dm+d

Unassigned

New Medicines

ComirnatyCoronavirus disease 2019 (COVID-19)

Information

Comirnaty
Vaccine
BioNTech and Pfizer
BioNTech and Pfizer

Development and Regulatory status

Launched
Launched
Launched
December 2020
Sep 21MHRA amend Regulation 174 to include information about use of a third booster dose [45].
Aug 21Pfizer and BioNTech initiate rolling submission of sBLA to FDA for booster dose of Comirnaty in individuals aged ≥16 years. sBLA includes data from PIII trial (n=306 age 18-55 yrs, received booster 4.8-8 months after second dose, median follow-up 2.6 months) which found SARS-CoV-2 neutralising titres against wild-type strain 1 month after booster dose were 3.3 times titres 1 month after second dose [44].
Aug 21US FDA give full approval to the Pfizer-BioNTech COVID-19 vaccine for pts 16 and older. Emergency use authorization remains in place for adolescents 12-to-15, and also applies to booster shots. [44]
Aug 21US FDA have amended EUA to allow for use of a third dose in solid organ transplant recipients or those diagnosed with conditions that are considered to have an equivalent level of immunocompromise [43].
Aug 21MHRA issues Conditional Marketing Authorisation for Pfizer/BioNTech vaccine for COVID-19[42].
Jul 21Pfizer and BioNTech announce plans to request Emergency Use Authorization for booster shots for their COVID-19 vaccine [41]
Jun 21MHRA approves extension of indication to include use in children aged 12 to 15 in UK [38].
May 21EMA´s CHMP recommends granting of extension of indication to include use in children aged 12 to 15 in EU [37].
May 21MHRA approves longer time for refrigerator storage of thawed vaccine prior to dilution. Once removed from the freezer, the undiluted vaccine now has a maximum shelf life of up to 1 month (31 days) when stored in refrigerator at 2°C to 8°C (previously 5 days). Extension applies to all existing batches currently in circulation with the UK [36].
May 21CHMP has recommended change to approved storage conditions that will facilitate handling of the vaccine in vaccination centres across the EU, as storage period of unopened thawed vial at 2-8°C has been extended from 5 to 31 days; MHRA has not yet issued a recommendation for UK [35].
May 21FDA expand the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after recent clinical data showed 100% efficacy and “robust antibody responses.” [34]
May 21FDA expand the Emergency Use Authorization for the Pfizer and BioNTech vaccine to include adolescents ages 12 to 15 after recent clinical data showed 100% efficacy and “robust antibody responses.” [34]
May 21Pfizer and BioNTech announce a rolling submission of a Biologics License Application with the FDA for full approval of their mRNA vaccine in individuals 16 and older has been initiated.[33]
May 21Pfizer and BioNTech announce a rolling submission of a Biologics License Application with the FDA for full approval of their mRNA vaccine in individuals 16 and older has been initiated.[33]
May 21EMA starts accelerated assessment evaluating use of Comirnaty in young people aged 12 to 15 [32].
Apr 21 Pfizer and BioNTech announce plans to submit data from study in adolescents to FDA and EMA for a requested amendment to the Emergency Use Authorization of BNT162b2 and the EU Conditional Marketing Authorization for COMIRNATY to expand use in adolescents 12-15 years. [31]
Jan 21European CHMP recommends updating the Pfizer Comirnaty Covid-19 mRNA vaccine product information to clarify each vial contains six doses [26].
Dec 20Comirnaty is indicated in the EU (and UK) for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 16 years of age and older [25].
Dec 20EMA recommends Pfizer/BioNTech COVID-19 vaccine, (Comirnaty), for conditional authorisation in the EU in people ≥16 years [25].
Dec 20EMA announced receipt of additional data to support MAA; an exceptional meeting is scheduled for 21 December to conclude review if possible. The meeting planned for 29 December will be maintained if needed [24].
Dec 20FDA has authorized the emergency use of the mRNA vaccine, BNT162b2, against COVID-19 in individuals 16 years of age or older [23].
Dec 20Advisers to the FDA have voted in favour of approving emergency use authorisation (this is not a full licence), with 17 votes to 4 vote. Some experts in the public meeting were concerned about the short length of the human trial so far as well as the potential side-effects for people with allergies or pregnant women. Already approved in the UK, this is the first time that mRNA technology has been used to create a vaccine. There were also concerns about whether the vaccine should be used in 16-17 year-olds because of a lack of safety data in this group, balanced against the fact people from this age group are unlikely to fall seriously ill. The committee also considered two cases of allergic reactions seen in the UK this week and has asked Pfizer to monitor for severe allergic reactions. This may lead to further advice on the label of the vaccine if the FDA decides to go ahead with the Emergency Use Authorization that Pfizer is asking for [22].
Dec 20FDA reviewers support approval of the Pfizer vaccine ahead of the Vaccines and Related Biological Products Advisory Committee meeting [19].
Dec 20MHRA approves COVID-19 mRNA Vaccine BNT162b2 for use in the UK. It has not been granted a UK marketing authorisation but has been given authorisation for temporary supply by the UK Department of Health and Social Care and the MHRA for active immunisation to prevent COVID-19 disease caused by SARS-CoV-2 virus in individuals aged 16 years of age and over [18].
Nov 20Pfizer and BioNTech are planning for an emergency use authorisation in US. If approved vaccine could be available in the US from early 2021 [17].
Oct 20MHRA starts rolling review of BNT162 [14].
Oct 20Filed in the EU. CHMP has started a rolling review of data, evaluating the first batch of non-clinical data on the vaccine. This is the second Covid-19 vaccine to be filed to the EMA [12].
Jul 20Granted FDA fast track status as plans to begin a PIIb/III trial in late July announced, enrolling up to 30,000 pts.[9]
Jul 20Positive early data from PI/II trial announced.[8]
Apr 20The Paul-Ehrlich-Institut (German regulatory authority) has approved the Phase 1/2 clinical trial for BioNTech’s BNT162 vaccine program to start [5].
Mar 20Clinical 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.
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

