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Bacxhe  17-11-2020

Updates: vaccines and medicines against the coronavirus
At the end of 2019, a new coronavirus epidemic (SARS-CoV-2) broke out in the Wuhan region of China. In the meantime, the coronavirus has spread further and also in the Netherlands. Measures are being taken worldwide to prevent further spread and to develop effective treatments. Together with the European Medicines Agency EMA and colleagues worldwide, Medicines Authority CBG supports scientists with advice in the development of a new vaccine or drug for the treatment of the disease (COVID-19).

Follow here for the latest updates on medicines against the coronavirus and the impact of the coronavirus on the availability of medicines.

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EEA to start accelerated assessment of third corona vaccine
Last update: Monday, 16 November 2020, 12:00

The European Medicines Evaluation Committee CHMP of the European Medicines Agency EMA has just launched the rolling review of a third corona vaccine. This is the mRNA-1273 vaccine from drug manufacturer Moderna Biotech. Medicines authority MEB participates in the committee on behalf of the Netherlands.

The CHMP’s decision to start the accelerated assessment is based on the preliminary results from the laboratory research and the first clinical studies in adults. The first results show that the vaccine stimulates the production of antibodies and T-cells against the virus.

In the case of an accelerated assessment, the manufacturer sends the first research results from studies, such as animal studies and early (phase 1/2) clinical studies, already for assessment, while the phase 3 study is still in progress. This allows the final assessment to be completed sooner. Accelerated assessment does not necessarily mean that a vaccine will be approved or that a corona vaccine will soon be less effective or safe.

Response to news corona vaccine Pfizer/BioNTech
Monday 9 November, 5:30 p.m.

News about the effectiveness of Pfizer/BioNTech’s corona vaccine appeared in various media today. At the beginning of October, a so-called rolling review was started for the assessment (see the message ‘EMA starts accelerated assessment second corona vaccine, on this page at 6 October).

Our response to today’s news:

The MEB is waiting for the official data to be submitted to the European Medicines Agency EMA, in which we are involved on behalf of the Netherlands. As soon as we have all the data, including those from the final stage of research, we will assess them with all our European colleagues as soon as possible. We will do this with extra commitment and capacity.

The starting point remains: is the vaccine effective and does it outweigh the risks? Only then will we be able to make a positive assessment of a corona vaccine. Citizens must rely on safe and effective corona vaccines.

Transparency: EMA publishes research data on corona medicines
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The European Medicines Agency (EMA) has published additional research data to provide more insight into the assessment pathways of coroname medicines and vaccines. These include the clinical data submitted for the assessment of Veklury (remdesivir) and the list of medicines and vaccines for which scientific advice has been provided by the EMA.

The list shows the stage of development at which this was done. The scientific advice offered by the EMA, free of charge and without obligation, helps developers to organise the drug development process in such a way that the dossier meets all the requirements required for the assessment. The EMA updates the list monthly.

Ton de Boer in Nieuwsuur on the assessment period for corona vaccines
Monday 26 October 2020, 10:00 a.m.

In the broadcast of News Hour on Friday evening 23 October, the chairman of the board, Prof. Ton de Boer, spoke. He spoke about the accelerated procedure for corona vaccines that are under development and the time frame in which the first vaccines can be expected.

Ton de Boer:

“I hope there will be a vaccine next year. It can go quickly if there is a positive study and we have few questions about the dossier. But it may still take months if the efficacy is disappointing or there are many questions. We really must await the results of the third phase of the study. In view of the seriousness of the pandemic, we need to make an extra effort, with more manpower. But at no time will this be at the expense of quality.

It normally takes up to a year and a half before a new vaccine is approved by the European medicines authorities. The expectation is that it can now be done faster, but speed must never be at the expense of safety.