FDA advisers back Novavax COVID-19 shots as new US option

[BumRushDaShow]

Source: AP

American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot. Next, the FDA must decide whether to authorize the vaccine made by latecomer Novavax, a protein vaccine that’s made with a more conventional technology than today’s U.S. options.

Novavax shots are already used in Australia, Canada, parts of Europe and dozens of other countries. But U.S. clearance is a key hurdle for the Maryland-based company. FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts -- whatever their reason -- to consider rolling up their sleeves.

“We do have a problem with vaccine uptake that is very serious in the United States,” Marks said. “Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.”

If the FDA authorizes Novavax as the nation’s fourth vaccine, it’s not clear how widely it would be used -- at least right away. Only about 27 million U.S. adults remain unvaccinated. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines. The shots are used elsewhere as a booster, regardless of which vaccine people got originally.

Read more: https://apnews.com/article/covid-science-health-united-states-business-99366fca038e009d7b73a453db39c565

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Have been watching this since 8:30 am and they just adjourned after holding a vote (20 yes - 1 abstain),



It would go to CDC next (assuming the Commish signs off).

As a note, this company and its product were originally part of Operation Warp Speed and was approved in other countries for awhile now.

[PSPS]

1. "Only about 27 million?"

Only about 27 million U.S. adults remain unvaccinated.

I dispute the use of the term "only," That's the deadly MAGA cohort that is keeping the pandemic alive and still dangerous for everyone.

[progree]

8. I dispute the 27 million figure. That's way too low

https://www.reuters.com/business/costs-going-unvaccinated-america-are-mounting-workers-companies-2022-03-25/

March 25 (Reuters) - Nearly a year after COVID vaccines became freely available in the U.S., one fourth of American adults remain unvaccinated,

https://www.census.gov/library/stories/2021/08/united-states-adult-population-grew-faster-than-nations-total-population-from-2010-to-2020.html#:~:text=In%202020%2C%20the%20U.S.%20Census,from%20234.6%20million%20in%202010.

In 2020, the U.S. Census Bureau counted 331.4 million people living in the United States; more than three-quarters (77.9%) or 258.3 million were adults, 18 years or older

So unvaxxed adults are: 1/4 * 258 million = 64.5 million

Not to mention that the vast majority of those who have been vaccinated but not boosted had their latest vax more than a year ago and protection is way down.

[IronLionZion]

2. It's good to have another option

but it may be best to vaccinate the developing world if the remaining unvaccinated Americans don't want it.

[BumRushDaShow]

3. When I listened to the discussions today

both from the Committee members and those who participated in the 5 minute public comment period - apparently there is constituency out there, who have had adverse reactions to the mRNA vaccines, and who want an alternative (including to the current EUA-approved Janssen (J&J) vaccine). And these people were pretty adamant about it.

I was shocked that anti-vax RW loons didn't bother joining because a few have actually had prepared remarks during the past public comment sessions for Pfizer, Moderna, and Janssen's approval meetings (both for the original doses and boosters).

In this case, these advocates believe that we could get another chunk of people vaccinated if given the choice of this type, and one of the Committee members even mentioned that because so much misinformation and CT has been put out there regarding the mRNA vaccines, that having this other option might be enough to persuade at least a subset of either unvaccinated or partially vaccinated people to try this.

I was looking at the mechanism for this vaccine and it looks kinda cool - create "spike nano-particles" (like a fake ball of spikes using the same proteins as a COVID spike as the "spike" ) and that little ball can generate the immune response without actually converting your own cells to make the spikes on their exteriors (like the mRNA vaccines do). It's like injecting little spike-covered balls!

[IronLionZion]

6. It is an interesting design

and it shows promise as some other countries have already started using it. If it works out, it could be a good technology to use for other viruses in the future.

[BumRushDaShow]

7. Apparently a similar platform is used for the HPV and Shingles vaccine among others

One of the sponsor's slides from their slide deck - https://www.fda.gov/media/159008/download (PDF)

[NickB79]

4. Let's be honest with ourselves. Those 27 million aren't unvaxxed because of the science

All the current vaccines have been proven safe, over and over again.

These holdouts aren't doing it because they're genuinely concerned about mRNA tech.

I expect this wont budge the needle on the unvaxxed numbers.