Sep 21Ongoing PIII trial (NCT04368728; n=44,165) reported in NEJM [46].
Jul 21Lithuanian study (NCT04871165, n=885) found patients with haematological malignancies had lower antibody responses after 2 Pfizer vaccine doses vs healthcare workers. Patients on bruton tyrosine kinase inhibitors, ruxolitinib, venetoclax, or anti-CD20 antibodies had lower responses than untreated patients [40].
Jun 21Ongoing PIII trial (NCT04368728) (n=2260) found in 12-15 year olds the immune response after two doses was non-inferior (indication of greater response) to that observed in 16-25 year olds, with an observed vaccine efficacy of 100% (95% CI 75.3 to 100) [39].
Apr 21Pfizer and BioNTech’s COVID-19 announced topline results from PIII trial (n=1160) in adolescents aged 12-15 years. This showed 100% efficacy and robust antibody responses in those who received the BNT162b2 vaccine. Pfizer and BioNTech are also assessing the vaccine in younger children.[31]
Feb 21 first participants dosed in global Phase 2/3 study to evaluate safety, tolerability, and immunogenicity of Cominraty in preventing COVID-19 in healthy pregnant women aged 18 years and older [30].
Jan 21Pfizer and BioNTech announced that their COVID-19 vaccine was probably just as effective against the variant strain of the virus, B.1.1.7, found in the U.K. Their study found “no biologically significant difference in neutralization activity” between strains. However, the work underpinning this has not been peer-reviewed yet. [28]
Jan 21The adolescent trial with 2,000 volunteers ages 12 to 15 has finished enrollment. [27]
Dec 20PII/III RCT (NCT04368728; n=43,548) found 2-dose regimen conferred 95% protection against Covid-19 in persons ≥aged 16 years; safety over median of 2 months was similar to tha of other viral vaccines. Efficacy (90-100%) was similar across age, sex, race, ethnicity, baseline BMI, and comorbidities [21].
Dec 20After two NHS staff with history of significant allergies suffered serious reactions to vaccine (recovered after treatment), the MHRA has issued a warning that people should not receive the Pfizer vaccine if they have had a significant allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenaline injection such as an EpiPen or others who have had potentially fatal allergic reactions. The medical regulator also said vaccinations should be carried out only in facilities that have resuscitation equipment. [20]
Nov 20Pfizer and BioNTech announce, in a press release, that PIII study (N > 43,000) has met all primary efficacy endpoints. BNT162b2 is found to be 95% (p 94%. The vaccine was well tolerated across all populations with no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%. [16]
Oct 20Oct 20: Pfizer announce that US FDA has approved enrollment of children ≥12 years of age in its COVID-19 vaccine trial. The goal is to determine the safety and efficacy of the vaccine in adolescents [13].
Sep 20PIII data so far shows to date, a “mostly mild to moderate” tolerability profile as observed in PI trials according to an investigator presentation. Pts who'd received only the first dose experienced mostly fatigue and headache, with other cases of muscle pain, diarrhea, chills and joint pain. [11]
Jul 20PII/III trial (n=30,000) begins in the US in which 30-µg of vaccine will be given as a two-dose regimen to adults aged up to 85 years. It will include ~120 sites globally, with a focus on areas with a high prevalence of Covid-19 still in the community. Primary endpoint will be prevention of COVID-19 pple who have not been infected by SARS-CoV-2 as well as the prevention of COVID-19 regardless of whether they have previously had the virus. Secondary endpoints include prevention of severe COVID-19 in those groups.[10]
Jul 20Pfizer 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 20PI/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 20Pfizer 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 20Approval 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]

