Mosialos: In October the new vaccines for the Omicron variants

With BA.4 and 5 underscoring in many countries BA.1 and 2 variants of the coronavirus microncompanies, governments and health institutions are adapting to the dynamic demands of the pandemic regarding vaccination, but also in general to search for more effective protection tools.

Last week the US Food and Drug Administration (FDA) recommended that the makers of the COVID-19 vaccines change the design of the booster vaccines we expect in the fall, says Prof. Ilias Mosialos underlining in detail:

“So what did the FDA ask for?

Basically what I was writing about 2 weeks ago, that is, effective vaccines for the variants that are circulating now. The FDA has asked the companies to adapt the vaccines to fight the currently dominant subtypes of the coronavirus, microns BA.4 and BA.5. And let’s mention here that the new booster vaccines will be bivalent, that is, they will target both the original virus (like the vaccines we already made) and the subvariants of the BA.4 and BA.5 micron.

Yes, but hadn’t we heard that several companies had already prepared vaccines for the BA.1/2 subvariants?

Yes, and the FDA recommends that they submit clinical trial results for the BA.1/2 subvariants for evaluation, but these vaccines will not be used.

Will vaccines targeting BA.4 and BA.5 need extensive clinical trials?

As with flu vaccines that are renewed at regular intervals, extensive Phase III clinical studies will not be needed to approve the new vaccine.

In other words, do we expect the same to happen in all countries? Will vaccines that address the BA.4 and BA.5 variants be used?

Some countries are targeting the use of the vaccine against the BA.1 subvariant. Pfizer’s new vaccine appears to induce a good immune response against BA.1, but has a lower response against BA.4 and BA.5.

When should we expect distribution to begin?

Pfizer, following the FDA’s recommendation, said it may be able to distribute a significant amount of BA.4/BA.5 vaccine in the first week of October, while Moderna is giving until the end of October or early November before the modified vaccine. get ready

Will these vaccines cost more?

The new vaccines should cost less as they are not based on new technology but a small modification of the existing one. Also companies will not do extensive Phase III clinical studies that cost a lot. The European Commission must therefore negotiate significant price reductions.

So we will wait for the distribution of installments from these two companies?

We know that Novavax is also working towards a micron vaccine, and that clinical trials for both a targeted micron vaccine and a bivalent vaccine (including the original and targeted micron) began on May 31st. At the same time from data that Novavax has announced (and we have not yet seen the publication) the booster dose of the vaccine, given eight months after the initial vaccination regimen, generates a strong immune response against all variants of omicron (and BA.5). . So it might make sense for now that Novavax’s vaccine is used for booster doses.

And the holistic or polyvalent vaccines we hear about?

The vaccine developed by researchers in the US Army (at the Emerging Infectious Diseases Branch, Walter Reed Army Institute of Research) has a similar nanotechnological base to Novavax. This vaccine, “SpFN” (which stands for ‘spike ferritin nanoparticle’ and is read as ‘spif-in’) essentially consists of ferritin nanoparticles that ‘carry’ the spike of the virus. But the difference is that given the polyhedral design of the nanoparticle, it can carry diverse and numerous forms of the spike to trigger immune protection against many variants and sub-variants simultaneously. SpFN can also be stored in the refrigerator for up to six months and at room temperature for up to one month.

We also know that BioNTech, together with Pfizer, will start clinical trials for next-generation coronavirus vaccines in the second half of the year. These new ‘next-generation’ vaccines go beyond the current approach by targeting cell (T) immunity, and pan-coronavirus vaccines will protect us from the wider family of coronaviruses and their mutations.

So these are the holistic vaccines that are ahead?

The truth is that there are other ‘next generation’ vaccines in development. Intranasal vaccines/sprays as we’ve said before, could go above and beyond in protecting us from the virus by targeting exactly where it enters the body. They may also be able to prevent infection altogether, and obviously without infection, we will not spread the virus and be protected from long-term COVID. So it is also optimistic that there are more than a dozen clinical trials of intranasal vaccines already underway in the US and worldwide.

Are we expecting more variants in the coming months?

There are sure to be new variations. Whether they will come from omicron or the original strain or another strain that is no longer prevalent is not known, nor can we predict. Nor can we predict whether a future variant or new strain will be more easily transmitted or more dangerous or milder. In this period, however, we have in at least 10 countries the appearance of BA.2.75, which was detected for the first time in India. This subvariant exhibits changes that lead some to recommend increased epidemiological surveillance, considering that BA.2.75 could potentially be of more concern than the BA.5 subvariant. But for this to happen, BA.2.75 should be so much more contagious that it surpasses BA.5. At the moment, however, we do not have such data.

RES-EMP

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