This article about the June 2020 ACIP meeting was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.
Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.
During June 2020, the Advisory Committee on Immunization Practices (ACIP) held its second annual meeting for the year. Because we are in the middle of the COVID-19 pandemic, and traveling is challenging for many – including, I suspect, for several of the Committee members, not all of which live near Georgia – the meeting, like most conferences this year (those which were not canceled) was held virtually. The CDC still provided an opportunity for oral comment, though there were some logistical challenges with their new system.
As with previous meetings, ACIP is a geek’s dream meeting and everyone else’s – except the experts, and I suspect – hope – most experts are geeks – boredom feast. I learned a lot.
One of the most important lessons is that the committee takes vaccine safety very, very seriously. The other is that decisions on vaccines – like most policy decisions – are always made on incomplete knowledge. We never know everything. That is where expert judgment comes in. Incomplete knowledge does not mean there is not enough knowledge to assess benefits/risks, though any such assessment should be reassessed when new knowledge comes in.
Finally, it’s important to remember – and something the anti-vaccine observers of these meetings seem unaware of, but that doctors treating patients likely are not – that a decision not to use a vaccine is a decision with costs and risks – the costs and risks of the disease the vaccine prevents.
The choice is never between no risk and the vaccine because we don’t have vaccines unless a disease causes substantial mortality and morbidity. The choice is always whether, given the information, an informed decision can be made and which risks that information suggests are higher – those of the vaccine or those of not vaccinating.
Finally, my notes are over 14 pages of text for the June 2020 ACIP meeting, and that’s because my computer crashed at the end and I lost my last two pages of notes, which is really frustrating – and I have 153 screenshots of slides (yes, I am surprised too). I really want this post to be shorter. So I’m going to try and be very brief, and I’m happy to share my full notes, just email me at [email protected]
The question presented to the committee by the meningococcal workgroup was whether to add a new meningococcal vaccine by Sanofi Pasteur – MenQuadfi, covering MenACWY – recently licensed by the FDA to the Vaccine for Children schedule. This would allow the vaccine to be covered by the federal government for children who are not insured. Sanofi Pasteur, as came out in a question, is planning to retire its current MenACWY vaccine, Menactra, but it will be gradual.
Meningococcal is a very serious disease and preventing it is important. But there are several licensed MenACWY vaccines, so the question was not about initial recommendations. The discussion, however, focused on safety evidence for the vaccine.
It included two main presentations. A presentation by a Sanofi representative on the six clinical trials Sanofi presented to support the vaccine. Since this is a vaccine for a disease for which there already are licensed vaccines, the comparison – correctly – was whether the vaccine was as safe and effective as existing vaccines, and the trial compared the new vaccines to existing ones (because it’s unethical to leave participants unprotected – certainly for a disease as serious as meningococcal – when there’s a vaccine available).
Sanofi’s representative described the six trials in detail.
Then the workgroup described their own data, based on a literature review that found initially 149 studies, narrowed to 10 clinical trials. Based on that data, the vaccine was found effective – more effective than current vaccines – and safe.
The committee asked multiple questions, but after public comment voted to add the vaccine to the Vaccine for Children program.
The discussion here had three-parts. The committee provided an update on the 2019-2020 influenza season; the committee provided an update on influenza vaccines, both their effectiveness and their safety; and the committee heard proposed changes to the language of the influenza vaccine’s contraindications in the “precautions and indications” table and voted on them.
To keep this short – and I know I’m not doing justice to the detailed presentations – I will say just a bit on it.
The influenza season was bad, with hundreds of thousands of hospitalizations and tens of thousands of deaths. The latter part of it was also hard to examine, because COVID-19 caused its own deaths, and during the rush of the pandemic, it was hard to separate out flu harms from COVID-19 harms.
The flu vaccine effectiveness was, overall, 39%, with differences across strains and age groups. We could all hope for a more effective flu vaccine, but 39% at preventing the disease completely – with additional impact on preventing death and serious complications – is better than some years. Still, scientists, we are eagerly awaiting that universal flu vaccine that’s more effective.
