SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causesCOVID-19, was isolated in late 2019.[1] Itsgenetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten the development of a preventiveCOVID-19 vaccine.[2][3][4] Since 2020, vaccine development has been expedited via unprecedented collaboration in themultinational pharmaceutical industry and between governments.[5] By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection.[3][6][7][8] According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development shows North American entities to have about 40% of the activity, compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.[2][5]
In February 2020, theWorld Health Organization (WHO) said it did not expect a vaccine against SARS‑CoV‑2 to become available in less than 18 months.[9] Virologist Paul Offit commented that, in hindsight, the development of a safe and effective vaccine within 11 months was a remarkable feat.[10] The rapidly growing infection rate of COVID‑19 worldwide during 2020 stimulated international alliances and government efforts to urgently organize resources to make multiple vaccines on shortened timelines,[11] with four vaccine candidates entering human evaluation in March (seeCOVID-19 vaccine § Clinical research).[2][12]
On 24 June 2020, China approved the CanSino vaccine for limited use in the military and two inactivated virus vaccines for emergency use in high-risk occupations.[13] On 11 August 2020, Russia announced the approval of its Sputnik V vaccine for emergency use, though one month later only small amounts of the vaccine had been distributed for use outside of the phase 3 trial.[14]
On 31 March 2021, the Russian government announced that they had registered the first COVID‑19 vaccine for animals.[30] NamedCarnivac-Cov, it is an inactivated vaccine for carnivorous animals, including pets, aimed at preventing mutations that occur during the interspecies transmission of SARS-CoV-2.[31]
In October 2022, China began administering an oral vaccine developed byCanSino Biologics using its adenovirus model.[32]
Since 2020, vaccine development has been expedited via unprecedented collaboration in themultinational pharmaceutical industry and between governments.[5] According to the Coalition for Epidemic Preparedness Innovations (CEPI), the geographic distribution of COVID‑19 vaccine development puts North American entities having about 40% of the activity compared to 30% in Asia and Australia, 26% in Europe, and a few projects in South America and Africa.[5][2]
Commitment to first-in-human testing of a vaccine candidate represents a substantial capital cost for vaccine developers, estimated to be fromUS$14million toUS$25million for a typical PhaseI trial program, but possibly as much asUS$70million.[35][36] For comparison, during theEbola virus epidemic of 2013–16, there were 37 vaccine candidates in urgent development with only one becoming a licensed vaccine at a total cost to confirm efficacy in PhaseII–III trials of aboutUS$1billion.[35]
TheAccess to COVID-19 Tools Accelerator (ACT Accelerator or ACT-A), or theGlobal Collaboration to Accelerate the Development, Production and Equitable Access to New COVID-19 diagnostics, therapeutics and vaccines, is aG20 initiative announced by pro-tem ChairMohammed al-Jadaan on 24 April 2020.[37] A call to action was published simultaneously by theWorld Health Organization (WHO) on 24 April.[38] As of January 2022, it was the largest international effort to achieve equitable access to COVID-19 health technologies.[39]
Canada announcedCA$275million in funding for 96 vaccine research projects at Canadian companies and universities, with plans to establish a "vaccine bank" that could be used if another coronavirus outbreak occurs.[40][41] A further investment ofCA$1.1billion was added to support clinical trials and develop manufacturing and supply chains for vaccines.[42] On 4May, the Canadian government committedCA$850million to the WHO's live streaming effort to raiseUS$8billion for COVID‑19 vaccines and preparedness.[43]
China provided low-rate loans to a vaccine developer through itscentral bank and "quickly made land available for the company" to build production plants.[44] As of June 2020, six of the eleven COVID‑19 vaccine candidates in early-stage human testing were developed by Chinese organizations.[45] Three Chinese vaccine companies and research institutes are supported by the government for financing research, conducting clinical trials, and manufacturing the most promising vaccine candidates, prioritizing rapid evidence of efficacy over safety.[46] On 18 May, China had pledgedUS$2billion to support overall efforts by the WHO for programs against COVID‑19.[47] On 22 July, China announced plans to provide a US$1 billion loan to make its vaccine accessible for Latin America and theCaribbean.[48] On 24 August,Chinese PremierLi Keqiang announced it would provide Cambodia, Laos, Myanmar, Thailand, and Vietnam priority access to the vaccine once it was distributed.[49]
USGovernment Accountability Office diagram comparing a traditional vaccine development timeline to a safe, possible expedited method timeline.
