OPINION - Safety Of COVID-19 Vaccines To Become Clear No Earlier Than In 2023

GENOA (Pakistan Point News / Sputnik - 29th December, 2020) It will take at least two years from the start of mass vaccination and the so-called Phase 4 of trials in order to properly evaluate the safety of COVID-19 vaccines, Paolo Bellavite, Italian author and immunopharmacology researcher, former professor of General Pathology at the University of Verona, told Sputnik.

On Sunday, Italy, alongside all other members of the European Union, started the bloc-wide vaccination against the coronavirus disease using the vaccine developed by the Pfizer and BioNTech pharmaceutical companies, the first one approved in the European Union.

Italy first vaccinated three employees of the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. As the first phase of the vaccination campaign, Italy will only vaccinate medical workers and hospital staff. Further roll out of the vaccine to the population will begin in January.

Italy with the population of 60 million people has secured over 202 million doses, according to the strategic plan published by the health ministry. In the first quarter of 2021, these will also be vaccines produced by Pfizer, AstraZeneca, Moderna and CureVac after they all get approvals.

"Now there is no choice, but it probably won't exist also afterward. When you say: I want to get a vaccine, they vaccinate you with what is available at this moment in the region. There is no choice now. It would be good to have it, but at the moment it can't be provided, because people don't even have the criteria to be able to choose," Bellavite, who is also a hematologist and health statistics and epidemiology expert, said.

Later in 2021, Johnson & Johnson and Sanofi/GSK vaccines should also be made available in Italy, once approved.

"It will take at least two years before we have a certain answer regarding the efficacy and safety of the vaccines applied on the Italian soil, in Italian people, with Italian methods. We can't know before then. So, in 2023 at least, given that studies are done in an honest and precise manner. We are now in a completely experimental phase. It's called Phase 4 of trials," Bellavite said.

In early November, Pfizer and BioNTech announced that their vaccine candidate against COVID-19 had 90 percent efficacy based on the first interim Phase 3 analysis. Two weeks later, the pharmaceutical companies announced conclusion of the Phase 3 and a 95-percent efficacy.

According to Bellavite, Phase 3 has not been completed in a proper manner and was untimely stopped.

"They made the following reasoning: since the vaccine is effective, we can no longer give placebo to people in the placebo group ... But this is a very wrong reasoning, because the goal of the study was not just efficacy, it was safety as well. If you stop the study, you will no longer have reliable information on what diseases the vaccine can cause. You can only see this after many months, comparing 18,000 or 20,000 people who took the vaccine with 20,000 who took placebo. But if you give the vaccine to everyone, you will no longer be able to have this information," he said.

Since the start of Pfizer/BioNTech vaccination, there have been six cases of severe allergy reactions reported in the United States (where inoculation started earlier than in the European Union) and one case in Europe (Greece, reported on Tuesday).

"An allergy is usually a specific phenomenon. One may be allergic to one substance and not allergic to another substance. It is difficult to know if one may be allergic to the vaccine. Theoretically, a small allergy test could also be done with a small amount of the vaccine on the skin to see if a reaction appears. But this complicates the whole vaccination procedure for thousands and thousands of people who want to do it quickly, so this is not possible. Therefore, there is a small risk that the person may be allergic, especially it seems that it can be for the substance called polyethylene glycol, both in Moderna and in Pfizer," Bellavite said, asked if people prone to allergies should be particularly cautious.

The expert also expressed hope that in Italy, health authorities would introduce a rigorous safety evaluation system, which is called "active surveillance of the vaccine safety."

"Practically, it means that the people who were vaccinated receive a questionnaire in which they report the symptoms they had in the days following the vaccination. It is different from the passive surveillance of the vaccine safety, because the passive one leaves it optional to indicate if there have been any reactions, and sometimes one says: okay, I had the reaction, but I don't have time or desire to report it," he explained.

Another issue of concern for people facing a choice of whether or not to take the vaccine is how long the potential immunity is going to last. The US Center for disease Control and Prevention notes it is impossible to know how long immunity from vaccination lasts until there is more data on how well the vaccine works. The world Health Organization also says it is too early to know if COVID-19 vaccines will provide long-term protection. Most of COVID-19 vaccines being tested or reviewed now use two dose regimens.

"Checking the level of antibodies is a good idea. The antibodies can definitely last a few months, according to the data that have been published. We don't know if they can last for years," Bellavite said.

