Published 20:52 IST, January 6th 2021
COVID-19: European Union recommends authorisation of Moderna's vaccine
The European Union's medicines agency gave its authorisation to Moderna's COVID-19 vaccine for final approval, the agency announced on Wednesday.
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The European Medicines Agency (EMA) on Wednesday gave its authorisation to Moderna's COVID-19 vaccine for final approval. After receiving permission for use by the European Commission, which is expected to happen soon, Moderna's mRNA-based drug would become the second COVID-19 vaccine to be approved in the region. Earlier the European Commission granted emergency use authorisation to Pfizer-BioNTech vaccine, starting the much-awaited vaccination drive for the 27-member bloc.
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“This vaccine provides us with another tool to overcome the current emergency. It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO. As for all medicines, we will closely monitor data on the safety and effectiveness of the vaccine to ensure the ongoing protection of the EU public. Our work will always be guided by the scientific evidence and our commitment to safeguard the health of EU citizens.," Emer Cooke, Executive Director of EMA said in a statement.
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'Clinical trials showed it's safe'
EMA said that a "very large clinical" trial showed Moderna's COVID-19 vaccine to be 94.1 percent effective. The EU agency said that the trial included 30,000 people between 18 to 94 years of age. The trial proved the vaccine is safe and effective and also showed the efficacy of 90.9% in people with chronic lung disease, heart disease, obesity, liver disease, diabetes, or HIV infection. Moderna's COVID-19 vaccine is administered in two doses, 28 days apart.
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Moderna has already received emergency use authorisation in the United Kingdom, which was part of the European Union until last year. The United States Food and Drug Administration (FDA) has also approved Moderna's vaccine and frontline essential workers, including medical professionals are already being inoculated across the country. Canada has also approved Moderna's vaccine. Moderna's vaccine is also easier to transport and handle if compared to Pfizer-BioNTech because it doesn't require to be stored at extreme temperatures.
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20:52 IST, January 6th 2021