Great Britain formed a COVID‑19 vaccinetask force in April 2020, to stimulate local efforts for accelerated development of a vaccine through collaborations of industry, universities, and government agencies. It encompassed every phase of development from research to manufacturing.[50] The vaccine development initiatives at the University of Oxford andImperial College of London were financed with£44million.[51][52]
In the United States, theBiomedical Advanced Research and Development Authority (BARDA), a federal agency funding disease-fighting technology, announced investments of nearlyUS$1billion to support American COVID‑19 vaccine development and manufacture of the most promising candidates. On 16 April, BARDA made aUS$483million investment in vaccine developerModerna and its partner,Johnson & Johnson.[44][53] BARDA has earmarked an additionalUS$4billion for development. It will have a role in other programs for development of six to eight vaccine candidates destined for clinical study into 2021 by companies such asSanofi Pasteur andRegeneron.[53][54] On 15 May, the government announced funding for a fast-track program calledOperation Warp Speed to place multiple vaccine candidates into clinical trials by the fall of 2020 and manufacture 300million doses of a licensed vaccine by January 2021. The project's chief advisor isMoncef Slaoui and its chief operating officer is GeneralGustave Perna.[55][56] In June, the Warp Speed team said it would work with seven companies developing vaccine candidates:Moderna,Johnson & Johnson,Merck,Pfizer, theUniversity of Oxford in collaboration withAstraZeneca, and two others,[57] although Pfizer later stated that "all the investment for R&D was made by Pfizer at risk."[58]
Large pharmaceutical companies with experience in making vaccines at scale, including Johnson & Johnson, AstraZeneca, andGlaxoSmithKline (GSK), formed alliances withbiotechnology companies, governments, and universities to accelerate progression to an effective vaccine.[44][45] To combine financial and manufacturing capabilities for a pandemic withadjuvanted vaccine technology, GSK joined withSanofi in an uncommon partnership ofmultinational companies to support accelerated vaccine development.[59]
By June 2020, tens of billions of dollars were invested by corporations, governments, international health organizations, and university research groups to develop dozens of vaccine candidates and prepare for global vaccination programs to immunize against COVID‑19 infection.[3][6][7][8] The corporate investment and need to generate value for public shareholders raised concerns about a "market-based approach" in vaccine development, costly pricing of eventual licensed vaccines, preferred access for distribution first to affluent countries, and sparse or no distribution to where the pandemic is most aggressive, as predicted for densely populated, impoverished countries unable to afford vaccinations.[3][45][7] The collaboration of the University of Oxford with AstraZeneca (a global pharmaceutical company based in the UK) raised concerns about price and sharing of eventual profits from international vaccine sales, arising from whether the British government and university as public partners had commercialization rights.[8] AstraZeneca stated that initial pricing of its vaccine would not include aprofit margin for the company while the pandemic was still expanding.[8]
In June, AstraZeneca made aUS$750 million deal allowing CEPI andGavi, the Vaccine Alliance to manufacture and distribute 300 million doses if its Oxford vaccine candidate proved to be safe and effective, reportedly increasing the company's total production capacity to over 2 billion doses per year.[60] Commercialization of pandemic vaccines is a high-risk business venture, potentially losing billions of dollars in development and pre-market manufacturing costs if the candidate vaccines fail to be safe and effective.[3][44][45][6] Pfizer indicated it was not interested in a government partnership, considering it to be a "third party" slowing progress.[61] Further, there are concerns that rapid-development programs – like Operation Warp Speed – are choosing candidates mainly for their manufacturing advantages rather than optimal safety and efficacy.[61]
CEPI classifies development stages for vaccines as "exploratory" (planning and designing a candidate, having no evaluationin vivo), "preclinical" (in vivo evaluation with preparation for manufacturing a compound to test in humans), orinitiation of PhaseI safety studies in healthy people.[5] Some 321 total vaccine candidates were in development as either confirmed projects in clinical trials or in early-stage "exploratory" or "preclinical" development, as of September.[5]
NIAID (NIH) scientist researching COVID‑19 vaccine examines agar plate. (30 January 2020)
After a coronavirus was isolated in December 2019,[1] itsgenetic sequence was published on 11 January 2020, triggering an urgent international response to prepare for an outbreak and hasten development of a preventive vaccine.[2][3][4]
