The FDA Lobs Another Curveball

The CDC intervention continues

FDA pitching again in the bottom of the 8th inning.

The FDA’s announcement this week regarding a major change to the EUA (emergency use authorization) governing COVID vaccination came out of left field, and was fairly stunning. After more than two years of telling us that two doses of either Pfizer or Moderna mRNA vaccine was necessary for adequate immunity, and necessary for a person to be legally “fully vaccinated”, the FDA announced that from now on a single dose of the bivalent vaccine would be all that was needed, and in fact the only option, for anyone wishing to get vaccinated. This is irrespective of any prior history of COVID infection. You might think that such a major about face in vaccination policy was predicated on some new scientific studies and data, but you would be wrong. The studies leading to the initial approval of the EUA showed very clearly that 2 doses of the original vaccine were necessary to provide protection, and that was at a time when the new vaccine exactly matched the then circulating Wuhan virus. Now we are taking a vaccine which is formulated with the RNA Spike sequences of two extinct viral clades, Wuhan and BA.5. Does it even make sense to GUESS that a single dose of this vaccine will offer significant protection for any reasonable amount of time? There are no studies and no data to support that decision; the best that can be said is that Director Peter Marks and the FDA have a nice wish and hope. Dr. Marks suggested that the FDA believes more unvaccinated people will come around to take the jab if the regimen is simplified to a single shot. Personally I think the change is unlikely to motivate anyone—especially when they find out they are now being offered a totally unproven vaccine regimen. Various new FDA and CDC slogan campaigns will undoubtedly follow. I’m hoping they will pick mine: “Get fully vaccinated today with just one shot—we don’t know if it works but it’s simple, like You!”. Don’t expect a run on vaccination clinics to rival the run on the banks. Who’s in charge is a legitimate question that can be aimed in many directions. What ever happened to “Follow the Science”? It turned out to be a great campaign slogan, and not much more. With so many instances of bungling by the CDC and FDA during this Pandemic, how could anyone honestly be expected to believe that any particular directive was truly based on well established scientific evidence.

The CDC’s intervention continues with the unexpected resignation today of Director Rachel Walensky. I made it abundantly clear not long after she took the helm at CDC that I thought she was doing a very poor job. She decided to lift mask requirements just as the Delta wave, with it’s known increase in infectivity and severity of illness, was scheduled to hit—only to be forced to quickly do an about face as cases, hospitalizations and deaths surged. Dr. Walensky elevated the art of confusing and poor communication to new heights. Her excuse was the the calcified bureaucracy of the CDC, which has become focused on esoteric academic studies in lieu of its primary job of rapid response and keeping the public safe. She vowed to fix the CDC, but instead will be getting a limo ride back to Boston—where it’s rumored she spent most of her time anyway.

On the other hand, there is some good news in the vaccine world from the FDA, which just approved the first vaccine to prevent RSV (respiratory syncytial virus) in adults over 60. This is a major respiratory pathogen in the older age group, causing between 60,000-120,000 hospitalizations, and 6,000-10,000 deaths in the US every year. The qualifying, randomized controlled studies enrolled 25,000 subjects. The vaccine demonstrated a very impressive 82% reduction in LRTD (lower respiratory track disease), and a 94% reduction in severe LRTD. This is a protein based vaccine (not mRNA) formulated with the pre-fusion F protein of the virus. That protein sits on the viral surface, enabling the virus to fuse with the target cell membrane and enter the human cell. GSK was in a race with Moderna and Pfizer to reach FDA approval for their vaccine. Protection for newborns, the other group at high risk for RSV morbidity, will hopefully become available later this year if the FDA approves Pfizer’s candidate vaccine. This vaccine is given during pregnancy, and the maternal antibodies pass to the fetus. Pfizer’s phase 3 study last year demonstrated high level protection during the critical first 3 months of life, with 69% protection out to 6 months. By that point the baby’s immune system has developed sufficiently so that RSV poses much less of a risk for severe pneumonia, but still accounts for a very large burden of pediatric respiratory illness. After the unprecedented Pandemic dislocations of the RSV seasonal epidemic pattern, it appears to be returning to historic norms.

