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 the real-time review of its COVID-19 vaccine candidate. In a statement, the company said that Britain has begun “rolling review process” of its experiment vaccine mRNA-1273. The announcement by the drugmaker is followed by the promising results of the preclinical viral challenge study of the potential vaccine as well as the positive interim analysis of the Phase 1 study of its RNA-based vaccine in the people aged between 18 to 55 and older adults that are 56+.

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

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

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

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Moderna CEO hails the ‘great example’

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

“We appreciate the collaboration we have had to date with regulatory authorities around the world, and the process established by the 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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