Statement Pedro Morago

CRITICAL APPRAISAL OF THE EVIDENCE REGARDING EFFICACY/EFFECTIVENESS AND
SAFETY OF COVID-19 VACCINES – METHODOLOGICAL LIMITATIONS OF THE COVID-19
VACCINES CLINICAL TRIALS
1. The Food and Drug Administration (FDA) is a federal agency of the Department of Health and
Human Services of the United States, responsible for controlling and supervising the effectiveness
and safety of -among other products- medical products such as vaccines
2. The FDA issued, in June 2020, guidance to assist sponsors in the clinical development and licensure
of vaccines for the prevention of COVID-19. https://www.fda.gov/media/139638/download
3. Section V, C. of the guidance refers to the design of the clinical trials that would test the efficacy and
safety of COVID-19 vaccines. This section establishes, amongst other requirements for vaccine
approval,, that:
• “Later phase trials, including efficacy trials, should be randomized, double-blinded, and placebo
controlled….
• … Follow-up of study participants for COVID-19 outcomes (in particular, for severe COVID-19
disease manifestations) should continue as long as feasible, ideally at least one to two years, to
assess duration of protection and potential for vaccine-associated Enhanced Respiratory Disease
(ERD) as immune responses to the vaccine wane.”
4. On the 6th
October 2020, the FDA issued guidance to provide sponsors of requests for Emergency
Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and
information needed to support the issuance of an EUA.
5. Section V, C, 3, c. of the guidance states that “Data from Phase 3 studies should include a median
follow-up duration of at least two months after completion of the full vaccination regimen to help
provide adequate information to assess a vaccine’s benefit-risk profile, including: adverse events;
cases of severe COVID-19 disease among study subjects; and cases of COVID-19 occurring during
the timeframe when adaptive (rather than innate) and memory immune responses to the vaccine
would be responsible for a protective effect.”
6. On the 22nd
October 2020, the FDA Advisory Committee (FDAAC) held remotely a meeting to to
discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-
19. No specific application was discussed at this meeting.
7. On the 26th
October 2020, the British Medical Journal published a rapid response paper by Dr.
Diana Zuckerman, President of the National Center for Health Research, Washington, D.C. In this
paper, Dr. Zuckerman raises a number of issues regarding the FDAAC meeting, in which she took
part.
https://www.bmj.com/content/371/bmj.m4037/rr-9
8. Below are some extracts:
“… [the meeting] was a crucial opportunity to urge the FDA to improve their study requirements,
at a time when the FDA is under tremendous pressure to get a Covid vaccine on the market as
soon as possible….”
“ …in his oral remarks before the FDAAC …… [professor Peter] Doshi pointed out that the
primary endpoint for the studies focused on people who tested positive and had at least one
symptom, but that those symptoms could be a mild cough or sore throat. While some company

protocols called for at least 2 symptoms, they also could be mild. Some point out that Johnson &
Johnson’s protocol lists the primary endpoint as “moderate to severe/critical disease”, which
sounds more stringent, but they define the term as moderate “or” severe, so it is actually a
distinction without a difference. As Doshi points out, a cough a headache with a positive lab test
would suffice. In fact, all the protocols have a primary endpoint that combines outcomes that are
at least mild but can also include moderate or severe symptoms, including those requiring
hospitalization or causing death…”
“..The secondary endpoints for the vaccine studies focus specifically on “severe” disease, but the
FDA defines “severe Covid-19,” as Doshi pointed out at the FDA Advisory Committee meeting,
such that it could include an otherwise mild case of Covid-19 with a blood oxygen saturation of
less than or equal to 93%, which is a level experienced by thousands of apparently healthy people
over 65. Moreover, there is no guarantee the trials will include enough hospitalizations or other
truly severe cases to draw any conclusions with statistical certainty...”
“…Several Advisory Committee members expressed similar concerns. For example, Dr. Luigi
Notarangelo, a laboratory chief at the National Institute of Allergy and Infectious Diseases,
described the efficacy measures as “skewed towards mild disease.” Dr. James Hildreth, the CEO
of Meharry Medical College, pointed out that "Since severe disease and death occur primarily
among minorities with this virus, if we put a vaccine out there that does not address that issue, it's
just going to perpetuate the perception that exists that [the nonwhite] segment of our population
does not matter much in dealing with this challenge…"
“…In contrast, the chair of the FDA Advisory Committee, Dr. Arnold Monto, defended the FDA
standards, stating that “things that prevent infection ... typically prevent serious disease."
