艾昆纬-监测新冠肺炎对欧盟4国和英国医药市场的影响（英）-2023

Impact

ofCOVID-19

onthePharmaceutical

Market–EU4

&UKQuarterly

Report:May

2023DataMonthEnding:

February2023European

Thought

LeadershipThetermLong

COVID

isused

throughout

thisnewsletter

torefer

toPost-acute

sequelae

SARS-CoV-2infection

(PASC).PASCistheclinical

termthat

isused

bytheEuropean

healthcare

authorities©2023.

Allrightsreserved.

IQVIA®

isaregistered

trademarkof

IQVIAInc.intheUnited

States,theEuropean

Union,

and

various

other

countries.Impact

of

COVID-19

on

the

PharmaceuticalMarket+

EvolutionofLongCOVID+

COVID-19:Variants

ofConcern

(VOC)+

DeepDive

intoCOVID-19

Vaccination+

Medicine

Demand

and

Supply+

Engagement

with

Health

Care

Professionals+

Appendix1Evolution

ofLongCOVID2LongCOVIDpresents

clinical

manifestations

involving

respiratory,cardiovascular,

gastrointestinal,

musculoskeletal&neuropsychiatric

systemOverview:Long

COVIDKey

HCP

reported

symptoms

inEU4

&UK3•

Long

COVIDoccurs

in

patientswithahistoryofCOVID-19infection,

usuallythree

months

fromthe

onset

ofCOVID-19

infection•

InLong

COVIDpatients,

thesymptoms

may

be

new

onset

after

following

initialrecovery

fromCOVID-19

ormay

persistfrom

theprevious

episode

ofinfection.Thesymptoms

last

for

at

least

2months

andcannotbeexplained

byalternative

diagnosis1,2Fatigue(77%)ShortnessofbreathDepressionandanxiety(50%)Memoryproblems(48%)Brainfog(37%)(57%)NIHhasgrouped

Long

COVIDpatientsinto

sixclusters

based

ondifferentclinicalfeatures8ManifestationsofLong

COVID:•

SARS-CoV-2

virus

infects

different

typesof

cellsand

have

multisystemmanifestations

inLong

COVID,whichinclude

respiratory,

cardiovascular,gastrointestinal,musculoskeletal,

neuropsychiatric

systems3,41.

Multisystem

+lab2.

Pulmonary

clusterHighfrequencies

ofHypoxemiaand

Cough3.

NeuropsychiatricHighfrequencies

ofHeadache,

Insomnia,Depression,

Sleep

apnea,Abnormality

of

movement,and

ParesthesiaNeuropsychiatric,

pulmonary,constitutional,

cardio,

gastroand

ENTwithmultipleUnderlyingmechanisms

ofLong

COVID:•

Pathophysiological

changes

caused

bythe

virus•

Persistent

inflammationwith

alteration

inimmune

homeostasis•

Autoimmunity

and

molecular

mimicry•

Hostmicrobiome

changes3,4laboratory

abnormalities4.

CardiovascularHighfrequencies

ofTachycardia,

Palpitations,Hypoxemiaand

Pulmonaryembolism5.

Pain/FatigueHighfrequencies

ofPain,Chest

pain,

and

Fatigue6.

Multisystem-PainSimilar

distribution

ascluster1with

lowerfrequencies

ofthelaboratory

abnormalities,but

highest

frequency

ofpainVulnerablegroups:•

IntheUK,the

prevalence

ofLong

COVID

isthehighest

among

people

aged35-69

years,

females,

people

livingindeprived

areas,

social

workers,

healthcare

workers,

individuals

>16

years

whowerenot

working,and

persons

withactivitylimiting

health

conditions

ordisability5Based

oncomputational

modellingof

Long

COVIDphenotype

datafrom

EHRs,NIHhasidentified6clustersshowingastatistically

significantdegree

of

associationof

clustermembership

with

arange

of

pre-existing

conditionsandwith

measures

of

severityduringacute

COVID-19Source:

1WHO

PASC

2023;2ECDC

PASC

2022;3IQVIA

Institute,Assessing

the

Global

Burdenof

Post-COVID-19conditions,

2021;4Facingthe

impact

of

PASC

2022;

5ONS

UK

2023;6Subramanianet

al.

