Vaccines to protect against Covid-19, the new coronavirus infection

Covid-19, the disease caused by the SARS-CoV-2 coronavirus, affects people all over the world. However, companies and research institutes are developing vaccines. Two vaccines have now been approved in the EU.

At least 246 vaccine projects have started against Covid-19 since January 2020: The World Health Organization (WHO) currently counts 235 (listing as of Jan. 12, 2021). In addition, there are at least eleven other projects that it does not yet list. These are projects of the following companies and institutes:

Sitemap Covid-19 Vaccine Activities in Germany

Status of vaccine development

Each project for a Covid 19 vaccine comprises seven parts, some of which overlap. They are shown in the graphic below:

The seven stages of vaccine development

Presentation of the individual development steps of vaccines

Vaccines against Covid-19 - The worldwide development status in figures:

Until a few years ago, it would have taken 15 to 20 years from virus analysis to vaccine approval. New technologies and prior experience with vaccine projects against related viruses (see below) make a tremendous acceleration possible. Two vaccines have already been approved, and many others are currently being tested with volunteers, some of which are already in the final phase III trials. This is shown in the following table (for explanations of the vaccine types, see below):

Company / Research instituteVaccineVaccine typeTesting with volunteersProductionFinancial supportSources
BioNTech / Pfizer // BioNTech / Fosun PharmaBNT162b2mRNA-based vaccineApproval in the EU on 21/12/2020. Emergency approvals in UK (02/12/2020), in the US (11/12/2020). Further approvals in other countries. Phase III trial since 27.07.2020 in the USA, Brazil, Argentina, Germany, Turkey and South Africa; result: 95% efficacy in preventing covid 19 disease, also in seniors. In addition, phase I trial with Fosun Pharma in China. EU approval was preceded by "rolling review".in Mainz / Idar-Oberstein / Marburg / Puurs (Belgium) / Kalamazoo (Michigan, USA) / Andover (Massachusetts, USA) / Chesterfield (Missouri, USA), also manufacturing steps at Rentschler Biopharma (Germany), Polymun (Austria), Dermapharm (Germany), Acuitas Therapeutics (Canada); filling at Siegfried (Hameln, Germany); sterile manufacturing services at Baxter BioPharma Solutions in Halle (Westphalia, Germany).Horizon 2020 InnovFin, European Fund for Strategic Investments, BMBFThe Wall Street Journal Entry EU Clinical Trials Register, Pr.mitt. Pfizer, Crain's Detroit Business, Pr.mitt. BioNTech, Mitteldeutsche Zeitung, Wiener Zeitung, Pr. mitt. BioNTech/Pfizer, Pr .mitt. BioNTech, DGAP, Pr. mitt. Rentschler Biopharma, Pr .mitt. BioNTech/Pfizer; Pr. mitt. BioNTech/Pfizer, Pr.mitt. Pfizer/BioNTech,, Pr.mitt. BioNTech/Pfizer; Pr.mitt. BioNTech/Pfizer, EMA, Pr .mitt. BioNTech, Pr.mitt. BioNTech
Moderna (USA)mRNA-1273mRNA-based vaccineApprovalin the EU on 06.01.2021. Approval also in the USA and other countries. Phase III study showed efficacy of 94.1% in preventing covid-19 disease and 100% in preventing severe covid-19 disease. The companies had already submitted parts of the marketing authorization application to EMA in advance for "rolling review".Manufactured at own facility in the US; by Lonza (in Portsmouth, New Hampshire [US], and in future in Visp [Switzerland]); formulation at Recipharm (France); filling at Recipharm (France), Catalent (US) and Rovi (Spain); lipid supply from Corden Pharma (facilities in Switzerland, France, US); distribution partners in Japan: TakedaCEPI, BARDAABC News, Bloomberg, Forbes, Reuters, Pr.mitt. Moderna, Pr. mitt. Moderna, Fierce Pharma, FoxSanAntonio, Der Aktionär, Pr. mitt. Moderna, Pr.mitt . Moderna, BBC News, Pr.mitt . EMA, Pr.mitt. Moderna,, EMA, Reuters
