EMA: COVID-19 updates

Since the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) meeting in July 2022, several recommendations related to COVID-19 vaccines and therapeutics were made.

• Authorising use of Nuvaxovid as a booster dose for adults who have had Nuvaxovid, an mRNA vaccine or an adenoviral vector vaccine as their primary vaccination. (The recommendation was made on 1 September 2022)
• Authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1 are for use in people aged 12 years and above who have received at least primary vaccination against COVID-19. For more information, see the news announcement. (The recommendation was made on 1 September 2022)

COVID-19 recommendations adopted during the last meeting of the CHMP (12-15 September 2022):

• Authorising the adapted bivalent vaccine Comirnaty Original/Omicron BA.4-5 for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19. This vaccine is an adapted version of the mRNA COVID-19 vaccine Comirnaty and targets the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. For more information, see the news announcement .
• Converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty and Spikevax into standard marketing authorisations. CHMP considered that the additional studies conducted by the companies as part of their post-authorisation obligations have provided ample information on the vaccines’ protection against COVID-19, as well as their quality and safety. For more information, see the news announcement.
• Approving a new manufacturing site in Dessau-Rosslau, Germany, for COVID-19 Vaccine Valneva.
• Authorising booster doses of Comirnaty for children from 5 to 11 years of age .
• Extending the use of COVID-19 therapeutic Evusheld for the treatment of adults and adolescents with COVID-19 who do not require supplemental oxygen.
• Extending the use of COVID-19 therapeutic Veklury in two paediatric populations:
  • Paediatric patients (of at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen or other non-invasive ventilation at the start of treatment.
  • Paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

SEE ALSO:

• Pfizer and BioNTech receive positive CHMP opinion for conversion of COMIRNATY® conditional marketing authorization to full marketing authorization in the European Union
• Gilead Sciences: CHMP adopts positive opinion to extend indication of Veklury® (remdesivir) for the treatment of pediatric patients with COVID-19