COVID-19 vaccines and treatments, regulatory status at a glance (2 of 2)

The table below shows the COVID-19 vaccines and treatments regulatory status at a glance. It is updated on an ad hoc basis. Regulatory status from 27 September 2021 is covered.

On mobile, the table is best viewed by scrolling sideways.

For regulatory status prior to 27 September 2021, please visit this page.

Other news including on vaccines, treatments, trials and side effects, here.

Company(ies)/ Organisation/
Others
ProductIssuing Regulatory Agency/OrganisationRegulatory status updateDate
GlaxoSmithKline  Xevudy (sotrovimab) antibodySwissmedicTemporary authorisation granted for treatment of COVID-19 in adults and adolescents aged 12 years and over and with a body weight of at least 40 kg if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19.14 Jan 2022
iQone Healthcare Switzerland Regkirona (regdanvimab)
antibody
SwissmedicTemporary authorisation granted for treatment of COVID-19 in adults if oxygen therapy or hospitalisation is not required due to the disease and there is a high risk of developing a severe form of COVID-19.13 Jan 2022
Janssen Biotech Inc. Janssen (Johnson and Johnson) COVID-19 Vaccine FDA/USEUA reissued
with the following changes:

1) Section 5 Warnings and Precautions of the EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (Full
Prescribing Information) is revised to include new information on an increased risk of immune thrombocytopenia
(ITP) during the 42 days following vaccination.

ii) Related changes were also made to the EUA Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) (short version) for consistency.

More information here.
11 Jan 2022
Pfizer Limited Paxlovid
(Paxlovid is PF-07321332 tablets co-packaged with ritonavir tablets.)
MHRA/UKThe MHRA website states, Updated the SPC and PIL for Paxlovid.

Drug Interactions stated in the SmPC and PIL have been harmonised following an MHRA request. Section 4.5 of the SmPC and Section 2 the PIL have been updated to achieve the harmonisation.
11 Jan 2022
Pfizer Europe MA EEIGoral antiviral Paxlovid (PF-07321332 and ritonavir)EMA/EUEMA has started evaluating an application for a conditional marketing authorisation, for the treatment of mild-to-moderate COVID-19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19.10 Jan 2022
MSDMolnupiravirCofepris/MexicoAuthorised for emergency use to treat patients with mild or moderate COVID-19, and with high risk of complications7 Jan 2022
ModernaTX, IncModerna COVID-19 VaccineFDA/USEUA amended to shorten the time between the completion of a primary series of the vaccine and a booster dose to at least five months for individuals 18 years of age and older. 7 Jan 2022
AstraZeneca Pty Ltd.tixagevimab and cilgavimab (Evusheld)TGA/AustraliaFurther provisional determination granted, for prevention and treatment of COVID-19 in individuals aged 12 years and older.4 Jan 2022
Pfizer-BioNTech Comirnaty, Pfizer-BioNTech COVID-19 Vaccine FDA/USEUA amended to:
-Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
-Shorten the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 Vaccine and a booster dose to at least five months.
– Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
3 Jan 2022
Pfizer LimitedPaxlovid
(Paxlovid is PF-07321332 tablets co-packaged with ritonavir tablets.)
MHRA/UKConditional Marketing Authorisation issued for Great Britain and a temporary Regulation 174 authorisation for Northern Ireland to ensure supply across all of the UK. More information here.

Paxlovid is indicated for the treatment of COVID-19 in adults who do not require supplemental
oxygen and who are at increased risk for progression to severe COVID-19.
31 Dec 2021
Center for Genetic Engineering and Biotechnology (CIGB) in Havana
Recombinant protein of the receptor-binding domain of the SARS-CoV-2 virus (Abdala COVID-19 vaccine)Cofepris/MexicoAuthorised for emergency use.

This is a three dose vaccine. More about the vaccien here.
28 Dec 2021
Janssen-Cilag AGCOVID-19 Vaccine JanssenSwissmedicApproval granted for booster dose so that persons aged 18 years and older can now receive a booster dose after a first vaccination.

