COVID-19 – Page 11 – Pediatric Infection Connection

History Repeats Itself 2

Bud WiedermannJuly 18, 20212 Comments

The "Pandemic of the Unvaccinated"

Dr. Walensky's sound bite this past week quickly became the standard catch phrase in the media, and it isn't misleading. Our current COVID-19 infection rate is in the same (but slightly lower) ballpark as last summer, but what isn't in the same ballpark are numbers of hospitalizations, ICU admissions, and deaths, at least not yet. The main difference between this summer and last is the target population: now we are seeing the pandemic being driven by younger (unvaccinated) individuals who are less at risk for the more severe outcomes of COVID-19 infections. Clearly vaccines work, and we now have real-world evidence that demonstrates this. We are still in a race between variants and reaching herd immunity, and each one of those newly-infected individuals might be the one to develop and spread a more troublesome variant that not only has increased infectivity but also increased severity and/or ability to evade vaccine protection.

As a slight aside, yesterday (July 17) I tuned into a regular CDC/IDSA COVID-19 Clinician Call, and this one I thought was particularly useful with explanation of immunity from natural infection versus vaccines and a summary of COVID-19 antibody testing. The key take-home for antibody testing is that it should not be used to infer immunity following vaccination. These tests were only designed to predict likelihood that an individual was previously infected and says nothing about degree of protection. Just say no if a patient requests an antibody test to determine if they are immune. The recording from the July 17 session should be available within a few days.

Ready for Monkey Pox?

Also in the category of history repeating itself, we learned this past week about an individual with monkey pox in Texas, likely picked up in Nigeria. We see sporadic cases of monkey pox in the US, it isn't unexpected. Do you know what to look for to spot a case?

First of all, in spite of the name, don't ask about monkey exposure. Most humans acquire monkey pox from other animal reservoirs, principally rodents, in endemic areas. These areas include Central and West Africa. It can be a difficult diagnosis before the rash appears; the prodrome is nonspecific and consists of fever, malaise, headache, and myalgias. After the 1-3 day prodrome, the rash appears initially as macules and then progresses to papules, vesicles, and pustules. It is very similar to smallpox in that lesions tend to distribute more peripherally. Transmission from infected individuals to other humans most commonly is via droplet spread and likely requires prolonged close contact. Skin lesions themselves also are contagious. Travel history is the key, be sure to ask about that for anyone with a nonspecific febrile illness. Incubation period is about 5-13 days, easily long enough to allow for international travel before symptoms begin.

Myocarditis Concerns, and Delta Marches On 2

Bud WiedermannJune 27, 20212 Comments

Better Data on Risks of Myocarditis and Pericarditis from COVID-19 Vaccines

The ACIP/CDC held their meeting, postponed from June 18 due to the new federal Juneteenth holiday, on June 24. It was worth the wait, and fortunately I was able to attend the meeting online. You can see all of the presentation slides on their website, in particular I'd recommend the risk-benefit discussion by Drs. Wallace and Oliver. I had 2 major take-aways from the approximately 5-hour presentation.

First, as more time and cases have accumulated, the link between vaccines and myocarditis/pericarditis in adolescents and young adults (primarily male) seems much more convincing. The timing after the second dose, the striking age distribution, and the mostly mild clinical features strongly suggest a link even though the rates are very rare. It is worth mentioning this potential risk to people considering vaccination, though in these same demographic groups the risk of adverse sequelae from COVID-19 disease itself is much higher. Also note that this association was seen with both of the mRNA vaccines, Pfizer and Moderna, but I don't think we have enough information yet to know if this will occur with other COVID-19 vaccines. The mechanism of injury is still unknown and is the subject of much research.

Second, recognize that the only reason this was brought to light so quickly is that we have very massive and effective surveillance of adverse events with these vaccines. Please encourage all of your patients to sign up for V-safe when they are vaccinated, and everyone should report any suspected vaccine adverse events to the VAERS system.

Delta Variant is a Real Problem Everywhere

Evidence continues to mount that the SARS-CoV-2 delta variant is a major problem worldwide. It is unquestionably more easily transmissible than other variants by a long shot. Both mRNA vaccines seem to provide very good protection against severe disease caused by the delta variant, though preliminary data suggests that a single dose, rather than the recommended 2 doses, is not very protective. The jury is still out about whether delta causes more severe disease than other variants, but clearly this is the strain responsible for the vast majority of hospitalizations in developed countries, primarily impacting children and young adults who represent a disproportionate number of unvaccinated individuals. It likely will be the dominant strain in the US in a matter of weeks. Please encourage everyone to be vaccinated.

