3. Whatisavaccine?
⢠Vaccines help thebodyâs immunesystemrecognize and respond to severe diseases
⢠Todo this,a vaccinemusttriggeran immuneresponse,usuallythroughtheuseofan
invaderâs(virus,bacteria,pathogen)surfaceproteins,weakenedorkilledvariantsofan
invader,ora byproductofa disease
⢠Whena vaccinatedindividualis exposedtothedisease,thebodycanmorereadilyand
quicklyrespondand neutralizethedisease
⢠Vaccines can prevent and/orreducethe severity of diseasesand areone public
healthâs most effectivediseaseprevention methods
4. ThepushforCOVID-19vaccines
⢠Given the benefitsof vaccines, global effortsfor a vaccine for COVID-19have been
massive
⢠Vaccines could not only protect individuals,but if large enoughpopulations
received them, a COVID-19vaccine could protect thosewho were ineligibleto
receive a vaccine throughherd immunity
5. ThepushforCOVID-19vaccines
⢠However:
⢠Vaccinesneedtoshowefficacy and effectivenessduringtesting;in otherwords,
COVID-19vaccinesneedtoprovethemselveseffectiveatpreventingCOVID-19
infections
⢠Vaccine Efficacy: How good avaccineisat preventing a diseasein a controlled experiment.
⢠Vaccine Effectiveness: Howgood a vaccineisat preventinga diseaseamong thegeneral
population
⢠Vaccinetestingmustbe thoroughand transparenttoensuretheriskofreceivinga
vaccinedoesnotputindividualsatunnecessaryrisk
⢠Vaccinesneedhighuptaketobeeffective;ifnobodyagreestoreceivea vaccine,itis
useless
6. Whatdoesvaccinedevelopmentnormallylooklike?
⢠Vaccine development is very similar to thedevelopment of pharmaceuticals
⢠Extensivetestingis completed throughmultiplephasesto determineefficacy(how
well the vaccine protects againstdisease)and safety (whether the benefitsof the
vaccine outweightheir potential side effects)
⢠Normally,a vaccine can take 10-15yearsto develop.
7. Pre-humanstagesofvaccinedevelopment
⢠Exploratory Stage: during thisphase,all testing is done in labs; intention is to find
antigensthat could prevent/treat disease
⢠Pre-clinicalstage: Candidate vaccines from the exploratory stageusedon animal
subjects to assessresponse;idea is to get a good picture of how living thingswill
react to the vaccine
⢠Assuming candidate vaccine makesit throughthe pre-clinical stage, the company
mustapply for an InvestigationalNew Drug (IND)application to the FDA; approval
allows clinical trials in human subjects
8. ClinicalTrials
⢠Phase I: Very few human subjectsare given the candidate vaccine, with an
emphasison determiningsafety
⢠Phase II: At thisstage, more subjectsare broughtin to test the vaccineâs safety and
immunogenicity (ability to trigger an immuneresponseâ good!); may also look at
potential schedules,dosing, and delivery methods
⢠Phase III: Generally, the finalstage of a vaccine trial; involve thousandsof
individualsand assessessafety and efficacy
⢠If vaccines can makeit throughPhaseIIItrials, developers get to apply for approval
and licensurethroughtheFDA; if approved can distributevaccine to general
population
⢠Among all drug trials that make it to PhaseI, less than 10% areapproved.
9. WhathappensonceaCOVID-19vaccineisdeveloped?
⢠Production, distribution,and storageare key.
⢠Manufacturersmustbereadytodevelopthevaccines
⢠Facilitiesmusthavethemeanstostoringthevaccines
⢠Vaccines would likely not be distributed to the general public untilseveralmonths
after development
⢠High riskindividuals(i.e.healthcare,incarcerated,olderadults)wouldbeprioritized
becausevaccinationsinthesepopulationswouldofferthehighestbenefit
⢠Even if logistic challengesare handled, individualscan opt out of receiving the
vaccine
⢠Herd immunityis onlypossibleif a largeportion of thepopulation is vaccinated!
11. Vaccineefficacyandherdimmunity
What do we know from other vaccines?
⢠The measlesvaccine is 98%effective. And in order to achieve herd immunity,
approximately a +70%vaccination rate is needed.
⢠The seasonalflu vaccine efficacy varies between 40-60%.
What about for COVID-19?
