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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Franco-Austrian Covid jab under EU review

A Covid-19 vaccine developed by Franco-Austrian biotech company Valneva is being assessed by the European Medicines Agency with a view to roll it out. The EU has already ordered close to 60 million doses.

An illustration picture shows vaccines made by the French-Austrian biotech firm Valneva.
An illustration picture shows vaccines made by the French-Austrian biotech firm Valneva. The EU is assessing its safety with a view to eventually rolling it out. (Photo by JUSTIN TALLIS / AFP)

Europe’s drug watchdog launched an accelerated review Thursday of a Covid-19 vaccine by Franco-Austrian biotech firm Valneva, for which the EU has already signed a deal for up to 60 million doses.

The jab — which uses “inactivated” viruses rather than the new mRNA technology of the Pfizer or Moderna shots — showed in trials that it produced antibodies against coronavirus, the European Medicines Agency (EMA) said.

“EMA’s human medicines committee has started a rolling review of VLA2001, a Covid-19 vaccine being developed by Valneva,” the Amsterdam-based regulator said in a statement.

“While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review,” it said.

It typically takes a few months for vaccines to go from the review stage to approval, although some such as those developed in Russia and China have been waiting longer.

The European Commission announced a deal with Valneva on November 10 to provide about 27 million doses in 2022 and 33 million in 2023.

Valneva’s shares rose on that announcement, but have not completely eclipsed their losses from September, when Britain cancelled an order for 100 million doses of the jab, wiping out more than half the stock market valuation.

The Nantes-based firm has received backing from the French government, which was embarrassed by the country’s failure to produce a Covid-19 jab following setbacks for national pharma champion Sanofi and the renowned Pasteur Institute.

The EMA said Valneva’s studies “suggest that the vaccine triggers the production of antibodies that target SARS-CoV-2, the virus that causes Covid-19, and may help protect against the disease.”

“EMA will evaluate data as they become available to decide if the benefits outweigh the risks,” it added.

Valneva’s jab uses the same inactivated virus method as most flu and many childhood vaccines, which health officials hope could reduce vaccine scepticism about some of the newer-technology jabs.

The EMA has so far approved four vaccines for use for adults in the EU.

The US-German jab by Pfizer-BioNTech and the shot by US pharma firm Moderna use messenger RNA technology. The British Swedish AstraZeneca-Oxford jab and Johnson & Johnson vaccine use viral vector technology.

A decision on a bid for approval by US pharma firm Novavax is expected within weeks.