FDA Authorizes use of Moderna COVID-19 Vaccine
Dec. 18, 2020 — As anticipated, the FDA granted Moderna an emergency use authorization for its COVID-19 vaccine, doubling the variety of vaccine doses anticipated to be accessible within the coming days for distribution nationwide.
There is one ultimate step — the CDC’s Advisory Committee on Immunization Practices might want to advocate its use, because it did 2 days after the Pfizer vaccine acquired its EUA on Dec. 10.
The EUA for the Moderna vaccine is “a major milestone in trying to contain this pandemic,” Hana Mohammed El Sahly, MD, instructed Medscape Medical News.
Scaling up distribution of the 2 vaccine merchandise will come subsequent.
“Even under less emergent conditions, sometimes making sure people who need to get a vaccine can be hard. I hope the media attention around this will make more people aware that there are vaccines that might help them,”
mentioned El Sahly, chair of the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC).
The emergency authorization for the Moderna vaccine follows a assessment by the impartial committee on Thursday, which voted to twenty to 1 with one abstention to advocate the authorization..
Emergency approval of a second COVID-19 vaccine “is great – we need all the tools we can to fight this pandemic. The early data coming from Moderna looks good, and I agree with the FDA that an EUA is indicated,” Stephen Schrantz, MD, infectious illness specialist and assistant professor of Medicine at UChicago Medicine, instructed Medscape.
“It’s incumbent upon all us health care professionals to put ourselves out there as supporting this vaccine and supporting people getting it,” Schrantz mentioned. “We need to make certain people who find themselves on the fence perceive it is a protected vaccine that has been vetted appropriately via the FDA and thru part III scientific trials.
“I know the critical role physicians play as vaccine influencers,” American Medical Association President Susan Bailey, MD, mentioned throughout a Dec. 14 webinar for journalists. “We have to continue to do what physicians have always done. Review the evidence and trust the science. Lives are at stake.”
Ramping Up Health Care Provider Immunizations
“I am very excited to see the FDA’s positive review of the Moderna vaccine. We have been waiting to have another vaccine we can use for health care workers and staff – and now we have it,” Aneesh Mehta, MD, of Emory University School of Medicine in Atlanta, instructed Medscape.
“We had been hoping for a vaccine with a 70% or 80% efficacy to see, and to see two vaccines now with greater than 90% efficacy is remarkable,” he added.
The efficacy ranges related to each the Pfizer and Moderna messenger RNA vaccines “did exceed expectations for sure – this is not what we built the studies around. It was surprising in the good sense of the word,” mentioned El Sahly, who can also be affiliate professor of molecular virology and microbiology and a researcher within the Vaccine and Treatment Evaluation Unit at Baylor College of Medicine in Houston.
Unanswered Questions Remain
Schrantz likewise mentioned the excessive efficacy fee was a constructive. “That being said, what we know about this vaccine is it is very effective at preventing disease. We don’t have any understanding at this time whether or not these vaccines prevent infection and transmissibility.”
Bailey mentioned, “The jury is still out on whether or not you can still transmit the virus after you’ve had the vaccine. Hopefully not, but we don’t really know that for sure.”
“It’s risky to think that once you get the shot in your arm everything goes back to normal. It doesn’t,” Bailey added.
Another unknown is the period of safety following immunization. The Pfizer and Moderna merchandise “have similar constructs, seem to have a reasonable safety profile and excellent short-term efficacy,” El Sahly mentioned. She cautioned, nonetheless, that long-term efficacy nonetheless must be decided.
Whether any uncommon opposed occasions will emerge is one other query. Answers may come over time from the continued part III trials, in addition to from monitoring vaccine recipients.
“Our work is not done after issuing an EUA,” FDA Commissioner Stephen Hahn, MD, mentioned in a JAMA webinar on Dec. 14. The FDA is intently monitoring for any opposed occasion charges above the traditional background incidence. “We are going to be transparent about it if we are seeing anything that is not at base level.”
Advantages Beyond the Numbers?
“The major advantage of having two vaccines is sheer volume,” Mehta mentioned. An further benefit of extra product is the potential to supply an choice when a particular vaccine just isn’t really useful for particular people. “We could offer someone a different vaccine … similar to what we do with the influenza vaccine.”
“The more the merrier in terms of having more vaccine products,” Schrantz mentioned. Despite variations in delivery, storage, minimal age necessities and dosing intervals, the Pfizer and Moderna vaccines are very comparable, he mentioned. “Really the only difference between these two vaccines is the proprietary lipid nanoparticle – the delivery vehicle if you will.”
Both vaccines “appear very similar in their capacity to protect against disease, to protect [people in] various racial and ethnic backgrounds, and in their capacity to protect against severe disease,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and member of the FDA advisory committee, mentioned.
In phrases of vaccines within the growth pipeline, “We don’t know but we might start to see a difference with the Johnson & Johnson vaccine or the Janssen vaccine, which are single dose. They might confer some advantages, but we are waiting on the safety and efficacy data,” Schrantz mentioned.
As a two-dose vaccine, the AstraZeneca product dose not supply a bonus on the dosing technique, “but it is easier to transport than the mRNA vaccines,” he mentioned. Some issues with the preliminary information on the AstraZeneca vaccine will seemingly should be addressed earlier than the corporate applies for EUA, Schrantz added.
“That is an important question,” El Sahly mentioned. The ongoing research ought to present extra information from contributors of all ages and ethnic backgrounds that “will permit us to make a dedication as as to whether there’s any distinction between these two vaccines.
She added that the Pfizer and Moderna vaccines appear comparable from the early information. “We’ll see if this stands in the long run.”
Now that the FDA authorized emergency use of two COVID-19 vaccines, “we need each state to quickly implement their plans to get the vaccines into the hands of providers who need to give the vaccines,” Mehta mentioned. “We are seeing very effective rollout in multiple regions of the country. And we hope to see that continue as we get more vaccine from manufacturers over the coming months.”
“Within a year of identifying the sequence of this virus we have two large clinical vaccine trials that show efficacy,” Offit mentioned. “That was an amazing technologic accomplishment, but now comes the hard part. Mass producing this vaccine, getting it out there, making sure everybody who most benefits gets it, is going to be really, really hard.”
“But I’m optimistic,” Offit mentioned. “If we can do this by next Thanksgiving, we’re going to see a dramatic drop in the number of cases, hospitalizations and deaths, and we can get our lives back together again.”