Original article (in Croatian) was published on 14/10/2022
Fringe media and social media users are falsely portraying the Pfizer CEO’s testimony as a “shocking confession” about vaccines.
The editors of Faktograf received a large number of questions from readers related to the public hearing held in the European Parliament, where the director of Pfizer, in response to a question from a Dutch representative, said that in the research that preceded the approval of Pfizer’s vaccine against Covid-19, it was not tested whether the vaccine prevents the transmission of the virus among to people.
“Was Pfizer’s Covid vaccine tested to stop the transmission (spread) of the virus before it was put on the market? If not, make it clear. And if it is, are you willing to share the data with this committee?”, asked Dutch MEP Rob Roos on October 10 during a hearing before the European Parliament’s special committee on the Covid-19 pandemic. A recording of the entire hearing can be viewed here. Janine Small, Pfizer’s director for international markets, answered the Dutch representative. “Did we know that it prevents the spread of the virus between people when we put [the vaccine] on the market? We didn’t”, Small replied.
Such an answer was presented in many fringe media and among users of social networks as a “shocking confession” and “revelation of the truth” of the Pfizer director and the basis for undermining the introduction and application of Covid certificates around the world. However, the fact that clinical trials prior to the approval of Pfizer’s vaccine did not test whether it reduced the spread or transmission of the virus between humans is nothing new. This information was known when the vaccine was approved in December 2020. It is also important to point out that vaccination itself was never the only condition for obtaining a Covid certificate, but it could also be obtained based on a previous illness or testing.
The WHO revealed the same information publicly in January 2021
In a January 2021 World Health Organization document, titled “Interim recommendations for the use of the Pfizer – BioNTech BNT162b2 vaccine against COVID-19 in emergencies”, published a few days after the World Health Organization approved the vaccine, in the “other issues” section, the sentence states: “Since there is no evidence yet of the effect of the vaccine on virus transmission, non-pharmacological interventions, including the use of face masks, physical distancing, hand washing and other epidemiological measures to prevent the transmission of the SARS-CoV-2 virus in certain settings, must continue”.
From that sentence, it is clear that when approving Pfizer’s vaccine in December 2020, the World Health Organization did not have “evidence of the vaccine’s effect on virus transmission”. This is proof that Pfizer’s director did not present some new truth or shocking discovery because the WHO stated this fact in its document from January 2021, that is, a year and 10 months ago.
In the same document, the World Health Organization mentions among the recommendations for research and monitoring after the approval of the vaccine, “research to determine whether vaccination reduces the transmission and spread of the SARS-CoV-2 virus”. And this confirmed that when the vaccine was approved, there were no clear effects on the spread of the virus in the population, but also that the World Health Organization did not hide this fact, but asked for additional research on the subject, which was then carried out.
EMA in December 2020: “The impact of vaccination on the spread of the SARS-CoV-2 virus in the community is not yet known”
Also, on December 21, 2020, the Croatian Agency for Medicines and Medical Products (HALMED) reported on its website that “the European Medicines Agency (EMA) recommended” on that day “granting conditional approval for the marketing of the Comirnaty vaccine produced by BioNTech and Pfizer for the prevention of the disease COVID-19 in people aged 16 and older”. On the same day, a summary of the EMA’s positive opinion was published on the Internet, explaining why Pfizer’s vaccine was approved.
In that document, the answer to whether Pfizer’s vaccine can “reduce the transmission (spread) of the virus from one person to another” is clearly stated. “The impact of vaccination on the spread of the SARS-CoV-2 virus in the community is not yet known. It is not yet known to what extent vaccinated people can continue to carry and spread the virus”, states the EMA document published on December 21, 2020.
And this claim from the EMA document shows that after the initial clinical research, the effect of Pfizer’s vaccine on preventing the spread of the virus in the population was not known, that this was published in the regulator’s documents back in December 2020, and that Pfizer’s director at the hearing in the European Parliament did not reveal anything that was not already known. The director of Pfizer only confirmed what the regulators who approved the vaccine publicly announced back in December 2020.
HALMED explained what was tested in Pfizer’s clinical research
The Agency for Medicines and Medical Products of the Republic of Croatia (HALMED) explained to Faktograf on which basis was Pfizer’s vaccine approved in the European Union in December 2020.
