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Restrict J&J COVID Vaccine in Women Under 50?

Editor’s be aware: Discover the newest COVID-19 information and steering in Medscape’s Coronavirus Resource Center.

Use of mRNA COVID-19 vaccines ought to be thought-about because the preferable possibility within the US moderately than Johnson & Johnson’s (J&J) Janssen COVID-19 vaccine in ladies below the age of 50 years, in response to one group of consultants.

The group makes their advice in an editorial in JAMA printed on-line April 30, accompanying a paper describing particulars of 12 case studies of cerebral venous sinus thrombosis (CVST) with thrombocytopenia following the J&J COVID-19 vaccine, also referred to as the Advert26.COV2.S vaccine.

The editorialists are Ruth A. Karron, MD, professor of worldwide well being at Johns Hopkins Bloomberg Faculty of Public Well being in Baltimore, Maryland; Nigel S. Key, MD, professor of hematology at College of North Carolina at Chapel Hill; and Joshua M. Sharfstein, MD, affiliate dean for public well being follow at Johns Hopkins Bloomberg Faculty of Public Well being.

They be aware that after an preliminary pause following studies of thrombosis with thrombocytopenia syndrome (TTS) linked to the J&J vaccine, and on the advice of the Advisory Committee on Immunization Practices, the US has permitted the usage of the J&J vaccine in all adults with data on the danger of TTS added to instructional supplies.

The editorialists level out that no instances of TTS have been confirmed following administration of greater than 180 million doses of the mRNA vaccines within the US.

They are saying that whereas the J&J vaccine will nonetheless be wanted for people with allergy symptoms to elements of the mRNA vaccines and for individuals who stay in distant areas the place the chilly chain for transport and storage of mRNA vaccines can’t be maintained, “US public well being companies and clinicians ought to take into account recommending mRNA vaccines as safer choices for individuals who could also be at considerably increased threat for TTS after Advert26.COV2.S vaccination, at present ladies youthful than 50 years.”

In the principle JAMA paper, a bunch led by Isaac See, MD, Facilities for Illness Management and Prevention (CDC) COVID-19 Response Group, report full particulars of 12 instances of CVST with thrombocytopenia following the J&J COVID-19 vaccine reported to the US Vaccine Adversarial Occasion Reporting System (VAERS).

The 12 US case studies, three of which have been deadly, present many similarities to instances described in Europe after the AstraZeneca vaccine.

The authors be aware that by April 12, roughly 7 million doses of the J&J vaccine had been given within the US. The 12 instances of CVST and thrombocytopenia following receipt of the vaccine have been reported to VAERS between March 2 and April 21. All 12 instances have been in white ladies, 11 of whom have been below 50 years of age.

As of April 25, an additional two instances have been confirmed and reported to VAERS; one in a person youthful than 40 years, the opposite in a girl aged between 40 and 59 years.

Within the 12 instances reported intimately, signs began between 6 and 15 days publish vaccination.

Not less than 1 threat issue for CVST was recognized in 7 sufferers (weight problems in 6, hypothyroidism in 1, and use of mixed oral contraceptives in 1). Not one of the sufferers was pregnant or inside 12 weeks postpartum, had prior thrombosis, a private or household historical past of thrombophilia, or documented prior publicity to heparin.

Along with CVST, seven sufferers had intracerebral hemorrhage and eight had non-CVST thromboses.

One affected person reported a historical past of SARS-CoV-2 an infection roughly four months previous to vaccination. Of the opposite 11 sufferers, 4 had damaging serologic checks and 7 weren’t examined.

All 12 sufferers have been hospitalized and 10 have been admitted to an intensive care unit (ICU). On the time of the final follow-up, three sufferers had died (all of whom had intraparenchymal hemorrhage), three remained within the ICU, two have been nonetheless hospitalized however not in an ICU, and 4 had been discharged dwelling.

The authors level out that the US instances of CVST with thrombocytopenia following the J&J vaccine have many similarities to these reported in Europe after the AstraZeneca vaccine, occurring primarily in ladies youthful than 40 years and in sufferers with out identified thrombophilia. Each European and US sufferers had a median platelet nadir depend of 19×103/µL and several other additionally had non-CVST large-vessel thrombosis.

