The EMA announced its decision this Friday afternoon
THE European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Covid-19 Vaccine AstraZeneca to prevent the disease in people aged 18 and over. This is the third Covid-19 vaccine that EMA has recommended for authorisation.
In a statement, issued this Friday evening the EMA said its human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.
EMA has just recommended granting a conditional marketing authorisation for the #COVID19vaccine AstraZeneca to prevent #COVID19 in people from 18 years of age. Read our press release: https://t.co/YDbOvZEMUN pic.twitter.com/Sbj6TdlGTW— EU Medicines Agency (@EMA_News) January 29, 2021
"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. “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," she added.
"Combined results from four clinical trials in the United Kingdom, Brazil and South Africa showed that Covid-19 Vaccine AstraZeneca was safe and effective at preventing Covid-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-Covid vaccine. People did not know if they had been given the test vaccine or the control injection," reads the statement.
The EMA says 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 six 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 four and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.
These showed a 59.5% reduction in the number of symptomatic Covid-19 cases in people given the vaccine (64 of 5,258 got Covid-19 with symptoms) compared with people given control injections (154 of 5,210 got Covid-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.
The EMA says most of the participants in the studies were between 18 and 55 years old and that 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. 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.
Covid-19 Vaccine AstraZeneca is given as two injections into the arm, the second between four and 12 weeks after the first.
The most common side effects with COVID-19 Vaccine AstraZeneca were usually mild or moderate and got better within a few days after vaccination. The most common side effects are pain and tenderness at the injection site, headache, tiredness, muscle pain, general feeling of being unwell, chills, fever, joint pain and nausea. The safety and effectiveness of the vaccine will continue to be monitored as it is used across the EU, through the EU pharmacovigilance system and additional studies by the company and by European authorities.