UK starts real-time review of Moderna's COVID-19 vaccine candidate
(Reuters) - Moderna Inc said on Tuesday United Kingdom's health regulator has started a real-time review of its experimental COVID-19 vaccine. The company has begun a rolling data submission from its vaccine candidate to UK's Medicines and Healthcare products Regulatory Agency (MHRA) for it to start its independent assessment of evidence as and when it becomes available.
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(Reuters) - Moderna Inc said on Tuesday United Kingdom's health regulator has started a real-time review of its experimental COVID-19 vaccine.
The company has begun a rolling data submission from its vaccine candidate to UK's Medicines and Healthcare products Regulatory Agency (MHRA) for it to start its independent assessment of evidence as and when it becomes available.
Such a process allows for a faster approval of a treatment, while maintaining the same standards of safety and effectiveness.
Moderna is among the frontrunners in the race to develop a vaccine for the new coronavirus , including Pfizer Inc, Johnson & Johnson and Astrazeneca - all in their late-stage trials, interim data from which are expected in the coming weeks.
"Though assessment of (Moderna's) early data has begun, it does not guarantee that this, or any other, vaccine will be available in 2020," said Stephen Evans, a professor of pharmacoepidemiology at London School of Hygiene & Tropical Medicine.
"But if the phase 3 results are good, then this unusual, if not unprecedented approach will allow the vaccine to be available more quickly," Evans said.
Moderna said earlier this month it was going to apply for real-time review of its experimental COVID-19 vaccine to Europe. It has also applied for a similar review in Canada.
Evans also explained that Moderna will have the opportunity to answer MHRA's questions about the early data, while the late-stage trial continues.
The results from Moderna's late-stage study should only be seen by the data and safety monitoring board and no data will be released outside the proper process, he added.
(Reporting by Trisha Roy in Bengaluru and Kate Kellend in London; Editing by Shinjini Ganguli)
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