COVID-19 vaccines and treatments, regulatory status at a glance

The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Other news including on vacinnes, treatments, trials and side effects, here.

Company(ies)/
Others
ProductIssuing regulatory agency or organisationRegulatory statusFurther informationDate
AstraZeneca AB Vaxzevria –
COVID-19 Vaccine (ChAdOx1-S [recombinant])

(formerly COVID-19 Vaccine AstraZeneca)
EMA/EU Conditional marketing authorisation granted on 29 Jan 2021.

Overview, authorisation details, Product information and assessment history.


The updated EMA recommendations for healthcare professionals are available in the vaccine’s product information updated on 20 May 2021. 

On 21 May 2021 EMA provided additional advice on blood clots or low blood platelets occurring after vaccination with Vaxzevria.

On 11 Jun 2021
PRAC has concluded that people who have previously had capillary leak syndrome (CLS) must NOT be vaccinated with Vaxzevria (i.e. a contraindication). It has also also concluded that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.

On 9 July 2021, The PRAC has recommended a change to the product information for Vaxzevria (formerly COVID-19 Vaccine Astrazeneca) to include a warning to raise awareness among HCPs and people taking the vaccine of cases of Guillain-Barre syndrome (GBS) reported following vaccination.
On 17 September 2021, CHMP has concluded its further analysis of data on the risk of unusual blood clots linked to low levels of blood platelets (Article 5(3) review). EMA’s recommendation remains to continue giving a second dose of Vaxzevria between 4 and 12 weeks after the first, in line with the product information

On 6 August 2021, as part of the review of monthly summary safety reports for Vaxzevria, the PRAC continues to analyse data provided by the marketing authorisation holder on cases of Guillain-Barré syndrome (GBS) reported following vaccination. In the context of the next monthly summary safety report, the PRAC has requested the marketing authorisation holder to provide additional data, to clarify whether further updates to the product information and the RMP are necessary.



17 Sep 2021
Pfizer-BioNTech Coronavirus mRNA vaccine Comirnaty® (BNT162b2) Swissmedic Approved via normal approval procedure on 19 Dec 2020.

On 30 March 2021, New storage conditions approved
This means that The vials can now be transported and stored for up to two weeks at – 25 to -15 degrees Celsius instead of between -90 and -60 degrees Celsius.

On 2 Jun 2021 Swissmedic approved an application for a quality amendment.
Thus from now on, the unopened, thawed vials of the COVID-19 vaccine Comirnaty® can be stored at 2–8 °C in a temperature-controlled refrigerator for up to a month.
On 16 September 2021, Swissmedic confirmed that Moderna has already submitted an applicaton seeking modification of the current dosage regime, to add a third booster dose and the application is under review.


On 4 Jun 2021,
Swissmedic extended the temporary ordinary authorisation of the Pfizer/BioNTech coronavirus vaccine to include young people aged between 12 and 15.

16 Sep 2021
Moderna Switzerland GmbH COVID-19 mRNA Vaccine Moderna (Spikevax) SwissmedicTemporary Authorisation granted on 12 Jan 2021 On 16 September 2021, Swissmedic confirmed that Moderna has already submitted an applicaton seeking modification of the current dosage regime, to add a third booster dose and the application is under review.

On 9 August 2021, approval of Indication extension for Spikevax vaccine for 12- to 17-year-olds
16 Sep 2021
Eli Lilly and Co. Monoclonal antibodies bamlanivimab and etesevimab administered together FDA/USOn 9 February 2021, Emergency Use Authorisation Issued.

On 18 March 2021, revised Fact sheet for healthcare providers to address SARS-COV-2 variants


Fact sheet for healthcare providers

On 16 September 2021 EUA revised, to include emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.
16 Sep 2021
BioNTech Manufacturing GmbH Pfizer-BioNTech Comirnaty® COVID-19 vaccine
Health CanadaAuthorised in accordance with section 5 of the Interim Order re COVID-19 on 9 Dec 2020.

Pediatric indication (ages 12-15) – Authorised (with terms and conditions) on 5 May 2021

Information for healthcare professionals
The vaccine was authorised under the Interim Order for use in relation to COVID-19. The interim order expired on September 16, 2021. On this date, the vaccine transitioned to an authorisation under the Food and Drug Regulations.16 Sep 2021
Pfizer/Biontech Comirnaty Vaccine SAHPRA/South Africa On 16 March 2021, emergency use authorisation granted under Section 21 of the Medicines and Related Substance Act 101 of 1965 On 10 September 2021, SAHPRA has granted emergency use authorisation for the use of the vaccine under Section 21 of the Medicines and Related Substance Act 101 of 1965 to include individuals twelve years (12) years and older.10 Sep 2021
Pfizer/BioNTech Coronavirus mRNA vaccine Comirnaty®
(BNT162b2)
EMA/EUConditional Marketing Authorisation granted on 21 Dec 2020.

Overview, Authorisation details, Product Information and assessment history

On 26 March 2021, CHMP gave a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C (i.e. the temperature of standard pharmaceutical freezers) for a one-off period of two weeks.

On 3 May 2021 EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15.

EMA will communicate the outcome of its evaluation, which is expected in June 2021 unless supplementary information is needed.

