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(CNN Spanish) – The race for a vaccine against the coronavirus increasingly defines the days of this pandemic. And while its progress is dizzying and the United Kingdom has already approved the candidate vaccine against the coronavirus developed by Pfizer and BioNTech, the world reacts as many questions appear. Specifically one that cannot be overlooked: What if the vaccine causes serious effects – adverse reactions – in people? Who Responds?
The first thing, however, It is noteworthy that the vast majority of people do not suffer serious side effects from vaccines, according to the website of the U.S. Department of Health and Human Services (HHS). This is due to the strict security process they are subjected to before being authorized. “Vaccines are safe. All approved vaccines are subjected to rigorous tests throughout the different phases of clinical trials, and continue to be evaluated regularly once they are marketed ”, details the World Health Organization (WHO) on their website. Which means that if a vaccine is approved, the adverse effects are minimal. “The rare serious side effects reported are immediately investigated”, WHO added.
In fact, the organization stressed that it is much easier to suffer “serious injuries from a vaccine-preventable disease than from a vaccine.” And holds that the benefits of receiving them “far outweigh the risks”, because “without vaccines there would be many more cases of illness and death.”
So, a number of common effects can occur, which are usually mild and go away quickly on their own, according to the HHS. These include pain, swelling, or redness where the vaccine was given; slight fever; chill; fatigue; headache and muscle and joint pain, according to the vaccines website of the US Department of Health. Fainting can even occur. Although, the WHO assures that it is very important “That vaccines and vaccination do not harm their process.”
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What is an adverse effect from a vaccine?
However, serious side effects, also called adverse effects, yes can occur after a vaccine. Although, the US Department of Health clarified, they are rare. “For example, if 1 million doses of a vaccine are given, one or two people can have a severe allergic reaction,” he said.
The WHO defines an adverse event as “Any medical setback that results in the death of the patient, his hospitalization or its prolongation, a persistent or significant disability or incapacity, or danger of death.” And an article published in 2010 in the medical journal Pediatrics Primary Care noted that adverse reactions can be classified according to their cause. In this sense, there are four types: those induced by the vaccination itself (where allergic reactions are included), those induced by program errors (such as in storage, distribution or administration), coincident (which could have occurred even though the patient was not vaccinated) and those of unknown cause.
Faced with an adverse effect after the vaccine, indicated the WHO, it is necessary to evaluate its cause. Not just because it “builds confidence in national vaccination programs.” Also because If the adverse effects can be attributed to the vaccine itself, it is necessary to determine “what measures should be taken, if necessary, in response to the event”. Therefore, the organization recommends, the diagnosis should be verified and the reports of all reported adverse effects reviewed. Then, subject them to a classification of causality: if they are fortuitous or not.
Who responds to the adverse effects of a vaccine?
The Pan American Health Organization (PAHO) has warned about the COVID-19 vaccine that “All countries must develop an introduction plan” for vaccination that “should be based on previous experiences with the introduction of new vaccines, as well as the experience of the influenza vaccine in the 2009 pandemic.” A strategy that, among others, it should include investigation of adverse events that could be attributed to the vaccine or immunization.
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In the case of the USA, there is the program Vaccine Adverse Reaction Reporting System (VAERS), established since 1990 and supervised by the US Food and Drug Administration. and the CDC. Its objective is to detect possible safety problems in vaccines approved in the country. The initiative receives reports of adverse events after a vaccination by people. Additionally, all vaccine manufacturers are required to report all adverse effects that come to their attention.
Vaccine Injury Compensation
Additionally, there is the National Vaccine Injury Compensation Program (VICP) which offers financial assistance to people who become seriously ill from a vaccine. This program was created after the effects of the DTT vaccine (diphtheria, tetanus and pertussis) were reported in the early 1980s, according to a VICP document. This situation raised doubts about the safety of the vaccine and the families of those affected filed several lawsuits against the pharmaceutical companies.
Which in turn had a double effect. As the document reads, some drug companies went out of vaccine production, causing a shortage of the latter. Which, in turn, threatened the health of the country. A group of doctors and organizations then asked the US Congress to sign “a new law to compensate people injured by vaccines.” The VICP covers more than a dozen vaccines and anticipates those that may be produced in the future.
Adverse effects in previous vaccines
The rigorous process that vaccines have in their development before they are authorized and distributed seeks to avoid previous incidents that put the lives of thousands of people at risk. Hence, after passing all phases of clinical trials, surveillance on vaccines is so strict.
Read also: Queen Elizabeth II will be one of the first to be vaccinated against COVID-19 to “encourage the population”
In 1955, the first polio vaccine went into mass production. But nevertheless, the batches made by Cutter Labs accidentally included live polio virus and caused an outbreak. More than 200,000 children received the polio vaccine, but within days the government had to abandon the program. “40,000 children contracted polio,” said the Dr. Howard Markel a CNN in September. After, Between 1955 and 1963, between 10% and 30% of polio vaccines were contaminated with simian virus 40 (SV40). Which also spread.
Later, during 1976, the government of President Gerald Ford launched a program for an influenza vaccine, due to the prediction of scientists about a pandemic due to a new strain of influenza. At least 40 million people were vaccinated against swine flu, according to the CDC. That vaccination campaign was later linked to cases of the neurological disorder known as Guillain-Barré syndrome, It can develop after infection or, rarely, after vaccination. In this case, it was a vaccine that contains an attenuated version of the virus.
If you’re wondering: no, vaccines don’t cause autism
On its page on vaccine safety, the WHO explained that a 1998 study “raised the possible relationship between the MMR vaccine (measles, mumps and rubella) and autism.” However, he clarifies that the investigation was later shown to be fraudulent and “had serious biases, which is why it was withdrawn by the journal that published it.” And he adds that “there is no evidence of the existence of a relationship between the MMR vaccine and autism or autism spectrum disorders.”
The importance of addressing adverse effects
The status of COVID-19 vaccines is too early to identify adverse effects among the population. Your distribution is needed first. Clinical trials of the Chinese CoronaVac, AstraZeneca and Johnson & Johnson vaccines were temporarily paused for effects in specific volunteers, but subsequently resumed.
Read also: COVID-19: Russia started vaccinating volunteers in Moscow with Sputnik V
However, they should not be lost sight of. Although they may not occur, WHO notes that “Claims regarding adverse events related to a vaccine that are not addressed quickly and effectively can undermine confidence in that vaccine. And, ultimately, have disastrous consequences on immunization coverage and disease incidence. In addition to, of course, affecting healthy people.
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