UK has a wonderful “Yellow Card Scheme” since 1964, where any adverse reaction to a drug or vaccine can be immediately reported. Earlier done through actual yellow cards, now it is online. Yesterday, two Pfizer vaccinated NHS workers reported an anaphylactoid reaction, which may cause a skin rash, breathlessness and a drop in blood pressure. Both vaccinees had a history of allergies. UK has now advised people prone to severe allergies to avoid the vaccine. The advice also requires vaccine facilities to have resuscitation measures available.
This has caused concern in the minds of those planning
to get the vaccine, and a sadistic joy to the anti-vaccine crowd. This analysis
will show why the concern is unfounded.
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Most drugs and vaccines have side effects. The
decision for any medical intervention is based on the risk-benefit analysis. Chemotherapy
drugs that cause exhaustion, hair loss, anemia, infertility, sleep problems are
an extreme example. This known debilitating impact is weighed against possible survival
from a terminal cancer.
Vaccines prevent, rather than cure, diseases. Here we
must weigh the risk of contracting Covid and dying from it versus the vaccine risks.
In the last eight months, nearly one person out of 1000 has died of covid in the
USA, UK, Italy or Spain. (In India, one out of 10,000). If you belong to a covid
vulnerable group, the probability of death is much higher.
Against that, the 95% effective Pfizer vaccine reports
injection site reactions (84%), fatigue (63%), headache (55%), muscle pain (38%),
chills (32%), joint pain (24%) and fever (14%).
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To help your decision on the Pfizer vaccine (in case
you can get it), I offer two documents that discuss your eligibility.
The first is the Pfizer protocol where they
clearly state who is excluded from the trials. (Pages 37-40). The second
is a fresh document. It will be used later today in the FDA meeting to discuss
the Pfizer vaccine approval in the USA. (Pages 48-49).
Pfizer protocol clearly excludes: “Those with history
of severe allergic reaction (e.g., anaphylaxis).
Without any medical knowledge, it is common sense that
categories excluded in the vaccine trials must be excluded from vaccination.
The UK regulatory authorities botched this up. The two NHS workers were not
eligible (they carried adrenaline pens on them, meaning they were known severe
allergic cases). Before vaccinating, it is the duty of the health authorities
to ensure the person qualifies for the shot.
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Who else is not eligible?
Mainly anyone below 16 years of age, pregnant or
breastfeeding women and immunocompromised people. AIDS patients, for example,
have their immunity compromised. In case of doubt, make sure with your doctor you
are immunocompetent rather than compromised. The protocol excluded some more:
those with a psychiatric condition, suicidal behaviour, prone to prolonged
bleeding. Pregnancy is such a sensitive issue that participants needed to promise
not to get pregnant, by following highly effective contraception consistently
and correctly.
Pfizer hasn’t revealed its vaccine recipe. But we know
many flu vaccines contain egg proteins. Those severely allergic to eggs are
advised not to take a flu vaccine.
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I will give you two more bits of news from the Pfizer report.
Six participants died since the start of the trial, two from the vaccine group
and four from the placebo group. This is not a concern, because in very large
trials some people are going to die as a matter of natural course. If the UK is
giving vaccines to people over 90, some may die in a matter of weeks after receiving
a vaccine. Let that news not bother you.
Pfizer also found that four vaccinated participants developed
Bell’s Palsy, a temporary facial paralysis. This again can be a chance event.
Surprisingly, between April and July, Mumbai and Bangalore reported many cases
where Covid-19 had caused Bell’s Palsy.
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In short, if you are older than 16, not pregnant now
or in near future, your immunity is not compromised, you don’t suffer from a
serious allergy, you can go ahead and get vaccinated. The risk is worth taking.
Ravi