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Wed Oct 13, 2021, 06:40 AM

U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters

Source: Reuters

Oct 12 (Reuters) - Scientists at the U.S. Food and Drug Administration said on Tuesday that Moderna Inc (MRNA.O) had not met all of the agency's criteria to support use of booster doses of its COVID-19 vaccine, possibly because the efficacy of the shot's first two doses has remained strong. FDA staff said in documents that data for Moderna's vaccine showed that a booster does increase protective antibodies, but the difference in antibody levels before and after the shot was not wide enough, particularly in those whose levels had remained high.

The documents were released ahead of a meeting later this week of the FDA's outside expert advisers to discuss booster doses of the vaccine. The FDA typically follows the advice of its experts, but is not bound to do so. A panel of advisers to the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to discuss specific recommendations on who can receive the boosters, if the FDA authorizes them. "There was boosting, sure. Was it enough boosting? Who knows?

There’s no standard amount of boosting that is known to be needed, and nor is it clear how much boosting happened in the study,” John Moore, a professor of microbiology and immunology at Weill Cornell Medical College in New York, said in an email. Moderna is seeking authorization for a 50-microgram booster dose, half the strength of the original vaccine given in two shots about four weeks apart.The company has asked regulators to clear a third round of shots for adults aged 65 and over, as well as for high-risk individuals, similar to the authorization gained by rivals Pfizer Inc (PFE.N) and German partner BioNTech for their mRNA vaccine.

President Joe Biden's administration announced plans earlier this year to roll out booster doses for most adults, but some FDA scientists later said in an article in journal The Lancet that there was not enough evidence to support boosters for all. Data on the need for boosters has largely come from Israel, which rolled out the additional shots of the Pfizer/BioNTech vaccine to large swaths of its population, and has provided details on the effectiveness of that effort to U.S. advisers. No similar real-world study populations exist for the Moderna or Johnson & Johnson (JNJ.N) vaccines.

Read more: https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-seeks-covid-19-vaccine-booster-clearance-older-adults-high-risk-2021-10-12/

The above was Last Updated October 13, 2021 5:50 AM EDT

Here is a link to the briefing document that FDA released - https://www.fda.gov/media/152991/download

I think what this means is what we have seen in the previously-released studies that actually graphed efficacy across the 3 approved vaccines that showed that Pfizer's and Janssen's (J&J) seemed to have more of an efficacy drop when compared to Moderna (although all were still within the "minimum acceptable 50% or greater" for vaccines in general). It would be good to confirm that a Moderna shot, which actually uses 3x the amount of active compared to Pfizer's, might be good for a year.

NYT article -

In Review, F.D.A. Stays Neutral on the Need for a Moderna Booster

The Food and Drug Administration set the stage Tuesday for a new round of decisions on which Americans should get coronavirus booster shots, releasing a review of data suggesting that an additional half-dose of Moderna’s vaccine at least six months after the second dose increased antibody levels. But the agency did not take a position on whether an additional shot was necessary.An independent advisory panel of experts will examine the available data on both Moderna and Johnson & Johnson boosters in a two-day meeting later this week. Votes are scheduled on whether to recommend emergency authorization of boosters for both vaccines. While the panel’s votes are not binding, the F.D.A. typically follows them.

In documents released Tuesday, Moderna argued that a third injection is needed because the potency of its vaccine wanes over time, with levels of neutralizing antibodies falling six to eight months after a second dose. The company also cited “real world evidence of reduced effectiveness against the Delta variant,” although the F.D.A. noted that the studies diverge on whether Moderna’s protection weakened over time against symptomatic infection or against the Delta variant. The company did not argue that a booster was necessary to prevent severe disease or hospitalization, but concentrated its arguments on preventing infection and mild to moderate disease.

Moderna said the mean antibody level of participants in its study was 1.8 times higher after the booster than it was after the second shot. In another measurement, the booster raised neutralizing antibodies at least fourfold in 87.9 percent of people compared to after the second dose, thus narrowly failing to meet the agency’s requirement of 88.4 percent. In a document that Johnson & Johnson submitted to the F.D.A. ahead of this week’s meeting, the company argued that booster shots of its vaccine increased protection against Covid-19, including against severe forms of the disease, and increased the strength of the body’s immune response against virus variants.

Johnson & Johnson said that a booster shot could be administered as early as two months after the first dose, but recommended doing so at least six months after, when it said recipients had been shown to have a more robust immune response. Only 14.9 million Americans have received the Johnson & Johnson vaccine, compared to 103 million fully vaccinated with Pfizer-BioNTech’s vaccine and 69 million with Moderna’s. The advisory panel will vote on whether to recommend booster shots for Moderna on Thursday and for Johnson & Johnson on Friday, after hearing from the companies, F.D.A. scientists and the public.


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Reply U.S. FDA staff says Moderna did not meet all criteria for COVID-19 boosters (Original post)
BumRushDaShow Oct 13 OP
JohnSJ Oct 13 #1
Scrivener7 Oct 13 #2
JohnSJ Oct 13 #5
JT45242 Oct 13 #3
riversedge Oct 13 #4
BumRushDaShow Oct 13 #6

Response to BumRushDaShow (Original post)

Wed Oct 13, 2021, 07:19 AM

1. I guess there aren't enough break through infections for the FDA to even approve an EUA of

the boosters

The problem is for one reason or another, since the pandemic started we have been behind the curve. It would be nice if we were ahead of the curve for once

I don’t blame the Biden administration, they made it clear they wanted boosters for those who had Completed their full vaccinations 6 months ago because all evidence points to waning immunity

While the number of cases is decreasing, it is still to high

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Response to JohnSJ (Reply #1)

Wed Oct 13, 2021, 08:20 AM

2. That would be interesting to know: what is the percentage, in breakthrough infections,

of people who got each of the three shots.

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Response to Scrivener7 (Reply #2)

Wed Oct 13, 2021, 10:33 AM

5. Yes it would

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Response to BumRushDaShow (Original post)

Wed Oct 13, 2021, 09:32 AM

3. too much missing data to draw any conclusions about breakthrough

For the vaccinated -- often cases are mild and asymptomatic, so we have literally no idea how many have had breakthrough cases because many would never have tested. Add to that, the CDC stopped tracking the number of breakthrough cases, so there is no central database of what little information exists.

Now, it would be possible to look at hospitalizations and deaths for each vaccine versus unvaccinated. That could then be cross plotted with time since last shot. That could prove informative.

I saw yesterday on a thread that 25% of the hospitalizations in the Des Moines area are vaccinated folks -- mostly very old (70+) with other comorbidities. Given that they were the first to be given the shot in Iowa, they would also be the first group to show waning immunity.

We all know that boosters are inevitably needed, it is just really an argument for the CDC as to how long after last dose -- 6 months, 12 months, etc. Even the manufacturers of the vaccines said so when they were developed.

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Response to BumRushDaShow (Original post)

Wed Oct 13, 2021, 10:30 AM

4. The headline took me back [concerned] but then I read the article which was more

reassuring for the Moderna which I--and most of family had gotten last spring.

Now just to follow the FDA and CDC recs.

But sad to say--and a bit scary--my 6 yr old niece tested positive--but she lives about 40 miles away and as far as we knew we have not been in contact. They think she picked it up at school [no masks mandates !!}. She has been feverish and just not well for a week now but dad says doing better --sleep all night last night.

She will have to be monitored for long term effects.. No enough data now to tell what long hauls will be for kids.

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Response to riversedge (Reply #4)

Wed Oct 13, 2021, 10:44 AM

6. I got Moderna too along with one of my BILs

so have been monitoring the progress of the possibility/need for a booster too...

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