U.S. will begin wide distribution of Covid booster shots next month, saying vaccine protection wanes over time - FDA/CDC/HHS statement - August 18, 2021

[Shiloh]

Source: https://www.cnbc.com/2021/08/18/covi...ext-month.html

U.S. will begin wide distribution of Covid booster shots next month, saying vaccine protection wanes over time
Published Wed, Aug 18 202110:30 AM EDTUpdated 34 Min Ago
Berkeley Lovelace Jr.

Key Points

U.S. agencies are preparing to offer booster shots to all eligible Americans beginning the week of Sept. 20.
It’s now “very clear” that immunity starts to fall after the initial two doses, top U.S. health officials said,

The United States will begin widely distributing Covid-19 booster shots next month as new data shows that vaccine protection wanes over time, top U.S. health officials announced Wednesday.

It’s now “very clear” that immunity starts to fall after the initial two doses, and with the dominance of the delta variant, “we are starting to see evidence of reduced protection against mild and moderate disease,” according to the statement signed by CDC Director Dr. Rochelle Walensky, acting FDA Commissioner Dr. Janet Woodcock, White House chief medical advisor Dr. Anthony Fauci and other U.S. health leaders.

“Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout.”...

[sharon sanders]

FDA NEWS RELEASE

Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

For Immediate Release:August 18, 2021


Today, public health and medical experts from the U.S. Department of Health and Human Services (HHS) released the following statement on the Administration’s plan for COVID-19 booster shots for the American people.

The statement is attributable to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC); Dr. Janet Woodcock, Acting Commissioner, Food and Drug Administration (FDA); Dr. Vivek Murthy, U.S. Surgeon General; Dr. Francis Collins, Director of the National Institutes of Health (NIH); Dr. Anthony Fauci, Chief Medical Advisor to President Joe Biden and Director of the National Institute of Allergy and Infectious Diseases (NIAID); Dr. Rachel Levine, Assistant Secretary for Health; Dr. David Kessler, Chief Science Officer for the COVID-19 Response; and Dr. Marcella Nunez-Smith, Chair of the COVID-19 Health Equity Task Force:

“The COVID-19 vaccines authorized in the United States continue to be remarkably effective in reducing risk of severe disease, hospitalization, and death, even against the widely circulating Delta variant. Recognizing that many vaccines are associated with a reduction in protection over time, and acknowledging that additional vaccine doses could be needed to provide long lasting protection, we have been analyzing the scientific data closely from the United States and around the world to understand how long this protection will last and how we might maximize this protection. The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time following the initial doses of vaccination, and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease. Based on our latest assessment, the current protection against severe disease, hospitalization, and death could diminish in the months ahead, especially among those who are at higher risk or were vaccinated during the earlier phases of the vaccination rollout. For that reason, we conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.

“We have developed a plan to begin offering these booster shots this fall subject to FDA conducting an independent evaluation and determination of the safety and effectiveness of a third dose of the Pfizer and Moderna mRNA vaccines and CDC’s Advisory Committee on Immunization Practices (ACIP) issuing booster dose recommendations based on a thorough review of the evidence. We are prepared to offer booster shots for all Americans beginning the week of September 20 and starting 8 months after an individual’s second dose. At that time, the individuals who were fully vaccinated earliest in the vaccination rollout, including many health care providers, nursing home residents, and other seniors, will likely be eligible for a booster. We would also begin efforts to deliver booster shots directly to residents of long-term care facilities at that time, given the distribution of vaccines to this population early in the vaccine rollout and the continued increased risk that COVID-19 poses to them.

“We also anticipate booster shots will likely be needed for people who received the Johnson & Johnson (J&J) vaccine. Administration of the J&J vaccine did not begin in the U.S. until March 2021, and we expect more data on J&J in the next few weeks. With those data in hand, we will keep the public informed with a timely plan for J&J booster shots as well.

“Our top priority remains staying ahead of the virus and protecting the American people from COVID-19 with safe, effective, and long-lasting vaccines especially in the context of a constantly changing virus and epidemiologic landscape. We will continue to follow the science on a daily basis, and we are prepared to modify this plan should new data emerge that requires it.

