Don’t jump the gun with Pfizer’s RNA vaccine

Don’t jump the gun with the RNA vaccine. The science is far from complete and not yet published for proper scientific scrutiny – and the numbers are very small. Here’s what I’ve learnt. Out of an apparent 43,538 people in the trial, so a bit more than 20,000 getting the vaccine and 20,000 getting the placebo (salt water), 94 became infected.

Firstly, nothing is published so we know nothing about how people were assigned to the vaccine group or placebo group. So the ‘randomisation’ is questionable at this stage. For example, if you had more in the placebo group in high risk areas that would skew results. Secondly, I don’t know how people were followed up to identify the 94 confirmed cases. Thirdly, I don’t know the nature of these cases – positive PCR test, mild or severe symptoms? These are important questions that need answering.

The decision to ‘go public’ with only 94 confirmed cases goes against the trial protocol, which was to do the final analysis at 164 cases. Either way this is a very small number of cases to make a national decision about. But, note that if there were 86 cases out of 21,769 people given the placebo this means that one’s risk of becoming infected is 0.004, or 0.4% or one in every 250 people.

They have not said how many of these cases were in the vaccinated group, but they have claimed 90 per cent effectiveness. This suggests that there might have been 8 cases in the vaccination group and 86 cases in the non-vaccinated group. If so you you could say that a vaccinated person is a tenth (or 90%) less likely to get an infection.

Apparently they’ve had no safety concerns. With over 20,000 receiving the vaccine this is rather unlikely but good news if it is the case. They can’t ‘break the code’ for this double blind trial because that would end the ongoing trial, but can ‘break the code’ for those who become infected. Also, I’ve looked but can’t find out what is in this vaccine. Aluminium as an adjuvant? I don’t know. If you do please let me know.

How effective is it in older people? There were people over 65 in the trial, so once there are enough cases (months away) this question can be addressed. How about young people? The trial was only for those over age 16 so this question won’t be answered in this trial.

This is a Phase 3 trial. If it proves effective the next step is a Phase 3b ongoing trial which means monitoring people over a year to look for adverse reactions. This is important because, unlike the vaccine trial, which is controlled by the vaccine maker (eg motivated to show benefit and no harm) in Phase 3b doctors and health authorities collect the data on adverse reactions. Personally, I wouldn’t have a vaccine before this phase is completed. The last ‘swine flu’ vaccine turned out to cause narcolepsy in this phase while thought safe in the initial trial. But I do understand why some ‘at risk’ people might take this risk. It would be completely wrong for a government to insist on having a vaccine before phase 3b is completed without being transparent about the unknown adverse effects at this stage.

However, life is a risk. The nice thing about eg getting your vitamin D level up and taking eg 1 gram an hour of vitamin C when infected until symptoms abate is that there is no risk. Also, the prerequisite to a vaccine working is a responsive immune system so taking vitamin C, D and zinc should help the immune system to respond. Hence, an older person would definitely be wise to take more vitamin C (and zinc) in the weeks before being vaccinated to improve their immune system’s responsiveness.

Also, don’t forget that Pfizer stands at No2. in terms of biggest health care fraud settlements, with GSK being at no.1. According to Wikipedia Pfizer paid $2.3 billion in 2009 as a health care fraud settlement to resolve criminal and civil allegations that the company illegally promoted uses of four of its drugs. I’d say let the results be published once 156 cases have occurred and let the scientific community dissect them before making any rash decisions.