Vaccine safety update

well it's thursday the 8th of april and you're most welcome to this talk let's try and get to the bottom of what's happening with the oxford astrazeneca vaccine and they these rare blood clots and these rare blood clots are occurring in combination with low levels of platelets these small clotting cell fragments in the blood low levels of platelets the platelets are called thrombocytes and a shortage of thrombocytes or a low level of thrombocytes is called thrombocytopenia peniamine meaning not enough of so it's these rare blood clots in combination with thrombocytopenia now let's start off with the european medicines agency before we look at the uk um authorities now they're saying possibility of very rare cases of blood clots combined with low levels of platelets occurring within two weeks of vaccination no they're not saying probability but the evidence is accumulating now so um probability is not a word they chose but it's one that we could possibly put in there now what i'm saying is that this linking this linking the probability of this being a causal link does seem to be getting stronger there is evidence accumulating but it's still remarkably rare 86 cases in europe and 18 deaths now the european medicines agency are also saying a plausible explanation for these rare side effects is an immune response to the vaccine so there is like a possible what we'll call a pathophysiological explanation for this related to immunity there is a remarkably rare condition called heparin-induced thrombocytopenia where there's an immune reaction to this drug heparin that's sometimes given tooth in the blood actually and so there's there's an analogous condition but it's remarkably rare i've certainly never come across it having given heparin out for many many years so they're saying this is a plausible explanation 86 cases 18 deaths but they're still saying the benefits of vaccine outweigh the risks 25 million doses given now i've just done brief calculations that works out that there's one case per 290 000 doses of vaccine given and one death for 1 million 388 000 doses of vaccine given now all drugs or vaccines have risks and this is a risk but it's a very small risk most cases of women under the age of 60 according to the european information but amir cook uh the the executive director of the european emergency agency said there's no available evidence of specific risk factors such as age gender or previous medical history of clotting disorders so they're kind of contradicting themselves really they are saying more cases in women but she's saying they can't really relate it to any cause in particular so um but she does say this vaccine has proven to be highly effective it prevents severe disease and hospitalization in covid19 and it's saving lives so how the european countries reacted well there was a meeting today of the european union but they didn't arrive at a particular common action so individual countries are going their own way belgium restricting astrazeneca to those age 56 and above italy it's over 60s not being given to under 60s in other words no evidence to stop people having a second dose of oxalistoxenica vaccine now this is true we believe because in the uk as we'll see when we look at the uk data all of the cases of this complication rare though it is but all of the cases occurred after the first dose none after the second dose of the vaccine france only to those aged over 55 our spain only seemed to be giving it between the ages of 60 and 64. so that doesn't quite make sense but that's what the bbc said so i'm not quite sure what's going on in spain france only to those aged over 55 germany um only to those aged over 60s plus high priority age groups and the germans have said that under sixes who've received an uh an extras astrazeneca vaccine for the first time should get a different vaccine for their second dose this is not what we're saying in the uk but it's what they're saying in germany so again we're seeing that different regulatory authorities going for different options here of how to implement this information norway and denmark apparently have gone for full suspensions what's the world health organization saying about it blood clot link was plausible but not confirmed very rare among 200 million people vaccinated with oxford astrazeneca globally is what they are saying now the uk authorities seem to be stressing the the risk benefits analysis so what they've come up with this was in i think it was professor van tam's news conference yesterday they've come up with this graphic here for the risks now this is weighing up the potential benefits and harms of the oxford astrazeneca covered 19 vaccine for 100 000 people with low exposure risk now at the moment we are at relatively low exposure risk because this is based on coronavirus incidence of two per 10 000 roughly the uk march figures so what they're saying in the younger age groups serious harm due to the vaccine could be 1.1 per hundred thousand and that's actually more dangerous than the effect of the disease itself which is 0.8 per 100 000 in people aged 20 to 29 years at the moment but as you can see as the age goes up the risk from the vaccine goes down so 60 to 69 year olds the risk from the vaccine is 0.2 cases per 100 000 people but of course the risk of icu admission here severe illness goes up with increasing age so that's kind of the situation now and as we'll see the vaccine is now not recommended for under 30 year olds in the uk so it's the risk and benefit of the vaccine so that's the figure we've chosen in the uk but we've seen that other european countries have chosen a much higher age threshold not to give the vaccine to to people below that age now if there's a higher risk hundred thousand people with medium risk of exposure now this was the case in um um six out of a ten thousand cases roughly the situation in february in the uk so of course the risk from the vaccine stays the same but the risk of covered 19 goes up so we can see the ratio of severe illness from covering 19. so we can see the rationale for the european countries that have restricted the use of the oxford astrozenica vaccine to the older age groups where the risks are less and