U.S. Calls for Pause on Johnson & Johnson Vaccine After Clotting Cases

[mountaineer]

Who'd J&J piss off?

Someone check Fauci's bank account.

[mountaineer]

Vaccine Recalled After Two People Who Took It Fell Down A Manhole And Died
April 14th, 2021 - BabylonBee.com
https://babylonbee.com/news/vaccine-recalled-after-two-people-who-took-it-fell-down-a-manhole-and-died

[PeteS in CA]

CDC chief admits they have NO proof J&J vaccine causes blood clots and says they're pausing it mainly to talk to doctors about how to treat the rare condition - as experts call it one big overreaction

https://www.dailymail.co.uk/news/article-9470175/CDC-chief-admits-NO-proof-J-J-vaccine-causes-blood-clots.html

The CDC's Deputy Director has admitted they have no proof Johnson & Johnson's vaccine actually causes rare blood clots and revealed one of the main reasons they've stopped giving it out is to give them time to talk to doctors about how to treat the condition, as some experts called the decision to suspend the shot an 'overreaction' that will stunt the US's COVID-19 recovery. 

The CDC and FDA on Tuesday made a shock announcement that they were recommending a pause in J&J's one-shot vaccine, which seven million people in the US have had and millions more were looking forward to getting.
...
On Wednesday morning, Acting CDC Principal Deputy Director Dr. Anne Schuchat was asked bluntly during an appearance on Good Morning America whether they had proof that the vaccine was causing the clots.

'A key component of why we are on this pause is so that we can educate the clinicians about how to diagnose and treat this condition because the usual treatment could actually make things worse,' she said.

George Stephanopoulos asked: 'Just to be clear, there's no evidence - you haven't established - that there's a link between the vaccine and these blood clotting events, have you?'

She replied: 'No'.

When I scheduled my vax appointment yesterday I started with a site that showed availability from multiple locations - CVS, Safeway, Rite Aid, Walgreens, etc.. The location nearest me had just the J&J vaccines, which would have been OK with me, but I figured it would at least temporarily be suspended and not making appointments. So I kept looking and found a slightly less close location with the Pfizer vax. In a very small way, this suspension affected me, and to read a CDC upper mangler admitting they have established no link between clots and the JNJ vax but are just "educating the clinicians about how to diagnose and treat this condition" leaves me less than thrilled.

The committee that is supposed to review the cases was scheduled to meet today, but I haven't seen any related news reports.

[PeteS in CA]

CDC panel adjourns without vote on extending J&J COVID vaccine pause

https://www.msn.com/en-us/news/us/cdc-panel-adjourns-without-vote-on-extending-j-26j-covid-vaccine-pause/ar-BB1fEPuB

A Centers for Disease Control and Prevention advisory committee did not vote Wednesday on whether to extend the nation's pause on Johnson & Johnson's COVID-19 vaccine, after experts on the panel argued there was still insufficient data to make final recommendations in light of the serious, rare blood clotting events potentially linked to the shots.

While the CDC's current pause on Johnson & Johnson's vaccine is not binding, the warning issued by federal health officials on Tuesday urged that vaccinations be suspended only until the panel voted on "updated recommendations" for using the vaccine. In response to the FDA and CDC advisory on the pause, all states and D.C. and Puerto Rico have opted to temporarily stop administering this vaccine.

  Not deciding is still a decision. In this case the bureaucrats "decided" to keep J&J and businesses holding stocks of J&J vaccine in limbo.

Nice vaccine you got there. It'd be a shame if a committee of bureaucrats made it worthless by not allowing it to be used.

[Gefn]

Bookmark

[libertybele]

CDC chief admits they have NO proof J&J vaccine causes blood clots and says they're pausing it mainly to talk to doctors about how to treat the rare condition - as experts call it one big overreaction

https://www.dailymail.co.uk/news/article-9470175/CDC-chief-admits-NO-proof-J-J-vaccine-causes-blood-clots.html

When I scheduled my vax appointment yesterday I started with a site that showed availability from multiple locations - CVS, Safeway, Rite Aid, Walgreens, etc.. The location nearest me had just the J&J vaccines, which would have been OK with me, but I figured it would at least temporarily be suspended and not making appointments. So I kept looking and found a slightly less close location with the Pfizer vax. In a very small way, this suspension affected me, and to read a CDC upper mangler admitting they have established no link between clots and the JNJ vax but are just "educating the clinicians about how to diagnose and treat this condition" leaves me less than thrilled.

The committee that is supposed to review the cases was scheduled to meet today, but I haven't seen any related news reports.

The CDC is further investigating.

[mountaineer]

Okay, I doubt this guy was taking birth control pills.

Mississippi man partially paralyzed, unable to talk after J&J vaccine
By Jackie Salo
April 15, 2021 | 5:20pm

A Mississippi man who experienced a blood clot after receiving the Johnson & Johnson COVID-19 vaccine, has been left paralyzed on one side of his body and unable to talk, his family said.

Brad Malagarie, 43, of St. Martin, suffered a stroke soon after stepping out last week to get the one-dose shot, news station WLOX reported.

“They called me and said he had that vaccine and something is wrong, we think it’s a stroke,” his aunt, Celeste Foster O’Keefe, told the outlet.

The father of seven was rushed to the hospital, where they determined that he had a stroke as a result of a blood clot in his brain, the outlet reported.