In terms of safety, with 174.5 million doses distributed (that doesn’t mean all were given) no new safety concerns were registered in VAERS. In the Vaccine Safety Datalink (VSD), where 5.8 million doses were given, no new safety concerns were identified. There is a study in progress through Clinical Immunization Safety Assessment (CISA) examining pregnant women, which has so far not raised safety concerns (but is not complete).
Next year’s vaccine composition is going to be substantially different than this year’s, with three of the strains different. This is not an ACIP decision – this is something Vaccines and Related Biological Products Advisory Committee(VRBPAC), the FDA’s topical advisory committee, determines.
The session also involved a report on the inclusion of two newly licensed influenza vaccines as options – Fluzone, a high dose quadrivalent (licensed November 2019, Sanofi Pasteur), and Fluad quadrivalent (licensed February 2020 for 65 and higher).
The last part of the discussion was about changes to the contraindications and precautions table. Some of it was just for clarity – like changing the title to Contraindications only.
I have notes about the changes, but it looks like I did not screenshot the full recommendations to change slide – I think the timing worked against me: This session started around 7:15 my time, and my kids were awake then and at times needed me – though my husband, as planned, helped that morning, so I can listen to the meeting. Classes start later.
Anyway, there was a detailed discussion of the changes and the data behind them. The changes were accepted in a vote after the public comments.
Public comments at the June 2020 ACIP meeting
I have previously criticized the use anti-vaccine activists made of the public comment period in ACIP, pointing out that their comments were generally not related to the committee’s work, did not include relevant asks, were grossly inaccurate, and were often – and increasingly – threatening, and occasionally even personally abusive.
In a recently published article with Prof. Barbara Romzek I also pointed out that using such comments as performance opportunities is a misuse, and recommended – after analyzing the law and concluding it’s legally permissible – that ACIP stops public commenting – while providing unlimited opportunity for written comments – because of that misuse. I still think ACIP should seriously consider it. Input is important, but there’s no reason to allow theater, and written comments can fill the role just as much as oral one, without taking up valuable meeting time.
The comments this time were better. For one thing, practically all of them included relevant asks –not about the issues voted on, but things within the Committee’s mandate. The “asks” included recommending vaccines to caregivers of the elderly, and a change of recommendations for shared decision making on those vaccines to a regular recommendation, both of which are well within ACIP’s mandate.
There were also multiple requests for careful oversight of COVID-19 vaccines in development, and two commenters (both Facebook friends and people I met in real life – Daniel Pyron and Liz Ditz) requested stronger ACIP involvement in countering vaccine hesitancy – Liz Ditz asked ACIP to create a workgroup on advancing vaccine confidence.
Even the sole commenter who raised concerns about vaccines had an on-point ask. The speaker – I’m not sure I spelled her name correctly since there was no visual list, and I wrote from hearing – lost a child who received the MMRV vaccine 7 days later.
The mom attributed the tragedy to an undiscovered febrile seizure, though that would be a very hard claim to demonstrate and relies on quite a bit of conjecture. At any rate, the mom clearly suffered a tragedy, losing a child, and her request directly addressed ACIP’s mandate: she asked ACIP to recommend that MMRV (for measles, mumps, rubella, and varicella or chickenpox) not be given under the age of 2, and those children get, instead, MMR and varicella vaccines separately.
I don’t know what the evidence of the risks and benefits of doing this is, but this comment was a dramatic improvement on the comments from the openly anti-vaccine group: it drew on demonstrated facts (MMRV has a higher rate of febrile seizures than MMR or V separately), the request is specific and within the committee’s purview, and it did not stoop to personal attacks or threats.
There were seven commenters. Six expressed strong beliefs in the benefits of vaccines. Dr. Cohn from ACIP mentioned that they received over 80 submissions and only had room for 8 speakers (one of which apparently did not talk). I know my request to speak was rejected, as were those of many of my friends, reflecting this high ratio.
