English transcript

So your result at that time, from those two, you had only eight participants with symptomatic

COVID confirmed by PCR test in the vaccine.

And you have 162 in the placebo.

But if you don't measure for the vaccine group, you don't have COVID.

So your main criterion is statistical bias.

It's a big issue because it's a violation to good clinical practices.

Because you can trust your 95% of efficacy.

So at the time, in December 2020, you had no efficacy proved on several cases.

You had no efficacy proved on the more than 75 years old.

In the clinical study report, you don't have statistical proof of efficacy on this population.

Into the clinical trial, you had pregnant women excluded, immunocompromised patients excluded,

patients with comorbidities excluded.

So you had no result on this population.

So you take a risk.

You take a risk because you don't know how will be the result of safety and efficacy

on this population because you had no result at this time.

Problem is urgency and going fast.

It's not often compliant with good work.

Immunogenicity.

So it's your neutralizing antibodies.

You say if you have neutralizing antibodies, you are immunized and it's okay.

It's good.

You won't have COVID or severe COVID or I don't know.

So at the time, results on macaques.

What can we see?

You have your dosage before product.

Then you have the vaccine and you have your neutralizing antibodies that increase and then

decrease.

Result of the phase one and two.

You measure neutralizing antibodies at one month after those two, two months after those two.

So it increases at one month and two months after those two, there is already a decrease.

And what can we see in the phase three?

That there is no measurement of the antibodies three months after those two.

Why?

One, we have the CDC with publication.

We have found that antibodies decrease after three or four months and you will have to

get a booster.

In December 2020, Pfizer already studied a booster.

And in September 2021.

So bad.

Our anti-neutralizing antibodies decrease and you will have to get a booster because

two doses are not enough.

So okay, you will get your normal life.

And no, because they knew that the booster would be necessary because your antibodies

decrease.

Decrease in three, four months.

But why they did not measure?

So if we had this measurement, why it's so important?

Because you will have a bar here.

And at that time, if the authorities had this weighing of the antibodies, the authorization,

we would have given the authorization with antibodies here at three months.

It would be more difficult.

More difficult to give an authorization with a result.

It's for the new vaccine that there is no result of clinical trials.

The new one with the BE5, BE4, that's for the new ones they are going to put on the

market in two months or one month.

So you have all this stuff.

So short duration of the follow-up, main criterion with bias.

And the question, was it so very representative of the disease?

Because if you look at the number of real patients with COVID into the clinical trial,

now we can compute this because we have the released documents and we have the released

SAS datasets that are the tables used by biostatisticians.

So when we compute this, the number of patients with COVID using the serology,

anti-nucleocapsid serology, then you find that you have only 55% of efficacy, not 95%.