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

In summary, EMA's human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine HIPRA, a protein-based vaccine developed by HIPRA Human Health S.L.U. as a booster for adults who have been fully vaccinated with a different COVID-19 vaccine. The vaccine contains two versions of the spike protein from the Alpha and Beta variants, and uses an adjuvant to enhance immune response. The company is already manufacturing the antigen and preparing for conditional marketing authorization, making it a promising addition to our fight against COVID-19.
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EMA starts rolling review of COVID-19 Vaccine HIPRA (PHH-1V)
European Medicines Agency said:
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

Managing Director Human Health HIPRA said:
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/
 
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I am excited to see the development of a bivalent recombinant protein vaccine specifically designed to target the Alpha and Beta variants of COVID-19. This approach may offer more comprehensive protection against these highly transmissible variants compared to single-antigen vaccines.

The use of an adjuvant in the vaccine is also promising, as it can help enhance the body's immune response and potentially provide longer-lasting protection. It is also encouraging to hear that the company is already manufacturing the antigen and preparing for conditional marketing authorization.

I look forward to following the progress of this vaccine through the EMA's rolling review process and potential approval, as it could be a valuable addition to our arsenal against COVID-19.
 

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

What is the HIPRA COVID-19 vaccine?

The HIPRA COVID-19 vaccine is a vaccine developed by HIPRA, a Spanish biotechnology company, to protect against the COVID-19 virus. It is currently in the rolling review stage of approval by the European Medicines Agency (EMA).

What is the purpose of the rolling review of the HIPRA COVID-19 vaccine?

The rolling review of the HIPRA COVID-19 vaccine allows the EMA to review data from ongoing clinical trials and other studies as they become available, rather than waiting for all the data to be submitted at once. This allows for a faster evaluation and potential approval of the vaccine.

Who is the HIPRA COVID-19 vaccine intended for?

The HIPRA COVID-19 vaccine is intended for adults as a booster shot to provide additional protection against the COVID-19 virus. It is not currently approved for use in children.

What are the potential benefits of the HIPRA COVID-19 vaccine?

The potential benefits of the HIPRA COVID-19 vaccine include protection against the COVID-19 virus, potentially reducing the severity of symptoms if infected, and helping to prevent the spread of the virus to others.

What are the potential side effects of the HIPRA COVID-19 vaccine?

Like any vaccine, the HIPRA COVID-19 vaccine may cause mild side effects such as pain or swelling at the injection site, headache, fatigue, or fever. These side effects are typically short-lived and resolve on their own. Serious side effects are rare but may include severe allergic reactions. It is important to discuss any concerns with your healthcare provider.

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