Recommendation paves way for FDA authorization of Moderna Covid vaccine in US
An advisory committee for the US Food and Drug Administration (FDA) has recommended the agency authorize a second Covid-19 vaccine, this one developed by Moderna and the National Institute of Allergy and Infectious Diseases (NIAID).
The recommendation paves the way for the FDA to give emergency approval for a second highly effective vaccine to be used in the US. That approval could come by the end of the week. An FDA analysis found Moderna’s vaccine is more than 94% effective at preventing Covid-19 in a trial of more than 30,000 participants.
The likely authorization of the second vaccine comes after more than 300,000 Americans have succumbed to Covid-19, in a winter-time “third wave” of the disease that is filling hospitals with patients and exhausting healthcare workers.
The recommendation comes from the FDA’s Center for Biologics and Evaluation and Research vaccine advisory committee, an independent panel of experts who last week recommended the agency authorize a vaccine developed by Pfizer/BioNTech.
“The question is never when do you know everything, it’s when do you know enough,” said Dr Paul Offit, a vaccine and infectious disease expert at the Children’s Hospital of Philadelphia. The answer to whether the advisory committee should recommend emergency authorization of the vaccine is, “Clearly, yes.”
“We’re talking about a pandemic in which we really need to move this forward,” said Dr Steven Pergam, another board member and an infectious disease expert at Seattle Cancer Care Alliance.
The Pfizer vaccine became the first drug authorized by the FDA to prevent Covid-19 in the US. It was earlier authorized by the UK and Canada. While the FDA does not always take the advice of its expert committees, the agency is expected to swiftly authorize the Moderna vaccine for emergency use.
Like Pfizer’s vaccine, the drug developed by Moderna to prevent Covid-19 uses messenger RNA technology. This technology introduces the body to the spike protein coating the surface of the coronavirus.
The vaccine was developed in a joint effort by Moderna Inc and NIAID. It received nearly $2.5bn in US government funding, and the federal government has already purchased 200m doses with an option to buy 300m more.
Emergency approval of a second vaccine would put the US on track to potentially immunize up to 150 million people between now and mid-2021, if the government can effectively roll out the most logistically challenging public health campaign in history.
Both vaccines require two dose “booster” regimens. About 6m doses are expected to begin being distributed immediately after FDA emergency authorization. The federal government will pay for both vaccines, with no outof-pocket costs to Americans.
Notably, the hearing for the second potential vaccine included doctors who spoke about the impact Covid-19 has had on themselves and their staff.
“There’s a real price to be paid for getting Covid,” said Dr. Douglas Dieterich, a professor of medicine at Mount Sinai’s institute of liver diseases who was infected with Covid-19, and lost his sense of smell, and feeling in his feet, among other long-term side effects. “I think the vaccine is the answer to prevent Covid-19,” he said.
Dr. Donald Middleton, a doctor at the University of Pittsburgh Medical Center, said one of his residents was about to sedate an intubated 70-yearold Covid-19 patient, when she wrote him a note. “I love y’all, my life is in y’all’s hands,” the patient wrote.
“Even though their staff does their duty daily, they are in hell,” said Middletown. “Please advise the FDA to give this outstanding vaccine full [emergency authorization] status.”
The second US authorization comes as the FDA is updating guidance given to doctors after a health worker in Alaska experienced an allergic reaction immediately after receiving the vaccine. Moderna’s scientists said there were two allergic reactions in its trial, one in the placebo arm and another in a vaccine recipient.
In the vaccine arm, the allergic reac
tion was more than 60 days after the participant received the vaccine, and was found to be related to a separate medical procedure.
The second approval also poses a substantial challenge to vaccine researchers, who are now “experiencing significant drop-out” in the blinded, placebo-controlled trial as vaccines become available, said Dr. Lindsey R Baden, one of three co-principal investigators and a doctor at Brigham and Women’s Hospital in Massachusetts. That means observational data, considered lower quality, will need to be carefully analyzed to learn more about the vaccine as it is distributed.
Even with this second approval, the US would still need to authorize more vaccines in order to vaccinate the majority of Americans. Moderna’s vaccine, like Pfizer’s, would be authorized for emergency use with the idea that the company would apply for a full approval in coming months.
Importantly, Moderna’s vaccine holds two distinct advantages over Pfizer’s. First, it does not require ultracold storage. That means the vaccine could be less susceptible to wastage and will be easier to transport to rural communities. It also does not require dilution or mixing, like Pfizer’s vaccine.
The second advantage is more subtle – Moderna’s Phase III clinical trial data showed no members of the vaccinated group developed severe Covid-19, where 30 placebo group members did. This means for the 6% of people who do not receive the preventive effects of the vaccine, the vaccine may still reduce severity of symptoms.
The Pfizer vaccine is authorized in children as young as 16, but Moderna’s vaccine can only be used in adults 18 and older. That could leave roughly a quarter of the population vulnerable to infection by the coronavirus, and increase the need to universally vaccinate adults.