AstraZeneca Life Science / Oxford University (UK)ChAdOx1 nCoV-19 (AZD1222)Vector virus vaccine (based on an adenovirus that cannot replicate in human cells)In the approval process in the EU since 12/01/2021 with the prospect of evaluation by the end of January, as part of the marketing authorization application has already been previously worked through in the "rolling review". Approved in UK since 30.12. for "emergency supply". Licensed version "Covishield" of the Serum Institute of India approved in India since 02.01. for "emergency use". Previously studies in Brazil (since end of June), USA (since beginning of September) and UK. Interim result from phase III with healthy participants up to 55 years of age and dosage "first half, then full dose": 90 % efficacy; interim result from phase III with participants of any age, including those with previous illnesses, and dosage "twice full dose": 62 % efficacy.Production in full or in individual manufacturing steps by AstraZeneca, Halix (Netherlands), Pall Life Science, Cobra Biologics (USA, UK, Sweden), Oxford Biomedica (UK), Novasep (Belgium), Albany Molecular (USA), Reig Jofre (Spain); in future also at the UK Vaccines Manufacturing and Innovations Centre (VMIC). Production under license also by Serum Institute of India (as "Covishield"), SK Bioscience (South Korea), R-Pharm (Russia + Germany), CSL (Australia), Siam Bioscience Group (Thailand), mAbxience (INSUD Group, Argentina).CEPI, UK's Natl. Institute for Health Research, UK Research & Innovation, BARDA (USA)The Guardian Online, Merck report, The Lancet, The Telegraph, inews, LiveScience, BBC, BBC,, Statnews, Fiercepharma Reuters, Oxford University, Reuters,Fierce Pharma, Pr.mitt. CSL, The Phuket News, NTV News, Pr.mitt. AstraZeneca, NTV, BBC, DAZ Online, Pr. mitt. Reig Jofre, Reuters, Pr.mitt . Novasep, Pr.mitt. EMA
Sinopharm / Wuhan Institute of Biological Products / Wuhan Institute of Virology of the Chinese Academy of Sciencesinactivated Novel Coronavirus Pneumonia (COVID-19) vaccine (Vero cells)Vaccine with inactivated virusin phase III in China, the United Arab Emirates and Bahrain and Peru; in an interim evaluation, the vaccine has an efficacy of 79% according to the publication of 29.12.2020; it was approved in China on 30.12.tbdn / aClinicaltrialsarena, ChiCTR, CGTN, Reuters, CNN, South China Morning Post
Sinovac BiotechCoronaVacVaccine with inactivated virusin Phase III in Brazil and other countries since 21.07.2020 (partnership with Instituto Butantan); interim results from studies indicate reliability between 50% and 91%; Hungary has signed supply agreement with Sinovac, according to media reportstbdn / aPr.mitt. Sinovac,, CGTN, Fierce Pharma,, Reuters, Bangkok Post, BBC, CGTN
Beijing Institute of Biological Products / SinopharmtbdDead vaccine (inactivated viruses)in phase IIIin own facilityn / aWHO, Reuters, Asharq Al-Awsat
Natl. Gamaleya Research Centre for Epidemiology and Microbiology (Russia), Ministry of Health of RussiaGam-COVID-Vac = Sputnik VVector virus vaccine (adenovirus)in Phase III trial since 31.08. in Russia, since 28.09. also in Belarus; already approved in Russia after Phase IIby Binnopharm (Russia)n / aSputnik Germany, TASS, AA
CanSino Biologics (China) / Beijing Institute of Biotechnology, Academy of Military Medical Sciences, PLA of ChinaAd5-nCoVVector virus vaccine (adenovirus type 5)in Phase III trials in Pakistan and Russia; trial planned in Saudi Arabia; planned trial in Canada cancelledwith the National Research Council of Canada (NRC) (cell line HEK293) in Montreal (Canada)Government of Canada (for production in Canada)Nature Reviews Drug Discovery, registry entryPr.mitt. Natl. Research Councel Canada, Hindustan Times, Reuters, TrialSiteNews
