On December 27th 2020, the administration of the COVID-19 vaccine began in Italy. What are the risks? Are mRNA vaccines really dangerous, or should we worry about side effects of other drugs?

Many countries before Italy have already begun their administration of the anti-COVID-19 vaccine by Pfizer-BioNTech and as of December 24th, more than 3.5 million people have received their first dose of the vaccine worldwide. First doses have already been administered in the US, the UK, Russia, China, Israel, Bahrain, and Canada (click here for complete data).

Many are wondering about the dangers associated with the various COVID-19 vaccines, and in particular Pfizer-BioNTech’s Comirnaty vaccine, which is based on recent mRNA technology.

35 Answers from the AIFA (the Italian Medicines Agency)

AIFA has made available a list of 35 questions to which it has responded. This is an excerpt of the most significant ones.

What is it and for what is it intended?

The COVID-19 mRNA BNT162b2 vaccine (Comirnaty) is a vaccine intended to prevent coronavirus disease 2019 (COVID-19) in individuals 16 years of age and older. It contains a molecule called messenger RNA (mRNA) with instructions to produce a protein, Spike protein, found on SARS-CoV-2. The vaccine does not contain the virus and cannot cause the disease.

How does it work?

The vaccine stimulates the immune response by causing the production of antibodies against the surface protein, called Spike, which acts as a key allowing the virus to enter human cells. The vaccine mRNA is degraded shortly after vaccination.

Has the trial been shortened, in order to have the product sooner?

Thanks to the huge amount of funding allocated by governments (the US and EU in the lead), it’s been possible to accelerate the research, to recruit a number ten times higher than the standards of similar studies for the development of vaccines, but always respecting the phases of verification of efficacy and safety of the vaccine. The short timeframes that led to rapid registration were made possible, thanks to the research already conducted for many years on RNA vaccines, the large human and financial resources made available in a very short timeframe, and the evaluation by regulatory agencies of the results obtained as they were produced and not, as is customary, only when all the studies are completed. These simple measures have led to years of savings in approval times (click here for more information).

Is the protection effective immediately after injection?

No, effectiveness has been demonstrated after one week of receiving the second dose. This means that the first results, in terms of herd immunity, may not be seen until several months.

Can the vaccine cause COVID-19 disease or other genetic changes?

This vaccine doesn’t use active viruses, only a genetic component (mRNA) that carries the information to produce specific antibodies in the body of the vaccine recipient. No whole or live viruses are involved, so the vaccine can’t cause disease. The mRNA of the vaccine (like all mRNAs produced by cells) naturally degrades after a few days in the person who receives it, and it doesn’t contain other gene sequences.

Can vaccinated persons still transmit the infection to other people?

Clinical trials to date have been able to evaluate the efficacy of the COVID-19 mRNA BNT162b2 vaccine (Comirnaty) on clinically manifested forms of COVID-19, but more time is required to obtain meaningful data to demonstrate whether vaccinated persons can become asymptomatically infected and infect other people.  Although it’s plausible that vaccination protects against infection, individuals who’ve been vaccinated and people in contact with them should continue to take protective measures against COVID-19 (click here for more information).

What adverse reactions have been observed?

The most frequently observed adverse reactions (more than 1 in 10 people) in the COVID-19 mRNA BNT162b2 (Comirnaty) vaccine study were generally mild to moderate and were resolved within a few days of vaccination. These included pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, and fever. Redness at the injection site and nausea occurred in fewer than 1 in 10 people. Itching at the injection site, pain in the limbs, enlarged lymph nodes, difficulty falling asleep, and feeling unwell were uncommon effects, affecting fewer than 1 in 100 people. Weakness in the muscles on one side of the face (acute peripheral facial palsy) occurred rarely, in fewer than 1 in 1,000 people.

What serious adverse reactions were observed during the clinical trial?

The only severe adverse reaction more frequently seen in the vaccinated than in the placebo group was the enlargement of the lymphatic glands. This is, however, a benign condition that heals on its own. In general, systemic reactions were more frequent and pronounced after the second dose. In the countries where mass administration of the vaccine has already begun, reports of adverse reactions have also begun; ranging from less severe to more significant, including allergic reactions. All the countries that are starting to administer the vaccine to their entire populations will collect and evaluate every report received by their drug surveillance systems of adverse reactions to the vaccine, so as to be able to define with increasing precision the type of risk profile linked to vaccination.

Who can report an adverse reaction to vaccination?