On 1 June 2021 EMA has recommended the approval of additional manufacturing and filling lines at Pfizer’s vaccine manufacturing site in Puurs, Belgium

On 22 June 2021, EMA has approved two additional manufacturing sites for the production of the vaccine.One site, located in Reinbek, Germany, is operated by Allergopharma GmbH & Co. KG. The other in Stein, Switzerland, is operated by Novartis Pharma. The sites will perform finished product manufacturing steps at different stages of the process.
On 9 September 2021, the CHMP has approved additional manufacturing sites for the production of Comirnaty.
One site, located in Frankfurt am Main, Germany, is operated by Sanofi-Aventis Deutschland GmbH. The other in Hameln, also in Germany, is operated by Siegfried Hameln GmbH. Both sites will manufacture finished product.

On 6 September 2021, EMA has started evaluating an application (via accelerated assessment) for the use of a booster dose of Comirnaty
to be given 6 months after the second dose in people aged 16 years and older.

Separately, EMA is also assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (Comirnaty) in severely immunocompromised people.


On 24 August 2021, CHMP has approved an additional manufacturing site for the production of Comirnaty, The site, located in Saint Rémy sur Avre, France, is operated by Delpharm and will manufacture finished product.

On 9 July 2021,
The PRAC has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with Comirnaty.  The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information together with a warning to raise awareness among healthcare professionals and people taking these vaccines.
9 Sep 2021
Oxford University/
AstraZeneca
Vaxzevria -COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant] MHRA/UK15 Apr 2021
Information for Healthcare Professionals and for UK Recipients on COVID-19 Vaccine AstraZeneca updated with new information about extremely rare, unlikely to occur blood clots.

On 24 June 2021 Conditional Marketing Authorisation granted. This replaces the temporary approval granted on 30 Dec 2020.

SmPC, Information for Healthcare Professionals and Patient Information Leaflet.
On 9 September 2021, the information for Healthcare professionals and UK recipients updated to include information on a third dose at least 8 weeks after the second dose when the potential benefits outweigh any potential risks.The information has not been added to the SmPC and PIL.
Also the Regulation 174 Conditions document updated with additional pharmacovigilance conditions.

On 20 August 2021, Updated the PIL and SmPC updated to include new warning on Guillaine-Barre Syndrome.


On 16 July 2021, updated to reflect the addition of capillary leak syndrome as a contraindication. Also the name of the COVID-19 Vaccine AstraZeneca in the Conditional Marketing Authorisation product information changed to the brand name – Vaxzevria.
9 Sep 2021
Pfizer/BioNTech COVID-19 mRNA Vaccine BNT162b2 MHRA/UKOn 21 December 2020, the Conditional Marketing Authorisation was issued by the European Medicines Agency (EMA) and was automatically converted to a GB CMA on 1 January 2021.


Information for healthcare professionals and the public

On 20 May 2021 the Information for Healthcare Professionals, Information for UK recipients and Conditions of Authorisation documents was updated to reflect a change that once removed from the freezer, the undiluted vaccine has a maximum shelf life of up to 1 month (31 days). This was previously 5 days.

4 June 2021
MHRA
Updated Conditions of Authorisation, Information for Healthcare Professionals and Information for UK Recipients documents in line with an extension to the current UK approval of the Pfizer/BioNTech COVID-19 vaccine that allows its use in 12- to 15-year-olds.
On 9 September 2021, the information for Healthcare professionals and UK recipients updated to include information on a third dose at least 8 weeks after the second dose when the potential benefits outweigh any potential risks.The information has not been added to the SmPC and PIL.
Also the Regulation 174 Conditions document updated with additional pharmacovigilance conditions.

On 2 August 2021 , the conditions of authorisation of the vaccine were
updated. In Section 4.4 of the SmPC (Special warnings and precautions for use), the following vaccine stress-related responses “tachycardia, paraesthesia and dizziness” have been listed. In Section 4.8 (Undesirable effects), The following ADR “Extensive swelling of the vaccinated limb” has been listed with frequencies and a related footnote has been added.  Name of product updated to Comirnaty.

On 25 June,
a warning on myocarditis added to the Information for UK recipients and the Information for Healthcare Professionals.


9 Sep 2021
MODERNA BIOTECH SPAIN, S.L. COVID-19 Vaccine Moderna (now known as Spikevax)

mRNA-1273 vaccine
EMA/EU Conditional marketing authorisation granted on 6 Jan 2021

Overview, Authorisation details, Product Information and assessment history

Clinical data to support the authorisation, published 2 March 2021

On 4 June 2021 two new sites for the manufacturing of active substance and finished product intermediates, located in the US (ModernaTX, Inc., Norwood, Massachusetts and Lonza Biologics, Inc., Portsmouth, New Hampshire), were approved by CHMP.

On 11 June 2021, the CHMP has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France.
Additionally, the CHMP has also given a positive opinion for the addition of several alternative sites responsible for batch control/testing.

On 9 July 2021, The PRAC has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with  Spikevax (previously COVID-19 Vaccine Moderna) .
The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.
On 6 September 2021 , EMA is assessing data from the literature on the use of an additional, third dose of an mRNA vaccine (SpikeVax) in severely immunocompromised people (i.e., with weakened immune systems)

On 24 August 2021, CHMP has approved an additional manufacturing site for the production of Spikevax,
The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site will perform finished product manufacturing.


On 30 July 2021 the CHMP has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US). recommendation is expected to have significant impact on the supply of Spikevax.

On 23 July 2021 the CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax  to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above. 24 August 2021, CHMP has approved an additional manufacturing site for the production of Spikevax,
The site, located in Bloomington, Indiana, United States (US), is operated by Catalent. The site will perform finished product manufacturing.


On 30 July 2021 the CHMP has approved a scale-up of the active substance production process at Moderna’s COVID-19 vaccine manufacturing sites in the United States (US). recommendation is expected to have significant impact on the supply of Spikevax.