Evidence based evaluations

VaxzevriaCoronavirus disease 2019 (COVID-19) prevention

Information

Vaxzevria
Vaccine
AstraZeneca
AstraZeneca

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
January 2021 (launched prior to conditional approval)
Sep 21MHRA amend Regulation 174 to include information about use of a third booster dose [47].
Jun 21MHRA issues Conditional Marketing Authorisation COVID-19 Vaccine AstraZeneca [46].
May 21EMA CHMP recommends that healthcare professionals: must not be administer Vaxzevria to anyone who has had thrombosis with thrombocytopenia syndrome (TTS) after receiving the vaccine; should check for signs of blood clots in any person who has low blood platelets within 3 weeks of vaccination; should check for signs of low blood platelets in any person who has blood clots within 3 weeks of vaccination; should ensure patients who have blood clots with low blood platelets after vaccination receive specialist care [45].
Apr 21EMA announce that unusual blood clots with low platelets should be listed as a very rare side-effect of the vaccine. But benefit of vaccination is considered to outweigh risk [44].
Mar 21The US Independent Data and Safety Monitoring Board (DSMB) have questioned if recently released data were complete. AstraZeneca has since announced that published data were from an interim analysis with a data cut off of 17th February. AstraZeneca is now reviewing the trials primary analysis. In meetings during February and March the DSMB reviewed evidence suggesting the vaccine was 69% to 74% effective [39].
Feb 21The Swiss health authority Swissmedic rejected AstraZeneca’s rolling authorization application for its COVID-19 vaccine a few days ago, saying more data is needed “to obtain more information about safety, efficacy, and quality. [35]
Jan 21Approved in the EU [36].
Jan 21Application for conditional marketing authorisation submitted to EMA - an opinion is expected by 29/1/21 [32].
Jan 21The NHS in England begins administering the new Oxford AstraZeneca coronavirus vaccine. The first vaccinations will be delivered at a small number of hospitals for the first few days for surveillance purposes, as is standard practice, before the bulk of supplies are send to hundreds of GP-led services later in the week. Oxford University NHS Hospitals Trust, where the vaccine was developed, is expected to be among the first sites to administer it on Monday morning (4 Jan) [31].
Dec 20MHRA approves Oxford University/AstraZeneca vaccine for COVID-19 for use in the UK for people 18 years or older. The decision to approve the supply of this vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic [30].
Dec 20The CMO announced in a press conference that vaccine approval is expected in early January [29].
Nov 20MHRA starts rolling review of AZD1222 [22].
Nov 20Primary Investigator for trial suggested a small chance that AZD1222 will come to market by the end of 2020 at a UK parliamentary committee [23].
Oct 20EMA starts the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford [19].
Sep 20Following a temporary suspension of the PIII trial programme due to a potential adverse effect, the FDA are assessing the case in order to decide whether to resume the programme in the USA. The MHRA have cleared the trial to resume in the UK. AstraZeneca said investigators and participants “will be updated with the relevant information and this will be disclosed on global clinical registries.”. [17]
Jul 20PIII trials underway in the UK, Brazil and South Africa and due to start in the USA. These will determine how well the vaccine will protect from COVID-19 and measure safety and immune responses in different age ranges and at various doses.[14]
Jul 20AstraZeneca is teaming up with a life science services company IQVIA to help drive faster delivery of clinical studies in the USA which are aimed at demonstrating efficacy of AZD1222. [13]
May 20Vaccine is now known as AZD1222 [9].
May 20AstraZeneca 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 20UK government confirms £20 million funding for University of Oxford vaccine trials [5].
Mar 20Oxford 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