then if there's severe disease around as they were the peak of the second wave in the uk then we can see that there's many more people um the the risk of admission to intensive care is much much higher in all age groups in fact so that's sort of the approach that the uk has taken that that risk benefit analysis and it does make say it just vaguely makes sense now the information i've got today all comes not all but most of it comes from here so official government sites now there's a lot of information here so i'm just going to go through some of the main points otherwise we'll be here for a long time so this is the the mhra the medicines of healthcare products regulatory uh what are they called the agency authority i can never remember um can't remember anyway it's the medicine healthcare regulatory people um so we've um we've seen those slides that the risk of adverse events from the vaccine so that they are anyway the mhr race is the medicines and healthcare regulatory agency sorry i've got it right now possible risk of extremely rare and unlikely to occur specific types of blood clots now these are particularly the cerebral sinus vein thrombosis but there are other some rare types as well now the mr mrha have undertaken a thorough review into uk reports as you'd expect it's very rare and unlikely to occur cerebral sinus venous thrombosis though has been reported but these are occurring together with low levels of platelets so this is quite an important point what we're concerned about initially we thought it was blood clots but it's not it it is these things occurring together so cerebral sinus cerebral venous sinus thrombosis occurring together with thrombocytopenia it's the combination of these that seems to be this complication of the vaccine now what else are they saying it uh it also considers other blood clotting cases thromboembolic events so it's it's it is also considering other blood clotting cases thromboembolic events alongside low platelets events what they're saying here is that there can be blood rare blood clots not just in the cerebral sinus venous system but in other parts of the body as well the key thing is is the blood clot in combination with the low platelets they also say that most of these complications occur within the first 14 days now these have been analyzed by the commission on human medicines and independent body and the covid19 vaccines benefit risk expert working group so there's a couple of groups that have given this recommendations now this is quite important i think to grasp that um up to and including the 31st of march in the uk we've had 20 to 20.2 million doses of oxford astrozenica vaccine overall risk of these blood clots is approximately four people per million i worked it out at one per 255 000. now this is interesting because the likelihood of occur the blood clots occurring from the european data was one case in 290 000 that was the european data the uk data one in 255 000. so we can see that these are really quite comparable figures indicating this data is probably accurate now the hmi hmra recorded these 79 cases now 44 of the 79 cases were cerebral venous sinus thrombosis with thrombocytopenia so 44 they're in the cerebral veins 33 of the 79 cases with thrombus in other major veins with thrombocytopenia so most of them are occurring in these large veins that drain the brain but 35 occurred in other parts of the body of the 79 cases there are more women than men 51 women and 28 men and they don't break it down by age but the age range that they took information from was 18 to 79 years more women have been vaccinated in the uk than men apparently anyway now um two reports of blood clots with thrombo uh with thromboembolism reported with thrombocytopenia uh after 11 million doses from the fisa vaccine so that's a that's an aside on the fisa vaccine so less doses of the fisa vaccine has occurred but there's still been two of these rare immunological reactions with thrombus formation with blood clots and low platelets could well be more data to come on that we don't know now sticking get getting back to the oxford astrozenica vaccine there's been 19 deaths tragically um so of of that group of that 79 there was 19 deaths now i did work out the deaths so that was the deaths i worked out in the uk that was the deaths from the european data 1.38 million from the european data one in just over a million from the uk data so again there is consistency now 19 people have died out of the 79 cases tragically 13 women and 16 13 females six males um and they are women and men boys and girls haven't been included they're not being vaccinated at the moment um 11 out of the 19 people who died were under 53 of whom were under 30. 14 of these 19 cases were cerebral sinus venous with thrombocytopenia so they were the causes of deaths in 14 out of 19 five of the 19 were thrombosis with cytoplania thrombocytopenia in other parts of the body but all 79 cases occurred after the first dose of the vaccine so these were all after the first dose of the vaccine now we need to keep this in context as of april the 8th uh last 24 hours another 53 people died of covered 19 still 126 980 deaths or 149 968 deaths if you take the death certificate data so when we remember the amount of people that have died of covered 19 this does put this into some sort of context now the level of risk the level of risk has gone up slightly now that there's more information available these are the numbers from the 31st of march slightly higher than the 24th of march so the data is evolving unfortunately in the wrong direction at the moment now guidelines now this is the this is the uh this is the hmra here and they're saying this hmra not recommending age restrictions for covenant 19 vaccine and astrazeneca use that's what they're saying but the joint committee on vaccination and immunization are saying acting on a precautionary basis these persons that's people under the age of 30 still unvaccinated it's preferable for them to be offered an alternative covered vaccine if available and in the uk that would be the pfizer or the modern and not the oxford astrozenica vaccine so that is uh that is that one saying not age restriction uh that is uh that is that