Careful testing in the EU does not lead to less vaccine available
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Peter Liese was assured by BioNTech
"More careful testing of the BioNTech vaccine will not result in fewer people being vaccinated in the other European countries compared to the UK by spring. The vaccine that is supposed to be supplied to the EU will not be delivered to the UK. The UK will receive vaccine for 400,000 people (800,000 vaccine doses) in a first batch and as soon as the vaccine receives conditional approval from the European Medicines Agency, delivery will begin for the other EU countries", says the MEP and health spokesperson of the largest political group in the European Parliament (EPP, Christian Democrats) Dr med Peter Liese after talks with the company BioNTech.
Sean Marett, the CCO and CBO of BioNTech, had assured Liese that the vaccine intended for the countries of the European Union had already been partially produced and stored. “When EMA gives approval, vaccination can start immediately. The emergency approval in the UK does not affect number doses delivered over the next months for other regions like the European Union. We expect millions of citizens in the EU will be vaccinated in the first quarter of 2021 if we receive regulatory approval this year”, Marett told Peter Liese in a written statement.
Read more: Careful testing in the EU does not lead to less vaccine available
BioNTech also applies for marketing authorisation
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BioNTech application much more important for the EU than Moderna / Emergency authorisation in Great Britain and the USA not recommended for imitation/ Hungarian behaviour highly problematic/ Better two weeks of more careful examination than hasty marketing authorisation
Following the US manufacturer Moderna, the German manufacturer BioNTech has also submitted an application for authorisation of a corona vaccine to the European Medicines Agency. "This application by BioNTech is much more important for the EU because although Moderna produces in the EU, we will receive almost twice as much from the BioNTech vaccine. The European Commission has secured 160 million vaccine doses for Moderna and around 300 million doses for BioNTech. This was stated MEP Peter Liese, health policy spokesman of the largest group in the European Parliament (EPP Christian Democrats). Liese explained that the examination by the European Medicines Agency will take several weeks and asks all parties involved to be patient. "We will see that the UK and the US will probably bring the vaccine to the market in the next few days with the help of an emergency marketing authorisation.
Then many will wonder why this is not happening just as quickly in the EU. The reason is that in an emergency marketing authorisation, only a very rough estimate of the effects and side effects is made and the data is not analysed as precisely as in the conditional marketing authorisation that Moderna and BioNTech have applied for from the European Medicines Agency.
Read more: BioNTech also applies for marketing authorisation
Emergency authorisation of corona vaccine in the UK not recommended to do the same
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Several weeks of thorough testing better than a hasty start of vaccination / Crisis management in the UK one of the worst in the world
"I consider this decision to be problematic and recommend that EU Member States do not repeat the process in the same way. A few weeks of thorough examination by the European Medicines Agency (EMA) is better than a hasty emergency marketing authorisation of a vaccine". This was stated by MEP Peter Liese, health policy spokesman of the largest political group in the European Parliament (EPP Christian Democrats) with regards to the emergency authorisation granted for the corona vaccine from Biontech/Pfizer in the UK. Liese stressed that the decision had nothing to do with Brexit.
Under the European rules to which the UK is still bound to until the end of the year, all EU Member States have the possibility to grant national emergency authorisation in certain cases. “Other member states are not following the UK example because they believe that careful consideration by the European Medicines Agency will give people additional security. The information of the last weeks was mainly based on press releases and much of the data has only been available for the authorities for a few hours now. However, with such a large-scale vaccination campaign, it is important to look closely and carefully check the information provided by the companies.
Read more: Emergency authorisation of corona vaccine in the UK not recommended to do the same
Vaccines are examined more carefully by the European Medicines Agency than by national authorities in the UK and the USA
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Fast examination, but no hasty examination / marketing authorisation within weeks and not within one or two days
MEP Peter Liese, health policy spokesperson for the largest group in the European Parliament (EPP-Christian Democrats), supports the authorisation procedure for vaccines in the European Union. In contrast to the regulation in the USA and the procedure in Great Britain, the European Union will not carry out an emergency approval procedure for vaccines. "The 27 Member States of the European Union would have the possibility to apply for emergency approval in the same way as the UK. This is only possible for the UK, despite Brexit, because of the provision in EU legislation. Any other Member State could do the same, but I do not recommend it.