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Some thoughts on the authorization of the AZ/Oxford COVID vaccine by the MHRA, permitting it to be used vaccinating people in the UK.
Very interesting to compare what MHRA has done with what EMA is doing, operating within the same legal framework.
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Very interesting to compare what MHRA has done with what EMA is doing, operating within the same legal framework.
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The Authorization for the AZ/Ox vaccine was announced at 7am, as a press release put out by AZ through the London stock exchange RNS system.
This is an "Emergency Use Authorization". It is not a full marketing authorization. It only applies to the UK
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https://www.londonstockexchange.com/news-article/AZN/astrazeneca-s-covid-19-vaccine-authorised-in-uk/14808576
This is an "Emergency Use Authorization". It is not a full marketing authorization. It only applies to the UK
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https://www.londonstockexchange.com/news-article/AZN/astrazeneca-s-covid-19-vaccine-authorised-in-uk/14808576
The UK is the first jurisdiction to authorize use of the AZ/Ox vaccine, just as it was first with the Pfizer one.
This decision seems more controversial than the earlier Pfizer authorization (which was rapidly followed by other countries).
What are other regulators doing?
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This decision seems more controversial than the earlier Pfizer authorization (which was rapidly followed by other countries).
What are other regulators doing?
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The EMA is doing its own rolling review of the AZ/Ox vaccine, using the same regulatory framework as MHRA. But unlike MHRA, the EMA is not doing "emergency use authorizations" but is going straight for "marketing authorization" basically accelerating the normal process.
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EMA put out a blunt press release today "Additional scientific information related to quality, safety and efficacy of the vaccine is deemed necessary to support the rigour required for a conditional marketing authorisation and this has been requested"
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https://www.ema.europa.eu/en/news/update-rolling-review-astrazenecas-covid-19-vaccine
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https://www.ema.europa.eu/en/news/update-rolling-review-astrazenecas-covid-19-vaccine
EMA states that they are aware that UK MHRA has granted temporary authorization for emergency use, but implicitly criticises this by saying that the EMA aims for a marketing authorization which as has more safeguards, controls and obligations.
They await more data in Q1.
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They await more data in Q1.
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So does this matter?
Medicines authorization is always about balancing risks: risk of no treatment vs risk of side effects. It seems MHRA has made a different judgement on risk: they accept less data than EMA (or it seems FDA) will accept for this vaccine authorization
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Medicines authorization is always about balancing risks: risk of no treatment vs risk of side effects. It seems MHRA has made a different judgement on risk: they accept less data than EMA (or it seems FDA) will accept for this vaccine authorization
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Interesting questions are:
1. will this impact MHRA international reputation - they could either look more agile at risk management, or less rigorous.
2. Will this give ammunition to anti-Vaxxers, who argue that vaccines are being rushed through with insufficient testing.
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1. will this impact MHRA international reputation - they could either look more agile at risk management, or less rigorous.
2. Will this give ammunition to anti-Vaxxers, who argue that vaccines are being rushed through with insufficient testing.
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3. Has there been any political pressure on MHRA, given the "British" pedigree of this vaccine?
This is one to watch. It isn't clear cut, but is a more controversial MHRA decision than their earlier decision on the Pfizer vaccine, as the AZ/Ox data is messier.
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This is one to watch. It isn't clear cut, but is a more controversial MHRA decision than their earlier decision on the Pfizer vaccine, as the AZ/Ox data is messier.
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I find it sad that the MHRA and EMA seem to be having a spat about vaccine authorization given how closely MHRA was integrated with EMA.
Some of you will just think me nostalgic, but it is really important regulators across jurisdictions can work effectively together.
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Some of you will just think me nostalgic, but it is really important regulators across jurisdictions can work effectively together.
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