Editor's note: This is the second in a series on Oregon’s COVID-19 vaccination plans, digging into the Oregon Healthy Authority's 125 page draft plan on vaccinations.

Today, the Advisory Committee for Immunization Practices of the CDC met to vote on adding the not-yet-approved COVID-19 vaccine to the recommended schedule of vaccines.

All but one voting members of the ACIP voted to add it to the schedule with this language:

When a COVID-19 vaccine is authorized by FDA and recommended by ACIP, vaccination in the initial phase of the COVID-19 vaccination program (Phase 1a) should be offered to both 1) health care personnel and 2) residents of long-term care facilities.

As previously reported on in our first installment of the COVID-19 vaccine issue, the US has implemented fast tracked mass vaccination programs twice. Once, with polio in 1954-1955 that was abandoned with the Cutter Incident causing polio paralysis and the 1976 Swine flu vaccine program that caused GBS paralysis. The cart-before-the-horse meeting felt rushed and questions by the panel as well as public comment was kept short. The compressed timeline means there is no long term follow up prior to administering millions of vaccine doses. The ACIP panel stated they will not approve and recommend the vaccine unless it is safe. That is why they are asking for everyone in the community to report adverse events in the early phases and the importance of this data. They are calling on the whole community to ensure safety of the COVID-19 vaccines. Oregon healthcare workers need to be prepared and trained on effective adverse event reporting on a regular basis. The last time the state of Oregon investigated and reported on adverse events, was in 2009.

Public health officials discussed the challenge of implementation plans of those who would be first in line to get the jab. They have a partnership with two pharmacies to attend long term care homes first to vaccinate both the staff and residents on three occasions to administer two doses of the vaccine. Things to keep in mind is that all COVID-19 vaccine trial info forthcoming has reported as having high side effects and Dr. Fryhoffer of the ACIP has recommended letting individuals know that getting the COVID-19 will “not be a walk in the park.” Some unblinded trial participants have suggested taking a few days off for the COVID-19-like symptoms of illness it produces. Due to that fact, the CDC suggests considering staggering personnel getting the vaccine as well as to have time away from clinical care because they could experience systemic symptoms post-vaccination. A panel member agreed, “It could wipe out that unit for 1-3 days. It could have quite a few of those people out of work.”

"Reactogenicity" refers to the property of a vaccine of being able to produce common, "expected" adverse reactions, especially excessive immunological responses and associated signs and symptoms, including fever and sore arm at injection site. There is no reactogenicity data in Long term care facility residents. The trials were only conducted with prescreened healthy individuals. Pfizer only used 94 participants for interim analysis. You can see the data on the Informed Consent Action Network website.

It's not clear if those who have contracted the COVID-19 symptoms previously will need to stay masked up or get vaccinated, nor any policies on exemptions for religious or medical reasons, though consent or assent will be obtained. The following were discussed.

• 5-10 Million doses are expected to be administered each week following approval and after the initial 40 million doses is given.
• They are not recommending prior testing to see if you already had COVID-19 before getting vaccinated.
• Dr. Sanchez, panel member suggested lactating women should get the COVID-19 vaccine.
• If jurisdictions place their orders, 20 million people will be vaccinated by end of December.
• There is also a new adverse even reporting system with the CDC called v-safe that will be tied into the existing Vaccine Adverse Event Reporting System or VAERS. This requires registration but will collect data on day zero for 12 months. If you choose to get the vaccine and experience an adverse reaction you can also report it on the Informed Consent Action Network website.

The ACIP voted to recommend the vaccine should Phase 3 clinical trials show safety and success and approval by the FDA. The FDA meets December 8-10 to discuss Emergency Use authorization of three who have submitted application.

Regardless of how people feel about getting the vaccine, this will mean we can all go back to normal and ditch the masks and grocery store directional stickers, right? Not so fast! We were told by the CDC’s committee that masks and social distancing will still be necessary for a long while. Some Oregon legislators have also said it will be many more months before we can go back to normal. It has already been a long nine months.

Photo by Ani Kolleshi on Unsplash.com


--Nicole DeGraff

Post Date: 2020-12-01 18:43:09

Last Update: 2020-12-01 19:05:58