A guide to Fall vaccine options - USA by Your Local Epidemiologist

[lankisterguy]

A guide to Fall vaccine options - by KATELYN JETELINA AND CAITLIN RIVERS AUG 17

yourlocalepidemiologist.sub...

It’s the first time we have vaccines for all three fall respiratory viruses that hospitalize and kill hundreds of thousands annually. This is a big deal, that is, if we utilize them. So, we thought collecting information about them in one place would be helpful. This is the what, who, and when for each.

At the bottom, we include a one-page PDF summary. (Many physician offices and health departments have previously found it helpful to print these.)

Seasonal influenza (flu)

What: The vaccine covers four strains of seasonal flu offered by four pharmaceutical companies. Selecting vaccine strains for rapidly changing viruses, like flu and COVID-19, is both an art and a science, so the vaccine formula doesn’t always align perfectly with the circulating virus. We are optimistic that this year’s is a good match because the vaccine composition matches flu strains that recently circulated in Australia (which is a good predictor of the upcoming Northern Hemisphere season). During the years when the vaccine does match, it can reduce the risk of needing to go to the doctor by 40% to 60%.

Who: Everyone ages 6 months and older. There are special formulations to provide added protection to older adults. Children should get two shots during their first flu season.

When: Protection wanes throughout a season. For most people, October is the best time to get vaccinated so that you’re fully protected before a flu wave. The complete list of timing recommendations for specific populations (pregnant people, older adults, young children) is available here.

COVID-19 vaccine

What: The fall Covid-19 vaccine has an updated formula targeting XBB.1.5, which should be a good match to the currently circulating Omicron subvariant. Moderna, Pfizer, and Novavax all plan to have boosters on the market this fall.

Who: We don’t know yet but should know in mid-to-late September. Why the delay? The CDC only determines who is eligible after the FDA fully approves the vaccine. The FDA can only fully approve it once the pharma companies submit data showing the vaccines are safe after manufacturing. We are waiting for this process to play out.

Last year, though, eligibility was dependent on the manufacturer, and it will likely be the same this year:

• Moderna: 6 months and older

• Pfizer: 6 months and older

• Novavax: 18 years and older

When: Guidance will be provided by the CDC soon. (Hopefully, they will guide recently infected people, too.) For protection against severe disease, you can get the vaccine when it becomes available because this kind of protection lasts longer. For protection against infection, though, keep in mind that protection wanes in a few months, so it’s best to get vaccinated right before a wave. Of course, this can be challenging to time.

More info: To understand why we need an updated vaccine and what clinical trials found, go to this previous YLE post.

RSV vaccine for older adults

What: For the first time, an RSV vaccine is available and from two manufacturers— GSK and Pfizer. Both effectively protect against severe illness, with 82-86% efficacy. The two vaccines are slightly different in design, but only at a microscopic level. And side effects like fever and body aches are uncommon.

Who: People ages 60 and older “may” get the vaccine in the U.S. In the U.K., those over 75 years “should” get the vaccine. People with underlying health conditions (like heart or lung disease or diabetes) and those living in long-term care facilities should strongly consider the vaccine.

When: They are available now. RSV vaccines do not wane as quickly as flu and COVID-19 vaccines, so getting one now should protect you throughout the entire season (and maybe even next season).

More info: For a breakdown of the clinical trial findings, go to this previous YLE post.

RSV vaccine for pregnancy

What: Pfizer is actively pursuing approvals for an RSV vaccine given to pregnant people. The protection will pass from mother to baby so that the baby is protected in the first 6 months of life, which is the riskiest time for severe RSV. Clinical trials showed 82% efficacy in preventing hospitalization during the first 3 months of life, and 69% efficacy at 6 months.

Who: If approved, the vaccine would be given between 24 to 36 weeks of pregnancy.

When: This vaccine is not yet available. It is still going through review by the FDA and CDC. We may have a decision this month. If so, it may become available this fall, but the timing is uncertain.

RSV medication for infants

What: AstraZeneca has a new monoclonal antibody called Beyfortus, which protects against severe RSV in infants. This is not a vaccine (i.e., doesn’t teach the body to make antibodies) but rather a medication (it provides antibodies). In clinical trials, it reduced the risk of hospitalization and healthcare visits by ~80%.

Who: All infants under 8 months should get it for their first RSV season. High-risk children between 8 months to 19 months should also get it. High-risk categories include:

• Chronic lung disease of prematurity

• Severe immunocompromise

• Cystic fibrosis

• American Indian and Alaska Native children

When: Beyfortus is not available yet, but the manufacturer has committed to making it available for this RSV season. The protection lasts about 4-6 months, so get this as soon as it’s available.

Bottom line

Get protected! It is one of the best things you can do this fall and winter to stay healthy and minimize disruption.

Love, YLE and CR

P.S. We know many people have many questions. Please comment or send them to us, as we plan on following up with a FAQ. And, of course, it’s always a good idea to consult with your pharmacy or clinician.

P.S.S. Below is a PDF version (English and Spanish) of the summary for paid subscribers. Feel free to download, print, share, or doodle on. ...

