which includes the White House’s $3 billion investment in supporting local efforts to increase vaccine confidence — Zients argued the Biden administration’s transparency on serious side effects reported in the J&J vaccines gives more reason for the public to have trust in the FDA and CDC as well as COVID-19 vaccines themselves.

“Yesterday’s action should give the American people confidence in the FDA and CDC, the thoroughness of the review process and their commitment to transparency and protection of public health,” Zients said. “We believe that by empowering Americans with data and facts, we will strengthen public’s trust in government and increase their confidence in the vaccines.”

CDC Director Dr. Rochelle Walensky echoed Zients’ message as well.

“I want to share with you my confidence with the system we have in place,” Walensky said. “Jointly the CDC and FDA were able to identify these rare events and act quickly to alert health care providers and the public. This demonstrates that the safety systems we have in place are working.”

Walenky affirmed that health officials will continue to monitor vaccinations and adverse events across the country, and that the pause on J&J vaccinations will allow officials to accelerate the reporting of serious side effects.

Watch the briefing below:

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Notable Replies

  1. I think this is wishful thinking. The vaccine hesitant don’t care about the CDC and they certainly don’t care about what Fauci says. They detest him. They’re mostly Trumpers. This backslapping among the CDC to say ‘hey, look at our process; look at our integrity!’ doesn’t do much for me. It feels more like a rationalization to avoid the fact that this pause on J&J does have an impact.

    One can argue that the pause is justified, but one can’t argue that there isn’t a cost associated with a pause now. It basically kills J&J as a top tier vaccine. Pfizer/Moderna are Tier 1, J&J Tier 2, everything else is Tier 3. You get to your targets faster with a one dose vaccine vs 2 doses and that does mean a saving of actual lives. That’s up in the air now. Perhaps we’ll be bailed out by Trump’s hatred of Pfizer so that the MAGA hordes take J&J to own Fauci and the libs.

    I maintain that it was possible to make a different decision. They could’ve announced publicly that they were investigating this matter of the 6 patients who experienced rising platelet counts and blood clots, convened the meeting scheduled for today, and then decided upon issuing a pause at that time or new guidance for clinicians or some combination of the two. An immediate pause wasn’t necessary, even if scientifically justifiable. It was a choice made because the CDC/FDA had the luxury of 2 other vaccines that are in significant supply and have reported no similar problems. If this were a problem with Pfizer, I don’t think there would be a pause because the cost-benefit analysis would be clearer: 1000 dead per day vs 1 dead per million vaccine recipients (and it’s not yet clear the vaccine caused said death).

  2. On issues like this America’s innumeracy stands out like a turd on a wedding cake - and that includes most pundits, reporters and otherwise seemingly highly educated people. Laws get passed over singular incidents that are almost statistically non-existent, but if it is something we love, like guns or cars, no amount of death and mayhem can even make us slow down.

    Want to talk about dangerous drugs? Let’s talk about Tylenol (acetaminophen) -
    Acetaminophen overdose is the leading cause for calls to Poison Control Centers (>100,000/ year ) and accounts for more than 56,000 emergency room visits, 2,600 hospitalizations, and an estimated 458 deaths due to acute liver failure each year .

  3. The shorter description (although I favor thoroughness) is that the CDC made a PR decision based on faulty reasoning and inconclusive science, but did so to seem proactive and honest. Given the obvious alternative of public notice and continued research, but simultaneously announcing that any complications are so rare and not even definitively caused by or tied to the J&J vaccine, people should take ANY vaccination opportunity since COVID poses 1000s of times higher risk than anything potentially associated with the vaccines.

  4. Statistics are wonderful things that are meaningless to the unlucky individual who makes up that statistic.

    Since vaccines are about individual decisions, it’s important that we not have big question-marks around them or we’ll have folks more concerned about becoming the statistic.

    Think you’re right that, had J&J been the only option, they may have chosen differently.

  5. The discussion around this is honestly quite astonishing.

    All these numbers about how likely the blood clotting is, etc. are all bullshit. Because we dont know! Comparing bullshit numbers to known numbers is pointless. The actual numbers could be well higher, but they could also be much lower. 0, in fact.

    The point is that we went from a 0% known risk, to a possible non zero % known risk. This is not just a quantative “the risk increased by some extremely small percentage” difference. This is a Qualitative difference. There is possible risk now where there was none before. This demands investigation.

    Beyond that, the current vaccines all have emergency approvals. They do not have regular approvals. To not take all risks extremely seriously would be a grave mistake.

    The medical and public health decision cannot be clearer. The pause was absolutely the right thing to do.

    However, the non medical factors are also extremely important. First, we need to look at the overall context of there being a raging pandemic taking a lot of lives. However, we need to add few more pieces of context here:

    1. We have at least 2 other vaccines that are not known to have any issues, and are unlikely to create issues because they are fundamentally less risky designs.
    2. The J&J vaccine output was gonna drop significantly anyways, thanks to the manufacturing SNAFU.
    3. We are very close to herd immunity. We need to err greatly on reaching immunity more slowly to eliminate even the smallest chance of losing our path to herd immunity. And since there are no known such chances, any such issue that may derail herd immunity is an unknown. So all unknowns need to be treated with extreme care.

    Finally, there’s the public relations aspect.

    In an ideal world, these blood clots would never have happened. But given that they did, you can either pause and say we will only proceed once we are absolutely sure we know what the risks are, or you can ignore this, and continue. The first may sound bad, but imagine how much worse it would be if a reporter found that there were non trivial reports that would normally lead to a pause and the CDC and WH suppressed them?

    In terms of public communications, the right thing to do is absolute transparency. Absolute transparency and truth will be the best path forward.

Continue the discussion at forums.talkingpointsmemo.com

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