Similarly, Dr. Philip Krause, deputy director of the FDA's Office of Vaccines Research and
Review, stated at the meeting that "there simply does not exist an example in vaccinology of
vaccines that are effective against mild disease that are not more effective against severe disease,
as Doshi pointed out, not enough is known about Covid-19 to know whether those statements are
accurate…”
“ …. the target enrollments for most of the vaccine studies are 30,000 adults each, but it is likely
that most of those volunteers will not be exposed to SARS-CoV-2 during the first months of the
study and relatively few of those will develop severe disease….”
“… an additional point brought up at the meeting is that the FDA was only requiring a MEDIAN
of 2 months follow-up after the vaccine was administered. The FDA defended the 2 months as a
compromise intended to evaluate short-term adverse events, which usually occur within 2 months,
while missing some longer-term risks. However, the 2-month median follow-up also drastically
limits information about efficacy, by reducing the number of people in the study who will become
infected, as well as failing to provide information about how long immunity generated by the
vaccine is likely to last. Krause defended the mild Covid-19 endpoint, saying “the trials may need
to be almost 10 times as big” if the goal is to focus on severe disease. However, requiring more
than 2 months of follow-up for all participants would also increase the number of severe cases for
those already enrolled…”
“…several panel members, such as Dr. Haley Alman-Gans from Stanford University Medical
Center and Archana Chatterjee, Dean of Chicago Medical School, also expressed concern about
the low standards to determine safety…”
9. The next meeting of the FDAAC relating the COVID-19 vaccines took place on the 10th
December
2020. The main point for discussion in that session was the Emergency Use Authorization (EUA)
of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 in individuals 16
years of age and older.
10. At least three of the attendees that raised objections at the FDAAC meeting of the 22nd
October –
Professor Kathryn Holmes, Dr. Luigi Notarangelo and Dr. Michael Nelson- did not participate on

the online session of 10th
December. Asked about the reason of such absences, Dr. Zuckerman
responds: “We only know they weren’t there.” https://www.youtube.com/watch?v=VTT-
J42de2o&t=1114s
11. On the 10th
December 2020, after examining the data available from Pfizer-BioNTech COVID-19
vaccine clinical trials (Phase III), Dr. Diana Zuckerman produced testimony before the FDAAC.
“Today I will focus on 2 major concerns and how to improve the data:
1. The 2 month median follow-up is too short, so it’s essential that the randomized
controlled trial be continued, to learn about long-term safety and efficacy.
2. 2: There’s a lack of diversity in COVID cases: There were 0 Black cases in the vaccine
group, and only 7 Black cases in the placebo group...” There were 0 cases who are ages
75+ in the vaccine group, 5 in placebo group. We need more cases in these groups in
order to understand the efficacy. I’m concerned that conclusions will be inappropriately
drawn, as when an article in the Wall Street Journal included a chart saying the vaccine
was 100% effective in Blacks.”
“THERE are also too few severe cases to draw conclusions:
There were only 4 severe cases after the 2nd dose: 3 of which were in the placebo group.
Not all these cases required hospitalization. In summary, there are too few severe cases
to draw conclusions about whether the vaccine prevents severe COVID.”
“Long-term care patients were not included in the study. About 800 people ages 75
and older were in the study but only 5 were cases (all of them placebo).”
“We want to save their lives, but how can we ensure informed consent to nursing home patients
with no data? How many frail elderly or their family members can make an informed decision
based on so little information?.”
“We need longer-term data to fully understand if benefits outweigh the risks for frail patients and
all races/ethnicities, and for everyone else as well. That’s why it is essential that FDA ensure the
continuation of the randomized controlled trial.”
“In conclusion, EUA is not approval and it should have more restrictions than approval would
have.”
13. On the 11th
December 2020, the U.S. Food and Drug Administration issued the first Emergency
Use Authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-
19). The EUA allowed the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United
States.
14. On Saturday the 12th
December 2020, BBC News published the article ‘Covid: FDA approves
Pfizer vaccine for emergency use in US’
https://www.bbc.co.uk/news/world-us-canada-55265477
“Has the FDA been leaned on?
On Friday [11th
December], President Trump sent out an angry tweet calling the FDA a "big, old,
slow turtle", adding: "Get the dam vaccines out NOW, Dr Hahn. Stop playing games and start
saving lives."