⢠The number of people who would need to be immunized depends on the efficacy of
the vaccine in the general populationand among particular sectors
⢠Willthevaccinebeas effectivefortheveryyoungand old
⢠Willconditionslikeobesityeffectefficacity
12. At this point in time, less than 16 million people would be immune due to infection. We would still
need to wait until 211.5 million more people become immune through infection or vaccination to
reach herd immunity
Out of the ~325 million people that live in the US, it is estimated that 70% will need to either be immune to
COVID-19 (either through infection or vaccination) to achieve herd immunity
14. WhatmakesCOVID-19vaccinesdifferent?
⢠Vaccine sponsors areattempting to safelycondense the usual vaccine
developmentprocess (10-15years)into 1-2 years
⢠PhasesII and III clinicaltrials(whichnormallytakeplaceseparately)now overlap
⢠COVID-19vaccine development is being fast-tracked via OperationWarpSpeed
(OWS)
⢠Huge amountsofresourcesfromthefederalgovernment(CDC,NationalInstitutesof
Health,BiomedicalAdvancedResearchand DevelopmentAuthority,and Department
ofDefense)havebeenfunneledtopharmaceuticalcompaniesand researcherslooking
tocreatea safeand effectiveCOVID-19vaccine
15. IsOperationWarpSpeed(OWS)safe?
⢠The shortanswer: Yes!
⢠This sped-up development process presents a financial risk to pharmaceutical
companies rather than a decrease in safety of thevaccine.
⢠Mostcandidatedrugs and vaccinesareeliminatedthroughthemulti-phasal
developmentprocess
⢠Thefurther a vaccinemakes itthrough themultiphaseprocess,themore expensiveit
becomestodevelopand testit
⢠E.g.Stoppinga vaccinecandidateat PhaseIclinicaltrialssaveshugeamounts of money
compared tostopping a vaccineat PhaseIII
⢠BecauseinOWS thesephases overlap,an ineffectivevaccinemightbestoppedatPhase
IIIwhenundernormalcircumstances,itmightbestoppedin PhaseI/II
⢠Long-term safety of the vaccine will be continually assessedover time (PhaseIV
clinical trials)
17. WhattypesofCOVID-19vaccinesarebeingdevelopedand
tested?
⢠Inactivatedvaccines:inactivatedvaccinesarea commonmethodfordesigning/creatinga
vaccine.Thisinvolvesutilizingan inactive(killed)variantofthediseaseofinterestand using
thesimilaritiesbetweenthedead formand ârealâformtostimulatean immuneresponse.
Commonexamplesincludeinfluenzaand poliovaccines.
⢠e.g. VaccinebeingdevelopedbySinovac
⢠Protein-basedvaccines:thesevaccinesaredesignedbasedonthesurfaceproteinsthat
areontheCOVID-19virus;theseproteinsaregenerallyhowthevirusesarerecognized.
⢠E.g. Vaccinebeingdeveloped byCanSino Biologics
⢠Viral-vectorvaccines:thesearenon-replicatingvirusesthatprovideinstructionsin the
formofviralDNA toutilizeyourbodyâscellstoproduceCOVID-19proteins.Theseproteins
theninducean immuneresponse
⢠E.g. VaccinesbeingdevelopedbyUniversityof Oxford and Johnson & Johnson
⢠Gene-basedvaccines:thesearesimilartoviral-vectorvaccines,butprovidethe
instructionsina differentform(mRNAinsteadofviral DNA)
⢠E.g. Vaccinesbeingdevelopby BioNTech/Pfizerand Moderna
18. Gene-basedvaccineswerethefirsttwotoseekFDA
approval
⢠Gene-basedvaccines carry genetic instructionsto our cells to produce an antigen
that is used to initiatean immuneresponse, justas it would in an actual infection.
⢠Inthecaseofcoronaviruses,theantigenofinterestis thesurfacespikeproteinthevirus
uses tobindand fusewithhuman cells.
⢠Ratherthantheproteinbeingsuppliedbythevirus itself, thegeneticmaterialinstructs
ourcellstomakethespikeproteinnecessaryforan antibodyresponse
⢠The approach taken is similar to that usedin live-attenuatedvaccines for diseases
like measles,mumps, and rubella
⢠Weakenedvirusesincorporatetheirgeneticinstructionsintohostcells,causingthe
bodyto produceviral copiesthatelicitan effectiveantibodyresponse(B-and T-cell
responses)
⢠In thecaseofmRNA vaccinesâscientistsinsertgeneticinstructionsfromthepathogen
ofinteresttoproduceantigensin hostcellsinsteadofutilizinga virus
19. Somecautioushope
⢠TheFDA had previouslyindicatedthatitwouldbewillingtoapprovea vaccineforusethat
was just50%effective
⢠On November 9th, Pfizer announced theirvaccinewas up to94.5%effective inpreventing
COVID-19.
⢠On November 15th, Moderna announced a vaccinethatis95%effective
⢠Bothofthesevaccinesrankrelativelyhigh ineffectivenesscomparedtootherwidelyused
vaccines.Forexample:
⢠1 doseof themeaslesvaccineis93% effective.2 doses(recommended)increasesthe
effectivenessto97%
⢠For theSeasonal Flu vaccine,theeffectivenessusually variesbecauseof thedifferencesinstrains
thatarebeingtransmittedeachyear,buttheyhaveranged between10-60% effective2004-2019
⢠Mostseasonalfluvaccinesare40-60%effectivethough.
⢠Thereare stillquestionsabout thesevaccines thatneedtobe exploredand
researched!