“The Comirnaty vaccine for protection against COVID-19 was first approved in the European Union in December 2020. The initial approval was given on the basis of an extremely extensive clinical trial of the vaccine, which included several tens of thousands of subjects. In this trial, the effectiveness of the vaccine was calculated in subjects aged 16 and older, including people older than 75 years, who had not previously had symptoms of infection with the disease of COVID-19. A clinical trial showed a 95 per cent reduction in the number of symptomatic cases of infection in people who received the vaccine compared to subjects who received a placebo. Likewise, the trial showed the effectiveness of the vaccine to be about 95% in people at risk of developing a severe form of the disease of COVID-19, including people with asthma, chronic lung disease, diabetes, high blood pressure or a body mass index of 30 kg/m2 and more”, says HALMED’s response to Faktograf, and they added that “the safety and effectiveness of the vaccine continued to be intensively monitored even after the vaccine was approved for marketing, especially through the system of collecting and analyzing reports of suspected side effects and through additional studies. After the initial variants of the vaccine were approved and put on the market, their manufacturers continued to optimize the vaccines to make them easier to use, transport and as accessible to people as possible”.
HALMED: “The aim of the study was not to evaluate the effect of the vaccine against virus transmission”
HALMED also confirmed the information that when Pfizer’s vaccine was approved, its effect on virus transmission in the population was not known.
“The clinical study on the basis of which the vaccine was approved was primarily aimed at proving the effectiveness of the vaccine in preventing infection and the onset of symptomatic disease of COVID-19, as well as its more severe forms. However, the aim of that study was not to evaluate the effect of the vaccine against transmission of the SARS-CoV-2 virus from subjects infected after vaccination. More information is available in the European public report on the evaluation of the documentation on the drug here“, states HALMED’s response.
In the document that HALMED referred us to, it is stated more than once that “it is not yet known” how the vaccine affects the transmission of the virus. “The study was not designed to evaluate the effect of the vaccine against transmission of SARS-CoV-2 from subjects who would have been infected after vaccination”, reveals the February 2021 assessment by the European Medicines Agency.
“It is important to emphasize that the effectiveness of the vaccine in preventing the spread and transmission of the SARS-CoV-2 virus, especially from people with asymptomatic infection, can only be assessed after approval in epidemiological or specific clinical studies”, HALMED told Faktograf.
Why is it difficult to “measure” the effect of vaccines on virus transmission?
Shortly after the start of vaccine use, in February 2021, the journal Nature published an article entitled “Can vaccines against COVID stop transmission?” Scientists are trying to find an answer”, which explains why it is difficult to measure it.
As a key argument for the problematic measurement of this parameter, it is stated that the decrease in infections in a region can occur for various reasons, not only because of vaccines. Among the reasons that can affect the reduced transmission are the so-called non-pharmacological measures such as lockdowns or changes in people’s behaviour. The problematic fact is that the virus is also spread by asymptomatic carriers, which makes it difficult to detect such infections.
On the other hand, in order to try to get precise results in clinical research about preventing the spread of the virus, an ethically very questionable operation would have to be undertaken in which healthy subjects would have to be placed together with infected ones and monitored to see if they would transmit the virus to them. In the case of Pfizer’s clinical trials before the vaccine was approved, this would mean that people would have to be infected with a new and relatively unknown disease for which, at that time, there was no cure.
HALMED: “In other vaccine approvals, the effect on virus transmission in the population was not primarily measured either”
HALMED confirmed that even in other cases of vaccine approval against infectious diseases, the effect of the vaccine on virus transmission in the population is not primarily measured.
“We can confirm that during testing for the purpose of approving vaccines against other infectious diseases, the effectiveness of the vaccine in preventing infection, creating an individual’s immune response to the causative agent, and preventing severe forms of infectious disease is also primarily tested, but not their impact on virus transmission in the population”, states HALMED’s reply. This means that in the case of Pfizer’s vaccine against Covid-19, the usual procedure for the approval of vaccines against infectious diseases was not “bypassed”, at least not in the part that refers to the “measurement” of preventing the transmission of the virus in the population.
In response, HALMED also warned us about the difficulties in conducting research on reducing the transmission of infectious agents.
“In general, it is difficult to measure how much vaccines in general, including vaccines against the disease of COVID-19, reduce the transmission of infectious agents. The effectiveness of the COVID-19 vaccine in preventing the transmission of the virus varies over time and between countries. Variations in transmission rates depend on other measures that countries may be implementing at the time to reduce transmission, but also on the specific variants of the virus that are spreading among the population. For example, several recently published preliminary reports suggest that the omicron variant of the virus is more transmissible even among vaccinated individuals. However, available data suggest that omicron transmission is still higher in unvaccinated individuals. Therefore, appropriate contextualization is needed in such research, which includes the aforementioned influences on the transmission of the causative agent of an infectious disease”, states HALMED’s response to Faktograf.
