The covid state of emergency has ended, both globally and in the US (the latter officially on May 11). On May 4, the director general of the World Health Organization, Dr. Tedros Adhanom Ghebreyesus, declared that covid is now an established and ongoing health issue that no longer requires resources needed for a public health emergency of international concern (known in the business as PHEIC). Future planning from the WHO is now detailed in a new document, the 2023-2025 COVID-19 Strategic Preparedness and Response Plan. It weighs in at only 20 pages, so needless to say it is short on details. For that, you'll need to dig into the document links.
Meanwhile in the US, our official emergency will end on May 11 as previously planned. So far we don't have any true future response plan.
Funding for Vaccines, Medications, and Tests
The official end of the emergency eventually means that the general public won't have access to free covid vaccines, medications and diagnostic tests. Naturally this varies with insurance type and also timing; any products still in circulation that were provided by the feds will remain free, but I haven't seen any estimates yet on how long these supplies will last. Nothing will really change for patients on Medicaid until September 2024, although access to Medicaid itself could change. The Infectious Diseases Society of America (IDSA) produced a nice table briefly outlining the situation. Unfortunately it's too big to copy well below, but a pdf version is available for download. Note that this all is completely separate from FDA's Emergency Use Authorization for vaccines, medications, and devices, which won't change until industry applications for full approval are submitted and evaluated.
Covid Vaccine Updates
First, I very much apologize for not mentioning in last week's post that the FDA on April 28 did make some allowances for additional vaccine doses for immunocompromised children. CDC has now posted this update in their Interim Clinical Considerations website for covid vaccination. Basically, any significantly immunocompromised person 6 months of age and older can receive additional bivalent vaccine, number of doses depending on prior vaccination status but also giving much leeway to the healthcare provider. Sadly, the site is still very messy, not user friendly for providers or individuals. CDC and IDSA did have a webinar on May 4 with some nicer graphics in some slides, but so far I've been unable to find the same graphics on the CDC website. Here's the quick look at vaccination for immunocompetent children ages 6 months to 4 years, and also for that "awkward" age of 5 years when the cutoffs for Pfizer and Moderna vaccines are different. You can download or watch the presentation yourself at the IDSA site.
The next major step for covid vaccines will be a meeting of the FDA's Vaccines and Related Biological Products Advisory Council (VRBPAC) on June 15. At that time the composition for the next vaccine will be determined, in time for a potential release in fall of 2023. The FDA's plan for subsequent covid vaccine adjustments was presented by Dr. Peter Marks, director of FDA's Center for Biologics Evaluation and Research, at the same May 4 IDSA meeting mentioned above. It is very similar to the process for annual influenza vaccine composition.
Covid Tracking Changes
We've been in more of a bind the past several months trying to track covid cases in an era of public exhaustion with the pandemic as well as non-reporting of home testing results. Additionally, CDC and local/state health departments have lessened their efforts, and most non-governmental groups have discontinued intense tracking as well. We are mostly left with tracking easily measurable data that probably are a good surrogate, at least for severe infections. Hospitalization rates for covid have been quite low for all age groups recently.
On May 5 CDC released 2 MMWR articles to clarify and justify tracking changes. Primary surveillance now will consist of the weekly hospitalization rates above as well as percentage of deaths attributed to covid. Secondary indicators are emergency department visits and percentage of positive covid testing in laboratories. Genomic and wastewater surveillance will be used to track variants. In the past, many of these outcomes have reflected in a timely manner the covid community levels when tracking of infection was more reliable, so perhaps it's not a bad trade off. Time will tell.
Other Changes and Events
The news has been saturated with Dr. Rochelle Walensky's announcement that she will step down as CDC director effective June 30. The announcement was short on rationale for the change. Previously Dr. Walensky had announced new strategic planning to revise CDC's structure and management, a badly needed overhaul. I hope this plan won't fall apart with her departure.
As I mentioned in a February posting, work on RSV vaccines is advancing, most recently with FDA approval of one vaccine for individuals 60 years of age and over. CDC and ACIP are expected to make recommendations at their June 21-23 meeting. Flu vaccine composition also will be discussed. In the meantime, FDA VRBPAC will discuss RSV vaccination of pregnant women to prevent or modify illness in newborns at their May 18 meeting.
Lastly, you may have seen press reports of a meeting of scientific advisors with the White House that attempted to put a number on the likelihood that we'll experience another big wave of covid in the next 2 years. Like all covid forecasts, many assumptions are made to produce such numbers and really should be accompanied by a sensitivity analysis that varies the assumptions so that we have a better range of what to expect. I haven't seen an actual publication for this latest estimate so can't really comment further.
My Book Report
I've been working on a book review that I hope to have completed in time for next week's blog. I'm also trying to remember when the last time was that I wrote a book report, probably elementary school. Stay tuned.