“Booster against Omicron but multiple calls unsustainable”

by time news

A report on anti-Covid vaccines, on the issue of efficacy against the Omicron variant of Sars-CoV-2, but also on how to face the future and which shield products will be needed to manage Covid-19 in the long term. Signed: drug agencies around the world, including the European Ema. Which warn: “Looking at the data on the impact of Omicron,” “it is becoming increasingly clear that a booster dose is needed to extend vaccine protection.”. But looking at “possible vaccination approaches against Omicron and other variants”, the regulatory bodies agreed that “administering multiple booster doses at short intervals is not a sustainable long-term approach“.

These are the fixed points put in black and white in the report drawn up after the world summit which was held under the aegis of the International Coalition of Medicines Regulatory Authorities (ICMRA) on 12 January. Based on the data available on Omicron, regulators reiterated, the conclusion is that “current vaccines offer less protection against infections and mild illnesses caused by this variant. However, they continue to offer significant protection from hospitalization and Covid-19 serious, especially after a booster dose “.

But for the experts the solution is not repeating boosters every few months. “There is a need to develop a long-term strategy on the types of vaccines needed to manage Covid-19 in the future. This is an ongoing global discussion, which lies at the crossroads of science, public policy and public health and will require coordination between the decision makers on the matter at all levels “, is highlighted in a note following the meeting co-chaired by EMA and the American FDA, which was also attended by representatives of the World Health Organization. On that occasion, the experts had stressed the need to align from a regulatory point of view to accelerate and simplify the global development and authorization of any new or modified Covid vaccines against the emerging variants of the Sars-CoV-2 coronavirus.

“COMPANIES EXPLORE VIA MULTIVALENT VACCINES AGAINST VARIATIONS” – “Regarding updated compositions of Covid vaccines, regulatory authorities” of the world “encourage the international scientific community and vaccine developers to examine alternative approaches to monovalent vaccines. Companies should also explore the feasibility of vaccine development. for bivalent or multivalent variants to determine if they offer advantages over monovalent vaccines “is the invitation made by the European drug agency Ema and the drug agencies operating globally.

“CLINICAL STUDIES ARE NEEDED TO PROVE THE NEW VACCINE SUPERIORITY” – “Clinical trials should be undertaken to support the use of a new anti-Covid vaccine”. “These studies should be designed to demonstrate that the immune response generated by the updated vaccine, measured in terms of neutralizing antibodies, is higher than that obtained with current vaccines,” note Ema and other regulatory bodies around the world.

OK CONDITIONED ALSO FOR VACCINES ADAPTED TO OMICRON – The EMA will proceed to recommend to the European Commission a conditional marketing authorization also for anti-Covid vaccines adapted to the Omicron variant, which will be examined with an accelerated procedure, being derived from a ‘mother’ vaccine already authorized in the EU. A spokesman for the European Medicines Agency explains this to time.news, after the President of the Commission Ursula von der Leyen had spoken, in the College of Commissioners of 8 December 2021, of an “emergency authorization process” for adapted vaccines to variants.

“Once the manufacturer has submitted the required data – explains the spokesperson – these will be examined in depth according to existing standards and a recommendation for marketing authorization will be issued, if the data confirm that the adapted vaccine meets all the requirements. concerning quality, safety and efficacy “.

The EMA has since last February plans that provide for an accelerated procedure to approve vaccines adapted to variants of Sars-CoV-2. The procedure can be used under two conditions: the mother vaccine must have obtained marketing authorization in the EU; furthermore, the manufacturing process, controls and facility for the production of the adapted vaccine must be the same, or very similar, as those of the parent vaccine.

You may also like

Leave a Comment

This site uses Akismet to reduce spam. Learn how your comment data is processed.