Mar 21Newly released primary analysis shows 76% efficacy against symptomatic COVID-19 and 85% efficacy against symptomatic disease in people 65 and over. The vaccine was 100% effective against severe disease and hospitalisation [40].
Mar 21The US Independent Data and Safety Monitoring Board (DSMB) have questioned if recently released data were complete. AstraZeneca has since announced that published data were from an interim analysis with a data cut off of 17th February. AstraZeneca is now reviewing the trials primary analysis. In meetings during February and March the DSMB reviewed evidence suggesting the vaccine was 69% to 74% effective [39].
Mar 21AstraZeneca prepares for FDA filing based on US study (n=32,449) which showed 79% overall efficacy against symptomatic COVID-19 (80% in the over 65 population). 100% protection against severe disease, hospitalization and death. Investigators found no cases of cerebral venous sinus thrombosis among 21,583 vaccine recipients [38].
Mar 21PI/II RCT (NCT04444674, n=2,026) found a two-dose regimen of the ChAdOx1 nCoV-19 (AZ) vaccine did not reduce mild to moderate Covid-19 due to the B.1.351 (South Africa) variant vs placebo (incidence >14 days after 2nd vaccine = 3.2% vs 2.5%, efficacy 21.9%, 95%CI -49.9 to 59.8%) [37].
Feb 21Pooled analysis of four trials (ISRCTN89951424 (COV003), NCT04324606 (COV001), NCT04400838 (COV002), and NCT04444674 (COV005) is consistent with those seen in trials and confirm that vaccine is efficacious (66.7% efficacy > 14 days after second dose), with results varying by dose interval in exploratory analyses (efficacy 76% from day 22 to 90 after vaccination) [36].
Feb 21Astra Zeneca announce new data from primary analysis of three PIII studies (COV002, COV003, COV005 in UK, Brazil and South Africa; n=17,177) which show that it is effective in providing 100% protection against severe disease, hospitalisation and death. Vaccine efficacy was 76% (CI: 59% to 86%) after a first dose, with protection maintained to the second dose. With a dose interval of >12 weeks, efficacy increased to 82% (CI: 63%, 92%). The potential for the vaccine to reduce asymptomatic transmission of the virus was also shown, based on weekly swabs from UK pts. [34]
Dec 20PIII trial data published in The Lancet. [28]
Dec 20Efficacy of 70.4% is lower than that for the mRNA vaccine developed by Pfizer-BioNTech (95% efficacy) and by Moderna (94% efficacy) [29].
Dec 20Interim results from 4 studies (11,636 participants from 23,848 participants overall) found an efficacy rate of 62.1% and 90% for those who received two standard doses, and those who received a low dose followed by a standard dose. The overall efficacy rate was 70.4% [27].
Dec 20Interim results from 4 studies (11,636 participants from 23,848 participants overall) found an efficacy rate of 62.1% and 90% for those who received two standard doses, and those who received a low dose followed by a standard dose. The overall efficacy rate was 70.4% [27].
Nov 20Data published in The Lancet from the PII single-blind, randomised, controlled trial (NCT04400838, n=560) in which participants were randomly assigned to receive either i.m. ChAdOx1 nCoV-19 (2·2 × 1010 virus particles) or a control vaccine, MenACWY given as an initial injection then a booster, 4 weeks apart. Co-primary outcomes were efficacy (measured by the no. of cases of symptomatic, virologically confirmed COVID-19) and safety (occurrence of serious adverse events). Full efficacy data reporting the no. of cases of confirmed Covid-19 were not presented but it is reported that 14 days after the boost dose, 208 (>99%) of 209 boosted participants had neutralising antibody responses and this was similar across the three age cohorts. Local and systemic reactions were more common (61-88% frequency) in ptps given ChAdOx1 nCoV-19 vs. control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache). Adverse effects were less common in older adults (aged ≥56 years) vs. younger adults. As of Oct 26, 2020, 13 serious adverse events occurred during the study period, none of which were considered to be related to either study vaccine. Investigators concluded that further assessment of the efficacy of this vaccine is warranted in all age groups and individuals with comorbidities.[24]
Nov 20AZD1222 vaccine achieved 70% efficacy as an average across two regimens given to 11,636 people, in a late-phase analysis. Most subjects, 8,895, received the same dose for their first and second vaccinations and achieved 62% efficacy. A smaller cohort got a half dose for the first vaccination followed by a full dose booster, this group achieved 90% efficacy [26].
Nov 20AstraZeneca announce that AZD1222 delivers similar immune responses in people over and under 70 years and suggests that the vaccine is better tolerated by seniors. In the 18 to 55 cohort, 8% of people reported severe fatigue after the first dose. 6% of participants reported severe chills and 'feverish' symptoms. There were no severe cases of these reactions in the over-70 group after the first dose and only one severe reaction of any kind, malaise. Nobody over 70 experienced a severe reaction after the boost dose [25].
Oct 20AstraZeneca said its Covid-19 vaccine produces a similar immune response in older and younger adults. Data are not yet published. [21]
Sep 20AstraZeneca announced that PIII trial of AZD1222 is expanding into the USA and will be referred to as D8110C00001. The trial is funded by BARDA, the NIAID and the COVID-19 Prevention Network (CoVPN) is also participating. Up to 30,000 adults (healthy or with stable medical conditions) from a broad range of ages, racial, ethnic and geographic groups will be recruited. Pts will be randomised 2:1 to receive two i.m doses of AZD1222 or saline placebo 4 weeks apart, on day one and 29. It is not known yet when the study will complete.[15,16]
Jul 20Interim results of PI/II trial (n=~500, median age 35) announced. Antibodies against the SARS-CoV-2 spike protein peaked by day 28 and remained elevated to day 56, indicating an immune response against the virus. T cell immunity peaked 14 days after vaccination and were still present two months later. The vaccine was associated with aches, headaches, fever and fatigue, which were generally controlled with paracetamol and did not develop into anything serious.[14]
May 20A 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 20PII clinical trial will begin in May, enrolling up to 6,000 people. [6]
Mar 20PI/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].