Janssen (Johnson&Johnson)Ad26.COV2-SVector virus vaccinein Phase III trial since Sept. 23; parts of marketing application in "rolling submission" already submitted to EMA in advance. Phase III trial ongoing in USA, Brazil, Chile, Colombia, Mexico, Peru, South Africa, Ukraine and Philippines. Meanwhile, the Phase II trial is ongoing in the Netherlands, Germany (UKE, Charité Berlin, Uniklinik Rostock) and own facilities in Bümpliz (Switzerland) and Leiden (Netherlands) / by Catalent Biologics (USA) / supplied by Emergent BioSolutions (USA) / supplied for vaccine for clinical trials by Vibalogics (Cuxhaven) / probably also manufactured by Aspen Pharmacare (South Africa)US Biomedical Advanced Research and Development Authority (BARDA)News Johnson&Johnson, Article Johnson&Johnson, Langenthaler Tagblatt, Biopharma Reporter, Biopharma Reporter, FiercePharma, Pr.mitt. Vibalogics Pr.mitt. Janssen, Biopharma Reporter, S&P Global Market Intelligence, MOPO,, Pr.mitt. Janssen, CNN, Reuters, Pr.mitt. EMA
NovavaxNVX-CoV2373Dead vaccine with genetically engineered viral antigen (nanoparticle technology) and saponin-based adjuvantin Phase III trial in UK since end of September, in USA since December; also planned for Mexicoby Emergent BioSolutions (USA) and in future by subsidiary Praha Vaccines (Czech Republic). Adjuvant supplied by AGC Biologics (USA and Denmark) and PolyPeptide Group (USA and Sweden) and antigen by Fujifilm Diosynth (UK) and Biofabri (Spain), SK Bioscience (South Korea) and Takeda Pharmaceuticals (Japan). Filling also by Par Sterlie Products (USA). Under license also antigen production and filling by Serum Institute of India (India).CEPI, US Government (Operation Warp Speed)Pr.mitt. Novavax,, Pr.mitt. Novavax, Novavax quarterly report, ABC News, Pr.mitt. Novavax, Handelsblatt; Pr. mitt. Novavax, pr.mitt . Novavax, NDTV, Reuters
Bharat Biotech / Indian Council of Medical Research / Natl. Institute of Virology (India)Covaxin (BBV152)Vector virus vaccineIn phase III in India since Nov. 12, 2020 (target: 26,000 participants); approved for "emergent use" in India since Jan. 02, 2021, although efficacy results have not yet been publishedn / an / aPr.mitt. Bharat Biotech,, Zeenews, Reuters, NDTV, Hindustan Times
Anhui Zhifei Longcom Biopharmaceutical / Institute of Microbiology, Chinese Academy of Sciencesn / aSubunit vaccine (antigen and adjuvant)in phase III since 30.11.2020n / an / aCNBCTV18, CHICTR
Research Institute for Biological Safety Problems / Natl. Scientific Center for Phthisiopulmonology of the Republic of Kazakhstan (Kazakhstan)QazCovid-inVaccine with inactivated SARS-CoV2in phase III trial in Kazakhstan since 25.12.2020n / an /,
Inovio (USA)INO-4800DNA-based vaccine administered by electroporationsince 16.11.2020 in Phase II part of a Phase II/III trial in the USAby Richter-Helm BioLogics (Germany), VGXI (USA), Ology Bioservices (USA), Advaccine (China, for China); Advaccine also participates in studies and may later commercialize the vaccine in ChinaCEPI, US Department of DefenseInovio, Inovio, registry entry, Pr.mitt. Inovio, Pr. mitt. Inovio, Pr.mitt. Inovio/Advaccine
Medicago (Canada) / GSKCoVLPDead vaccine with virus-like particles from antigens produced in plants and adjuvant from GSKsince 19.11.2020 in phase II part of a phase II/III trial in Canadan / an / aMedicago, Financial News, Pr.mitt. Medicago/GSK
Vector Virology Institute (Russia)EpiVacCoronainactivated vaccine with peptide antigensApproved in Russia on Oct. 14, 2020, following phase II trialn / an / aClinicaltrialsarena,, TASS
