Author: Shelby

DID CDC MAKE THE RIGHT CALL?

The CDC released new guidance today for folks that are fully vaccinated with the basic message that if you’re fully vaccinated, you can basically get back to pre-pandemic behavior. Today’s guidance says that fully vaccinated people can resume activities without wearing a mask or even physically distancing including in local business and workplace guidance (like healthcare facilities and where local rules still require masks).

Is this the right call? I think it is.

The CDC waited to make this policy change until the data were clear about how protective the vaccines are in real life. Importantly, they also waited for a sufficient number of Americans to get vaccinated, ensuring that we won’t have another hospital capacity crisis or even a significant rise in infections.

Will some unvaccinated people claim that they have been vaccinated and go to public places without a mask? Sure they will. Will that kind of behavior create a dangerous environment? Not really, because:

• So many folks have now been vaccinated now (especially people over 65);

• We now know that the real-life efficacy of the dominant vaccines is as good or better than what was found in the clinical trials;

• We have evidence that persons that have been vaccinated are very unlikely to carry or shed the virus to others; and

• The vaccines are working on all known variants.

I’m hoping that we see a bump in the number of people that get vaccinated because of this announcement. While it’s true that many unvaccinated people will say they are vaccinated in order to not be judged for not wearing a mask in public, many won’t want to. Some folks that have been on the fence will see that vaccines have a tangible real-life benefit and decide to finally go ahead and get vaccinated.

Let’s hope that this added incentive to get vaccinated makes a difference and more people that have been delaying getting the vaccine decide to take the plunge. But even if they don’t, today’s new recommendations are evidence-based, make common sense, and reflect the diminished risk that the virus now poses in the U.S.

Editorial Note: It’s important that we use evidence to drive our decision-making (and avoid making recommendations out of ‘an abundance of caution’). It’s also important for us to weigh risks and benefits when making policy. When we make decisions that are overly restrictive, that aren’t based on evidence, that don’t consider real risks in a clear-eyed fashion, or that don’t consider both the risks and benefits we risk losing our credibility with the public (e.g. we get a reputation for saying that the sky is falling).

Our credibility as a profession is really important because people will only follow our public health recommendations if they view us as reasonable and evidence-based.

P.S. The persons that could potentially be harmed by the CDC’s change in policy are those folks that are immunocompromised. Folks with weakened immune systems may not form a robust immune response after being vaccinated, and will need to keep in mind that some persons that they will see in the community without masks may not be vaccinated.

P.S.S. This virus is still posing and will continue to pose a substantial public health risk in many developing countries for many months and perhaps years to come. Our commitment to COVAX (the international effort to get vaccine to developing nations) is critical- not just because it’s our ethical responsibility as a rich nation to help less wealthy countries acquire vaccine, but also to prevent the virus from boomeranging on us. The more opportunities this virus has to mutate (e.g. worldwide infections) the more likely it is that a new variant will evolve that’s resistant to immunity acquired from previous infections or vaccinations- potentially resulting in COVID-22.

Want to learn more about these recommendations? Read the CDC’s expanded Public Health Recommendations for Fully Vaccinated People.

POLICY AND OPERATIONAL ADJUSTMENTS NEEDED TO ACCOMMODATE ADOLESCENT ROLLOUT

The FDA just authorized the Pfizer vaccine for use in kids 12-15 years old.  Pfizer says in their press release (not via peer reviewed data) that their clinical trial (of 2,260 participants) showed that their vaccine was 100% effective in 12-15 year olds and had minimal side effects.

The CDC’s Advisory Committee on Immunization Practices is meeting Wednesday morning to decide whether to recommend the vaccine’s use in 12-to-15-year-olds (here’s the Agenda and webcast link). CDC Director Dr. Rochelle Walensky will decide whether the agency will recommend its use in the new age group. Most likely, the vaccine will be both authorized and recommended for 12-15 year olds by the end of the week.

There are some tricky things about the logistics of administering the Pfizer vaccine that will require the ADHS to make some adjustments in order to make it easy for adolescents 12-17 to get vaccinated in their medical home (the best place for them to be vaccinated).

For one thing, the Pfizer vaccine can only be held in a normal (-20C) freezer for 2 weeks. In order to store it longer than that, doctor’s offices need to have an expensive ultra-cold freezer (-70C).

