The Guardian :
The European Medicines Agency has authorised the Oxford/AstraZeneca Covid-19 vaccine for use in all adult age groups after days of doubt.
A month after it received approval in the UK, the EU’s regulator declared the vaccine safe for general use across the 27 member states.
The shot is the third Covid-19 vaccine given the green light by the EMA, after ones made by Pfizer and Moderna. Both were authorised for all adults.
There had been concerns that a lack of data about the effects of the vaccine on older people could put authorisation for those aged over 65 in doubt.
Earlier this week, a committee at Germany’s public health body, the Robert Koch Institute, said there was insufficient data to judge, and as a result it could only recommend using the vaccine on people aged 18 to 64. The final decision rests with the government, but it is likely to follow this advice.
In an interview with la Repubblica on Tuesday, AstraZeneca’s CEO, Pascal Soriot, said his company’s latest studies had shown “very strong antibody production against the virus in the elderly, similar to what we see in younger people”. The British prime minister, Boris Johnson, had also said he had confidence that the vaccine was safe and “produced an immune response in all age groups”.
On Friday Soriot welcomed the EMA’s decision. “Today’s recommendation underscores the value of AstraZeneca’s Covid-19 vaccine, which is not only effective and
well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” he said in a statement.
The agency cited the immune responses seen and experienced with other vaccines in recommending it for older people. “At least some protection is expected,” Bruno Sepodes from the EMA’s expert committee said at a news briefing. He acknowledged that “the exact level of protection cannot be estimated for the time being”.
The decision will now allow the deployment of 400m doses ordered by the EU for its population, once they are delivered. The company has warned the European commission that it will only be able to deliver 25% of the 100m expected doses in the first quarter of this year due to low yield at its Belgian production plant, causing huge controversy.
Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up. On top of the recent news that the drugmaker would supply fewer doses in an initial batch, there were concerns that an age restriction would further hamper Europe’s vaccination program.
While the AstraZeneca vaccine has been authorised for all adults in other countries, only 12% of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results.
A large trial published last month showed the vaccine was about 70% effective in preventing people from getting sick from the coronavirus, although it is unknown whether the shot stops disease transmission.
“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, the EMA’s executive director.
“As in previous cases, the CHMP [human medicines committee] has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”
The European Medicines Agency has authorised the Oxford/AstraZeneca Covid-19 vaccine for use in all adult age groups after days of doubt.
A month after it received approval in the UK, the EU’s regulator declared the vaccine safe for general use across the 27 member states.
The shot is the third Covid-19 vaccine given the green light by the EMA, after ones made by Pfizer and Moderna. Both were authorised for all adults.
There had been concerns that a lack of data about the effects of the vaccine on older people could put authorisation for those aged over 65 in doubt.
Earlier this week, a committee at Germany’s public health body, the Robert Koch Institute, said there was insufficient data to judge, and as a result it could only recommend using the vaccine on people aged 18 to 64. The final decision rests with the government, but it is likely to follow this advice.
In an interview with la Repubblica on Tuesday, AstraZeneca’s CEO, Pascal Soriot, said his company’s latest studies had shown “very strong antibody production against the virus in the elderly, similar to what we see in younger people”. The British prime minister, Boris Johnson, had also said he had confidence that the vaccine was safe and “produced an immune response in all age groups”.
On Friday Soriot welcomed the EMA’s decision. “Today’s recommendation underscores the value of AstraZeneca’s Covid-19 vaccine, which is not only effective and
well-tolerated, but also easy to administer and, importantly, protects fully against severe disease and hospitalisations,” he said in a statement.
The agency cited the immune responses seen and experienced with other vaccines in recommending it for older people. “At least some protection is expected,” Bruno Sepodes from the EMA’s expert committee said at a news briefing. He acknowledged that “the exact level of protection cannot be estimated for the time being”.
The decision will now allow the deployment of 400m doses ordered by the EU for its population, once they are delivered. The company has warned the European commission that it will only be able to deliver 25% of the 100m expected doses in the first quarter of this year due to low yield at its Belgian production plant, causing huge controversy.
Many countries on the continent have been struggling to vaccinate people as quickly as Britain, Israel, the US and elsewhere, and it was long hoped that the AstraZeneca shot would help speed things up. On top of the recent news that the drugmaker would supply fewer doses in an initial batch, there were concerns that an age restriction would further hamper Europe’s vaccination program.
While the AstraZeneca vaccine has been authorised for all adults in other countries, only 12% of the participants in its research were over 55 and they were enrolled later, so there hasn’t been enough time to get results.
A large trial published last month showed the vaccine was about 70% effective in preventing people from getting sick from the coronavirus, although it is unknown whether the shot stops disease transmission.
“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, the EMA’s executive director.
“As in previous cases, the CHMP [human medicines committee] has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”