CureVacCVnCoVmRNA-based vaccinein Phase IIb/III study in Europe and Latin America since 14.12.2020in own facility in Tübingen; mRNA production also by Wacker in Amsterdam; formulation by Polymun (Austria); filling and packaging by Fareva (France); Tesla will build mobile production facilitiesCEPI, EU Commission, Federal Government (KfW Bank)Pr.mitt. CureVac, Grenzecho, Pr.mitt. CureVac, Pr. mitt. CureVac, dpa, Pr. mitt. CureVac, Fierce Pharma, Mitteldeutsche Zeitung; Pr.mitt. Curevac, FAZ, Pr.mitt. Curevac, Pr. mitt. CureVac and Fareva, Pr.mitt. CureVac, Polymun
AnGes (Japan) / Osaka University / Takara BioAG0302-COVID19DNA-based vaccine with adjuvantin Phase II/III in Japan since November 23rdby Takara Bio Inc. (Japan)n / aJapan Times, Japan Times,,
Shenzhen Kangtai Biological Products / Beijing Minhai Biotechnologyn / ainactivated SARS-CoV-2 (produced with Vero cells)since 27.10. in Phase II in Chinan / an / aCHICTR
Beijing Wantai Biological Pharmacy / Xiamen UniversityDelNS1-2019-nCoV-RBD-OPT1Vector virus vaccine based on influenza virus (intranal spray)in phase II trial in China since approx. 17.11.2020n / an / aCHICTR
West China Hospital, Sichuan Universityrecombinant SARS-CoV-2 vaccine (Sf9 cell)Inactivated vaccine with genetically engineered protein antigen and adjuvantPhase II trial in China since 17.11.2020n / an / aChinese Clinical Trial Registry,
Israel Institute for Biological Research (IIBR) of the Israeli Ministry of DefenseBrilifeVector virus vaccine based on the virus VSVin phase II part(since approx. 16.12.2020) of a phase I/II study in Israeln / an / aThe Jerusalem Post, Haaretz, MENAFM, The Jerusalem Post
AstraZeneca / R-PharmAZD1222Combination of two vector virus vaccines: ChAdOx1 (from AstraZeneca) and rAd26-S (adenovirus type 26 component of the Gam-COVID-Vac vaccine). The vaccines are injected 28 days apart.In phase II (since 29/12/2020) in Azerbaijan.n / an /
Zydus Cadila Healthcare (India)ZyCoV-DDNA-based vaccine (plasmid)In phase I/II since 07/14/2020, in Singapore; phase III trial approved.n / an / aCTRI, News18, Pr.mitt. Zydus Cadila
Arcturus Therapeutics (USA) / DukeNUS Medical School (Singapore)COVID-19 RIGID (ARCT-021)mRNA-based vaccine (self-replicating mRNA)Phase I/II trial in Singapore since Catalent (USA) and Recipharm (headquarters in Sweden); formulation by Polymun (Austria)n / aPM Arcturus Therapeutics, quarterly report Arcturus Therapeutics, Pr.mitt. DukeNUS,, pr.mitt. Recipharm, Polymun
Instituto Finlay de Vacunas (Cuba)FINLAY-FR-1 anti SARS-CoV-2inactivated vaccine with protein antigen and adjuvantPhase I/II study in Cuba since 24.08.2020n / an / aRegistro Público Cubano des Ensayos Clínicos
Sanofi / GSKn / aInactivated vaccine with antigen and adjuvant produced by genetic engineering (with baculoviruses)in phase I/II trial in the USA since 03.09.2020; start of a phase IIb trial planned from February 2021, after revision of the composition of the vaccine with regard to efficacy also in seniorsin own facilities and at Unigen (Japan)U.S. governmentPr.mitt. Sanofi/GSK, Pr.mitt. Sanofi,,
Genexine / Binex / GenNBio / Int. Vaccine Inst. / Korea Advanced Inst. of Science & Technology (KAIST) / Pohang Univ. of Science and Technology (POSTECH)GX-19DNA-based vaccinein phase I/II since 17.06.2020 in South Koreaby Binexn /, Korea Biomedical Review, Reuters
Spy Biotech/Serum Institute of IndiaRBD SARS-CoV-2 HBsAg VLP vaccineSubunit vaccine with genetically engineered viral proteinsin phase I/II trial in Australia since 22.08.2020n / an / aANZCTR
Institute of Medical Biology / Chinese Academy of Medical Sciencesn / aVaccine with inactivated virusPhase I/II in Chinatbdn / aWHO