20. Pfizer'sandModernaâsgene-basedvaccines
⢠Bothvaccinesdelivera moleculeknownas messengerRNA, ormRNA.WhilemRNA-based
vaccinesseemlikenoveltechniques,theresearchtodevelopmRNA vaccinesbeganmany
years beforethecurrentpandemic
⢠Currently,no other vaccinesutilizemRNA
⢠Pfizer'sand Moderna'svaccineshavesimilarresults (>90%effectivenessinpreventing
symptoms)and usethesame techniquetoactivatethebody'simmunesystem.
⢠Thenearly identicaleffectivenessof thevaccinesfrom Pfizer and Moderna validatestheuseof
mRNA as avaccination technique.
⢠Bothvaccinesare givenintwo doseswith3-4 weeksbetweeneachdose.
⢠Thevaccineshavebeengenerallywelltoleratedwithfewsideeffectsamongthosewho
havealreadyreceivedthem
⢠Sideeffectsreportedthusfar aremild and short livedâ similartoother seasonal flu vaccines
21. DetailsaboutPfizerâsstudy
â˘
ThePfizer trialinvolvedmorethan43,000participants(witha 1:1randomizationtovaccine
orplacebo)and a totalof170confirmedcases ofCOVID-19wereevaluated,with162
observedintheplacebogroup versuseightin thevaccinegroup
⢠Thetrial isongoing, and recruitmentisnow including a more diversepopulation intermsof age
⢠AmongUS participantsin thetrial, themajoritywerewhite:
⢠5.5% Asian
⢠10.1% Black
⢠13.1% Hispanic/Latinx
⢠1.0% NativeAmerican
⢠Whatdoes94.5%effectivemean?
⢠Thismeans thatthosethatreceived thevaccine were 94.5%less likely toexhibitsymptoms
⢠ItdoesNOTmeanthatthevaccinereducestransmissibility
⢠Otherdetailsregardinghavenotbeenreleasedyet,butpublicationswillberollingoutsoon
24. FivequestionsaboutthePfizervaccine
5. Could a prematureannouncement hurt future vaccines? The Pfizer vaccine
may not be the bestfor all age groups.But if the FDA approves it quickly, that
may makeit harder for manufacturersof other vaccines to recruit participants
for clinical trials.
⢠People may decline outofconcerntheycouldgeta placeboornot beabletotakean
existingvaccinethatmay provepartially,ifnotwhollyeffective.
25. TheModernavaccine
⢠In Moderna's trial of 30,000participants, half of study participants (15,000)were
given a placebo whereasthe other half were given the vaccine.
⢠Overseveralmonths,90ofthosewhoreceiveda placebodevelopedCOVID-19,with11
developingsevereformsofthedisease.
⢠OnlyfiveparticipantswhoreceivedthevaccinedevelopedCOVID-19
⢠Modernaâs vaccineappearsto have also been protective in important subsets
of participants â the elderly and people from racial and ethnic minority
groups:
⢠The30,000-persontrialincluded11,000participantsfromcommunitiesofcolor,making
up 37%ofthetotalstudypopulation.
⢠Italsoincludedmorethan7,000participantsovertheage of65and >5,000people
youngerthan65whohavechronichealthconditionsthatputthemathigh riskof
sufferingfroma severeinfection( e.g., diabetes,severeobesityand heartdisease).
26. WhatwedonotknowaboutthePfizer/Modernavaccines
⢠For both vaccines, we do not yet know how effective the vaccine is in the long-
term⌠we will not know how long the immunity offeredby either of thesevaccines
last untilthey begin to wear off.
⢠Thishasimplicationsfor:
⢠Howfrequentlypeoplemight havetogetboostersshotstomaintainimmunity
⢠Theongoingrisk oftransmissionofSARS-CoV-2
⢠Itisnot yetknown whetherthevaccinejust preventspeoplefrom becoming severelyill,or if
itpreventsthemfrom spreading thevirus
27. Modernaâs vaccinehasapracticaladvantageoverPfizer's
⢠Pfizer's vaccine needs to be kept at -75° Celsius.
⢠Moderna's vaccine can be kept at -20° Celsius.
⢠Othervaccines,such as theoneagainstchickenpox,needtobekeptat that
temperature.
⢠Most doctors' offices and pharmacieshave freezers that are able to maintain the
-20° Celsiustemperatureneeded to storeModernaâs vaccine
⢠Furthermore,Moderna's vaccine can stored for up to 30 days in the refrigerator,
whereasPfizer's vaccine can last only five days in the refrigerator.
28. ⢠Currently, we donât know the extent to which thesevaccines will prevent
asymptomaticinfection. But we do know that becausethey reduce symptomatic
infection, they shouldalso reduce deaths, hospitalizations, and intubationsin those
who becomeinfected.