Within the European instances of CVST with thrombocytopenia, 50% of sufferers died, in contrast with 25% of US sufferers.

Just like the European instances, the US instances had constructive heparin-PF4 HIT antibody ELISA checks within the absence of prior publicity to heparin, as could be seen in autoimmune HIT.

Nevertheless, within the preliminary European CVST studies, 88% of sufferers examined with useful platelet HIT antibody checks had constructive outcomes, in contrast with solely 11% of the US instances. However the authors be aware that lack of standardization in useful platelet HIT antibody assays might result in variations in outcomes by completely different laboratories.

“It could be essential to inform testing laboratories that post-vaccination TTS is being evaluated, in order that testing strategies might be adjusted if wanted,” they are saying.

They conclude that these case studies counsel that the pathogenesis of TTS could also be just like autoimmune HIT, triggered by the formation of antibodies directed in opposition to PF4, a constituent of platelet alpha granules launched throughout platelet activation. In distinction to traditional HIT during which exogenous heparin triggers antibody formation, in autoimmune HIT, an endogenous polyanion triggers PF4 antibody formation.

They be aware that the exact mechanism of TTS in relation to COVID-19 vaccination has not but been established. The International Advisory Committee on Vaccine Security has said {that a} platform-specific mechanism associated to adenovirus vector vaccines can’t be excluded. Each the J&J and AstraZeneca vaccines use an adenoviral vector, however they’re completely different; J&J makes use of a human vector, whereas AstraZeneca makes use of a chimpanzee vector.

In addition they level out that CVST and thrombocytopenia following SARS-CoV-2 an infection has been reported in no less than two instances, however HIT testing was not carried out in these instances. There haven’t thus far been any studies to VAERS of CVST with thrombocytopenia following mRNA COVID-19 vaccines.

The authors say these findings have essential medical and public well being implications, noting that the CDC has up to date its interim medical issues to be used of approved COVID-19 vaccines to point that ladies aged 18 to 49 years ought to concentrate on the elevated threat of TTS after receipt of the J&J vaccine, and to make use of a nonheparin anticoagulant in suspected instances.

They be aware {that a} subacute presentation of headache is current in 90% of sufferers with typical CVST. Whereas headache is a standard symptom after the J&J vaccination, most complications start and resolve inside two days. Whereas within the US instances of CVST after vaccination, headache signs started no less than six days after vaccination and continued for no less than per week for many.

“Pressing session with a neurologist is prudent when a affected person is suspected or confirmed to have CVST. As well as, because the median time from symptom onset to hospitalization was seven days within the US CVST case collection, affected person and clinician schooling would possibly shorten the time to medical analysis and subsequently therapy,” they state.

The authors additionally be aware that VAERS is a passive surveillance system, so instances of CVST with thrombocytopenia could also be underreported.

Of their accompanying editorial, Karron et al level out that along with the 12 sufferers with CVST with thrombocytopenia described on this case collection, no less than three sufferers with out CVST however assembly diagnostic standards for TTS have been reported to VAERS (as of April 21), all in ladies aged 18 to 59 years (median age, 37 years).

The editorialists report that the speed of CVST with thrombocytopenia after the J&J vaccine is roughly 5 per million ladies aged 18 to 50 years. That is in contrast with a background fee of roughly 0.05 to 0.13 per million per 30 days.

They are saying that the supply of an interim standardized case definition of this adversarial impact will facilitate potential case ascertainment by assessment of enormous linked databases and energetic case discovering.

This may also allow larger understanding of whether or not people who’re in any other case at elevated threat for hypercoagulation typically and for CVST specifically (for instance, ladies taking hormonal contraceptive medicines or who’re pregnant) are additionally at elevated threat for TTS.

Acquiring this data will help dynamic country-specific assessments of the dangers of every vaccine in contrast with the danger of COVID-19 illness for his or her populations and subpopulations, they add.

JAMA. Revealed on-line April 30, 2021. Full text, Editorial

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