In February 2020, the WHO said it did not expect a vaccine againstsevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative virus, to become available in less than 18 months.[9] The rapidly growing infection rate of COVID‑19 worldwide during 2020 stimulated international alliances and government efforts to urgently organize resources to make multiple vaccines on shortened timelines,[11] with four vaccine candidates entering human evaluation in March (see the table ofclinical trials started in 2020, below).[2][12]
By April 2020, "almost 80 companies and institutes in 19 countries" were working on this virtual gold rush.[62] Also in April, CEPI estimated that as many as six of the vaccine candidates against COVID‑19 should be chosen by international coalitions for development through PhaseII–III trials, and three should be streamlined through regulatory and quality assurance for eventual licensing at a total cost of at leastUS$2billion.[5][12][63] Another analysis estimates ten candidates will need simultaneous initial development, before a select few are chosen for the final path to licensing.[63]
NIAID (NIH) scientist researching COVID‑19 vaccine. (30 January 2020)
In April 2020, the WHO issued a statement representing dozens of vaccine scientists around the world, pledging collaboration to speed development of a vaccine against COVID‑19.[67] The WHO coalition is encouraging international cooperation between organizations developing vaccine candidates, national regulatory and policy agencies, financial contributors, public health associations, and governments, for eventual manufacturing of a successful vaccine in quantities sufficient to supply all affected regions, particularly low-resource countries.[2]
Industry analysis of past vaccine development shows failure rates of 84–90%.[2][68] Because COVID‑19 is a novel virus target with properties still being discovered and requiring innovative vaccine technologies and development strategies, the risks associated with developing a successful vaccine across all steps of preclinical and clinical research are high.[2]
To assess the potential for vaccine efficacy, unprecedented computer simulations and new COVID‑19-specific animal models are being developed multinationally.[69] Of the confirmed active vaccine candidates, about 70% are being developed by private companies, with the remaining projects under development by academic, government coalitions, and health organizations.[5] Historically, the probability of success for an infectious disease vaccine candidate to pass preclinical barriers and reach PhaseI of human testing is 41–57%.[35]
The rapid development and urgency of producing a vaccine for the COVID‑19 pandemic may increase the risks and failure rate of delivering a safe, effective vaccine.[70][2][71] One study found that between 2006 and 2015, the success rate of obtaining approval from PhaseI to successful PhaseIII trials was 16.2% for vaccines,[68] and CEPI indicates a potential success rate of only 10% for vaccine candidates in 2020 development.[2]
Early research to assess vaccine efficacy using COVID‑19-specific animal models, such asACE2-transgenic mice, other laboratory animals, and non-human primates, indicates a need forbiosafety-level3 containment measures for handling live viruses, and international coordination to ensure standardized safety procedures.[70][2]
Although the quality and quantity ofantibody production by a potential vaccine is intended to neutralize the COVID‑19 infection, a vaccine may have an unintended opposite effect by causingantibody-dependent disease enhancement (ADE), which increases the virus attachment to its target cells and might trigger acytokine storm if a vaccinated person is later attacked by the virus.[70][74] The vaccine technology platform (for example,viral vector vaccine,spike (S) protein vaccine orprotein subunit vaccine), vaccine dose, timing of repeat vaccinations for the possible recurrence of COVID‑19 infection, and elderly age are factors determining the risk and extent of ADE.[70][74] The antibody response to a vaccine is a variable of vaccine technologies in development, including whether the vaccine has precision in its mechanism,[70] and choice of the route for how it is given (intramuscular,intradermal, oral, or nasal).[74]
Prior to the pandemic, ADE was observed in animal studies of laboratory rodents with vaccines forSARS-CoV, the virus that causes severe acute respiratory syndrome (SARS). Researchers therefore emphasized the need to carefully assess the potential for ADE to occur with COVID-19.[75][76]However, as of 27 January 2022[update] there have been no observed incidences with vaccines for COVID-19 in trials with nonhuman primates, in clinical trials with humans, or following the widespread use of approved vaccines.[33][77][76]
Volunteer receives CoronaVac injection during Phase III trial by Sinovac in Indonesia.