⢠The trials were conducted with symptomaticendpoints, rather than testing
everyone every day or every few days to look for infection, to save resources(let's
say 30,000participants, tested every threedays over a courseof two months- thatâs
600,000PCR teststhat need to be run).
⢠The hope is that once approved and with widespread use, we will see
epidemiologic evidence to showreduction in transmission as well as reduction in
symptomatic disease.
WillthePfizerandModernavaccinesprevent
transmission?Wewillhavetowaittofindout
31. ⢠ModifiedAdenovirusesdo not causeillness and are effective carriers of antigens
for infectiousdiseases
⢠Adenoviralvectorsactas vaccinecarrierswhenarmed withforeigngenesand canelicit
specificantibodyand T-cellresponses.
⢠Adenovirus-basedvaccines generally havefew side-effects,likeother vaccines.
⢠These types of vaccinesareused against a wide varietyof pathogen
including Mycobacterium tuberculosis,human immunodeficiency virus(HIV),
and Plasmodiumfalciparum.
WhatareAdenoviruses?
32. TheOxford-AstraZenecavaccine
⢠The resultsreported on November 23rd fromOxford-AstraZeneca come from their
PhaseIIItrials involving 23,000participants in Britain and Brazil.
⢠The Oxford-AstraZeneca vaccine usesan adenovirus(a weakened versionof a
common cold virus)with genetic material for the characteristic spikeprotein of the
coronavirusthat causesCOVID-19.
⢠Like the other vaccines discussed thusfar, the spikeprotein from the vaccine
primes the immunesystemto attack the coronavirusif it later infects the body.
⢠Theweakenedversionofthevirusused in thevaccinehas beengeneticallychangedso
thatthevirus is unabletoreplicateorcauseillnessin humans.
33. TheOxford-AstraZenecavaccine
⢠A half-doseof the vaccine followed by a fulldose at least one monthlater was found
to be 90%effective.
⢠A secondregimenusingtwofulldosesonemonthapartwas 62%effective.
⢠Thecombinedresultsshowedan averageefficacyrateof70%.
⢠Questionshavebeenraisedaboutthehalfdoseregimewhichwasnotintentionaland
turnedouttobeserendipity
⢠However, the extent to which the vaccine inducesstrong antibody and T cell
immuneresponsesamong elderly populationshasyet to be determined because
the half dose-fulldose regimen was not tested in older participants.
34. ⢠Adenoviralvaccines can be stored in standard refrigerators,rather than needing
freezers.
⢠TheAstraZeneca-Oxfordvaccinecan betransportedunderânormalrefrigerated
conditionsâof36°Fto46°F
⢠The Oxford-AstraZeneca vaccine is cheaper than the Pfizer and Moderna vaccines
as well.
⢠AstraZeneca,whichhaspledgednottomake aprofitonthevaccineduringthepandemic,
has reachedagreementswithgovernmentsand internationalhealthorganizationsthat
putitspriceatabout$2.50a dose.
⢠Pfizerâsvaccinecostsaround$20a dosewhileModernaâsvaccinecostsbetween$15to
$25a dosebasedontheagreementsbetweenthecompaniesand theU.S. government
Advantagesofadenovirusvaccines
35. LikelyvaccinerolloutaccordingtoDrFauci
⢠Several vaccine candidates are in late-stageclinical trials in theU.S. and safety and
efficacy data could be ready for review by the end of the year.
⢠That would make initial dosesof the vaccine available to frontlineworkers around
the end of 2020and beginningof 2021and pave theway for widespread
distribution several monthsinto 2021.
⢠Mitigation strategies such as wearing facemasks, social distancing and
avoiding largecrowds will still be important in preventing the spreadof
infection for âquite some time.â
37. WhatisthecurrentstatusofCOVID-19vaccinesfor
children?
⢠Childrenâsimmunesystems differfromadolescents.
⢠Therearecertainvaccinesthatwork betterinchildrenthanadults. And thereare certain
vaccinesthatwork lesswellinchildrencompared toadults.
⢠So far,PfizerâsCOVID-19vaccinehas onlybeenfullytestedonadults.
⢠In September,Pfizer beganincluding teenagersas young as 16 inan ongoing trial,and last
month theybegana new trialincludingchildrenas young as 12. Buttheseresultshaveyettobe
shared.
⢠Children(age18and under)accountfor1/5ofthepopulationoftheU.S. (~73million
individuals).Additionally,3.7millioninfantsareborneachyear.Thispoolofunvaccinated
peoplewouldstillbeatriskforCOVID-19diseaseand couldcontributetoitstransmissionis
significantand herdimmunitycannotbeestablishedwithoutvaccinatingthem.
