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Moderna closer to US FDA nod after advisory panel supports emergency use

Moderna working with US Centers for Disease Control and Prevention and Operation Warp Speed to prepare distribution of mRNA-1273 if FDA chooses to grant an emergency use authorisation

twitter-logoBusinessToday.In | December 18, 2020 | Updated 15:44 IST
Moderna closer to US FDA nod after advisory panel supports emergency use
Moderna's vaccine has shown efficacy rate of 94.1 per cent

The US could have another vaccine available for people days after the country gave emergency approval to Pfizer and BioNTech vaccine candidates. Moderna Inc, which is also developing its vaccine on new mRNA platform like Pfizer, has confirmed that a panel of outside advisers to the US drug regulators have fully endorsed its vaccine candidate. Of the total 21 members in VRBPAC, twenty members voted in favour of authorising Moderna vaccine, while one abstained.

"We just confirmed that the @US_FDA VRBPAC recommended that the FDA grant an Emergency Use Authorisation for our COVID-19 vaccine candidate, mRNA-1273. 20 VRBPAC members recommended for EUA, 0 members voted against, and 1 abstained," the pharma major said. "We thank the committee for their review," said Stephane Bancel, Chief Executive Officer of Moderna.

He said Moderna is working with the US Centers for Disease Control and Prevention and Operation Warp Speed to prepare the distribution of mRNA-1273 if the FDA chooses to grant an emergency use authorisation. The VRBPAC based its recommendation on Phase 3 clinical study data shared by Moderna on November 30. The primary efficacy analysis conducted on 196 cases had shown that Moderna's vaccine had the efficacy rate of 94.1 per cent.

The most common solicited adverse reactions after the two-dose series included injection site pain (88.2 per cent), erythema (8.6 per cent), swelling (12.2 per cent), and ipsilateral lymphadenopathy (14.2 per cent), the trial data shows. Adverse reactions were mild or moderate, while some also observed severe reactions in the mRNA-1273 group after the second jab, Moderna said.

Also read: WHO in talks with Pfizer, Moderna for affordable COVID vaccines

All participants in Moderna study will be monitored for two years after their second dose to assess long-term protection and safety, said the pharma giant.

Moderna phase 3 study included over 30,000 participants in the US. The trials are being held in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.

Notably, the FDA advisory committees provide non-binding recommendations. While taking the final call, the FDA will take the VRBPAC recommendation into consideration. Under EUA, the FDA can allow unapproved medical products or unapproved uses of approved medical products for emergency use to serious or life-threatening diseases.

Moderna has said its vaccine can be transported under controlled conditions in a liquid state at 2-8 degree C. "In some cases, this may be the only practical means of distribution from clinics and for remote locations," the company said. This shows the requirement of maintaining a certain temperature during shipping and handling of the vaccine remains a barrier for Moderna.

"Moderna remains committed to supporting efficient distribution," the company said.

On December 12, Pfizer Inc and BioNTech SE became the first pharma duo to get the US FDA approval of their mRNA-based vaccine, BNT162b2, for emergency use.

US President Donald Trump had termed the Pfizer vaccine a "medical miracle" in a video message. "We've delivered a safe and effective vaccine in just 9 months. This is one of the greatest scientific accomplishments in history," he said.

Also read: COVID-19 crisis: Moderna's vaccine offers hope to people at high-risk

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