US FDA plans to give Moderna authorisation for emergency use

WASHINGTON: Advisors to the US Food and Drug Administration (FDA) voted in favour to recommend that the agency must give Emergency Use Authorisation (EUA) to Moderna’s COVID-19 vaccine.

According to CNN, top FDA officials said that they planned to quickly move ahead with the EUA.
“Following today’s positive advisory committee meeting outcome regarding the Moderna COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization,” FDA Commissioner Dr. Stephen Hahn and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement, as quoted by CNN.

It added, “The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution.”

It was further reported that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 20-0 with one abstention to recommend EUA for the Moderna vaccine ” which is very similar” in design, composition, safety and efficacy to Pfizer/BioNTech’s vaccine.

“There’s no doubt in my mind that the data — it looks like the benefits outweigh the risks, from what I’ve seen,” committee member Dr. Steven Pergam, of the University of Washington and Fred Hutchinson Cancer Research Center, said before the vote.

Lengthy discussions among academics, physicians, public health specialists and others whether Moderna should offer the vaccine to people who got saline shots — something that might have the effect of reducing long-term data on “how well and safely the vaccine protects people from infection.”

“Academics have a way of getting involved in details, and what we have done for the last eight or nine hours was to go over the details,” Dr. Arnold Monto, an infectious disease specialist and professor of epidemiology at the University of Michigan, who chairs the panel, said after the vote, quoted by CNN.

He added that the vote was “more one-sided” than what was the case for Pfizer/BioNTech’s vaccine, which came down 17 for, 4 against, with one abstention.

“And some people took the issues last week — especially those involving the different age groups, the 16- and 17-year-olds — to drive the decision that they made, which clearly was made based on that issue and not on the overwhelming evidence for the risk being less than benefit — clear benefit — for these vaccines,” Monto said.

Moderna said it expected its vaccine to remain stable when refrigerated at between 2C and 8C for 30 days, significantly longer than the shot developed by BioNTech-Pfizer, which can survive in a normal fridge for only up to five days and must otherwise be stored at minus 75C.

“The independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5 per cent,” the company said in a statement.

Moderna uses the messenger RNA, or mRNA which prompts the body to produce compounds that look like the outside of the coronavirus, and in turn, that causes an immune response that protects against infection.

Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences, abstained from Thursday’s vote recommending EUA, according to CNN.

“I abstained because I’m very uncomfortable with the language. I think in the midst of a pandemic, and with limited vaccine supply available, that blanket statements for individuals 18 years of age and older is just too broad,” Kurilla said after the vote, which came down 20-0 with just his abstention.

“I’m not convinced that for all of those age groups, the benefits do actually outweigh the risks, and I would prefer to see it more targeted towards people at high risk of serious and life-threatening Covid disease,” Kurilla explained.

“I would have preferred to have seen, rather than an emergency use authorization route — an expanded access program. I think it would have given us a lot more opportunities to continue to collect the data,” he added.

This comes after the FDA, last week, approved Pfizer’s COVID-19 vaccine for emergency use across the country.

President Donald Trump said that he “was thrilled” about the Pfizer vaccine being approved, adding that the administration had given “Pfizer and other companies, a great deal of money.” Trump went on to thank the “brilliant” scientists, technicians, doctors, and workers who made this all possible.

“Pfizer and Moderna have announced their vaccines are approximately 95 per cent effective, far exceeding expectations. These vaccines are also very safe. American citizens also participated in clinical trials that were far larger than normal and had no serious side effects,” he said.(ANI)