Coronavirus COVID-19 (2019-nCoV) Thread - 2021 Breaking News

Yes and no. It’s worth reading that article - another unintended consequence is that, because flu incidence is being severely depressed (in the southern hemisphere winter, say), the sample size for predicting which strains will work in next season’s northern hemisphere vaccines is reduced (and vice-versa) making strain selection all somewhat of a crapshoot all round.

j

Strain selection has always been a crap shoot. Some years are better than others. I still figure being flu vaccinated is loading the dice in my favor.

Oh, I agree with that.

j

112,654,146 total cases
2,496,749 dead
88,239,672 recovered

In the US:

28,897,718 total cases
514,996 dead
19,212,517 recovered

Yesterday’s numbers for comparison:

27 posts were merged into an existing topic: I am beginning to think that this pandemic won’t end

Greeeeeeat. Another horror movie come to life.

So some expected but important breaking news:
The Food and Drug Administration released an analysis of Johnson & Johnson’s COVID-19 vaccine Wednesday morning that supports its authorization for emergency use.

'Course we’re friends. BTW - you know I said the EMA did not go easy on the AZ application? Take a look at section 3.3 of this (large!) PDF when you have the time. (Two pages, rather technical.)

j

Interesting indeed. Thanks for directing me to it.

I haven’t posted here in a while, because it appears that all the states haven’t had a record high number of (seven day averaged) high cases in many weeks, going back to some time between November and early January.

the only exception seems to be Iowa, which reported a ne record high only two days ago. But that is clearly some sort of weird error or adjustment, because it makes no sense

The Global number of cases keeps falling, as does the number of global deaths. You can even see a difference in the recent slope of Cumulative Cases globally.

The US daily caseload is going down – we’re actually approaching that of Brazil

I’m pretty sure Iowa has changed how the numbers are being reported. Before if someone was tested more than once they were considered just a case “1”. Now if someone is tested more than once they become cases “1”, “7”, “11”.

I think my governor decided to do it that way so it appears like the cases of positive are smaller looking compared to number of tests.

(the new website has already been dropped)

More details:

Johnson & Johnson’s single-dose coronavirus vaccine has a 64% efficacy rate at preventing the more contagious South African variant, according to new report posted online by the Food and Drug Administration in the US on Wednesday.

The new report, prepared by the company, found its efficacy rate against the 501Y.V2 variant is seven percentage points higher than an earlier report released by the company. Johnson & Johnson previously said that the vaccine offers 57% protection against moderate to severe Covid-19 infections in South Africa.

Vaccine efficacy against severe Covid cases was 73%, 14 days after vaccination, increasing to 82% at least 28 days after vaccination.

There were no deaths due to Covid among South African trial participants who received the J&J vaccine. More than 5,000 South Africans took part in the J&J vaccine trial, of which around half received a placebo vaccine.

“These results suggest that the vaccine is efficacious against mortality associated with Covid-19,” the report found.

South Africa became the first country in the world to officially roll out the vaccine last Wednesday.

18 years since my last flu shot. Guess I’m a prime target for the first flu bug that wanders past… :smiley:

113,100,769 total cases
2,508,922 dead
88,722,431 recovered

In the US:

28,974,623 total cases
518,363 dead
19,340,329 recovered

Yesterday’s numbers for comparison:

This is the breaking news thread. I think the discussion of how to allocate limited available vaccine doses is very interesting, but it really belongs in its own thread, not here. Perhaps sometime could start that thread and link it. I can move some posts if requested.

(With apologies to @Colibri , but this thread IS moving fast.)

Thanks

So: about these COVID variants - we’re going to have to tweak existing vaccines in order to provide protection against them, right? But how do we test the revised vaccines for efficacy before they are made available?

The European Medicines Agency released a reflection paper [Link is to PDF] today - a reflection paper being pretty much what it says - the agency is sharing its thoughts with us; in due course, and taking account of comments from medical, industry and other experts, this will become a guideline which tells you what you have to do.

The (current) EMA position is that no large scale efficacy studies will be required; approval of the updated vaccine - presuming that it is formulated, manufactured, tested etc etc like the “parent” vaccine was - will be based on human immunogenicity studies. Basically, trial subjects get a shot of the vaccine, their immune response gets tested to show that the new vaccine does the same thing against the new strain, compared to old vaccine/old strain. The paper covers combi vaccines (old + new in a single shot) - the approach is similar but (obviously) a bit more complicated. Safety data for authorisation would come from the subjects included in these studies.

The FDA moved faster (I was a couple of days late getting to this) and have already revised existing guidance. As you would hope, they are thinking pretty much along the same lines as the EMA. Link to announcement (from which you can hunt down the guidance document, if you wish).

The updated guidance outlines the FDA’s scientific recommendations for modifications to authorized vaccines. For example, the FDA expects that manufacturing information will remain generally the same for an authorized vaccine and a modified vaccine candidate from the same manufacturer. For clinical data, the guidance recommends that a determination of effectiveness be supported by data from clinical immunogenicity studies, which would compare a recipient’s immune response to virus variants induced by the modified vaccine against the immune response to the authorized vaccine. Manufacturers are also encouraged to study the modified vaccine in both naïve (non-vaccinated) individuals and in individuals previously vaccinated with the authorized vaccine. Additionally, the guidance outlines the FDA’s recommendations for assessments of safety to support an EUA for a modified vaccine. Finally, the guidance states that further discussions will be necessary to decide whether in the future, modified COVID-19 vaccines may be authorized without the need for clinical studies.

Obviously this is just a very brief summary of the documents. If you have questions, I can try to field them, but I’m not an immunologist. @BippityBoppityBoo - you may be better than me in that area (it wouldn’t be difficult!).

j

I think you missed this modnote:

FWIW: the change in booster timing was discussed a fair bit in this older thread:

Thank you. I have just moved a bunch of posts there. Hopefully I didn’t mess up the flow of any of the conversations too badly.

(I’m also going to change the title of that thread.)