Institut Pasteur / Themis (an MSD company) / Univ. of PittburghV591 (TMV-083)Vector virus vaccine (based on measles virus)Phase I/II trial in France and Belgium, since 10/08/2020.n / an /
Serum Institute of India / AccelagentbdVaccine with virus-like particles from Receptor Binding Domain (RBD) SARS-CoV-2 and Hepatitis B Surface Antigen (HBsAg)in Phase I/II trial in Australia since 22.08.2020n / an /
Biological E (India)n / aSubunit vaccine using Receptor Binding Domain of SARS-CoV-2 as antigen.Phase I/II study in India since 16.11.2020n / aby CEPICTRI, Pr.mitt. Biological E
Center for Genetic Engineering and Biotechnology (CIGB) (Cuba)CIGB-669Subunit vaccinesince 07.12.2020 in phase I/II study in Cuban / an / aRPCEC
Center for Genetic Engineering and Biotechnology (CIGB) (Cuba)CIGB-66Subunit vaccinein phase I/II trial in Cuba since 07.12.2020n / an / aRPCEC
Valneva (France and UK)VLA2001Vaccine with inactivated viruses, with adjuvantin phase I/II trial, since 16.12.2020 in UKat own plant in Livingston (UK)Government of UKPr.mitt. of UK government, Pr.mitt. of UK government, Pr.mitt. Valneva
Shenzhen Geno-Immune Medical InstituteLV-SMENP-DCVaccine with dendritic cellssince 24.03.2020 in phase I/II in Chinan / an /
Nanogen Biopharmaceutical (Vietnam)NanocovaxSubunit vaccine with recombinant antigen + adjuvantPhase I/II study since 10.12.2020 in Vietnamn / an / aNanogen, Nanogen
Shionogin / aSubunit vaccine with viral antigen and adjuvant produced by genetic engineering (with baculoviruses)Phase I/II study since approx. 15.12.2020 in Japanby Api Co., Ltd, through its company UNIGEN Inc.n / aPr.mitt. Shionogi
Imperial College London / VacEquity Global HealthLNP-nCoVsaRNARNA-based vaccine (with self-propagating RNA)in Phase I; Phase III trial involving Indonesian medical institutions is plannedtbd; multiple manufacturers planned; formulation by Polymun (Austria)Government of UK, COVID-19 Response Fund of Imperial College London Alumni, Morningside Ventures (Hong Kong)Imperial College, Imperial College, Thomson Reuters Foundation News; Imperial College London, Imperial College London, Imperial College London, Polymun
Beijing Minhai BiotechnologySARS-CoV-2 Vaccine (Vero Cells)Vaccine with inactivated virus propagated in Vero cellsPhase I in Chinatbdn / aWHO
Clover Biopharmaceuticals / GSK / DynavaxSCB-2019Subunit vaccine (antigen: genetically engineered trimeric spike protein; adjuvant: either from GSK or from Dynavax)Phase I in Australia since mid-June with positive results; Phase II/III trial with GSK adjuvanted version of vaccine plannedin own facility in ChinaCEPICanberra Times, Reuters, Pr.mitt. Clover, Fierce,
Walvax Biotechnology / People's Liberation Army (PLA) Academy of Military Sciences / Suzhou Abogen BiosciencesARCoVmRNA-based vaccinein phase I since 02.07.2020 in Adelaide, Australian / an / aChina Global Television Network Online
Vaxine (Australia) / Medytox / Flinders University (Australia)COVAX-19Inactivated vaccine with genetically engineered viral proteinPhase I (conducted in China) completed; Phase II plannedn / an / aABC News,
ReiThera (Italy) / Leukocare (Germany) / Univercells (Belgium)GRAd-COV2Vector virus vaccine (Gorilla Adenoviral Vector)in Phase I since 24.08., in Italyin Belgium at UnivercellsItalian Ministry of Research with the CNR and the Lazio RegionPr.mitt. ReiThera/Leukocare/Univercells, Rainews, BioSpace, Pr.mitt. Reithera
Adimmune (Taiwan)AdimrSC-2fSubunit vaccine with adjuvantIn Phase I trial since Aug. 24, 2020 in Taiwan.n / an /
COVAXXUB-612 COVID-19 vaccinePeptide-based vaccine (multitope vaccine)in phase I trial in Taiwan since approx. 01.09.2020; phase I/II trials in the USA and phase II/III trials in Brazil plannedn / an /, Pr.Mitt. COVAXX; Pr.mitt. COVAXX