“We also want to emphasize the ongoing urgency of vaccinating the unvaccinated in the U.S. and around the world. Nearly all the cases of severe disease, hospitalization, and death continue to occur among those not yet vaccinated at all. We will continue to ramp up efforts to increase vaccinations here at home and to ensure people have accurate information about vaccines from trusted sources. We will also continue to expand our efforts to increase the supply of vaccines for other countries, building further on the more than 600 million doses we have already committed to donate globally.”

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Inquiries

Media: FDA Office of Media Affairs 301-796-4540

https://www.fda.gov/news-events/pres...-booster-shots

[Mary Wilson]

And, of course, this...more confusion...more contradiction

No need for COVID booster jabs for now - WHO

August 18, 202112:46 PM CDT Last Updated 4 hours ago

GENEVA, Aug 18 (Reuters) - Current data does not indicate that COVID-19 booster shots are needed, the World Health Organization (WHO) said on Wednesday, adding that the most vulnerable people worldwide should be fully vaccinated before high-income countries deploy a top-up.

The comments came just before the U.S. government said it planned to make the booster shots widely available to all Americans starting on Sept. 20 as infections from the Delta variant of the coronavirus rise.

... (WHO chief scientist Soumya Swaminathan) "We believe clearly that the data today does not indicate that boosters are needed."

https://www.reuters.com/business/healthcare-pharmaceuticals/no-need-covid-booster-jabs-now-vaccine-supplies-short-who-2021-08-18/

[gsgs]

So, USA is saying a 3rd shot is needed and WHO says it isn't.
van Kerkhove, Ryan, Tedros,Swaminathan
vs. Walensky,Woodcock,Murthy,Collins,Fauci,Levine,Kess ler,Nunez-Smith
Obviously (p=2e-4) some of these people are not saying, what they really think,
but rather what their employer wants them to say.
Why this WHO argument, a nation should rather donate the vaccine,
which it needs, since it can be much more helpful elsewhere.
It looks new to me.
How many saved 3rd world lifes should be worth one saved US-life for the US-government ?
Well, it comes to money anyway. The main US-debate is about economy vs. NPIs.
And more vaccine can just be produced, given money.
The timing is a problem, since delta is threatening, but still money buys warpspeed
as we learned last year.
And money buys 3rd world lifes at a lower price than US-lifes, we knew that since long
and WHO had no problem with it, AFAIR.
I assume WHO had already expected to get the spare US-doses from vaccination hesitancy
and they had already been in talks about it and now USA needs them for themselves
and WHO is disappointed. That would explain their reactions.

-------------------------------------------------------
But I'd be interested in the analysis : could we donate enough vaccine for the world ?
What would it cost, how long takes it ?
At least for the elderly and essential workers. Could be doable/reasonable.
It should be discussed, there should be papers ?!
But is it more important than the usual development-help or e.g. the projects
of the Gates Foundation ?
3.6M died in India's wave in Apr-May , I just read !

[Emily]

If the US federal and academic health leaders mentioned in the first post were concerned about citizens' lives, they would be recommending antibody assessments after vaccination of immune suppressed individuals, and they would be educating about monoclonal antibody treatments and perhaps other early interventions for at risk people. WHO may have no agenda other than scientific correctness in this case. Even a broken clock is right twice a day.

Are the vaccines really losing efficacy to a significant degree? Are we just seeing the results of a higher infection count and this is as good as it gets for the vaccines?

https://www.covid-datascience.com/po...are-vaccinated
Jeffrey Morris

• • 4 days ago
  • 10 min read

Israeli data: How can efficacy vs. severe disease be strong when 60% of hospitalized are vaccinated?
Updated: 19 hours ago

A surge involving the rapidly-transmitting Delta variant in heavily vaccinated countries has led to much hand-wringing that the vaccines are not effective against Delta, or vaccine efficacy wanes after 4-6 months. This has fueled anti-vaccine sentiment suggesting the vaccines are not working, and causing much stress in vaccinated people that they are not as protected as they thought they would be.

In this post, I will focus on vaccine efficacy vs. severe disease/hospitalization, which is the key factor for public health. I will not deal with vaccine efficacy vs. symptomatic or asymptomatic disease here -- that has its own set of nuances that I will save for a future post...