The Washington Post said that White House chief of staff Mark Meadows had ordered Mr Hahn
to approve the vaccine on Friday or submit his resignation, citing three sources.”
But Mr Hahn told US media he had only been "encouraged to continue working expeditiously" on
the vaccine's approval, and that the media representation of the chief of staff's phone call was
"untrue".
Amid the reports of White House pressure, President-elect Joe Biden said he wanted to make it
clear to the public that they should have confidence in the vaccine, adding: "There is no political
influence."
16. Asked about the speed at which FDA’s EUA had been issued, Dr. Zuckerman responds: “The
thing that, let me say, I’ve never seen, ever, is that, you know, the [FDA] Advisory Committee’s
meeting was held one day and the vaccine was authorized the next day. I’m not even sure it was
24 hours. You know, FDA always takes months to make these decisions. They never make them
immediately like that. Which, you know, to some extent, felt like they had already made the
decision.” https://www.youtube.com/watch?v=VTT-J42de2o&t=1114s
17. On the 17th
December 2020, after examining the data available from Moderna COVID-19 vaccine
clinical trials (Phase III), Dr. Diana Zuckerman produced testimony before the FDAAC.
18. Below are some extracts with the objections raised by Dr. Zuckerman in her testimony:
1. “The 2-month median follow-up is too short, so Moderna’s proposal to immediately unblind
and offer to vaccinate the entire placebo group should be rejected.
2. Moderna made a good effort to include a diverse group of participants, but only 4 COVID
cases were in Black patients, and there were even fewer in other racial groups. We can’t assume
that the vaccine was highly effective in demographic groups with so few cases because just 1
Covid case in the vaccinated group would have greatly reduced the efficacy rate.
The data on cases for participants with co-morbidities was slightly more substantial, with 24
placebo cases and only 1 vaccinated case
3. I’m glad to see that unlike Pfizer, Moderna provided info on the total number of participants
who reported 1 or more adverse events. That’s important. Unfortunately, the total of severe
systemic adverse events after the 2nd dose was over 17% for vaccinated group compared to
2% for the placebo group.
There are also too few severe cases to draw conclusions:
There were 30 severe cases after the 2nd dose, and none were in the vaccine group. This is a
strong finding. However, only 9 of the severe cases required hospitalization; 12 involved the
questionable criteria of at least slightly low blood oxygen saturation.
Long-term care patients were not included in the study. About 1300 people ages 75 and
older were in the study, almost half of them vaccinated, but only 3 were cases (all of them
placebo). Only 15 cases were in patients over 65...”
19. On the 18th
December 2020, the U.S.A. Food and Drug Administration issued an Emergency Use
Authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The
Emergency Use Authorization allowed the Moderna COVID-19 Vaccine to be distributed in the
U.S.A. for use in individuals 18 years of age and older.
20. On the 26th
February 2021, after examining the data available from Janssen (Johnson & Johnson)

COVID-19 vaccine clinical trials (Phase III), Dr. Diana Zuckerman produced testimony before the
FDAAC.
21. Below are some extracts with the objections raised by Dr. Zuckerman in her testimony:
“Our center [NCHR] scrutinizes the safety and effectiveness of medical products, and we don’t accept
funding from companies that make those products. However, I inherited J & J stock, so my criticisms
today are counter to my financial interests ..”
“I’m concerned about the hype that this vaccine is specifically effective against moderate and severe
COVID. Those are PR claims. They are misleading.
Not all symptomatic cases are moderate or severe. The other two vaccine companies just counted
cases and severe cases. Since Janssen reported only 4 mild cases, what the company calls moderate
cases is almost identical to what the other 2 companies called “cases” – and can include mild
symptoms.
All 7 deaths in the study were in the placebo arm and were in South Africa, so let’s focus on severe
COVID in terms of hospitalization and medical interventions, as the FDA did on page 33 of their
briefing document. 10 study participants developed severe COVID at least 2 weeks after their
shots, and only 5 developed severe COVID at least 4 weeks after their shots. Most were in the
placebo group, but these are very small numbers and the differences are not statistically significant.
It’s misleading to tell the public that nobody who was vaccinated was hospitalized unless you also
tell them that only 5 people in the placebo group were hospitalized.