In April 2020, the WHO published an "R&D Blueprint (for the) novel Coronavirus" (Blueprint). The Blueprint documented a "large, international, multi-site, individually randomized controlled clinical trial" to allow "the concurrent evaluation of the benefits and risks of each promising candidate vaccine within 3–6 months of it being made available for the trial." The Blueprint listed aGlobal Target Product Profile (TPP) for COVID‑19, identifying favorable attributes of safe and effective vaccines under two broad categories: "vaccines for the long-term protection of people at higher risk of COVID‑19, such as healthcare workers", and other vaccines to provide rapid-response immunity for new outbreaks.[11] The international TPP team was formed to 1) assess the development of the most promising candidate vaccines; 2) map candidate vaccines and their clinical trial worldwide, publishing a frequently updated "landscape" of vaccines in development;[78] 3) rapidly evaluate and screen for the most promising candidate vaccines simultaneously before they are tested in humans; and 4) design and coordinate a multiple-site, internationalrandomized controlled trial – the "Solidarity trial" for vaccines[11][79] – to enable simultaneous evaluation of the benefits and risks of different vaccine candidates under clinical trials in countries where there are high rates of COVID‑19 disease, ensuring fast interpretation and sharing of results around the world.[11] The WHO vaccine coalition will prioritize which vaccines should go into Phase II and III clinical trials, and determine harmonized PhaseIII protocols for all vaccines achieving thepivotal trial stage.[11]
PhaseI trials test primarily for safety and preliminary dosing in a few dozen healthy subjects, while PhaseII trials – following success in PhaseI – evaluateimmunogenicity, dose levels (efficacy based onbiomarkers) and adverse effects of the candidate vaccine, typically in hundreds of people.[80][81] A PhaseI–II trial consists of preliminary safety and immunogenicity testing, is typically randomized, placebo-controlled, while determining more precise, effective doses.[81] PhaseIII trials typically involve more participants at multiple sites, include acontrol group, and test effectiveness of the vaccine to prevent the disease (an "interventional" orpivotal trial), while monitoring foradverse effects at the optimal dose.[80][81] Definition of vaccine safety, efficacy, andclinical endpoints in a PhaseIII trial may vary between the trials of different companies, such as defining the degree of side effects, infection or amount of transmission, and whether the vaccine prevents moderate or severe COVID‑19 infection.[82][83][84] Phase III trials of AstraZeneca's intervention started 28 August 2020 and ended 5 March 2021.[85]
In January 2022 'Moderna' and 'Pfizer' both started trials of vaccine tailored to immunize against theOmicron variant.[86]
Vaccine developers have to invest resources internationally to find enough participants for PhaseII–III clinical trials when the virus has proved to be a "moving target" of changing transmission rate across and within countries, forcing companies to compete for trial participants.[82] As an example in June, the Chinese vaccine developer Sinovac formed alliances inMalaysia, Canada, the UK, and Brazil among its plans to recruit trial participants and manufacture enough vaccine doses for a possible PhaseIII study in Brazil where COVID‑19 transmission was accelerating during June.[82] As the COVID‑19 pandemic within China became more isolated and controlled, Chinese vaccine developers sought international relationships to conduct advanced human studies in several countries, creating competition for trial participants with other manufacturers and the international Solidarity trial organized by the WHO.[82] In addition to competition over recruiting participants, clinical trial organizers may encounter people unwilling to be vaccinated due tovaccine hesitancy[87] or disbelieving the science of the vaccine technology and its ability to prevent infection.[88]
Having an insufficient number of skilled team members to administer vaccinations may hinder clinical trials that must overcome risks for trial failure, such as recruiting participants in rural or low-density geographic regions, and variations of age, race, ethnicity, or underlying medical conditions.[82][89]
Eligibility criteria for AstraZeneca's Phase III trial included: Ages, 18 to 130 Years, All Sexes, and Healthy Volunteers. Inclusion Criteria specified, Increased risk of SARS-CoV-2 infection and medically stable. Exclusion criteria included; 1) confirmed or suspected immunosuppressive or immunodeficient state, 2) significant disease, disorder, or finding, and 3) Prior or concomitant vaccine therapy for COVID‑19.[85]
