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The supposed “legal immunity” from the effects of vaccines

You have asked us through our verification service WhatsApp (+34 627 28 08 15) for a message asking about the effectiveness of health measures against COVID-19. “If masks work, what is social distancing for? If social distancing works, why should we wear masks? If both work, what is isolation good for? “Asked in the text, which is accompanied by an image of American businessman Bill Gates.

The scientific evidence available to date indicates that, in order to reduce the spread of the coronavirus, health measures must be complementary. According to the World Health Organization (WHO), “wearing a mask is not enough to achieve a sufficient degree of protection or source control, so it is necessary to adopt other personal and community measures”Such as social distance and hygiene, says the WHO.

In a review of everything that has been published about protection against SARS, MERS and COVID-19, compiled in June in the scientific journal The Lancet, the researchers determined that the masks “reduce the risk of infection by 85%” . In addition, they agree that no measure is “completely protective and that combine measurements of physical distancing, use of masks and other actions ”such as isolation, which separates people to reduce the risk of contagion.

The responsibility for the adverse effects of vaccines lies with the companies

“If masks, social distancing, and isolation are effective, why do we need a vaccine?” The text asks. As we explain in this article, vaccines are designed to “generate immunity against the disease”, something that is not achieved through health measures.

The message also says that “if coronavirus vaccines are safe, why are pharmaceutical companies asking for legal immunity against side effects? ”.

According to an article published in July by ., the pharmaceutical AstraZeneca, which is working on the development of a vaccine against COVID-19, “has been guaranteed protection against future product liability claims related to its COVID-19 vaccine that await most of the countries with which it has reached supply agreements ”. The outlet cites Ruud Dobber, a member of the AstraZeneca executive team, as a source.

«In the contracts we have in force, we ask an indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest, ”Dobber told ., adding that safety it is a top priority in vaccine development.

In another . article, published in September, it is stated that “European governments will bear the bill above an agreed limit in eventual claims against the pharmaceutical AstraZeneca for the possible side effects of its vaccine for COVID-19” , based on statements from an anonymous source.

From Newtral.es we have contacted AstraZeneca to confirm these statements, but as of today they have not responded. For their part, the European Commission (EC) explains to Newtral.es that “any suggestion that the contracts that the EC is negotiating do not respect the Product Liability Directive is categorically false.” Article 1 of this regulation establishes that “the producer will be responsible of the damages caused by the defects of its products ”.

However, “in this race against time, vaccine manufacturers have to produce vaccines much faster than under normal circumstances. In order to compensate for these high risks assumed by manufacturers, advance purchase agreements provide that Member States indemnify the manufacturer due to certain responsibilities contracted under specific and strict conditions ”, they explain from the EC, who emphasize that“ the responsibility it is still from the companies “.

“This means that Member States are willing to financially cover some of the risks of the companies to guarantee that the vaccines are really available for the citizens of the EU in order to protect the public health ”, they add from the organism, although they do not specify what concrete risks will assume the governments of the Twenty-seven.

[Hacia una cura para la pandemia: ¿qué se sabe hasta el momento de las vacunas contra la COVID-19?]

We have also asked Pfizer if its sales agreements include a “statutory immunity” clause. From the pharmaceutical company they inform us that they cannot say “anything on the subject, beyond what is in the press release that they took out with the EC”, but they refer us to a statement from the European Federation of the Pharmaceutical Industry ( EFPIA).

EFPIA members are currently in talks with authorities and relevant stakeholders to “define a compensation system that works for any affected individual, for health systems and for all those working to end the coronavirus pandemic. “Said in the statement.

Vaccine purchase agreements in Spain

Europe It has already signed vaccine purchase contracts with four pharmaceutical companies: AstraZeneca (300 million doses), the French Sanofi-GSK (another 300 million doses), Janssen (200 million doses) and Pfizer (300 million doses). In addition, community authorities hold conversations with CureVac (Germany) and Modern

For its part, the Spanish Ministry of Health has announced that 1,000 million euros will be allocated for the purchase of vaccines for COVID-19. Specifically, you will buy 20 million doses of the Pfizer vaccine. It is also in negotiations with Moderna to close its purchase agreement, as confirmed on Monday by the director of the Center for the Coordination of Health Alerts and Emergencies, Fernando Simón.

As the Ministry of Health explains to Newtral.es, “the contracts that are negotiated and closed by the European Commission in the context of the European Vaccine Strategy fully respect the European directive on liability for product damage, which dictates a strict liability regime for defective products that is applicable in all Member States ”.

“This legislation does not allow an exemption from liability as occurs in other countries, so the responsibility always belongs to the company “they insist.

“However, taking into account the special characteristics of these vaccines and to compensate for the risks assumed by the manufacturers to bring them to the market, it is expected a compensation scheme by which the Member States would cover the expenses that companies could incur when the liability regime is applied, except in cases of intentional misconduct or non-compliance with the rules of correct manufacturing ”, they add.

Vaccine safety

This does not mean that vaccines are not safe. Before going on the market, treatments have to go through several research stages that guarantee their quality, efficacy and safety, as reported by the Spanish Agency of Medicines. Currently, the experimental drugs leading the scientific race against the virus are in the clinical trial phase.

In phase III of the clinical trial, the stage prior to approval, “the vaccine is administered to thousands of people. The evolution of the immune response of vaccinated people is compared to those who were not vaccinated (control group), evaluating the efficacy of the vaccine. Any symptoms that arise in people are also closely monitored in order to detect any possible adverse effect”, Informs the Ministry of Health.

[El ensayo clínico paso a paso: cómo serán las pruebas en humanos de la vacuna de la COVID-19 en España]

In addition, the health authorities add that “vaccines continue to be evaluated after their authorization and marketing.” The objective is “to continue gathering information to enhance its safety and efficacy, with a much larger sample of people. In this phase, adverse effects may appear that have not been seen in previous phases, precisely because they are less frequent ”, they add.

In short, sanitary measures must be complementary to reduce the spread of the virus. Regarding the “supposed legal immunity” of pharmaceutical companies against the side effects of vaccines, the health authorities indicate that pharmaceutical companies will be responsible for the adverse effects of vaccines. However, some European countries could financially hedge “some of their risks”.

Sources:

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