Coronavirus Vaccine: Who Will Take Charge If It Causes Adverse Effects In Patients?

Irene Hartmann

07/10/2020 - 17:50

• Clarín.com

• Society

A pessimistic but possible scenario: a coronavirus vaccine is approved.

It goes on the market and we apply it, thirsty for immunity.

What if something happened that nobody dares to discard?

If the vaccine

ended up producing

in some patients?

Who would take over?

Who would settle eventual

?

The questions fly over what at this point is already a network of twists and turns, between pressures, impositions and conditioning, whose protagonists are basically

.

The Argentine, among them.

A little for scientific prestige, a little for commercial profit (although some laboratories swear to work "at cost") and the same - it is assumed - for a certain philanthropic sensitivity (avoiding more deaths in this pandemic), the laboratories accepted the challenge and

external

against the clock to bring an effective and safe vaccine to market.

This, like everything in life has its

.

What are they asking for in exchange for the sacrifice of plunging into a crazy scientific career that involves them investing in developments that could fail in five minutes, in exchange for -in specific cases- choosing to subsidize their company, following the well-known motto “

”(“

lose ”)? 

The development of vaccines against the coronavirus advances.

Many will go to the market with facilitated procedures and doubts arise about what will happen to the potential lawsuits in the event of adverse effects.

Reuters photo

That the governments facilitate / alleviate / make them more flexible, cover them or a little turn a blind eye to certain

that, in the future, could be a stick in the wheel.

On the one hand,

, that is, situations of litigation by what in the sector is called

, or "Events Supposedly Attributable to Vaccination or Immunization."

On the other,

on the part of the laboratories themselves.

That is, from delays in deliveries to smaller items than agreed or problems with the cold chain, to mention just a few items.

To close this general screenshot, as well as the United States and Europe had to conclude negotiations of this type with the pharmaceutical companies that more "cooked" have the longed-for vaccine, it is Argentina's turn.

The rules of the game are set by them.

And it's in "

"

mode

.

The Russian coronavirus vaccine.

So that clauses such as those requested by the laboratories can be agreed here, the Government (embodied in the Ministry of Health) needs to be "loose of its sleeves."

Therefore, at the end of this note, the Chamber of Deputies discussed (with chances to pass) a bill promoted by

the ruling, which will allow the portfolio that leads Ginés González García have green light on some

when to sign the

mentioned. 

Superpowers

"Superpowers?

No, I don't think that's the term.

This is an exceptional situation and, of course, not just any vaccine will be approved.

The developments will have to continue being evaluated by the normal lanes: the ANMAT, the (National Immunization Commission) CoNaIn and the Ministry of Health ”, explained to

the author of the project of the“

”, the national deputy for Tucumán (from the Frente de Todos)

.

On the sidewalk opposite, the PRO deputy Graciela Ocaña, member of the Health Commission, the area where the project in question was evaluated and modified, was emphatic: "We discussed it and improved it, but

."

The central points of the opinion are three. 

In the first place, the deputies would give Salud the freedom to agree that the laboratories have what is legally called "

."

The interior of the laboratory that will produce the country the "active substance" of vaccine against Oxford University.

Photo Maxi Failla

In this way, in the event of entering into a dispute with the Argentine State (due to any contractual difference: non-compliance in payments, in deliveries, in quality or quantity of lots ...), the

that will hear the case will not be the local but

.

It follows that each company will choose the one in its country-headquarters.

"But it must be clarified that 

, not in Tokyo or Singapore," Yedlin stressed, referring to possible "adverse effects", that is, ESAVI.

The second point is derived from this:

.

The project enables the Ministry of Health to include clauses that establish -in favor of the manufacturers- “

regarding compensation and other related pecuniary claims (…) with the exception of those originated in fraudulent maneuvers, malicious conduct or negligence by of the subjects referred to ”.

One of the sources consulted translated it into

: "Basically, if a problem arises, we couldn't kick a lot."

But, returning to the demands of eventual victims, it is uncertain what will be agreed.

Perhaps it serves as context that the governments of the

already agreed to

in the event of litigation by ESAVI.

Considering whether third world countries could meet such demands, Yedlin said that, in any case, "the price that the pandemic and quarantine are having is of immense magnitude for the Argentine and world economies."

Nobody rules out that here a

or totally

is reached

.

By the way, 

been consulting the Ministry of Health on this issue for a couple of weeks, but at the end of this note a response was still expected.

Fast track

Is it forced to talk about adverse effects when the vaccine was not even approved?

In the sector, it is said that a drug went through the “fast track” when, in fact, the main supervisory bodies of the world pharmaceutical industry, the

(FDA) and the

( EMA) - something like the older brothers of the ANMAT - authorized to shorten the process that any drug goes through before reaching the consumer.

Laura Raccagni

, pharmacist and coordinator of the Observatorio Salud, Medicamentos y Sociedad of the Argentine Pharmaceutical Confederation (COFA), explained that, “in this special situation, all the times for the redemptive vaccine to appear are being shortened.

And a lot ”.

How much?

This point was explained by

, former Minister of Health of the Nation, doctor of Medicine and Master in Clinical Epidemiology: “All those who are at the fore, that is, Moderna, Pfizer, AstraZeneca or the Chinese vaccine, have published in prestigious magazines its preliminary phases 1 and 2 and are now in phase 3. There is no reason to think that things are being done wrong.

In any case,

with regard to the

, which usually takes a couple of years and will now be done in months ”.

Precisely, the inclusion of that point in the aforementioned law was being debated in Deputies at the close of this note.

"We ask that this modification be removed, which they added in the last minute on Tuesday night," Ocaña complained.

For Rubinstein, if due to the rush there will be greater risks, "it is not easy to anticipate ... it was a good sign that AstraZeneca suspended their tests due to a complication they observed. He talks about the fact that things are taken seriously, that they are not passing the traffic lights in red. But, yes, 

, "he added.

Raccagni was tougher: "Although fast track is a route thought out when there is no alternative for a certain disease, it is usually used in medicines for very rare diseases that affect few people in the world. There are already experts who are warning about the

”.

Confidentiality

The third topic is as complex as the previous ones.

In Argentina, two types of

:

between the country and each laboratory;

and those involving the international

fund

(of the WHO, similar to the revolving fund of PAHO, but global in scope).

Ocaña said he does not know what is being signed "because they have

" and added: "At least we managed to get them to join the project that these contracts are made known to the National Auditor's Office (AGN) and to the members of the Health commissions of both chambers ”.

But, Yedlin explained, some issues will be a summary secret, for example, "the laboratories asked that the contract state that they reserve the

, that is, how it is made."

In other words,

that will compete with the vaccine that comes from abroad.

As with the famous internationally renowned soft drink, the formula will be unique and magical.

DD