Thursday, October 15, 2020

CDC: 10 Things Healthcare Professionals Need to Know about U.S. COVID-19 Vaccination Plans

HHS Sample Framework For Vaccine Distribution 


Given the increasing evidence that SARS-CoV-2 infection leaves behind limited, and potentially short-lived immunity (see EID Journal: Waning Antibody Response In Asymptomatic and Symptomatic SARS-CoV-2 Infection), our best hope for curbing - and eventually ending - our COVID-19 pandemic lies in the creation and deployment of a safe, effective, and long-lasting vaccine. 

Of course, that's a tall order, since previous attempts to create a coronavirus vaccine for SARS and MERS-CoV have been unsuccessful.

Assuming that a safe and effective vaccine can be developed, the logistics of getting it into the arms of billions of people (who will likely require two doses, 28 days apart) is enormous.  

During the 2009 pandemic, there were optimistic estimates that nearly 5 billion doses of the H1N1 vaccine could be produced in the first 12 months (see Recommendations of the Strategic Advisory Group of Experts (SAGE) on Influenza A (H1N1) vaccines.)

In the end those manufacturing goals fell short by 75% (see 2010's ECDC: Global Vaccine Goals And Realities), as the yield from the seed virus proved less than anticipated and the use of adjuvants – to reduce the amount of antigen needed per shot – was met with public resistance.


While the public has been repeatedly assured there should be a vaccine by the end of the year - or by early spring (see `Forward Looking' & `Aspirational' Vaccine Press Releases- left out (or glossed over) has been the reality that in the opening months, vaccine quantities will be limited and some groups (i.e. children, pregnant women) may not be offered the vaccine at all. 

As the anticipated arrival of a vaccine grows nearer, the CDC has released a 10-point COVID-19 Vaccine reality-check for physicians, who will likely have a lot of patients clamoring for information about the availability of the vaccine. 

Updated Oct. 14, 2020
In the United States, there is currently no authorized or approved vaccine to prevent coronavirus disease 2019 (COVID-19). Operation Warp Speed  has been working since the pandemic started to make a COVID-19 vaccine(s) available as soon as possible. CDC is focused on vaccine planning, working closely with health departments and partners to get ready for when a vaccine(s) is available. CDC does not have a role in developing COVID-19 vaccines.

With the possibility of one or more COVID-19 vaccines becoming available before the end of the year, here are 10 things healthcare professionals need to know about where those plans currently stand.
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Many COVID-19 vaccine candidates are in development, and clinical trials are being conducted simultaneously with large-scale manufacturing. It is not known which vaccines will be authorized or approved—CDC is planning for many possibilities.

CDC is working with partners at all levels, including healthcare associations, on flexible COVID-19 vaccination programs that can accommodate different vaccines and multiple scenarios. CDC is in contact with your state public health department and immunization program manager, and we will continue to stay in contact throughout this entire process.
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The safety of COVID-19 vaccines is a top priority.

The current vaccine safety system is strong and robust, with the capacity to effectively monitor COVID-19 vaccine safety. Existing data systems have validated analytic methods that can rapidly detect statistical signals for possible vaccine safety problems. These systems are being scaled up to fully meet the needs of the nation. Additional systems and data sources are also being developed to further enhance safety monitoring capabilities. CDC is committed to ensuring that COVID-19 vaccines are safe. Learn more about how CDC works to ensure the safety of vaccines in the United States.

As a patient’s most trusted source of information about vaccines, you will play a critical role in helping build confidence in COVID-19 vaccination.

As you talk with patients, acknowledge the disruption COVID-19 has had on all our lives. This allows you to establish common concerns that can be addressed by vaccination. It’s understandable that patients will have questions and CDC is developing resources to help you address these concerns.
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At least at first, COVID-19 vaccines may be used under an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

Learn more about FDA’s Emergency Use Authorization authority  and watch a video on what an EUA is.

Once FDA authorizes or approves use of COVID-19 vaccine(s), limited quantities will become available very quickly because of advance planning by the U.S. government and other entities.

Typically, it can take months for a vaccine to become available after it receives FDA authorization or approval, but in the case of COVID-19 vaccine(s), it could be a matter of days. CDC is already planning, in collaboration with many partners, for delivering vaccines. With funding from the federal government, manufacturing capacity for selected vaccine candidates is being advanced while they are still in development rather than waiting to scale up after approval or authorization.
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Limited COVID-19 vaccine doses may be available this year, but supply will increase substantially in 2021.

The goal is for everyone to be able to easily get a COVID-19 vaccine as soon as large quantities are available. The federal government began investing in select vaccine manufacturers to help them increase their ability to quickly make and distribute a large amount of COVID-19 vaccine.
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If there is limited supply, some groups may be recommended to get a COVID-19 vaccine first.

Experts are working on figuring out how to give these limited vaccines in a fair, ethical, and transparent way. The National Academies of Sciences, Engineering, and Medicine (NASEM) gave input  to the Advisory Committee on Immunization Practices (ACIP). ACIP will issue recommendations to CDC once a vaccine(s) is authorized or approved for use.
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All interested vaccination providers may not receive vaccines immediately.

If there is a limited supply of COVID-19 vaccines, doses will likely be distributed to providers that serve groups identified to get vaccinated first. There will be an application and onboarding process for those interested in providing COVID-19 vaccines. There are specific logistical requirements, including requirements for vaccine storage and handling, product tracking, administration, and reporting. It will be important to work with your state and local health department to get the latest information on vaccine distribution and availability in your community.
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At first, COVID-19 vaccines may not be authorized, approved, or recommended for children.

Only non-pregnant adults participated in early clinical trials  for various COVID-19 vaccines. However, clinical trials continue to expand who is recruited to participate. The groups recommended to receive the vaccines could change in the future.

COVID-19 vaccine planning is being updated as new information becomes available.

CDC will continue to update this website as plans develop.


For some past blogs on pandemic vaccine creation, manufacturing, and deployment you may wish to revisit: