Emer Cooke, EMA: only thing EMA can do in terms of production capacity is to work with companies and MS to ensure new manufacturing sites become available as soon as possible
"We will do everything we can to facilitate production from a scientific and regulator perspective"
Cooke: (AstraZeneca) Studies done have a very small quantity of elderly populations. Our scientific committee is looking at the totality of the data to see what that data means in terms of the populations that are studied
The committee can decide to approve the vaccine on the strength of the scientific data. It is possible to conclude an authorisation that would focus on a particular age group for for a wider age group
For the two mRNA vaccines, both data sets included 30-40,000 patients. IN both data sets a very large number of patients over 60 (Pfizer) and over 80 (Moderna) were studied. No reason to assume vaccines won't work on pregnant women, need additional studies to make is conclusive
Cooke: studies were not designed to show whether transmission of the disease is affected. This will be looked at in the post authorisation phase. We're asking the comanies to look at this.
NEW: The process in the UK is for temporary use for an unlicensed vaccine for the three vaccines the UK has authorised. This facility to have temporary use authorisation is not within the remit of the EMA
We are confident that the process the EMA uses provides a robust scientific review which can be relied on in all 27 MS
The intervals between doses we include in our product information are those studied in the clinical trials. We made a judgement provided in the data provided - ie, 21 days between doses for Pfizer. 28 day interval for Moderna. We have to authorise on the basis of the data
The AZ vaccine was given temporary use authorisation in the UK before it was submitted to the EU. THis is a reflection of the additional data that was needed, we're still receiving data as we speak on the AZ vaccine, still trials ongoing
I can assure you we're in close contact with international regulators, including the UK, FDA, Canada, Japan. A number of regulators have participated in our authorisation process
NEW: For those vaccines authorised we've asked companies to look at the effect of the new variants on the vaccines. The initial indication is these vaccines will continue to be effective for at least the UK variant, more work done on the SA/Brazil variants

• • •

Missing some Tweet in this thread? You can try to force a refresh
 

Keep Current with Tony Connelly

Tony Connelly Profile picture

Stay in touch and get notified when new unrolls are available from this author!

Read all threads

This Thread may be Removed Anytime!

PDF

Twitter may remove this content at anytime! Save it as PDF for later use!

Try unrolling a thread yourself!

how to unroll video
  1. Follow @ThreadReaderApp to mention us!

  2. From a Twitter thread mention us with a keyword "unroll"
@threadreaderapp unroll

Practice here first or read more on our help page!

More from @tconnellyRTE

27 Jan
.@SKyriakidesEU: In our contract it is not specified that any country, or the UK, has priority because it signed earlier. Our contract foresees a quarter by quarter schedule.
If this was the case [ie, because the UK signed earlier] AZ should have proposed a clause in the contract acknowledging that they would have prioritised deliveries to the UK, but here is no such clause
Commissioner says: the numbers shared with us on Fri [by AZ] did not correspond with what was in the advanced purchase agreement and to what we expected.
Read 7 tweets
27 Jan
NEW: EU official says EU has contacted AstraZeneca to seek approval to publish vaccine contract
Official says the company has been "very, very" protective of the contract, so it is "surprising" that Pascal Soriot revealed elements of the contract in the interview with Die Welt and La Republicca
Official says AZ contract was worth EUR 336m
Read 8 tweets
25 Jan
NEW: the EU has challenged AstraZeneca to spell out where its has sent vaccines so far. Stella Kyriakides, EU health commissioner: "The new AstraZeneca vaccine schedule is not acceptable to the EU." Kyriakides says she wrote letter to AZ asking "important and serious" questions:
2/ Kyriakides: "The EU has prefinanced the development of the vaccine and its production and wants to see its return. The EU wants to know exactly which doses have been produced where by AstraZeneca so far, and if, or to whom, they have been delivered.
3/ "These questions were also discussed today in the Joint Steering Board of the Commission and the 27 member states with AstraZeneca. The answers of the company have not been satisfactory so far. That's why a second meeting is scheduled for tonight.
Read 6 tweets
20 Jan
Here are some observations from the EU side on the touring issue facing musicians bbc.com/news/entertain…
2/ The European Commission offered the UK a standard mobility clause in its draft legal text back in March last year that would cover musicians, sportspersons etc... It's on page 354 of the EU's opening text ahead of the negotiations ec.europa.eu/info/sites/inf…
3/ Under a standard mobility clause, acc to one official, EU member states can ask for visas for certain people coming to carry out paid activity. However, there's a list of exemptions for people who don't need visas:
Read 25 tweets
20 Jan
EU diplomat say ambassadors will discuss the governance of the EU-UK TCA on Friday, esp the new Joint Partnership Council, its 30 subcommittees, its relationship with the Commission, the role of member state.
2/ Diplomat says it is natural for the EU to need more time beyond the end of February deadline to ratify the treaty, which is currently being applied provisionally...
3/ Diplomat says it normally takes quite a number of months to get such a treaty translated into the 23 languages. "It’s going to be quite diff to achieve this by the end of Feb, we might have to come to a decision to prolong that. I’ll leave it up to the Commisison first.
Read 4 tweets
18 Jan
The EU will seek an extension to the deadline by which the free trade agreement with the UK must be ratified, @rtenews has learned.

Two sources have said member states want to extend the deadline from the end of Feb to some time in April.
2/ RTE News also understands that the Slovak Commissioner Maros Sefcovic, who is an executive vice president of the Commission, will be the EU’s representative on the new Joint Parternship Council (JPC) which will manage the new relationship with the UK.
3/ Sefcovic is already the EU chair of the Joint Committee, which has been overseeing the implementation of the Brexit Withdrawal Agreement, including the Northern Ireland Protocol.
Read 18 tweets

Did Thread Reader help you today?

Support us! We are indie developers!


This site is made by just two indie developers on a laptop doing marketing, support and development! Read more about the story.

Become a Premium Member ($3/month or $30/year) and get exclusive features!

Become Premium

Too expensive? Make a small donation by buying us coffee ($5) or help with server cost ($10)

Donate via Paypal Become our Patreon

Thank you for your support!

Follow Us on Twitter!