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COVID-19 VACCINES

EU medicines agency approves Covid-19 booster vaccine for all adults

The European Medicines Agency has given its approval for a third Pfizer Covid-19 vaccine for all adults in order to increase immunity levels, paving the way for booster jabs to be rolled out across the EU.

A nurse administer a booster shot of the Pfizer Covid-19 vaccine
A nurse administer a booster shot of the Pfizer Covid-19 vaccine. Photo by JUSTIN SULLIVAN / GETTY IMAGES NORTH AMERICA / Getty Images via AFP

The EMA announced on Monday that its human medicines committee (CHMP) has concluded that an extra dose of the COVID-19 vaccine Comirnaty (BioNTech/Pfizer) may be given to all over-18s. It is studying data to see whether a third Moderna jab could also be administered as a booster vaccine.

The extra jab could be given a least six months after the individual received their second dose of the vaccine.

“The CHMP has evaluated data for Comirnaty showing a rise in antibody levels when a booster dose is given approximately 6 months after the second dose in people from 18 to 55 years old,” read the EMA statement.

“On the basis of this data, the Committee concluded that booster doses may be considered at least 6 months after the second dose for people aged 18 years and older.”

It also concluded that an extra dose of the Pfizer or Moderna COVID-19 vaccines may be given to people with severely weakened immune systems, at least 28 days after their second dose.

Each country in the EU and has implemented its own policy towards Covid-19 vaccines and the goes for booster shots. Certain countries have already began booster campaigns for elderly residents with weakened immune systems.

“At national level, public health bodies may issue official recommendations on the use of booster doses, taking into account emerging effectiveness data and the limited safety data,” the EMA said.

“The implementation of vaccination campaigns in the EU remains the prerogative of the national immunisation technical advisory groups (NITAGs) guiding the vaccination campaigns in each EU Member State.

“These bodies are best placed to take into account the local conditions, including the spread of the virus (especially any variants of concern), the availability of vaccines and the capacities of national health systems.”

The EMA said there was no know side effects following a booster jab.

“The risk of inflammatory heart conditions or other very rare side effects after a booster is not known and is being carefully monitored. As for all medicines, EMA will continue to look at all data on the safety and effectiveness of the vaccine,” the regulator added.

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COVID-19 VACCINES

Italy approves fourth Covid vaccine doses for over-60s

Italy has extended the availability of a second Covid-19 vaccine booster shot as infection rates surge across the country.

Italy approves fourth Covid vaccine doses for over-60s

The Italian health ministry announced that fourth Covid vaccine doses, or second booster shots, will soon be available to all residents aged 60 and over, as national medicines regulator Aifa gave the green light on Monday.

Health minister Roberto Speranza said on Monday that doses could be administered to this age group “immediately”, as Italy “moves in line” with recommendations from the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC).

“In the coming hours, immediately, already today, we will adapt our guidelines, our circulars and our indications. We will immediately open up administration in our regions.

“We mustn’t think that the battle against Covid is won. It is still ongoing and we must keep the level of caution high,” he said.

The health ministry confirmed in an update on its website that second booster doses were now recommended to “all persons aged 60 years or older, provided there has been an interval of at least 120 days since the first booster dose or the last post-booster infection (date of positive diagnostic test)”.

READ ALSO: Fourth jabs and isolation: Italy’s plan to control Covid cases this summer

The availability of fourth doses will vary by region, as each local health authority is responsible for managing the timing of its own vaccination campaign.

Several regions, including Lazio (around Rome) and Lombardy (around Milan), said on Monday that they would allow over-60s to book their fourth jabs within the coming days.

A fourth dose can be booked as usual, via pharmacies or family doctors, and via regional booking websites where available. (Find more information in a separate article here.)

Speranza didn’t say when second booster shots may be rolled out to all age groups, stating only that “a new vaccination campaign” is set to begin in September.

Health authorities have previously said they are not planning to make a fourth dose mandatory, though an annual “top-up” shot is likely to be offered.

Until now, only over-80s, care home residents, and clinically vulnerable patients have been eligible for a fourth shot in Italy.

READ ALSO: At a glance: What are the Covid-19 rules in Italy now?

But health experts are also urging the government to speed up the administration of fourth jabs to these vulnerable groups: uptake remains far lower than hoped so far, with 78 percent of over-80s not getting theirs yet.

With the coronavirus infection rate now at its highest level since February, and the number of hospitalisations expected to keep rising in the coming weeks, the health ministry has not said whether it plans to bring back any recently-scrapped health measures.

For now, the government’s strategy appears to be focused on maintaining the relatively high rate of vaccination coverage in Italy: 90 percent of the population over 12 years old has been fully vaccinated with at least two doses, official figures show.

Find out more about booking a booster shot in Italy in a separate article here. See the government’s ‘prenotazione vaccino‘ (vaccine booking) website for links to regional authorities’ appointment reservation platforms.

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