Vaccine for weakened immune systems approved by EU

Image copyright Getty Images Image caption The J&J vaccine blocks recurrences of diseases such as Hepatitis B

The European Commission has approved a booster shot of a vaccine developed by Johnson & Johnson for people with weakened immune systems.

CoVID-19 (adjuvant vaccine potentiation of virus immunogenicity) will be given to those suffering from “rare, chronic or severe” forms of chronic hepatitis B infection.

The introduction of the vaccine had been delayed by European Union regulators because of safety concerns.

However, at least one other health board had already allowed it to be administered to people infected with the virus.

The Common European Vaccine Network (CEV) asked for safety data to be vetted for a booster dose for the vaccine.

CoVID-19 contains adjuvants – or drugs added to a vaccine – to boost the effectiveness of the jabs and have been used in vaccines for warts and flu for many years.

Because the vaccine blocks the transmission of the virus to others – known as the “epidemic response”, it needs to be administered by injection to be fully effective.

But in some cases even multiple doses of the vaccine are needed to prevent infection.

As a result, this must be done with a booster vaccination at least once every three years.

The developers then submitted clinical data to the CEV to show the non-inferiority (neither better nor worse) profile of the combination jab when compared to a yearly dose of the antigenic vaccination.

All vaccines carry extra doses for “spare point administration”, to use a common medical term. This is because the doses delivered using a needle will vary in size. The equivalent vaccine can be delivered by injection.

But not all governments have agreed to use a jab two years apart, known as quadrivalent. This is one shot of four with a 50% chance of effectiveness.

In the case of this vaccine, the second dose must be given at least three years later than the first dose, to protect against additional reactivation of the virus by chance.

The effects of some vaccines are similar for people of all ages, the CEV said.

The EU is already the largest single market for the vaccine because of the number of countries where it is available.

However, additional nations cannot only benefit from the vaccine but also from the ‘look-out’ for the regions where a vaccine is available and those with vaccination coverage lagging.

After a previous licensure, in 2018, the Department of Health, Social Care and Sport of Brazil recommended it be added to the standard immunisation schedule for people infected with hepatitis B.

Earlier this year, the same country said that CoVID-19 would be the main vaccine for young school-age children in endemic areas.

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