Doctor’s offices can usually turn-around their vaccine inventory in 2 weeks but a single standard order of Pfizer vaccine contains about 1,170 doses, too much for a small pediatric office to administer over a 2 week period.

One work-around would be for the county/state health departments to “break down” the big Pfizer order into smaller packages so pediatric and family practices won’t need to commit to such a big order (Pfizer has said that by the end of May they will have smaller minimum order boxes, so that’ll help).

Another issue is that we’ll need more pediatric providers to be able to order the SARS CoV2 vaccine. Up until now, doctors offices need to go through a complex ADHS on-boarding process in order to be able to receive the COVID shot.

A good work-around for that is to allow all Vaccines for Children (VFC) providers to be auto-enrolled in the COVID vaccine program. Easy to do. Let’s hope ADHS is flexible enough to make that happen.

Note: Last week the ADHS finally began to allow doctors offices to order vaccine for their practice. The offer was made to providers that were already on-boarded using their process. Only 65 doctors actually ordered vaccine (see this Arizona Republic story).

ADHS needs to do a root-cause analysis to figure out why so few ordered vaccine last week. Is it the cumbersome ordering process? Poor communication? Unreasonable reporting requirements? A combination? Only by figuring out way last week’s effort failed will they be able to make the policy and operational changes to fix this big problem.

In other news, Pfizer submitted their application for full approval (licensure) of their mRNA vaccine last week. The application review will likely take several weeks. Full approval would provide more assurance to some people that are still holding out that the vaccine is safe.

Dr. Gerald just released his latest epidemiology and hospital capacity report. Below is a summary but as always we encourage you to explore the full report for details.

• Covid-19 cases and hospitalizations are little changed over the past two weeks. We can expect similar levels of viral transmission for the next 4 – 6 weeks before rates begin to substantially improve.

• Overall, cases are being diagnosed at a rate of 68 per 100K residents per week- in-between the moderate and substantial spread categories.  Case rates will likely remain “stuck” at around the 50 cases per 100K residents per week for the next 4 – 6 weeks owing to more transmissible variants (e.g., B.1.1.7) and continued normalization of behaviors.

• Test positivity for traditional nasopharyngeal PCR testing is holding steady at 10%.

• Hospital Covid-19 occupancy is slowly increasing in the ward and ICU. Access to care remains somewhat restricted as overall occupancy remains unseasonably high (85%) while the backlog of medically necessary non-Covid procedures is being addressed.

• Arizona continues to slip relative to other states when it comes to the percentage of our population that is vaccinated. Arizona now ranks 40th in vaccines administered per capita.

Note: This is the next-to-last regularly scheduled update. Barring unforeseen circumstances, the last report will be published on May 21, 2021. If you have found this report valuable and would like to send a note of appreciation, please e-mail my Department Chair, Dr. Kelly Reynolds at reynolds@arizona.edu

 UPDATED ASU MODELING TEAM REPORT

The ASU COVID-19 Modeling Group recently updated their model (April 29, 2021) to incorporate vaccination efficacy and increasing prevalence of the B117 variant. This model is based on their prior work charting the course of the COVID-19 outbreak using a traditional SEIR epidemiological model.

To incorporate the impact of vaccines, the model accounts for a differential effectiveness attributable to the first and second dose, 50% and 95% respectively. Vaccination data are derived from the ADHS dashboard at the state-level and does not account for differential rates or outcomes by age.

The model assumes a single homogenous risk pool throughout the state. Furthermore, their model assumes a B117 variant dominance by the end of May with its associated 60% increase in transmission. No changes due to increased behavioral interactions are modeled.

Figure 3A in the report shows their best-case scenario (gold line) where COVID-19 vaccinations continue at a pace of 50,000 vaccinations per day. Under this scenario, case rates will peak and then begin to decline towards the end of May. Clearly, there is little-to-no risk of a no summer resurgence.

Under their worst-case scenario (blue line) where no new vaccinations are initiated after April 28th , case rates will slowly trend upwards and remain in the substantial category (50 – 100 cases per 100K residents per week) through much of the summer.

However, even under this pessimistic scenario, there is little-to-no risk of a summer resurgence on par with June 2020. Altogether, this is really good news.