What do the studies’ results after the vaccine’s approval say?
Published results of studies conducted after the vaccine’s approval and its application to many people show that the vaccinated are less likely to transmit the infection to other people in the environment than the unvaccinated. Such studies were mainly carried out by analysing data on the infection of close contacts, mainly those in the same household, and measuring how much virus was excreted by vaccinated and unvaccinated people. According to this second parameter, studies have shown that the amount of virus excretion decreases faster in vaccinated people compared to non-vaccinated people.
In November 2021, in the midst of the introduction of Covid certificates, the Croatian Institute of Public Health published a statement with analyses of studies that showed that vaccinated people are significantly less susceptible to infection than unvaccinated people. “Even if they do get infected, the vaccinated are less likely to develop a severe form of the disease. Also, there is less chance that the vaccinated will transmit the infection to other people in the environment compared to the unvaccinated”, stated the announcement.
“The Dutch study on the effectiveness of the vaccine in preventing the transmission of the virus by contacts in the household shows that in 63% of cases the transmission of the virus from a vaccinated sick person to one of the household members who is vaccinated will be prevented, and only 40% if the household members are unvaccinated.
A British study also showed that vaccinated people who get sick infect their close contacts to a lesser extent than unvaccinated people. Effectiveness in preventing transmission decreases over time after vaccination with both vaccines (Pfizer and AstraZeneca)
The experiences of health workers in Scotland vaccinated with Pfizer’s or AstraZeneca’s vaccines are also interesting. Households of vaccinated healthcare workers had a 30% lower chance of infection 14 days or more after the healthcare worker received the first dose of the vaccine, and a 54% lower chance of infection 14 days or more after the healthcare worker received the second dose of the vaccine.
On the other hand, in one of the studies published in The Lancet, researchers found that the risk of infection among household contacts was the same regardless of whether the index case was vaccinated or not. The maximum amount of virus excretion was the same in vaccinated and unvaccinated patients. However, it decreased faster in vaccinated individuals.
A similar conclusion was reached by the authors of another study who, by comparing periodic smears and determination of amplification cycles in hospitalised patients, found that vaccinated and unvaccinated patients excrete an equally large amount of virus at the peak of infectivity, but in vaccinated individuals, the amount of virus excretion decreases significantly faster than in unvaccinated people.
In addition to the above, there are many other studies as well as practical experiences in different environments that provide sufficient evidence that vaccination significantly affects the reduction of virus transmission in the population, and that, if a vaccinated person does get sick, she/he has a lower chance of transmitting the infection to her/his contacts than a sick unvaccinated person. This comparative advantage that vaccinated people have decreases over time, which is compensated for by additional vaccinations”, the press release said.
An American study investigated the spread of omicron among prisoners
Also, in August of this year, Nature published an article titled “Vaccines against Covid reduce the risk of the spread of the omicron variant, and the same effect is also seen in earlier infections”, while the subtitle reads: “But the benefits of vaccines in reducing the spread of omicron do not last long”.
In this article, they refer to the results of a study that analysed data from more than 22,000 Covid-19 patients in 35 prisons across California. They analysed data covering a period of five months, starting at the end of 2021 when the first wave of the omicron variant started in the US.
“The team found that among people with Covid-19, those who received at least one dose of the vaccine had a 24 per cent lower chance of infecting close contacts, in this case prisoners in the same cell, compared to unvaccinated prisoners. Those who had previously recovered from Covid-19 had a 21 per cent lower chance of infecting others compared to those who had not been vaccinated, and those who were both vaccinated and had previously recovered from the disease had a 41 per cent lower chance of infecting others compared to unvaccinated persons with no previous infection”, the article states.
Each subsequent dose of the vaccine reduced the risk of transmission of the virus by an additional 12 per cent on average. It was also important when someone received the vaccine: for every five weeks after receiving the last dose, the risk of transmitting the virus to close contacts increased by 6 per cent. Although vaccination and early recovery have been shown to help reduce the infectivity of omicrons, neither has been sufficient to stop new infections among prisoners. In four out of five cases, the people who spread the virus to others were either vaccinated or previously infected. Inmates were placed in isolation after testing positive, but the study’s author Nathan Lo said that close contacts were typically exposed for about two days before a positive person would be isolated.
