We are all painfully aware by now that the current generation of COVID vaccines are largely failing to prevent recurrent infections. Any extra protection from boosters, following three initial doses, is partial at best, and fades quickly in a matter of weeks. Although three doses of the Moderna or Pfizer vaccine continue to provide much needed protection from severe disease against the newer Omicron variants, there are some Inconvenient Facts we all should take note of. There continues to be completely uncontrolled transmission of the SARS2-Cov19 virus around the US and the world. While cases have been decreasing in New York and the Northeast, where the current surge began, the virus is increasing rapidly in areas of the south and west. Waste water data from northern California shows some of the highest levels of virus recorded since the Pandemic started. And while accurate new case counts are a thing of the past, new daily hospitalizations have continued a steady increase for several months, currently reaching 5000/day. As a consequence, there are now about 30,000 persons hospitalized, with daily deaths slowly increasing as predicted. The current rate of 300+ deaths per day, which has been sustained for months now, equates to a yearly total of 109,000, more than double the number of people who die every year in auto crashes, or from colon cancer. It’s right in line with the number of Americans dying from overdoses, mostly attributable to the fentanyl that is flooding across our southern border. As an Infectious Disease doctor I have to admit that it’s easy to loose sight of the fact that all epidemics are not caused by tiny bundles of nucleic acids wrapped in protein. One can argue the issue of whether the Pandemic was man made, but the fentanyl epidemic is Homo sapiens at its finest.
We have entered a phase of the Pandemic where most of us have been vaccinated, and or infected. Recent data, discussed in my last post, shows quite clearly that natural immunity is the equal of vaccine induced immunity in the Sons of Omicron era. We once were presented with a picture of herd immunity that was billed as the end of the Pandemic. I would argue that here in the US, we have basically achieved herd immunity right now, but because of a poor understanding of this virus from the beginning, the reality is not what we hoped for. Who is getting particularly sick, hospitalized or dying at the present time? It is a mix of vaccinated and unvaccinated folks, some of whom have been previously infected. The biggest risk factors right now are age over 65-70, a compromised immune system that prevents your body from responding appropriately to the vaccines, and being unvaccinated without prior history of infection. Three doses of RNA vaccine still offer significantly increased protection from severe disease with the current variants, compared to the initially approved two doses, but unfortunately uptake of the third dose has been low in the US, around 34%. If you are over 65 and haven’t received a single booster dose, it clearly ups your risk that you might contribute to the ranks of the hospitalized or deceased.
There were important developments in the vaccine sphere this week. Following the FDA and CDC approval of COVID vaccines in the youngest age group, initial uptake was extremely slow. The CDC reported only 1200 shots administered in the first two days, compared to hundreds of thousands of shots when the vaccines were released for teenagers. So far, fewer than 30% of children in the 5-11 yo group have received two shots since this was approved on October 29 of last year. Perhaps as a society we have passed the point of demonizing people who choose not to take the vaccine; otherwise, it looks like the cadre of the morally superior will be have to be affronted by the vast majority of parents of young children. Perhaps we will also see an end to the official and media drumbeat that parents are not vaccinating their children solely because they are being inundated by disinformation (not that plenty of this doesn’t exist), and an acknowledgement that just maybe intelligent, well informed people, with the data in hand, are reaching a different conclusion than the pharmaco-government complex.
I had provided data previously (April 2) regarding the risk of severe SARS2-Cov19 infection in this youngest age group, as well as a discussion of the risk of the most significant side effect, myo-pericarditis. A little further information is available currently. As previously noted, the recognized risk of myocarditis in the young has consistently risen over time with increased numbers vaccinated, and heightened awareness by physicians. An Invited Commentary in JAMA Networks June 24, by Eric Weintraub, et al. JAMA Netw Open. 2022;5(6):e2218512. doi:10.1001/jamanetworkopen.2022.18512
reviews recently reported findings of a large population based study from Canada looking at vaccine complications in the 12 yo and older group. As noted in prior studies, the highest risk of vaccine induced myocarditis was in the 18-24 yo age group and following the second dose. What has added to our understanding here is the finding that the risk of this complication was almost 6 times higher when the second dose of vaccine was Moderna versus Pfizer. (Please reference the original paper by Buchanan, et al. JAMA Network Open, June 24th for the observed second dose risks of 300/million with Moderna, and 59.2/million for Pfizer). Also important is the finding that the rates of this side effect were only one fifth as likely when the interval between the first and second shot was 56 days or greater compared to 30 days or less. We have had the data for quite a while that increasing the interval between first and second shots from the originally trialed 3-4 weeks to 8-12 weeks, increases the levels of neutralizing antibodies and the duration of protection. While we have no information on what the incidence of myocarditis will be in the youngest children just green-lighted for vaccination, the implications of this large scale study in a population similar to the US seems obvious to me. If you deem that your child needs vaccination, this information could form a valuable point for discussion with your pediatrician. We are no longer in the hyperacute phase of the Pandemic and more than 75% of children have already been infected. After 2 1/2 years, an extra month or two in the primary vaccination series to lower the risk of a serious complication does not seem unreasonable.