Subscribe to Your Local Epidemiologist to read the rest.

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[ClassyLady3]

do you know if shots like a new type of Evusheld will be used this fall for immune compromised individuals?

[lankisterguy Volunteer in reply to ClassyLady3]

Hi ClassyLady3,

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I recall seeing that a 2nd generation of Evusheld was in development. See

astrazeneca-us.com/media/st...

cbsnews.com/news/new-covid-...

AstraZeneca says new COVID drug could guard against all variants of concern to date

BY ALEXANDER TIN -APRIL 28, 2023 / 11:07 AM / CBS NEWS

A replacement for a key COVID-19 antibody drug that has been used to protect immunocompromised Americans could be available within months, executives for drugmaker AstraZeneca said Thursday, after promising early results suggested it may work against "all known variants of concern" to date.

The company's new experimental drug, currently named AZD3152, is being tested in a trial dubbed "Supernova" with the hope of preventing symptomatic infection in people with weakened immune systems. Results from that study are on track to be out by September, an AstraZeneca spokesperson confirmed to CBS News.

That could tee up a potential emergency use authorization from the Food and Drug Administration to make the drug available by the end of the year, when another fall and winter resurgence of COVID-19 is expected.

The company has already announced early promising data from lab research of the drug, testing it against current and previous strains of SARS-CoV-2.

"In vitro studies demonstrated that AZD3152 neutralizes all COVID-19 variants, including Arcturus, the latest variant of concern," AstraZeneca's Mene Pangalos told investors on an earnings call this week.

AstraZeneca says the drug could benefit some 2% of the population who cannot mount an effective immune response from COVID-19 vaccines.

"We hope to make AZD3152 available as a new prophylactic treatment in the second half of this year," said Pangalos.

"A matter of some urgency"

Federal officials have been voicing concern over the gap in options for immunocompromised Americans, even as the emergency phase of the pandemic subsides.

An onslaught of immune-evasive Omicron variants over the past year has in part limited the options for treatment and prevention of Covid-19 for these more vulnerable patients.

AZD3152 relies on some of the same technologies that undergirded its predecessor Evusheld, which had also been authorized with the hope of shielding immunocompromised Americans from infection.

The FDA effectively pulled that prophylactic drug's emergency use authorization in January, citing the growing prevalence of variants that it would not work against.

AstraZeneca says its new AZD3152 drug is based on a different antibody – derived from donated B cells of people who have recovered from infections – and it is "designed to have broader variant coverage" than Evusheld for six months.

Immunocompromised patients who do end up getting infected can be treated with COVID-19 antiviral drugs, like Pfizer's Paxlovid or Gilead's Veklury treatments. However, these drugs can sometimes lead to the virus only being suppressed – but not eliminated – in immunocompromised patients.

"There are successors to the monoclonals that are in the process of being updated so that they will get the next generation of variants. And I expect, again, we'll hear more about those in the coming few months," the FDA's Peter Marks said last month at a webinar hosted by the National Foundation for Infectious Diseases.

Other options that might benefit people with weakened immune systems, like GSK's monoclonal antibody treatment sotrovimab, have also been thwarted by new Omicron strains.

"Obviously, there is a matter of some urgency there because, for immunocompromised individuals, it would be nice to have something," said Marks.

The Biden administration has blamed a lack of funding from Congress for hobbling production of new antibody drugs for COVID-19, though a new infusion of some federal funding is now planned.

"I think we've been very clear that we're running out of COVID dollars. We have indicated that over and over again, but we didn't have the winter surge we expected, and we had additional funds," Assistant Secretary for Preparedness and Response Dawn O'Connell told a House hearing last week.

Federal officials recently announced they had been able to free up $5 billion for a "Project NextGen" effort to subsidize new vaccines and antibody drugs.

"We think creating the next generation of tools to protect Americans from COVID is a reasonable use of these next dollars," said O'Connell.

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Len

[CLLerinOz Administrator Volunteer in reply to ClassyLady3]

With a bit of luck, the results from the Phase 3 trial of AZD3152, nicknamed 'Evusheld 2.0' by some, will be available in September and then it will be up to countries to decide if they will approve and fund it.

There was some additional discussion here about it a few days ago: healthunlocked.com/cllsuppo....

CLLerinOz

[lankisterguy Volunteer]

I went to CVS this morning and got my RSV vaccine (GSK AREXVY VIAL KIT) and they offered me the seasonal Flu (FLUZONE HIGH-DOSE QUAD 2023-24), even though it is not yet publicized widely. These were both available on request, no prescription and fully covered by Medicare with no copay.

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When I scheduled the Flu online, the CVS software offered a Hep B vaccine, but the Pharmacists advised that Medicare would not cover it, and the CVS charge was $178. she suggested that I get my CLL expert doctor to prescribe and administer it, so it would be covered by Medicare Part B.

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Len

[jijic in reply to lankisterguy]

That’s really good to know. I live abroad and don’t have US insurance and can share that the flu vaccine is free usually and the COVID one is $25..

[Mprm]

Thank you for sharing this— very helpful in sorting out these important immunizations.