On 23 July 2021 the CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax  to include use in children aged 12 to 17 years. The vaccine is already authorised for use in people aged 18 and above.
6 Sep 2021
Moderna Australia Pty Ltd mRNA COVID-19 Vaccine,
Spikevax (elasomeran)
TGA/AustraliaOn 9 August 2021 Provisional approval granted for use in individuals aged 18 years and older.

Provisional determination granted on 24 June 2021.

Product information available here.
On 3 September 2021 provisional approval granted for use in individuals 12 years and older.
3 Sep 2021
Pfizer Inc and BioNTech Comirnaty COVID-19 vaccine Anvisa/Brazil On 28 May, new conditions of storage authorised 
allowing the vaccine to be kept at a controlled temperature between 2 and 8 degrees Celsius for up to 31 days.

Full approval granted on 23 February 2021.

Prescribing information and package leaflet in Portuguese.
On 1 September 2021, inclusion of the company  
Exelead
 , located in Indianapolis, Indiana, in the US approved as an alternative manufacturer of Pfizer’s vaccine,  
Comirnaty.

On 11 June 2021, Anvisa authorised the vaccine in children 12 years of age or older.
1 Sep 2021
Pfizer/BioNTechmRNA
Pfizer-BioNTech COVID-19 Vaccine
(Comirnaty)
FDA/USEmergency Use Authorisation granted on 11 Dec 2020

FDA Allows More Flexible Storage, Transportation Conditions on 25 Feb 2021


On 7 May 2021, Initiation of a Biologics License Application (BLA) with the (FDA) for approval of the vaccine to prevent COVID-19 in individuals 16 years of age and older.

10 May 2021 Emergency use authorisation (EUA) for the prevention of COVID-19 expanded to include adolescents 12 through 15 years of age
On 23 August 2021,
approval granted for the prevention of COVID-19 disease in individuals 16 years of age and older.

Prescribing information and other information


On 12 August 2021,
the FDA amended the EUA to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.



23 Aug 2021
MODERNA BIOTECH SPAIN, S.L.COVID-19 vaccine Moderna (Spikevax)MHRA/UKTemporary approval was granted on 8 Jan 2021.
This was replaced with a conditional marketing authorisation granted on 1 Apr 2021.

An SmPC, a Patient Information Leaflet and a Public Assessment Report are available here.

On 25 June 2021, the Summary of Product Characteristics and the Patient Information Leaflet were updated to include a warning about myocarditis and pericarditis
On 20 August 2021, sections 6.3, 6.4 and 6.6 of the SmPC were updated.

Further information on all updates is available on the MHRA website here by clicking on ‘See all updates’.

On 17 August 2021,
Conditional Marketing Authorisation (CMA) extension granted that allows its use in 12- to 17-year-olds.

20 Aug 2021
Celltrion Healthcare Australia Pty Ltdregdanvimab
monoclonal antibody treatment
TGA AustraliaProvisional determination granted20 Aug 2021
Roche Products Pty Ltd combination monoclonal antibody therapy casirivimab + imdevimab (Ronapreve)TGA/AustraliaProvisional determination granted20 Aug 2021
Zydus Cadil, IndiaDNA Covid vaccine ZyCoV-D CDSCO/ IndiaEmergency use Authorisation granted20 Aug 2021
GlaxoSmithKline Australia Pty Ltd (GSK)Monoclonal antibody treatment, Sotrovimab (Xevudy)TGA/AustraliaProvisional determination granted on 14 April 2021On 20 August 2021, provisional approval granted for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require initiation of oxygen due to COVID-19 and who are at increased risk of progression to hospitalisation or death.20 Aug 2021
Roche Products Ltd. UK

Developed by Regeneron/Roche.
Ronapreve monoclonal antibody combination product (consisting of  casirivimab and imdevimab)MHRA/UKOn 19 August 2021 Conditional Marketing Authorisation granted with an indication for use in the prevention and treatment of acute COVID-19 infection for the UK.Information for healthcare professionals19 Aug 2021
Roche Registration GmbH  tocilizumab (RoActemra  
anti-inflammatory 
EMA/EUOn 16 August 2021 EMA has started an accelerated assessment to decide whether to to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation.EMA will communicate on the outcome of its evaluation, which is expected by mid-October unless supplementary information is needed16 Aug 2021
Moderna TX Inc.Moderna COVID-19 VaccineFDA/USEmergency Use Authorisation on 18 Dec 2020

On June 25, 2021, the FDA revised the patient and provider fact sheets regarding the suggested increased risks of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the tissue surrounding the heart) following vaccination

On 12 August 2021,
the FDA amended the EUA to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

Updated Fact sheet for healthcare providers on 12 August 2021
12 Aug 2021
Merck Sharp & Dohme (Australia) Pty Ltd (MSD)oral antiviral monotherapy, MolnupiravirTGA/AustraliaProvisional determination granted.10 Aug 2021
 Johnson & Johnson’sCovid-19 vaccineCDSCO/IndiaEmergency Use Authorisation Granted7 Aug 2021
Janssen-Cilag International N.V.COVID-19 Vaccine Janssen

Ad26.COV2.S
viral vector vaccine
EMA/EUConditional marketing authorisation granted on 11 Mar 2021.

Overview, authorisation details, Product information and Assessment history.

14 April 2021
Janssen has announced their decision to proactively delay the rollout of the vaccine in the EU while investigations continue.

20 April 2021
EMA finds possible link to very rare cases of unusual blood clots with low blood platelets.
Its safety committee, (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. 
PRAC also concluded that these events should be listed as very rare side effects of the vaccine.

