EMA head Emer Cooke responds to questions about AstraZeneca's trial data, and the fact that there were a relatively small % of older people in the trial:
"The studies that were done that have been included in the file so far have a very small quantity of elderly populations..."
"This is what is being discussed in the media atm
Our scientific committee is looking at the totality of the data to see what that data means in terms of the populations that were studied and what could reasonably be expected in populations that maybe have not been studied yet."
"This is a normal process in relation to any vaccines. We have to look at the data that’s there, look at the science behind it, and what we can expect that data to mean."
"I’m not going to prejudge any decision because this is a scientific and expert decision that is ongoing. But it is possible to conclude an authorisation that would focus on a particular age group, or it’s possible to conclude for a wider age group," Cooke said.
⬆️ Since AstraZeneca's application for approval in the EU on January 12, the question has been floated: will EMA approve it for older age groups given the trial data available?
Very important question for national vaccine rollout plans.
Initial in vitro studies of the already-approved Pfizer and Moderna vaccines suggest they are effective "at least against the UK variant", Emer Cooke says.
"The South African variant is more complicated" and further study is needed on whether vaccines work against it, she says.
More mutations are expected, and the EMA is currently figuring out what the regulatory approval process would be for updates/tweaks to vaccines to make them effective against new variants, Cooke says.
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My understanding of AstraZeneca's EU doses:
- contract signed in August
- EU expected over 100 mln doses delivered by end-March, possibly 120 mln
- in early Dec, AZ revised down to 80 mln
- on Jan 22, AZ revised to 31 mln
- distributed proportionally: eg Ireland's share is ~1.1%
Meanwhile, on Jan 13, AstraZeneca chief Tom Keith-Roach told a UK parliament hearing it was scaling up vaccine deliveries "very rapidly" and by mid-Feb would be able to deliver two million doses to the UK every week.
Up to that point, 1.1 mln doses had been delivered to UK.
AZ and UK govt have represented UK doses as made in UK, and visa versa for EU.
However, on December 8, the UK's Vaccine Taskforce manufacturing lead Ian McCubbin told reporters that
"The initial supply... actually comes from the Netherlands and Germany." reuters.com/article/uk-hea…
The EU has asked AstraZeneca to make the contract public as it disagrees with the interpretation put forward by CEO Pascal Soriot, according to an official, who suggests this could be a breach of the contract confidentiality the company had insisted on.
The EU believes there are stocks of vaccines produced in Europe, that it wants to be delivered to the EU to fulfil its contract.
The factory that has an issue is not the most vital to supply, according to official.
"We are trying to get the vaccines that are somewhere in Europe."
The idea that there are separate supply chains for the UK is not reflected in the contract, according to official.
Two factories located in the UK are the primary ones slated for EU supply, followed by one in Belgium (which has a problem) and one in Germany, official says.
If you only have a few infections, you can really put resources into making sure they don't spread further.
In Australia, if you have to self-isolate you are handed an official order that explains exactly what you can and can't do... health.nsw.gov.au/Infectious/fac…
Getting an official order on paper in itself is enough to get compliance from the vast majority of people, @NICU_doc_salone told me.
The order also notes that if you break the rules, the maximum penalty is a $11,000+ fine and six months in prison... health.nsw.gov.au/Infectious/fac…"
How is international media reporting Ireland's dramatic Covid-19 surge that has taken it from one of the lightest-affected in Europe to a global hotspot in a matter of weeks?
Always interesting to see an international perspective.
A press review:
"Ireland is the country in the world where the epidemic is spreading the fastest, ahead of the Czechia and the United Kingdom," reports Belgium's @RTBFinfortbf.be/info/societe/d…
"It must be said that the Irish situation is in fact much more serious: if in the United Kingdom, infections have increased by 50% in one week, in Ireland, they have quadrupled!" @RTBFinfo adds
Ireland has climbed to be ranked 2nd in the world out of 189 countries in a United Nations index measuring longevity education and wealth.
What's behind the country's rapid climb since the index was launched in 1990? I spoke to lead author @pedrotconceicaoirishtimes.com/news/ireland/i…
A few interesting things in summary:
- it's more to do with a rapid increase in average education than it is with economic growth, though that is significant (Ireland's economy basically doubled)
- the economic growth aspect is not inflated by the presence of multinationals in Ireland. The index uses a different measure to GDP (GNI) specifically to avoid that distortion