dm+d

Unassigned

New Medicines

tozinameran (Comirnaty)Coronavirus disease 2019 (COVID-19) prevention

Information

tozinameran (Comirnaty)
Vaccine
BioNTech and Pfizer
BioNTech and Pfizer

Development and Regulatory status

Launched
Launched
Launched
December 2020
Nov 21Comirnaty is the first COVID-19 vaccine to be granted approval by the FDA [62].
Nov 21EMA CHMP recommends approval for children aged 5 to 11, based on a study showing the immune response to a lower dose (10mcg) in this age group was comparable to that seen with 30mcg in 16- to 25-year-olds [60].
Nov 21With the latest results from their PIII trial in patients aged 12-15 years, the companies will file for full FDA approval in this age group [58].
Oct 21FDA approve Pfizer-BioNTech vaccine for children aged 5 to 11 years [56].
Oct 21FDA Vaccines and Related Biological Products Advisory Committee recommend Pfizer-BioNTech vaccine for children ages 5-11 [55].
Oct 21EMA approve a new ready-to-use formulation (available 2022), which does not require dilution and can be stored at 2-8°C for up to 10 weeks [54].
Oct 21EMA starts evaluating use of BioNTech/Pfizer COVID-19 vaccine Comirnaty in children aged 5 to 11 [53].
Oct 21Filed in US for use in children aged 5-11 years [51].
Oct 21EMA CHMP recommends an extra dose of COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax (Moderna) may be given to people with severely weakened immune systems, at least 28 days after their second dose [49].
Sep 21US FDA amend EUA to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in certain populations [48].
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

Evidence based evaluations

tozinameran (Comirnaty)Coronavirus disease 2019 (COVID-19) prevention in children aged 5 to 11 years

Information

tozinameran (Comirnaty)
Licence extension / variation and new formulation
BioNTech and Pfizer
BioNTech and Pfizer

Development and Regulatory status

Approved (Licensed)
Approved (Licensed)
Approved (Licensed)
Dec 21MHRA approves new paediatric formulation for children aged 5 to 11 years [7].
Nov 21EMA CHMP recommends approval for children aged 5 to 11, based on a study showing the immune response to a lower dose (10mcg) in this age group was comparable to that seen with 30mcg in 16- to 25-year-olds [6].
Oct 21FDA approve Pfizer-BioNTech vaccine for children aged 5 to 11 years [5].
Oct 21FDA Vaccines and Related Biological Products Advisory Committee recommend Pfizer-BioNTech vaccine for children ages 5-11 [4].
Oct 21EMA starts evaluating use of BioNTech/Pfizer COVID-19 vaccine Comirnaty in children aged 5 to 11 [3].
Oct 21Filed in US for use in children aged 5-11 years [2].

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 in children aged 5 to 11 years
Intramuscular

Evidence based evaluations

SPC

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)
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

Evidence based evaluations

Spikevax Coronavirus disease 2019 (COVID-19) prevention

Information

Spikevax
Vaccine
Moderna Therapeutics
Moderna Therapeutics

Development and Regulatory status

Launched
Approved (Licensed)
Pre-registration (Filed)
April 2021
Nov 21EMA start evaluating use in children aged 6 to 11; an opinion will be issued in approximately 2 months, unless supplementary information or analysis is needed [54].
Nov 21France’s health authority advise against people < 30 yrs from having the Moderna COVID-19 vaccine after a research study suggested a slightly higher risk of myocarditis and pericarditis. [53]
Oct 21EMA CHMP concludes a booster dose of Spikevax, given 6 to 8 months after the second dose, may be considered in people aged 18 years and above [52].
Oct 21FDA amend EUA to allow a booster dose six months after primary course for all aged ≥65 years, and others aged 18-64 years who are high risk for severe COVID-19, or are frequently exposed to SARS-CoV-2 due to their occupation or lifestyle [50].
Oct 21An FDA advisory committee voted unanimously to recommend Moderna´s COVID-19 vaccine as a booster (50mcg/half-dose) for people 65 and older and others at high risk. A final decision is anticipated next week [49].
Oct 21EMA has authorised a third dose given at least 28 days after the second dose to severely immunocompromised individuals 12 years of age or older.
Sep 21Moderna announce submission for conditional marketing approval (CMA) with EMA for evaluation of 50 microgram booster dose [45].
Sep 21Moderna submit initial data to US FDA for use of a 50-microgram booster dose. Submissions to EMA and other regulatory authorities are expected in the coming days [44].
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]
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 20FDA advisory panel meeting votes 20-0 in favour of approving the Moderna vaccine for emergency use authorisation [28].
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].

