COVID-19 Alaska Clinical Update
Wednesday, December 23

Alaska cases

There have been 43,001 COVID-19 cases total in AK residents, with 930 cumulative hospitalizations and 193 deaths. Cases continue to rise across the state, but growth has reversed over the past two weeks. Daily test positivity has also nearly halved since its peak in mid-November, from 9.2% to 4.7%, so the decrease in newly reported cases is thought to likely reflect a true decline in daily new cases in Alaska.  

Vaccine news

Having received an Emergency Use Authorization, the first doses of the Moderna COVID-19 mRNA vaccine are expected to arrive in Alaska this week.

Vaccination of Phase 1a, Tier 1&2 (frontline inpatient healthcare workers, EMS, CHAPs, and long-term care facility residents across all regions of Alaska) continues. The Alaska Allocation Committee, following ACIP recommendations, voted to allocate Tier 3 doses to workers in health care settings at highest risk of contracting COVID-19 who are essential to the health care infrastructure and who regularly provide health care services that cannot be postponed or provided remotely.

ACIP met last weekend to determine that Phase 1b will include frontline essential workers and persons aged 75 years and older. Phase 1c will include persons aged 65–74 years, persons aged 16–64 with high-risk medical conditions, and other essential workers. For more information on the status of the vaccination effort in Alaska, please see the DHSS vaccine home page. To provide comments on Phase 1b of the Alaska vaccine allocation process for the Monday, December 28 public meeting at 4PM, submit written comments ahead of time or sign up on the list to provide live comments during the meeting.

Similarities between the Moderna and Pfizer mRNA vaccines against COVID-19:

• Mechanism of action: Both vaccines administer mRNA that codes for the spike protein of SARS-CoV-2. The vaccines are designed to give cells the blueprints to briefly make spike proteins for the immune system to recognize. No DNA is involved and the mRNA does not enter the nucleus. No virus is involved.
• Ingredients: Both vaccines contain mRNA, salts, sugars, buffers and a lipid layer. Both vaccines’ lipid layers contain polyethylene glycol, or PEG, a substance used in many other common medications such as Miralax. The lipid layers are a little different in each vaccine in terms of chemical structure. Neither vaccine contains preservatives or adjuvants. Neither vaccine contains latex.
• Contraindications: A history of severe allergic reaction (e.g., anaphylaxis) to any vaccine component is a contraindication to vaccination. A risk assessment should be conducted for anyone who has a history of anaphylaxis to any other vaccine or injectable therapy; these people may still receive vaccination but should be counseled about the unknown risks of developing a severe allergic reaction and balance these risks against the benefits of vaccination. Vaccine sites must be prepared to recognize and manage anaphylaxis with immediate IM epinephrine.
• Not all patients with anaphylaxis have skin reactions
• Symptoms are considered generalized if there are generalized hives and/or more than one body system is involved (any respiratory symptom including throat closing, stridor, shortness of breath, wheeze cough; any GI symptom including nausea, vomiting, abdominal pain, diarrhea; any cardiovascular symptom including tachycardia, dizziness, fainting, hypotension; any skin symptom including generalized hives, itching, swelling of lips/face/throat).
• Any generalized symptom should prompt epinephrine administration and emergency medical services
• If a patient develops itching and swelling confined to the injection site, they should be observed longer for development of generalized symptoms
• Early symptoms of anaphylaxis can resemble a mild allergic reaction
• Efficacy: Both vaccines are highly effective (94-95%) in preventing symptomatic COVID-19. Both vaccines also look like they are effective at preventing severe COVID-19 even in the small number of people who get COVID-19 after getting the vaccination. We do not know yet exactly how well they prevent asymptomatic COVID-19 or the ability to transmit SARS-CoV-2. We do not have good data on the efficacy of a single dose so patients should plan on getting both doses.
• Safety: Both Phase 3 trials had a low number of serious adverse events and deaths; these were balanced between the placebo and vaccine arms. Slightly more cases of Bell’s palsy were seen in both vaccine arms, but not more than the expected number given the number of participants.
• People with current SARS-CoV-2 infection or who are on quarantine for being a close contact should postpone vaccination until after they are off of quarantine or isolation to avoid exposing others.
• A history of an autoimmune condition, Bell’s palsy or Guillain-Barre syndrome is not a contraindication to vaccination.
• Pregnant and lactating people were not included in either study. CDC notes pregnant and lactating people may choose to be vaccinated if they are part of a group recommended to receive a vaccine (for example, healthcare workers). A conversation with their doctor may help, but is not required, and the CDC website notes that ‘based on current knowledge, experts believe that mRNA vaccines are unlikely to pose a risk to the pregnant person or the fetus’. By December 18, 2020, more than 500 people vaccinated in the US were pregnant at the time of vaccination.
• There is no evidence of effects on fertility.
• Of note, these vaccines are not contraindicated for people who have food, pet, insect, venom, environmental, latex or other allergies not related to vaccines or injectable therapies. If someone has had anaphylaxis to something other than a vaccine or injectable therapy in the past, they should be watched for 30 minutes after receiving the vaccine. Everyone else should be watched for 15 minutes after receiving the vaccine. 
• A waiting period of 14 days before and after a mRNA COVID-19 vaccine is recommended before receiving other vaccines, however if inadvertently administered, doses do not need to be repeated.
• Please encourage vaccine recipients to enroll in V-SAFE after their vaccination.
• Reactogenicity: Many participants in trials experienced mild to moderate symptoms after receiving the vaccine such as injection site reactions, fatigue, headache, muscle pain, chills, joint pain and fever. 80-89% of vaccinated persons have at least one local symptom and 55-83% have at least one systemic symptom following vaccination. For both vaccines, these are self-resolving within 1-3 days. In both trials, younger people and people getting their second shot were more likely to have these expected immune responses. This type of reactogenicity, or expected immune response, is not an allergic or other vaccine reaction and should not prevent anyone from getting a second shot. The CDC does not recommend taking acetaminophen or an NSAID beforehand to prevent these symptoms, but does recommend taking an appropriate medication for symptoms if they occur. In both trials, around 20% of vaccine recipients (and around 10% of placebo recipients) took acetaminophen after their second shot. CDC published guidelines for healthcare workers who have post-vaccine symptoms discussing when it might be appropriate to continue to work, when to rest, and when a SARS-CoV-2 test is needed.
• Hypersensitivity-related events in clinical trials: Both vaccine Phase 3 trials reported more hypersensitivity-related adverse events in the vaccine arms of the study than the placebo arms: 0.63% in Pfizer recipients (vs 0.51% placebo) and 1.5% Moderna recipients (vs 1.1% placebo). Anaphylaxis was not seen in either trial.
• Recommendations after getting vaccinated: Vaccinated persons should continue to follow all current guidance to protect themselves and others, including masking, distancing, avoiding crowds, avoiding gatherings, etc. Data are limited on whether either vaccine prevents asymptomatic disease or transmission. Receipt of either mRNA vaccines will not affect results of PCR/molecular or antigen tests.

