Europe: COVID-19 Vaccines – Announcements/Regulatory Actions/Deployment
European Medicines Agency
News: EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
Last updated: 12/02/2021
EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID19 vaccine being developed by CureVac AG.
The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults. These studies suggest that the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, the virus that causes COVID19.
The company is currently conducting trials in people to assess the vaccine’s safety, immunogenicity (how well it triggers a response against the virus) and effectiveness against COVID-19. EMA will evaluate data from these and other clinical trials as they become available.
The rolling review will continue until enough evidence is available for a formal marketing authorisation application….
News: EMA preparing guidance to tackle COVID-19 variants
Last updated: 10/02/2021
EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new virus variants. In order to consider options for additional testing and development of vaccines that are effective against new virus mutations, the Agency has requested all vaccine developers to investigate if their vaccine can offer protection against any new variants, e.g. those identified in the United Kingdom, South Africa and Brazil, and submit relevant data.
EMA will shortly publish a reflection paper that will set out the data and studies needed to support adaptations of the existing vaccines to current or future mutations of SARS-CoV-2 in the European Union (EU). The questions that will be addressed as part of this reflection paper include:
:: Which are the options for introducing a new strain into an existing approved vaccine?
:: What will be the minimal regulatory requirements to demonstrate the quality, safety and efficacy?
:: Which bridging studies will be required to provide adequate reassurance of a vaccine’s efficacy against a new strain, either as first vaccination or as booster…
News: Clarification on Sputnik V vaccine in the EU approval process
Last updated: 10/02/2021
The European Medicines Agency has to date not received an application for a rolling review or a marketing authorisation for the vaccine developed by the Gamaleya National Centre of Epidemiology and Microbiology in Russia, the Sputnik V vaccine (Gam-COVID-Vac), despite reports stating the opposite.
The developers have received scientific advice from EMA providing them with the latest regulatory and scientific guidance for the development of their vaccine. In line with the Agency’s transparency policy, the vaccine is included in the list of COVID-19 medicines and vaccines that have received scientific advice from the Agency.
EMA is in dialogue and collaborating with the company to define the next steps. The developers have expressed their interest that the vaccine be considered for a rolling review…
News: International regulators working together to enhance collaboration on COVID-19 observational research
Last updated: 08/02/2021
In a dedicated COVID-19 workshop, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), medicine regulators from around the world emphasised the importance of international collaboration and sharing expertise and best practices on observational studies of real-world data to facilitate regulatory decision-making on COVID-19 treatments and vaccines. The workshop was co-chaired by Health Canada and EMA and took place on 25 January 2021. The main findings of the workshop are summarised in a report, which has been published today…