Rolling Review of HIPRA COVID-19 Vaccine: Booster for Adults

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TL;DR Summary

EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)

EMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine HIPRA (also known as PHH-1V). This protein-based vaccine is being developed by HIPRA Human Health S.L.U. as a booster vaccine for adults who have already been fully vaccinated with a different COVID-19 vaccine.
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How is the vaccine expected to work?

COVID-19 Vaccine HIPRA works by preparing the body to defend itself against COVID-19. It contains two versions of part of the spike protein (the receptor binding domain) which have been produced in the laboratory: one version corresponds to part of the spike protein of the alpha variant and the other corresponds to that of the beta variant. The spike protein is found on the surface of SARS-CoV-2 (the virus that causes COVID-19) and is used by the virus to enter the body’s cells. The vaccine also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

Source:
https://www.ema.europa.eu/en/news/ema-starts-rolling-review-covid-19-vaccine-hipra-phh-1v

See also:
https://clinicaltrials.gov/ct2/show/NCT05246137

The vaccine developed by HIPRA is the first (and so far, the only one) bivalent (Alpha and Beta) recombinant protein vaccine developed to fight against variants, and it is now at the final steps of Phase III clinical studies in Europe and about to start the Rolling Review in front of the European Medicines Agency (EMA). [As of March 14, 2022, four vaccine candidates are under EMA rolling review: Sinovac, Sanofi, Valneva and Russia’s Gamaleya Research Institute]

Our shot is designed to serve as a booster. Our new and exclusively dedicated facilities were inspected in January 2022 and are already GMP certificated. The company feels ready and is already manufacturing the antigen for the vaccine in order to deliver the product as early as mid-June when we expect to receive conditional marketing authorisation.

Source:
https://pharmaboardroom.com/interviews/carles-fabrega-managing-director-human-health-hipra/

 

[Laroxe]

Of course vaccination against Covid now has a history, we now know a great deal about the vaccines and their use. At this point in time it is the mRNA vaccines which are the most popular, they induce a good antibody response after the second dose and are considered the least likely to cause serious side effects. They can be produced quickly and reliably and it is easy to modify the vaccine as new variants arise. Having said that the vaccines are expensive and the costs can be prohibitive for some countries, they also require special storage and transport.

In the quest to develop new vaccines there are some very clear aims, along with a limited amount of information, it seems the main issues are around the vaccine's effectiveness and its availability. It's now well established that while the mRNA vaccines produce a good antibody response, though only really after the second dose, these antibodies have a limited ability to prevent infection and the antibodies themselves are short-lived. We have seen a marked shift away from the antibody response as a useful marker of effectiveness towards the effects of the vaccine on other parts of the immune response. While these vaccines are very effective in preventing severe disease the search is now on for vaccines that induce a broader more enduring level of protection and this is likely to rely on local tissue immunity and T cell responses, areas we know far less about. It is also unclear whether having vaccines that can be changed in response to new variants is needed or has any useful effects. It may be that we need a far more detailed picture on the functions of the large number of antibodies produced after a Covid infection, rather than the relatively few induced by vaccination. While we do now have more information about some of the adverse effects, some were unexpected and because most are uncommon, they were difficult to identify.

The cost of the global vaccination program continues to be an issue, the mRNA vaccines continue to be under the control of commercial interests and remain expensive despite several small initiatives and international help with funding. It's also true that problems remain in the production, storage and transport, a more stable vaccine, and one that needed fewer doses would help, but the problem is far more complex than it would appear.

The latest vaccines to appear are the recombinant, protein based vaccines, Bimarevax the new name of the hipra belongs to this group. The vaccine is stable and easily stored, and it is thought that these vaccines have the potential to produce a more enduring and more broadly protective response, but this needs to be confirmed. While the rolling reviews allows for the continuous monitoring of the vaccine's use and effectiveness, the fact that these reviews are happening in a world in which the majority have a history of exposure to other vaccines or infection, this does slow everything down.

We also have no real information about costs, and the introduction of approval for these vaccines for use as a booster and for a limited age range will inevitably affect the likelihood of it being a commercial success in its early use. How many services will want to expand the number of vaccines available with any clear advantage.

It's worth considering that in this later stage of vaccine development, there has been a number of vaccines that have gained approval, only for the manufacturer' to withdraw the product. The question has become less about safety and effectiveness and more about whether it's worth the effort.