Differences between Moderna and Pfizer mRNA vaccines:

• Storage and handling: Moderna can be stored at refrigerated temperatures for 30 days instead of 5 days. Both vaccines have different handling requirements, please see Moderna and Pfizer-specific information.
• Administration: Moderna shots are given 28 days apart. Pfizer shots are given 21 days apart. They are not interchangeable.
• Eligibility: Moderna shots are authorized for age 18 and up. Pfizer is authorized for age 16 and up. This is because 16 and 17 year olds were included in Phase 3 trial data reviewed by the FDA for Pfizer, while Moderna only recently started enrolling teenagers.
• Doses in vials: FDA has approved the use of additional Pfizer COVID vaccine doses within each vial. Per the AK Vaccine Team: Partial remaining doses cannot be combined.  The amount of vaccine you are able to pull from the vial is dependent on the needle size.  If you can guarantee that the needle size you use for the first doses will be the same needle size for the follow up second doses then you should be able to pull the same amount of vaccine out of each vial. We can’t guarantee that the needle sizes in the ancillary kits will be the same, so you need to be able to guarantee this from your own supply of needles.  Hubless, small needles used with small syringes are getting more out of each vial than needles with hubs, big needles and big syringes. We will provide additional clarification as we receive it.

New and upcoming from DHSS

COVID-19 vaccine tracker: Now with more than 7000 Alaskans vaccinated! The most up-to-date vaccine count is available here.

The Vaccine ECHO is a chance to discuss and learn more about COVID-19 vaccines and the Alaska vaccination campaign. Although normally held each Thursday 2–3 PM, the 12/24 and 12/31 Vaccine ECHOs are rescheduled to Wednesday, December 23 and Wednesday, December 30 at 2PM (same link). Recordings are available afterwards.

An Alaska Epidemiology Bulletin released this week on self-harm and unintentional drug overdose during the COVID-19 pandemic found that while suicide death rates remained largely consistent during the first three quarters of 2018–2020, overdose death rates were higher in 2020 than 2018 or 2019.

More from CDC

Any vaccine reaction or other unexpected event must be reported to VAERS. This includes anaphylaxis, minor allergic reaction, other symptoms, and other occurrences after getting the vaccine whether they seem related or not. Clinicians should file a VAERS report as soon as possible after learning of the adverse event.

After a reaction, once the patient is stabilized, please try to collect one or both of the following two blood tests within 30-90 minutes after the reaction starts: tryptase (released from mast cells during anaphylaxis) and SC5b-9 (terminal complement complex). These can help us characterize a reaction after the fact and can assist with investigation of vaccine reactions.

New strain in the UK: CDC notes a variant of SARS-CoV-2 has been found widely in London and the surrounding area. It has not yet been identified in the US. This variant may spread more quickly, although does not seem to make people sicker than other variants.

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.

Other resources

AlaskaHousingRelief.org now hosts a clearinghouse of rent and mortgage relief programs in the state of Alaska.

COVID-19 Frequently Asked Questions (FAQs) on Medicare Fee-for-Service (FFS) Billing  includes information on hospital outpatient billing of EUA products. See page 121 (question #6). CMS also published a centralized toolkit for clinicians and partners on the COVID-19 vaccine, billing, administration and patient information.