UK starts real-time review of Moderna's COVID-19 vaccine to reduce 'time to authorisation'

UK’s pharmaceutical company, Moderna Inc said on October 27 that British health regulator has started real-time review of its COVID-19 vaccine candidate. In a statement, company said that Britain has begun “rolling review process” of its experiment vaccine mRNA-1273. anuncement by drugmaker is followed by promising results of preclinical viral challenge study of potential vaccine as well as positive interim analysis of Phase 1 study of its RNA-based vaccine in people d between 18 to 55 and older adults that are 56+.

Moderna Inc said that it has initiated rolling submission of COVID-19 vaccine candidate in consideration of possible authorisation by Medicines and Healthcare products Regulatory ncy (MHRA) in UK. However, it would only be possible if mRNA-1273 meets “rigorous standards of safety, effectiveness, and quality standards.”

Moreover, this real-time review would allow British health regulator to begin its own independent assessment by utilising information already submitted by pharmaceutical company along with accepting new evidence as and when it becomes available. This process, refore, reduces "time to authorisation" without compromising standards of safety and efficacy.

company said in a statement, “Moderna, Inc., (Nasdaq: MRNA) a biotechlogy company pioneering messenger RNA (mRNA) rapeutics and vaccines to create a new generation of transformative medicines for patients, today anunced that Medicines and Healthcare products Regulatory ncy (MHRA) in United Kingdom has started rolling review process of mRNA-1273, Company’s vaccine candidate against COVID-19.”

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Moderna CEO hails ‘great example’

Moderna Inc Chief Executive Officer Stéphane Bancel hailed initiation of real-time review in UK as “great example” of what can be achieved in supporting efforts of delivering a safe and efficient COVID-19 vaccine to British citizens in fastest way possible. Bancel also welcomed efforts made by regulatory authorities across globe and process established by MHRA.

“We appreciate collaboration we have had to date with regulatory authorities around world, and process established by MHRA to address this ongoing public health emergency,” said Stéphane Bancel, Chief Executive Officer of Moderna. “This is a great example of what’s being done to support efforts to deliver a safe and effective vaccine to UK citizens as safely and efficiently as possible.”

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