Covid Vaccines and Allergies
Updated 15 August 2022
Caveat (1): I am not clinically qualified and this note has not been peer reviewed. It is subject to change. Please bear this in mind and follow up the reference documents it links to, before either believing or denouncing it.
Caveat (2): This latest update is more of a warm-over. The thrust of my commentary is back up to date, but many details have evolved since April and I have not yet had time to incorporate all of them.
"Get your Covid vaccine shots" will soon be the cry again for the new season, and that is indeed what we will all need. But what if you have allergies? Will it be safe for you? Quite possibly not; recorded reactions against the jabs range from the widely experienced Covid arm to a few rare cases of death. This note tries to paint the overall clinical picture, in the hope that someone out there might find it useful – or even do something to improve matters. That improvement is desperately needed by some of the most vulnerable among us, who are being ignored by the medical establishment. Contrary to uninformed official claims;
There is NO allergy-safe Covid vaccine or prophylactic available in the UK! There is only one even potentially allergy-safe post-infection treatment.
In the years since the issue first came to light and the authorities were alerted, nothing has been done to stop the tide of common allergens being added to any and every new Covid medication. Ask yourself this question:
"Is it likely that dozens of new active ingredients, based on several quite different approaches, are all causing the same allergic reactions in the same people, given that Covid itself does not?"
In the steady rise of reported allergies to these medications and the search for alternatives, the authorities blindly assume it is the active ingredients to blame, nobody in the UK establishment ever stopped to consider the elephant in the room – the additives they all have in common.
This message is at last beginning to get through, but inaction, ignorance and downright disinformation remain the norm. The Green Book is paid lip service but flouted by authorities who remain unwilling to face the realities. There are in fact some simple and obvious things that the authorities could do about it, but are resolutely refusing to take on board.
Allergies and lesser reactions can arise to all sorts of substances. Often, what begins as a mild reaction increases on each dose until it soon becomes life-threatening. Two allergens of particular concern here are polyethylene glycol (PEG or macrogol) and its close relative polysorbate (or tween). Every Covid vaccine available in the West contains a form of at least one of these substances, while all but one post-infection treatment in the UK contains one of these or a related allergen. They are typically used as "adjuvants", to enhance the action of the active ingredients, although at least one vaccine includes one of them as an excipient (an inactive ingredient, including adjuvants) for another reason. Although relatively new to us, they have become widely used in cosmetics, hygiene products and even packaged foods, and are now finding their way into medications of all kinds. As your reaction develops with each Covid shot or layer of sun cream, what might have been tolerable to start with can become severe enough to be life-threatening when you get your next booster shot.
PEG and polysorbate each come in various forms. A given individual's reaction to each form can be different, while two individuals will react differently to any given form. Moreover, most sufferers will have relatively mild symptoms and not report them; only the rare, severe cases come to clinical attention, and the way that previous exposures may have felt OK can complicate the diagnosis. So systematising any meaningful results from test or symptomatic data is difficult and challenging.
PEG (macrogol) and Polysorbate 80 (Tween 80, E 433) have recently seen increasing use in vaccines and post-infection treatments, and today they are extremely common. The extent to which these additives may cause allergic and other immune reactions is still unclear. PEG is an acknowledged risk and is currently under investigation. Canada at least knew about the risks pose by polysorbate 80 some eight years ago; Polysorbate 80 risks, Vaccine Choice Canada, 2013. Others kept up the reminders, such as Truth Snitch (2017), Polysorbate 80 in Vaccines: Is it safe?. Yet as late as 2021, Stone et. al. pretty much acknowledged that we had taken not a blind bit of notice; Immediate Hypersensitivity to Polyethylene Glycols and Polysorbates: More Common Than We Have Recognized, J. Allergy Clin. Immunol. Pract., May-Jun 2019;7(5), pp1533-40.
Covid vaccines and post-infection treatments are no exception (see for example COVID-19 Vaccines and Allergy from the Melbourne Vaccination Education Centre). For more recent studies, see for example Bigini et. al.; The role and impact of polyethylene glycol on anaphylactic reactions to COVID-19 nano-vaccines, Nature, November 2021. Of course, the sufferers are rather more clear about it, but may not accurately diagnose the causes of their own symptoms. Nevertheless, the body of evidence is growing, and is supported by conversations with my local allergy clinician who is seeing a steady rise in reported issues with these allergens.