Category

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
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

Evidence based evaluations

COVID-19 Vaccine JanssenCoronavirus 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)
Dec 21CHMP recommends approval of a booster dose at least two months after the first in people aged ≥18 years. It may also be given after two doses of one of the mRNA vaccines authorised in the EU [23].
Nov 21EMA start evaluation of application for use of a booster dose to be given at least two months after the first dose to people aged ≥18 years [22].
Oct 21FDA amend EUA to allow a booster dose two months after primary course for all aged ≥18 years [21].
Oct 21US FDA recommends booster dose for Emergency Use Authorisation [20].
Oct 21Johnson and Johnson announce submission of EUA amendment to FDA for booster dose of vaccine [19].
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 21A positive opinion an emergency FDA authorisation is anticipated over the coming days, after FDA staff endorsed the vaccine as being safe and effective in a briefing document [10].
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

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

Evidence based evaluations

Nuvaxovid; CovovaxCoronavirus disease 2019 (COVID-19) prevention

Information

Nuvaxovid; Covovax
Vaccine
Novavax
Novavax

Development and Regulatory status

Pre-registration (Filed)
Approved (Licensed)
Pre-registration (Filed)
Dec 21Approved in EU [24].
Dec 21World Health Organization has issued an emergency use listing (EUL) for NVX-CoV2373, expanding the basket of WHO-validated vaccines against the SARS-CoV-2 virus. The vaccine, named Covovax, is produced by the Serum Institute of India under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries. Covovax is a subunit of the vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI). The originator product produced by Novavax, named Nuvaxovid, is currently under assessment by the EMA. WHO will complete its own assessment of this vaccine once the EMA has issued its recommendation. FDA Emergency Use Authorization is expected by the end of 2021 [23].
Oct 21Novavax announce they have finalised and submitted all documents to the MHRA for a conditional marketing authorisation. Rolling submission to the FDA is due to complete by the end of 2021 [21].
Aug 21Novavax announce that request for emergency use authorisation has been pushed back, the delay is anticipated to be weeks rather than months. Rolling submission to the EMA is planned to be complete this quarter and the company plan to file to the UK later this quarter [20].
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].
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].

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

COVID-19 vaccine (CoVLP)Coronavirus disease 2019 (COVID-19) prevention

Information

COVID-19 vaccine (CoVLP)
Vaccine
Medicago & GSK
Medicago & GSK

Development and Regulatory status

Pre-registration (Filed)
Phase III Clinical Trials
Pre-registration (Filed)
Dec 21Medicago has initiated the regulatory filing process with FDA and MHRA [4].

Category

plant derived recombinant spike (S) glycoprotein expressed as virus-like-particles (VLPs), with adjuvant
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

COVID-19 vaccine (VLA2001)Coronavirus disease 2019 (COVID-19) prevention

Information

COVID-19 vaccine (VLA2001)
Vaccine
Valneva
Valneva

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase II Clinical Trials
Dec 21Valneva confirms EMA has started a rolling review of VLA2001 [5]
Oct 21Valneva initiated the filing process in UK in August and anticipates filing to be complete by the end of November with approval by end of 2021. The company anticipates filing via conditional approval process in EU shortly [5].

Category

inactivated, adjuvanted COVID-19 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

Sputnik VCoronavirus disease 2019 (COVID-19) prevention

Information

Sputnik V
Vaccine
R-Pharm
Not Known

Development and Regulatory status

None
Pre-registration (Filed)
None
May 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

CoronaVacCoronavirus 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
Intramuscular