Looking back over my previous posts, it seems that I neglected to discuss the reported efficacy of the vaccines in the youngest age group, which formed the basis of the FDA EUA approval. Let’s take Moderna, since the confidence intervals for the data presented by Pfizer were so wide. Moderna vaccine efficacy in preventing disease was 51% in the 6 mo-2 yo group and 36% in the 2 yo-5 yo group. Not very good, but right in line with what we know about the ability of the vaccines to prevent infection now in adults. (This is all Omicron era data— the only virus that matters right now). If you accept the recent data that prior natural infection gives equivalent immunity to vaccination, both in terms of preventing infection and protection from severe disease, and that 75% or more of children have been infected, that leaves 25% who might get only 36% reduction in infection in the 2 yo - 5 yo group. It does make sense to vaccinate children when they have little chance of encountering a disease (say polio), and hence little chance of personally benefitting from vaccination, if you are trying to eradicate the disease, or if the consequences of infection are frequently severe. None of those conditions applies here. One thing seems inevitable on the vaccination horizon. Given the amount of money invested, and the desire to claim early childhood vaccination as a major accomplishment for the administration, you can expect a relentless media campaign—particularly if the vaccine program is perceived as failing in its goal. The point has been made by several authors recently that the time for masking and other restrictions on young children is well past, and that the most significant contributions we can make as a society to their protection involve the investment in modernizing school and other indoor ventilation and air quality.
On Tuesday the FDA’s Vaccine and Related Biologic Products Advisory Committee voted to recommend the use of updated COVID vaccines for the fall, which will target the Omicron BA.1 spike. I have written previously about what I consider to be the misguided attempt to chase variant spike sequences. For a thorough analysis of the recent decision, I refer you to the excellent STAT article of June 24 by Professors John P. Moore and Paul A. Offit, with the transparent title, “FDA: Don’t rush a move to change the COVID-19 vaccine composition”. https://www.statnews.com/2022/06/29/fda-dont-rush-to-change-covid-19-vaccine-composition/
Pet Peeves department will round out this update. The following is the logical extension of last week’s revelation of the Director General of the WHO, and Professor Jeffrey Sachs of the Lancet Commission on COVID-19, expressing the belief that the Pandemic was caused by a lab leak from the Wuhan lab. This week, the House Appropriations Committee approved an amendment to the 2023 budget bill which would ban any US funding of the Wuhan Institute of Virology, as well as funding of any labs in countries which are clearly our enemies, including China, Iran, Russia, and North Korea. This was a bipartisan vote. You have two choices, either our representatives believe there is compelling evidence of complicity of China in the origin of the Pandemic, and the early withholding of critical information regarding its origin and mechanism of spread— or you believe some representatives are backing this bill solely because they think it will improve their chances in the mid-term elections. The highly vocal group that vehemently attacked people suggesting the lab origin needed thorough investigation seem to either be on vacation, or have forgotten all about that episode. What goes around, comes around.
The final bit of Monkey Business is the Pox. Documented cases now exceed 5300 world wide with 400 in the US, and 50 countries where the disease is not endemic reporting at least one case. There has been one reported death, and that was in an immunocompromised individual. That equates to a mortality rate of .00018 or .018%, which is incredibly low. The vast majority of cases have involved a limited number of vesicular skin lesions, primarily in the anogenital region and sometimes fever. The US government is ramping up its vaccination program of those considered at risk, and purchased 119 million dollars worth of Jynneos vaccine, with the option to up that to 299 million. Will we find out that the vaccine is effective in preventing severe outcomes and death, which apparently never happens, but not so effective in preventing disease? The virus has clearly changed clinically from the strain that was circulating when vaccine trials were conducted, and the answer to that question is unknown in my opinion. Is this a reasonable utilization of funds and resources? I have no idea, but perhaps you all do.
Remember to stay flexible in your thinking, and always incorporate new data into your evolving assessment of what’s known to be true, highly likely or just a guess. Be cautious of people who always are certain they have all the answers, and set themselves up as the arbiters of misinformation and disinformation. Enjoy the Fourth of July holiday with family and friends, and celebrate this great country.