Random discussion of Covid-19 not specifically related to restaurants or food

If you mean that they get PCR tested (and appear in official statistics) after they test positive with rapid tests that is definitely not the case. Of the >100 people I mentioned before all were tested positive in rapid tests but not a single person took a PCR test to confirm (or report the positive rapid test). They were just asked by the companies to quarantine for 5 days and then use rapid tests until they test negative. The “true” positivity rate in the US currently is much higher than the official numbers indicate

Interesting, but anecdotal. It’s not necessarily true that the (morally responsible) people that you interact with reflect the policies and actions of the larger population and their employers.

Reportedly it’s the policy at some businesses that if you have symptoms and get a negative home test you follow up with a PCR test, and/or if you stay home because of a positive home test you need a negative PCR before you go back to work.

The Alameda county web site’s test positivity stats don’t match the NY Times’ at all, so maybe there’s nothing to explain.

At least in the biotech/pharma area I know very well perhaps 40-50 companies (ranging from small startup to big pharma) and none of them requires a PCR test to confirm. Obviously it is still anecdotal but also talking with friends in the tech companies in SF it looks not very different. I think there will be companies requiring a PCR test but I doubt it will be a large majority.

It’s common in restaurants and other businesses where exposure means shutting down. They want the most authoritative negative tests ASAP so they can safely reopen.

Well, I guess that people like me and my DH companion who just recently got fourth-shot mRNA “monovalent” boosters will have just missed getting early vaccination with this improved version from Moderna. I wish I had known that its availability was this imminent earlier, because I’d have waited for it. I’d understood that it would be available in the near future, but not until maybe by late in the year, if that soon. I think that if clinics administering the current boosters knew about this they should have advised those of us getting “monovalent” boosters in the May-June timeframe that the improved one was imminent so we could have chosen whether or not to wait for it. Frankly, I’m a bit pissed off about that. If one has to wait 5 - 6 months between boosters, as before, we now won’t be eligible for the improved shot until November – at the earliest.

It won’t be approved by August.

The company has been manufacturing shots of the vaccine, called mRNA-1273.214, ahead of it getting regulatory approval in order to be ready for the fall and winter …

I was waiting for an Omicron-specific second booster, but when there wasn’t one at the beginning of May when the latest wave started I went ahead.

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First sentence in the article:

Moderna expects a new COVID-19 vaccine the drugmaker is developing that it says offers protection against the Omicron variant of the virus to be ready for public distribution by August.

And the last:

the company hopes to have product ready to ship “toward the end of August, early September, October-ish time frame.”

So the information in this article is not to be believed?

The FDA and CDC will want to get in front of a winter outbreak and will, I’m betting, approve the new Moderna vaccine ASAP when it’s ready to go.

Both Pfizer and Moderna (there are some press releases) have said that they expect their BA4/5 relevant omicron vaccines being available for the public by September. Moderna has a first early FDA meeting on 6/27.

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What it says is, “Moderna expects a new COVID-19 vaccine … to be ready for public distribution by August … ahead of it getting regulatory approval in order to be ready for the fall and winter …”

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SF Bay Area’s finally heading in the right direction. Alameda and Contra Costa counties are back down to Medium.

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… which will be pushed through in one week, I’ll bet.

Everyone is anxious for this to be available before fall and winter, and there is almost no reason that approvals will be delayed even the slightest bit. I’m willing to bet the new shots will be available by the end of August. With a lot of fanfare in the media.

Don’t forget that it takes two weeks after an mRNA vaccine injection for it to develop maximum effect, which would move protection to mid-September for those who are first in line – if it’s available to the public by August 30. (And that won’t include people like you and me who got a 4th shot in late spring, because we won’t qualify until later.)

Fantasize whatever you like, but Moderna doesn’t expect approval until fall or winter. That’s already super-fast for the FDA, which in normal circumstances takes years.

You are mixing up the types of approvals - none of the covid vaccines got full approvals in their first waves over the last years. What the FDA has given and will also aim for the B4/B5 vaccine ones are EUAs which, excluding pre-meetings (those are starting next week) will take only several weeks). Your timelines are for BLA or NDA but Pfizer and Moderna are not aiming for them in the short-term (BTW even NDAs and BLA approvals don’t take years (these are the clinical phase timelines) but normally take between 6-10 months)

It’s not a “fantasy”, Robert. It’s an expectation based on my perception of the ongoing urgency to keep ahead of the virus as much as possible. The emergency approvals will come as quickly as possible. Honkman is correct about confusing emergency vs.full approvals.

I’m just going by what Moderna said.

It’s moot in any case for people like you and me who sought out a second mRNA booster in the May-June timeframe, as I’ve said previously. For those like us, it won’t matter if it gets emergency approval at the end of August or as late as November because we won’t qualify for another shot until then.

Not sure about that - data I have seen so far (Israel - which double boosted early) indicates that the booster effect of the 2. booster shot is actually relatively modest (B cell count and duration which has also most likely a similar effect on T-cell count and duration). In addition, B4 and B5 variants seem to be quite evasive for the current vaccine and so I would expect that higher risk people (precondition and/or age) will get another improved booster offered soon.

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Emergency approval seems unlikely given that current national policy in the US is essentially to pretend the pandemic is over. That’s unlikely to change so long as hospitals are not overwhelmed.

Moderna is looking for a FDA authorization (EUA) not an approval