Nat

Med

2022;7ECDC

Europe

2023;

8The

LancetAbbreviation:

Cardio-

cardiovascular;

EHRs-Electronic

Healthcare

Records;

Gastro-

Gastrointestinal;

NIH-National

Institutes

ofHealthImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20233Nearly

2.9%(1.9M)oftheUKpopulation

issufferingfromLong

COVID,andthedailyactivities

of1.5

Mofthemareadversely

impactedEpidemiology

ofLongCOVIDEstimated

Long

COVIDpatientsbyusing

population-based

studiesEuropean

UnionUnited

KingdomLongCOVIDprevalence(2022)Self-reported

LongCOVID

prevalence(2023)8M11.9

M(2.9%

ofpopulation)2Key

Insights1-5•

In

theUK,Long

COVIDsymptoms

haveadversely

affecteddailyactivitiesof1.5Mindividuals

(2023)•

The

most

common

symptoms

reportedby

patients

intheUKare

–fatigue(72%),difficultiesinconcentration

(51%),muscle

ache

(49%)andshortness

ofbreath

(48%)•

The

prevalenceof

Long

COVIDwasthehighestamongfemales

andindividuals

ofagegroup

35-69

years•

In

Germany,

acohort

study

(2020-2022)

estimated

diagnosedincidenceofLong

COVIDsyndrome

as

14.2%

oftheconfirmed

COVID-19cases(N=391,990).

The

highest

treatment

incidenceamong

Long

COVIDpatients

was

inadults

aged

40-59

years(19%)

and

the

lowestinchildren

aged<12years(2.6%)•

In

France,

asurvey(N=27,537,

Mar-Apr2022)

states4%

(N=1,086)

oftheparticipantssuffered

fromLong

COVID.Prevalence

was

higher

infemales

(4.6%)

than

inmales

(3.3%).

Prevalence

as

per

agegroup

were,

18-34

years:6%,35-49

years:4.7%,

50-64

years:3.4%

and

≥65years:1.8%•

In

aSpanishcohort

study

in2020-2021

(N=569,534),

persistent

symptoms

were

morecommoninhospitalized

(52.3%)

patientsthan

innon-hospitalized

patients(38.2%).Chronicpulmonaryobstructivedisease

(COPD),female

gender,andtobaccoconsumption

were

theunderlying

risk

factorsfor

persisting

symptomsSource:

1EU-US

Conferenceon

LongCOVID

2022;

2Prevalenceof

COVID-19

in

UK:

2023;

3Donnachieet

al.

BMJ

Open

2022;

4Makovski

et

al.

EuropeanJournalof

PublicHealth

2022;

5Pérez-Gonzálezet

al.

ScientificReports2022;ImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20234LongCOVIDpatientadvocacygroupsaredriving

stakeholders’