one the j c v i statement saying there should be an age restriction so we are going with the uh joint committee on vaccination and immunization and not giving it to the under 30s in the uk um that's what the current guidelines are saying um i'm just going to read some of these guidelines out we haven't got time to do them all indeed they are all on those reports i've just got them straight from the reports these are not from popular news outlets the direct from these websites uh hmra is not recommending age restrictions but as we say that the vaccination people are so that's what we're following people any age who are at higher risk of blood clots only if should only be given the vaccine if the protection outweighs the potential risk so what they're saying to doctors administering vaccines and teams administering vaccines that people of any age who are high risk of the blood clots should only be given the vaccine if it's overall safer for them as an individual to be given the vaccine and in most cases that will mean they probably won't be able to imagine um cerebral or other major blood clots with low levels of platelets after the first dose should not have a second dose in other words if people have had major blood clots or the platelets have dropped after the first dose of the oxford estrogenic vaccine they should not be given the second dose but anyone who didn't have the side effects should be given the second dose and remember all of the 79 complications occurred after the first dose pregnancy should say pregnancy disposes to thrombosis discuss with their healthcare professionals so if you any possibility that someone could be pregnant flag that up to the team before vaccination now the guidelines don't mention oral contraception i think oral contraception is worth flagging up to the vaccination team if uh you're an oral contraception they don't say that but uh the the cerebral sinus venous thrombosis normally although it's very rare i understand it to be more common in people that are on oral contraception so it's worth discussing that with the team and then the decision can be made um evidence to date does not suggest that astrazeneca vaccine causes venous thromboembolism without a low platelet count now we talked about this when we talked about deep venous thrombosis and pulmonary embolism because that's initially what it looked like they were talking about but here they're saying that the vaccine is not causing that this is this specific type of of blood clots of thrombosis but accompanied by low levels of platelets it's the low levels of platelets now they do give some precautions that for people to look out for after they've been vaccinated um so people with shortness of breath persistent abdominal pain or leg swelling should report for medical attention blurred vision confusion or seizures so basically the shortness of breath uh chest draw persistent abdominal pain they're related to blood clots so the shortness of breath could be pulmonary embolism for example blurred vision confusion or seizures are brain related things related to the blood clots in the vein veins draining the brain pin prick rash or bruising beyond the injection site that could be a sign of blood leaking into the tissues which could be a sign of the low levels of platelets so that should be reported new onset of severe or persistent headache that does not respond to simple painkillers starting four days or more um after vaccination those people should speak to their doctor so in other words headaches in the first few days after the vaccine is not too uncommon but they're say they're saying if it starts four days after the vaccine doesn't respond to painkillers should speak to their doctor i think that's what that's saying new onset is a real persistent headache that does not respond to simple painkillers starting four days or more after vaccine should speak to their doctor and of course speak to your doctor if you're worried now uh dr june rain uh chief executive officer of the mhra over 37 million doses of vaccine against carbon 19 have been administered in the uk saving thousands of lives let's not forget that no effective medicine or vaccine is without risk absolutely not you know people are always saying to me is is this treatment safe well no no no treatment is safe there's always an element of risk all medical treatments have an element of risk as as i've said before the only safe treatments are homeopathic treatments because no doses of the active molecule is given therefore they're safe any other time there is an element of risk there's an element of risk taking aspirin that's been quite a few of us taking aspirin actually ibuprofen that there's risks with all of these things but also potential massive benefits again direct quote we continue to monitor safety during widespread use of any vaccine these blood clots remain extremely rare and unlikely to occur okay she then encourages the use of the yellow card system which is click on that website anyone can report there it is still vitally important that people come forward to their vaccines for their actions when invited to do so so so so that there we have it um that's basically what's happening the the thing that's really convinced me that there is a genuine uh my current belief evidence can change is that there was a causal link between the oxford estrogenic vaccine and these extremely rare events they are extremely rare remember the european data 25 million vaccines given 86 cases so very rare events and all medicines all vaccines have an element of risk and as we've seen it's always this balance of risks now the risk here is that people will not want the oxford astrozenica vaccine and would prefer to go for an alternative vaccine that's understandable but of course as more data comes out from these alternative vaccines then it may turn out that there's uh there's there's complications from them as well so more to come on that story but that's where we are now and uh the european country is restricting the use of the oxford astrological vaccine in younger groups does seem to be a reasonable precaution now um i think i will say one more thing this is advice for healthcare professionals from the website following