German Center for Infection Research (DZIF) / Univ. Munich / Univ. Marburg / UKEMVA-SARS-2-SVector virus vaccine based on MVA virusesIn phase I trial since beginning of October at the University Hospital Eppendorf, Hamburg. Insufficient immunization was found. Possibilities for improvement are being IDT Biologika (Dessau-Roßlau)BMBF (supports production and study capacity)Pr.mitt. of the consortium, Pr.Mitt. IDT Biologika, Mitteldeutsche Zeitung, Hamburger Morgenpost,; Pr.mitt. DZIF, NDR, Pr.mitt. DZIF
VaxartVXA-CoV2-1tablet-based vector virus vaccine (based on adenovirus)in Phase I since October in the USAn / aUS government (Operation Warpspeed)bioRXiv; Pr.mitt. Vaxart,
Medigen with National Institutes of Health (USA) and DynavaxMVC-COV1901Subunit vaccine with adjuvant CpG 1018in Phase I in Taiwann / aGovernment of TaiwanAA, pipeline review
ImmunityBio / NantKwesthAd5-S-Fusion+N-ETSDVector virus vaccine based on an adenovirus with two SARS-CoV-2 phase I in the USA since 19.10.2020n / an / aPr.mitt. ImmunityBio,
MSD and IAVIV590Vector virus vaccine based on the virus rVSVin Phase I study in the USA since 30.10.2020tbdDefense Threat Reduction Agency (DTRA) of the U.S. Department of Defense, BARDA (U.S.), the Japanese government (planned), World Bank (planned).Pr.mitt. MSD, IAVI, Pr.mitt. IAVI,
Symvivo (Canada)bacTRLVaccine with genetically modified bifidobacteriain Phase I trial in Australian / an / aSymvivo
Instituto Finlay de Vacunas (Cuba)FINLAY-FR-2 anti SARS-CoV-2Inactivated vaccine with protein antigen chemically linked to tetanus toxoidPhase I trial in Cuba since 02/11/2020.n / an / aRegistro Público Cubano des Ensayos Clínicos
TC Erciyes University (Turkey)ERUCOV-VACVaccine with inactivatedPhase I study since 05.11.2020 in Turkey.n / an / aThe Hindu Business Line, COVIDVAX
City of Hope Medical Center /National Cancer Institute of the USACOH04S1Vector virus vaccine based on MVA virusesIn phase I, since approx. 25.11.2020 in the U.S.n / an / aPr.mitt. City of Hope
University Hospital TübingenP/T-pVAC-SARS-CoV-2inactivated vaccine with SARS-CoV-2 HLA-DR peptidesin phase I, since 27.11.2020 in Tübingencurrently at the University of TübingenState government of Baden-WürttembergState government of Baden-Württemberg,, Pr.mitt. University Hospital Tübingen
CodagenixCOVI-VACLive vaccine with attenuated SARS-CoV-2 virusesPhase I study since 11.12.2020 in UKn / an /
Shifa Pharmed (Iran)CoviranVaccine with inactivated SARS-CoV-2 virusesPhase I trial started in Iran on Dec. 29, 2020.n / an / aThe Hindu
Kentucky Bioprocessing (USA)KBP-COVID-19Subunit-tot vaccine with genetically engineered antigens (produced in tobacco)Phase I trial in the USA since December 2020n / an /, Bloomberg,, Pr.mitt. BAT
Shenzhen Geno-Immune Medical InstituteCovid-19/aAPC vaccineVaccine with artificial antigen presenting cells (aAPCs)since 15.02.2020 in phase I in Chinan / an / a
Entos PharmaceuticalsCovigenix VAX-001DNA-based vaccinePhase I study plannedn / an /
Chulalongkorn University (Thailand)ChulaCov19mRNA-based vaccineStart of Phase I trial delayed as production is delayedn / aFundraising campaign in the population of ThailandFortune,, International SOS, report Chulalongkorn University,
Providence Health & Services / OncoSec Medical IncorporatedCORVaxVaccine with DNA plasmid containing gene for spike proteinPhase I study planned in the USAn / an /
Aivitan / aDendritic cell vaccinePhase I study plannedn / an /
AltimmuneAdCOVIDVector virus vaccine administered as a nasal sprayPhase I trial plannedn / an /,Pr.mitt.
University Groningen / Akston BiosciencesAKS-452VaccinePhase I/II study planned in the Netherlandsn / an /

