European Medicines Agency Recommends AstraZeneca COVID-19 Vaccine for Authorization

02 February 2021

BioPharm International

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

The European Medicines Agency (EMA) announced on Jan. 29, 2021 that it is recommending conditional marketing authorization for AstraZeneca’s COVID-19 vaccine. The recommendation is based on an assessment of quality, safety, and efficacy data by the agency’s human medicine’s committee (CHMP). The AstraZeneca’s vaccine is the third COVID-19 vaccine to receive authorization by EMA.

According to the agency, results from four clinical trials in the United Kingdom, Brazil, and South America, which included 24,000 people, showed the vaccine is safe and effective in people 18 years and older. “The safety of the vaccine has been demonstrated across the four studies. However, the Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen,” EMA stated in a press release.

Despite the fact that the majority of study participants were between 18 and 55 years old, the agency stated that while there were not enough results regarding people aged 55 and older, EMA’s experts believe the vaccine can be used in older adults based on the immune response seen in the age group and experience with other vaccines.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA, in a press release. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

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