The mad rush to vaccinate humanity against Covid is an especially chaotic environment to try to work in. This might explain why sufficient work is still not being done. All Covid vaccines and treatments have side effects, and other reactions to them are also noticed in clinical trials. A big problem is, if allergens are present in the formula, then how many of those reactions are to the allergen and how many to the active ingredients? To answer that it is imperative to baseline the potential allergens. For example if we know that four in every thousand react to the allergen, and six in every thousand to the vaccine, then two in every thousand are reacting to the active ingredient alone, and up to four might be reacting to both. While PEG2000 is already under the spotlight, I can find no such studies on polysorbate 80. We have no real idea of its prevalence as an allergen, and hence no idea of the safety (or otherwise) of the active ingredients it gets packaged with. Anecdotal evidence, such as provided by the case study below, is just not enough.
If you or someone you know is experiencing adverse reactions to a Covid vaccine, or is concerned at the possibility, you might want to check out the Anaphylaxis Campaign's web page on Covid-19 Vaccines and Allergies. They also have a useful FAQ, instructions on What to Do in an Emergency in case of an acute attack (anaphylaxis) and other resources. Allergy UK also have a COVID-19 Vaccinations and Allergies FAQ. I have not found any similar resource for post-infection treatments.
The vaccines and treatments approved for use in any given country may vary, for example not all are available in the UK.
The UK Health Security Agency maintains an up-to-date list of vaccines and UK equivalents, the COVID-19 vaccination programme: Information for healthcare practitioners (Current version 4.2, dated 9 March 2022, or later).
Fuller lists of vaccines around the world, including a list of the many still in the lab and not yet approved anywhere, is provided by the Regulatory Affairs Professionals Society (RAPS) COVID-19 vaccine tracker (Current version dated 8 April 2022, or later). "COVID-19 Vaccine Platforms: Challenges and Safety Contemplations", Vaccines, 9, 2021. p.1196, also gives a long list of vaccines under development.
The table below is slightly different. It aims to list all the Covid vaccines and specific drug treatments available in the UK, along with relevant examples of those available elsewhere, together with their key properties relating to allergens and availability within the UK. It includes non-specific antivirals that I know of, but not more generic drugs such as the steroid dexamethasone. I have been astonished to find that nobody else seems to have pulled even this information together in one place yet. Certainly, the very obvious lessons that scream out from it are acknowledged only by a very few sufferers and specialist practitioners. I hope you find it instructive and, perhaps even, useful.
Notes to the table:
|Convidecia (CanSino, Pakvac)||Vaccine||Viral vector||Polysorbate 80||WHO emergency approved. Not approved in the UK.|
|Covaxin (BBV152)||Vaccine||Deactivated Covid virus||Phenoxyethanol (known to cause contact allergies)||Approved for visitors but not for residents||Ingredients: inactivated SARS-CoV-2 antigen NIV-2020-770, aluminium hydroxide gel, imidazoquinolinone (TLR 7/8 agonist), 2-phenoxyethanol, phosphate buffer saline.|
|Polysorbate 80||Approved||"Prophylactic" or preventative treatment, provides protection against infection for around six months.|
|Janssen (Johnson & Johnson)||Vaccine||Viral vector||Polysorbate 80||Approved but not currently available|
|Moderna (spikevax)||Vaccine||mRNA||PEG2000||Approved||Now with added Omicron variant protection.|
|Molnupiravir (Lagevrio)||Early‑onset treatment||Antiviral drug (Pill)||Propylene glycol (PG, E1520)||Approved and available||Propylene glycol is a common cause of allergic contact dermatitis (ACD), but there is no literature on anaphylactic reactions to it.|
|Novavax (Nuvaxovid, Covovax)||Vaccine||Spike protein||Polysorbate 80||Approved but not currently available||The main adjuvant is Matrix-M saponins. Note that polysorbate 80 is not listed as an adjuvant as such, but is included as an excipient (presumably for some other reason).||Paxlovid PF-07321332 (Nirmatrelvir) and ritonavir||Early‑onset treatment||Antiviral drugs (Two separate pills)||PEG, polysorbate 80, lactose||Approved||Also reacts badly with many other medications. Lactose is not discussed here, but is a well-known allergen.|
|Pfizer (BioNTech, Comirnaty)||Vaccine||mRNA||PEG2000||Approved and available||Not to be given to anybody with a history of allergies.|
|Ronapreve||Early‑onset treatment||Antibody (Intravenous or injected)||Polysorbate 80||Approved and available||Allergic reactions affect 1 patient in 10.|
|Sinopharm (Beijing)||Vaccine||Deactivated Covid virus||None that I know of||Approved for visitors but not for residents||Ingredients: inactivated antigen of SARS-CoV-2 WIV04, aluminium hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate, water.|
