EMA recommends approving the Pfizer vaccine adapted to omicron XBB.1.5

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the authorization of the Pfizer/BioNTech vaccine adapted to combat the omicron subvariant XBB.1.5which is called ‘Comirnaty Omicron XBB.1.5’, to prevent COVID-19 in children from six months of age and adults.

The administration guidelines for this vaccine will follow the previous ones. EMA recommendations and the European Center for Disease Prevention and Control (ECDC), according to which adults and children from 5 years of age who are required to be vaccinated should receive a single dose, regardless of their vaccination history against COVID-19. . Children from 6 months to 4 years of age may receive one or three doses, depending on whether they have completed a primary vaccination cycle or have had COVID-19.

In making the decision to recommend the authorization of this drug, the CHMP has considered all available data on Comirnaty and its other adapted vaccines, including available information on safety, efficacy and immunogenicity (its effectiveness in generating immune responses).

The Committee has also evaluated new laboratory data showing a potent response of the adapted vaccine against XBB.1.5 and related strains of the SARS-CoV-2 coronavirus responsible for COVID-19. More data on emerging variants is awaited and will be evaluated by the Committee when it becomes available.

An effective vaccine against omicron XBB.1.5

COVID-19 vaccines are modified to better match circulating variants. This vaccine was developed to combat omicron XBB in accordance with the recommendations of the EMA and ECDC, as well as other international regulators and the World Health Organization.

As omicron XBB.1.5 is closely related to other variants currently in circulation, the vaccine is expected to help maintain optimal protection against COVID-19 caused by these other variants, as well as omicron XBB.1.5.

Since Comirnaty’s first authorization, the authorities have gained extensive knowledge about the safety of the vaccine. Side effects are usually mild and short-lived, the most common being headache, diarrhoea, joint and muscle pain, tiredness, chills, fever, and pain or swelling at the injection site. Rarely, more serious side effects may occur.

The EMA will now forward the CHMP recommendation to the European Commission for a legally binding decision across the European Union. As with other COVID-19 vaccines, the national authorities of the EU Member States will determine how to use this vaccine in national vaccination campaigns, taking into account factors such as infection and hospitalization rates, the risk to vulnerable people and the availability of the vaccine.

How vaccines adapted to new variants work

Adapted vaccines work just like the original vaccines. This vaccine contains molecules called mRNAs that have instructions for making the spike protein of the omicron subvariant XBB.1.5. The spike protein is found on the surface of the coronavirus, is required by the pathogen to enter cells in the body, and may differ between virus variants.

When a person receives the vaccine some of their cells will read the mRNA instructions and temporarily produce the spike proteins. The individual’s immune system will then recognize this protein as foreign and will activate the natural defenses (antibodies and T cells) against it.

If the vaccinated person later comes into contact with the virus, their immune system will recognize the spike protein on its surface and be prepared to attack it. Antibodies and immune cells can protect against COVID-19 by helping to kill the virus, preventing it from entering cells in the body, and killing infected cells.

Comirnaty was first authorized in the EU in December 2020, and adapted versions targeting BA.1 and BA.4-5 strains obtained additional authorization in September 2022.

Source: European Medicines Agency (EMA)

Source: www.webconsultas.com

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