Only one vaccine project has been terminated prematurely after clinical trials: by University of Queensland and CSL. Although the vaccine stimulated the immune system in an appropriate way, it led to false positive results in HIV tests. This led to the decision to terminate the project.

Regulatory requirements for Covid 19 vaccines

An ideal Corona vaccine would achieve complete and lifelong protection against infection with SARS-CoV-2 in everyone vaccinated with it, with few and mild side effects. However, no vaccine will fully achieve this ideal goal.

For EU countries, the European Medicines Agency (EMA) is responsible for approving Covid 19 vaccines, but Member State authorities play a key role in the approval process. They have previously advised vaccine developers and approved clinical trials of vaccine candidates if they were to be conducted in their country.

The EMA, like the US Food and Drug Administration (FDA), insists first and foremost that Covid 19 vaccines are safe and that this has been convincingly demonstrated in large clinical trials. The FDA has announced that it will require an efficacy of at least 50 percent, meaning that no more than half as many of a larger group of vaccinated people will contract the disease as in a comparable group of unvaccinated people. The EMA has not yet made a determination in this regard. However, with their high efficacy rates of 95% and 94%, the first two vaccines submitted for approval have already far exceeded this threshold.

The EMA prioritizes all regulatory submissions for Covid 19 vaccines or therapeutics. In addition, the EMA offers a "rolling submission" option that allows companies to submit some chapters of their marketing authorization application for processing while the Phase III trial is still ongoing. Five companies (BioNTech/Pfizer, Moderna, AstraZeneca and Janssen) have already made use of this option.

The FDA and EMA, on the other hand, did not consider approval based on the results of Phase II trials. On September 8, 2020, nine Western pharmaceutical companies, which are already testing their vaccines with volunteers, also announced that they would not compromise on safety and ethical standards when testing their vaccines and would only apply for approval on the basis of Phase III results.

For the Phase III trials, the EMA, the FDA and other medicine regulatory authorities that are members of the ICMRA have agreed on a detailed list of requirements. According to this, several thousand participants are to be recruited for each of these trials, including people older than 55 years and those with concomitant diseases. Participants who have not yet been infected with SARS-CoV-2 are to be recruited in the main, and the degree of reliability of the vaccine is to be calculated only on the basis of their results. Nevertheless, the vaccine will also be tested with people who have already survived a SARS-CoV-2 infection. This is to ensure that there is no safety problem after approval if such individuals are also vaccinated. Whether or not pregnant women are eligible to participate in a particular Phase III trial will be decided on a case-by-case basis for each vaccine candidate, based primarily on animal test results. In all Phase III studies, interim evaluations are to be carried out in order to be able to identify possible risks or insufficient efficacy at an early stage, as well as the proof of efficacy that has been provided.

A vaccine can only be approved for minors if it has also been tested with them. However, most manufacturers will not start this process until the Phase III trial with adults has produced results on efficacy and tolerability that are suitable for approval. One exception is the company duo BioNTech/Pfizer, who have set up two arms with participants aged 12 to 18 years in their first Phase III study (one arm with the real vaccination, one arm with the sham vaccination). However, usable results from these arms are still pending, at least for participants under 16 years of age. For more on ongoing and planned vaccine trials with minors, see the article "How Covid-19 vaccines are being tested."

The first two covid-19 vaccines in the EU are therefore expected to be licensed only from 18 years of age or at most from 16 years of age.

The first companies and research institutes have already announced plans to expand their production capacity for a Covid-19 vaccine. Manufacturers Janssen (Johnson & Johnson), Kentucky BioProcessing, Moderna/Lonza, BioNTech/Pfizer as well as Oxford University, the Serum Institute of India, AstraZeneca and the ReiThera/Leukocare/Univercells consortium will furthermore already produce their vaccines on a large scale, while testing with volunteers is still ongoing - even at the risk of having to dispose of the produced goods if the study results turn out to be negative. CureVac announced in mid-May that it had already produced larger quantities of the main component of its active ingredient (mRNA) - although testing with volunteers has not even begun.

Production for world demand

Many companies have expanded their production capacities and recruited contract manufacturers to supply components or take over individual manufacturing steps.

Other companies not working on their own Covid 19 vaccine have offered to support the production of other companies' vaccines, such as Japan's Takeda.

In the UK, for its part, the development of the Vaccine Manufacturing and Innovations Centre in Oxfordshire is being accelerated. This non-commercial facility is expected to produce a vaccine against Covid-19 from the end of 2021. It will be partly government-funded, with Janssen, MSD and Cytiva as backers.

In the meantime, the availability of filling facilities and puncture vials has been identified as a possible bottleneck to supply. For this reason, the German government, for example, wants to support the expansion of such filling facilities with up to 250 million euros (in addition to vaccine development). As far as glassware is concerned, three major suppliers and the Coalition for Epidemic Preparedness (CEPI) (see below) have promised sufficient capacity.

Several manufacturers have announced that they will supply their vaccines against Covid-19 on a no-profit basis as long as the pandemic persists. The price is thus to be based on the costs incurred by the manufacturer itself.

Worldwide access to COVID-19 vaccines

The vaccines are needed in every country. On September 30, the Bill and Melinda Gates Foundation and 16 pharmaceutical and diagnostics companies countered concerns about focusing vaccine development solely on the needs and opportunities of the developed world with the statement "Commitments to Expanded Global Access for COVID-19 Diagnostics, Therapeutics, and Vaccines." Signatories are committed to developing innovations for patients worldwide, working toward affordability and rapid availability for all countries, supporting mechanisms for fair global resource allocation such as the COVAX Facility, and building confidence in Covid-19 vaccines (as well as therapeutics and diagnostics) by making user safety the paramount requirement for any product.

More on the COVAX Facility can be found here.