I would add that there was, in my view, an error in managing this by the CDC – they called during the meeting for speakers to contact an officer and give the phone number of calling in. The day-of seems too late to organize something like that: commenters should have been told this by email at least a day or two in advance, so they could set it up. Since the CDC said there were 8 slots but only 7 people spoke, I suspect the eighth had a problem getting in, and this might be why – but that’s a guess.
The speakers, in order of speaking, were Daniel Pyron, a Georgia Nurse, Elizabeth Sobczyk from the Gerontological Society of America, Amy Pisani from Vaccinate Your Family, Michelle Cantu from NACCHO, Ms. Aclum (I am not sure I got the spelling right), the mother who lost her child, Liz Ditz, a disability advocate from California (and friend), and Pablo Ancato (I’m not sure I got the spelling right) from the National Association of Nutrition and Aging.
The rest of the meeting focused on Covid-19 and its vaccines. I’ll try to keep this, too, brief.
Covid-19, the disease
This presentation was by Dr. John Brooks, chief medical officer of Covid-19 response. And it was fascinating. And I’m going to drastically shorten it, too. I really hope people ask for the full notes.
Dr. Brooks reminded us of the basics of the virus and how quickly it spread. He pointed out that despite a genetic link, this virus differs from SARS and MERS in two ways. The incubation periods are about the same, but people can infect others before symptoms. And a substantial fraction, 30-35%, are asymptomatic – but can transmit to others, though how infectious asymptomatic carriers are is still being worked out.
SARS-CoV-2 transmits via respiratory droplets, which can travel 6 feet, but likely not via aerosols (that can go further). In immunocompetent people with mild/moderate disease, replication-competent viruses cannot be recovered after 8-10 days. From severely ill/immunocompromised they can be recovered up to 20 days.
Symptoms – fever is common, so is cough. Some people had GI illness first, fever and cough later. No reliable set of signs or symptoms to discriminate it from viral illnesses such as influenza. Most people have anosmia/dysgeusia – loss of taste/smell. This is highly predictive of infection. For some, it’s their only symptom.
Most recover spontaneously with supportive care. Severe complications were found in a substantial portion, 13.8%, while 4.7% were critically ill, and about half of critically ill died.
Note that this means that over 18% had the severe disease – over 1 in 6 people. In children, there was a lower percentage of severe or critical – only 2.5% severe, critical 0.4%. With age severity increases. There are several unique and dangerous complications.
High-risk groups – comorbidity and advanced age. Cardiovascular disease, diabetes, chronic respiratory diseases increase the risk. Once over 50 there’s a steady increase in risk. For immunocompromised people, there is no strong evidence whether those with HIV or cancer do worse, including those undergoing immunosuppressive cancer therapy.
What’s next? Unclear. This infection is not like influenza, in fact, it’s not like any human virus before. It has unique epidemiological problems nobody expected. New and serious disease, desperately need vaccine/effective therapy.
The next and very detailed presentation looked at the immunology of SARS-CoV-2 and was by Dr. Natalie Thornburg. The main takeaway was that there’s evidence most people infected have a neutralizing antibody response, and the magnitude of response was correlated to disease severity.
But there are many unknowns, including – are COVID-19 patients susceptible to reinfection? Are antibodies a correlate of immunity? If so what, quality? Is there a threshold of protection? If so, how long will serum antibodies last?
Dr. Thornburg spent a lot of time discussing the spike protein and how to neutralize it.
Dr. Oliver, who followed her, talked about the COVID-19 epidemiology, and basically, things are bad. WE have a lot of cases, deaths substantially over the pandemic threshold. She also talked about the high rate of cases in healthcare personnel, long-term care facilities, and prisons, as well as meat and poultry processing plants.
Dr. Oliver also discussed children. Children may have different or minimal symptoms relative to adults, including abdominal pain or gastrointestinal symptoms. It also may be more likely to be asymptomatic. Their role in transmission is unclear.
Early in the outbreak, school-age children had the highest number of contacts, but that doesn’t mean they spread the virus. Data on school spread is so far reassuring but inconclusive. Children are at risk of the pediatric multisystem inflammatory syndrome, documented both in Europe and the United States.