|Sinovac (Coronavac)||Vaccine||Deactivated Covid virus||None that I know of||WHO emergency approval. UK approved for visitors but not for residents||Ingredients: inactivated SARS-CoV-2 CZ02, aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, water.|
|Sotrovimab||Early‑onset treatment||Antiviral drug (Intravenous)||Polysorbate 80||Approved and available|
|Sputnik V and Sputnik Light (Gam-COVID-Vac)||Vaccine||Viral vector||Polysorbate 80||Not approved in the UK, even for visitors||Sputnik Light is simply the first dose of Sputnik V, administered as a single-dose vaccine.|
|Valneva||Vaccine||Deactivated Covid virus||Polysorbate 80||Approved|
|Vaxzevria (AstraZeneca, Oxford, Covishield)||Vaccine||Viral vector||Polysorbate 80||Approved and available|
|Veklury (remdesivir)||Early-onset treatment||Antifiral drug (Intravenous)||Allergic reaction to betadex sulfobutyl ether sodium is rare||Interim approval and availability||Remdesivir (RNA polymerase inhibitor), betadex sulfobutyl ether sodium, USP, water. May also include hydrochloric acid and/or sodium hydroxide (for PH balance).|
Of the 17 treatments currently listed, the vast majority contain either PEG or polysorbate 80. A few contain other known allergens, including phenoxyethanol and propylene glycol. Two are allergen-free but not approved for use in the UK (owing to a lack of clinical information from the parent country, China) Just one early-onset treatment, Veklury (remdesivir), is both free of established allergens and is approved for UK use, but even then only under strict observation.
The Novavax vaccine is a brave attempt by the USA to offer an alternative, low-allergy excipient. It uses Matrix-M, a mix of plant-derived. But it is not UK approved. Moreover, astonishingly, it also has polysorbate 80 thrown in for luck; the UK is not the only country whose authorities are capable of missing a trick.
Other allergens present in certain post-infection treatments include propylene glycol (PG) and betadex sulfobutyl ether sodium (melphalan). The prevalence of allergies to these when administered directly also appears largely unknown, although some information on the intravenous use of melphalan is available, such as at WebMD. All these allergens described are cyclic organic compounds. Most are surfactants, although I do not know why Veklury (see table) includes melphalan as an excipient, as its main use is as an active anti-cancer drug.
Evusheld is a "prophylactic"; its usage is similar to a vaccine in that it helps prevent infection, but it works in a different way. Because of this, it has been claimed to be suitable for those who are allergic to regular vaccines. Dr June Raine, the UK Medical Healthcare products Research Agency's Chief Executive, said on its release that:
“While the COVID-19 vaccines continue to be the first-line defence against COVID-19, we know that some people may not respond adequately to these vaccines and for a small number of individuals COVID-19 vaccines may not be recommended for other reasons, such as a previous allergic reaction to one of the vaccine ingredients.
“For these people, Evusheld could provide effective protection against COVID-19.”
Yet the information released by the manufacturer with the product (see links in the table) contains all the usual warnings, it makes no such claim. Moreover Evusheld also contains polysorbate 80.
Here we see the thoughtless mistake of blaming the active ingredient emerge clearly. The UK has simply not done any research to check whether Evusheld is any safer than the vaccines which also contain polysorbate 80 (or if they have, they have not published it where I can find it). Dr. Raine has stepped beyond clinical prudence and made an unsubstantiated, or at best highly misleading, claim. Worse, the claim has been echoed widely in the media. I notified the government of the falsehood on its official web page, but I was ignored and the falsehood has not been withdrawn. If you are a practitioner or and allergy sufferer, take care!
So, what should you do if you suspect that you may be allergic to PEG or polysorbate 80 or some other ingredient in Covid vaccines? And what should your GP and other clinical specialists do about you? The UK's clinical guidelinmes on Immunisation Against Infectious Disease Is better known as the "Green Book".
Chapter 14a of the Green Book covers "COVID-19 - Sars-CoV-2", in other words, Covid. This link is to the update of 28 February 2022. Allergies are dealt with specifically on pages 36-39.
This 2022 update does acknowledge the risks posed by both PEG and polysorbate 80. Curiously, it remarks that "Evidence now shows that PEG allergy is implicated in only a minority of allergic reactions reported after COVID-19 vaccines" but does not say how many of those other reactions are down to polysorbate. Nor does it attempt to quantify how the longstanding warnings over PEG might have biased incidents away from vaccines containing that additive. It is a sadly misleading statement, saying nothing in fact while suggesting that other (unstated) concerns are more important.
