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Key points: European Medicines Agency vaccinations update – no 50% efficacy threshold
Penelope Liersch
A volunteer taking part in the CureVac vaccine trial in March. Recent results from the trial show the vaccine is only 47% effective against COVID-19. /Reuters /Yves Herman

A volunteer taking part in the CureVac vaccine trial in March. Recent results from the trial show the vaccine is only 47% effective against COVID-19. /Reuters /Yves Herman

 

The European Union's regulatory body, the European Medicines Agency (EMA), has held a regular press briefing to update the public on its latest findings and recommendations. Here are the key topics the panel covered.

 

Would the EMA consider a vaccine for review if trials show less than 50 percent efficacy?

Results from German company CureVac have shown its mRNA vaccine demonstrated an interim efficacy of 47 percent against COVID-19 in large-scale clinical trials. 

The EMA panel noted that it is difficult to define a threshold to start reviewing a vaccine, particularly in the current climate where variants are circulating, saying the current results do not mean the body wouldn't look at benefits and the data collected. A 50 percent efficacy or higher had previously been considered a marker for vaccine regulatory bodies to review vaccines. The EMA stated full trial data are necessary to make an assessment of any vaccine.

 

 

How is the EMA safeguarding the quality of the Johnson & Johnson vaccine?

Following contamination at a U.S. site, authorities recommended not releasing vaccine batches containing the active substance made around the same time the contamination occurred. 

The EMA noted the contamination did not occur during the manufacturing of substances destined for the EU but took these steps to safeguard supplies and is looking at using other batches. The EU will continue to receive J&J shots from other manufacturing sites including in the Netherlands.

 

Can people who have had capillary leak syndrome be vaccinated with AstraZeneca?

A warning label will be added to Vaxzevria, AstraZeneca's COVID-19 vaccine, to prevent people who had capillary leak syndrome from getting the jab. This decision was made by the EMA's safety committee, which also noted the need to raise awareness among healthcare workers and patients about this risk. 

The EMA describes capillary leak syndrome as a very rare, serious condition that causes fluid leakage from small blood vessels. The decision came after a review of six cases of capillary leak syndrome in people who had received the vaccine. 

Most of the cases occurred in women within four days of vaccination, three of those affected had a history of capillary leak syndrome and in one case the patient died. As of May 27, more than 78 million doses of the vaccine had been administered across the European Economic Area and the UK.

The EMA safety committee is continuing to assess reports that a small number of people suffered myocarditis and pericarditis – inflammation conditions around the heart – following vaccination with a range of jabs.

 

Is vaccine production being increased in the EU?

The EMA says the continent is scaling up production capacity, noting a new manufacturing site for the production of Moderna's vaccine has been approved. The site is located in Monts, France. 

There is also likely to be the addition of several alternative sites to run batch control and testing.

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