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A Recap of Johnson & Johnson’s COVID-19 Vaccine Craze Why its Pause was Necessary in the United States | Masatami Cauller
A Recap of Johnson & Johnson’s COVID-19 Vaccine Craze: Why its Pause was Necessary in the United States
By Masatami Cauller
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On Tuesday April 13th, 2021, the US rollout of Johnson & Johnson’s single-shot Covid-19 vaccine was paused afterreportsofarareblood-clottingsideeffectwerelinkedtotheshot.TheCDC(CenterforDiseaseControl) and the FDA (Food and Drug Administration) came together to formally recommend a pause in J&J covid vaccine distribution after a total of six cases of the blood-clot side effectwere reported.With over seven million Americans already given the shot at the time of its pausing, six total cases of blood clots were reported all in women ages 18-48, between six to thirteen days after receiving the initial shot. Scientifically, this reaction is called cerebral venous sinus thrombosis (CVST), where blood clots flowing in and out the brain can cause serious bodily damage and in some cases, even death. Dr. Anthony Fauci--head of the National Institute of Allergy and Infectious Diseases--supported the FDA’s and CDC’s decision, stating that they were utilizing “an abundance of caution” and emphasized the temporary state of the vaccine’s pausing.
What is CVST and Why Has it Become Apparent in the J&J Covid Vaccine?
CVSTisanextremelyrareformofastroke,whichblocksbloodfromleavingthebrain.Itaffectsonlyfivepeople in a million, and symptoms include blurred vision, headaches, seizures, and potentially death. The reason why CVST resulted from the vaccine is because of thrombocytopenia, a medical condition where blood cells that help form blood clots (called platelets) become reduced to increasingly low levels, causing uncontrollable bleeding. The six patients experiencing CVST from the vaccine were previously diagnosed with thrombocytopenia, which created an adverse reaction to the vaccine’s antibodies. Normally, white blood cells target any antibodies deemed dangerous to the body by bindingwiththem,butinthecaseofthosewiththrombocytopenia,theirwhitebloodcellsbindwithdifferentproteins triggering their blood cells to develop clots. These clots are both unnecessary and dangerous for the body to make and with a vast amount of clots spreading throughout the body and having no way of stopping them, CVST symptoms developastheseclotsareleavingthebrain.Inaddition,individualssufferingfromeitherCVSTorthrombocytopenia take blood thinners as treatments for these clots, but medical research states otherwise: in this case, such medication could make the situation worse. This lack of treatment supports the CDC’s and FDA’s decision to pause the shot, wanting to gain more information about the situation at hand.
The FDA’s, ACIP’s, and CDC’s Decision to Reinstate the Vaccine:
ASIAN OUTLOOK4
Afterinitiallyendorsingthepausingof J&JCovid-19vaccinesonTuesdayApril13th,2021,groupsof theFDA,CDC, and ACIP met twice on April 14th, 2021 and April 23rd, 2021 to discuss the state of the vaccine and potential solutions forbringingitback.Onthenightof the23rd,federalhealthofficialsrepresentingthesegroupsdecidedina10-4vote toliftthepauseof thevaccine,statingthebenefitsof theshottofaroutweighanyrisksof araretypeof bloodclot.In anefforttocircumventadditionalCVSTcasesandgeneralanxietyaboutthevaccine,theFDAandJohnson&Johnson have now updated the vaccine’s label to strictly specify a warning about developing blood clots like CVST. Acting FDA commissioner Janet Woodcock had this to say about the 10-4 decision: “We have concluded that the known and potential benefitsofthe[Johnson&Johnson]Covid-19vaccineoutweighitsknownandpotentialrisks.Thisisnotadecisionthe agenciesreachedlightlyandwe’reconfidentthatthevaccinemeetsourrobuststandardsforsafety,effectivenessand quality.”Overall,thisdecisionallowsstateandfederalofficialstoonceagainresumegivingthevaccine,andprocedures will include giving fact sheets and additional communication materials about the shot’s potential symptoms and health-careprovideradvice.Byaddressingsuchcomplicationsandspecificallyidentifyinggroupsathigherriskfor developing serious blood clots, Americans can safely resume the J&J vaccination process. Ultimately, having a third vaccinebackintheU.S.canhelpvaccinationgapsinthegoalof reachingherdimmunity,specificallybecausetheJ&J vaccine only requires one dose.
Why Getting Vaccinated is Important, Even With Risks of Getting CVST:
While complications from CVST related symptoms are serious, it’s clear how extremely rare developing CVST from the vaccine is. As of March 3, 2021, eight million J&J shots have been administered in the United States and onlyfifteencasesof thishaveoccurred.Inaddition,doctorsacrossAmericacontinuetopraisetheJ&Jvaccine evenwithsuchsideeffects,suchasthetestimonyof RobertBrodsky,directorof HematologyatJohnsHopkins University.Hestatesthat,“Thebenefitsof thevaccinefaroutweightherisk,atleastintheolderpopulation”, andfirmlybelievesthattheriskofdevelopingbloodclotsfromexperiencingCOVID-19ismuchhigherthanthe likelihoodof developingclotsfromgettingvaccinated.“It’saveryeffectivevaccine,”hereiterates.Inaddition, AMAChief HealthandScienceOfficerMiraIrons(MD)andAMA’sliaisonfortheCDCSandraFryhofer(MD) alsohighlyendorsedthevaccine’scapabilities,highlightingitseffectiverateinpreventingsevereCOVID-19 symptoms, in particular emphasizing how the J&J vaccine prevents hospitalization and serious breathing issues. Dr. Fauci states that for people who already received the vaccine over a month ago, they are safe from developing any CVST related symptoms to the vaccine. But if people have had the shot administered to them recently and begintoexperienceCVSTrelatedsymptoms—specificallysevereheadaches—theymustalertandgetintouch withtheirdoctorimmediately.ForthoseconfusedaboutthetimelineforexperiencingCVSTaftertheshot,Fauci explains, “If you look at the time frame where this occurs, it’s pretty tight, from six to thirteen days from the time of the vaccination.” Overall, individuals who got or want to get vaccinated with J&J’s single shot should not be worried,ashavingtopubliclyanalyzeandexplainuncommonsideeffectswithvaccineswasforeseeable.J&J’s Covid-19 vaccine was tested initially within smaller demographics in clinical trials, and its results were shown to besafewithmildtomoderatesideeffectsandan85%effectivenessrate.Butwhenavaccineelevatesfrombeing tested in thousands of hand-picked trial participants to millions of everyday people in the US, rare vaccine complicationslikeCVSTemerge.Overall,Americansshouldremainconfidentinthevaccineandcontinueto get the shot.
The Trust of US Residents Towards the J&J Covid Vaccine:
The main issue about the pause of the Johnson & Johnson COVID-19 vaccine was how it could potentially decrease public trust in vaccines, highlighted by the Biden administration. In an efforttocombatanti-vaccinegroupsandsentiment, PresidentBidenendorsedthesafetyandeffectiveness ofotherCOVID-19vaccinations(ModernaandPfizer), aswellasreiteratingtheeffectivenessof theJ&Jshot andtheampleamountofworkfederalhealthofficials had conducted to reinstate the J&J shot. A September 7th, 2021 poll of 600 adults administered by Echelon Insights found that 58% of respondents were more confident in Covid-19 vaccines after the pause, whereas23%of respondentswerelessconfidentand 20% remained unsure. By majority rule, it seems most Americans were not troubled by the vaccine’s pause. With the established success of both Pfizer and Moderna COVID-19 vaccines as well as the newly reinstated J&J single shot vaccine, the end goal of herd immunity looms closer and closer.