attention

ondiseaserecognition,

R&D,andpatient

rehabilitationPatientPerspectives

onLongCOVIDEuropeUKGermanyFranceSpainLongCOVIDDeutschlandAssociation

COVIDLongFranceLongCOVIDEuropeLongCOVIDKidsACPE••Strivingtogetrecognition

ofLongCOVIDasan

impactful

pandemicDevelopment

ofuniversalguidelines

for

thediagnosis

ofLongCOVIDby

patient-centric

researchRehabilitation

based

on

specificmanifestations

of

Long

COVIDinthepatients1•••Education

andawarenesscampaign

for

theaffected

populationand

health

care

systemProviding

uniformcaretothepatients

followingcurrent

medicalguidelinesPromotion

ofresearch

anddevelopment

ofbiomedicaltherapyoptions

for

Long

COVIDpatients4•Recognition

ofLongCOVID

basedon

multi-systemic

symptoms

ofpatientsRehabilitation

support

tothepatientsCollaboration

withphysicians

andresearchers

toinform

generalpopulation

about

Long

COVIDResearch

involving

patients

toimprove

LongCOVIDdiagnosisandmanagement5••Adviseandsupport

patientsontheir

role

inmedical,

social,

andemotional

levelCollaborative

initiatives

with

publicand

privateinstitute

forLongCOVIDrecognition6•Wellbeing

and

positive

future

ofchildren

withLong

COVID2••LongCOVIDSupport••Providing

patient

and

public

voices

toUKregulatory

bodies

involvedwithLong

COVID

(NHS,NIHR,NICE)andWHOInvolved

indeveloping

UKclinicalguidelines

for

Long

COVIDSupport

workersto

returntoworkfocusing

on

employment

andbenefits3•LongCOVIDGuidelines•••Development

ofguidelinesfor

LongCOVIDtreatment

in

collaboration

withSpanish

Society

ofGeneral

andFamily

Physicians

(SEMG)7PatientssufferingfromLong

COVIDshared

theirexperiences

on

how

persistent

ornew-onset

symptoms

impacted

theirwell-beingBrainfog:

“Normally,

Iamaverystrategicand

analytical

thinker,

but

Iwas

unableto

manage

complex

information

and

Iwas

forgetting

words.Ihad

problems

doingsimpletasks

andbasiclogicproblems.

Iwould

normally

dothese

easily.”Lungabnormalities:

"Ihavebeen

havingproblems

with

theoxygen.

Iam

on

oxygen

24/7…They

(consultant)

didsome

tests

andsaidto

me,

your

lungs

arebetterthan

theywere

lasttime…I

stillcannot

walk

more

than

20paces“Cardiacissues:“Icouldbesittingdown

watchingthetelevisionorhavingacuddle

with

my

childrenandsuddenlyI’dfeel

my

heart

racing.”8,9Note:Italy

hasapatient

led

support

groupand

association

forresearch

and

care

for

Long

COVID

patients

named

as‘Long

COVID

Italia’Source:

1Long

COVID

Europe;

2Long

COVID

Kids;3Long

COVID

Support;

4Long

COVID

Deutschland;

5AssociationCOVID

LongFrance;

6ACPE

Spain;

7Long

COVID

ACTS;

8BrithishHeart

Foundation2023;

9Skilbecket

al.Journalof

Patient-Reported

Outcomes2023;

ACPE-ThePersistent

COVIDPatient

AssociationImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20235Patients

are

struggling

togetnecessary

supportfromHCPs

because

LongCOVIDis

still

notauniversallyrecognizedmedicalconditionChallenges

intreatment

careand

market

accessCaregaps

intreatment

for

LongCOVID1-4Lack

ofrecognitionbyhealthcaresystemsInsufficient

supportfor

treatmentDifficulties

inaccess

to

healthcareDifferences

intreatment

coverage•

Majority

ofEU

healthcare

systemsdo

notrecognizeLong

COVIDasamedically

accepted

diseasecondition:•

Insufficientanddelayed

support•

Non-hospitalized

individualswithLong

COVIDrequiresignificanthealthcareinvestment

forprimarycaretreatment•

Mostinsurance

providersareexcludingcoverage

for

chronicsymptoms

(PESE,ME,fromhealthcare

systems-

Dueto

enormousnumbersofdysautonomia,

autoimmunity)Long

COVIDpatients-

Long

COVIDdiseasemechanisms

are

unknownbecause

ofinsufficient

researchand

awareness•

Incontrast,some

providers

aregivingfocusedbenefitstotheirmembers-

Lack

ofspecific

guidelines-

Non-hospitalized

patientsformallydiagnosedornotdiagnosedwithLong

COVID,butpreviously

infectedwithSARS-CoV-2,elderly,•

Patients

forced

toseekalternativetreatment

options

whichhaveless

robustevidence-

Fore.g.,

Axa

Health:membersreferred

by

aGP

can

getconsultations

and

access

torehabilitation

programs

for

LongCOVIDpatients-

Lack

of

currently

availableevidence-based

treatment-

Fore.g.,off-label

medicines,OTCmedicines,

supplements

&dietary

changesfemales,

obesepatientsfacemore

difficulties

toaccesshealth

careSource:

1Brown

et

al.