On 25 June 2021, Approval of additional manufacturing site located in Anagni, Italy, operated by Catalent Anagni SRL. The site will perform finished product manufacturing.

On 2 July 2021
EMA has approved a scale-up of the active substance 
manufacturing process at Janssen Biologics B.V. The plant, which is located in Leiden, the Netherlands, produces all active substance 
for the manufacture of the EU supply of COVID-19 Vaccine Janssen, the COVID-19 vaccine developed by Janssen-Cilag International NV.
On 6 August 2021 PRAC recommended updating the product information  to include immune thrombocytopenia as an ADR, as well as a warning to alert HCPs and people taking the vaccine of this possible side effect.

PRAC has also recommended amending the product information 
to add dizziness and tinnitus as adverse reactions to alert HCPs and people taking the vaccine of these potential side effects.

On 22 July PRAC has confirmed that Guillain-Barré syndrome (GBS) will be listed as a very rare side effect of COVID-19 Vaccine Janssen and a warning will be included in the product information 
to raise awareness among healthcare professionals and people taking the vaccine.


On 9 July 2021, The PRAC has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen. The Committee also recommended that capillary leak syndrome should be added to the product information as a new side effect of the vaccine, together with a warning to raise awareness among healthcare professionals and patients of this risk.



6 Aug 2021
GlaxoSmithKline IncSotrovimab

Immune sera and immunoglobulins, for human use
Health CanadaAuthorised for use in relation to the COVID-19 pandemic, in accordance with section 5 of the Interim Order Resources for healthcare professionals and consumers 30 Jul 2021
Regeneron Pharmaceuticals, Inc.Monoclonal antibodies
casirivimab and imdevimab (REGEN-COV)
FDA/USEmergency Use Authorisation granted on 21 Nov 2020.


Fact sheet for healthcare providers revised to address SARS-COV-2 variants on 18 March 2021.

Fact Sheet for Healthcare Providers

3 June 2021
FDA recently issued significant updates to the EUA  to include:
 
1) Authorised dosage is now 600 mg of casirivimab and 600 mg of imdevimab.

2) Addition of Subcut. route of administration when IV infusion is not feasible & would lead to delay in treatment.

3) Addition of new REGEN-COV co-formulated product in single vial.
On 30 July 2021 FDA revised the EUA authorising REGEN-COV for emergency use as post-exposure prophylaxis (prevention) for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.


30 July 2021
Eli Lilly and Company baricitinib (Olumiant) FDA/USEmergency Use Authorisation granted on 19 Nov 2020 for use in combination with remdesivirOn 28 July 2021 , The EUA for baricitinib no longer requires baricitinib be used in combination with Veklury (remdesivir).

fact sheet for health care providers

28 July 2021
Bharat Biotech International Ltd. Covaxin COVID-19 vaccine ANVISA/Brazil
On 4 June 2021 Exceptional import authorised. To be used under specific conditions listed.
On 27 July, ANVISA decided to provisionally suspend the exceptional and temporary authorisation for import and distribution of the vaccine against Covid-19  Covaxin.27 Jul 2021
AstraZeneca K.KCOVID-19 Vaccine (ChAdOx1-S [recombinant])
Vaxzevria Intramuscular injection
PMDA/Japan (Approval based on article 14-3 of the PMD Act i.e Special approval for emergency on 21 May 2021.


On 27 July 2021, precautions revised.27 Jul 2021
Pfizer Australia Pty Ltd.COVID-19 vaccine COMIRNATYTGA/AustraliaProvisional approval granted on 25 Jan 2021

Updated storage conditions approved on 13 Mar 2021

Supporting regulatory documents with updated Product information

On 24 May 2021,
more flexible storage conditions approved.

This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal refrigerator after taking out of deep-freeze conditions) at the point of use from five days up to one month (31 days).
On 23 July 2021, addition of safety information about myocarditis and pericarditis to Product Information.

On 23 July 2021, provisional approval granted to include 12- 15 year age group.



23 July 2021
Sanofi PasteurVidprevtyn COVID-19 vaccineEMA/EURolling review commenced.20 July 2021
Swedish Orphan Biovitrum AB (publ), SwedenKineret (anakinra) an immunosuppressant authorised since March 2002.EMA/EUEMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia who are at risk of developing severe respiratory failure.


EMA will communicate on the outcome of its evaluation, which is expected by October 2021 unless supplementary information is needed.
19 July 2021
Janssen Biotech Inc.Ad26.COV2.S
viral vector vaccine
FDA/USEmergency Use Authorisation granted on 27 Feb 2021

Factsheet for healthcare providers
On 13 July 2021, FDA announced revisions to the vaccine recipient and vaccination provider fact sheets for the Johnson & Johnson (Janssen) COVID-19 Vaccine to include information pertaining to an observed increased risk of Guillain-Barré Syndrome (GBS) following vaccination. 13 July 2021
Pfizer/BioNTechCoronavirus mRNA vaccine Comirnaty® (BNT162b2)PMDA/JapanApproval based on article 14-3 of the PMD Act i.e. Special approval for emergency on 14 February 2021On 7 July 2021, revision of precautions was applied.