The data indicate the vaccine is effective, but does not prove that the vaccine is especially effective
against moderate and severe COVID.
After 28 days, there were 0 COVID cases for ages 75+ in the vaccine arm & 4 cases in placebo
arm – too few to draw conclusions about efficacy in the oldest patients.
The vaccine is effective, but the median follow-up is only 8 weeks after the shot. Does human
immunity last only 2 months, 4 months, a year? We won’t know unless the randomized controlled
trial is continued.
In conclusion, the FDA guidance for COVID vaccine approval specified at least a year or 2 of
follow-up. FDA’s Guidance for EUA drastically shortened that to a median of 2 months, and
that’s exactly what the companies provided. The companies said the double blinded studies would
continue after EUA, but that no longer seems likely, and FDA said today approval might be based
on 6 months. As soon as a vaccine is authorized, we start losing the placebo group. If FDA lets
that happen, that’s a huge loss for public health and a huge loss of information about how we can
all stay safe. A cross-over design is a reasonable compromise, but only if the placebo group has
at least 6 months of data so we’ll know more about long-term efficacy. At the very least, we need
to be honest with the American public about what we know and don’t know.”
22. On the 26th
February 2021, after examining the data available from Janssen (Johnson & Johnson)
COVID-19 vaccine clinical trials (Phase III), Professor Peter Doshi raised the following comment at
FDAAC meeting:
“Hello and thank you. I’m Peter Doshi. I am on the faculty at the University of Maryland and a medical
journal editor at The BMJ. I have no relevant conflicts of interest, no one has paid for my attendance,
and these comments are my own.
First point - I’m nervous about the prospect of there never being a covid vaccine that meets the FDA’s
approval standard. The agency has already authorized two covid vaccines as meeting the EUA standard
of “may be effective.” Granting another EUA to Janssen would begin to create a kind of marketplace
of vaccines good enough to be authorized, but never approved.

The briefing documents say Janssen is seeking an EUA, but they don’t say why. My question is, if
Janssen is fully confident in the data, why not seek a full approval – a BLA?
Looking forward, I worry about FDA lowering its approval standards. Last June, FDA outlined its
expectations for an approvable vaccine, saying participant follow-up should continue for “at least one
to two years.” We know Moderna and Pfizer can’t meet this standard, as placebo recipients are already
being vaccinated. And in its briefing document, Janssen says if an EUA is granted, they will unblind
their trial. It is quickly seeming the only way a vaccine will ever be approved is if FDA lowers its
standards to the “may be effective” standard of the EUA. Is this what we want? And if the FDA now
believes that a few months of follow-up is sufficient to be certain benefit outweighs risk, the agency
needs to tell us why it changed its mind.
We thankfully have a waning epidemic in the US right now, and manufacturing capacity of already
EUA’d vaccines continues to grow. The argument that we don’t have the luxury of time to demand
better evidence doesn’t hold as much water as it might have two months ago.
Second, I worry about process. The way it’s supposed to work is the FDA asks the advisory committee
for its honest, independent view. But the media reporting on this suggests an EUA is a foregone
conclusion. I want to know if FDA is doing anything to ensure advisory committee members can truly
vote their mind, and not bow to the pressure that there is only one right decision?
Third, it is unreasonable to accept Janssen’s labeling of its primary endpoint as “moderate to
severe/critical Covid-19,” because included what most would call mild disease. A lab-positive test
plus 2 symptoms (like cough and headache) would be sufficient. Everyone knows that the majority of
covid cases are mild; yet in Janssen’s trial, there were only 4 cases of mild covid compared with 390
so-called “moderate” cases (see p.17) . Clearly Janssen’s “moderate” is what everybody else would
call “mild.” The case definition of “severe” covid also needs scrutiny as PCR-positive cases with no
other symptoms other than a blood oxygen saturation of 93% or less would qualify.
There’s a real urgency to stand back and look at the forest here as well as the trees and I urge the
committee to consider the effect FDA’s decisions may have on the entire regulatory approval process.
Thank you.”
23. On the 27th
February 2021, the U.S.A. Food and Drug Administration issued an Emergency Use
Authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019
(COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The
EUA allows the Janssen (Johnson & Johnson) COVID-19 Vaccine to be distributed in the U.S for
use in individuals 18 years of age and older.
24. In addition to the objections mentioned above, a number of methodological issues regarding
COVID-19 vaccine trials have been raised in clinical journals.