There are also uncertainties in relation to the effects of the disease in pregnancy. A study from New York had positive pregnant women hospitalized more than others, but it’s unclear if that’s because of bias in hospitalizations – clinicians more inclined to hospitalize women who were pregnant – or because of more severe disease. Pregnant women were also more likely to be ventilated, but their rate of death was similar to women of similar ages who were not pregnant. 98% of newborns were negative to Covid-19. The preterm birth rate was higher than the general population. So the data is not quite clear, and more studies are required to further our knowledge.
Other Vaccines and COVID-19
The next presentation at the June 2020 ACIP meeting addressed two problems and what could be done about them. The first problem is a dramatic drop in childhood vaccines for routine vaccines during the COVID-19 period. The second was that influenza season – people getting influenza while Covid-19 is still raging – poses a special challenge, and the United States needs to make an effort to maximize influenza vaccination rates to reduce the problem.
The presentation described the issue and suggested several steps to address it, including messaging, helping providers come up with safe ways to open, and so forth. The presentation also addressed the fact that manufacturers are aiming for a record number of vaccines available to the public.
- Nothing has been done yet.
- We need to get kids caught up so we can move on to influenza and avoid disparities in groups.
June 2020 ACIP meeting – COVID-19 vaccines
Dr. Bell, who chairs the COVID-19 vaccines workgroup, introduced it. The workgroup was established in April 2020 and has 41 members with broad expertise. He stated that they have a vaccine safety technical sub-group.
Dr. Bell stated that they stand for evidence-based decision making, equity, and transparency in the process. Frankly, I was just glad to know ACIP is monitoring this.
Next, we heard from Dr. Matthew Hepburn, who is not part of ACIP. He leads operation Warp Speed, which, according to him, focuses on coordinating the federal government’s efforts to speed up development, especially by providing financial resources to promising candidates and setting up trials and preparing for production – shifting the financial risks of testing and preparing for production before a vaccine is licensed from the specific manufacturers to the United States government.
Dr. Hepburn’s presentation gave me mixed feelings. On one hand, some parts were reassuring. He emphasized his past – he served 23 years as an infectious disease physician in the military and then worked in the Department of Defense.
So he is not only a physician but also a civil servant. And he sounded like he sees his main job as coordinating groups of experts, and that he respects their expertise.
He also emphasized that the goal is to not cut corners on safety.
On the other hand, he gave very few details on their actual work. It makes sense that he cannot name vaccine candidates they’re focused on if they haven’t chosen them, but still.
The next presentation went through the vaccine candidates and approaches to creating vaccines. Here is a slide covering the options:
Note that the Skeptical Raptor covered these in detail as well.
From Dr. Neuzil’s detailed presentations, the most advanced ones in terms of testing are Moderna’s mRNA vaccines and the UK vaccine. However, Dr. Neuzil reminded us that the reason more traditional platforms aren’t as advanced is that they take time to develop – but they are coming along in the next month and will be tested. She also, on the other hand, reminded us that the fact that a platform is new does not mean it won’t work – every approach was new once. Basically, it really is the data that will determine what are the best vaccines against Covid-19.
The last two presentations addressed the considerations in prioritizing who will get the vaccine first – since it will take time to get the vaccine up and running. Dr. Mbaevi who gave that presentation explained that they are drawing on lessons learned during the H1N1 pandemic – but trying to be careful about the uncertainties.
I want to say two things about this. First, there is a lot of uncertainty here. Second, one of the largest topics of discussion was prioritizing African American and Latin American communities, because of the disproportionate impact of COVID-19 on these communities – the high rates of deaths.
This is a legal minefield because bringing in race can lead to strict scrutiny of any decisions. It’s also an ethical and practical minefield because however good the intent – the desire to protect people – there is a risk in doing this that minority communities will be painted as having higher rates of disease, which could increase stigma. I hope the committee brings in experts in equal protection and ethics in relevant areas (that’s not me).
My last two pages – about next steps and updates – were not saved because my computer crashed, and it’s frustrating, since I think those were important. On the other hand, that keeps this post somewhat shorter.
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