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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.

Published: 4 October 2021 17:26 CEST
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

First batches of Novavax Covid vaccine to arrive in Italy

Italy will begin to administer the new anti-Covid vaccine in the coming days, as millions of doses are scheduled for dispatch across the country and in other EU nations.

Published: 25 February 2022 10:58 CET
First batches of Novavax Covid vaccine to arrive in Italy

People in Italy aged 18 and over are now eligible to get vaccinated against Covid-19 with ‘Nuvaxovid’ – the name of the new Covid vaccine from the company Novavax.

Around one million doses are initially due to arrive in Italy by the end of February, according to Italian media reports.

Some 100 million initial doses in total have been shipped to Italy and other EU countries from the company’s Dutch distribution centre, the US medical company announced in a statement.

It’s hoped that Novavax could offer a more attractive alternative for previously unvaccinated people who are sceptical about the mRNA and vector vaccines.

“It’s a protein vaccine, like the flu vaccines,” said Italian medicines agency director Nicola Magrini earlier in February. “It will be a small supplement compared to the other mRna vaccines. Some seem to prefer it.”

READ ALSO: When and how will Italy offer a fourth Covid-19 vaccine dose?

Some regions of Italy have already opened bookings for the new vaccine, noted Italian newspaper La Repubblica.

The Marche region and Lombardy, for example, have started accepting vaccine bookings for the new inoculation, while Emilia Romagna is set to offer vaccine hubs with the new jab.

Each regional healthcare system can decide how it will administer the shot, so people looking to book their dose will need to check their region of residence’s guidelines. Find links here.

On a national level, Italy’s Ministry of Health has published a circular with instructions on the vaccine’s use ahead of its delivery.

Novavax, whose trade name is ‘Nuvaxovid’, has so far only been approved for the primary cycle. The first and second doses are given three weeks apart, while approval is pending for the third dose.

READ ALSO: How to try to get a Covid-19 vaccine without a health card in your region of Italy

A medical worker prepares a dose of Novavax

A medical worker prepares a dose of Novavax’s Covid vaccine for vaccination during a trial at St George’s University Hospital in London. Photo: picture alliance/dpa/AP | Alastair Grant

Nuvaxovid is a so-called protein vaccine which contains coronavirus-like particles that stimulate the immune system to produce defence antibodies and T-cells against SARS-CoV-2 – that is, white blood cells specialised to fight the virus to protect against Covid-19.

The ministry’s circular states that, “the duration of protection offered by the vaccine is not known, as it is still being determined in ongoing clinical trials”.

“None of the components of this vaccine can cause Covid-19,” the circular reads.

READ ALSO: Reader question: Do I need to update my Italian green pass after a booster shot?

“Protection may not be complete until seven days after administration of the second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccinees,” it added.

Its efficacy, calculated during the trials, is 90 percent in preventing symptomatic disease, slightly lower than for the RNA vaccines, which reached 95 percent.

Tests were carried out before the arrival of the Omicron variant, however. It is possible that the protection of Novavax has dropped a little since then.

The vaccine rollout follows its approval by the Italian Medicines Agency (AIFA) in December, after the European Medicines Agency (EMA) gave the go-ahead just days before.

Find more information about Italy’s Covid-19 vaccination campaign on the Italian health ministry’s website (available in English).

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