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COVID-19 vaccines and treatments approved by the EMA

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The global effort on fighting the on-going COVID-19 pandemic, declared so by the World Health Organization in 11 March 2020, is bearing fruit. The endeavor made in the last year has achieved the development of vaccines and treatments that will help the world to overcome the pandemic.

Today, from Revio, we want to share with you a review on the global status of vaccines to prevent COVID-19. According to the Regulatory Affairs Professionals Society report (RAPS), there are currently 13 vaccines that have achieved regulatory authorization or approval around the globe. Furthermore, there are a total of 60 candidate vaccines in Phase 1-3 clinical trials or early development. RAPS also brings a summary of every vaccine, the type, developer, country of origin, and countries where it was approved, and in-depth information about each one. You can check their weekly-updated vaccine tracker here.

Authorized/approved vaccines in the EU

For the EU, there are currently 4 authorised vaccines that can be used to prevent COVID-19, as they have been granted with a conditional marketing authorisation, meaning that the companies will continue to provide results and information from on-going clinical trials on how long protections lasts, how well the vaccine prevents severe COVID-19, how well it protects immunocompromised people, children, and pregnant women, and whether it prevents asymptomatic cases.

  • Comirnaty has been developed by Pfizer, BioNTech, Fosun Pharma. It is based in mRNA with instructions for producing a protein from SARS-CoV-2, given as two injections 3 weeks apart that demonstrated a 95% efficacy in the clinical trial.
  • COVID-19 Vaccine Janssen (made by Johnson & Johnson), made up of another virus (a non-replicant adenovirus) modified to contain the gene for making a protein found on SARS-CoV-2. This vaccine is given as a single injection and demonstrated a 67% efficacy in the clinical trial.
  • COVID-19 Vaccine Moderna (by Moderna, BARDA, NIAID), also based in mRNA, given as two injections 28 days apart and demonstrated a 94.1% efficacy in the clinical trial.
  • Vaxzevria (AstraZeneca) made up of an adenovirus modified to contain a gene from SARS-CoV-2. It is given in two injections, between 4 and 12 weeks apart and showed a efficacy around 60% in the clinical trials.

Vaccines under review

Also, there are 3 vaccines currently under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP): CVnCoV, from CureVac AG; NVX-CoV2373, Novavax CZ AS and Sputnik V, from Russia’s Gamaleya National Centro of Epidemiology and Microbiology.

And besides of the vaccines, the EMA has also authorised a treatment that can be used to treat COVID-19, called Veklury (remdesivir), indicated for adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This treatment is given via infusion, between 5 and 10 days, and it consists in a viral RNA polymerase inhibitor that will prevent the coronavirus from multiplying inside cells, helping patients get better faster and overcoming the virus infection.

Furthermore, there are several COVID-19 treatments under review. All of them are monoclonal antibodies to stimulate the patient’s immune system against the viral particles of the coronavirus. These antibodies are bamlanivimab, etesevimab, regdanvimab, casirivimab and imdevimab.

This is some of the information you need to know on the current vaccines and treatment for COVID-19. Nevertheless, we have launched a dedicated webpage to bring you the latest updates, guidance and developments. You can also follow us on LinkedIn.

We hope you find this useful and of interest. If you would like to discuss any of these updates with the team at REVIO, please get in touch here.

If you want to know more, check out the official sources here.