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There are three new vaccinations currently on the agenda. Two are out now; the other is in clinical trials, but for how long? There is a debate about how to justify short-cuts in safety testing.
The first two are fresh booster Covid jabs which the US FDA
authorised for emergency use last week. Made by Moderna and Pfizer, these are ‘bivalent’, i.e. a combination of the formulations against the original Covid-19 disease, with other ones to combat a couple of the newer Omicron variants.
Part of the information to support this decision is ‘nonclinical’ since the bivalent versions have not had the customary extensive testing, although thanks to mass vaccination there is plenty of evidence about the effects of the individual elements in them.
There is a parallel with the easier approval route for annual influenza jabs, as an
article in Science magazine explains:
Influenza vaccines are updated each spring to try to match the strain most likely to circulate in the fall and winter. The reformulated shots don’t have to undergo new clinical trials unless the manufacturers significantly change the way they make the vaccine. A similar approach for new COVID-19 variants makes sense, says Leif Erik Sander, an infectious disease expert at the Charité University Hospital in Berlin. The changes to the mRNA are minor and providing updated vaccines as quickly as possible is “an ethical issue,” Sander says. “We need to allow people to protect themselves from a virus that we can’t fully control.”
The speeding-up may help protect the public but raises the issue of trust, as the writer goes on to say:
But there is a potential downside: Authorizing updated vaccines without clinical data could lower public acceptance. “If a variant booster is going to reduce overall uptake, that’s a potential problem” that could offset the gains in protection from the new vaccine, says Deborah Cromer, a mathematical modeler at the Kirby Institute of the University of New South Wales.
For the drug companies, Emergency Use Approval (EUA) not only gets their product earning money sooner but indemnifies them against lawsuits for damages. This is bound to raise suspicion that for Big Pharma, given carte blanche, profits could trump safety.
It must be stressed that there are definitely risks associated with vaccination against diseases. The UK
introduced a compensation scheme in 1979 and the first
Vaccine Damage Payments in respect of Covid-19 jabs were made in
June this year.
Public confidence has also been damaged by previous over-emphatic Covid-related communications from governments, the use of social pressure to enforce mass vaccination and other strategies, and the associated campaigns of suppression of dissident voices.
There are signs that the government has rethought its position. Last December, the
House of Lords voiced concerns about making vaccination mandatory for NHS staff;
this April, the NHS deemed ‘non-urgent’ and merely ‘recommended’, jabs for children aged 5-11 who are not in a higher-risk category; and although
twice as many people died this summer ‘with’ Covid as in the same period last year, we are no longer forced to wear masks, observe ‘social distancing’ or endure more of the lockdowns that have caused great and lasting damage to the economy and had negative side-effects on physical and mental health. Former Chancellor Rishi Sunak
has recently said he never received a cost-benefit analysis of the proposed measures to tackle the pandemic; today we are paying the price.
Now about the third newbie vaccination. One jab-dissident is Dr Vernon Coleman, a retired British GP who has long been skeptical of the safety and efficacy of vaccines in general. This and his opinions on some other matters have earned him a
carefully damning opening paragraph in Wikipedia (a crowd-compiled site notoriously vulnerable to misinformation and malicious use) as well as abuse, censorship by e.g. Youtube and so on.
Nevertheless, Dr Coleman has
raised concerns over a new-style influenza vaccine (BPL-1357) that,
it is hoped, will protect against many or all variations of the virus.
Initial clinical tests were run on mice (but in the case of the Covid boosters, only 8 of them
according to this anti-vaccine writer !) and ferrets, and the formulation is now undergoing a Phase 1 clinical trial with humans.
A
standard Phase 1 trial is conducted on a small number of healthy people, with a control group taking a placebo. This can’t prove that the medication is safe for everyone, but at least (one supposes) it will indicate that it’s not extremely dangerous for young-to-middle-aged people in good condition and without certain risky lifestyle factors. Larger-scale and longer-term trials (often taking years) follow.
What concerns Dr Coleman - perhaps prematurely, but we shall see - is that as with Covid/Omicron, there may be a rush to get this vaccination cleared for rollout. The motive for the government is that influenza kills tens of thousands in the UK every year; for manufacturers, the commercial incentive is obvious.
The efficacy of Covid vaccinations at least, is clearly not complete. It is generally accepted that you can get and spread Covid despite the immunisation; even quadruple-jabbed President Biden came down with the illness recently.
As to risks, I myself have had the double jab and a booster, and each time I was not advised of any potential hazards; in short, I was not put in a position to give informed consent. Nurses were injecting us as though on an assembly line,
raising up to £20 a time for the group practice. GPs were earning
well into six figures during the pandemic.
With all these rewards for medical professionals and product providers, there needs to be a counterweight of extra caution to protect the interests of the patient. So the real issue is Hippocrates’ principle, ‘
First, do no harm.’
