[ad_1]
In the last week, the public debate around vaccines for COVID-19 has intensified, regarding a bill that is being discussed in Congress that seeks, among other things, to grant compensation to vaccine manufacturers, in a way that they do not have to take responsibility for the adverse events that they may cause.
(You may be interested in: Minsalud says that for now it will not request PCR tests to enter the country)
These are the points we have discussed with many people, even strangers on Twitter. Thanks to all who have been encouraged to dispute, share or enrich the ideas expressed. Here are our reflections.
There is political and citizen pressure to access vaccines early, but there is much uncertainty about their safety and efficacy.
In this context of collective anxiety and fatigue, there is nothing more dreamed of than the magic solution that will get us out of this pandemic by making the leader who manages to secure it popular.
For this reason, the financing of the vaccine, but especially the guarantee of its purchase, has become an arms race. Global doses of the vaccine will probably be insufficient to supply all countries sufficiently.
The supply of the vaccine then becomes a raptor, a kind of piñata in which all countries tear their clothes and attack the others in order to guarantee some units.
The speed of development and production of vaccines for COVID-19 implies that there will be a lot of uncertainty about their safety and efficacy. If we want fast vaccines, we must be willing to sacrifice the safety and efficacy standards that we traditionally impose on NEW health technologies.
The Ministry of Health is under enormous pressure to solve this dilemma: Vaccine faster, but more risky or vaccine safer but more delayed?
On the one hand, there are voices that are hopeful about the vaccine as a way out of the pandemic, which rebuke the Minister to acquire many vaccines at all costs, despite the very high uncertainty about their safety and efficacy.
(Further: Most of the Colombian population would receive covid vaccine in 2022)
These voices, in turn, criticize his management for not having done enough for the country to be first in line for the global distribution of vaccines.
On the other hand, there are skeptical voices (among which we find ourselves) that ask for a cool head and caution, since massively vaccinating the population with a product about which little is known would be equivalent to doing a clinical experiment with humans, big scale.
At this time, there are more questions than answers: there are many vaccines being tested, we do not know which one can be better, if it is scalable, what population it is aimed at and the distribution capacity that would have to be installed. Vaccines would have to respond to the differential needs of countries with different contexts.
Faster but riskier vaccine or safer but more delayed vaccine?
(You may be interested in: Children, the great forgotten in the HIV epidemic)
We don’t know yet how many doses we will need either. Covax guarantees us 20 million doses, for 10 million people, although we do not know when they will arrive, or at what price, or under what conditions.
It could be that with the doses already acquired via Covax, it is sufficient. In less than two months, between December 2020 and February 2021, information on the progress of the large-scale clinical trials being carried out for at least 7 vaccines will be presented to the public.
This information will also increase the options for competition for lower prices and the possibilities of negotiating better conditions of access to the population of low- and middle-income countries.
In other words, we will have better clinical information, better prices to negotiate and therefore the Ministry of Health could make better decisions. All this would indicate that there is not much time to wait and it would not be justified
push for accelerated purchase decisions.
It is much better for public health to have the results of clinical trials, subjected to peer scrutiny, to decide which vaccine to acquire and when to start mass immunization of the population.
It is important that Colombian society is willing to accept a balance between waiting a short time and tolerating a lower level of risk, as well as having better prices for a portfolio of vaccines that allows us to exit in an intelligent way in the middle of the pandemic. , while seeking careful hygienic behaviors.
II. What to do with the risk?
Many countries have already resolved the dilemma and decided that they will try to immunize the population with uncertain vaccines, as an exit strategy from the pandemic. They accept that there is a higher risk than usual and they assume it. The risk is then foreseeable, in the sense that it is known that “something” is going to happen even though it is not yet known what it is. What to do about it?
1. Establish pharmacovigilance and monitoring plans for adverse effects that occur
could generate. This is in line with what has already been done in the USA or in the EU with
fast-track approved drugs. In relation to this point, we share
fully what has recently been said by various groups of experts in pharmacovigilance and scientific societies in the country.
2. Be transparent. If the government is going to accept a higher risk than usual, it should not do so in secret, nor keep the negotiations and clauses confidential.
contractual. The government must be accountable to the public for its decision to
buy vaccines with considerable uncertainty. Transparency also allows you to mitigate risk in a certain way, shield your decisions because they will have been subject to public scrutiny. For any decision on this matter to have legitimacy, we need to know the conditions under which any agreement is signed.