40. Whatfactorsleadtovaccinehesitancy
⢠Trustand safety are the two major issuesgiven the amountof mis-and
disinformationcirculating in our highly networked society
Trust
⢠Distrust in the motives of vaccine
manufacturers
⢠Distrust in the federal agencies responsible
for regulating the vaccine industry and the
fast-track warp speed imperative of the
government
⢠Distrust in public health experts promoting
vaccination
⢠Other vaccines that have been controversial
and promoted by the same public health
stakeholders
Safety
⢠Short-term and long-term side effects
⢠How long will it take to know if there are
side effects
⢠Safety concerns for the very young and old
⢠Differences in opinion about the relative
effectiveness of â naturalâ vs vaccine
acquired immunity and disease â
resistanceâ
41. Vaccineskepticismandsuspicionaremajorchallenges in
reachingherdimmunity
⢠The ability to reach 70-80%herd immunity to control COVID-19is underminedby
both:
⢠Skepticismaboutmedicalauthorityand expertise.Thishas beenmorecommon
amongTrumpsupporterseventhoughthepresidenthas beenpromotingvaccinesas
thesooncomingmagic bullet.Thisis paradoxical.
⢠Suspicion thattheadministrationis cuttingcornersonsafetytorush thrua vaccinefor
politicalreasons(morecommonamongDemocrats).
46. ⢠The study included 13,426randomly selected individualsacross 19 countries, most
with a highCOVID-19burden.
⢠Surveyrespondentsrepresenteda randomsampleofthepopulationsof19countries
thatcomprisearound55%oftheglobalpopulation.
⢠Of these, 71.5%responded that they would take a vaccine if it were proven safeand
effective, and 61.4%said that they would get vaccinated if their employer
recommended it
Resultsofalargeinternationalstudyofpotential
acceptanceofaCOVID-19vaccine
47. ⢠However, therewas a highof heterogeneity in responsesbetween countries,which
could be related to trustin oneâsgovernment
⢠Countrieswhereacceptanceexceeded80%tendedtobeAsian nationswithstrong
trustin centralgovernments(China,SouthKoreaand Singapore)
⢠RespondentsfromPolandreportedthehighestproportionofnegativeresponses:
27.3%
⢠Russianrespondentsgavethelowestproportionofpositiveresponses:54.9%.
⢠Untiltheoriginsofwidevariationinwillingnesstoaccepta COVID-19vaccineare
addressed,differencesinvaccinecoveragebetweencountriescoulddelayglobal
controlofthe pandemic
⢠Note: Reporting oneâs willingness to get vaccinatedmight not be necessarilya
good predictor of acceptance,as vaccinedecisions aremultifactorial and can
change overtime.
Resultsofalargeinternationalstudyofpotential
acceptanceofaCOVID-19vaccine
54. Newsweeksurvey,June2020
HowmanyAmericanswouldbewillingtotakeaCOVID-19vaccine?
⢠30%of respondentsagreed with the conspiratorialsentimentthat âthe dangers of
vaccines are being hidden by the medical establishment.â
⢠Agreementwiththestatementvariedbyraceand ethnicity:25%ofwhitepeopleagreed
comparedwith29%ofLatinosand 49%ofBlackpeople.
⢠25%ofrespondentsagreedwiththestatementâthecoronavirusis beingused toforcea
dangerousand unnecessaryvaccineonAmericans.âOnly22%ofwhitepeopleand
Latinosagreed while42%ofBlackpeopledid.
⢠âIf a vaccine for COVID-19becomesavailable, would you be willing to take it?â
⢠Nearlytwo-thirdsofrespondentsindicatedtheywouldbewillingtotakeit.
⢠Butraceand ethnicitymattered:While70%ofwhitepeopleagreed,only62%ofLatinos
and 44%ofBlackpeopledid.
65. NovemberpollfindsmajorityofCanadiansopento
gettingCOVIDvaccine,butmanywanttowait
⢠A new Ipsos/Radio-Canada poll hasfound that mostCanadians intend to get
vaccinated againstCOVID-19, but that many would prefer to wait at leasta month
or two after a vaccine is approved
⢠Theinternetpollsurveyed3001peopleovertheage of18acrossthecountrybetween
November20th and November25th.
⢠Of thosewho responded, 64%said they would probably or certainly get vaccinated,
while16%said they would not.
⢠20%oftheserespondentssaid theywereunsureas towhethertheywouldget
vaccinated.
⢠Of thosewho said they would get vaccinated, only 36%said they'd get vaccinated
as soonas possible. Another 38%said theyâd wait one or two months,and 11%
were undecided as to when.
68. Hesitancytoreceivefirstgenerationvaccines
*Fromasurveyof1,075 U.S.adults,Sept.24-27, 2020
How likely would you be to take a first generation COVID-
19 vaccine ifâŚ
(Very/somewhat
likely)
⌠your doctor said it was safe 62%**
⌠the cost were completely covered by insurance 56%
⌠the FDA said it was safe 54%
⌠you could get it easily, from a walk-in or drive-thru clinic 50%
⌠you were paid $100 to receive the vaccine 44%
⌠you had to make an appointment and get it at a hospital 37%
⌠it cost you $100 26%**
⌠President Trump said it was safe 19%**
69. Trustissuesmayaffectlowertierhealthcareworkers
willingnesstoacceptvaccines
⢠âIf Thereâs No Trust, Thereâll Be More Hesitancyâ: Nursing Homes Must
OvercomeStaff Skepticism of COVID Vaccineâ (SkilledNursing News
12/2/2020)
⢠Thismay especially be the case if the healthcare worker is from a minority group
that may havesuspicionsthat thosewho are firstto receive vaccination are guinea
pigs to test the vaccineâs safety and efficacy.
