(Credit: THIBAULT SAVARY / . via .)

Editor’s Note: Roberto Izurieta is director of Latin American Projects at George Washington University. He has worked in political campaigns in several countries in Latin America and Spain, and was an adviser to Presidents Alejandro Toledo of Peru, Vicente Fox of Mexico and Álvaro Colom of Guatemala. Izurieta is also a contributor to CNN en Español. José Luis Di Fabio, PhD, is an independent international consultant, retired from the Pan American Health Organization / World Health Organization in 2015, where he served for almost 25 years. During his career at PAHO / WHO, he served as Regional Advisor on Vaccines and Biologics, Manager of the Technology, Health Care and Research Area, Manager of the Health Systems Area based on Primary Health Care and culminated as representative of the PAHO / WHO in Cuba. After retired, he acted as a consultant on issues related to vaccines, drugs and health regulation. The opinions expressed in this comment are those of the authors. See more opinions at CNNe.com/opinion.

(CNN Spanish) – Significant progress is seen in the development of coronavirus vaccines with several quite well advanced and with the prospect of ready-to-use doses in the population at risk by the end of 2020 or the beginning of 2021. There are also important efforts to ensure that these vaccines they also reach the most needy population in low- and middle-income countries, in quantity and opportunity. All this facilitated by the World Health Organization (WHO), the BMGF (more popularly known as the Gates Foundation), the GAVI Vaccine Alliance, the Coalition for Epidemic Preparedness Innovation (CEPI) and other governmental and non-governmental organizations.

Many of these vaccines will be produced by new technological platforms, not yet used in the production of vaccines in general, and therefore it is necessary to understand them, study them, clearly identify the pros and cons, and be ready to give answers with evidence and clarity. to the population when they ask. Therefore, it is up to the health, regulatory and, on the other hand, producers to explain the processes, the results of clinical studies and the possible adverse events that these could cause.

The FDA, the European Medicines Agency (EMA) and the European Commission (EC) have developed very important guiding documents to take into account when registering these new vaccines, and have promoted regulatory cooperation to combat COVID-19.

Country leaders need to maintain transparent communication with their populations, providing the information they have, the best available evidence on the safety and efficacy of vaccines.

It should be clear that not all are the same, and therefore it is important to have all the information before making decisions. For example, let’s take the case of vaccine administration, we have several ways depending on the vaccine; the traditional form, an intramuscular injectable vaccine, but an oral vaccine (ref 1), in tablet form, is also in development. At the same time, new nucleic acid vaccines, especially DNA vaccines, require a special device that injects while emitting a very short electric shock to facilitate the entry of DNA into cells.

Not all vaccines will have the same stability against changes in temperature, those stable at ambient temperatures being easier to handle. But what will happen to those that need refrigeration or freezing? All this has an impact on the distribution of the vaccine and on its efficacy (since vaccines kept at inadequate temperatures lose it) in each of our countries.

We must consider that introducing a coronavirus vaccine in a country is only part of the great challenge. The main one is to ensure that a good level of immunization is achieved in the population. There has been a lot of talk about herd immunity (“Herd immunity”), which is the level of immunity that the population reaches when an epidemic begins to decline because there are no longer enough people to infect. But this It is achieved by combining two fundamental aspects: the efficacy of the vaccine on the one hand and the vaccination coverage (proportion of the population that receives it) on the other.. We can have a very effective vaccine, such as measles, but if coverage is low, we will continue to have outbreaks. The situation is complicated if two or three doses are needed for a vaccine to achieve the desired efficacy.

There has recently been news that is a wake-up call and will require prompt action. One is related to vaccines and their efficacy. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) has indicated that he would accept, given the conditions, a covid-19 vaccine that is between 70 and 75% effective. On the other hand, the FDA has announced in its Industry Development Guide, that the vaccine should have a minimum margin of efficacy of 50% to be considered suitable for registration.

On the other hand, worrying information is that the results of surveys in the United States indicate that only 43% of the population consider or plan to be vaccinated against SARS-CoV-2. This could be related to several factors, the main one could be a lack of confidence of the population in its leaders, who have not always relied on their scientists to make decisions.

If we multiply the efficacy of the vaccine (let’s assume 75%) by those who would be vaccinated (let’s assume 60%), we see that only 45% of the population would be protected, which would not be enough to achieve herd immunity, which has been estimated at least 60%. Therefore, if this lack of confidence is replicated in other highly populated and well-connected countries, whose leaders also initially refused to accept the existence or severity of the pandemic (such as Britain, Brazil, India or Russia), then We will have a pandemic for a while, with or without a vaccine.

An option to consider, and to think about from now on, is require the mandatory application of the vaccine. This measure has proven to be very effective in epidemic cases in many countries of all income levels. This will surely generate commitments and conflicts, as opposition to vaccination causes a confrontation between the individual right not to be vaccinated and the responsibility of each individual to contribute to community or herd immunity. The decision must take into account that, by immunizing myself, I am contributing to collective health, especially that of higher-risk subpopulations, such as grandparents, people with chronic diseases, health and security workers. And also to a job and economic openness that is a very important aspect of the health of a community, particularly for those who depend on their daily wages to satisfy their minimum needs. In exchange for this commitment, the population has the right to expect to be administered a vaccine with adequate characteristics, which should alert politicians who, for reasons not related to health (and yes with electoral calculations), wish to unreasonably accelerate the Timelines necessary to ensure that vaccines meet the minimum safety and efficacy requirements before being administered to the public. Meanwhile, various treatments to decrease mortality are being investigated and used, including several mentioned in previous articles on the subject.

While the health authorities work on these tasks, we – as citizens – cannot forget the measures that are within our reach, maintaining social distance, wearing the masks in public and frequently washing our hands to protect ourselves, while living this transition that will still take a few months.

Source link