Further information available here.
7 July 2021
JanssenCOVID-19 vaccineMedsafe/New ZealandProvisional approval granted7 Jul 2021
Manufactured by Sinovac Life Sciences Co, and imported by Curanto Pharma (Pty) LtdCoronaVac COVID-19 vaccine

Inactivated whole virion vaccine
SAHPRA/South AfricaEmergency use access under Section 21 of the Medicines and Related Substance Act 101 of 1965, subject to certain conditions.3 Jul 2021
Cipla, India partnered with Moderna Inc.Moderna Covid-19 vaccineCDSCO/IndiaEmergency use approval granted29 Jun 2021
Janssen-Cilag Pty Ltd.Ad26.COV2.S
viral vector vaccine
TGA/AustraliaProvisional approval granted.25 Jun 2021
Pfizer, Inc, / BioNTechBNT162b2 mRNA vaccineCofepris/MexicoAuthorised for emergency use on 11 Dec 2020.On 24 June 2021 modification to the authorisation conditions for emergency use of the expanding the therapeutic indication for its possible application from the age of 12 years.24 Jun 2021
Hoffmann-La Roche, Ltd.
C/O Genentech, Inc.
Actemra (tocilizumab)

Actemra is a monoclonal antibody. 
FDA/USEmergency Use Authorisation (EUA)

Fact sheet for healthcare providers
EUA for the treatment of hospitalised adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). 24 Jun 2021
China National Pharmaceutical GroupSinopharm vaccineSAHPRA/South AfricaSAHPRA has received documentation for the vaccine and will now commence with evaluating the data in assessing the efficacy of the vaccine.23 Jun 2021
MODERNA BIOTECH SPAIN, S.L.COVID-19 Vaccine Moderna

mRNA-1273 vaccine
EMA/EUConditional marketing authorisation granted on 6 Jan 2021

Overview, Authorisation details, Product Information and assessment history

Clinical data to support the authorisation, published 2 March 2021
On 11 June 2021, the CHMP has approved a new manufacturing site for the production of Moderna COVID-19 vaccine finished product. The site, operated by Recipharm, is located in Monts, France.

On 8 June 2021 EMA has started evaluating an application to extend the use of the COVID-19 Vaccine Moderna to include young people aged 12 to 17.
11 Jun 2021
Gilead Sciences Ireland UCVeklury (remdesivir) Concentrate for solution for infusionEMA/EUOn 23 Feb 2021, EMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require supplemental oxygen.
EMA will communicate on the outcome of the evaluation, which is expected before the summer.

25 Jun 2020
Conditional marketing authorisation granted.
On 11 Jun 2021, the PRAC has recommended a change to the product information 
for Veklury to include sinus bradycardia (heart beats more slowly than usual) as an adverse reaction of unknown frequency for this medicine.

On 21 May 2021 The CHMP recommended to renew the conditional marketing authorisation for Veklury (remdesivir), the only authorised antiviral treatment for COVID-19
11 Jun 2021
Hoffmann-La Roche LimitedCasirivimab and Imdevimab
(monoclonal antibodies)
Health CanadaAuthorised in accordance with section 5 of the Interim Order re COVID-19.

Authorised with conditions
Resources for healthcare professionals9 Jun 2021
Developed by
Russia’s Gamaleya National Centre of Epidemiology and Microbiology
Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine


Anvisa/BrazilThe vaccine may be imported on an exceptional basis by Brazil, in specific quantities, for the purposes of distribution and use under controlled conditions determined by Anvisa.4 Jun 2021
Moderna TX Inc.Moderna COVID-19 VaccineFDA/USEmergency Use Authorisation on 18 Dec 2020

Additional information including factsheets for healthcare providers and recipients
1 Jun 2021
SinovacSinovac-CoronaVac COVID19 vaccineWorld Health Organisation (WHO)Emergency Use Listing (EUL) On 1 June 2021
Moderna announced that it has has initiated the rolling submission process with the FDA
 for a Biologics License Application (BLA) for the licensure of its mRNA COVID-19 Vaccine to prevent COVID-19 in individuals 18 years of age and older.
1 Jun 2021
Pfizer New Zealand LimitedComirnaty
COVID-1 mRNA vaccine
Medsafe/New ZealandApproval under section 23 of the Medicines Act with conditions, 3 February 2021

Datasheet
On 28 May 2021, Medsafe has approved new storage conditions for use.
This change means that the refrigerated (2°C to 8°C) shelf life of an unopened vial of Comirnaty vaccine is extended from 5 days to 31 days.
28 May 2021
Pfizer/BioNTechCoronavirus mRNA vaccine Comirnaty®
(BNT162b2)
EMA/EUConditional Marketing Authorisation granted on 21 Dec 2020.

Overview, Authorisation details, Product Information and assessment history

On 26 March, CHMP gave a positive opinion to allow transportation and storage of vials of this vaccine at temperatures between -25 to -15˚C for a one-off period of two weeks.
28 May 2021
EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above.

On 17 May 2021, the EMA has recommended a change to the approved storage conditions of Comirnaty. This change extends the approved storage period of the unopened thawed vial at 2-8°C (i.e. in a normal fridge after taking out of deep-freeze conditions) from five days to one month (31 days).

28 May 2021
Janssen Cilag Ltd. UKCOVID-19 Vaccine Janssen suspension for injection
COVID-19 vaccine (Ad26.COV2-S [recombinant])
MHRA/UKConditional marketing authorisation granted.Information for healthcare professionals and the public.28 May 2021
Eli Lilly and CompanyInvestigational monoclonal antibody therapy sotrovimabFDA/USEmergency Use Authorisation granted.

Healthcare providers factsheet.
26 May 2021
Pfizer-BioNTechCOVID-19 vaccine COMIRNATYHSA singaporeInterim authorisation under PSAR route – 14 Dec 2020

HSA Extends the Use of Pfizer-BioNTech COVID-19 Vaccine to Adolescents of Ages 12 to 15 – 18 May 2021
25 May 2021 HSA Approves New Storage Condition at Refrigerator Temperature for up to 31 Days.25 May 2021
GlaxoSmithKline and Vir BiotechnologySotrovimab (VIR-7831)
a monoclonal antibody
EMA/ EUEMA has
completed its review.