⢠In order to get buy-in from thisgroup that is at greatest riskto COVID-19,they must
feel that they have a safety net in the event that they fall ill from taking the vaccine
and are unableto come to work and/or get a paycheck.
71. ⢠Whenyou experiencerelativelymild side effectsfrom a vaccine,thismeans thatyour
immunesystemhasstarteda responsetothevaccine. Thisis whatyouwanttohappen!
⢠Publichealthofficialsand vaccinedevelopersneedtowarnpeoplethatthecoronavirus vaccines
may havesideeffectsthatmimicthesymptomsofa mild COVID-19disease.
⢠By beingtransparent about thepossiblediscomforts peoplemay experience,theywillbelesslikelyto be
scaredaway from gettingthesecond scheduleddoseof thevaccines
⢠Thesesideeffectsarelikelytoinclude:
⢠Sorearm, musclepain, chills,headache,fatigue,and fever.
⢠Oneshould plan for a day of restand recuperationafter gettingvaccinated
⢠Thesesymptomshaveonlylastedforadayinthethreevaccinessoontobeavailabletothepublic.
⢠As withothervaccines,thepublic needsto be encouragedtothinkof short-termvaccineside
effectsas evidencethatthevaccineis workingas intendedand of sideeffectsas a âpositive
responseâinsteadof an âadversereaction.â
Vaccinesideeffectsasdemonstrationsofefficacy
72. Whataboutreactionsinpeoplewithsevereallergies?
⢠At the momentit is recommended that anyonewith a history of severe allergic
reactions to a vaccine, medicine or food, or thosewho carry an adrenaline
autoinjector pen, should wait to get Pfizerâs vaccine.
⢠The warning came after two NHS workers in the UK had allergic reactions on
Tuesday after receiving the vaccine
⢠BothNHS workershavea historyofseriousallergiesand carryadrenalinepensaround
withthem
73. Whataboutreactionsinpeoplewithsevereallergies?
⢠They are understoodto havehad an anaphylactoid reaction, which tends to involve
a skinrash, breathlessnessand sometimesa drop in blood pressure. Thisis not the
sameas anaphylaxiswhich can be fatal
⢠Reactionslikethisareuncommonformostpeoplewithminorallergies
⢠Theydooccurwithothervaccines,includingtheannualinfluenzavaccines
⢠Thesereactionsarealso shortlivedand do not resultinlongtermconsequences
⢠As with other vaccinations, individualswith a history of severeallergiesshould
ALWAYS consult with their medical provider/physicianbeforereceiving ANY
vaccine. If you and your medical provider decide that you shouldreceive the
vaccine, it can be administered under closesupervision to mitigateany potential
reactions you may experience as a result.
75. ⢠In 2019, beforethe pandemic hit, the World HealthOrganization (WHO)listed
vaccine hesitancy as one of the top 10 globalhealththreats.
⢠Thosewho hold off on getting the eventualCOVID-19vaccine pose a threat to
developing herd immunity to the virus.
⢠Vaccine hesitancy is a persistentproblem fostered by both mistrustin oneâs
governmentand misinformation propagated by stakeholderswith a variety of self -
serving agendas.
⢠SomeofthesesamestakeholdershavechallengedCOVID-19policieslinkedtomask
wearingand shutdownsas waysofmitigatingthevirus.
⢠Mis/disinformationdoes not only reinforce the views of anti-vaxxers but leads many
othersto also become vaccine hesitantwhich will ultimately delay herd immunity.
Vaccinehesitancyisaglobalpublichealthproblemthat
mustbeaddressed
76. Communityvariationinratesofvaccination
⢠If the membersof a particularcommunity chose not to vaccinate,then the
entirecommunity is vulnerableto an epidemic (thinkof a pandemic, but only
contained to that specific community/neighboringcommunities).
⢠Once a critical massof infected individualsis reached in one locale, it enablesa
contagion to spread throughoutthe rest of the population
⢠Thisis trueevenifa significantfractionoftheoverall populationis vaccinated.
⢠Remember, if and when a community has reachedherd immunity, there will
still be a proportion of people in that community that will be susceptible to
infection.
⢠Weneedtothinkofcommunitiesas fluid.As isolatedas a communitymay be, there
willstillalways be somelevelof travelin and out of thatcommunitywhich would
allowfortransmissionofthevirusfroma localethatchoosesnottovaccinatetolocales
thatdo receivevaccinations.
78. Whatisthegovernmentsroleininsuringvaccination
coverage?Anticipatesomepoliticalcontroversy.