Types of vaccines

Companies and research institutes are working towards different vaccines. Most of their projects target one of the following three types of vaccines:

Live vaccines with vector viruses: Several projects use well-known, harmless viruses as a starting point, for example the "Modified Vaccinia Virus Ankara" (MVA), the adenovirus serotype 26 or the virus from measles vaccine. Such so-called vector viruses can multiply in humans without causing disease. It is also known how they can be produced in large quantities in cell cultures. Now researchers are adding one or more genes for surface proteins of SARS-CoV-2 to them. Some vector viruses are "disguised" in this way because they then carry these proteins themselves on their surface and can thus fool the immune system into thinking they have a Covid-19 infection. Other vector viruses do not look like SARS-CoV-2, but induce the production of the SARS-CoV-2 proteins in cells they have invaded. In both cases, this leads to the build-up of immune protection that can also fight off a real infection - or so the plan goes. Based in each case on a vector virus, the first licensed Ebola vaccines, the first dengue vaccine and other experimental vaccines have also been developed. Vector virus vaccines are now being developed by, for example, Janssen, the German Centre for Infection Research (DZIF), the University of Oxford with AstraZeneca, the IAVI / MSD collaboration and the ReiThera / Leukocare / Univercells consortium.

Inactivated Vaccines with Viral Proteins: These vaccines either contain selected viral proteins (such as at Novavax, Greffex, the University of Queensland, UMN Pharma (subsidiary of Shionogi) and Sanofi / GSK); or they contain the whole material of inactivated SARS-CoV-2 viruses (such as at Beijing Institute of Biological Products / Sinopharm). Thus, they are essentially based on long-proven technology: very many approved vaccines are composed in this way; for example, those against hepatitis B or influenza. However, it may be easier to produce large quantities of vaccine units quickly with other vaccines. However, this will only become clear when the time comes.

RNA vaccines: These vaccines contain a selected gene of the virus in the form of RNA, or more precisely, the form of RNA in which transcripts of individual genes that are required for protein production are produced in all living cells: messenger RNA (mRNA for short). After injection, the mRNA from the vaccine is supposed to induce the production of (harmless) viral protein in the body, which then in turn causes the build-up of immune protection, just as with a conventional vaccine. mRNA vaccines have the advantage that many injection doses can be produced from them very quickly. However, no such vaccine against any disease is yet on the market. Companies and institutes developing such vaccines against Covid-19 include BioNTech/Pfizer, Moderna, CureVac, Arcturus Therapeutics and eTheRNA. The way these vaccines work is explained in more detail in this video from #EUmythbusters.
- Similarly, vaccines that contain a piece of DNA with a viral gene instead of mRNA also work; the companies working on this include Inovio, the Genexine consortium and the OpenCorona consortium led by the Swedish Karolinska Institute and with the participation of the University of Giessen. So far, however, no DNA-based Covid 19 vaccine has progressed beyond Phase I.

Application forms
There are also differences in the forms of application. Although most projects are aimed at injectable vaccines, there are exceptions:

The Coalition for Epidemic Preparedness Innovations (CEPI)

Several vaccine projects are financially supported by CEPI, the Coalition for Epidemic Preparedness Innovations. They are the projects of:

Das Bild zeigt eine symbolische Impfstoffflasche mit der Aufschrift Coronavirus Vaccine sowie eine Spritze, beides gehalten von einer Hand, die einen blauen Schutzhandschuh trägt.

Does a tuberculosis vaccination help against Covid-19?

It is possible that other vaccines can help to protect against infection, even though they were not developed against coronaviruses: Tuberculosis vaccines. The idea behind this: Vaccinations with these vaccines increase the general immune defence against germs and could therefore also help people to ward off SARS-CoV-2 or at least not to fall so seriously ill with it.

The suitability of the old tuberculosis vaccine BCG is to be tested at clinics in Nijmegen and Utrecht (Netherlands). This vaccine has not been used in Germany for a long time.

In Germany, the companies Vakzine Projekt Management (Germany) and Serum Institute of India are running trials to test the newer tuberculosis vaccine VPM1002, which has not yet been approved because final studies against tuberculosis are still ongoing. The Covid-19 trials are being conducted at several German clinics with the elderly and with healthcare workers. The vaccine was originally developed at the Max Planck Institute for Infection Biology in Berlin.

(1) are "boosters" for vaccines that, among other things, can allow significantly less viral protein per injection of vaccine to be sufficient for immunization or more doses of injection to be produced with a given amount of viral protein produced.