The booster dose of the vaccine can be administered, at the earliest, two months after the first dose.
27 Dec 2021
Bharat BiotechCovaxin COVID-19 vaccineCDSCO/IndiaApproval granted for emergency use in children aged 12 to 18.25 Dec 2021
Moderna, Biotech Spain, S.L. Spikevax vaccineMHRA/UK The MHRA update states ‘Frozen storage instructions’. It seems that the following text has been deleted from section 6.4 of the SmPC
‘Do not store on dry ice or below -50ºC’. The leaflet will have been updated accordingly. Note that the date of the updated SmPC is 22 Dec 2021.
24 Dec 2021
RocheRonapreve (a combination of antiboides casirivimab and imdevimab)SwissmedicSwissmedic has approved the product which was already authorised for prescription use, for use under COVID-19 Ordinance 3.

Ronapreve is indicated in adults and adolescents aged 12 years or older with a bodyweight of at least 40 kg:
– for treatment of COVID-19 if oxygen therapy or hospitalisation is not required and there is a high risk of developing a severe form of COVID-19.
– for prevention of COVID-19 when an adequate immune response to COVID-19 vaccination is not possible.
23 Dec 2021
JanssenCOVID-19 Vaccine JanssenSAHPRA/South AfricaBooster dose granted approval for use with conditions, under section 15 Medicines and Related Substance Act (Act 101 of 1965), for 2nd dose at least 2 months after primary vaccination. 23 Dec 2021
Merck Sharp & Dohme CorpmolnupiravirFDA/USEmergency Use Authorisation (EUA) issued for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate.23 Dec 2021
Moderna, Biotech Spain, S.L. Spikevax vaccineMHRA/UKThe MHRA update states ‘SmPC & PIL updated’. No further infromation is provided. It seems that the section 6.4 of the SmPC has been updated to change the sotrage time period for the unopened vial from 7 months to 9 months. The leaflet will have been updated accordingly.22 Dec 2021
?Turkovac COVID-19 vaccineTITCK/TurkeyEmergency use approval granted.22 Dec 2021
Pfizer Inc.Oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use)FDA/USEUA issued for Paxlovid for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Paxlovid should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.
22 Dec 2021
BioNTech Manufacturing GmbHComirnaty vaccineMHRA/UKApproval granted for a new age-appropriate formulation of Comirnaty, for use in children aged 5 to 11 years old. This new authorisation to the Conditional Marketing Authorisation (CMA) granted by the MHRA is valid in Great Britain only.22 Dec 2021
Pharmac?Ronapreve monoclonal antibodyMedsafe/New ZealandRonapreve is approved for:
-the treatment of COVID-19 for people who are affected by COVID-19 and are at increased risk of progressing to severe COVID-19 disease.  
-for preventing COVID-19 for people who have been exposed to the virus and have a medical condition that makes them unlikely to be protected by vaccination.
21 Dec 2021
Novavax CZ, a.s.Nuvaxovid (also known as NVX-CoV2373)EMA/EUConditional Marketing Authorisation granted, to prevent COVID-19 in people from 18 years of age20 Dec 2021
Vaxine Pty LtdCOVID-19 vaccine: Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2TGA/AustraliaProvisional determination granted.20 Dec 2021
Gilead Sciences Ireland UCVeklury (remdesivir)EMA/EUThe CHMP adopted a change to the existing indication to add that
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:
adults who do not require supplemental oxygen and who are at increased risk of
progressing to severe COVID-19.
16 Dec 2021
BioNTech Manufacturing GmbHComirnaty COVID-19 vaccineFDA/USApproval to include a new
30 mcg dose formulation (Tris/Sucrose) manufactured at the
Pfizer Manufacturing Belgium NV, Puurs, Belgium (Pfizer, Puurs) facility.