administration of the s glyco approaching of starts coronavirus 2 is expressed locally stimulating neutralizing antibodies and cellular immune response so in other words when you give this vaccine you're giving the the you're giving it in these adenovirus vectors that contain this that contain this um in the case of the adenovirus the dna to code for the spike protein and that goes into the cells in the arm where you give the injection and then that causes the cells in the arm to start producing these spike proteins they're the same shape as the spike proteins on the size coronavirus 2 that are then recognized by the immune cells to generate the immune response that's the way it's working so following administration of the s glycoprotein of sars coronavirus 2 is expressed locally stimulating neutralizing antibodies in cellular immune response so this in this case would be a muscle cell in in the deltoid muscle where that's been given so you would give the vaccine into the deltoid muscle the adenovirus vector carrying the information to make the uh the spike protein goes into that cell it's made by that cell it's expressed by that cell locally and it'll also be picked up by what's called antigen presenting cells and go into to the lymph nodes as well so that's what's supposed to happen now in denmark they've thought that there's a risk that when you give an intramuscular injection um that you can give it into a blood vessel by mistake now this possibility is not mentioned you see these are all these things that we've been discussing are all blood problems the thrombocytopenia and the clotting they're affecting the blood so i'm just wondering that this is a question for the regulatory authorities this is my question if if the vaccine was inadvertently given into a blood vessel that would mean that the vaccine went into the blood vessel would that mean that the vaccine then went to blood into blood cells and instead of the muscle cells in the arm expressing the spike protein generating the immune response blood cells started expressing the spike protein now if that's the case could that expression of the spike protein and the immunological response that would generate in the blood cause this rare complication now in denmark they think that's a possibility so they've told people to make sure they give the vaccine into a muscle now um i've been given intramuscular injections since i was 18. and um don't worry this is not the the vaccine's not as big as this but what you do is you you stick this into the muscle and we were always trained to draw back to see if you get blood and if you don't get blood then you inject because you know you're in a uh you're in a muscle not you're not giving it into a vein and in fact i used to give um what we call depot phenothiazine see that bubble there it was just habit to knock those out so um not that i'm injecting anyone with this so so what what i used to do giving these thick oily things and of course you don't want to give those into a blood that's so that would be very serious so you'd stick you would stick it in and we used to use the gluteal muscle at the top of the the buttock upper right and upper right quadrant of the buttock used to stick it in aspirate inject some of the vac inject some of the the medication then halfway through i'd actually aspirate again just to make sure the needle hadn't slipped and then give the rest so that's important but the world health organization guidelines don't mention aspirating the um the green book infection against disease guidelines in the uk actually say you don't need to aspirate so i would like to ask the regulatory authorities why don't you need to aspirate because it could be given into a vessel inadvertently then would that make blood cells generate the spike protein and have an immunological response as opposed to the muscle cells and could this be responsible for for these side effects well the danish authorities think that's a possibility and have changed their guidelines accordingly so that's my question to the regulatory authorities um why aren't we ensuring we give it intramuscularly by aspirating and i can i can just show you um what you see when you're asked but i have shown you this before it doesn't do any arm to look again if i can get the right one there we go yeah so um imagine that's a imagine that's a blood vessel there and instead of giving it into the muscle you get into a blood vessel then then what you see when you draw back is very obvious you can see blood coming into your syringe and you know it's in a blood vessel so you don't inject it so that would be my question to the regulatory authorities wouldn't it be safer to consider a danish approach to this and uh change the guidelines to advise vaccinators to respirate prior to injection just a simple question if if uh hmra or the uh the vaccine people want to get back to me i would love to hear from them okay so um bit long and complicated there is a link it's still very rare and the government is still saying come forward for vaccination when you were called personally well my first vaccine as it happened was pfizer but um personally for my sex and age i wouldn't hesitate to have the oxford oxford estrogenic vaccine um but we must go by our regulatory authorities and they are varying slightly uh depending where you live in the uk or whether you live in the european union area so i think that i hope that makes sense i know it's a bit of a quick whiz but that's roughly where we are and as i say look on all these websites so all that information i got apart from the european ones i got from the bbc but all this is from the so that's the jvc i that's on that one there you can download the full document that's the hmra one and again everything there with additional links and that was the powerpoint we looked at for the relative risk so uh everything available for you to check out for yourself but for now thank you for watching

Channel: Dr. John Campbell

Views: 252,539

Keywords: physiology, nursing, NCLEX, health, disease, biology, medicine, nurse education, medical education, pathophysiology, campbell, human biology, human body

Id: vEg523BilxI

Length: 29min 32sec (1772 seconds)

Published: Thu Apr 08 2021