The European Medicines Agency (EMA) has approved another vaccine against COVID-19 developed by Oxford University and AstraZeneca. This is the third vaccine to be approved for use in Europe less than a year since the pandemic was declared in March 2020.
The other approved vaccines are made by Pfizer/BioNTech and Moderna. A fourth made by Johnson & Johnson/Jannsen is under rolling review by the Agency. More than 100 vaccines are in development, with results from Novavax making headlines last week. (Vaccines Today is funded by Vaccines Europe, a trade association whose members include Pfizer, Moderna, AstraZeneca & Janssen.)
Emer Cooke, EMA's Exec. Director: "With EMA’s recommendation today, we are further expanding the range of #COVID19vaccines available to EU and EEA member states to bring the pandemic under control and protect their citizens.”— EU Medicines Agency (@EMA_News) January 29, 2021
The EMA’s key decision-making body, the Committee on Human Medicinal Products (CHMP), said it thoroughly assessed the data on safety, quality and efficacy before reaching a consensus.
The vaccine will be offered to adults of all ages, including people aged 65 and older. While there is limited data in older groups because fewer people in that age category were recruited to the early trials, the regulator says it expects the vaccine to protect older people. It is given in two doses separated by between 4 and 12 weeks.
The decision is based on results from four clinical trials in the UK, Brazil and South Africa showing that the vaccine is safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people in total.
In assessing how well the vaccine worked, the EMA worked on the results from the UK and Brazil studies as the other two trials had too few cases of COVID-19 to measure the preventive effect of the vaccine.
Bruno Sepodes, CHMP Vice-chair: "After evaluation of all available data EMA's committee for human medicines (#CHMP) has agreed that the benefits of this #COVID19vaccine outweigh the known and any potential risks in people from 18 years of age.”— EU Medicines Agency (@EMA_News) January 29, 2021
Most of the participants in these studies were between 18 and 55 years old. ‘There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group,’ the EMA said in a statement.
‘However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults.’
More information is expected from ongoing studies, which include a higher proportion of elderly participants. As with all vaccines and medicines, safety will continue to be monitored after approval.
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