This new formulation:
-is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers.
-does not need to be diluted before use, thus, vaccination providers can more readily prepare and deliver appropriate doses.
-contains Tris buffer, a commonly used buffer in other FDA-approved vaccines and biologics.
16 Dec 2021
Janssen-Cilag International NV.COVID-19 Vaccine JanssenEMA/EUCHMP approves an additional manufacturing site for the production of the vaccine.
The site, located in Marcy-l’Étoile, France, and operated by Sanofi Pasteur, will manufacture finished product
16 Dec 2021
BioNTech Manufacturing GmbHComirnaty VaccineEMA/EUCHMP approves an increase in production of the active substance of the vaccine at manufacturing site operated by Wyeth BioPharma Division of Wyeth Pharmaceuticals, located in Andover, MA, USA.16 Dec 2021
Moderna Biotech Spain, S.L. COVID-19 vaccine SpikevaxEMA/EUCHMP has given a positivie opinion for an increase in production of Spikevax, at the manufacturing site operated by ROVI Contract Manufacturing, located in Madrid, Spain.
The increase in production includes a 50% scale-up of the batch size of the finished product and a second fill-and-finish line
16 Dec 2021
PfizerPaxlovid (PF-07321332/ritonavir) an oral treatment for COVID-19. EMA/EUThe CHMP has issued advice on the use of Paxlovid and ritonavir for the treatment of COVID-19.
The medicine, which is not yet authorised in the EU (butreview has started) , can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease. Paxlovid should be administered ASAP after diagnosis of COVID-19 and within 5 days of the start of symptoms. The separate tablets, should be taken together twice a day for 5 days.
16 Dec 2021
Swedish Orphan Biovitrum AB (publ)
Immunosuppressive, Kineret (anakinra)
EMA/EUThe CHMP has recommended extending the indication of the product, to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml.16 Dec 2021
GlaxoSmithKline Trading Services Limited monoclonal antibody Xevudy (sotrovimab) EMA/EUThe CHMP has recommended authorising Xevudy for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. 16 Dec 2021
ModernaModerna COVID-19 vaccinePMDA/JapanBooster dose approved.

No information yet, on the PMDA website.
15 Dec 2021
Janssen-Cilag International NVCOVID-19 Vaccine JanssenEMA/EUThe CHMP has concluded that a booster dose of COVID-19 Vaccine Janssen may be considered at least two months after the first dose in people aged 18 years and above.

CHMP has also concluded that that a booster dose with COVID-19 Vaccine Janssen may be given after two doses of one of the mRNA vaccines authorised in the EU, i.e.  Comirnaty  or Spikevax. 
15 Dec 2021
Janssen Biotech Inc.Janssen (Johnson and Johnson) COVID-19 Vaccine FDA/USEUA amended with the following changes:

EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (Full
Prescribing Information) is revised to include new informatin in the following sections:
4 CONTRAINDICATIONS
4.2 Thrombosis with Thrombocytopenia

5 WARNINGS AND PRECAUTIONS
5.2 Thrombosis with Thrombocytopenia Syndrome (TTS)

6 OVERALL SAFETY SUMMARY
6.1 Clinical Trial Experience

Related changes were also made to the EUA Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) (short version) for consistency

More information here.
14 Dec 2021
Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics oral antiviral medicine Lagevrio (molnupiravir) EMA/EUFollowing EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio (molnupiravir) prior to marketing authorisation, the Agency will review more data from the main study of Lagevrio (MK-4482-002)

EMA has started evaluating a marketing authorisation 
application under a reduced timeline.