The Agency concluded that sotrovimab can be used to treat confirmed COVID-19 in adults and adolescents (aged 12 years and above and weighing at least 40 kg) who do not require supplemental oxygen therapy and who are at risk of progressing to severe COVID-19.
21 May 2021
Moderna Inc.
Applicant. Takeda Pharmaceutical Company Limited.
COVID-19 Vaccine Moderna Intramuscular InjectionPMDA/JapanApproval based on article 14-3 of the PMD Act i.e Special approval for emergency21 May 2021
Fiocruz / AstrazenecaCOVID-19 vaccine recombinantANVISA/BrazilFull approval granted on 12 March 2021.

Prescribing information and package leaflet in Portuguese
On 10 May 2021, ANVISA recommended the immediate suspension of the use of the Covid vaccine from AstraZeneca/Fiocruz in pregnant women10 May 2021
Janssen-Cilag, SA de CVCOVID-19 AD26.COV2.S vaccineCofepris/MexicoEmergency Use Authorisation granted.7 May 2021
Beijing Bio-Institute of Biological Products Co Ltd, a subsidiary of China National Biotec Group (CNBG). Sinopharm COVID-19 vaccine ((Vero Cell)World Health Organisation (WHO)Emergency Use Listing (EUL)7 May 2021
GlaxoSmithKline and Vir BiotechnologySotrovimab (VIR-7831)
a monoclonal antibody
 
EMA/EUEMA has started a ‘rolling review’ of data on sotrovimab7 May 2021
Developed by Sinovac Life Sciences Co., Ltd. The EU applicant is Life’On S.r.l.COVID-19 Vaccine (Vero Cell) InactivatedEMA/EUThe EMA has commenced a rolling review of this vaccine and this will continue until until enough evidence is available for a formal marketing authorisation application.4 May 2021
ModernaModerna COVID-19 vaccine (mRNA 1273)World Health Organisation (WHO)Emergency Use Listing (EUL)30 Apr 2021
SK BioscienceNovavax COVID-19 vaccine MFDS/Republic of KoreaMFDS Begins Rolling Review of Novavax COVID-19 Vaccine29 Apr 2021
Huons Co., LtdSputnik V COVID-19 vaccine MFDS/Republic of KoreaMFDS Begins Rolling Review of Sputnik V COVID-19 Vaccine 29 Apr 2021
Eli Lilly Nederland B.V.Olumiant (baricitinib) 

Olumiant is an immunosuppressant
EMA/EUEMA has started evaluating an application to extend the use of Olumiant (baricitinib) to include treatment of COVID-19 in hospitalised patients from 10 years of age who require supplemental oxygen.

Olumiant was first authorised in the EU in February 2017
29 Apr 2021
Eli Lilly Canada IncMonoclonal antibody
Bamlanivimab
Health CanadaAuthorised in accordance with section 5 of the Interim Order re COVID-19 on 20 Nov 2020

Resources for healthcare professionals and consumers
28 Apr 2021 Potential Risk of Treatment Failure Due to Circulation of Resistant SARS-CoV-2 Variants identified.28 Apr 2021
Eli Lilly Japan K.K.Baricitinib-
Olumiant Tablets 2 mg /
Olumiant Tablets 4 mg
PMDA/JapanApproval details23 Apr 2021
Roche Pharma (Switzerland) AGcasirivimab and imdevimab, the active substances contained in “RegN-Cov2”, an artificial antibody cocktail that was developed to produce resistance to the SARS-Cov-2 coronavirusSwissmedicSwissmedic has given the go-ahead for the distribution of “RegN-Cov2“, a concentrate for solution for infusion from Roche Pharma (Switzerland) AG. As a result, this medicinal product is available even before the authorisation decision has been taken.  

The above has been facilitated under Annex 5 of COVID-19 Ordinance 3 lists those active substances that may be placed on the market before the authorisation procedure is concluded, provided Swissmedic has received an authorisation application.

The required authorisation application has been submitted to Swissmedic by Roche.
20 Apr 2021
CureVac Swiss AGCOVID-19 vaccine candidate CVnCoVSwissmedicRolling review commenced. 19 Apr 2021
Eli Lilly and CompanyMonoclonal antibody
bamlanivimab
FDA/USEmergency Use Authorisation granted on 9 Nov 2020Emergency use authorisation revoked on 16 April 2021.

Link to FDA letter to Eli Lilly and Company.
16 Apr 2021
GSKMonoclonal antibody VIR-7831 (also known as GSK4182136)EMA/EUEMA starts review of VIR-7831 for treating patients with COVID-19.

This review is being undertaken to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation.
15 Apr 2021
Janssen-Cilag Farmacêutica LtdaCOVID-19 vaccineANVISA/BrazilTemporary authorisation for emergency use granted on 31 March 2021.On 14 April 2021, approval of increased shelf life  
from  three to four and a half months under conditions of storage at 2 
°C  to 8 ° C.
14 April 2021
AstraZeneca ABVaxzevria –
COVID-19 Vaccine (ChAdOx1-S [recombinant])
EMA/EUConditional marketing authorisation granted on 29 Jan 2021.

