THEL new vaccine against Covid has received approval from theEuropean Medicines Agency (EMA): is called Comirnaty and has been adapted to be effective against the subvariant Omicron XBB.1.5. Here’s what we know about the new vaccine, who it’s recommended for, what the potential side effects are, and why it’s safe.
New Covid vaccine: what you need to know
Just as a new increase in Covid-19 cases is spreading in many countries, including Italy, the go-ahead has arrived in Europe for Comirnaty, the first vaccine updated to the Omicron XBB.1.4 variant, better known as Kraken. “The Committee for Medicinal Products for Human Use (CHMP) of the EMA has recommended the authorization of the vaccine adapted against the subvariant Omicron XBB.1.5″, the official government sources announce.
The new vaccine for adults and children from 6 months
“The vaccine – known by the name of Comirnaty Omicron XBB.1.5 – will be used to prevent COVID-19 in the adults and in children from 6 months of age. In line with previous recommendations from EMA and the European Center for Disease Prevention and Control (ECDC), adults and children aged 5 and over scheduled for vaccination should receive a single doseregardless of any previous vaccination cycle against COVID-19 “.
And for children from 6 months to 4 years?
L’Italian Medicines Agency recommends that “children between the ages of 6 months and 4 years can receive one or three doses, depending on whether they have completed the primary vaccination course or had COVID-19″. The vaccination doctor will therefore examine the situation on a case-by-case basis and suggest the safest solution for each child.
Is the new vaccine safe?
To reassure the most doubters, the Italian Medicines Agency confirms that “in its decision to recommend the authorization of Comirnaty Omicron XBB.1.5, the CHMP took into account all available data on Comirnaty and its adapted versions. Including the data of safety, efficacy and immunogenicity (i.e. the degree of ability to evoke the immune response)”.
New incoming variants and vaccine: what protection?
Furthermore, “the CHMP evaluated new laboratory data which show a robust response of the adapted vaccine against the XBB.1.5 variant and related strains of the virus that causes COVID-19”.
Regarding the new variants that are spreading in Italy and abroad, and on the vaccine’s ability to protect against these too, “further data on the emerging variants are expected. These will be assessed by the CHMP as they become available.”
Ema is evaluating other vaccines updated to the variants in circulation: one procedure began on August 7, the second on August 24.
What are the side effects of the new vaccine?
As also reported byHANDLE“The Comirnaty is the first vaccine updated to protect against the latest variants of the Covid virus to receive a positive assessment from the EMA. The EU should formalize the authorization within a few hours. Comirnaty was first authorized in the EU in December 2020, with adapted versions targeting BA.1 and BA.4-5 strains gaining further authorization in September 2022.
“Since Comirnaty’s first authorization – recalls Ema in a note – the authorities have acquired in-depth knowledge of the safety of the vaccine. The side effects are usually mild and short-lived“.
“The over 60s get vaccinated”
The new vaccine isstrongly recommended for over-60s and fragile subjects to avoid the risk of serious illnesswhich for these subjects is concrete despite the SarsCoV2 virus now worrying less than in the past”, the epidemiologist told ANSA Gianni Rezza, former director of General Prevention of the Ministry of Health. In fact, the last few weeks have recorded a doubling of cases of contagion in Italy, a fact that the researchers expected, as explained by the Professor Fabrizio Pregliasco in the interview on iODonna two days ago (read the article here).
Cases will increase with the cold season
The SarsCoV2 virus, Professor Rezza explained to ANSA, «continues to circulate with several new subvariantsOmicron recombinants, which can lead to a rise in cases and a small increase begins to be observed. we expect afurther circulation in the cold season, as is the case with respiratory viruses in general. So protecting the elderly and frail is important since many have not gone beyond the second or third booster dose and have not been vaccinated for some time.
To be done together with the flu vaccine
The advice of experts, always for the population groups most at risk, is to also get the flu vaccination starting next October. “For the over-60 and the frail it is appropriate get both vaccinations For avoid the risk of serious illness, which is always present for these categories. Furthermore, to facilitate the procedures, you can carry out the two separate vaccinations in the same session», recommends the expert. “At the present stage, the objective of the anti-Covid vaccination is not primarily to reduce the circulation of the virus, but rather to avoid serious illness in risk categories» concludes Rezza.
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