14 Dec 2021
Pfizer/BioNTech Comirnaty vaccineSwissmedicApproval granted for use in children aged 5 to 11 years.10 Dec 2021
Pfizer-BioNTechComirnaty VaccineHSA SingaporeHSA extends the PSAR authorisation for use in children of ages 5 to 11 years for the prevention of COVID-19, at a lower dose of 10mcg.10 Dec 2021
BioNTech Manufacturing GmbHPfizer-BioNTech COVID-19 Vaccine. FDA/USEmergency use authorisation (EUA) amended, authorising the use of a single booster dose for administration to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech COVID-19 Vaccine.9 Dec 2021
AstraZeneca Pharmaceuticals LPEvusheld (tixagevimab co-packaged with cilgavimab and administered together) FDA/USEmergency Use Authorisation granted for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kg [about 88 lbs). The product is only authorised for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not recently been exposed to an individual infected with SARS-CoV-2.8 Dec 2021
PfizerComirnaty vaccineSAHPRA/ South AfricaBooster dose granted approved for use under section 21 of the Medicines and Related Substance Act (Act 101 of 1965) as follows:

A third dose of the Comirnaty® COVID-19 vaccine:
– in individuals aged 18 years and older, to be administered at least 6 months after the second dose.
– in individuals aged 12 years and older who are severely immunocompromised, to be administered at least 28 days after the second dose.
8 Dec 2021
Moderna Australia Pty Ltd COVID-19 vaccine SpikevaxTGA/AustraliaProvisional approved granted for a booster dose of the vaccine, for individuals 18 years and older.

In addition, the TGA Product Information (PI) also now includes a statement in relation to a 3rd primary dose of COVID-19 vaccine for severely immunocompromised people aged 12 years and over at least 28 days after the second dose. A 3rd primary dose is intended to address the risk of suboptimal or non-response to the standard 2 dose schedule
8 Dec 2021
MODERNA BIOTECH SPAIN, S.L.Spikevax vaccineMHRA/UKProduct Information Updated. Sections 2, 4.2, 4.4, 4.8, 5.1, 6.5 and 6.6 of the SmPC updated to include a booster dose. PIL updated accordingly. 6 Dec 2021
Roche Registration GmbH RoActemra (tocilizumab) EMA/EUCHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation.6 Dec 2021
Celltrion Healthcare Australia Pty Ltdmonoclonal antibody, regdanvimab (REGKIRONA)TGA/AustraliaProvisional approval granted for the for the treatment of adults with COVID-19 who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.6 Dec 2021
Pfizer Australia Pty Ltd. COVID-19 vaccine, ComirnatyTGA/ AustraliaProvisional approval granted for use in children 5-11 years of age. 5 Dec 2021
Eli Lilly and companymonoclonal antibodies bamlanivimab and etesevimabFDA/USThe EUA (previously authorised for pediatric patients 12 years of age and older weighing at least 40kg, or about 88 lbs), revised to additionally be used for:
i) the treatment of mild/moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalisation or death.
ii) post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalisation or death
3 Dec 2021
ValnevaVLA2001, COVID-19 vaccineEMA/EURolling review commenced.2 Dec 2021
GlaxoSmithKline UK LimitedMonoclonal antibody, Xevudy (sotrovimab)MHRA/UKConditional Marketing Authorisation granted (valid in GB only) and an emergency use authorisation granted in Northern Ireland, for the treatment of symptomatic adults and adolescents (aged 12 years and over and weighing at least 40 kg) with acute covid-19 infection who do not require oxygen supplementation and who are at increased risk of progressing to severe covid infection.2 Dec 2021
bamlanivimab and etesevimab combinationCofepris/MexicoAuthorised for emergency use, for the treatment of mild to moderate coronavirus disease in adults and pediatric patients (12 years and older weighing at least 40 kilograms), with positive direct diagnostic test results for the SARS-CoV-2 virus. , and who present very high-risk comorbidities that are not controlled1 Dec 2021
AstraZeneca ABVaxzevria COVID-19 Vaccine EMA/EUThe CHMP has approved a new site (operated by WuXi Biologics, in Leverkusen, Germany) to manufacture Vaxzevria finished product.

