The company (GSK) says that narcolepsy in subjects having had Pandemrix vaccination was caused by wild type H1N1-virus. That is not true. There is some evidence for that in China but not elsewhere.
Interestingly COVID-19 seems to
be rather mild in China and in other Asian countries as compared to Europe or
USA. So if/when we will have a vaccine against SARS-CoV-2, would it be needed
and used mainly in China or in Europa and USA? The US did not accept any
adjuvanted H1N1 vaccines. Have they changed their mind of the AS03 adjuvant?
Will they accept it now? Why not then? Why now? Many questions remain.
Narcolepsy was caused by Pandemrix made by GSK at their Dresden factory in Germany. They had another H1N1 vaccine Arepanrix that was made in Quebec. The adjuvant AS03 was the same in both, and serious adverse events (including having narcolepsy) were statistically significantly more common after Pandemrix than after Arepanrix. It seems that the adjuvant AS03 is safe, but not totally safe as the past history has shown. Even that AS03 probably can be used in other setting using different procedure (different from the past D-pan procedure), it should be carefully studied.
The COVID-19 pandemic seems to slow down in Europe. It has already slowed down in Australia and in most Asian countries. It is still strong and increasing for example in South America, but we still do not know whether there will be any strong second or third wave. We do not know how the SARS-CoV-2 is behaving.
The
H1N1 swine flu influenza pandemic was mild and it killed less people than an
average seasonal flu epidemic. COVID-19 is in that respect much more dangerous.
It just destroys lungs of susceptible people. Therefore at present moment it
seems that we really need a vaccine, but the choice of future vaccines must be
done using all prior knowledge.
Hopefully the development of a safe vaccine is
fast - but can we just pass normal safety studies?
At least it seems that the first testings of a COVID-vaccine should be done in susceptible high risk groups and not in children and adolescents (who had the highest figures of narcolepsy with Pandemrix, and who have a small risk of develping serious COVID-19).
At least it seems that the first testings of a COVID-vaccine should be done in susceptible high risk groups and not in children and adolescents (who had the highest figures of narcolepsy with Pandemrix, and who have a small risk of develping serious COVID-19).
What is the problem? Well, it does not increase TRUST towards the GSK if they first say something that is not true... and then they announce to sell and adjuvant saying that it is safe. Reminds of the past when the company also claimed that Pandemirx was totally safe even that they had evidence in their own safety database that it was not true.
Has the company already done a survey asking if people would choose 1) a vaccine without AS03 or 2) a vaccine without AS03?
They need to increase trust
by starting to speak true. Anybody can make mistakes, but a wise person
(company) admits it and says that we are sorry for the errors that we have done
in the past.
Link to the news on AS03 plans of GSK:
https://www.fiercepharma.com/manufacturing/glaxosmithkline-aims-to-make-1b-doses-vaccine-booster-for-multiple-covid-19-partners
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