Evidence based evaluations

SpikevaxCoronavirus disease 2019 (COVID-19) prevention

Information

Spikevax
Vaccine
Moderna Therapeutics
Moderna Therapeutics

Development and Regulatory status

Launched
Approved (Licensed)
Pre-registration (Filed)
April 2021
Sep 21a 50-microgram booster dose of its two-dose vaccine. The original Moderna vaccine contains 100 micrograms of mRNA per dose. It expects to submit data to European Medicines Agency and other regulatory authorities in the coming days
Aug 21Moderna has completed the rolling submission process for its BLA to the US FDA for the full licensure of in adults, requesting Priority Review designation. The submission is based on data from the PIII COVE study (n > 30,000). [43]
Aug 21US FDA have amended EUA to allow for use of a third dose in solid organ transplant recipients or those diagnosed with conditions that are considered to have an equivalent level of immunocompromise [42].
Aug 21MHRA approves Spiekvax for use in 12- to 17-year-olds. The new indication is Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older [41].
Jun 21Moderna file for Emergency Use Authorisation for use in adolescents in US [40].
Jun 21EMA CHMP are evaluating use of COVID-19 Vaccine Moderna in young people aged 12 to 17; a decision is expected in July [39].
May 21Moderna announces plans to initiate a rolling submission of a Biologics License Application with the FDA for full approval of their mRNA vaccine [38]
May 21Moderna announces plans to initiate a rolling submission of a Biologics License Application with the FDA for full approval of their mRNA vaccine [38]
Apr 21UK licenced indication is active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older [37].
Apr 21UK rollout of the Moderna coronavirus vaccine begins in Wales. The government has ordered 17 million doses, which is given in two doses between four and 12 weeks apart [35].
Mar 21MHRA grants a conditional marketing authorisation in Great Britain (consisting of England, Scotland and Wales) on 31 March [37].
Jan 21MHRA approves Moderna vaccine for use in the UK in people aged 18 years and older. The decision to approve the supply of this vaccine was taken under Regulation 174 of the Human Medicine Regulations 2012, which enables rapid temporary regulatory approvals to address significant public health issues such as a pandemic [33].
Jan 21European Commission (EC) grants a conditional marketing authorisation for the Moderna COVID-19 vaccine, after a positive opinion from the CHMP was issued yesterday (6 Jan) [32].
Dec 20FDA approves mRNA-1273 for emergency use in people over 18 years of age [30].
Dec 20Moderna COVID-19 Vaccine was previously referred to as mRNA-1273 [29].
Dec 20FDA advisory panel meeting votes 20-0 in favour of approving the Moderna vaccine for emergency use authorisation [28].
Dec 20FDA Advisory Committee will vote today on authorisation for emergency use [27].
Dec 20Moderna have initiated a trial in 3,000 adolescents. Participants will receive two doses of either placebo of 100mcg of vaccin 28 days apart [25].
Dec 20Modena announced that antibody levels stayed elevated in the 90 days after people received second dose of mRNA-1273 [24].
Nov 20Moderna plans today to request EUA from the U.S. FDA, to apply for a conditional marketing authorization with the European Medicines Agency (EMA) and to progress with the rolling reviews, which have already been initiated with international regulatory agencies [23].
Nov 20Moderna plans to seek FDA emergency use authorisation (EAU) in the coming weeks [22].
Oct 20MHRA starts rolling review of COVID-19 vaccine candidate, mRNA-1273. The rolling review enables the MHRA to launch its independent assessment of the vaccine using the information submitted by Moderna, and also accept new evidence as and when it becomes available, until the application is deemed complete [21].
Jul 20Delayed 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 20Moderna plans to start PIII study in July 20 and is investing in scaling up manufacturing. [10]
May 20Moderna agreed to a 10-year supply partnership with Lonza aiming to produce up to 1 billion vaccine doses per year. [9]
May 20Granted fast-track status in US.[8]
Mar 20Moderna´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

Aug 21The Chief Executive Officer of Moderna notes that “We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months after dose 2". [43]
Aug 21Ongoing PII/III TeenCove placebo controlled trial (n=3732), found the Moderna vaccine had an acceptable safety profile in adolescents and the immune response was similar to that in young adults (absolute difference in serologic response 0.2%; 95% CI, −1.8 to 2.4, meeting noninferiority criterion) [40].
May 21PIII PREVENT-19 study (n=29,960) meets primary endpoint, demonstrating 90.4% efficacy (63 COVID-19 cases in placebo group vs 14 in vaccine group) and key secondary endpoint demonstrating 100% efficacy against variants "not considered Variants of Concern/Interest" [18].
May 21PII/III TeenCOVE trial in adolescents meets primary immunogenicity endpoint; efficacy in ~2,500 adolescents was 100%, meaning none came down with COVID-19 [40].
Apr 21Data from an ongoing PI trial (NCT04283461) found antibody activity remained high in all age groups of 33 healthy adult participants at day 209 (180 days after second dose of Moderna vaccine) [36].
Jan 21Moderna announced their vaccine appears effective against the B.1.1.7 UK variant. Their study found no biologically significant difference in antibody neutralization activity vs. prior variants. It was also effective against the South African variant but antibody titers were sixfold less than for the UK variant. As a result, Moderna is designing a booster vaccine. [34]
Jan 21RCT for the Moderna COVID-19 vaccine (n=30,420) found that it had a 94.1% efficacy (95% CI 89.3 to 96.8%). Moderate, transient reactogenicity occurred more frequently with the vaccine than placebo, but serious adverse events were rare, with similar incidence between arms [31].
Nov 20Moderna´s phase III COVE study has achieved its primary endpoint with efficacy of 94.5%. 90 cases of COVID-19, including all 11 severe cases seen so far, happened in the placebo cohort, versus 5 cases among people who received mRNA-1273. Most of the grade 3 events occurred after the second dose. At that time, 9.7% of subjects experienced fatigue, 8.9% suffered muscle pain and 5.2% reported joint pain. Smaller number of patient experienced grade 3 headache, pain or redness at the injection site [22].
Oct 20Moderna have completed enrollment of 30,000 participants for the Phase 3 COVE study of mRNA-1273. The cohort includes patients aged over 65 and others with diabetes and CKD under 65 [20].
Aug 20Moderna presented further PI data which show efficacy across age groups inc. those aged >70. [19]
Jul 20Primate data published data in The New England Journal of Medicine showing the vaccine protected against infection in the nose and lungs and prevented pulmonary disease in all the monkeys. Both doses protected against the virus replicating in the lungs and lung inflammation. The larger dose protected against viral replication in the nose.[18]
Jul 20PIII COVE study begins July 27 (NCT04470427). The protocol has been reviewed by the U.S. FDA and is aligned to recent guidance for COVID-19 vaccine studies. The randomized placebo-controlled trial includes approximately 30,000 participants given 100 µg. Primary endpoint will be prevention of symptomatic COVID-19 disease. Secondary endpoints include prevention of severe disease (need for hospitalization) and prevention of infection by SARS-CoV-2 [17].
Jul 20In a not-yet-peer-reviewed paper, Moderna have shared PI/II data on antibody and T cell responses after BNT162b1 vaccination from a second, non-randomised open-label trial in 12 healthy adults, 18-55 years of age. Two doses of 1 to 50 µg of BNT162b1 elicited robust CD4+ and CD8+ 32 T cell responses and strong antibody responses compared with COVID-19 convalescent human serum panel (HCS). At day 43 SARS-CoV-2 serum neutralising geometric mean titers were 0.7-fold (1 µg) to 3.5-fold (50 µg) those of HCS. [16]
Jul 20Preliminary report published in the NEJM reporting results of the PI, dose-escalation, open-label trial in 45 healthy adults. After the first vaccination, antibody responses were higher with higher dose (day 29 mean titer; 40,227 in the 25-μg group, 109209 in the 100-μg group, and 213,526 in the 250-μg group). After the second vaccination, titers increased further (day 57 mean titer; 299,751, 782,719, and 1,192,154, respectively). Solicited common adverse events included fatigue, chills, headache, myalgia, and pain at the injection site. Systemic adverse events were more common after the second vaccination and dose related.[15]
Jun 20PIII 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 20PIII 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 20PII 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 20Positive 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 20Two 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 20PI trial has begun recruiting in the US (NCT04283461) [4]