A clinical trial design in progress may be modified as an"adaptive design" if accumulating data in the trial provide early insights about positive or negative efficacy of the treatment.[90][91] The WHO Solidarity trial of multiple vaccines in clinical studies during 2020, will apply adaptive design to rapidly alter trial parameters across all study sites as results emerge.[79] Candidate vaccines may be added to the Solidarity trial as they become available if priority criteria are met, while vaccine candidates showing poor evidence of safety or efficacy compared to placebo or other vaccines will be dropped from the international trial.[79]
Adaptive designs within ongoing PhaseII–III clinical trials on candidate vaccines may shorten trial durations and use fewer subjects, possibly expediting decisions for early termination or success, avoiding duplication of research efforts, and enhancing coordination of design changes for the Solidarity trial across its international locations.[79][90]
Challenge studies are a type of clinical trial involving the intentional exposure of the test subject to the condition tested, an approach that can significantly accelerate vaccine development.[92][93][94][95] Human challenge studies may be ethically controversial because they involve exposing test subjects to dangers beyond those posed by potentialside effects of the substance being tested.[93][94] Challenge studies have been used for diseases less deadly than COVID‑19 infection, such as common influenza,typhoid fever,cholera, andmalaria.[94][95] The World Health Organization developed a guidance document with criteria for conducting COVID‑19 challenge studies in healthy people, including scientific and ethical evaluation, public consultation and coordination, selection andinformed consent of the participants, and monitoring by independent experts.[96] Beginning in January 2021, dozens of young adult volunteers will be deliberately infected with COVID‑19 in a challenge trial conducted in a London hospital under management by the British government COVID‑19 Vaccine Taskforce.[97] Once an infection dose of COVID‑19 is identified, two or more of the candidate COVID‑19 vaccines will be tested for effectiveness in preventing infection.[97][needs update]
At the beginning of the COVID‑19 pandemic in 2020, the WHO issued a guideline as an Emergency Use Listing of new vaccines, a process derived from the 2013–16Ebola epidemic.[98] It required that a vaccine candidate developed for a life-threatening emergency be manufactured using GMP and that it complete development according to WHO prequalification procedures.[98]
Even as new vaccines are developed during the COVID‑19 pandemic, licensure of COVID‑19 vaccine candidates requires submission of a full dossier of information on development and manufacturing quality. In the UK and the EU, companies may use a "rolling review process", supplying data as they become available during Phase III trials, rather than developing the full documentation over months or years at the end of clinical research, as is typical. This rolling process allows theUK's regulator (MHRA) and the European Committee for Medicinal Products for Human Use to evaluate clinical data in real time, enabling a promising vaccine candidate to be approved on a rapid timeline by both the UK's MHRA and theEuropean Medicines Agency (EMA).[99] A rolling review process for the Moderna vaccine candidate was initiated in October byHealth Canada and the EMA,[100] and in November in Canada for the Pfizer-BioNTech candidate.[101]
On 24 June 2020, China approved the CanSino vaccine for limited use in the military and two inactivated virus vaccines for emergency use in high-risk occupations.[13] On 11 August 2020, Russia announced the approval of its Sputnik V vaccine for emergency use, though one month later only small amounts of the vaccine had been distributed for use outside of the phase 3 trial.[14] In September, theUnited Arab Emirates approved emergency use of theSinopharm BIBP vaccine for healthcare workers,[102] followed by similar emergency use approval fromBahrain in November.[103]
In the United States, anEmergency Use Authorization (EUA) is "a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID‑19 pandemic."[104] Once an EUA is issued by the FDA, the vaccine developer is expected to continue the Phase III clinical trial to finalize safety and efficacy data, leading to application for licensure (approval) in the United States.[104] In mid-2020, concerns that the FDA might grant a vaccine EUA before full evidence from a Phase III clinical trial was available raised broad concerns about the potential for lowered standards in the face of political pressure.[105][106][107] On 8 September 2020, nine leading pharmaceutical companies involved in COVID‑19 vaccine research signed a letter, pledging that they would submit their vaccines for emergency use authorization only after Phase III trials had demonstrated safety and efficacy.[108]
Pfizer-BioNTech COVID-19 vaccine.
