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Johnson & Johnson files application for European use of one-shot Covid-19 vaccine

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The Johnson & Johnson vaccine requires just one dose be given and was proved to be 66pc effectivy globally.

The Johnson & Johnson vaccine requires just one dose be given and was proved to be 66pc effectivy globally.

The Johnson & Johnson vaccine requires just one dose be given and was proved to be 66pc effectivy globally.

The European Medicines Agency (EMA) has received an application for conditional marketing authorisation of Johnson & Johnson’s one-shot Covid-19 vaccine.

If the vaccine is approved by the EMA, Ireland will receive more than two million doses of the vaccine as part of EU advanced purchase orders.

Authorisation of the vaccine may greatly aid the rollout of Ireland’s vaccination programme as it requires just one dose to vaccinate each person in comparison to other two-dose vaccines.

The EMA’s human medicines committee will now assess the vaccine “under an accelerated timetable” and may issue a decision by the middle of March 2021, it said.

This is provided the company’s data on the vaccine’s “efficacy, safety and quality are sufficiently comprehensive and robust,” an EMA statement said.

The EMA said such a short timeframe for evaluating the vaccine is only possible due to a “rolling review” of the Covid-19 vaccine’s data up to now.

The EU drug regulator said it had already assessed data from laboratory studies which looked at how well the vaccine triggers the production of antibodies and immune cells that target SARS-CoV-2, which causes Covid-19.

A large global trial that concluded in January found the drug was 66pc effective in preventing severe infection. While this figure is lower than previous vaccines, the drugmaker pointed to the trial being conducted while a number of new variants were circulating.

The vaccine was found to be 72pc effective in the US but just 59pc effective in South America, where the Brazilian variant is circulating widely.

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The Johnson & Johnson vaccine works by delivering the SARS-CoV-2 spike protein gene into cells in the body. The cells will then use the gene to produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) to attack it.

If, later on, the person comes into contact with SARS-CoV-2 virus, their immune system will recognise the spike proteins on the virus and be ready to defend the body against it.

The EMA said if the “benefits of the vaccine outweigh its risks”, it will recommend granting authorisation. The European Commission will then issue a decision on whether to grant a CMA valid in all EU and EEA member states within days.

This is the fourth application for a Covid-19 vaccine since the start of the current pandemic in Europe. It comes after EMA’s evaluation of vaccines from BioNTech/Pfizer, Moderna and AstraZeneca. These vaccines are now authorised in the EU and are among the tools Member States are using to combat Covid-19.



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