January 6, 2021

expert reaction to EMA recommending the Moderna COVID-19 vaccine for authorisation in the EU

It has been announced today that the European Medicines Agency (EMA) has recommended the COVID-19 vaccine Moderna for authorisation in the EU.

Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:

“This is extremely good, but not unexpected, news.  The more vaccines that are given authorisation, even if it is under emergency legislation or as for the two vaccines authorised in the EU, a “Conditional” approval, the better.

“We need many vaccines to be shown to be efficacious, to have no serious harms and to be of high quality.  This is firstly because we need as many doses as we can get in this pandemic.  Secondly, it is possible that we will find differences in some aspect of efficacy or safety between vaccines and having multiple options will enable this coronavirus to be suppressed worldwide.

“This vaccine has very good efficacy, though the emphasis on the exact value of “94.1%” efficacy is misplaced since the statistical uncertainty is such that a value little below 90% is compatible with the data, but even this is extremely good.

“As with all vaccines, there are frequent mild effects like a sore arm or a rash, but these do not usually last a long time.

“This vaccine, like the Pfizer vaccine needs to be kept frozen for long term storage but can be kept in a fridge for up to 30 days.  Each vial has 10 doses so again, once the vaccine has reached room temperature there is a need to ensure that it is all used within 18 hours at most so the logistics of delivering the vaccine are more complicated than for say flu vaccines.

“While the second dose is recommended at 28 days, the report from the EMA states “A dosing window of –7 to +14 days for administration of the second dose (scheduled at day 29) was allowed for inclusion in the PPS [“The primary efficacy analysis population (referred to as the Per Protocol Set or PPS)].  98% of vaccine recipients received the second dose 25 days to 35 days after dose 1 (corresponding to -3 to +7 days around the interval of 28 days)”.  This shows that having the second dose precisely at 28 days was not what was done in the trial.

“It is noted that we do not yet know how long efficacy will last, though the participants were followed for a median of 92 days.”

https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-moderna-authorisation-eu

All our previous output on this subject can be seen at this weblink:

www.sciencemediacentre.org/tag/covid-19

Declared interests

Prof Stephen Evans: “No conflicts of interest.  I am funded (one day per week) by LSHTM.  They get funding from various companies, including Astra Zeneca and GSK but I am not funded by them, I have no involvement in obtaining funding from them and I am not an investigator on any grants obtained from them.  I am the statistician to the ‘meta-Data Safety and Monitoring Board’ for CEPI.  I am paid for my attendance at those meetings and will be paid expenses for travel if that occurs.  I am a participant in the Oxford/Astra Zeneca trial, but am still “blind” to the vaccine received.”