| COVID-19 Alaska Clinical Update|
Monday, December 21, 2020
42,413 COVID-19 cases total in AK residents, with 917 cumulative hospitalizations and 183 deaths. Cases continue to rise across the state, but acceleration has slowed and shown signs of reversing in recent weeks.
The first doses of the Pfizer COVID-19 mRNA vaccine arrived in Alaska last week.
The FDA issued an emergency use authorization for Pfizer’s mRNA vaccine just over one week ago. The EUA authorizes the vaccine for use in individuals age 16 and older. Dosing is two doses 3 weeks apart. The EUA requires Pfizer to report every month on safety, including by age groups and by special populations such as pregnant women, and on any adverse events. Vaccination providers must report any administration errors, serious adverse events, cases of multisystem inflammatory syndrome in children and adults who have received the vaccine, and cases of COVID-19 that result in hospitalization or death in people who have received the vaccine. Reporting is via phone or online to the Vaccine Adverse Event Reporting System (VAERS).
The FDA’s recommendation is based on their analysis of the raw data from Pfizer trials, which they published in an extensive document. ASTHO’s summary of that document includes:
Safety and Side Effects
The study demonstrates the vaccine was safe and well-tolerated in participants ≥16 years of age. Reactogenicity and adverse events were generally milder and less frequent in older participants (≥56 years of age) compared with the younger group (≤55 years of age). Reactogenicity was considered mostly mild to moderate and short-lived, and the adverse events profile did not suggest any serious safety concerns. There is a significant occurrence of side effects, including injection site reactions (84.1%), fatigue (62.9%), headache (55.1%), muscle pain (38.3%), chills (31.9%), joint pain (23.6%), and fever (14.2%). Median onset of symptoms is 0-2 days after vaccination and duration was 1-2 days. There were four cases of Bell’s palsy in the vaccine group, which is not outside the parameters of the general population, but is something to watch. A total of six people died during the study period: four in the placebo and two in the vaccination group (heart attack and arteriosclerosis). All deaths were determined not to be vaccine/study related. Pregnant and breastfeeding women were not included in the study.
Study results show the vaccine provided protection against COVID-19 in participants who had no evidence of prior infection, with more severe cases observed in the placebo group. The vaccine was >90% effective in preventing confirmed COVID-19 occurring at least seven days after the second dose. The vaccine shows some protection after the first dose, but the study does not validate that it can be administered as one dose. There is a slight decrease in vaccine efficacy in older populations, but not a significant change. The vaccine is effective across gender, race and ethnicity demographics, and persons with comorbidities. However, there were not enough racial minorities enrolled in the study to make specific statements about the vaccine effectiveness broken down by race/ethnicity. There is limited data surrounding the vaccine efficacy against asymptomatic disease and transmission.
An analysis of Pfizer’s Phase 2/3 trial was published last week in the NEJM, with similar conclusions as to safety and efficacy.
The FDA issued an EUA for a similar mRNA vaccine made by Moderna late last week; shipment of the Moderna vaccine is expected to begin shortly.
Vaccines and allergic reactions
After vaccination started in the UK, two anaphylactoid reactions were reported in heathcare workers who had histories of anaphylaxis to other allergens. CDC addressed this in
their clinical considerations for use of the Pfizer vaccine with the following table:
If you watch one thing about vaccines, try EMRAP’s Deeper Dive into COVID-19, a 23 minute videocast with accurate, concise, specific information about mRNA vaccines. The host interviews Dr. Barker of This Week in Virology, a podcast where experts discuss COVID-19, virology and, recently, paper virus snowflake patterns to augment holiday decorations.
New and upcoming from DHSS
Alaska COVID-19 testing guidelines have been updated to include the new quarantine options of 7 days with a negative test or 10 days without a test. A table on page 2 outlines the new options. Antigen testing guidance is also updated.
A clinical practice guideline from ACOG and a statement from SMFM address whether pregnant and lactating people should receive the vaccine, noting that while the vaccine was not tested in these populations, it is expected to benefit and there are not specific theoretical risks to a pregnancy, fetus or breastfeeding baby. Live virus vaccines are not recommended in pregnancy because of a risk of viral reactivation if transmitted to the fetus; mRNA vaccines do not contain a live virus. Both ACOG and SMFM recommend offering the vaccine to pregnant and lactating people if they are otherwise eligible, as does the CDC, and recommend encouraging patients to have a risk-benefit discussion with their physician prior to vaccination.
The Vaccine ECHO is a chance to discuss and learn more about COVID-19 vaccines and the Alaska vaccination campaign, held each Thursday 2-3 PM.
Please help contact tracers by including full patient address and phone numbers in the patient contact section when you request COVID-19 testing at the Alaska State Public Health Lab. ASPHL now allows these to be routed directly to COVID-19 response partners. The updated form is here: http://dhss.alaska.gov/dph/Labs/Documents/SARS-CoV-2RequestForm.pdf
New from CDC
Updated clinical guidance for management of COVID-19
Expanded quarantine guidelines to include option of 10 day quarantine or testing out of quarantine after 7 days, and a scientific brief explaining the reasoning for this change
CDC vaccine communication toolkit and key messages for patients about mRNA vaccines
VSAFE: to use the free national reminder and safety test messaging system, anyone can text ENROLL to 1-833-VAX-TEXT when they get their vaccine and get text reminders about the second dose as well as texts asking about any side effects. Vaccine recipients can also go to the website provided on the information they get at the time of vaccination.
AK Clinical Reminders COVID-19 testing guidelines and test site locator
Report any positive test to the state Section of Epidemiology using the COVID Reporting Hotline at 1-877-469-8067 or by faxing in the Infectious Disease report form. If you suspect COVID-19 in an outpatient who cannot isolate in their own home (for example they are unsheltered or from out of town) or for another urgent situation call SOE at 907-269-8000 or 800-478-0084 (after-hours). Join us for the ECHO series for more information and discussion:
Use the links below to register beforehand for the online meeting
COVID-19 for Alaska Healthcare Providers: Every other Tuesday, 7-8:30PM
Science ECHO for the general public: Wednesdays, 12-1PM
Healthcare Specific COVID-19 Situational Awareness: Thursdays, 12-1PM
School Health ECHO: Mondays 3-4PM
Alaska Perinatal ECHO: Thursday, 6-7PM
Palliative Care in COVID-19 ECHO: Wednesday, 12-1PM
EMS ECHO: 2nd & 4th Friday, 10-11AM
Vaccine ECHO:Thursday, 2-3 PM
AK COVID-19 clinical hotline for physicians: 833-751-4212. Staffed 24/7.
8PM-8AM is for urgent/emergent questions only.
AK Responders Relief Line: 24/7 behavioral health for everyone working in healthcare
during the COVID-19 pandemic: 1-844-985-8275