The Pfizer-BioNTech partnership submitted an EUA request to the FDA for the mRNA vaccine BNT162b2 (active ingredienttozinameran) on 20 November 2020.[15][16] On 2 December 2020, the United Kingdom'sMedicines and Healthcare products Regulatory Agency (MHRA) gave temporary regulatory approval for thePfizer–BioNTech vaccine,[17][18] becoming the first country to approve this vaccine and the first country in the Western world to approve the use of any COVID‑19 vaccine.[19][20][21] On 8 December 2020, 90-year-old Margaret Keenan received the vaccine atUniversity Hospital Coventry, becoming the first person known to be vaccinated outside of a trial,[109] as theUK's vaccination programme began.[110] However, other vaccines had been given earlier in Russia.[111] On 11 December 2020, the USFood and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) for the Pfizer-BioNTech vaccine.[25][112] On 19 December 2020, theSwiss Agency for Therapeutic Products (Swissmedic) approved the Pfizer-BioNTech vaccine for regular use, two months after receiving the application. This was the first authorization by astringent regulatory authority under a standard procedure for any COVID‑19 vaccine.[113][114] On 23 December, a 90-year-oldLucerne resident became the first person to receive the vaccine in continental Europe.[115]
As of December 2020, many countries and the European Union[22] have authorized or approved the Pfizer-BioNTech COVID‑19 vaccine.Bahrain and theUnited Arab Emirates granted emergency marketing authorization for theSinopharm BIBP vaccine.[23][24] In the United Kingdom, 138,000 people had received the Pfizer-BioNTech COVID‑19 vaccine Comirnaty by 16 December, during the first week of theUK vaccination programme.[116] On 18 December 2020, the US FDA granted an EUA formRNA-1273, the Moderna vaccine.[26][27][28] Vaccine manufacturers are awaiting full approvals to name their vaccines.[117][118]
Moderna submitted a request for an EUA formRNA-1273 to the FDA on 30 November 2020.[119][120] On 18 December 2020, the FDA granted an EUA for the Moderna vaccine.[26][27][28]
In October 2020, the AustralianTherapeutic Goods Administration (TGA) granted provisional determinations to AstraZeneca Pty Ltd in relation to its COVID‑19 vaccine, ChAdOx1-S [recombinant] and to Pfizer Australia Pty Ltd in relation to its COVID‑19 vaccine,BNT162b2 [mRNA].[124][125] Janssen Cilag Pty Ltd was granted a provisional determination in relation to its COVID‑19 vaccine, Ad26.COV2.S, in November 2020.[126]
On 24 January 2021, the TGA granted provisional approval to Pfizer Australia Pty Ltd forComirnaty.[127][128][129][130]
On 24 June 2021, the TGA granted provisional determination to Moderna Australia Pty Ltd forElasomeran.[131]
In October 2020, theCommittee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) started 'rolling reviews' of the vaccines known asCOVID‑19 Vaccine AstraZeneca (ChAdOx1-SARS-CoV-2) andPfizer-BioNTech COVID‑19 Vaccine (BNT162b2).[132][133][134] The EMA released an update on the status of its rolling review of the COVID‑19 Vaccine AstraZeneca in December 2020, after the UK granted a temporary authorization of supply for the vaccine.[135]
In November 2020, the EMA published a safety monitoring plan and guidance on risk management planning (RMP) for COVID‑19 vaccines.[136] The plan outlines how relevant new information emerging after the authorization and uptake of COVID‑19 vaccines in the pandemic situation will be collected and promptly reviewed.[136] All RMPs for COVID‑19 vaccines will be published on the EMA's website.[136] The EMA published guidance for developers of potential COVID‑19 vaccines on the clinical evidence to include in marketing authorization applications.[137]
In November 2020, the CHMP started a rolling review of the Moderna vaccine for COVID‑19 known as mRNA-1273.[138]
In December 2020, the EMA received application for conditional marketing authorizations (CMA) for the mRNA vaccinesBNT162b2 andmRNA1273 (Moderna Covid‑19 vaccine).[139][140] The assessments of the vaccines are scheduled to proceed under accelerated timelines with the possibility of opinions issued within weeks.[139][140][141][142]
In December 2020, the CHMP started a rolling review of the Ad26.COV2.S COVID‑19 vaccine from Janssen-Cilag International N.V.[143]
On 21 December 2020, the CHMP recommended granting a conditional marketing authorization for the Pfizer-BioNTech COVID‑19 vaccine, Comirnaty (active ingredient tozinameran), developed by BioNTech and Pfizer.[144][145][22] The recommendation was accepted by theEuropean Commission the same day.[144][146][147][148]