The

Lancet2022;

2Tufts

et

al.

medRixv

2023;

3UK

Health

Insurance2023;

4Turner

et

al.

Trends

in

Endocrinology

and

Metabolism2023Abbreviation:

HCPs-Health

CareProviders;

OTC-

over-the-counter;

PESE-post

exertionalsymptom

exacerbation;

ME-

myalgic

encephalomyelitisGP-GeneralPhysicianImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20236Majority

ofLong

COVIDpatients(62%)

are

treatedin

primarycare;pulmonologists

provide

morethan60%referralsfor

LongCOVIDPhysicians'role

inthe

therapeutic

management

ofLongCOVIDReferral

for

Long

COVID

diagnosis1,3Referral%PulmonologistCardiologistNeurologistPsychiatristOthers6258•

In

anonline

survey

with

PCPsand

SCPsinGermany

(2021),

10%

ofallthe

primarycare

patients

withhistory

of

SARS-CoV-2

infection

suffered

from

Long

COVID.Itresembles

the

international

statistics

of

Long

COVID

prevalence

(10-20%)•

71.1%

ofPCPshaveincorporated

secondary

care

in

the

treatment

of

Long

COVIDpatients1Pulmonologistwithmaximumreferralfor4024diagnosis11Mostcommonsymptoms

observedbyGPs2Physicians’

Observations1Pre-existing

Conditions1•

8.5%

cases

arehospitalized

patientsfor

LongBackpainFatigue13.0%HypertensionDepression48%Difficulty

in

focusMuscleAcheCOVID297%2%•Patientswithout

medical

confirmation

are18.8times

higherthan

patientswith

medical

confirmationofLong

COVID41.0%18.0%4StressdisorderShortnessof

Breathe49%~72%patientspresenttheBackpainis

themostdetectedpreexistingconditionby

HCPs•

~34.1

minadditionalconsultingeffort

for

treating51%symptom

ofFatigue37.0%Long

COVIDpatientsPrimary

care

physician

involvement

indiagnosis1Referral

totertiary

care

center

byphysician1Healthcare

availed1PatientsPatientstreatedinsecondary•Ina

routinestudyin

Germany,76%ofthe

LongCOVIDpatientswere

treated

onlyin

primary

care•On

average,each

physician

referred

15.4%

ofpatientstoambulatory

carecentersfor

LongCOVIDtreatment62%38%treatedinprimarycarecareNote:Dataincluded

fromhospital

surveyconducted

in

Germany

(December

2021)

and

UK(March2023);

Source:

1Strumannet

al.

Res

HealthServ

Reg

2023;

2ONS

UK

2023;

3IQVIA

Webinar,

30

Sep

2021Abbreviation:

PCPs-Primary

care

physicians;

SCPs-Secondary

care

physicians;

GPs-Generalpractitioners;

HCPs-

Healthcare

practitionersImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20237Evidence-based

treatmentoption

islacking

forLongCOVID;guidelinesmajorly

focus

on

symptomatic

managementandrehabilitation

careCurrent

treatment

options

forLongCOVIDLongCOVID

diagnosis1-3SymptomaticmanagementRehabilitationcareMultidisciplinaryapproach

ofcarePharmacologic

symptoms

management

(treatment

recommendations

inpercentages

byGPs)2Respiratory

complications1Chest

radiograph,

chest

CTNeurological

complications1Rehabilitation

management3Bronchodilators

(32.3%)DyspneaTelehealthElectromyography,

Nerveconduction

studyCorticoids(25.2%)FatigueSSRIs(0.8%)Pulmonary

rehabilitationPsychological

assessmentNon-OpioidAnalgesics(24.8%)Muscle

AcheSymptomatic

management

and/orrehabilitationLow/moderate

physicalexerciseLossofSmellandTasteCorticoids(2.4%)••Ina

UK-basedstudyconducted

between

Dec2020to

Jul2021(n=

1,240,009),

doublevaccinatedindividuals

had

a50%lessriskofdevelopingLong

COVID4Accordingto

anonline-basedsurvey(n

=143GPs)

