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Green light of the Ema for the new anti-variant vaccines Omicron

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Green light of the Ema for the new anti-variant vaccines Omicron

Given the languishing campaign for the fourth dose, the imminent arrival of the new anti-Covid vaccines is good news. In fact, many are waiting for the spread of anti-variant immunizations and today the European Medicines Agency’s (EMA) Committee for Human Medicines has recommended authorizing two vaccines adapted to provide broader protection against Covid-19. These are Comirnaty Original / Omicron BA.1 and Spikevax Bivalent Original / Omicron BA.1, Pfizer Biontech and Moderna. They are intended for people aged 12 and over who have received at least the primary vaccination against Covid-19.

Immune response and side effects

Ema explains that studies have shown that the two bivalent vaccines can trigger strong immune responses against Omicron BA.1 and the original SarsCov2 strain in previously vaccinated people. In particular, they are more effective in triggering immune responses against the BA.1 sub-variant than the original vaccines. The side effects observed in the adapted vaccines are comparable to those of the original vaccines: typically mild and of short duration. The two CHMP opinions will now be forwarded to the European Commission, which will take a final decision.

Vaccines under review

Other adapted vaccines incorporating different variants, such as Omicron’s BA.4 and BA.5 subvariants, are currently under review by the EMA or will soon be introduced and, if authorized, will further extend the arsenal of available vaccines. Clinical data generated with the original / BA.1 bivalent vaccines recommended today will support the evaluation and authorization of further adapted vaccines. The drug agency also explains that the original vaccines, Comirnaty and Spikevax, are still effective in preventing serious illness, hospitalization and death. associated with Covid-19 and will continue to be used in vaccination campaigns in the EU, in particular for primary vaccinations.

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Adapted vaccines also work on mRna

National authorities in EU member states will determine who should receive which vaccines and when, taking into account factors such as infection and hospitalization rates, risk to vulnerable populations, vaccination coverage and vaccine availability. The adapted vaccines work the same way as the original vaccines: Each vaccine contains the mRna molecules with the spike protein instructions of the original SarsCov2 and Omicron’s BA.1 sub-variant.

Commissioner Kyriakides: plan to avoid new wave

The positive views of the European Medicines Agency on the first two mRNA vaccines adapted for Covid variants “are important to protect Europeans from the probable risk of waves of autumn and winter infections,” we will now proceed with an accelerated authorization of these vaccines to ensure that they can be introduced quickly across the EU“This is the comment of the EU Commissioner for health Stella Kyriakides on the green light of the EMA for the new BioNtech and Moderna vaccines. The adapted versions can be used as booster doses for the original virus and the sub-variant Omicron BA.1.” next weeks – the Commissioner reminds us – we also expect an opinion on vaccines adapted against the variants Omicron BA.4 and BA.5 “. In May, Hera, the EU Authority for the preparation and response to health emergencies created following the Covid pandemic, secured contracts that could be modified to include the new vaccines. “I invite the Member States – Kyriakides reiterates – to plan and launch their vaccination campaigns, the Commission will soon present measures to avoid a wave this autumn and winter”.

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Costa: Aifa approval is scheduled for 5 September

We now await the green light from Aifa, scheduled for Monday 5 September, and then we will be able to leave in the next few weeks to administer the bivalent vaccine.“, Undersecretary for Health Andrea Costa declares it in a note.” Also in this case, in record time, the scientific community, to which we are deeply grateful, has provided us with an additional and valuable tool to secure the population. in view of the autumn and finally defeating the pandemic. Once again science and research – concluded Costa – prove to be strategic, decisive and indispensable assets to face the great health challenges of the future “.

“With updated boosters strong increase in protection”

The new updated vaccines against Omicron BA.1 “will significantly increase protection from Covid, this is excellent news”. This was underlined by Sergio Abrignani, full professor of general pathology at the University of Milan. The new boosters “are indicated for those who have already received a first vaccination with immunizers with the original strain of the SarsCoV2 virus, namely the Wuhan strain. They are indicated to evoke a response against the Omicron variant by using part of the memory that the organism retains of the original strain Wuhan, as the two strains share part of the sequences. The differences are concentrated in the Spike protein of the virus. “Of course,” new variants cannot be ruled out, and vaccines will have to be updated as they do for those against influenza viruses annually. It is true that influenza viruses are more predictable than SarsCoV2 but the hope is that an equally predictable management will be achieved “. In fact, Abrignani clarifies,”mRna vaccines can be updated within three months with respect to any new variantsso the hope is precisely a management similar to seasonal flu, since we have a technology that allows us to rapidly update “.

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