Evidence based evaluations

COVID-19 Vaccine Janssen Coronavirus disease 2019 (COVID-19) prevention

Information

COVID-19 Vaccine Janssen
Vaccine
Janssen
Johnson & Johnson

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Pre-registration (Filed)
May 21Approved by the MHRA for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain only and was approved via the European Commission (EC) Decision Reliance Route. COVID-19 Vaccine Janssen is authorised in Northern Ireland under the CMA granted by the European Medicines Agency on 11 March [18].
Apr 21Use of Janssen COVID-19 vaccine is to be resumed in the US. Following the pause to investigate risk of thrombosis and thrombocytopenia in six cases, the FDA and CDC have determined that available data show a favourable risk benefit profile [17].
Apr 21EMA has offered renewed backing for the Janssen vaccine confirming that the overall risk-benefit balance remains positive despite very rare reports of unusual blood clots with thrombocytopenia. Warnings about these side effects will be added to the product information. The cases reviewed by the committee were very similar to the cases that occurred with the AZ vaccine [15].
Apr 21FDA are recommending a pause in use of this vaccine following rare reports of clots. Rollout in Europe is currently delayed whilst the EMA proceed with an investigation [14].
Mar 21Approved in EU for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older [13].
Mar 21EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU [12].
Mar 21Approved for emergency use in US [11].
Feb 21Janssen-Cilag has submitted a conditional Marketing Authorisation Application (cMAA) to the European Medicines Agency (EMA) seeking authorisation for its investigational single-dose Janssen COVID-19 vaccine candidate [9].
Feb 21Johnson & Johnson has filed for emergency FDA authorisation of its one-dose COVID-19 vaccine [8]

Category

Single dose vaccine
A novel coronavirus (Covid-19) was identified as the cause of pneumonia cases in Wuhan, China in November 2019 and declared by the WHO as a global pandemic in March 2020.
Coronavirus disease 2019 (COVID-19) prevention
Intramuscular

Trial or other data

Apr 21Apr 21: PIII ENSEMBLE Trial (n=39,321) found single dose of Ad26.COV2.S vaccine protected against moderate-severe–critical Covid-19 with onset ≥14 days after administration (116 cases vaccine vs. 348 placebo; efficacy, 66.9%) and ≥28 days after administration (66 vs. 193 cases; efficacy, 66.1%) [16].
Jan 21PIII ENSEMBLE study in 43783 patients to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate with co-primary endpoints of 14 days and 28 days following vaccination found level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination, with 85 percent effectiveness in preventing severe disease. Overall, it was ~66% effective at preventing moderate-to-severe COVID-19, demonstrating complete protection against hospitalisation and death.[7]
Jan 21Published interim PI/II data showed an immune response that lasted at least 71 days. It was generally well-tolerated. [6]
Nov 20PIII ENSEMBLE 2 trial will run parallel to ENSEMBLE and examine a two-dose test. The test is focused on adults with and without comorbidities associated with an increased risk for severe COVID-19. The second dose will be given at 57 days. Recrutiment is anticipated to be complete by March 2021, and the trial will last for one year [3].
Oct 20PIII trial on hold due to a patient becoming unwell until independent drug safety monitoring board (DSMB) are able to investigate further. It isn´t known what the illness is nor which group the patient was in. [4]
Sep 20PIII EMSEMBLE trial (n=up to 60,000) begins in the U.S. and other countries with a high incidence of COVID-19 (Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa) to study efficacy of single dose trial. In parallel, a separate PIII trial in the UK will explore a 2-dose regimen. [3]
Aug 20 A double-blind, randomised, PIII (n=60,000) trial will begin next month comparing Ad26.COV2.S vaccine to placebo for the prevention of SARS-CoV-2-mediated COVID-19 in adults. Primary study completion is expected March 2023 [1,2].