in

Germany

(2021),most

GPsin

the

EU

considered

the

present

methods

for

diagnosisforLong

COVID(4–12

weeks)inpatientsas

excellent(62.8%),

while

ratingthecurrent

treatment

choices

as

poor(47.4%)2Treatment

optionsDiagnosisTypeofSymptomsPreventative

MeasuresNote:Theincluded

symptoms

arethe

most

diagnosed

symptoms.

Symptoms

such

ascough,

reduced

mental

health,

thrombosis,

metabolic

dysfunction,

chest

pain

arealso

observedSource:

1Munipalli

et

al.

Clinicalmedicine2022;

2Schrimpfet

al.

NIH

2022;

3WHO

guideline2022;

4Strumannet

al.

Res

Health

Serv

Reg

2023Abbreviation:

CT-

computed

tomography;

GP-general

practitioner;

SSRI-selective

serotonin

reuptake

inhibitor;

HCP-healthcare

personnelImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20238Implementing

multidisciplinary

rehabilitation

supportforLongCOVIDmanagement

mayleadtobetterquality

oflifeRehabilitation

ofLongCOVIDpatients•

Duringtheacute

stageof

the

disease,

rehabilitation

professionalssupportwith

patient

counselling,

interventionstargetingrespiratory

andpsychologicaldistress1•

All

rehabilitating

patientswere

providedwith

guidance

toresumeday-to-day

activity

with

amaintainedpace1Components

of

Rehabilitation1•

Multidisciplinary

rehabilitationteams•

Standardizedsymptoms

assessment•

Patient

educationPsychologicalassessment2•

71%

experts

strongly

recommend

formalpsychologicalassessment

for

patients

withsymptoms

of

psychological

distress•

Screeningstarts

after

6-8

weeksofhospitaldischarge.

Common

screened

symptomsinclude

anxiety

(34%),

depression(33%)andpost-traumatic

stress

disorder

(19%)Respiratory

assessment2•

70%

experts

strongly

recommendcomprehensivepulmonary

rehabilitationprogram

for

patients

withpre-existing/ongoinglungfunction

impairment2•

Referral

system•

The

current

guidance^

recommends

routinepost-exacerbation

pulmonary

rehabilitation,four

weekspost

dischargeRehabilitation

assessment4•

Persistence

of

symptoms

over10-12

weeksmay

require

referral

to

psychologistandtreatment•

Experts

suggest

the

additionof

toolstoanalyze

outcome

measures

(e.g.,•

HCPs

recommend

assessment

ofrehabilitationneeds/complexity

of

allindividuals

previously

hospitalized

forCOVID-19breathlessness,

dyspnea)to

plananddeviseappropriate

interventions

to

the

patientsTelehealth

entrenchmentExercise2•

Studiessuggest

that

atelerehabilitationprogram

spanningoveranaverage

of

30days,leadsto

improvements

indyspnea,muscular

fatigue,

tolerance

to

exercise5•

Patients

areencouraged

to

dolow/moderate

intensity

physical

exercises•

It

is

recommended

to

perform

anexercise

test

(e.g.,

cardiopulmonary

exercisetest,

6-minute

walk

test,shuttle

walk

test)

after

6-8

weeksof

hospitaldischarge

to

screenthe

traits

treatable

with

rehabilitationNote:“Expert”denotes

clinical

expertsand

key

opinion

leaders

fromsocieties

relevantfor

thefield

of

pulmonary

rehabilitation;

^GuidancefromaEuropean

Respiratory

Society

and

American

Thoracic

Society-coordinatedInternational

TaskForce;

Source:1WHO

guideline2022;2Martijin

et

al.