CHMP has also given a positive opinion to scale up manufacturing to triple the batch size of finished product at a site operated by Amylin Ohio in West Chester Township, Ohio, US.
1 Dec 2021
Roche Products Pty Ltd COVID-19 monoclonal antibody, tocilizumab (Actemra) TGA/AustraliaProvisional approval granted for the treatment of coronavirus
disease 2019 (COVID-19) in hospitalised adults who are receiving
systemic corticosteroids and require supplemental oxygen or
mechanical ventilation
1 Dec 2021
ModernaSpikevax vaccineSwissmedicBooster dose approved. A booster dose (half-dose) can now be administered to anyone aged 18 or over with immediate effect. High-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously.26 Nov 2021
BioNTech and Pfizer Comirnaty COVID-19 vaccineEMA/EUThe CHMP has recommended granting an extension of indication to include use in children aged 5 to 11 years.25 Nov 2021
Novavax Inc.COVID-19 vaccine NVX-CoV2373HSA/SingaporeApplication submitted for interim authorisation under the Pandemic Special Access Route (PSAR).24 Nov 2021
Pfizer/BioNTech Comirnaty vaccineSwissmedicIndividuals aged 16 years and over can now be administered a booster dose. As stipulated in the Swissmedic decision of 26 Oct 2021, high-risk individuals can still obtain the booster from age 12. In both cases, however, the second dose must have been administered at least six months previously.23 Nov 2021
Janssen-Cilag International NVCOVID-19 Vaccine JanssenEMA/EUEvaluation started of an application for the use of a booster dose of the vaccine to be given at least two months after the first dose to people aged 18 years and older.22 Nov 2021
Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp,Taiwan)COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).TGA/AustraliaProvisional determination granted. The vaccine will be considered for for the active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals aged 18 years of age and older22 Nov 2021
PfizerPaxlovid (PF-07321332/ritonavir) an oral treatment for COVID-19. EMA/EUReview started to support national authorities who may decide on its early use for COVID-19 e.g. in emergency use settings, prior to marketing authorisation. 19 Nov 2021
BioNTech Manufacturing GmbHComirnaty (tozinameran) COVID-19 vaccine Health Canada

Authorised for use (with terms and conditions) in children 5 to 11 years of age.

Authorised under Food and Drug Regulations for drugs for use in relation to COVID-19 
19 Nov 2021
Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics molnupiravir (also known as MK 4482 or Lagevrio) EMA/EUCHMP has issued adivce on use while the rolling review is in progress.
The medicine, currently not authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19.
19 Nov 2021
Pfizer-BioNTechComirnaty vaccineFDA/USEmergency use authorisation (EUA) amended, authorising use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorised or approved COVID-19 vaccine.19 Nov 2021
Janssen Biotech Inc. Janssen (Johnson and Johnson) COVID-19 Vaccine FDA/USLetter of authorisation of EUA reissued. Revisions incorporated to amend the EUA to authorize the vaccine as a single booster dose following completion of primary
vaccination with another authorized or approved COVID-19 vaccine

More information here.
19 Nov 2021
ModernaTX, IncModerna COVID-19 vaccineFDA/USEmergency use authorisation (EUA) amended, authorising use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorised or approved COVID-19 vaccine. 19 Nov 2021
Pfizer Schweiz AGComirnaty vaccineSwissmedicApplication submitted to request extension of the use of the vaccine in children aged 5 to 11 years.19 Nov 2021
ModernaCOVID-19 vaccine, Spikevax®SwissmedicApplication to submitted to extend the indication of vaccine to children aged 6 years and older.18 Nov 21
BioNTech Manufacturing GmbH Comirnaty vaccine MHRA/UK
Sections of the SmPC and PIL updated to include information about receiving a 3rd/booster dose and two new reagents, sodium hydroxide and hydrochloric acid, which are used in small quantities during the preparation of one of the solutions used in the manufacturing process. The official International non-proprietary name ‘tozinameran’ has also been added.
15 Nov 2021
Roche Registration GmbHRonapreve (casirivimab/imdevimab), monoclonal antibodiesEMA/EURonapreve is authorised in the EU for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.

Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms.
12 Nov 2021
Celltrion Healthcare Hungary KftRegkirona (regdanvimab) monoclonal antibodyEMA/EURegikrona is authorised in the EU
for the treatment of adults with COVID 19 who do not require supplemental oxygen and who are at increased risk of their disease becoming severe.
 