Evidence based evaluations

Coronavirus disease 2019 (COVID-19) prevention

Information

Vaccine
Novavax
Novavax

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Jun 21CureVac announce PIIb/III study failed to meet prespecified measures of success. Preliminary data showed it was only 47% effective at preventing any severity of COVID-19 [11].
May 21Novavax announce they will not file for approval of vaccine until July at earliest. The delay is due to manufacturing issues related to an assay needed to show regulators that vaccine manufacturing process is consistent across different sites [16].
May 21Novavax initiate paediatric expansion of PIII PREVENT-19 trial. Additional arm will evaluate efficacy, safety and immunogenicity of NVX-CoV2373, in up to 3,000 adolescents aged 12-17 across up to 75 sites in US [14].
Mar 21Novavax is targeting Q2 FDA filing for EAU. If the FDA agree to use UK data the vaccine may receive EAU in US by May [11].
Feb 21Novavax starts rolling review of it Covid vaccine with US FDA [10].
Feb 21EMA starts rolling review of NVX-CoV2373) [9].
Jan 21Novavax initiate a rolling submission to MHRA [8].
Dec 20PIII trials start in US and Mexico [7].
Sep 20Novavax initiate PIII efficacy trial of COVID-19 vaccine in the UK. Trial is expected to enroll and immunise up to 10,000 individuals between 18-84 years of age, with and without relevant comorbidities, over the next four to six weeks [6].
Jun 20Novavax has been awarded a contract by the U.S. Department of Defense (DoD) for the manufacture of NVX‑CoV2373. NVX‑CoV2373 consists of a stable, prefusion protein antigen made using its proprietary nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant [4].
Jun 20Novavax enlist AGC Biologics to scale up and produce its vaccine. [3]
May 20Novavax has received funding from CEPI to help develop a Covid-19 vaccine [1].

Category

adjuvant-enhanced vaccine based on coronavirus spike protein
COVID-19 is an infectious disease caused by coronavirus SARS-CoV-2. Most people infected 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

Jul 21PIII RCT conducted at 33 sites in UK (n=15,187) reports that two-dose regimen of recombinant nanoparticle NVX-CoV2373 vaccine (Novavax) administered to adults conferred 89.7% protection against SARS-CoV-2 infection and showed high efficacy against the B.1.1.7 (alpha) variant (86.3%) [19].
Jun 21PIII PREVENT-19 study (n=29,960) meets primary endpoint, demonstrating 90.4% efficacy (63 COVID-19 cases in placebo group vs 14 in vaccine group) and key secondary endpoint demonstrating 100% efficacy against variants "not considered Variants of Concern/Interest" [18].
May 21Phase 2a–b trial (NCT04533399) in South Africa (n=4387) found the NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative patients (60.1%) and of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant [17].
May 21Novavax is targeting Q2 FDA filing for EAU. If the FDA agree to use UK data the vaccine may receive EAU in US by May [11].
Jan 21Novavax announce positive interim data from PIII study in UK. NVX-CoV2373 met primary endpoint, with a vaccine efficacy of 89.3%, during a period with high transmission and with the new UK variant strain of the virus emerging and circulating widely [8].
Dec 20PIII trials PREVENT-19 starts, a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo, harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed [7].
Dec 20Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date [6].
Aug 20PIIb clinical trial in South Africa starts, one cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults [5].
May 20First pts enrolled and dosed in P I/II study. Phase I of the study will evaluate the immunogenicity and safety based on two dosing levels. Phase II will be commenced if safety is demonstrated in phase 1 and will assess immunity, safety and COVID‑19 disease reduction in a broad age range. Preliminary immunogenicity and safety results from phase 1 are expected in July 2020. [2]
May 20Phase I trial starting this month in Australia, results due in July [1].

Coronavirus disease 2019 (COVID-19) prevention

Information

Vaccine
Cure-Vac
Cure-Vac

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase II Clinical Trials
Feb 21rolling submission for authorisation initiated with the European Medicines Agency (EMA) for CVnCoV [10].
Feb 21GSK announce they will help CureVac manufacture up to 100 million doses of their first-generation mRNA COVID vaccine candidate, CVnCoV, in 2021. The two companies will also work on a next-generation vaccine to tackle emerging variants, with development to begin immediately targeting vaccine availability in 2022. The announcement follows Bayer´s announcement that it will produce 160 million doses of CureVac´s CVnCoV in 2022 [8].
Dec 20Phase IIb/III clinical trial has begun. The phase 2b trial will generate safety, reactogenicity and immunogenicity data to inform the start of the phase 3. Once 1,000 subjects have at least one week of follow-up after the first vaccination, the Data and Safety Monitoring Board will review the data and make a decision on the phase 3. PIII study will recruit 32,500 subjects and CureVac plans to pool data from both portions of the trial [7].
Nov 20A phase IIb/III clinical trial is planned to start Q4 2020, CVnCoV will be administered at a dose of 12 micrograms[6].
Jul 20GSK have acquired a 10% stake in CureVac. [4]
Jul 20Tesla has signed a deal to help produce additional quantities of CureVac´s vaccine using molecular machine technology. CureVac already has approved manufacturing facilities in Germany where it can turn out hundreds of millions of doses. [3]
May 20positive pre-clinical results at a low dose for vaccine candidate against the novel Coronavirus (SARS-CoV-2). The data showed a fast induction of a balanced immune response with high levels of virus neutralizing titers (VNTs) and T-cell responses [1].

