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
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