Somewhat more in the rumor category, a "delta-plus" variant has cropped up in the lay press. It is a strain that carries an additional mutation, K417N, that was known to be present in the beta variant and has been associated with poor response to treatment with monoclonal antibody preparations. We still need more information about this new sub-lineage strain to know its clinical significance.

Coming Up For Air

Bud WiedermannJune 20, 2021Leave a comment

Well, vaccines are starting to turn the tide and even the cicadas are retreating now. I'm hoping to recommit to Pediatric Infection Connection this summer and try to post weekly commentary that will be at bit more concise than my traditional rambling style. I will try to limit myself to just 2 topics a week, but starting off I'm already breaking that pledge with 3 topics.

1. A Conflict of Interest

For the first time in maybe a couple decades, I need to declare a conflict of interest up front. I am overseeing the Pfizer COVID-19 vaccine trial at Children's National Hospital for children 6 months through 11 years of age. While I don't think this will color any of my commentary here, implicit bias has been recognized as a confounder in scientific and Evidence Based Medicine circles for many years. I will do my best to recognize that and be objective.

2. Keeping Straight with SARS-CoV-2 Variants

In case you hadn't noticed, the terminology for variants has changed yet again, I think for the better but also adding to the public confusion. The purpose is laudable: eliminating the possibly pejorative naming of variants by site of first detection and also doing away with confusing codes. I'm very much in favor of getting rid of the geographic references to outbreak agents. Some of you know that the 1918 H1N1 influenza A pandemic was also known as the Spanish Flu, but in fact the evidence would suggest that a better name is the Kansas flu. Such nomenclature opens the door to discriminatory practices.

Now we are just using Greek letters for SARS-CoV-2 variants, though I fear we will run out very soon! The CDC has a summary of these.

I want to focus on the delta variant which has been the focus of much attention in the lay press. This variant is officially a "variant of concern" and is very much worthy of concern. I don't think it is oversimplifying to focus principally on 3 features of variants. First is transmissibility, or how easily the variant can spread in a population. As the pandemic has evolved, probably the most accurate early sign of transmissibility is how quickly a new strain becomes predominant in a population. The delta variant is striking in its spread, now the most common variant in the UK and soon to achieve that status in the US. It is clearly more contagious than the original strain and early variants.

The second feature is virulence, or whether the variant causes higher rates of severe disease and death. In my opinion, the jury is still out on this for the delta variant. Certainly we have seen appalling severity of disease with this variant in India, but I cannot sort out from the reports how much of this could be due to properties of the virus itself versus healthcare access and other issues.

The third, and perhaps most fearsome to those residing in highly-vaccinated communities, is whether the variant is able to evade host immunity and cause a higher rate of infection in those who have immunity from either natural infection from another SARS-CoV-2 strain or from immunization. In this regard, the delta variant clearly can evade immunity to some extent. Thankfully full vaccination seems to protect from severe disease, but partial vaccination is much less effective. It really causes concern for all those people who skipped the second dose of the Pfizer or Moderna vaccines.

Also remember that every person who is infected with SARS-CoV-2 represents a new opportunity for new variants to appear.

Myocarditis and COVID-19 Vaccines

We must be certain that these new vaccines are safe, and in particular that the risk/benefit ratio is favorable. This is especially important for children where, although severe COVID-19 and MIS-C cases occur, the rates are much lower for complications than for adults.

The CDC had planned an update on myocarditis cases associated with COVID-19 disease for June 18, but this was postponed for a week due to the new Juneteenth national holiday. Now it is to be incorporated into the regular meeting of the ACIP scheduled for June 23-25.

However, based on the data that have been released so far, it does seem increasingly plausible that one or more of the COVID-19 vaccines can cause myocarditis. They are still so rare that it is difficult to be certain that it is happening above the expected rate of myocarditis from other causes in the population. It is unlikely to be anywhere near as common as the rates of myocarditis from natural SARS-CoV-2 infection and thus at this time suggests a clear benefit from vaccination. If you're interested, check out a nice study of COVID-19 myocarditis in Big 10 conference athletes.

Stay safe and enjoy the summer!

Another Week of Vaccine News 2

Bud WiedermannDecember 20, 20202 Comments

It's been another whiplash week in covid-land, with crushing numbers of hospitalizations and deaths juxtaposed against the first vaccine administrations to healthcare providers and a second vaccine granted Emergency Use Authorization by the FDA followed by a positive vote from the ACIP/CDC. Presumably we will see the Moderna vaccine shipped this week, along with ongoing distribution of the Pfizer vaccine. I won't spend any time detailing the basics of the Moderna vaccine; it is an mRNA vaccine very similar to the Pfizer vaccine and much detail is available at FDA and CDC websites. However, I did want to mention a few nuances.

