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Vaccines, here’s what CureVac and Gsk have in mind

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Vaccines, here's what CureVac and Gsk have in mind

CureVac asks EMA to stop the authorization process for its Covid vaccine and projects with GSK. All the details

Stop the revision of the CureVac Covid vaccine (CVnCoV). The German pharmaceutical company has asked the European Medicines Agency (Ema) to stop the process for approving the serum. Let's see what happened and what new horizons CureVac will head towards.

CUREVAC, MODERN AND PFIZER IN COMPARISON

As with Moderna and Pfizer's vaccines, CureVac's vaccine was also mRNA but its mRNA was natural and unmodified. In addition, it contained a lower dose (12 micrograms compared to Moderna's 100mcg and Pfizer's 30mcg), which resulted in lower production costs and less storage difficulties as it was stable even with normal refrigerator temperatures.

THE EFFECTIVENESS OF THE CUREVAC VACCINE

If the sera from Pfizer and Moderna are 95% effective against the original strain of the virus, the test results of that of CureVac – as Start wrote a few months ago – had been disappointing from the start. Only 47% effective was the outcome of an intermediate analysis at an advanced stage. A fact that, commented the Financial Times , made it one of the least effective vaccines among those tested.

Nonetheless, CureVac decided to continue testing and then decide after evaluating the final data.

DOUBTS TO CLEAR

When today the company decided to withdraw its vaccine from the approval process, the EMA said, the Committee for Medicinal Products for Human Use was in possession of non-clinical data, i.e. laboratory data, but also data from ongoing clinical studies, data on the quality and manufacturing process of the vaccine and the risk management plan.

Although the regulatory authority, writes AdnKronos , was accelerating the review of the data, "some questions" about the quality of the vaccine, impacting on the risk-benefit ratio, still remained to be satisfactorily addressed, and the fact that the results of the main study had shown only modest efficacy in adults ".

WHY THE REVIEW PROCESS HAS BEEN INTERRUPTED

In the letter to the EMA, the news agency reports, the company said it had withdrawn because it decided to focus its efforts on a different Covid vaccine development program. Withdrawing means that the EMA has already stopped studying the data presented on the candidate and will not conclude the review.

THE PROJECTS OF CUREVAC AND GSK

According to CureVac, the wide diversity of variants represents an unprecedented challenge and for this reason it has decided to focus on the development of second generation mRna vaccines, for which as early as June, it had an agreement with the British pharmaceutical company GlaxoSmithKline (GSK). .

"The decision – explained CureVac – is also aligned with the evolving dynamics of the response to the pandemic: in fact, there is a greater need for differentiated vaccines to address a situation in which the Sars-CoV-2 virus will be endemic".

THE SECOND GENERATION VACCINES

GSK and CureVac plan to enter the clinical development phase of second-generation mRna vaccines in the coming months, with the aim of obtaining EMA approval for the market debut of an "improved" Covid vaccine in 2022.

The two companies seem to strongly believe in this new project, so much so that they have announced that they have strengthened their collaboration, adding additional resources and experts to accelerate development and production.

THE FIRST RESULTS

The preclinical results published – reads a note – have shown "the strong potential" of a candidate, CV2CoV, compared to that of the first generation of CureVac. The data show "up to 10 times higher immunogenicity" in animal models.

THE CONSEQUENCES OF THE STOP

One of the consequences of the stop decided today is that the company "will terminate the current advance purchase agreement with the European Commission, which was based on the use of the candidate vaccine CVnCoV" to contribute to the fight against the pandemic.

In addition, people who have taken part in clinical trials with CVnCoV and have questions about their vaccination status and the Green Pass, CureVac said, "should contact the competent authorities in their country of residence."

This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/vaccini-ecco-cosa-hanno-in-mente-curevac-e-gsk/ on Wed, 13 Oct 2021 11:59:59 +0000.