COVID-19 vaccine

Unassigned

New Medicines

Coronavirus disease 2019 (COVID-19) prevention

Information

Vaccine
Oxford Vaccine Group and Jenner Institute
Not Known

Development and Regulatory status

Phase III Clinical Trials
Pre-clinical
None
May 20 · Vaccine is now known as AZD1222 [9].
May 20 · AstraZeneca secures global manufacturing and distribution rights for this vaccine, working in partmentship with the Oxford Vaccine Group and Jenner Institute. They aim to be able to manufacture 30 million doses by Sept 20. [7,8]
Apr 20 · UK government confirms £20 million funding for University of Oxford vaccine trials [5].
Mar 20 · Oxford University team have a candidate vaccine based on a chimpanzee adenovirus vaccine vector (ChAdOx1) and have been working on it since January 2020. Trials are due to start late Spring 2020 [1]. 3

Category

Single dose vaccine based on chimpanzee adenovirus (ChAdOx1 nCoV-19; AZD1222)
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems are more likely to develop serious illness [2].
Coronavirus disease 2019 (COVID-19) prevention
Intramuscular

Trial or other data

May 20 · A PII/III trial to assess the efficacy, safety and immunogenicity of AZD 1222 (COV002; EudraCT2020-001228-32; NCT04400838) has started recruitment. The randomised, single-blind trial intends to enrol up to 10,260 volunteers in the UK. Oxford University reported that they intend to enrol small number of older adults of age 56-69, aged over 70 and children aged between 5-12 years. Adult participants in both the phase II and phase III groups will be randomised to receive one or two doses of either the AZD 1222 vaccine or a MenACWY vaccine that will be used as a control for comparison. Vaccinations will be taking place across the UK sites in May and June. Estimated primary completion date is Aug 2021 [10-12].
Apr 20 · PII clinical trial will begin in May, enrolling up to 6,000 people. [6]
Mar 20 · PI/II trial (NCT04324606) is now open for recruitment, initially at two centres in the UK - NIHR Imperial Clinical Research Facility, Imperial College and University Hospital Southampton NHS Trust. The single-blinded, randomised, multi-centre study aims to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers aged 18-55 years. The vaccine will be administered intramuscularly (IM). There will be 5 study groups and it is anticipated that a total of 510 volunteers will be enrolled. Volunteers will participate in the study for approximately 6 months, with the option to come for an additional follow up visit at Day 364. The comparator will be the MenACWY vaccine, also delivered IM [3,4].

Coronavirus disease 2019 (COVID-19) prevention

Information

Vaccine
Moderna Therapeutics
Moderna Therapeutics

Development and Regulatory status

None
None
Phase I Clinical Trials
Jul 20 · Jul 20: Delayed start of PIII trial though Moderna still close to being on target for that and trials are expected to begin in July 20.[14]
May 20 · Moderna plans to start PIII study in July 20 and is investing in scaling up manufacturing. [10]
May 20 · Moderna agreed to a 10-year supply partnership with Lonza aiming to produce up to 1 billion vaccine doses per year. [9]
May 20 · Granted fast-track status in US.[8]
Mar 20 · Moderna´s vaccine is just one of several vaccines in early clinical development for prevention of Covid-19 infection. Although it is the first to move into PI testing, experts have cautioned it could be overtaken by more conventional vaccines if these prove more effective. Government officials have said a vaccine could be available within 12 to 18 months, but experts have suggested that´s overly optimistic [1].

Category

mRNA-1273; covid-19 vaccine; coronavirus vaccine. A novel mRNA vaccine which works by embedding the genetic instructions for a component of a virus into a nanoparticle, which can then be injected into people [1]
Coronaviruses are a family of viruses transmitted between animals and people that can lead to respiratory illness, including MERS and SARS. On January 7, 2020, a novel coronavirus (Covid-19) was identified as the cause of pneumonia cases in Wuhan, China. As a group, coronaviruses are common across the world. Covid-19 was declared a pandemic on 11 March 2020. As of 16 March, the WHO reports 168,837 cases and 6,470 deaths worldwide [2,3].
Coronavirus disease 2019 (COVID-19) prevention
Intramuscular