3. Have a clear and assertive communication regarding the level of risk and the data on
vaccine safety and efficacy. Report openly about what is known and what is not known. This implies that within the immunization plan, a “reinforced” informed consent is included, so that each person individually can make a better decision on whether to vaccinate or not.
It seems that companies have understood the development of vaccines for COVID-19 as a favor they are doing to society
III. Who takes the risk?
As there is a tacit agreement that the risk posed by vaccines is greater than
usually tolerated, companies are seeking compensation. That is, not having to respond to the lawsuits that are filed against them when adverse events arise that could not be detected in the low-demand clinical trials (short and with little relevant outcomes) through which the vaccines are being tested.
Everything indicates that the Colombian Ministry of Health would have to sign multilateral and / or bilateral agreements to access vaccines with leonine clauses based on the premise that in order to access vaccines, pharmaceutical companies need to be completely exempted from any responsibility.
It seems that companies have understood the development of vaccines for COVID-19 as a favor that they are doing to society, when the truth is that this work would not have been possible without the amount of public resources that have been invested around the world . Colombia has also participated in this global cow to accelerate the development of vaccines through COVAX.
However, Many countries have accepted the indemnity condition as part of the incentive package to accelerate vaccine development, but have decided to share the risk with companies. It is a shared responsibility between manufacturers and the State.
Against this point, the following aspects should be taken into account:
1. Not grant full indemnity to the companies neither in the law, nor in the contracts that the
government subscribe with them for the purchase of vaccines. In the event of malicious acts or gross negligence, companies must continue to respond. The State should only take responsibility for rare and severe adverse events, which could not be foreseen given the short duration of clinical trials.
2. Do not transfer the risk to citizens by creating additional requirements to be able to file claims, modifying procedural law or mixing the regimes of
extra-contractual civil liability and State liability, which generate
confusion and make access to justice difficult. Neither should requirements be created
additional only for this case, which do not exist for other types of claims of
responsibility.
3. On the contrary, the compensation scheme should be facilitated by creating a compensation fund that citizens can access through a procedure.
simple and fast administration.
4. In any case, if you insist on the point that is currently in the bill that before being able to sue (procedural requirement of the action) you must obtain an expert opinion on the causal relationship between the vaccine and the adverse effect, it should be INVIMA and not the IETS that issues this concept, since an entity that already has that competence, that has developed capacities, expertise, international work networks. At this point, we also share what the experts in pharmacovigilance have expressed.
5. Additionally, so that obtaining this concept does not become another formal procedure, it should be stipulated in the law that in case INVIMA considers that there is a causal relationship between the vaccine and the adverse effect, said concept must be compulsorily accepted by the judge. If not, then it would be one more evidence like any other, which the judge has to enter to weigh and determine what probative weight it has.
In that case, the only real purpose of the procedure would be to hinder access to justice for citizens, since in any case the causal link would have to
be tested again within the process.
IV. Not all citizens access at the same time. Prioritization criteria for vaccination.
Assuming that there is an effective vaccine, the next question is who to prioritize in accessing it. Our bet is that the criterion must incorporate socioeconomic vulnerability and not just biological.
To date, the prioritization of vaccine allocation based on biological variables (age, comorbidities, etc.) has been discussed. However, the evidence shows that there are socioeconomic variables that must be taken into account to make alternative prioritization and probably more socially desirable. Prioritization must also have a perspective
of human rights as follows:
1. Right to health. Vaccinate health professionals. This is widely
described in the literature, but it is about those who take care of us and therefore should be
privileged.
2. Right to education. Vaccinate educators and care professionals as well
guaranteeing the right to education of children and adolescents. Also, we know
that many of the educators are populations at high biological risk.
3. Right to work. Vaccinate those who perform essential duties. Is about
those who carry out infrastructure and support tasks for other activities
economic. These people should obtain special protection, taking into account
who perform tasks that support the rest of society.
* Alejandro Gaviria, Rector of the University of Los Andes.
* Tatiana Andia, Professor at the University of Los Andes.
* Claudia Vaca, Director of the Medicines, Information and Power Thought Center.
* Carolina Gómez, Founding member of the Medication, Information and Power Thought Center.
We recommend other news of the day:
–Abece of measures and restrictions for Christmas and New Year
–Learn about the country’s measures to face covid-19 at the end of the year
–They propose to temporarily pay less than the minimum without pension to new hires
–The crime for which Pulgar was arrested, who has already reached the Prosecutor’s Office