Overview, authorisation details, Product information and assessment history.
14 April 2021
EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
In line with a request from the EU’s Commissioner for Health and Food Safety following a meeting of EU Health Ministers, EMA is undertaking a review of vaccination data and data on disease epidemiology (including infection rates, hospitalisations, morbidity and mortality).
14 Apr 2021
Russian Direct Investment Fund (RDIF) partnered with Dr. Reddy’s Laboratories Ltd.Sputnik V Gam-COVID-Vac
Combined vector vaccine (Component I & II)
CDSCO/IndiaEmergency use authorisation granted

Summary of Product characterisctis
12 Apr 2021
Green Cross CorporationModerna COVID-19 vaccineMFDS/Republic of KoreaReview of marketing authorisation application in progress.12 Apr 2021
AstraZeneca Pty Ltd.ChAdOx1-S [recombinant]
viral vector vaccine
TGA/AustraliaProvisional approval granted on 16 Feb 2021

Supporting regulatory documents updated on 8 April 2021 to include the latest information about the risk of very rare cases of thrombosis (blood clots) with thrombocytopenia (low blood platelet count) as per this update.
TGA approves CSL-Sequirus to manufacture the AstraZeneca vaccine in Australia on 21 March 20218 Apr 2021
Janssen KoreaJanssen COVID-19 vaccineMFDS/Republic of KoreaMarketing authorisation granted.7 Apr 2021
Bharat Biotech International Limited, IndiaCovaxin vaccineCofepris/ MexicoEmergency Use Authorisation granted.6 Apr 2021
Janssen Pharmaceutica (Pty) Ltd.COVID-19 VACCINE JANSSEN (AD26.COV2-S) SAHPRA/South AfricaRegistered under Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, with conditions1 April 2021
CelltrionRegdanvimab, a
monoclonal antibody (also known as CT-P59)
EMA/EUOn 26 Mar 2021, EMA’s CHMP has completed its review on
regdanvimab to treat patients with COVID-19. It concluded that regdanvimab can be used for the treatment of confirmed COVID-19 in adult patients who do not require supplemental oxygen therapy and who are at high risk of progressing to severe COVID-19.
 A rolling review of regdanvimab, which started on 24 Feb 2021, is currently ongoing. Once finalised, the rolling review will be the basis for an EU marketing authorisation application for this medicine.26 Mar 2021
Janssen-Cilag AGAd26.COV2.S
viral vector vaccine
SwissmedicTemporary authorisation granted.22 Mar 2021
Janssen (Johnson & Johnson)COVID-19 vaccine Ad26.COV2.S,World Health Organsiation (WHO)Emergency Use Listing (EUL)12 Mar 2021
Eli Lilly Nederland B.VMonoclonal antibody combination bamlanivimab and etesevimab
EMA/EURolling review commenced on 11 Mar 2021.

The review will also look at bamlanivimab used alone
Advice from review completed on 5 Mar 2021

and

Conditions for use, distribution etc. for unauthorised products.
11 March 2021
Janssen IncAd26.COV2.S
viral vector vaccine
Health CanadaAuthorised in accordance with section 5 of the interim order.Resources for healthcare professionals and consumers.5 Mar 2021
Pfizer KoreaCOVID-19 vaccine, COMIRNATY InjMFDS/Republic of KoreaMarketing authorsation granted.5 Mar 2021
R-Pharm Germany GmbHSputnik V (Gam-COVID-Vac), a COVID-19 vaccine

EMA/EURolling review commenced4 Mar 2021
Verity Pharmaceuticals Inc. and Serum Institute of India (SII) (in in partnership with AstraZeneca Canada Inc.#0Covishield
ChAdOx1-S (recombinant)
Health CanadaAuthorised in accordance with section 5 of the Interim OrderResources for Healthcare professionals and consumers26 Feb 2021
AstraZeneca Canada IncAstraZeneca COVID-19 Vaccine
ChAdOx1-S (recombinant)
Health CanadaAuthorised in accordance with section 5 of the Interim OrderResources for Healthcare professionals and consumers26 Feb 2021
Regeneron Ireland DACMonoclonal antibody combination casirivimab, imdevimab (REGN-COV2)
EMA/EUReview completed.
The Agency concluded that REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.

EMA’s recommendations can now be used to support national advice on the possible use of the antibodies before a marketing authorisation is issued.
Conditions for use, distribution etc. for unauthorised product.26 Feb 2021
Sputnik V vaccine developed by the Gamaleya Institute in RussiaSAHPRA/
South Africa
SAHPRA has received documentation for the Sputnik V vaccine and will commence evaluation24 Feb 2021
AstraZeneca-SKBio (Republic of Korea)Astrazeneca
ChAdOx1-S [recombinant]
vaccine
World Health Organisation (WHO)Emergency Use Listing
(EUL)
This is a version of the Astrazeneca vaccine15 Feb 2021
Serum Institute of IndiaAstrazeneca ChAdOx1-S [recombinant]
vaccine
World Health Organisation (WHO)Emergency Use Listing
(EUL)
This is a version of the Astrazeneca vaccine15 Feb 2021
Gilead Sciences Ireland UCVeklury (remdesivir) Concentrate for solution for infusionEMA/EU
25 Jun 2020
Conditional marketing authorisation granted.
12 Feb 2021
PRAC concludes product not associated with kidney disease and starts new safety signal procedure for sinus bradycardia.
12 Feb 2021 -PRAC news






