FDA advisory panel backs Moderna’s Covid-19 vaccine

FDA advisory panel backs Moderna’s Covid-19 vaccine

A panel of scientific experts has endorsed Moderna’s Covid-19 vaccine, paving the way for it to become the second jab to receive emergency authorisation for use in the US by the end of the week.

All but one of the 21-member panel voted that the available evidence indicated the vaccine’s benefits outweighed its risks for people aged 18 and older, with one member abstaining.

The Food and Drug Administration could announce an emergency use authorisation by the end of the week. The FDA granted the first EUA for a coronavirus vaccine to Pfizer and BioNTech last week.

Hayley Gans, a Stanford professor on the panel, said the evidence had been studied “in great detail” and outweighed any issues. “I think it really supports us being able to get the pandemic in the background . . . and finally, provide a safe and effective way to get to herd immunity,” she said.

Doran Fink, deputy clinical director of the FDA’s vaccine division, kicked off Thursday’s meeting by saying Covid-19 continued to worsen in the US and worldwide. Even though the Pfizer/BioNTech vaccine is available in the US, it remains “unapproved and its quantity is not sufficient for mass vaccination needed to address a pandemic in the US”, he added.

The US is in the midst of the deadliest surge of coronavirus infections yet. On Wednesday, a record new 3,400 deaths were attributed to Covid-19, while hospitalisations continued to increase, compounding the strain on states’ healthcare systems.

Dr Fink said the FDA and the Centers for Disease Control and Prevention are investigating two incidents of healthcare workers in Alaska suffering serious allergic reactions to the Pfizer/BioNTech vaccine. The FDA is working with Pfizer to revise factsheets given to providers to ensure they are able to monitor and treat such reactions. 

“The totality of data at this time continues to support vaccinations under the Pfizer EUA without new restrictions,” he said. “These cases underscore the need to remain vigilant during the early phase of the vaccination campaign.”

Last week, the FDA decided not to exclude people with a history of serious allergic reaction from receiving the vaccine, even though the UK regulator has done so. Instead, the US regulator warned against administering it to people who had previously had a reaction to the vaccine components. 

In a report issued this week ahead of the meeting, the FDA’s scientists found that the Moderna vaccine was “highly effective” and there were no significant safety concerns.

Moderna’s vaccine is based on the same messenger ribonucleic acid technology — known as mRNA — as Pfizer/BioNTech’s. A genetic code to the virus’s spike protein is delivered into the body in a bubble of fat, to teach the immune system to respond to the virus.

But there are some differences. Moderna is applying for an EUA for over-18s only, whereas Pfizer and BioNTech’s vaccine was approved for 16- and 17-year-olds, even though some outside advisers were concerned about the lack of evidence regarding the vaccine’s use in that age group.

Moderna’s vaccine can be stored at normal medical freezer temperatures, so does not require the same special equipment to transport and store as Pfizer/BioNTech’s inoculation. 

The US government has secured a larger supply of Moderna’s vaccine. It signed a second deal with the company last week, bringing its total pre-order to 200m by the second quarter of 2021.

It has pre-ordered 100m doses of Pfizer/BioNTech’s vaccine and is trying to help the partners increase production in order to secure another 100m. 

Alex Azar, health secretary, told CNBC on Thursday that the US was poised to ship 5.9m doses of Moderna’s vaccines to states once it was approved.

“We’re ready to start shipping this weekend to them for rollout Monday, Tuesday, Wednesday of next week. We’re ready to go,” he said.

Additional reporting by Matthew Rocco in New York

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