On 6 January 2021, the CHMP recommended granting a conditional marketing authorization for COVID-19 Vaccine Moderna[149][150] and the recommendation was accepted by the European Commission the same day.[148][151][152]
In January 2021, the EMA received an application for conditional marketing authorization (CMA) for the COVID‑19 vaccine known asCOVID‑19 Vaccine AstraZeneca, developed by AstraZeneca and Oxford University.[153] On 29 January 2021, the CHMP recommended granting the conditional marketing authorization[154][155] and the recommendation was accepted by the European Commission the same day.[156][157]
In February 2021, the CHMP started a rolling review ofNVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.)[158] and a rolling review ofCVnCoV, a COVID‑19 vaccine being developed by CureVac AG.[159]
In February 2021, the EMA announced that they are developing vaccine guidance to address thevirus variants.[160]
In February 2021, the EMA received an application for conditional marketing authorization (CMA) for theCOVID-19 Vaccine Janssen developed by Janssen-Cilag International N.V.[161] The EMA recommended a conditional marketing authorization of the COVID-19 Vaccine Janssen on 11 March 2021,[162][163] and it was accepted by the European Commission the same day.[164]
In March 2021, the CHMP started a rolling review ofSputnik V (Gam-COVID-Vac).[165] The EU applicant is R-Pharm Germany GmbH.[165]
In May 2021, the CMMP started evaluating the use of Comirnaty to include young people aged 12 to 15,[166] and it started a rolling review ofSinovac COVID-19 Vaccine.[167] The EU applicant for Sinovac is Life'On S.r.l.[167]
^Offit P (13 February 2021)."TWiV 720: With vaccines, Offit is on it".This Week in Virology Podcast. Vincent Racaniello Youtube Channel.Archived from the original on 25 May 2021. Retrieved14 July 2021.
^abcdef"Update on WHO Solidarity Trial – Accelerating a safe and effective COVID-19 vaccine".World Health Organization (WHO). 27 April 2020.Archived from the original on 30 April 2020. Retrieved2 May 2020.It is vital that we evaluate as many vaccines as possible as we cannot predict how many will turn out to be viable. To increase the chances of success (given the high level of attrition during vaccine development), we must test all candidate vaccines until they fail. [The] WHO is working to ensure that all of them have the chance of being tested at the initial stage of development. The results for the efficacy of each vaccine are expected within three to six months and this evidence, combined with data on safety, will inform decisions about whether it can be used on a wider scale.
^abcYamey G, Schäferhoff M, Hatchett R, Pate M, Zhao F, McDade KK (May 2020)."Ensuring global access to COVID‑19 vaccines".Lancet.395 (10234):1405–06.doi:10.1016/S0140-6736(20)30763-7.PMC7271264.PMID32243778.CEPI estimates that developing up to three vaccines in the next 12–18 months will require an investment of at leastUS$2billion. This estimate includes Phase1 clinical trials of eight vaccine candidates, progression of up to six candidates through Phase2 and3 trials, completion of regulatory and quality requirements for at least three vaccines, and enhancing global manufacturing capacity for three vaccines.
^"Fact-checking the battle for credit over Pfizer's vaccine announcement". CNN. 10 November 2020.Archived from the original on 16 November 2020. Retrieved13 November 2020.Pfizer is one of various vaccine manufacturers participating in Operation Warp Speed as a supplier of a potential COVID-19 vaccine," Castillo said in an email. "While Pfizer did reach an advanced purchase agreement with the U.S. government, the company did not accept (Biomedical Advanced Research and Development Authority) funding for the research and development process. All the investment for R&D was made by Pfizer at risk. Dr. Jansen was emphasizing that last point.
^ab"Vaccine Safety – Vaccines".vaccines.gov. US Department of Health and Human Services.Archived from the original on 22 April 2020. Retrieved13 April 2020.
^"How flu vaccine effectiveness and efficacy are measured". Centers for Disease Control and Prevention, National Center for Immunization and Respiratory Diseases, US Department of Health and Human Services. 29 January 2016.Archived from the original on 7 May 2020. Retrieved6 May 2020.
.svg)
COVID-19 portal.jpg)
.jpg)
_G.jpg)
This article incorporates text from this source, which is in thepublic domain.