⢠In orderto reachherd immunity, it is likely that vaccineswill needto be
mandated for workplacesand schools.
⢠As is thecaseofmeasles,thosewhorefusetogettheirchildrenvaccinatedforreligious
reasonsmay findtheirchildrenarebarredfrompublicschools,day care,other
childcarefacilities,etc.
⢠However, thereis a difference between COVID-19and measles.
⢠Measlesis highlyinfectiousand resultsin seriousdiseasefora significant percentageof
children.
⢠Althoughthelikelihoodwillchildrenexperiencea severeillnessfromCOVID-19is
relativelylowerthanmeasles,theycan stilltransmittheinfectiontoothervulnerable
populations(teachers/schoolfaculty)whomay experienceseveredisease.
79. Employercitizenshipandcivilliberties
⢠If the governmentdoes not mandatevaccination , it may be left up to employersto
mandate vaccination (similar to howsomeemployers havemandated mask
wearing indoors and physicaldistancing).
⢠Thiswill be a major headachefor businessowners and humanrelations
departments who will be left with a decision as to whether to mandate or
encouragevaccination for COVID-19.
⢠Iftheymandatevaccinations(oncedeemedsafeand available),thenbylawtheymust
allowforexemptions
⢠However,thosewhochosenot vaccinatedue to someconvictionwill likelybe
requiredto protectotheremployeesby alternativemeans likecontinuedmask
wearing and physicaldistancingfor sometimeinto thefutureuntilvaccination is
no longerrequiredto preventtransmission.
81. ⢠Vaccines are not 100%effective, buttwo of the vaccines under developmentfor
COVID-10 have reported that they are 95%effective in preventing severeCOVID-19.
⢠So,ifyouarevaccinateditis highlyunlikelyyou willget severeCOVID-19overthenext6
monthsorperhapslonger(thedurationofefficacyremainstobeseen).
⢠It is possibleto be re-infected with COVID-19â rare but possible.
⢠It takes time for vaccines to work: It typically takes a few weeks for the body to build
immunity after vaccination. That meansitâs possiblea person could be infected
with the virusthat causesCOVID-19justbeforeor justafter vaccination and get sick.
Thisis becausethe vaccine hasnot had enoughtime to provide protection.
IfIgetvaccinated,canIstillgetCOVID-19?
82. WillthosewhohavealreadyhadCOVID-19beencouraged
togetvaccinated?
⢠It is âvery likelyâ that adults who have recovered from COVID-19will be encouraged
to take the vaccine.
⢠The reason is becausethe duration of protection from someonewho has already
been infected is unknown. We do not yet know how long protection will last in
general and for specific categories of people
⢠Factorsthatmightinfluencedurationofimmunityincludethestateofpersonâshealth,
whethertheyweresymptomaticvs asymptomatic,and howsevertheirillnesswas.
⢠Untilweknowforcertain,vaccinationwillmostlikelyberecommended.
⢠Some recovered COVID-19patients were among the participants in the Moderna
trial.
83. IfIgetthevaccine,howwillIknowwhether Ihave thediseaseifI
amexposedtosomeonewhohascomedownwithit? WillItest
positivejustbecauseIhavebeenvaccinated?
⢠If you areexperiencing symptoms consistent with COVID-19, you will be
administereda diagnostic test such as a PCR or antigen test.
⢠Neitherofthesetestslookforantibodiestothevirus
⢠Thesetypesoftestsdeterminewhetheryouhavean activeinfectionbydetecting
proteinsthatareexpressedbythevirus orbydetectingthegeneticmaterialfromthe
virus.
⢠COVID-19 vaccinesdo not contain the virus that causesthe diseaseand will
thereforenot cause you to test positive on COVID-19 viraltests.
⢠Thesevaccinescauseyourimmunesystemtoproduceantibodiestothevirus.
⢠IfyouhavebeenvaccinatedforthevirusthatcausesCOVID-19,youwilllatertest
positivevia an antibodytest.
84. ⢠YES
⢠Getting vaccinated for COVID-19will not mean theend of wearing face masksin
public places, physicaldistancing or frequenthand-washingto prevent the spread
of COVID-19.
⢠Thisis duetothefactthatthevaccinesmay notentirelypreventCOVID-19infection,so
thereis a chanceyou may stillbeabletogetCOVID-19and spread ittoothersevenafter
vaccination.
AftergettingvaccinatedwillIstillhavetowearamask?
85. Soberingscenariorelatedtotheimpactof vaccines
takingaccountthecurrentinfectionrates
⢠At the current level of infection in the U.S. (about200,000confirmednew infections
per day), a vaccine that is 95%effective â distributedat the expected pace â would
stillleave a terrible toll in thesix monthsafter it was introduced. Almost10 million
or so Americanswould contract the virus, and more than 160,000would die.