25. Below are some extracts of the journal article written by Professor Peter Doshi and published on
the British Medical Journal on the 21st
October 2020
https://www.bmj.com/content/371/bmj.m4037
Evaluating mild, not severe, disease
“..None of the trials currently under way are designed to detect a reduction in any serious outcome
such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to
determine whether they can interrupt transmission of the virus.”
“.. In Pfizer and Moderna’s trials, for example, people with only a cough and positive laboratory
test would bring those trials one event closer to their completion…..Part of the reason may be
numbers. Severe illness requiring hospital admission, which happens in only a small fraction of
symptomatic covid-19 cases, would be unlikely to occur in significant numbers in trials. Data
published by the US Centers for Disease Control and Prevention in late April reported a
symptomatic case hospitalisation ratio of 3.4% overall, varying from 1.7% in 0-49 year olds and

4.5% in 50-64 year olds to 7.4% in those 65 and over. Because most people with symptomatic
covid-19 experience only mild symptoms, even trials involving 30 000 or more patients would
turn up relatively few cases of severe disease…”
“…Tal Zaks, chief medical officer at Moderna, told The BMJ that the company’s trial lacks
adequate statistical power to assess those outcomes. “The trial is precluded from judging [hospital
admissions], based on what is a reasonable size and duration to serve the public good here,” he
said. Hospital admissions and deaths from covid-19 are simply too uncommon in the population
being studied for an effective vaccine to demonstrate statistically significant differences in a trial
of 30 000 people. The same is true of its ability to save lives or prevent transmission: the trials are
not designed to find out. Zaks said, “Would I like to know that this prevents mortality? Sure,
because I believe it does. I just don’t think it’s feasible within the timeframe [of the trial]—too
many would die waiting for the results before we ever knew that.”
Stopping transmission
“ ..What about … interrupting virus transmission, which some experts have argued should be the
most important test in phase III studies? “Our trial will not demonstrate prevention of
transmission,” Zaks said, “because in order to do that you have to swab people twice a week for
very long periods, and that becomes operationally untenable.” He repeatedly emphasised these
“operational realities” of running a vaccine trial. “Every trial design, especially phase III, is always
a balancing act between different needs,” he said. “If you wanted to have an answer on an endpoint
that happens at a frequency of one 10th or one fifth the frequency of the primary endpoint, you
would need a trial that is either 5 or 10 times larger or you’d need a trial that is 5 or 10 times longer
to collect those events. Neither of these, I think, are acceptable in the current public need for
knowing expeditiously that a vaccine works.” Zaks added, “A 30 000 [participant] trial is already
a fairly large trial. If you’re asking for a 300 000 trial then you need to talk to the people who are
paying for it, because now you’re talking about not a $500m to $1bn trial, you’re talking about
something 10 times the size. And I think the public purse and operational capabilities and
capacities we have are rightly spent not betting the farm on one vaccine but, as OperationWarp
Speed [the US government’s covid-19 vaccine plan] is trying to do, making sure that we’re funding
several vaccines in parallel.”
Debating endpoints
“..It’s fair to say that most of the general public assumes that the whole point of the current trials,
besides testing safety, is to see whether the vaccine can prevent bad outcomes. “How do you
reconcile that?” The BMJ asked Zaks. “Very simply,” he replied. “Number one, we have a bad
outcome as our endpoint. It’s covid-19 disease.” Moderna, like Pfizer and Janssen, has designed
its study to detect a relative risk reduction of at least 30% in participants developing laboratory
confirmed covid-19, consistent with FDA and international guidance.21 22 Number two, Zaks
pointed to influenza vaccines, saying they protect against severe disease better than mild disease.
To Moderna, it’s the same for covid-19: if its vaccine is shown to reduce symptomatic covid-19,
it will be confident it also protects against serious outcomes.”
“But the truth [says Doshi] is that the science remains far from clear cut, even for influenza
vaccines that have been used for decades. Although randomised trials have shown an effect in
reducing the risk of symptomatic influenza, such trials have never been conducted in elderly
people living in the community to see whether they save lives. Only two placebo-controlled trials
in this population have ever been conducted, and neither was designed to detect any difference in
hospital admissions or deaths. Moreover, dramatic increases in use of influenza vaccines has not
been associated with a decline in mortality.