Earlier studies were mainly based on investigating contacts in the same household, where there is still less possibility of spreading the virus than in crowded prison cells. Another difference between this and earlier studies is that it dealt with the omicron variant. Data from studies conducted after the vaccine’s approval clearly show the vaccine’s positive effects against Covid-19 on the spread of the virus in the population, that is, that the vaccine reduces the possibility of spreading between people.
Vaccination was never the only condition for obtaining Covid certificates
In their questions to the editorial office of Faktograf regarding the statement of the director of Pfizer, the readers used the fact that after the initial clinical tests, the effectiveness of the vaccine against the spread of the virus in the population was not clear, and connected it with the introduction of Covid certificates. That is, they claim that this statement “destroys” the foundation of the introduction of Covid certificates as a way to combat the pandemic. As we stated earlier, in November 2021, the HZJZ published the results of previous research that showed that vaccination reduces the possibility of spreading the virus.
On the other hand, and as can be seen from the EU Regulation from June 14 entitled “Regulation of the European Parliament and of the Council on the framework for issuing, verifying and accepting an interoperable certificate on vaccination, testing and recovery from the disease of COVID-19 (EU digital COVID certificate) facilitating free movement during the COVID-19 disease pandemic”, vaccination was only one of the three bases for obtaining certificates.
Article 3 of this Regulation clearly states: “The framework for the EU digital COVID certificate enables the issuance, cross-border verification and acceptance of any of the following certificates: (a) a certificate confirming that the holder has received a vaccine against the disease of COVID-19 in a Member State which issues a certificate (vaccination certificate); (b) certificates confirming that the holder has undergone a NAAT test or a rapid antigen test from the common and updated list of rapid antigen tests for the disease of COVID-19, which was compiled on the basis of the Council Recommendation of 21 January 2021, and which was carried out by the health employees or professional staff in the Member State issuing the certificate stating the type of test, the date when it was carried out and the result of the test (test certificate); (c) a certificate confirming that, following a positive result of a NAAT test or a rapid antigen test from the EU common list of rapid antigen tests for the disease of COVID-19 agreed by the Health Security Committee, carried out by health professionals or professional staff, the carrier has recovered from infection with the SARS-CoV-2 virus (certificate of recovery)”.
So, the conditions for obtaining a COVID certificate, in addition to vaccination, were providing evidence of a negative test or an earlier recovery from the disease. In the same way, the Croatian Law on the Protection of the Population from Infectious Diseases was amended, in which Article 8.a was added, which introduced “the obligation to present proof of testing, vaccination or recovery from an infectious disease in order to enter certain premises”. And on the official page about Covid certificates, it is clearly stated that the conditions for obtaining this document are a vaccination certificate or a test certificate or a recovery certificate. And the Constitutional Court emphasised in its decisions on Covid certificates that “citizens have a choice between vaccination and testing”.
With all of the above, it is clear that at no time was vaccination itself a requirement for obtaining a Covid certificate, but those who did not want or could not get vaccinated could also obtain it with a certificate of recovery, as well as by testing before going to the event or in an institution where it was mandatory to show a Covid certificate.
In conclusion, the “confession” of Pfizer’s director Janina Small that the company did not test the effect of the vaccine on reducing the transmission (that is, the spread) of the virus in the population in clinical research before the approval of the vaccine against Covid-19 is not new because in the publicly released documents of the World Health Organization and the European Medical Agency in December 2020 and January and February 2021, it is stated that the effect of the vaccine on the transmission of the virus in the population is unknown. That this information was known almost two years ago, the Croatian Agency for Medicines and Medical Products confirmed in its reply to Faktograf.
Studies on the effectiveness of vaccines in reducing the spread of the virus conducted after their approval have shown that this effect varies by virus variant and declines over time. However, they also showed that there is less chance of infected vaccinated people infecting others, as well as that the amount of virus in their nose drops faster than in unvaccinated people.
There is no argument that the Pfizer director’s statement destroys the foundations on which the Covid certificates were introduced. First of all, the fact that the effect of the vaccine on transmission was not tested in clinical research was known immediately after they ended, that is, when the Covid certificates were introduced. Preliminary research, which began almost immediately after the approval of the vaccine, showed that the vaccine has an effect on reducing the transmission of the virus. Vaccination was not the only condition for obtaining Covid certificates, as they could also be obtained on the basis of an earlier recovery from the disease, as well as testing.
