FDA updated their guidance offered to healthca... - CLL Support

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FDA updated their guidance offered to healthcare providers concerning Evusheld

bkoffman profile image
bkoffmanCLL CURE Hero
9 Replies

Hi, 

On October 3, 2022, the FDA updated their guidance offered to healthcare providers concerning Evusheld, the only authorized Pre-Exposure Prophylaxis (PrEP) monoclonal antibody used to prevent the development of severe COVID-19 disease in those who are immunocompromised.

The updated Evusheld Fact Sheet indicates that Evusheld DOES remain effective against BA.5, which is the dominant circulating COVID-19 variant in the US right now that accounts for over 80% of cases.However, the slowly growing variant known as BA.4.6 currently makes up 12.8% of cases in the US, and Evusheld does NOT retain neutralizing activity against BA.4.6. 

Read more about the updated guidance here and our perspective on this inevitable development: cllsociety.org/.../update-t... 

Stay strong. 

We are all in this together.  

Brian Koffman MDCM (retired) MS EdCo-Founder,

 Executive VP and Chief Medical Officer CLL Society, Inc 

cllsociety.org 

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bkoffman
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9 Replies
OmBewok profile image
OmBewok

Thanks so much for this post. Having recently had Evusheld while under treatment with Venetoclax and Obinutuzumab (in Australia) I have been delighted to feel a bit more able to get "out and about" to socialise after many cautious months of relative self-isolation.

I was wondering if anyone in the community might know how significant the BA.4.6 variant is in Australia?

regards,

Om

CLLerinOz profile image
CLLerinOzAdministrator in reply toOmBewok

It's hard to get information about cases and variants these days. An article, written in July, about the arrival of variant BA.2.75 in Australia, noted that "tracking and analysing newer variants was becoming more difficult, meaning there is less available information on BA.2.75. Dr Van Kerkhove [WHO COVID-19 technical lead] said data from around the world identifying such characteristics is becoming increasingly limited."

sbs.com.au/news/article/the...

However, this variant tracker shows that in Australia at the end of September 2022, about 5% of cases were BA.4.6, with a relative growth advantage per week of about 7%.

3.4% were other BA.4 variants, 7.5% were BA.2.75 (relative growth advantage per week of 42%) and 82% were BA.5 (relative growth advantage per week of 44%).

cov-spectrum.org/explore/Au...

When you open the link above, you should see a list of variants to the left of your screen (on a desktop or laptop computer). If you click on a variant that interests you, you can get state-by-state prevalence data for that particular variant. For example, at present, if you choose BA.5.2.1, you can see 6.9% prevalence in Victoria and 23.3% in Tasmania.

The site isn't easy to use but it is possible to set all sorts of different parameters, including different countries to find data relevant to particular locations. (To do that, use the drop-down box that appears at the very top of the screen when you open the link above.)

OmBewok profile image
OmBewok in reply toCLLerinOz

Thanks for that information. For a non-scientist it's a difficult situation to get one's head around!! But I am glad that I've been able to get Evusheld to at least give me a greater sense of 'normality' in facing up to the ever-present risk of COVID.

regards, Om

Thanks for the update Brian.

Ibru profile image
Ibru

Thank you for this very important information.

CLLBGone profile image
CLLBGone

Great information.

Quick question:

Does Paxlovid work and kill off BA4.6?

bennevisplace profile image
bennevisplace in reply toCLLBGone

I have read nothing to the contrary. It has been highly effective against all major variants to date.

CLLBGone profile image
CLLBGone in reply tobennevisplace

Excellent ..... I hope that remains true for the 4.6

Ginajetta profile image
Ginajetta

Thank you so much for all you do and for sharing important information.

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