"But I hope that the virus will calm down on its own, even without the vaccine. For example, there are no more cases in China even without the vaccine. In China they managed to get the virus under control without vaccine, simply by imposing lockdown when it was the right time for it, and they did a much more frequent swab measurement than in Italy, and then they also used the traditional Chinese medicine together with official medicine. In addition, the population was very well-instructed on how to avoid contagion," he explained.

Secure social distancing and regular washing of hands and frequently used objects, such as cellphones, are the most important factors in contagion prevention, according to the expert.

Moreover, like any infectious disease, COVID-19 develops in peaks, or waves, one or two per year, he noted. Therefore, if the level of contagions starts falling, it may be a mere coincidence rather than the effect of mass vaccination, same as if the wave continues to grow, it does not necessarily mean inoculation does not work.

So far, all anti-COVID vaccinations are voluntary. However, some controversial issues related to the pressure on those who prefer to opt out may arise in future.

On Tuesday, Spain's health minister said the country would set up a specific register of people who refuse to be vaccinated against COVID-19 and share it with other EU members.

Earlier in December, San Marino Secretary of State Roberto Ciavatta proposed that those citizens who choose not to take anti-COVID vaccine when it is available, should pay for their medical treatment in case they get sick.

"It is a very serious topic. If health authorities do so [require vaccine certificate], it will be grave, dangerous, because it will mean to divide citizens in categories and to put them against each other. I want to be free in choices related to my health and to decide for my own what to do about my health," Bellavite said.

The expert noted that there have already been studies showing that asymptomatic people are not contagious, which means that the maximum that the authorities can ask for is whether a person has had the disease recently, if a person has had cough and other symptoms, and they can measure body temperature.

"Then if a private airline asks for it [vaccine certificate], I think they have the right to do it, but I can simply choose another company to travel. ... I don't want to make no-vax arguments, but I absolutely don't accept that one may talk about an obligation to make a vaccine, or pressure that if you don't get vaccinated you won't have the right to do this and that," he said.

Any choice should be made after the calculation of the "costs and benefits," the researcher noted.

The researcher further argued, citing the report "Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine" published by the US The National Center for Biotechnology Information on December 10, that the Pfizer vaccine had prevented only "less than 1 percent" of severe COVID-19 cases in a group of roughly 20,000 persons who were given the vaccine.

"But four out of 100 of these people, as it was written, can have severe systemic effects from the vaccine, that is a disease that more or less resembles COVID-19. So with the rate four out of 100, if you calculate for 2,000 people, that's 80 people. So, to avoid one grave COVID-19 case, we would have 80 people who have had severe effects of the vaccine," the expert continued.

The above-mentioned report says severe fatigue was observed in approximately 4 percent of BNT162b2 recipients.

Same scrupulous "cost and benefit" evaluation the researcher proposes to the vulnerable categories of people, primarily pregnant women and those who have autoimmune illnesses.

"Pregnant women, it has already been written in the Pfizer vaccine, should not do it. The Moderna one, however, says that they can do it. I do not understand why, it does not make any sense, these are two vaccines that work with the same principle practically, it is absurd that one says it can be taken by pregnant women and other says not," Bellavite said.

As for the cases of autoimmune diseases, not only people who have them but also those who have them in family history should be cautious, since such illnesses have a genetic basis and many factors that can add up and influence them.

"Then age, nutrition, presence of other viruses, other diseases that overlap, endocrine factors, medicines must be taken into consideration. It's a very complicated thing. The problem is that it is not being said. Now there is a mania to vaccinate everyone, so they cannot start screening people and say: for these yes, for these no. For now, they have said that everyone can be vaccinated in practice," Bellavite said.

In cases, however, when the person with an autoimmune disease is constantly exposed to the risk of COVID-19 contagion, it may be worth taking [taking into consideration] the risk of the disease aggravation but [without ignoring] the risk of COVID-19. In any case, it should always be a personal choice, the expert insisted.

For future assessments and conclusions, the researcher believes a cohort study should be performed where a large group of those who were vaccinated is compared with a same large group of those who opted out of inoculation. Such study should take into account not only the frequency of COVID-19 cases, but also manifestations of all other possible diseases - diabetes, arteriosclerosis, cancer, autism, psychiatric diseases etc.

"If I can compare 10,000 people from one group with 10,000 from another, I can have an answer in three years or so as to whether it was a good idea to get vaccinated or not. Of course, we will know only afterward, but it is needed for our children, for our grandchildren, for the future of the Italian people," Bellavite said.