Brief Messages or Announcements – Page 44

The COVID-19 Delta Variant

I’m passing along the University of Iowa Hospitals & Clinics information about the Delta variant of COVID-19. If you’re vaccinated and you get infected with the Delta variant, you might feel like your symptoms are from allergies or a cold. If you’re not vaccinated, you’re a lot more likely to get sick enough to be hospitalized.

According to Dr. Claudia Corwin, MD, MPH, an occupational medicine specialist and associate director of the University Employee Health Clinic, about 97% of those with a severe case of Delta variant are unvaccinated. That doesn’t mean the vaccines make us bullet proof and breakthrough infections of the Delta variant occur.

That’s probably part of the reason why the Advisory Committee on Immunization Practices (ACIP) thinks vaccine booster shots might be better reserved for the most vulnerable patients, such as the very elderly, those in Long Term Care Facilities, and health professionals. The ACIP met yesterday and there was no firm decision about booster rollout specifics and there was no vote on the matter. They plan to meet again in mid-September to review the need for boosters.

Advisory Committee On Immunization Practices Meeting On Boosters Today

Judging from the slides in Dr. Sarah Oliver’s presentation, “Framework for booster doses of COVID-19 vaccines” in the ACIP meeting this afternoon, there is limited data to support COVID-19 vaccine boosters for the general population at this time. The target populations for boosters would be the residents of Long Term Care Facilities (LTCF), health professionals, and those over 65 and 75 years of age, although the goal of ensuring that as many unvaccinated individuals get vaccinated should be actively pursued. There will continue to be further meetings to discuss the role of boosters.

FDA Approves First COVID-19 Vaccine

Today the FDA approved the Pfizer COVID-19 vaccine (now marketed as Comirnaty). Excerpt of the media announcement below:

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” said Acting FDA Commissioner Janet Woodcock, M.D. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

COVID-19 Boosters for The Immunocompromised: University of Iowa Hospitals & Clinics

Information from The University of Iowa Hospitals & Clinics on COVID-19 vaccine boosters for the immunocompromised is here.

Advisory Committee on Immunization Practices Meeting on Boosters

There is a meeting of the Advisory Committee on Immunization Practices (ACIP) scheduled for August 30, 2021 to discuss COVID-19 vaccine boosters. It looks like it was originally scheduled for August 24, 2021 but was rescheduled. This link to the Federal Register announcement identifies the matters to be considered (booster doses) of the meeting although the date for the meeting had not been updated at the time I wrote this post. Further ACIP meeting information is here.

COVID-19 Vaccine Booster Doses May Be available September: Joint Statement from HHS PUblic Health & Medical Experts

The CDC and FDA released a Joint Statement today indicating COVID-19 vaccine booster doses for all Americans possibly beginning as soon as September 2021. An excerpt is below:

“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.”

CDC Publishes Data Prompting the Mask Guideline change

Today the CDC posted the data supporting the change in the mask guidelines for the fully vaccinated. It’s in the July 30, 2021 Morbidity and Mortality Weekly Report (MMWR) describing the outbreak of several hundred new cases of the Delta variant COVID-19 infection in Barnstable County, Massachusetts following July 4th events. Those who were fully vaccinated shed virus as much as the unvaccinated.

Organizers of the Iowa State Fair and those planning to attend, take note.

Brown CM, Vostok J, Johnson H, et al. Outbreak of SARS-CoV-2 Infections, Including COVID-19 Vaccine Breakthrough Infections, Associated with Large Public Gatherings — Barnstable County, Massachusetts, July 2021. MMWR Morb Mortal Wkly Rep. ePub: 30 July 2021. DOI: http://dx.doi.org/10.15585/mmwr.mm7031e2external icon.

Update on Advisory Committee On Immunization Practices Meeting July 22, 2021

Presentation slides for the ACIP meeting today are available here. Updates to clinical communication indicate that, while patients with a history of Guillain-Barre Syndrome (GBS) are eligible for any of the authorized vaccines, they should discuss with their clinical teams the availability of mRNA vaccines given the association of GBS with the J&J vaccine.

For the summary of the issues regarding giving booster vaccine doses to immunocompromised patients, see data from slide 15 onwards.

Advisory Committee On Immunization Practices Meeting July 22, 2021

The Advisory Committee on Immunization Practices (ACIP) will meet with the CDC July 22, 2021 to discuss COVID-19 vaccine boosters for immunocompromised individuals and the association of the J&J vaccine with Guillain-Barre Syndrome. See the draft agenda here.

New FDA Warning Regarding association of Guillain-Barre Syndrome with J&J Covid-19 Vaccine

On July 13, 2021, the FDA issued a revision to the J&J COVID-19 vaccine fact sheets regarding the increased risk of Guillain-Barre Syndrome (GBS) with the vaccine. According to the announcement, the benefits still outweigh the risks for getting the vaccine and so far no causal association has been found. GBS is rare and has been associated with other vaccines, including the flu vaccine. GBS has not been associated with the mRNA vaccines, so far.