12 Nov 2021
Moderna Biotech Spain, S.L.COVID-19 vaccine, SpikevaxEMA/EUEvaluation of an application to extend the use of the vaccine in children aged 6 to 11 has commenced.10 Nov 2021
AstraZeneca Pty Ltd.COVID-19 monoclonal antibody treatment tixagevimab and cilgavimab (Evusheld)TGA/AustraliaProvisional determination granted. To be considered for the prevention of COVID-19 in adults aged 18 years and older.4 Nov 2021
Merck Sharp & Dohme (UK) Limited Lagevrio (molnupiravir)
oral antiviral
MHRA (UK)Conditional Marketing Authorisation granted (valid in GB only) and an emergency use authorisation granted for Northern Ireland,   for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease.

SmPC and PIL
4 Nov 2021
AstraZeneca AGCOVID-19 Vaccine AstraZenecaSwissmedicAstraZeneca withdraws authorisation application.4 Nov 2021
Bharat Biotech, IndiaBBV152 COVAXIN vaccineWHOEmergency Use Listing (EUL) .3 Nov 2021
Novavax Inc.COVID-19 vaccine, NVX-CoV2373Medsafe/ New ZealandSubmission completed.3 Nov 2021
Janssen-Cilag Ltd.COVID-19 Vaccine Janssen suspension for injectionMHRA/UKUpdated SmPC and PIL.
SmPC Sections updated were: 4.3 (addition of Capillary Leak syndrome (CLS)), 4.4 (addition of CLS and Guillain -Barre Syndrome), 4.8, 5.0 and 6.4.

PIL sections updated were: 2 and 4, including information on CLS and Guillain-Barre Syndrome.
3 Nov 2021
AstraZeneca CanadaAZD7442  is a combination of two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061) Health CanadaRolling review New Drug Submission initiated with Health Canada for the prevention of symptomatic COVID-19.3 Nov 2021
Bharat BiotechCovaxin vaccineWorld Health Organsiation (WHO)Emergency Use Listing (EUL)3 Nov 2021
Elli Lilly Netherlands BVantibodies bamlanivimab and etesevimabEMA/EURolling review ended upon company withdrawing from the process.2 Nov 2021
Novavax Inc.COVID-19 vaccine candidate, NVX-CoV2373 Health CanadaRolling submission completed, for authirisation.1 Nov 2021
Novavax Inc.COVID-19 vaccine candidate, NVX-CoV2373TGA/AustraliaRolling submission completed, for provisional approval.29 Oct 2021
Pfizer-BioNTech Comirnaty COVID-19 VaccineFDA/USEUA authorised for the prevention of COVID-19 to include children from 5 to 11 years of age.

FDA also authorised a manufacturing change for the vaccine to include a formulation that uses a different buffer.
This new formulation is more stable at refrigerated temperatures for longer periods of time, permitting greater flexibility for vaccination providers
29 Oct 2021
BioNTech Manufacturing GmbH Comirnaty vaccine MHRA/UK Updated figures in HCP information Table 5: Vaccine efficacy – First COVID-19 occurrence from 7 days after Dose 2 – participants without evidence of infection and with or without evidence of infection prior to 7 days after Dose 2 – adolescents 12 to 15 years of age evaluable efficacy (7 days) population.

The above information appears in section 5.1 Pharmacodynamic Properties in the document Information for Healthcare Professionals on COVID-19 Vaccine Pfizer/BioNTech (Regulation 174).
28 Oct 2021
Novavax IncCOVID-19 vaccine, NVX-CoV2373MHRA/UKRolling submission completed, for authorisation.27 Oct 2021
BioNTech Manufacturing GmbHComirnaty vaccineMHRA/UKUpdate to the SmPC sections 4.8 Undesirable effects and section 5.1 Pharmacodynamic Properties and patient information leaflet section 4 Possible side effects. 27 Oct 2021
Pfizer Australia Pty Ltd.COVID-19 vaccine, Comirnaty.TGA/AustraliaProvisional approval of a booster dose of for individuals 18 years and older.27 Oct 2021
ModernaSpikevax vaccineSwissmedicBooster half dose approved for people at especially high risk e.g. older people or at-risk patients approved for use at least 6 months after the second dose.