⢠Thisis far worse than the toll in an alternate universein which the vaccine was only
50%effective, butthe U.S. had reduced the infection rate to its current level in early
September (about35,000new daily cases). In that scenario, thedeath toll in the
next six monthswould be kept to about60,000.
⢠No vaccine can eliminatea pandemic immediately,justas no fire hosecan put out a
forestfire. Whilethe vaccine is being distributed, the viruscontinuesto do damage.
âBluntly stated, weâll get outof thispandemic faster if we give the vaccine lesswork
to do.â
88. COVID-19andtheSeasonalFlu
⢠The seasonalflu caused an estimated400,000hospitalizationsand 22,000deaths in
the US during the lastflu season, according to theCDC.
⢠Both the flu and COVID-19have many of thesamesymptoms.
⢠OnesymptomthatdifferentiatesflufromCOVID-19is lossoftasteorsmell,especially
smell
⢠Ifyouloseyoursenseofsmell, geta COVID-19 testas soon as possible.
⢠It is possibleto haveCOVID-19and the flu at thesametime.
⢠For your own safety and to keephospitals from being overwhelmed,pleaseget
a flu vaccination NOW and a COVID-19 vaccination as soon as it becomes
available.
89. ShouldIgetaseasonalfluvaccineifIhavenotdoneso?
Yes!Forfourgoodreasons:
1. It is possibleto gettheâfluâand COVID-19at thesametimeand thiswould increase
theseverityof your illness.
2. As thecoronaviruscontinuestospread acrossthecountry,doctorssay it'smore
importantthaneverto build up herdimmunity forstrainsof âflu.â
⢠Thisprotectstheelderly and othervulnerable people .
3. It is veryimportantto protectyourselffromtheinfluenza virus and not put more
pressureon thehealthsystemwiththeimpending casesof coronavirus.
⢠Thelastthingtheyneed isthisdouble burden.
⢠Thebest timetogetaseasonal influenza vaccine ismid September tomid October
4. Crossâprotectionat somelevelis a possibilitythatis presentlybeing investigated
for severaldifferentvaccines.Thishasnot yet beendemonstrated forCOVID-19,
but crossprotection hasbeen documentedfor otherdiseases.
90. Doesgettingaflushotmakeyoutemporarilymore
susceptibletoCOVID-19
⢠Does receiving a flu vaccine lower your immunity, making you briefly more
susceptibleto catching COVID-19?
⢠Probablynot,there'sverylittlescientificbasisthatgettinga flu shotwilltemporarily
weakenyourimmunesystem.
⢠Yourimmunesystemencountersand reactstomultiplepathogensall thetime,so itis
highlyunlikelythatreactingtoonevaccinewillputyouat greaterrisk toinfectionfrom
otherpathogens.
92. Pragmaticissuesrelatedtovaccinecoverage:
⢠Will COVID-19vaccines be free or affordable?
⢠Will insurance cover it?
⢠Will vaccines be easy to access?
⢠Ifprovidedoutsidea clinic,willtheybeprovidedinplaces thatall segmentsofthe
populationfeelcomfortablevisiting?
⢠Willtheybegivenbypeoplewhoare trusted?
93. HowdoIestimate whatpositionIammostlikelytohave
wheninlineforaCOVID-19vaccination?
⢠The New York Tines in conjunctionwith the Surgo Foundation and Ariadne
Labs have created a vaccine tool to calculate thenumber of people who will need a
vaccine in each stateand county â and where you mightfit in that line.
⢠You can access thistool at :
https://www.nytimes.com/interactive/2020/12/03/opinion/covid-19-vaccine-
timeline.html?referringSource=articleShare
94.
95. EmergencyCOVID-vaccineapprovalsposeadilemmafor
scientistsfortworeasons
⢠Once a vaccine is granted emergency approval, thereis pressureon developers to
offer the immunizationto trial participants who received a placebo.
⢠But if too many people cross over to thevaccine group, the companies mightnot
have enoughdata to establish:
⢠Long-termoutcomes,such as safety
⢠Howlongvaccineprotectionlasts
⢠Whetherthevaccinepreventsinfectionorjustthedisease
96. EmergencyCOVID-vaccineapprovalsposeadilemmafor
scientistsfortworeasons
⢠It will become more difficultto recruit volunteersfor thetrails of other new
vaccines.
⢠Ifa vaccineexiststhathas beenidentifiedas efficaciousin themedia,whywould
someonewanttobepartofa trialofa yettobefullytested vaccineifbeingpartofthat
trialmeanstheycan nottakeanotherprovenefficaciousvaccineuntilthetrialends?
⢠IfthecomparatorfornewCOVID-19vaccinesbecomesvaccineslikethoseproducedby
Pfizerand Moderna(withefficacyrates>90%)insteadofa placebogroup,itmay be
hardertorecruitthesampleneededtodemonstratethelevelofefficacytheFDA would
demand.*
⢠In thiscase,drop out of new candidatevaccinesinphaseI and IItrialsmay occur.
