Thread by @GrahamNeary

🧵 A thread on vaccines! 🧵

Many people have already taken the AstraZeneca vaccine, or want to take it.

So I thought I'd read its official Product Information file from the European Medicines Agency.

Some might call this "the small print".

Here is what I learned:

👇👇

Firstly, is it safe for children?

"The safety and efficacy of Vaxzevria in children and adolescents (less than 18 years of age) have not yet been established. No data are available."

How about people with weak immune symptoms - is it safe for them?

"The efficacy, safety and immunogenicity of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy.

How long does protection last?

The EMA says that ongoing clinical trials will tell us:

"The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials."

How about older people - will the vaccine work for them? Many of them have already taken it, of course.

This is what the document says:

"Currently available clinical trial data do not allow an estimate of vaccine efficacy in subjects over 55 years of age."

Sounds important!

And for pregnant women:

"There is limited experience with use of Vaxzevria in pregnant women.

Animal reproductive toxicity studies have not been completed.

Based upon results from the preliminary study, no effects are expected on development of the fetus."

Again, later in the document:

"Animal studies of potential toxicity to reproduction and development have not yet been completed.

A preliminary reproductive toxicity study in mice does not show toxicity in dams or foetuses."

Hopefully the animal trials will show it is safe!

How about studies relating to the risk of cancer and genetic mutations?

"Neither genotoxicity nor carcinogenicity studies were performed. The components of the vaccine are not expected to have genotoxic potential."

Adverse reactions:

- headache (52.7%)
- fatigue (53.0%)
- muscle pain (43.9%)
- malaise (44.4%)
- feverishness (33.5%), fever (7.6%),
- chills (32.2%)
- joint pain (26.6%)
- nausea (22.2%)

Most reactions were "mild to moderate in severity and usually resolved within a few days"

And now the results:

In the control group, 3% suffered "Covid" with at least one symptom.

In the vaccinated group, 1.2% suffered "Covid" with at least one symptom.

None of the vaccinated group were hospitalised by Covid, versus 0.2% of the control group (8 people out of 5,210)

It has the medical equivalent of a provisional driving licence:

"This medicinal product has been authorised under a so-called ‘conditional approval’ scheme. This means that further evidence on this medicinal product is awaited."

A report from a clinical study on how Vaxzevria relates to blood clots/bleeding is due by November 2023.

All of the items in the table below need to be provided to the EMA, most of them "to confirm the efficacy and safety of Vaxzevria".

The final report is due by March 2024.

So that's what I've learned. A good reminder to read the small print!

Do you want to read it for yourself?

Here's the link (PDF file):

ema.europa.eu/en/documents/p…

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