Category

m-RNA vaccine
COVID-19 is an infectious disease caused by a coronavirus SARS-CoV-2. Most people infected 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

Dec 20PIII double-blind, randomised, placebo-controlled trial (NCT04674189) to investigate the safety and immunogenicity of CVnCoV vaccine has started recruiting healthy adults (n=2,520) in Germany. Estimated primary completion date is Jun 21 [9].
Dec 20PIIb/III HERALD trial to determine the safety and efficacy of CVnCoV vaccine in the prevention of Covid-2019 infection in healthy adults (n=36,500) has started recruiting in Belgium, Germany and the Netherlands (NCT04652102; Eudra CT 2020-003998-22). Estimated primary completion date is Mar 21 [9].
Nov 20CureVac announce that administration of CVnCoV, at a dose of 12 micrograms, raised levels of binding and neutralising antibodies to levels seen in the plasma of a set of 67 seriously ill COVID-19 patients, including 16 patient who were hospitalised. The 12 microgram dose was well tolerated, with no related serious adverse events. Grade 3 adverse events included; fatigue, headache, chills and muscle pain and fever. Events occurred after administration of the second dose of vaccine and resolved within 48 hours in the majority of cases [6].
Sep 20first participant has been dosed in a Phase 2a clinical trial of COVID-19 vaccine candidate, CVnCoV in Panama and Peru. A total of 690 healthy participants in two groups will be enrolled: older adults ages 61 and above, and younger participants 18 to 60 years old, each will receive two vaccinations at intervals of 28 days [7].
May 20PI/IIa clinical trial in healthy volunteers to start in in June 2020 [1].

Vidprevtyn Coronavirus disease 2019 (COVID-19) prevention

Information

Vidprevtyn
Vaccine
Sanofi Pasteur
Sanofi Pasteur

Development and Regulatory status

None
Pre-registration (Filed)
Phase III Clinical Trials
Jul 21EMA starts rolling review of COVID-19 vaccine Vidprevtyn [4], following initiation of enrollment in PIII study in May [5].
May 21Pivotal PIII trial anticipated following positive topline results of PII trial. Commercial production is planned to coincide with PIII development with possible launch in Q4 21 if trial data positive [3].
Mar 21PI/II trial starts [1].

Category

mRNA vaccine
COVID-19 is an infectious disease caused by coronavirus SARS-CoV-2. Most people infected 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

Jul 21Topline result so of PII study (n=722) indicates 95% to 100% seroconversion following two doses [3].
Mar 21PI/II trial is a randomized, double blind and placebo-controlled study to evaluate the safety, reactogenicity (tolerability) and immunogenicity of MRT5500, a COVID-19 vaccine candidate in 415 healthy adults [1].

Sputnik V Coronavirus disease 2019 (COVID-19) prevention

Information

Sputnik V
Vaccine
R-Pharm
Not Known

Development and Regulatory status

None
Pre-registration (Filed)
None
Mar 21EMA start rolling review of the Sputnik V COVID-19 vaccine [3].

Category

rAd26 and rAd5 vector-based vaccine
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 [1].
Coronavirus disease 2019 (COVID-19) prevention
Intramuscular

Trial or other data

Mar 21Currently in PIII trials in Russia; estimated primary completion date of NCT04530396 is May 21 [2].
Mar 21Sputnik V vaccine is administered as two separate doses; Ad26 is used in the first dose, and Ad5 is used in the second to boost the vaccine´s effect [3].

CoronaVac Coronavirus disease 2019 (COVID-19) prevention

Information

CoronaVac
Vaccine
Not Known
Sinovac Life Sciences

Development and Regulatory status

None
Pre-registration (Filed)
None
May 21WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) complete review of COVID-19 Vaccine (Vero Cell) Inactivated vaccine and grant emergency approval for use globally; for adults 18 years and older, in a two-dose schedule with a spacing of three to four weeks [3].
May 21EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated. The EU applicant is Life´On S.r.l. [2].

Category

Inactivated SARS-CoV-2 virus (CZ02 strain), two-dose schedule vaccine
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 [1].
Coronavirus disease 2019 (COVID-19) prevention
Bladder instillation

Trial or other data

Jul 21PIII Turkish study NCT04582344 (n=10,218) found the CoronaVac vaccine (IM injection day 0 and 14) had a vaccine efficacy against PCR-confirmed symptomatic COVID-19 of 83.5% (95% CI 65.4-92.1; p<0.0001), with an adverse event frequency of 18.9% (vs. 16.9% placebo group; p=0.0108) [3].
May 21WHO´s SAGE find efficacy for symptomatic and hospitalised disease was estimated to be 79%, all age groups combined. The easy storage requirements of COVID-19 Vaccine (Vero Cell) Inactivated make it highly suitable for low-resource settings. It is the also first vaccine that will carry a vaccine vial monitor, a small sticker on the vaccine vials that change colour as the vaccine is exposed to heat, letting health workers know whether the vaccine can be safely used [3].