“I said be sure to tell the doctors he took that J & J vaccine and that, to me, is what caused his stroke,” his aunt said.

O’Keefe said he took medication for high blood pressure, but was otherwise a “young, healthy” man.

Now, the medical episode has left him paralyzed on the right side of his body, she said. ...

NY Post


The question is whether his blood pressure problem played a part in this.

[PeteS in CA]

Johnson & Johnson COVID-19 Vaccine Roll-out to Resume in Europe Following European Medicines Agency (EMA) Review

https://www.jnj.com/johnson-johnson-covid-19-vaccine-roll-out-to-resume-in-europe-following-european-medicines-agency-ema-reviewema-confirms-overall-benefit-risk-profile-remains-positive

NEW BRUNSWICK, N.J., April 20, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has provided updated guidance for use of the Company’s COVID-19 vaccine and confirmed the overall benefit-risk profile remains positive. The guidance follows PRAC review of a small number of cases of a very rare adverse event involving blood clots in combination with low platelet counts that can occur within approximately one to three weeks following injection with the Company’s COVID-19 vaccine.

As a result, Johnson & Johnson will update its COVID-19 vaccine Summary of Product Characteristics and Package Leaflet to include important information on the diagnosis and management of this very rare adverse event. Healthcare professionals will be alerted to the signs and symptoms of thromboembolism with thrombocytopenia, as well as the appropriate course of treatment.

Here's the link to the EMA PRAC conclusion, https://www.ema.europa.eu/en/news/covid-19-vaccine-janssen-ema-finds-possible-link-very-rare-cases-unusual-blood-clots-low-blood .

Because its vaccine had not yet been distributed in EuroLand J&J (Janssen Research is a J&J subsidiary) had suspended distribution to allow the EMA to do their evaluation. The decision reflects these types of blood clots in people who had received the J&J vaccine being very rare. The rate of occurrence among vaccine recipients (less than 1 in a million) is similar or lower than the rate of occurrence in the general population. As with the AZ vaccine, the EMA will continue to monitor safety and effectiveness. For the present healthcare providers will be informed about recognition and treatment of this type of blood clot.

The speculation I've seen is that the FDA will approve resumption of J&J usage, probably with similar info being given to healthcare providers. How the FDA handles J&J may be applied to AZ's vaccine, if AZ applies for and receives approval.

Despite the clot rate associated with the vaccine being similar or less than the random population rate, and being a thousand times lower than ordinary clots from birth control medication, this kerfuffle may have severely diminished public acceptance of the J&J vaccine.

[sneakypete]

6  people out of 7 MILLION had negative reactions????

Seems like pretty good odds to me!

BTW,I just got my first Covid vaccination yesterday. So far the only side effect is that I seem to be growing horns.

Then again,being horny at my age ain't such a bad thing if my heart holds out.

[thackney]

6  people out of 7 MILLION had negative reactions????

ON AVERAGE, 274 PEOPLE DIE EVERY DAY FROM BLOOD CLOTS

https://www.stoptheclot.org/blood-clot-information/blood-clots-in-the-united-states/

[PeteS in CA]

CDC committee votes to resume Johnson & Johnson COVID-19 vaccine despite possible blood clot link

https://www.foxnews.com/health/cdc-committee-votes-resume-johnson-johnson-covid-19-vaccine-despite-possible-blood-clot-link

A Centers for Disease Control and Prevention (CDC) advisory committee is recommending that the Johnson & Johnson COVID-19 vaccine resume rollout, but include new language on the product’s emergency use authorization (EUA) warning remote risks of serious blood clots. The Advisory Committee on Immunization Practices held the vote Friday after the FDA and CDC had recommended a pause in the Johnson & Johnson COVID-19 vaccine rollout last week due to several instances of a rare, severe blood clot amid a backdrop of over 7 million recipients.

The vote was 10 to 4.

One committee member abstained.

The recommendation will now go before CDC Director Dr. Rochelle Walensky for approval.

A couple of days ago the EU's similar agency decided to proceed with the J&J vaccine roll-out, https://www.jnj.com/johnson-johnson-covid-19-vaccine-roll-out-to-resume-in-europe-following-european-medicines-agency-ema-reviewema-confirms-overall-benefit-risk-profile-remains-positive .

From https://www.jnj.com/johnson-johnson-single-shot-covid-19-vaccinations-to-resume-in-the-u-s-for-all-adults-aged-18-and-older-following-cdc-and-fda-decision :

NEW BRUNSWICK, N.J., April 23, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced that vaccinations with the Company’s COVID-19 single-shot vaccine will resume for all adults aged 18 years and older in the U.S., under Emergency Use Authorization (EUA), following a decision from the United States Centers for Disease Control (CDC) and Food and Drug Administration (FDA).

The decision was based on a recommendation from the U.S. CDC Advisory Committee on Immunization Practices (ACIP), which followed a rigorous evaluation of data relating to a very rare adverse event involving blood clots in combination with low platelet counts (thrombosis with thrombocytopenia) observed within approximately one to two weeks following vaccination.
...
Johnson & Johnson has updated the EUA Fact Sheets for Healthcare Providers Administering Vaccine (Vaccination Providers), and Recipients and Caregivers for the Company’s COVID-19 vaccine, to include information about the diagnosis and treatment of thrombosis with thrombocytopenia. The revised EUA fact sheets is available at: www.janssencovid19vaccine.com.