EMA approves COVID-19 vaccine of AstraZeneca

The COVID-19 vaccine developed by AstraZeneca and Oxford University was authorized for use by the European Medicines Agency (EMA), the drug regulator of the European Union (EU), on Friday, reported Xinhua.

The EMA said it had assessed the safety and effectiveness of the vaccine and recommended that a formal conditional marketing authorization be granted by the European Commission, the executive arm of the EU.

"With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA (European Economic Area) member states to combat the pandemic and protect their citizens," Emer Cooke, executive director of the EMA, said in a statement.

Cooke said that as in previous cases, the EMA's human medicines committee rigorously evaluated the vaccine, and "the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens."

Combined results from four clinical trials in the United Kingdom, Brazil and South Africa, involving around 24,000 people, showed that the vaccine was safe and effective at preventing COVID-19 in people from 18 years of age, according to the EMA.

The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, a general feeling of being unwell, chills, fever, joint pain and nausea, the conclusion report said.

Replying to questions about concerns voiced by the German authorities and their recommendation that the vaccine should not be administered to people older than 65, EMA Executive Director Bruno Sepodes told a press conference that 13 percent of the patients included in the analysis were elderly.

"At least some protection is expected in this subgroup, although the exact level of protection cannot be estimated for the time being," he confirmed.

Based on data relating to patients who received standard doses followed by second standard doses, the conclusion was drawn that the vaccine demonstrated around 60 percent efficacy in the clinical trials, Sepodes said.

As the world is struggling to contain the pandemic, vaccination is underway in the EU with two already-authorized coronavirus vaccines, one developed by Pfizer and BioNtech, another by Moderna.

Meanwhile, 236 candidate vaccines are still being developed worldwide -- 63 of them in clinical trials -- in countries including Germany, China, Russia, Britain and the United States, according to information released by the World Health Organization on Jan. 26.