US Gets Dose Of Europe’s Vaccine Woes, As J&J Shot Paused

US Gets Dose Of Europe’s Vaccine Woes, As J&J Shot Paused

Risk sentiment took a hit early Tuesday when US health officials called for an immediate halt to Johnson & Johnson’s COVID vaccine, a potential setback for the Biden administration’s speedy effort to inoculate Americans in time to turbocharge a summer economic boom.

The “pause” (as it was billed) came after a half-dozen people who received the single-dose shot developed a blood cot disorder around two weeks after being vaccinated. One person died, and another was hospitalized in critical condition. All of the six recipients were women between 18 and 48.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC said, adding that,

As of April 12, 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the US. CDC and FDA are reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot.

Exceptionally rare though this is, the news certainly won’t do much to embolden anyone reluctant to receive a vaccine or otherwise win over any hearts and minds among those who long ago decided against being vaccinated.

Comparisons to the controversial AstraZeneca vaccine are inevitable and, in the absence of an all-clear from federal agencies, it’s possible the J&J vaccine could suffer the same fate as Astra’s shot — namely, scientists and doctors could begin to debate whether its use should be limited to specific demographics.

Thankfully, most of America’s vaccine supply is comprised of the Pfizer and Moderna shots, neither of which are the subject of any known serious safety issues. Still, as The New York Times wrote Tuesday, “the move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy.” The Biden administration, the Times noted, “had still been counting on using hundreds of thousands of doses every week.”

I’m not a doctor and, unlike so many folks writing daily for public consumption, I’ve never implicitly masqueraded as one over the past year. But, from a common sense perspective, it seems reasonable to suggest that if this type of clot is, as the FDA and CDC called it, “rare” and requires “different” treatment from what would “typically be administered,” doctors probably aren’t prepared for it and will need additional information to ensure they can respond. “Usually… heparin is used to treat blood clots [but] in this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” officials said.

As the Times went on to say Tuesday, “government experts are concerned that an immune system response triggered by the vaccine was the cause.”

This isn’t the first time the issue has come up. A few days ago, European regulators said they were evaluating similar cases. Australia says it won’t buy J&J’s vaccine because it’s based on the same platform as the Astra shot. “[It’s] an adenovirus vaccine,” a spokesman told The Guardian Australia. “The government does not intend to purchase any further adenovirus vaccines at this time.”

The Pfizer-BioNTech and Moderna shots are based on different technology.

“At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine,” J&J said, in a statement.

The FDA went on to reiterate that COVID vaccine safety “is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”

Full FDA statement

SILVER SPRING, Md.April 13, 2021 /PRNewswire/ — The following statement is attributed to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Dr. Anne Schuchat, Principal Deputy Director of the CDC

As of April 12, more than 6.8 million doses of the Johnson & Johnson (Janssen) vaccine have been administered in the U.S. CDC and FDA are reviewing data involving six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine. In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination. Treatment of this specific type of blood clot is different from the treatment that might typically be administered. Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given.

CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance. FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.

Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. People who have received the J&J vaccine who develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider. Health care providers are asked to report adverse events to the Vaccine Adverse Event Reporting System at https://vaers.hhs.gov/reportevent.html.

CDC and FDA will provide additional information and answer questions later today at a media briefing. A recording of that media call will be available on the FDA’s YouTube channel.


 

5 thoughts on “US Gets Dose Of Europe’s Vaccine Woes, As J&J Shot Paused

  1. Don’t think it’s an overstatement to note that this will permamently change the way vaccines are developed in the future. From a purely mercenary/investor perspective, this should be good news for Moderna an BioNTech.

  2. Interesting news for those of us who have already received the J&J vaccine. I got mine 5 days ago and though I am a 59 year old male, I’d be lying if I said this won’t be in the back of my mind for another week or so.

  3. If it starts to look like rare but serious thrombosis is a class effect of viral vector-based vaccines, that would also cast doubt on some of the Chinese vaccines and on Russia’s Sputnik vaccine.

    This would be positive for PFE/BNTX (plan 2.5BN dose capacity by year-end), for MRNA (production capacity only 700MM but trying to expand), and – pending confirmatory US trial data – for NVAX (licensed to Serum India and others, plan production capacity 2.0BN doses by mid-2021).

    Realistically, the US will get all the doses it needs by mid-year (vaccine refusal is the bigger issue). Most of the DM/G7 will secure enough supply by late-year (assuming EU gets its act together and exports from India are permitted). The EM will have to deal with any adverse effects of the AZN and/or JNJ vaccines, or wait until 2022 . . .

    Here’s a scenario not being discussed much: what happens if Covid majorly breaks out in China again?

  4. The rates of clotting disorders are very low for both AZ and J&J, possibly to the point of being similar to background. I suspect the underlying causality will be determined fairly rapidly–the similarity to heparin-induced thrombocytopenia is already noted and being followed. The problem is that our society is not good at digesting scientific discovery reported in real time, and we are utterly incapable of quantitative understanding of risk, or of rational risk-benefit analysis.

    “What happens if COVID breaks out in China again?” There are ongoing outbreaks in various parts of China. China deals with them the same way they dealt with the original outbreak: rigorously enforced lockdowns and triage. I think the bigger question is how the pandemic(s) will evolve over the next year or two. In the US we feel we’re near the end of the pandemic, but in Brazil, India, and elsewhere it’s as bad as it’s ever been. The virus is actively replicating in hundreds of thousands or millions of people at any given time. As the US population approaches 60-70% immunity to the WT/UK/California strains in the late summer (which is my guess for as far a we’ll get with vaccination and/or prior infection in the US), there will be strong selection pressure for SARS-CoV2 to evolve to be able to infect vaccinated or previously-infected people, similar to what happened in Manaus with P1. There is no reason to believe that such vaccine escape won’t happen–after all, we already know that a few simple Spike protein mutations in the B.351 and P1 strains are sufficient to cause diminished efficacy of the current vaccines in lab studies, and apparently also in the real world (though this is still being sorted out). Will we be able to stay a step ahead with updated vaccines? What will the mood be like if all of the people who are currently purchasing airline tickets and lining up to go to Disneyland discover that they are effectively no longer vaccinated? I hope we do stay a step ahead–but I don’t think markets are really pricing in the concept that this vaccination campaign is likely round 1 of many in this fight.

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