Safety and side effects
“Finding severe rare adverse events will require the study of tens of thousands of patients, but this
requirement will not be met by early adoption of a product that has not completed its full trial

evaluation,” Harvard drug policy researchers Jerry Avorn and Aaron Kesselheim recently wrote
in JAMA. Covid-19 vaccine trials are currently designed to tabulate final efficacy results once 150
to 160 trial participants develop symptomatic covid-19—and most trials have specified at least
one interim analysis allowing for the trials to end with even fewer data accrued..”
Not enrolling enough elderly people or minorities
“ …There are large gaps in the types of people being enrolled in the phase III trials. Despite
recruiting tens of thousands, only two trials are enrolling children less than 18 years old. All
exclude immunocompromised people and pregnant or breastfeeding women, and though the
trials are enrolling elderly people, few or perhaps none of the studies would seem to be
designed to conclusively answer whether there is a benefit in this population, despite their
obvious vulnerability to covid-19…”
“..If we don’t have adequate data in the greater than 65 year old group, then the greater than 65
year old person shouldn’t get this vaccine, which would be a shame because they’re the ones who
are most likely to die from this infection,” said vaccinologist Paul Offit…… I can’t see how
anybody—the Data and Safety Monitoring Board or the FDA Vaccine Advisory Committee, or
FDA decision-makers—would ever allow a vaccine to be recommended for that group without
having adequate data.” “I feel the same way about minorities,” Offit added. “You can’t convince
minority populations to get this vaccine unless they are represented in these trials. Otherwise,
they’re going to feel like they’re guinea pigs, and understandably so.”
26. Below are some extracts of the journal article written by Professor Peter Doshi and published on
the British Medical Journal on the 4th
January 2021
https://blogs.bmj.com/bmj/2021/01/04/peter-doshi-pfizer-and-modernas-95-effective-vaccines-
we-need-more-details-and-the-raw-data/
“Suspected covid-19”
“[In the past weeks] … all attention has focused on the dramatic efficacy results: Pfizer reported
170 PCR confirmed covid-19 cases, split 8 to 162 between vaccine and placebo groups. But these
numbers were dwarfed by a category of disease called “suspected covid-19”—those with
symptomatic covid-19 that were not PCR confirmed. According to FDA’s report on Pfizer’s
vaccine, there were “3410 total cases of suspected, but unconfirmed covid-19 in the overall study
population, 1594 occurred in the vaccine group vs. 1816 in the placebo group.
With 20 times more suspected than confirmed cases, this category of disease cannot be ignored
simply because there was no positive PCR test result. Indeed this makes it all the more urgent to
understand. A rough estimate of vaccine efficacy against developing covid-19 symptoms, with or
without a positive PCR test result, would be a relative risk reduction of 19% —far below the 50%
effectiveness threshold for authorization set by regulators. Even after removing cases occurring
within 7 days of vaccination (409 on Pfizer’s vaccine vs. 287 on placebo), which should include
the majority of symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low:
29%.
If many or most of these suspected cases were in people who had a false negative PCR test result,
this would dramatically decrease vaccine efficacy. But considering that influenza-like
illnesses have always had myriad causes—rhinoviruses, influenza viruses, other coronaviruses,
adenoviruses, respiratory syncytial virus, etc.—some or many of the suspected covid-19 cases may
be due to a different causative agent…..
…..there is a clear need for data to answer these questions, but Pfizer’s 92-page report didn’t
mention the 3410 “suspected covid-19” cases. Nor did its publication in the New England Journal
of Medicine. Nor did any of the reports on Moderna’s vaccine. The only source that appears to
have reported it is FDA’s review of Pfizer’s vaccine.”

The 371 individuals excluded from Pfizer vaccine efficacy analysis
“Another reason we need more data is to analyse an unexplained detail found in a table of FDA’s
review of Pfizer’s vaccine: 371 individuals excluded from the efficacy analysis for “important
protocol deviations on or prior to 7 days after Dose 2.” What is concerning is the imbalance
between randomized groups in the number of these excluded individuals: 311 from the vaccine
group vs 60 on placebo. (In contrast, in Moderna’s trial, there were just 36 participants excluded
from the efficacy analysis for “major protocol deviation”—12 vaccine group vs 24 placebo group.)
What were these protocol deviations in Pfizer’s study, and why were there five times more
participants excluded in the vaccine group? The FDA report doesn’t say, and these exclusions are
difficult to even spot in Pfizer’s report and journal publication.”