Three-dose schedule for patients with a weakened immune system approved i.e. for immunocompromised individuals or patients with a suppressed immune response for use at least 28 days after the second dose
26 Oct 2021
Pfizer/BioNTechComirnaty vaccineSwissmedicBooster dose approved for people at especially high risk e.g. older people or at-risk patients approved for use at least 6 months after the second dose.

Three-dose schedule for patients with a weakened immune system approved i.e. for immunocompromised individuals or patients with a suppressed immune response for use at least 28 days after the second dose
26 Oct 2021
Moderna Biotech Spain, S.L.Spikevax COVID-19 vaccineEMA/EUEMA has concluded that a booster dose may be considered in in people aged 18 years and above.25 Oct 2021
Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeuticsmolnupiravir (also known as MK 4482 or Lagevrio)EMA/EURolling review commenced, for the treatment of COVID-19 in adults.25 Oct 2021
Sinovac BiotechSinovac-CoronaVac Vaccine an inactivated SARS-CoV-2 vaccineHSA/SingaporeInterim authorisation granted under the Pandemic Special Access Route, for the prevention of COVID-19 in individuals aged 18 years and above.23 Oct 2021
AstraZeneca UK LimitedVaxzevria vaccine MHRA/UKGuillain-Barré syndrome [GBS] added as a very rare side effect.21 Oct 2021
Moderna TX Inc.Moderna COVID-19 VaccineFDA/USEUA amended
to allow for the use of a single booster dose as follows:

i) to allow for the use of a single booster dose at least 6 months after completion of the primary series as detailed.

ii) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

20 Oct 2021
Janssen Biotech Inc. Janssen (Johnson and Johnson) COVID-19 Vaccine FDA/US EUA amended to allow for the use of a single booster dose as follows:
i) to allow for the use of a single booster dose at least 2 months after completion of the single-dose primary regimen

ii) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
20 Oct 2021
Pfizer/BioNTech Pfizer-BioNTech COVID-19 VaccineFDA/US EUA amended
to allow for the use of a single booster dose as follows:

i) The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.

ii) To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
20 Oct 2021
AstraZeneca UK Limited.Vaxzevria vaccineMHRA/UKMHRA website states ‘Updated information for healthcare professionals and for patients’. No other information provided.19 Oct 2021
CureVac Swiss AG CVnCoV vaccineSwissmedicApplication withdrawn.
CureVac will no longer be developing its first-generation COVID-19 vaccine to market readiness, and will instead be focusing on a second-generation COVID-19 vaccine.
19 Oct 2021
?Sputnik V vaccineSAHPRA/South AfricaRolling review ongoing since Feb 2021. Vaccine will remain unapproved at this time until concerns are addressed.18 Oct 2021
BioNTech and PfizerComirnaty, COVID-19 vaccineEMA/EUTwo additional manufacturing sites approved
One site, located in Monza, Italy, is operated by Patheon Italia S.p.A. The other in Anagni, Italy, is operated by Catalent Anagni S.R.L. Both sites will manufacture finished product.

