COVID-19 medicines: Article 18 and Article 5(3) reviews

The European Medicines Agency (EMA) may review COVID-19 vaccines and treatments under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

This is intended to support national decision-making on the possible use of these medicines before a formal authorisation is issued.

During an Article 18 review, EMA's Emergency Task Force (ETF) reviews the available data on the use of the medicine and submits this to the Committee for Medicinal Products for Human Use (CHMP)">Committee for Medicinal Products for Human Use (CHMP) for an opinion.

Article 18 reviews of COVID-19 vaccines replaced those previously conducted under Article 5 (3) of Regulation establishing EMA (Regulation (EC) No 726/2004) when the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123) took effect in March 2022.

Ongoing reviews for COVID-19 vaccines

EMA's ETF is currently not reviewing data on any vaccine under under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

Completed reviews for COVID-19 vaccines

EMA's CHMP has reviewed data on the following vaccines, under Article 5(3) of Regulation (EC) No 726/2004:

Vaccine	Key milestones	More information
Vaxzevria (previously COVID-19 Vaccine AstraZeneca)	Start of review: 14/04/2021 Interim opinion: 23/04/2021 Final opinion: 17/09/2021	Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 September 2021 AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very rare blood clots with low blood platelets AstraZeneca’s COVID-19 vaccine: benefits and risks in context Article 5(3) opinions: Use of Vaxzevria to prevent COVID-19

For more information, see:

• Article 5(3) opinions

Ongoing reviews for COVID-19 treatments

EMA's ETF is reviewing the available data on the use of the following medicines to treat certain patients with COVID-19, under Article 18 of the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123):

Treatment	Key milestones	More information
Sabizabulin	Start of review under Article 18: 27/07/2022	EMA reviewing data on sabizabulin for COVID-19

Completed reviews for COVID-19 treatments

The following medicines can be used in the EU to treat COVID-19, after EMA's CHMP completed its review under Article 5(3) of Regulation (EC) No 726/2004:

Treatment	Status	More information
Paxlovid(PF-07321332 / ritonavir)	Use endorsed after Article 5(3) review	EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19 (16/12/2021) Paxlovid: product information
Dexamethasone	Use endorsed after Article 5(3) review	EMA endorses use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation (18/09/2020)
Casirivimab / imdevimab	Use endorsed after Article 5(3) review	EMA issues advice on use of REGN-COV2 antibody combination (casirivimab / imdevimab) (26/02/2021) Ronapreve: product information
Bamlanivimab / etesevimab	Use endorsed after Article 5(3) review	EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) (05/03/2021)
Lagevrio (molnupiravir)	Use endorsed after Article 5(3) review Marketing authorisation application withdrawn	EMA issues advice on use of Lagevrio (molnupiravir) for the treatment of COVID-19 (19/11/2021)
Regdanvimab	Use endorsed after Article 5(3) review	EMA issues advice on use of regdanvimab for treating COVID-19 (26/03/2021) Regkirona: product information
Sotrovimab	Use endorsed after Article 5(3) review	EMA issues advice on use of sotrovimab (VIR-7831) for treating COVID-19 (21/05/2021) Xevudy: product information

For more information on Article 5(3) evaluations, see:

• Article 5(3) opinions on any scientific matter: human medicines