CureVac AGCVnCov an mRNA COVID-19 vaccineEMA/EURolling review commenced12 Feb 2021
AstraZeneca KoreaKorea AstraZeneca COVID-19 Vaccine InjMFDS/Republic of KoreaMarketing authorisation granted.10 Feb 2021
Sinovac Research and Development CoronaVac
Inactive Virus vaccine
Cofepris/MexicoAuthorised for emergency use.9 Feb 2021
CanSino Biologics IncAd5-nCoV
Non-replicating viral vector vaccine
Cofepris/MexicoAuthorised for emergency use.9 Feb 2021
Gamaleya InstituteSputnik V
Non-replicating viral vector vaccine
Cofepris/MexicoAuthorised for emergency use.9 Feb 2021
Celltrion Inc.recombinant neutralising antibody
regdanvimab
(Regkirona Injection 960mg)
MFDS/Republic of KoreaMarketing Authorisation granted with conditions.5 Feb 2021
ModernaModerna COVID-19 vaccineHSA/SingaporeInterim authorisation under PSAR route.3 Feb 2021
Novavax CZ AS (a subsidiary of Novavax, Inc.)NVX-CoV2373 a COVID-19 vaccineEMA/EURolling review commenced3 Feb 2021
AstrazenecaCOVID-19 Vaccine (ChAdOx1 S [recombinant])SwissmedicRolling review ongoing.
Swissmedic has requested additional data. 3 Feb 2021
Regeneron 
Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche)
REGN-COV2 antibody combination
(casirivimab/ imdevimab)
EMA/EURolling review commencedThe rolling review will continue until enough evidence is available to support a formal marketing authorisation application1 Feb 2021
Taw pharmaCorticosteroid
Dexamethasone TAW
EMA/EUWithdrawnTaw pharma withdrew the MA application on 20 January 2021 because it was unable to remove preservatives from the medicine within the timeframe required by EMA.29 Jan 2021
Sinovac Life Sciences Co., LTD (China)Coronavac vaccineANVISA/BrazilTemporary authorsation for emergency use granted.22 Feb 2021
Sinovac in partnership with the Butantan InstituteCoronaVac vaccine,ANVISA/BrazilFirst temporary authorisation for the emergency use approved on 17 January 2021.On 22 January 2021, second temporary authorisation for the emergeny use appoved.22 Jan 2021
COVISHIELD
an Adenovirus-
Vectored COVID-19 vaccine manufactured by the Serum Institute of India
SAHPRA/ South AfricaSection 21 Authorisation granted.22 Jan 2021
Biocelect Pty Ltd (on behalf of Novavax IncCOVID-19 Vaccine, NVX-CoV2373TGA/AustraliaProvisional determination granted20 Jan 2021
MODERNA BIOTECH SPAIN, S.L.COVID-19 Vaccine Moderna

mRNA-1273 vaccine
EMA/EUConditional marketing authorisation granted

Clinical data to support the authorisation, published
Overview, Authorisation details, Product Information and assessment history6 Jan 2021
AstraZeneca /Oxford UniversityAZD1222
Adenovirus vaccine
Cofepris/MexicoAuthorised for emergency use.4 Jan 2021
Bharat Biotech, IndiaCovaxin
Whole Virion Inactivated Corona Virus Vaccine 
CDSCO/IndiaEmergency use authorisation granted.

Summary of Product Characteristics
3 Jan 2021
Serum Institute of India Pvt. LtdCovishield
 ChAdOx1 nCoV- 19 Corona Virus Vaccine (Recombinant)
CDSCO/IndiaEmergency Use authorisation granted

Summary of Product Characteristics
3 Jan 2021
Pfizer/BioNTechCoronavirus mRNA vaccine Comirnaty®World Health Organisation (WHO)Emergency Use Listing (EUL)Recommendation for EUL + product insert31 Dec 2020
Moderna Therapeutics Inc.Moderna COVID-19 Vaccine
mRNA-1273 SARS-CoV-2
Health CanadaAuthorised in accordance with section 5 of the Interim Order re COVID-19

Clinical data to support the authorisation, published
Resources for healthcare professionals and consumers23 Dec 2020
Dr Reddys Laboratories LtdFavipiravirHealth CanadaUnder review18 Dec 2020
BioNTech Manufacturing GmbHTozinameran
Pfizer-BioNTech COVID-19 Vaccine 
mRNA vaccine, BNT162b2
Health CanadaAuthorised in accordance with section 5 of the Interim Order re COVID-19Resources for healthcare professionals and consumers9 Dec 2020
Janssen IncAd26.COV2.S
viral vector vaccine
Health CanadaUnder review30 Nov 2020
Gilead Sciences Inc.Veklury (remdesivir) for injection, for intravenous useFDA/USApproved via fast track and priority reviewPrescribing information22 Oct 2020
AstraZeneca Canada Inc.COVID-19 Vaccine AstraZeneca (ChAdOx1 S [recombinant])Health CanadaUnder review1 Oct 2020
VariousCorticosteroid
Dexamethasone
EMA/EUReviewed under Article 5(3) of Regulation 726/2004
and
endorsed for use.
18 Sep 2020
US Dept. of Health and Human Services (HHS)COVID-19 Convalescent Plasma (CCP)FDA/USEmergency Use AuthorisationFact sheet for healthcare providers23 Aug 2020
Gilead Sciences Canada Inc.Veklury (remdesivir) solution for injectionHealth CanadaNotice of compliance issued Issued under Notice of Compliance with conditions guidelineResources for healthcare professionals and consumers27 July 2020
Gilead Sciences Ireland UC
Veklury (remdesivir) Concentrate for solution for infusion
EMA/EUConditional marketing authorisation granted.
Overview, Authorisation details, Production Information and assessment history
25 Jun 2020
Gilead Sciences, IncRemdesivirPMDA/JapanApproval based on article 14-3 of the PMD Act i.e Special Approval for Emergency
8 May 2020

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