UK First To Trial Mass Roll Out of Pfizer’s Barely Tested COVID-19 Vaccine

The first lucky few to get the vaccination will be those over the age of 80 and care home workers. The first vaccinations will occur in Scotland within days.

So just how effective is this Vaccine?

Pfizer have stated that their new BNT162b2 vaccine is 95% effective. This was determined from the first 170 cases of COVID-19 identified from over 40,000 participants enrolled in the trial.

From these 170 cases, 162 were in the Placebo group and just 8 were in the Vaccinated group.

The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol, of which 162 cases of COVID-19 were observed in the placebo group versus 8 cases in the BNT162b2 group. – Businesswire[2]

Specifics surrounding how they’ve been testing the participants is not clear, are all 40,000+ participants being tested daily? How many in total were in the placebo group and how many were in the vaccine control group?

The truth is, we really don’t know much, Pfizer have yet to release full details on the study findings, just the press release which can be found HERE[2]

How safe is the vaccine?

Pfizer are claiming:

To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. A review of unblinded reactogenicity data from the final analysis which consisted of a randomized subset of at least 8,000 participants 18 years and older in the phase 2/3 study demonstrates that the vaccine was well tolerated, with most solicited adverse events resolving shortly after vaccination.

The only Grade 3 (severe) solicited adverse events greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.8% and headache at 2.0% following dose 2. Consistent with earlier shared results, older adults tended to report fewer and milder solicited adverse events following vaccination. – [2]

I have been unable to find the study data relating to Phase 3 of the trial, but here is what they found from the Phase 1 & 2 trials:

Adverse events (Extended Data Table 2) were reported by 50.0% (6 out of 12) of participants who received either 10 or 30 μg of BNT162b1, 58.3% (7 out of 12) of participants who received 100 μg of BNT162b1, and 11.1% (1 out of 9) of placebo recipients.

Two participants reported a severe adverse event: grade 3 fever 2 days after vaccination in the 30-μg group, and sleep disturbance 1 day after vaccination in the 100-μg group.

Related adverse events were reported by 25% (3 out of 12 in the 10-μg group) to 50% (6 out of 12 each in the 30-μg and 100-μg groups) of individuals who received BNT162b1 and by 11.1% (1 out of 9) of participants who received the placebo. No serious adverse events were reported. 

But the truth is, right now – we don’t really know how safe this vaccine is. It’s been just a few months since the first participants in the trials took their first dose, so for now we’ll have to wait and see.

But one thing we do know is that there are adverse effects and they are not pleasant, in fact 25% of participants in the vaccine group suffered from chills, nausea, shaking, fatigue and headaches. This poor guy was shaking so violently he chipped his tooth:

Another coronavirus vaccine trial participant, testing Pfizer’s candidate, similarly woke up with chills, shaking so hard he cracked a tooth after taking the second dose. CNBC[3]

Which is a little concerning, to say the least. There are many statements being banded about surrounding the new COVID-19 vaccines, such as ‘it alters your DNA’ and ‘it disables your ability to love and feel empathy’; now these sound like baseless conspiracy theories, and of course they are being touted as such in the blessed mainstream media. However, there may be some foundation to both these theories. But we’ll dig into that another day.

For more information on the vaccine, its ingredients, storage requirements, administering protocols and much more go to the GOV.UK website[4]

 I’ll be sifting through the literature over the coming days.

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