Let’s turn now to the COVID situation. Identified cases in the US continue to decline, but you would never know it based on the CDC. Late last month the CDC’s annual EIS meeting, the premier epidemiology meeting in the country, turned out to be a superspreader event with 35 COVID infections so far linked directly to the event, and more contact tracing ongoing. I suspect there wasn’t much masking going on at the Atlanta meeting, and overall it’s not a good look for the CDC. Remember when the media would endlessly cover superspreader events, or predict in advance what events would “almost certainly” lead to many infections? That kind of coverage, and the head shaking accompanying it, fell by the wayside when it became apparent that everyone was getting this virus sooner or later, irrespective of their behavior, support for mask use, or vaccination status. Current US COVID hospitalizations are below 9000, but deaths seem to have plateaued, and are still 1100 per week. One thing COVID accomplished that the legislative process has been unable to do, was push back the dates at which the Social Security Trust and Medicare will be bankrupt. As the COVID Public Health Emergency ends next week, the CDC will no longer be monitoring and reporting community disease levels, but relying on hospitalizations, deaths and waste water monitoring to track the disease. The WHO announced today, May 5th, that COVID-19 no longer represents a Public Health Emergency. Unfortunately India continues to have a surge in disease, driven by the XBB.1.16 Omicron variant, which does not appear to have peaked yet, with 3900 infections diagnosed in the last 24 hours, and current active cases at 36,000, which of course is the tip of the samosa. World wide this “Arcturus” variant is now close to 50% of viral sequences.

The last item today concerns the recent epidemic of severe hepatitis of unknown cause affecting young children around the world. The syndrome was recognized in early 2022, and by July over a thousand cases had been reported with many progressing to liver transplant and 22 deaths. Many of these children were found to be infected with Adenovirus, a very common virus in the population, causing respiratory infection, gastroenteritis and conjunctivitis, but not previously known to cause fulminant hepatitis in immunocompetent kids. Several different strains of common Adenovirus (as well as other viruses) were found in the cases making it difficult to pin down the cause of this apparently new syndrome. The following paper makes a convincing case that the disease is caused by dual infection with Adeno-associated virus 2 (AAV-2) and common Adenovirus strains. AAV-2 is a common single stranded DNA parvovirus which has been thought to be non-pathogenic. It is a defective virus in the sense of requiring the presence of another DNA virus within the cell in order to replicate. The authors found that 93% of the cases infected with Adenovirus strains also had AAV-2 present, versus 3% of controls. In a group of gastroenteritis cases caused by Adenovirus infection AAV-2 was rare. It seems likely that co-infection with AAV-2 and Adenovirus (or other DNA viruses) has been the cause of this severe hepatitis syndrome.

Adeno-associated virus type 2 in US children with acute severe hepatitis. https://doi.org/10.1038/s41586-023-05949-1

These two viruses are ubiquitous in the human population, neither of them is a new pathogen. AAV-2 has been felt to be so safe that it is often used as a vector for gene therapy. They must frequently intersect in the same human host, and have been for a long time—so that leaves the question, why did they cause this dramatic illness in very young children all of a sudden? Did this illness exist all along in the past, perhaps at a much lower rate and we failed to recognize it? That seems to be a reasonable possibility, but why would it suddenly increase in late 2021 enough to cross the threshold of observation and recognition? Is it another unintended consequence of the prolonged social distancing of children during the Pandemic resulting in abnormally high numbers of children with no immunity to either virus? When those children started coming together again there would be a large pool of susceptible targets for dual infection. I don’t know the answer, but perhaps we could ask Randi Weingarten of the Teachers Union, she seemed eminently qualified to lobby for the untested, unscientific experiment in endless school closures.

Thanks for your attention and interest. Please forward and comment. If anyone has the ability to either forward this to Randi, or pass my name to President Biden as an interested candidate for CDC Director, I would be be most appreciative.