Europeanrespiratoryjournal2020;

3Mar

NegreiroEuropeanparliament2021;

4Wahlgren

et

al.

eClinicalMedicine

2022;5Valverde-Martinezet

al.Healthcare(Basel)

2023ImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

20239Despitehigher

expenditureinhealthcare&research,

Long

COVIDcontinuestoimpactjobs

andworking

hours,

resulting

inreducedearnings

andQoLEconomic

and

Social

ImpactofLongCOVIDIssuesof

concernDescription•

The

patient

advocacy

group—Long

COVIDEurope—has

requested

the

European

Uniontocreate

anemergency

fund

of

€500

Mfor

biomedical

research

and

clinical

trials

for

Long

COVIDand

related

health

conditionsResearchburden1•

In

the

UK

primary

healthcare,

non-hospitalized

adults

withLong

COVIDcost

additional

£2.44

perIncreased

healthexpenditure2patient

per

year

than

patients

withnohistory

of

SARS-CoV-2infection•

Cost

of

primary

care

services

for

consultations

associated

with

Long

COVIDexceeds

£20

Minthe

UKReduced

quality

oflife

(QoL)3•

OECDcountries

may

havelost

~7.0

MQALYsannually

due

toLong

COVID•

The

cost

of

reduction

inquality

oflife

yearsinOECDisestimated

as$723

BnLost

earningsfromreducedlabormarket3,4•

2.6-6.0

Mworkers

aremissing

from

the

workforce

for

OECDcountries•

Estimated

lost

earnings

inOECDcountries

is

$141-$317

Bn•

Lost

earnings

due

to

Long

COVIDinthe

UK

alone

isup

to£1.5

Bnper

yearSource:

1EU-US

Conferenceon

longCOVID

2022;

2Tufts

et

al.

medRixv

2023;

3EU-US

Conferenceon

longCOVID

2022;

4UK

lost

earnings2022Abbreviation:

OECD-

Theorganization

for

Economic

Cooperation

and

Development;

QALY-quality-adjusted

life-yearImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

202310Research

on

LongCOVIDis

focusedonunderstandingits

mechanism,accurate

diseasediagnosis,

andimproved

diseasemanagementLongCOVIDresearchinitiativesEuropeUKUSIncellDx

incellKINELongCOVID

InVitro

Diagnostic2Paxlovid(Nirmatrelvir/ritonavir)7Program/TechnologyTheLongCOVIDConsortium1LongCOVIDResearch3CoverScanMDTechnology4PhenoRiskPACS™

RuO6DreamLab

App5In

vitro

diagnostictest

(receivedEUCEmarking)Governmentresearch

projectGovernmentresearch

projectMRI-basedtest(approved

byMHRA)Research-use-onlyNMR

testAI/MLApplicationTherapyCategoryFundVodafoneFoundationincollaborationwithImperial

College

ofLondon,

UKEuropeanUnionIncellDxNIHR(UK)PerspectumBruker

CorporationPfizer•

Understand

themechanism

ofLongCOVID•

Providetreatment•

Improve

diseasemanagement

andcare•

Diagnosisbyidentification

ofimmune•

Understand

themechanism

ofLongCOVID•

Diagnosis•

Treatment•

Identification

ofsystemic

organdamage

inLongCOVID•

Identify

hyperfoods

andexistingdrugs

for

Long•

Molecular•

LongCOVIDtreatment•

Reducing

the

riskof

hospitalizationanddeathObjectivephenomicsresearch

withbiomarkers

frombloodsamples•

Diagnosisof

early-stage

riskfactorssignatures

inbloodsampleofLongCOVIDpatientsCOVID

treatment•

NIHRLongCOVID

research

fund

is

distributed

among

15projects

(STIMULATE-ICP,

LOCOMOTION,

EXPLAINetc.)

across

UK3ProgramsTechnologyTests•

The

project

for

DreamLab

Appis

expectedto

becompleted

bythe

endof

20235•

Paxlovid

is

approvedfor

COVID-19

inthe

USandother

countries,

and

iscurrently

beinginvestigatedfor

LongCOVID7,8Key:TherapiesSource:

1The

Long

COVID

Consortium;

2InCellDx2022;3NIHR

fundedLong

COVID

research;

4CoverScan

MD

technology;

5DreamLabApp

2022;

6PhenoRiskPACS™

RuO

2022;

7Xie

et

al.