Trial or other data

Jun 20 · PIII trial starting in early July has released further details. 30,000 people in the US will be randomised one-to-one to receive either 100micrograms of mRNA-1273 or placebo. The primary efficacy endpoint is a reduction in symptomatic Covid-19 disease. The secondary endpoints are reduction in hospitalisation and reduction in infection with SARS-COV-2. Enrolment in the PI and PII trials continues. The cohort of patients in the PII trial that are aged 55 years and over is fully enrolled [13].
May 20 · PIII will begin in early July with 30,000 pple mostly aged between 18 and 55, but the trial will include some older ppple who are at that are most at risk of serious illness from COVID-19. Manufacturing will begin before trial results become available. [12]
May 20 · PII study starts and will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 μg or a 100 μg dose at both vaccinations [11].
May 20 · Positive interim PI data announced. In the PI trial (n=45 pts aged 18-55), 3 dose levels were given in 2 injections (a month apart). Pts (n=8) who received 25mcg and 100mcg doses, developed neutralising antibodies to SARS-COV-2 after 2 weeks of receiving the second dose. The response (inc. antibody levels) was noted to be similar to those seen in pts who have recovered from SARS-COV-2. Of pts receiving 25mcg or 100mcg, 1 reported a serious side effect (redness around the injection site). Pts receiving the 250mcg dose developed transient fever, muscle pain and headache and this dose will not be used in PII trials. The study is testing the vaccine in pts aged 56 to 70 and those >71. [10]
Mar 20 · Two independent Italian research teams sequenced multiple samples and identified the presence of gene variants when compared against the original Wuhan coronavirus reference genome. The low number of variants discovered in the Italian samples 2 months after the virus was first sequenced in China suggests that SARS-CoV-2 is a relatively slow-mutating pathogen. This implies that it would be possible to develop effective vaccines. [6]
Mar 20 · PI trial has begun recruiting in the US (NCT04283461) [4]

Coronavirus disease 2019 (COVID-19)

Information

Vaccine
Imperial College London
Not known

Development and Regulatory status

PII clinical trials
PII clinical trials
None

Category

vaccine using self-amplifying RNA (saRNA)
25th June 2020 · COVID-19 is caused by a newly discovered coronavirus SARS-CoV-2. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems are more likely to develop serious illness [3].
Coronavirus disease 2019 (COVID-19)
prevention
Intramuscular

Coronavirus disease 2019 (COVID-19)

Information

Vaccine
BioNTech and Pfizer
BioNTech and Pfizer

Development and Regulatory status

None
Phase II Clinical Trials
Phase II Clinical Trials
Jul 20 · Positive early data from PI/II trial announced.[8]
Apr 20 · The Paul-Ehrlich-Institut (German regulatory authority) has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to start [5].
Mar 20 · Clinical testing of this m-RNA vaccine to start in April 2020 [1].

Category

mRNA vaccine, which causes the body to produce solitary (non-infectious) viral protein which the immune system detects to produce a defensive response to.
2nd July 2020 · COVID-19 is caused by a newly discovered coronavirus SARS-CoV-2. Most people infected with the virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems are more likely to develop serious illness
Coronavirus disease 2019 (COVID-19)
Prevention
Intramuscular

Trial or other data

Jul 20 · Pfizer and BioNTech announce early positive data from ongoing PI/II study of BNT162b. At day 28 (7 days after dose 2), all pts who received 10 or 30 mg of BNT162b1 had SARS-CoV-2 neutralising antibodies with mean titers (GMTs) of 168 and 267, 1.8- and 2.8-times, respectively, the GMT of levels from convalescent sera of SARS-CoV-2 pts. Levels of IgG antibodies also showed signifcant elevation. No serious adverse events were reported in this interim analysis and local reactions and systemic events were dose-dependent, generally mild to moderate, and transient. A PII/III study could begin in Q2/3 2020. The companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially >1.2 billion doses by end of 2021.[8]
May 20 · PI/II study begins in the US to determine the safety, immunogenicity and optimal dose level of four mRNA vaccine candidates. The dose level escalation part (Stage 1) will enroll up to 360 healthy pple into two age cohorts (18-55 who will be immunised first and 65-85 years who may receive a different dose after testing in younger adults has provided initial evidence of safety and immunogenicity). If sucessful, vaccine may be available from 2020.[7]
Apr 20 · Pfizer chief announces that US trials will start within weeks and if successful, the vaccine could be ready for emergency distribution in the Autumn. [6]
Apr 20 · Approval granted in Germany to begin PI/II trial. The dose escalation portion of the trial will have around 200 healthy pple aged 18 to 55 and will target a dose range of 1 µg to 100 µg aiming to find the optimal dose. It will also look at the effects of repeated immunisation. Pple with higher risk for a severe COVID-19 infection will be included in the second part of the trial. A trial is also expected to begin in the US and in partnership with Fosun Pharma in China.[4]