First, evidence to date is insufficient to compare safety and efficacy of the two vaccines. The study findings were very similar, and given the minor differences in study design it would be improper to consider any head-to-head comparison at this time. Eventually we should know about any significant differences such as duration of immunity.

Note that a good deal of the discussion at the FDA/VRBPAC meeting concerned how to continue the ongoing Pfizer and Moderna trials: ethics and practical considerations of how to manage the placebo recipients in those trials who do have the ability to drop out of further follow up in the trials as well as seek their own antibody testing and immunization. The logistics of continuing a double-blinded crossover design trial (placebo recipients receive vaccine, vaccine recipients receive placebo) are large. Many have advocated continuing with an open-label trial where placebo recipients receive vaccine but agree to continue in some modified follow up within their study.

A few more details about side effects have emerged. As in the Pfizer study, a few people developed Bell's palsy in the Moderna trial, too few to determine if this is above expected rates in the general population or greater in vaccine versus placebo recipients. Also, as in the Pfizer trial a handful of women were pregnant in both groups. These pregnancies are being followed by study investigators.

Of interest are a few cases of facial swelling following vaccine, all in individuals who underwent cosmetic injections in lips and similar areas. Apparently this has been reported with other vaccines such as flu vaccine, as well as with natural viral infections. It appeared these reactions resolved with no permanent sequelae but again are being watched.

In the meantime, a few more healthcare providers have developed anaphylactic-like reactions that may be tied to the Pfizer vaccine, even though this wasn't seen in the clinical trials. Note that a far greater number of people have received vaccine in the past week, over 500,000 in the US, than received vaccine in the trials. Rare events sometimes are noted after approval of any drug or vaccine due to larger numbers of people receiving the product.

I'm hoping I will be called to receive my COVID-19 vaccine soon, but regardless of vaccine status remember we all must continue safe public health practices and promote them to our patients.

Update on Pfizer COVID-19 Vaccine

Bud WiedermannDecember 12, 2020Leave a comment

I wanted to give a quick update and some suggestions about the now-authorized vaccine. Unless you've been carefully avoiding all media notices, you know that the FDA published their Emergency Use Authorization for this vaccine late on December 11. I had attended the Advisory Committee on Immunization Practices (ACIP) meeting earlier that day, and because of the EUA coming through they moved their scheduled Sunday meeting to today (December 12) at 11 AM, which I also attended. The ACIP and CDC did comment about many of the special considerations (e.g. pregnant and breastfeeding women, immunocompromised individuals); ultimately the recommendations passed unanimously.

Many details will be evolving in terms of guidance, etc, but I did want to give front-line providers some useful links to peruse in the meantime.

First, all of the slide presentations for the 2 ACIP meetings are posted. I'd particularly recommend the session on Clinical Considerations from December 12, but recognize much is changing with guidance for certain situations including allergies and pregnancy.

Another extremely important resource is the Vaccination Communication Toolkit. This also is still an evolving resource, but I'd strongly recommend all providers start to become familiar with these tools. Know that educational videos for vaccine storage, administration, etc are in the works, as are fact sheets for the general public in several languages.

Next Steps? At this point, don't worry about your specific role in this entire process, except in helping your patients and families realize that the vaccine was approved after a very transparent and extensive review of data and that they will be notified when they or family members are eligible to receive vaccine based on the pre-established allocation plan. Vaccine is in very limited supply now, so very few individuals will be vaccinated next week.

Some of the public may be concerned about the rapidity with which this vaccine was studied and authorized, not to mention concerns with possible undue political pressures. I am completely satisfied that FDA and ACIP/CDC have been very thoughtful and transparent in all their proceedings. From my point of view there is only 1 difference for this vaccine's approval compared to other vaccines approved under "normal" circumstances, and that is the duration of immunity. We will know the answer to that question relatively soon, but I don't find anything about safety or efficacy that has been short-circuited by the EUA process.

Probably every day the next week we'll see new materials and information made available. Next Thursday the FDA will again meet, this time regarding EUA for the Moderna vaccine. ACIP/CDC has planned the same Friday and Saturday or Sunday discussion schedule if this vaccine moves forward from FDA.

Also, you might be interested in upcoming Clinician Outreach and Communication (COCA) call entitled "What Every Clinician Should Know about COVID Vaccine Safety."

Be Well and Stay Safe!

Tag: COVID-19