Table 5 gives clinical guidance on patients who have a general history of allergy. But if you have already experienced an allergic reaction to a previous dose of COVID-19 vaccine, then your guideance is in the flowchart on the next page.
My advice to you is to download a copy, because not every clinician or authority may apply it properly. Get tk now the bits that apply to you. Attach it to your online correspondence, print off a copy and take it with you to the clinic.
A few years ago, a patient whom I will call A. had begun suffering from what seemed like a sensitivity to sunlight. In summer, when they went out in the sun their face would increasingly turn red, swell and become painful. A. suspected their sunscreen and tried every brand in the shops but nothing helped. Some cosmetics also brought on itchy reactions and A. had to try different brands until they found one which was comfortable. One autumn, their annual flu jab caused their arm to swell up and become sore for a few days – it never had before.
At this point, A. received their first Covid jab, which at that time was AstraZeneca. They felt lousy and their arm was worse than before, and it lasted a week. After the second jab it was even worse and lasted a month. Then, a new tube of their favourite toothpaste caused their tongue to get sore, swell and even to split painfully.
It all seemed too much to be a coincidence. A. started looking for explanations on the Internet. Two common factors soon emerged: PEG and polysorbate. They were new wonder ingredients, being introduced into one product after another. They were even appearing in processed foods. Every one of those products she had tried turned out to contain one or other of these new wonder ingredients. Even her flu jab had been a new formula, only just introduced that year.
A. eventually persuaded their GP to refer them to an allergy clinician. Sensitivity to PEG was already under study, and the specialist also recognised the polysorbate sensitivity as something they had encountered often enough before to know the answer, at least for the sunscreen. They recommended an imported Australian brand called Blue Lizard (SPF 30+), which did not contain either chemical. It was expensive but it worked, and A. can at last go out in strong sunlight again. For the present topic, this highlights that polysorbate must be taken seriously as an allergen. Magnifying glass in hand to read the small print, they also changed their brand of toothpaste and, abandoning the big name retailers for cheap bargain shops, found safe cosmetics (presumably they were made so cheaply that the manufacturers didn't want to pay for additives).
A. is over 65 and therefore at high risk from Covid, so vaccinations and boosters are especially important for them. And presently it became time for their booster jab. Their reaction to PEG means that Pfizer and Moderna are unsafe. The only other vaccine available in the UK is AstraZeneca, the one that had given them Covid arm. The best that A. could do was to take antihistamines against the swelling and suffer the consequences a dose of Polysorbate 80 in the AstraZeneca shot. Such reactions tend to increase as the patient becomes sensitised on each occasion, but what choice has a high-risk patient got? And indeed, A. turned out to be no exception. From mild arm swelling with the 'flu jab, through moderate to severe with the two Covid shots, now the booster caused their whole face, throat and tongue to swell and become painful. It was a struggle even to swallow the next antihistamine pill. A. was taken to hospital, where they were diagnosed with acute angioedema. A rare symptom of this is swelling around the heart as well, which can be lethal. Luckily, this had not happened, but A. was given a course of strong steroids to keep the swelling down. The problem with steroids is that they interfere with the action of the vaccine, making it less effective.
The next day A. came down with a sore throat and sniffle, every sign of a common cold. Was that all, coincidentally caught off someone in passing, or was it another reaction to the vaccine? Or, there was a third possibility. AstraZeneca uses a viral vector, a live virus genetically modified to carry Covid markers. The vector virus is specially chosen to be almost harmless but, with their immune system suppressed by the steroids, might it be able to attack them worse than usual?
A. now faces a bleak future. With their booster reduced in effectiveness they are not only especially vulnerable, but are also relatively defenceless. A recent communication from the NHS has confirmed that there are no Covid vaccines available in the UK which are safe for them. Any future booster would cause more harm and danger that it could prevent, so there is no medical intervention that can help them any more. This has not stopped their local (Hereford and Worcester) Covid board recommending that they be given Pfizer under hospital supervision – which means being sent home after half an hour. This is in flat contradiction to the Green Book flowchart guidance for A, which goes: Had an allergic reactions > Symptoms delayed beyond 2 hrs > Hospital intervention > Seek advice from Allergy Specialist. But then, H&W have no allergy specialist, only a couple of chest doctors with an "interest" in the field. Be warned, maybe your local health service is in equal disarray.