JAMA

InternalMedicine

2023;8Pfizer

news

2022;Abbreviation:

CE-Conformité

Européenne;

MRI-

Magneticresonance

imaging;

MHRA-

Medicines

and

Healthcare

Products

Regulatory

Agencies;

NMR-

Nuclear

magnetic

resonance;

NIHR-NationalInstitute

forHealth

and

CareResearchImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

202311COVID-19:Variants

ofConcern

(VOC)12Variants

ofSARS-CoV-2:

Introduction

andKey

HighlightsThe

constant

mutation

ofSARS-CoV-2

resulting

in

different

variants

hascreated

significant

challenge

among

thehealthcare

community

to

track

andcontrol

spreadof

the

virusAlpha

(B.1.1.7)

wasconsideredas

one

of•

All

virusesincluding

SARS-CoV-2undergo

mutationovertime,whichchangesitsproperties

like

diseaseseverity,

spreadingcapacity,

efficacyof

vaccines1thefirstvariantsdetected.

ItwasdetectedintheUKand

designated

as

variantofconcern

(VOC)

inDec20203,4•

InJun2020,

aVirusEvolution

WorkingGroup

was

establishedbyWHO

totrack

andmonitorSARS-CoV-2variants,whichlaterbecame

The

Technical

Advisory

Group

onSARS-CoV-2VirusEvolution(TAG-VE)1,2Omicron

XBB.1.5,asub-lineage

ofXBBiscurrently

estimated

tohavelargegrowth

overEurope

as

most

ofthecountries

already

witnessed

aspike

incases4,5•

WHO

latergroupedtheseinto3broadcategories:1-

Variants

under

Monitoring

(VUM)-

Variants

of

Interest

(VOIs)According

toECDCas

of4th

May2023,there

are4VariantsofInterest(VOI)and

2Variants

Under

Monitoring

(VUM)designatedin

EU6-

Variants

of

Concern(VOCs)Sources:

1SARS-CoV-2

variants;

2TAG-VE;

3LambethUK;4ECDC

assessment

of

the

XBB.1.5;5Country

overview

report

ECDC;6EuropeanCentre

for

DiseasePreventionand

ControlAbbreviation:

ECDC-

European

Centre

forDisease

Preventionand

Control;

WHO-

World

Health

Organization;

TAG-VE-

Technical

AdvisoryGroupon

SARS-CoV-2Virus

EvolutionImpactofCOVID-19

on

thePharmaceutical

Market

–

EU4

&UK-May

202313Consideringtheevolving

nature

ofSARS-CoV-2,

WHO

hasclassifieditsvariantsinto

3

broadcategoriesDefinitions

forVariants

andExamplesChange

in

Variant

DesignationIn

Apr

2023,

WHO

hasupgradedXBB.1.16

toVOI2,

however

itisstillreported

asVUMbyECDC1VUMVOIVOCMar2023:

ECDC

hasde-escalatedBA.2,

BA.4

andBA.5

from

itslistofSARS-CoV-2

VOC1Variant

Under

MonitoringVariant

of

InterestVariant

of

ConcernDefinitionDefinitionDefinitionVariant

with

genetic

changesthat

areVariant

with

genetic

changesthat

areVOIthat

meets

at

leastone

of

thefollowing

criteriaVariant

to

Monitor•

Suspected

toaffect

viruscharacteristics

and

earlysignals

ofgrowth

advantage•

Evidence

ofphenotypic

orepidemiological

impactremains

unclear•

Predicted

orknown

toaffectvirus

characteristics

liketransmissibility,

virulence,antibody

evasion,

susceptibilityand

detectability•

Identified

tohave

agrowthadvantage

overother

variantsinmore

than

one

WHO

region•

Detrimental

change

inclinicaldisease

severity•

Change

inCOVID-19