F.D.A. to Allow 'Mix and Match' Approach for Covid Booster Shots

[BumRushDaShow]

Source: New York Times

WASHINGTON — The Food and Drug Administration is planning to allow Americans to receive a different Covid-19 vaccine as a booster than the one they initially received, a move that could reduce the appeal of the Johnson & Johnson vaccine and provide flexibility to doctors and other vaccinators. The government would not recommend one shot over another, and it might note that using the same vaccine as a booster when possible is preferable, people familiar with the agency’s planning said.

But vaccine providers could use their discretion to offer a different brand, a freedom that state health officials have been requesting for weeks. The approach was foreshadowed on Friday, when researchers presented the findings of a federally funded “mix and match” study to an expert committee that advises the Food and Drug Administration.

The study found that recipients of Johnson & Johnson’s single-dose shot who received a Moderna booster saw their antibody levels rise 76-fold in 15 days, compared with only a fourfold increase after an extra dose of Johnson & Johnson. Federal regulators this week are aiming to greatly expand the number of Americans eligible for booster shots. The F.D.A. is expected to authorize boosters of the Moderna and Johnson & Johnson vaccines by Wednesday evening; it could allow the mix-and-match approach by then.

The agency last month authorized booster shots of the Pfizer-BioNTech vaccine for at least six months after the second dose. An advisory committee of the Centers for Disease Control and Prevention will take up the booster issue on Thursday; the agency will then issue its own recommendations. By the end of the week, tens of millions more Americans could be eligible for extra shots.

Read more: https://www.nytimes.com/2021/10/18/us/politics/fda-mix-and-match-boosters.html

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I know CDC's ACIP is due to meet Wednesday and Thursday, with the first part of Wednesday's meeting tentatively to deal with OTHER vaccines and the latter to begin to discuss the Moderna booster and then all day Thursday is all-COVID-19 vaccine discussion (and I'm assuming voting).

[luv2fly]

1. As a J&J recipient in April

When my turn comes, I welcome the mix and match option if indeed it comes to pass.

[underpants]

2. I as well. I'm glad the FDA is saying this.

[NurseJackie]

15. I'm glad you have an authoritative recommendation and advice now.

[Merlot]

3. Are all J&J 1st dose recipients eligible for the booster?

Or just those age/condition qualified?

[LisaL]

5. We have to wait and see. I don't think it's clear at the moment.

NT

[BumRushDaShow]

6. The FDA VRBPAC recommendation for Janssen (J&J) was for "all" 18 and up

https://www.democraticunderground.com/10142813570



The FDA Commissoner needs to do the final sign-off on that and then CDC's ACIP meets this week (Wednesday & Thursday) to discuss that, with their Director to finalize the recommendation at some point just after (hopefully by the end of the week or at least over that weekend).

[LisaL]

7. But this is for another J&J shot, not mix and match.

The mix and match study showed Moderna booster produced the most antibodies for J&J recipients. Moderna booster for J&J recipients has not been authorized yet.

[BumRushDaShow]

10. The person I replied to asked

Are all J&J 1st dose recipients eligible for the booster?

vs saying something like

Are all J&J 1st dose recipients eligible for a different booster

And regardless of any "mix or match" (which I know the OP is about), a "booster" is going through the process of being recommended/allowed for Janssen recipients, with no restrictions in age other than 18+, nor regards to health condition.

My assumption of that question was whether there was a restriction for a Janssen (J&J) "booster" outside of the one already approved in the EUA for all 3 vaccines that is specific to age (65+) and/or with certain severe/chronic medical conditions.

[SCantiGOP]

8. And also,

If you had Moderna originally, the booster is a half dose.
If you are getting the Moderna as a booster for J&J I wonder if that will be a half or full dose?

[LisaL]

9. Decisions, decisions...

NT

[ananda]

11. My third Moderna was full dose, last Thursday.

And I'm not complaining.

If I had gotten J&J, I would get Moderna as a booster.

[BumRushDaShow]

12. They have to work out how to do the Moderna "booster"

because unlike the Pfizer vaccine that is "boosting" with a "3rd (full) dose" (in other words, a "3-dose series" ), Moderna applied to do a 1/2 dose shot as "booster". That means Moderna would be a "2-dose series with a 1/2 dose booster".

Meanwhile Janssen is looking at a 2nd (full) dose as their "booster", basically that one would be a "2-dose series" vs a "single-dose with booster".

A number of Committee members from both FDA and CDC have continued to try to implore that the terminology should have the sponsors using a "full dose" for the 2nd in a "single-dose" vaccine or using a "full dose" for the 3rd in a "2-dose vaccine", to call them a "2-dose series" and a "3-dose series".

The issues to be discussed later this week will hopefully help to clarify how one might handle Moderna in a "mix/match" scenario by perhaps only allowing a 1/2 dose Moderna in a new EUA as THE "booster" for all 3 - Moderna (2-dose), Pfizer (but only for those with 2-doses of that) or Janssen (J&J) (but only for those with a single dose of that). That recommendation might exclude those already covered under the EUA that is permitting a full dose of Moderna - as a "3rd dose in a series" - for current Moderna recipients who fall in the specific age/medical condition criteria defined in that EUA (mainly because those in that category generally haven't been found to have a robust immune response to the initial 2 doses).

The "mix/match" scenario introduces all sorts of combinations that need to be hashed out. However as an interesting note, one of the VRBPAC members was commenting near the end exactly what I had been thinking too - that at some point, the Committees are going to have to allow " mix/match" between manufacturers because that sort of thing is already happening with other vaccines from different manufacturers, with interchangeability going on, particularly with the childhood ones that are done in a series - either months apart or years apart.

[SCantiGOP]

13. Thanks

I’ve had my 3 Pfizer shots, but it’s my wife who really needs the full vax because of immune issues, and she had the J&J.
Your answer illustrates that there is no simple answer.

[BumRushDaShow]

14. I think anyone with immune issues who had Janssen (J&J) as their primary vaccine

would probably be recommended to have a full dose of any of the approved vaccines as a 2nd dose. I.e., another Janssen full dose or a Pfizer full dose, or a Moderna full dose.

And the "mix/match" trial that included Moderna was done using the "full dose" vs the "half dose" (the latter being what Moderna submitted separately as a normal "booster" / "half dose" for other categories of the population - 18 - 64 with certain underlying conditions and/or in occupations that have a higher risk of exposure to infection).

[Rhiannon12866]

16. When I stopped at the pharmacy today to pick up my prescription, I asked if they'd have the Moderna

Booster - and they said "yes," when it's approved for distribution. I had to get my initial two shots in Saratoga since the appointments at the CVS up here were fully booked at the time. I'm wondering if the CVS will contact me when I qualify? However, like everyone else, I would rather that the unvaccinated population get their first two shots...

[LisaL]

17. If you are planning to wait until un-vaxxed get their two shots, you will have to wait a long time.

I presume we are down to most vaccine resistant people at this point. When under 12 will become eligible, they will be eligible for Pfizer and not Moderna.
My advice would be to figure out when you become eligible, sign up and get it, without waiting for anyone else to get it first.

[Rhiannon12866]

18. Oh, I was just saying what makes the most sense, not what I expect to happen

We've all gotten vaccines to avoid severe illness and death since we were born, it makes no sense that there are idiots out there that would rather spread illness than take advantage of a free vaccine for "political" reasons.

[SCantiGOP]

19. A stolen meme:

It’s amazing that people who couldn’t do their sixth grader’s math homework last week can now become infectious disease experts just by doing research on the Internet.