QualPharma December 2020

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CORONAVIRUS SPECIALS.No CANDIDATE Mechanism SPONSERTRIALPHASE41 HaloVax Self-assembling vaccineVoltron Therapeutics, Inc.;Hoth Therapeutics, Inc.Pre-clinicalUniversity of Washington;42 HDT-301 RNA vaccineNational Institutes ofHealth Rocky MountainPre-clinicalLaboratories; HDT Bio CorpINSTITUTIONMGH Vaccine and ImmunotherapyCenter43 LineaDNA DNA vaccine Takis Biotech Pre-clinical Takis Biotech44 MRT5500 Recombinant vaccine Sanofi, Translate Bio Pre-clinical45 No name announcedIi-Key peptide COVID-19vaccine46 No name announced Protein subunit vaccine47 No name announced mRNA-based vaccineGenerex Biotechnology Pre-clinical GenerexUniversity of SaskatchewanVaccine and Infectious DiseaseOrganization-International Vaccine CentreChulalongkorn University’sCenter of Excellence in VaccineResearch and DevelopmentPre-clinicalPre-clinical48 No name announced gp96-based vaccine Heat Biologics Pre-clinical49 No name announced Inactivated vaccine50 PittCoVaccRecombinant protein subunitvaccine (deliveredthrough microneedle array)Shenzhen Kangtai BiologicalProductsUPMC/University of PittsburghSchool of MedicinePre-clinicalPre-clinical51 T-COVIDTM Intranasal vaccine Altimmune Pre-clinicalUniversity of SaskatchewanVaccine and Infectious DiseaseOrganization-International Vaccine CentreUniversity of Miami MillerSchool of MedicineUniversity of PittsburghQualPharma *Dec 2020* , Vol.3 ISSUE 12
OXFORD TECHNOLOGYCORONAVIRUS SPECIALThe Oxford COVID-19 vaccine team is ledby Prof Sarah Gilbert, Prof Andrew Pollard,Prof Teresa Lambe, Dr Sandy Douglas,Prof Catherine Green and Prof AdrianHill. Their team includes scientists fromboth the Jenner Institute and the OxfordVaccine Group, who bring together decadesof internationally recognised experiencein vaccine research, including respondingto the Ebola outbreak of 2014.The teams had already used ChAdOx1vaccine technology to produce candidatevaccines against a number of pathogensincluding flu, Zika and Middle East RespiratorySyndrome (MERS), anothercoronavirus. They had already begunwork on pandemic preparedness with thetechnology behind ChAdOx, in preparationfor 'Disease X'. When the diseaseemerged in China, they moved quickly. Assoon as the genetic sequence was available,they began work on a trial.How the Oxford COVID-19 vaccineworksThe ChAdOx1 vaccine is a chimpanzeeadenovirus vaccine vector. This is a harmless,weakened adenovirus that usuallycauses the common cold in chimpanzees.ChAdOx1 was chosen as the most suitablevaccine technology for a SARS-CoV-2vaccine as it has been shown to generate astrong immune response from one dosein other vaccines. It has been geneticallychanged so that it is impossible for it togrow in humans. This also makes it saferto give to children, the elderly and anyonewith a pre-existing condition such as diabetes.Chimpanzee adenoviral vectors area very well-studied vaccine type, havingbeen used safely in thousands of subjects.Coronaviruses have club-shapedspikes on their outer coats, whichform a corona – Latin for crown –on the virus surface. Immune responsesfrom other coronavirusstudies suggest that these spikes area good target for a vaccine.The Oxford vaccine contains the geneticsequence of this surface spike protein.When the vaccine enters cells inside thebody, it uses this genetic code to producethe surface spike protein of the coronavirus.This induces an immune response,priming the immune system to attack thecoronavirus if it later infects the body.The Oxford COVID-19 vaccine trialsThe main focus of the Phase I, II and IIIstudies is to assess whether the ChAdOx1vaccine is going to work against COVID-19, that it doesn’t cause unacceptable sideeffects and if it induces good immuneresponses.Adult participants will be randomisedto receive one or two doses ofeither the ChAdOx1 nCoV-19 vaccineor a licensed vaccine(MenACWY) that will be used as a‘control’ for comparison.Phase I: The phase I trial in healthyadult volunteers began in April 2020.More than 1,000 immunisations weregiven in the UK.Phase II: The phase II part of thestudy expands the age range of peoplethe vaccine is assessed in, to include asmall number of older adults and children.Researchers will be assessingthe immune response to the vaccinein people of different ages, to find outif there is variation in how well theimmune system responds in olderpeople or children. The group of childrenwill be recruited later in the trial,once extensive safety data is availablefrom the adult studies.Phase III: The phase III part of thestudy involves assessing how the vaccineworks in a large number of peopleover the age of 18. This group willassess how well the vaccine works toprevent people from becoming infectedand unwell with COVID-19. Itinvolves multiple locations, includingother countries.Vaccine results and productionTo assess whether the vaccine works toprotect from COVID-19, the statisticiansin our team will compare the number ofinfections in the control group with thenumber of infections in the vaccinatedgroup.QualPharma *Dec 2020* , Vol.3 ISSUE 12
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QualPharma December 2020

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