The report of any reaction to the administration of the vaccine can be made to the family doctor or to the ASL of affiliation, as well as for all other adverse reactions to any drug, according to the national system of pharmacovigilance, active for some time throughout the country. In addition, anyone can personally report an adverse reaction to a vaccine using the forms published on the AIFA website (in Italian): https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

A new variant of the SARS-CoV-2 virus has been reported: will the vaccine also be effective against this new variant?

RNA viruses such as SARS-CoV-2 are subject to frequent mutations, the majority of which don’t significantly alter the structure and components of the virus. Thousands of SARS-CoV-2 variants have been reported in 2020, but so far, these variants haven’t altered the natural behavior of the virus. The variant reported in the UK is the result of a series of mutations in proteins on the surface of the virus, and assessments of the effects these may have on the course of the epidemic are underway, while an adverse effect on vaccination appears unlikely.

Should (or can) anyone who has already had a confirmed COVID-19 infection be vaccinated?

Vaccination does not counteract a previous COVID-19 infection; in fact, it enhances its immune memory, so testing prior to vaccination is not useful. However, those diagnosed as COVID-19-positive don’t require vaccination in the early phase of the vaccination campaign, whereas it could be considered when data on the duration of immune protection is obtained.

Some Data on Vaccines

Because of the pandemic, everyone, including the mass media, is extremely focused on the possible risks of vaccination; however, there are drugs that we take much more frequently that have important side effects but that have faded into the background, despite causing many deaths that are proven and not “possible”, as is the case with vaccines.

Moreover, it should be remembered that vaccines have defeated terrible diseases, such as smallpox and neonatal tetanus, and have made many others, such as diphtheria and polio, rare. The latter, for example, has seen the number of cases worldwide drop from 350,000 in 1988 to 33 in 2018 (Italy and the WHO European Region are now polio-free), and mortality from measles has also been dramatically reduced: from 550,000 deaths in 2000 to about 90,000 in 2016; an 84% reduction. Globally, it’s been estimated that vaccinations prevent up to 3,000,000 deaths each year (7,000 per day) (source: ISS).

All drugs have undesirable effects; in particular, we’d like to shine some light on the effects of antibiotics. According to the principle of natural selection, the overuse of antibiotics leads to the resistance of microorganisms to antibiotics themselves and thus their ineffectiveness (more on this here). In summary, the excessive use or misuse of antibiotics, selects resistant bacterial strains exposing us to the risk of not having more weapons (i.e. antibiotics) to fight a bacterial infection, the least of which being pneumonia.

Definitive Numbers for Antibiotic Resistance

If we take the flu vaccine as an example, Claudio Cricelli, President of the Italian Society of General Medicine (SIMG) said: “Every day, according to statistics, 800 elderly people die who have been vaccinated for the flu, but there is no correlation between the vaccine and deaths.” (source: AIFA)

Instead, deaths caused by the resistance of microorganisms to antibiotics are very well known and documented. There were more than 33,000 deaths in Europe in 2015 (source: Epicentro/Italian) and another 30,000 in the United States (source: CDC).

The cause of these deaths is certain and would also be largely avoidable if the following steps were to be taken:

  • all citizens should become aware of this dangerous phenomenon and its consequences, and therefore don’t take antibiotics that you have at home because you experience symptoms similar to those experienced in the past and for which the antibiotic was prescribed by the doctor
  • take an antibiotic only with a prescription
  • remember that our body is the result of evolution of millions of years and with it, the immune system that has the function to protect us from external infections, let it do its job and intervene only in cases of actual need; the fever is not only a symptom but also a weapon of defense!

Fleming himself, in his speech during the award ceremony for the Nobel Prize, warned against the incorrect use of penicillin; specifically referring to the use of a low quantity of the antibiotic that would not eradicate the bacterium while it would select the resistant strain.

“The time may come when penicillin can be bought by anyone in the shops. Then there is the danger that the ignorant man may easily under – dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant. Here is a hypothetical illustration. Mr. X. has a sore throat. He buys some penicillin and gives himself, not enough to kill the streptococci but enough to educate them to resist penicillin. He then infects his wife. Mrs. X gets pneumonia and is treated with penicillin. As the streptococci are now resistant to penicillin, the treatment fails. Mrs. X dies. Who is primarily responsible for Mrs. X’s death? Why Mr. X whose negligent use of penicillin changed the nature of the microbe. Moral: If you use penicillin, use enough.”

Alexander Fleming, Penicillin – Nobel Prize Lecture, December 11th 1945

This post is also available in: Italiano


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