[BumRushDaShow]

5. Per the article, it's not just all unvaxxed

there are apparently a pile of people out there who are only partially vaxxed - i.e., just had one dose and never came back to complete the series. And then you have another large chunk who have not been boosted either.

According to one of the Committee members who is a physician, she mentioned that there was still that hesitancy out there in some of the minority communities due to the persistent and continual misinformation. Hell, we're STILL trying to get the firefighters here in Philly vaccinated and that effort went through months of arbitration.

[progree]

9. 64 million unvaxxed as of March, according to "my own research" and Google :)

#8 upthread
https://www.democraticunderground.com/?com=view_post&forum=1014&pid=2927140

[BumRushDaShow]

10. It's possible that they are also counting the "single dose and done" people

as "unvaxxed" because they would not be considered "fully vaxxed" (this is not including Janssen (J&J) recipients as that shot's indication was for one and done with an optional booster).

The slide decks are here - https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-7-2022-meeting-announcement#event-materials

I briefly started going through some of them but had been in and out to my back patio taking potted tropical plants out for summer, posting here, and listening/streaming that FDA VRBPAC meeting, so....

[progree]

12. I figured the one vax thing might be part of the explanation, but no way does it account for the

Last edited Tue Jun 7, 2022, 10:01 PM - Edit history (1)

27 million vs. 64 million (a 2.4 multiple difference). I could "do my own research" some more, but the differences I've seen in the percentages having one dose (Pfizer and Moderna) compared to those having a completed series (counting J&J in the latter), is not anything like that, or so I linklessly assert.

Edit - just saw #11, I don't believe it, but will have to do "some of my own research" I guess.

Edit#2 - From #14

U.S. At least one dose: 77.4% fully vaxxed: 66.1%
https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker

In Minnesota it's https://mn.gov/covid19/vaccine/data/index.jsp
Minnesota age 5+: at least one dose: 75.2%, completed series: 71.3%. "up to date": 46.8%

[BumRushDaShow]

13. Just saw #11 as well

and I know here in Philly, it was a big concern and I think that is why Janssen (J&J) wanted to do a "single dose" vaccine because trying to get people to come back for a 2nd or 3rd dose as part of a series/regime would be very difficult. And this is why early on, that single dose vaccine was being given by city health officials and volunteer health groups, to the transient population because they knew there was no way to find them again to give them a 2nd dose at the right time.

I know`that states were struggling with the tracking of that because you had people get first doses in one county and then a 2nd dose in another or even out of state, and trying to reconcile that became nearly impossible.

[keep_left]

11. Yes, I think that the figure is something like 50% "non-completers".

In other words, about 50% of the population that received the Covid vax only got one dose (out of two), meaning that they are nowhere close to immunity. For some of these people, it may have been more than a year since they received their first dose. At that point, they aren't much better off than the unvaxxed.

[progree]

14. U.S. At least one dose: 77.4% fully vaxxed: 66.1%

https://www.mayoclinic.org/coronavirus-covid-19/vaccine-tracker
This page doesn't have one for "plus boosters" or I missed it, but that would be interesting to know as well. When I've seen numbers in the past, there wasn't that much of a drop off between one dose and fully vaxxed (counting J&J in the latter), but there is a big dropoff from there to "and boosted".

Me, I had a great incentive to getting boosted -- my completed vax series was one dose of J&J which has a crappy record after a couple months or 4 months or whatever. So I got boosted, but Moderna's booster is half ot the primary series dose (or 1/4 of the total of what you get with 2 shots of Moderna in the primary series). So I was very eager to get my 2nd boost (Pfizer).

But apparently a lot of people think they've "done enough" after completing the primary vax series.


In Minnesota it's https://mn.gov/covid19/vaccine/data/index.jsp
Minnesota age 5+: at least one dose: 75.2%, completed series: 71.3%. "up to date": 46.8%
(I realize age 5+ is quite a lot different than adult population, but oh well, it's a start )

[keep_left]

15. So 77.4% of the US population received at least their first dose...

...and 66.1% completed their series...wow, that's actually better than I thought.

As you say, the Mayo site doesn't appear to have any information about how much of the population has received a booster. The various sites disagree somewhat on the numbers, but are usually close. The Covid Act Now site for Minnesota claims 75.4% received one dose of a two-dose series, 69.5% received both doses of a two-dose series (or the one-dose J&J), and 40.6% received an additional booster.

https://covidactnow.org/us/minnesota-mn/?s=34852283