A. has only one faint rays of hope left. Veklury is the only post-diagnostic treatment which is free of known allergens. So firstly, A. must hope that if they do go down with Covid, they will be awake enough to catch the hospital doctors before they administer a different one. And secondly, before they inject the right one, they must test A. for allergies to propylene glycol and betadex sulfobutyl ether sodium. Failing those precautions, post-viral treatments will be more lethal than the virus itself.
The UK government's advice in such cases has been to contact your GP, who may refer you to an allergy specialist, or arrange a particular vaccine for you. But allergy specialists are in desperately short supply and (as A. and others have found to their cost) a GP's attitude to your case or their facilities for handling vaccines can vary widely. And besides, there is no suitable vaccine anyway. There is no other guidance or immediate action to make available safe vaccines for the vulnerable.
Nor is any significant clinical data available. Some specialists have been recording their own data based on their case notes, but this is fragmentary and uncoordinated. Some local health authorities do not even have any allergy specialist to refer Covid patents to, as required by the Green Book. For example Hereford and Worcester have only a couple of respiratory specialists "with an interest in allergies". The vaccine manufacturers are of course organising studies into the side effects of their own vaccines, but the extent to which allergies and similar reactions to different ingredients might be involved – and especially might be aggravated by repeat exposure – is not on their agendas; indeed, in the rush to market they tend to actively avoid testing their vaccines on known allergy sufferers.
This laxity was in the past some extent been understandable. In the desperate rush to roll out effective measures for the vast majority, in the face of ever-evolving new variants, it was inevitable that governments, researchers and manufacturers had no time or resources left for the marginal cases. That is understandable enough. Studies of a sort into allergic reactions have at least been conducted, but it is unclear whether they were able to tease out the distinction between the active ingredients and the various additives, so the usefulness of their ultimate conclusions is at best debatable.
But as the years begin to roll by, the excuses for not getting the research done and making safe vaccines available are falling away. There is a danger that the Evusheld blunder, conflating the overall package with the active ingredient, will remain institutionalised and endemic. Even the early results on allergic reactions are not being acted on as they should be, while the more targeted research in other countries seems to be making little impact on our own authorities.
If you are already an allergy sufferer, or are steadily becoming sensitised, then for now at least you are still pretty much on your own. Even almost two years down the line, you have little more than this page of notes to help you through.
While patient A. started out as a rare case, casual conversations with those involved, such as the allergy clinician and various other frontline staff, have revealed an increasing awareness of such sensitivities appearing and progressively becoming more aggravated in the wider population. Covid arm is, of course, already widespread and a growing issue. Coupled with the way in which these sensitivities will in some individuals worsen violently with repeated exposure to the allergen, there is clearly much cause for concern in the future. We must take A. not as an unusual rarity but as an indicator of what is to come for many of us.
I am not given to startling headlines when analysing complex health issues, but one conclusion stands out starkly. Despite a dozen or more vaccines and treatments for Covid being approved in the UK,
There is NO allergy-safe Covid vaccine or prophylactic available in the UK! The only even potentially allergy-safe medication is the Veklury post-infection intravenous drug.
Note that even Veklury is not without its side effects. It may be allergy-safe (as far as we know) but it still needs to be administered under specialist hospital care.
Patient A. has spent months and months researching the Internet, calling NHS support lines, emailing those responsible and contacting the media. Many hours have been spent by NHS staff following up or escalating the issues raised, some even responding to or treating them as best they can. Many hours of NHS time have been spent on A. that should not have been necessary, including two emergency ambulance calls to A&E. Had the information been made available and the UK Government taken a few simple measures, this could easily have been avoided. Yes, they can easily do something about this, even if the full monty will take them years to work through. What we need right now is to:
The first three actions are especially easy to do; they could begin saving lives and releasing NHS staff to focus on their mainstream tasks, right now. Yet in the years since A. and myself and others alerted the authorities, nothing has been done to stop the tide of polysorbate 80 appearing in any and every new Covid medication.
One substitute adjuvant already in use is the saponin formulation Matrix-M, just don't combine it with Polysorbate 80! Another promising candidate might prove to be peptide SN50, according to new research by the University of Chicago Pritzker School of Molecular Engineering. See "New vaccine design reduces inflammation, enhances protection".
Meanwhile the truly desperate or the continuing traveller might consider visiting a country where Covaxin, Sinopharm or Sinovac is approved and available. An allergy test for Phenoxyethanol will tell you if Covaxin is safe. Sinopharm is a more effective vaccine than Sinovac (If you are OK with the one, then getting the other as a booster is thought to be the most effective approach). However there can be no guarantee that these vaccines meet the UK's stringent clinical safety standards.
And if you see a Covid treatment available in the UK but not mentioned here, please do let me know!