EMA Backs Comirnaty Omicron XBB.1.5 Vaccine for Varied Ages Amid Variant Concerns

EMA Backs Comirnaty Omicron XBB.1.5 Vaccine for Varied Ages Amid Variant Concerns

(IN BRIEF) EMA proposes Comirnaty Omicron XBB.1.5 vaccine for ages 6 months+, tailored to combat Omicron XBB.1.5 variant. One dose suffices for ages 5+, while kids 6 months to 4 years may need 1 or 3 doses based on prior exposure. EMA’s choice stems from robust efficacy data against XBB.1.5 and similar strains. Vaccine aligns with global guidance, offering targeted defense. EMA forwards recommendation to EU Commission for final decision. Vaccine’s mRNA approach boosts immunity. Comirnaty’s journey began in 2020, adapting to new strains in 2022.

(PRESS RELEASE) AMSTERDAM, 30-Aug-2023 — /EuropaWire/ — The European Medicines Agency (EMA) has taken a significant stride in the battle against COVID-19 by advocating for the authorization of the adapted Comirnaty vaccine, designed specifically to address the Omicron XBB.1.5 subvariant.

The vaccine, named Comirnaty Omicron XBB.1.5, is intended to thwart COVID-19 in both adults and children starting from 6 months of age.

Consistent with previous recommendations from both the EMA and the European Centre for Disease Prevention and Control (ECDC), individuals aged 5 years and older who require vaccination are advised to receive a single dose, regardless of their prior COVID-19 vaccination status.

Children aged 6 months to 4 years may receive either one or three doses, contingent on their completion of a primary vaccination course or previous encounter with COVID-19.

The EMA’s decision to propose authorization was informed by a comprehensive evaluation of data concerning Comirnaty and its adapted counterparts. This encompassed assessments of safety, efficacy, and immunogenicity, along with fresh laboratory data demonstrating the robust response of the adapted vaccine against XBB.1.5 and its related COVID-19 strains.

Anticipating the emergence of new variants, the Committee remains poised to evaluate and incorporate these data into its considerations.

Precision Targeting of Omicron XBB.1.5

Adapted COVID-19 vaccines are meticulously engineered to align with prevailing viral variants.

The development of Comirnaty Omicron XBB.1.5 was guided by recommendations from the EMA, ECDC, as well as global regulators including the World Health Organization. This targeted approach addresses Omicron XBB.1.5 while also fortifying protection against other circulating variants, given the close relationship between them.

Since the initial authorization of Comirnaty, an extensive body of safety knowledge has been amassed. Adverse effects, when present, tend to be mild and transient, encompassing symptoms like headache, diarrhea, joint and muscle discomfort, fatigue, chills, fever, and localized injection site reactions. Infrequent occurrences of more severe side effects have been documented.

EMA will promptly transmit the CHMP’s recommendation to the European Commission, paving the way for a legally binding EU-wide decision.

Mechanism of Action

Adapted vaccines operate on the same fundamental principles as their predecessors.

Comirnaty Omicron XBB.1.5 employs messenger RNA (mRNA) molecules that encode the spike protein specific to the Omicron XBB.1.5 subvariant. This protein, found on the virus’s surface, facilitates its entry into host cells and can differ across various viral strains.

Upon vaccine administration, the recipient’s cells interpret the mRNA instructions, temporarily generating spike proteins. The immune system recognizes these proteins as foreign entities, rallying natural defenses – antibodies and T cells – to combat them.

Should the vaccinated individual later encounter the virus, their immune system promptly identifies the spike protein, readying itself for a targeted defense. The concerted efforts of antibodies and immune cells act to neutralize the virus, preventing cellular infection and eliminating infected cells.

Comirnaty was initially granted EU authorization in December 2020, with subsequent adaptations targeting BA.1 and BA.4-5 strains receiving further approval in September 2022.

Media contacts:

Tel. +31 (0)88 781 8427
E-mail: press@ema.europa.eu

SOURCE: EMA