“Shared expectations lead to predictability.”
161. Mixed messages over upcoming vaccinations.
Q: Why are there so many contradictory news reports about vaccination availability?
A: There is confusion and conflicting expectations over the imminent distribution of COVID-19 vaccines. For example: When can we get it? Who will get theirs before it’s my turn? Where will it be given? As the title of this ongoing column suggests, this unpredictability is the result of expectations not being shared – by and between the government, the pharmaceutical companies, and scientists (the epidemiologists). The primary cause for this lack of shared expectations is the continuing absence of a national coordination program since the disease emerged as a pandemic ten months ago.
For the vaccines now being readied for distribution, this lack of central coordination has created uncertainty. The messaging on each vaccine product has been left to the different pharmaceutical companies. Their focus is on their individual products through press releases. The necessary public education on the role of vaccinations in public health has remained absent. The planning for distribution and providing vaccinations have been left to the states. Yet the CDC is responsible for setting guidance for the states to follow – which has just now been updated. The unique logistics required for each vaccine including storage, transportation, multiple dosages required, etc. will be formally established as the vaccines are individually authorized. The states have assumed the manufacturers’ proposals will be adopted by the FDA, but if the federal authorizations change any of these recommendations, the states will have to rapidly modify their plans.
- Differences between vaccinations with the Pfizer and Moderna products
Q: Once they are distributed, will the two proposed vaccines be managed the same way?
A: What we know now is the Pfizer vaccine product will be scientifically reviewed prior to authorization on December 10. Moderna’s review will be on December 17, a week later.
- Pfizer’s proposal is that this vaccine must be administered in 2 doses, the second being given 21 days after the first.
- Moderna’s vaccine is also proposed to be given in 2 doses, the second 28 days after the first.
To demonstrate the considerations (and costs) to deploy these vaccines, Connecticut, as with all the states, must plan for and put in place the mechanisms for transporting and storing the vaccines at very super-low temperatures once arriving at designated sites from the manufacturer:
- Pfizer recommends its vaccine must be stored at – 90o F before being thawed before use. It can be stored in a regular refrigerator for only 10 hours.
- Moderna recommends its vaccine be stored at – 4o F before thawing. It can be stored in a refrigerator for up to 30 days.
Storage at super-cold temperatures may require specialized freezers that cost $10,000 each. These can each hold 30,000 doses. Portable freezers cost $8,000 each and can store 12,000 doses. Portable freezers can be deployed in mobile units that move from site to site. The costs for this are not provided by the federal government, and lack of state funding could seriously impede the timely vaccination of the public.
To implement the priorities for vaccination of groups. the CDC has identified broad outlines as new doses are being produced over time. But then the CDC has asked each state to set their own priorities. The complete federal guidelines have only partially been defined for the first priority groupings, and as a result, each state is waiting for further guidance before their plans are finalized. This “work in progress” approach has led to confusion when adjacent states are setting different schedules from their neighbors, and overlapping news media appear to be stating different, often contradictory decisions.
- Connecticut’s “draft state distribution plan” for vaccinations
Q: Is there a state plan for when vaccines are scheduled to arrive as they are continually being manufactured?
A: Connecticut recently submitted to the CDC a 77 page “draft state distribution plan”: for COVID-19 vaccines. This plan is really a discussion guideline to develop an ongoing flexible plan, working into the future as new information requires attention to the new issues that lie just ahead. This “plan” identifies the initial doses of vaccine that are expected very soon.
- If the FDA grants emergency use authorization (EUA) for Pfizer after a December 10 review, and Moderna after its review a week later, the following medications will be shipped to Connecticut.
- By December 14 31,000 doses from Pfizer will be received in CT.
- By December 21 61,000 doses from Moderna will be received.
- By January 4, 2021 31,000 doses will arrive.
- By January 25 212,000 doses are expected
- This will allow 167,500 people to become vaccinated (2 doses each) into February, 2021.
- Initial priority of groups to be vaccinated
Q: How long do I wait before it’s my turn to be vaccinated?
A: The first priority group to receive the vaccine is identified as “1a” and includes:
- Healthcare Workers:
- 204,000 staff in hospitals, nursing homes, and in other clinical settings;
- 22,000 nursing home residents
- 6,000 first responders
This first priority (1a) group totals 232,000 people (464,000 doses.)
The second priority group “1b” will start in “Mid-January, 2021”, and includes:
- People 65 and older
- People in congregate settings – prisons, jails, group homes
- “High-risk” people under age 65
- “Critical Workers”
- Teachers,
- Child care employees
- Correction staff,
- Public transit workers,
The number of people in these group is not yet identified.
The third priority group will start in “early June 2021” and includes:
- Children and teens,
- Others under age 65
- “the rest of the population”.
The best way to anticipate when an individual might become eligible to be vaccinated would be to remain vigilant to the changing timelines in the daft state plan. Unanticipated resources and demands can and will alter this current preliminary time line:
- Group 1a – starting in late December,
- Groups 1a continuing and 1b starting after “mid-January”
- Groups 1a, 1b continuing, and “remaining populations starting after “early June.”
- Special considerations affecting future vaccinations
Q: What other factors are there that will affect future vaccinations?
A: Several considerations have been identified as this process is advancing:
- A major issue anticipated is the “anti-vax” movement. Many people will not take the vaccine when it is available – they either want to wait to be see if it is safe, they are against all vaccinations, or they believe COVID-19 is a hoax. It will take greater than 70% of the population to be immunized before community spread can be halted. Immunity is assumed to be two weeks after the second dose is taken.
- If the effectiveness of the first two vaccines is as high as 95%, as many as 500 of every 10,000 vaccinated people will not gain immunity. Everyone should continue to wear a mask when outside, keep socially distant, and maintain hand hygiene.
- Clinical studies will be done to determine the appropriate dosing for children. This will lead to formal approval not currently in place to vaccinate people under age 18.
- Data from the original Phase 3 clinical trials will be retrospectively studied to identify women who did not know or who later became pregnant. This could then lead to formal approval to vaccinate pregnant women.
- Additional vaccines by different manufacturers will become approved over time. CDC advises each of us to not “overthink” in deciding which one is best. Take the one that is available when your turn comes up.
- The first dose may cause soreness or mild side effects. It is important not to become discouraged – immunity will not come until about two weeks after the second dose is taken. Get that second shot!
- On Sunday, December 6, Moncef Slaoui, chief advisor to the U.S. government’s Operation Warp Speed initiative stated “the US plan relies on the state health agencies to deliver the vaccine. “I think that plans are out there,” he said, “things are well planned.” He intends to meet with Biden’s team this week. Stand by…!
