Post by icemandios on Dec 15, 2020 17:47:54 GMT
December 15, 2020 10:35 AM EST RegulatoryCoronavirus
FDA docs give Moderna green light, while spotlighting differences with Pfizer
Jason Mast
Editor
The US looks set to go from zero to two Covid-19 vaccines in a week.
On Tuesday, the FDA released its in-house assessment of Moderna’s mRNA vaccine, drawing a cautious note in one area, but largely offering a ringing endorsement for a candidate that, like Pfizer and BioNTech’s, has already vastly exceeded most expert expectations. With the New York Times reporting that the FDA plans to authorize the vaccine on Friday, the US could have two different vaccines being transported across the country by the start of next week.
In the FDA’s analysis, the Moderna vaccine proved 94.1% effective at preventing symptomatic cases of Covid-19, with that benefit spread across subgroups. That included people with co-morbidities, who comprised about a fifth of the trial and where the vaccine appeared 96% effective. And it included all racial groups.
The trial overall was 83.1% White, 9.1% African American, and 4.3% Asian. Twenty-eight percent of participants were Hispanic or Latino and just over a fifth were over the age of 65.
The two vaccines also appeared to have a similar side effect profile.
Still, while the two mRNA shots appeared broadly similar, the two FDA reviews spotlighted key differences in the two data packages.
Most notably, Moderna convinced the FDA that one of the “known benefits” of its vaccine was its ability to prevent severe cases of Covid-19. Their data showed 30 cases of severe cases in the placebo group, including 9 hospitalizations, vs. zero in the vaccine group.
By contrast, the FDA review of the Pfizer vaccine said their data — 9 severe cases vs. 1 in the placebo group — only “suggested” protection against severe disease, a wording that became a center of discussion at the subsequent advisory committee hearing. The agency has cautioned repeatedly, though, that vaccines that protect against mild disease are very likely to protect against severe disease.
Pfizer’s vaccine, though, may be slightly more tolerable. Although both were broadly safe and cross-trial comparisons are inexact, Moderna investigators found higher rates of severe adverse events such as fatigue and fever.
The FDA also spotlighted an apparent reduced efficacy in volunteers over 65, where the vaccine was only 86.5% effective in the final analysis. The efficacy “in participants≥65 years of age appears to be lower than in younger adults 18 to <65 years,” the reviewer wrote.
That difference was not statistically significant, though, and in other areas, Moderna confirmed positive findings from the Pfizer study.
Notably, they saw a similar benefit after just a single dose as Pfizer did, and they broke down the data on a deeper level than in the previous review documents. They calculated the efficacy between 14 days after dose 1 — when the immune response might be expected to kick in — and the second dose at 92%.
The data are encouraging, showing that the vaccine starts working in short order and that a relatively low amount of neutralizing antibodies can provide protection. Still, public health experts have cautioned that the data are extremely limited single-dose vaccines, particularly on durability. Limited results also pointed to less protection from a single dose after severe disease, with 2 severe cases occurring in the vaccine group between day 14 and dose two, compared to 4 in the placebo group.
The same advisory committee that reviewed the Pfizer vaccine will review the Moderna one on Sunday. Barring any surprises, that will likely set the stage for an authorization on Friday.
Although Pfizer obtained the first approval, Moderna may yet have the bigger impact in the US. The company’s mRNA vaccine is easier to distribute, particularly to sparsely populated areas, as, unlike Pfizer’s, it can be shipped at normal vaccine refrigerator temperatures.
The US government has also simply ordered more doses. After reportedly rejecting an offer from Pfizer to acquire more doses in November, the federal government on Friday exercised an option for 100 million extra doses from Moderna, setting the country up to have at least 300 million doses of vaccine by the second half of next year.
In the short term, Moderna says they can have around 20 million doses available this month, the same number as Pfizer.
FDA docs give Moderna green light, while spotlighting differences with Pfizer
Jason Mast
Editor
The US looks set to go from zero to two Covid-19 vaccines in a week.
On Tuesday, the FDA released its in-house assessment of Moderna’s mRNA vaccine, drawing a cautious note in one area, but largely offering a ringing endorsement for a candidate that, like Pfizer and BioNTech’s, has already vastly exceeded most expert expectations. With the New York Times reporting that the FDA plans to authorize the vaccine on Friday, the US could have two different vaccines being transported across the country by the start of next week.
In the FDA’s analysis, the Moderna vaccine proved 94.1% effective at preventing symptomatic cases of Covid-19, with that benefit spread across subgroups. That included people with co-morbidities, who comprised about a fifth of the trial and where the vaccine appeared 96% effective. And it included all racial groups.
The trial overall was 83.1% White, 9.1% African American, and 4.3% Asian. Twenty-eight percent of participants were Hispanic or Latino and just over a fifth were over the age of 65.
The two vaccines also appeared to have a similar side effect profile.
Still, while the two mRNA shots appeared broadly similar, the two FDA reviews spotlighted key differences in the two data packages.
Most notably, Moderna convinced the FDA that one of the “known benefits” of its vaccine was its ability to prevent severe cases of Covid-19. Their data showed 30 cases of severe cases in the placebo group, including 9 hospitalizations, vs. zero in the vaccine group.
By contrast, the FDA review of the Pfizer vaccine said their data — 9 severe cases vs. 1 in the placebo group — only “suggested” protection against severe disease, a wording that became a center of discussion at the subsequent advisory committee hearing. The agency has cautioned repeatedly, though, that vaccines that protect against mild disease are very likely to protect against severe disease.
Pfizer’s vaccine, though, may be slightly more tolerable. Although both were broadly safe and cross-trial comparisons are inexact, Moderna investigators found higher rates of severe adverse events such as fatigue and fever.
The FDA also spotlighted an apparent reduced efficacy in volunteers over 65, where the vaccine was only 86.5% effective in the final analysis. The efficacy “in participants≥65 years of age appears to be lower than in younger adults 18 to <65 years,” the reviewer wrote.
That difference was not statistically significant, though, and in other areas, Moderna confirmed positive findings from the Pfizer study.
Notably, they saw a similar benefit after just a single dose as Pfizer did, and they broke down the data on a deeper level than in the previous review documents. They calculated the efficacy between 14 days after dose 1 — when the immune response might be expected to kick in — and the second dose at 92%.
The data are encouraging, showing that the vaccine starts working in short order and that a relatively low amount of neutralizing antibodies can provide protection. Still, public health experts have cautioned that the data are extremely limited single-dose vaccines, particularly on durability. Limited results also pointed to less protection from a single dose after severe disease, with 2 severe cases occurring in the vaccine group between day 14 and dose two, compared to 4 in the placebo group.
The same advisory committee that reviewed the Pfizer vaccine will review the Moderna one on Sunday. Barring any surprises, that will likely set the stage for an authorization on Friday.
Although Pfizer obtained the first approval, Moderna may yet have the bigger impact in the US. The company’s mRNA vaccine is easier to distribute, particularly to sparsely populated areas, as, unlike Pfizer’s, it can be shipped at normal vaccine refrigerator temperatures.
The US government has also simply ordered more doses. After reportedly rejecting an offer from Pfizer to acquire more doses in November, the federal government on Friday exercised an option for 100 million extra doses from Moderna, setting the country up to have at least 300 million doses of vaccine by the second half of next year.
In the short term, Moderna says they can have around 20 million doses available this month, the same number as Pfizer.