New ready-to-use-formulation approved. It does not require dilution prior to administration, will be available in a 10-vial (60 dose) pack size and can be stored at 2-8°C for up to 10 weeks.
18 Oct 2021
Roche Products Pty Ltd.combination therapy, casirivimab + imdevimab (Ronapreve)TGA/AustraliaProvisional approval granted for the treatment and prevention of COVID-19 in specific target populations18 Oct 2021
PfizerComirnaty InjectionPMDA/JapanOther precautions revised to include myocarditis and pericarditis15 Oct 2021
AstraZeneca ABEvusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab)EMA/EURolling review started, for the prevention of COVID-19 in adults.14 Oct 2021
CureVac AGCVnCoV COVID-19 vaccineEMA/EUEMA has ended the rolling review of the vaccine, after the company informed the Agency that it was withdrawing from the process.12 Oct 2021
Chugai Pharmaceutical Co LtdMonoclonal antibody Ronapreve (casirivimab /imdevimab)PMDA/JapanApplication filed for additional indications for prophylaxis of COVID-19 and treatment of asymptomatic COVID-19 infected patients. This application also contains subcutaneous administration in addition to the drug’s current intravenous administration and seeks the Special Approval for Emergency.11 Oct 2021
Merckoral molnupiravirFDA/USEUA application submitted to the U.S. FDA for for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalisation.11 Oct 2021
Roche Registration GmbHRonapreve, a monoclonal antibody combination (casirivimab / imdevimab)EMA/EUEvaluating of an an application for marketing authorisation has commenced, for the treatment of COVID-19 in adults and adolescents from 12 years of age who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19, and for the prevention of COVID-19 in adults and adolescents aged 12 years and older.11 Oct 2021
Janssen-Cilag International N.V. COVID-19 Vaccine Janssen

Ad26.COV2.S
viral vector vaccine
EMA/EU An additional manufacturing site been approved. It is located in West Point, Pennsylvania, US and operated by MSD Corp. It will manufacture finished product.7 Oct 2021
AstraZenecaAZD7442, long-acting antibody (LAAB) combination consisting of  two LAABs – tixagevimab (AZD8895) and cilgavimab (AZD1061).FDA/USRequest submitted to the US FDA for an EUA for AZD7442 for prophylaxis of symptomatic COVID-19.5 Oct 2021
Celltrion Healthcare Hungary Kftmonoclonal antibody Regkirona (regdanvimab, also known as CT-P59)EMA/EUEvaluation of an application for a marketing authorisation commenced, to treat adults with COVID-19 who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID 19.

Will be assessed under a reduced timeline with opinion potentially in two months.
4 Oct 2021
Pfizer AustraliaCombination medicine containing PF-07321332 (oral antiviral) and ritonavirTGA/AustraliaProvisional determination granted for the treatment of adult patients with symptomatic, confirmed coronavirus infection.1 Oct 2021
AstraZeneca ABVaxzevria –
COVID-19 Vaccine (ChAdOx1-S [recombinant])
EMA/EUImmune thrombocytopenia (ITP)
The committee assessed all the available data and recommended updating the PI  to include ITP as an adverse reaction with an unknown frequency.
1 Oct 2021

Janssen-Cilag International N.V.
COVID-19 Vaccine Janssen

Ad26.COV2.S
viral vector vaccine
EMA/EUVTE
The PRAC has concluded that there is a possible link to rare cases of venous thromboembolism (VTE) with this vaccine.
and is therefore recommending listing VTE as a rare side effect in the PI, plus a warning to raise awareness among HCPs and vaccine recipients, especially those who may have an increased risk of VTE.

Immune thrombocytopenia (ITP)
The committee assessed all the available data and recommended updating the PI  to include ITP as an adverse reaction with an unknown frequency.

1 Oct 2021
Special Approval for Emergency under Article 14-3Xevudy (sotrovimab)PMDA/JapanSpecial Approval for Emergency under Article 14-3 granted.27 Sep 2021
Pfizer/BioNTech Comirnaty
COVID-19 mRNA Vaccine
MHRA/UKVaccine shelf-life extended from 6 months to 9 months27 Sep 2021
Moderna Biotech Spain, S.L. COVID-19 Vaccine Moderna (now known as Spikevax)

mRNA-1273 vaccine
EMA/EUEMA has started evaluating an application (via accelerated assessment) for the use of a booster dose of Spikevax to be given at least 6 months after the second dose in people aged 12 years and older. 
27 Sep 2021

Image by Miroslava Chrienova from Pixabay