Source: United Kingdom – Executive Government & Departments
Moderna have announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) is to begin a rolling review of Moderna’s mRNA vaccine against COVID-19.
Prof Stephen Evans, Professor of Pharmacoepidemiology, London School of Hygiene & Tropical Medicine, said:
“Most major regulators have said that they will start to assess early data from the first phases of development of a vaccine.
“Normally a company submits all the results at one time when the phase 3 trials are complete. This usual process means that the regulator will inevitably take a long time to do the assessment of all the data. In this unprecedented pandemic situation, regulators are prepared to begin assessment of the basic laboratory, animal studies, and early phase data prior to the phase 3 data being available.
“This means that the time from completing the phase 3 trials, which, if they confirm safety and efficacy, to granting a licence is dramatically reduced. The company at this stage should be unaware of the phase 3 results and so are hoping that they will show the vaccine is safe and reduces symptomatic infections. They do not know (or should not know) that the results indicate this vaccine to be as good as it is hoped.
“The regulators may have questions about the early data and the company will have the opportunity to answer them, if necessary doing extra studies, while the phase 3 study continues. The phase 3 study results should only have been seen by the data and safety monitoring board and they will have signed agreements to ensure that they do not release data outside their proper process. The phase 3 results and the follow-up, if not recruitment, of trial participants will continue and be analysed in confidence, while this assessment of early data goes on.
“Regulators have, in the past, sometimes been criticised for the time taken to assess a new application for a medicine (drug or vaccine), but they are now making every effort to ensure that any delay in an effective vaccine being made available is not down to their response.
“Though assessment of the early data has begun, it does not guarantee that this, or any other, vaccine will be available in 2020, but if the phase 3 results are good, then this unusual if not unprecedented approach will allow the vaccine to be available more quickly.
“It is entirely possible that other companies have been doing the same thing, either through the UK or other countries’ regulatory system, but they have possibly not felt it necessary to announce it publicly. The regulators themselves do not usually make comment on applications while the assessment is ongoing.”
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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.”