We need the raw data
“Addressing the many open questions about these trials requires access to the raw trial data. But
no company seems to have shared data with any third party at this point. Pfizer says it is making
data available “upon request, and subject to review.” This stops far short of making data publicly
available, but at least leaves the door open. How open is unclear, since the study protocol says
Pfizer will only start making data available 24 months after study completion.
Moderna’s data sharing statement states data “may be available upon request once the trial is
complete.” This translates to sometime in mid-to-late 2022, as follow-up is planned for 2 years.
Things may be no different for the Oxford/AstraZeneca vaccine which has pledged patient-level
data “when the trial is complete.” And the ClinicalTrials.gov entry for the Russian Sputnik V
vaccine says there are no plans to share individual participant data.”
27. Below are some extracts of the comment of the 2nd
March 2021, written by Professor Peter Doshi and
Dr. Robert M. Kaplan, to the article published in the Journal of the American Medical Association
(JAMA) on the 17th
February 2021.
Inaccurate Statement
“… Drs. Walensky, Walke, and Fauci write that “Clinical trials have shown that the vaccines
authorized for use in the US are highly effective against COVID-19 infection, severe illness, and
death.” However, this statement is inaccurate and inconsistent with the data.
Pfizer reported zero covid-19 deaths among the vaccinated and placebo groups in its phase 3 trial.
Moderna reported 1 covid-19 death (in the placebo group). In other words, among more than 73,000
participants in two trials, there was only one COVID-19 death. And the FDA’s review of both vaccines
correctly stated, “A larger number of individuals at high risk of COVID-19 and higher attack rates
would be needed to confirm efficacy of the vaccine against mortality.” In addition to COVID-19
deaths, differences in all-cause mortality were non-significant in both trials. The findings are limited
by the relatively short follow-up period, and the fact that fewer than 200 study participants in each
trial had symptomatic COVID-19. Although more hospitalizations and deaths would emerge with
longer follow-up, it will not be possible to evaluate this because both companies are now unblinding
and vaccinating placebo recipients.
Conclusions of high efficacy against severe illness are debatable, depend on the definition of severe
illness, and one’s comfort with drawing conclusions from a small number of events in trials not
powered to study a relatively rare endpoint like hospitalization. It is notable that Pfizer, in interpreting
its own data, conveyed less certainty than Walensky and colleagues, characterizing efficacy against
the severe covid-19 endpoint as only “preliminary evidence.” Moderna was also cautious, stating the
results suggested its vaccine “is likely to have an effect on preventing severe illness.”
With respect to SARS-CoV-2 infection, none of the vaccine trials were designed to determine whether

vaccines reduce risk of infection, but rather to determine if they had tested positive after experiencing
COVID-19 symptoms. Pfizer said “a serologic end point that can detect a history of infection
regardless of whether symptoms were present (SARS-CoV-2 N-binding antibody) will be reported
later,” and Moderna reported "the data were not sufficient to assess asymptomatic infection.” Whether
or not the vaccines deliver the efficacy the authors say they do is an important but separate issue from
accurately reporting what is currently known from clinical trials.
The results reported for both trials show significant reductions in the trials’ primary endpoint --
adjudicated symptomatic COVID-19, after a median follow-up of around 2 months. However, that is
a different conclusion than saying they are highly effective against “infection, severe illness, and
death.”
28. Below is the testimony of Professor Peter Doshi at the Panel convened by U.S. Senator
Ron Johnson, chair of the Senate Homeland Security and Governmental Affairs Committee, on Capitol
Hill, Washington, D.C., on the 2nd
November 2021. about vaccines injuries and mandates.
https://rumble.com/vorxj3-peter-doshi-this-is-not-science-it-is-business..html
29. Despite its scientific relevance, Professor Doshi’s testimony at the Panel mentioned above has been
repeatedly censored by video platform Youtube.
PFIZER’S AUTHORISATION PROCESS IN THE UK
30. Authorisation for the temporary supply of COVID-19 mRNA Vaccine BNT162b2 (Pfizer/BioNTech)
was granted in the UK on 1 December 2020, which made the UK the first western country to license
a vaccine against Covid-19.
31. Below are some extracts of the journal article written by Owen Dyer and published in the British
Medical Journal on the 3rd
December 2020
https://www.bmj.com/content/371/bmj.m4725
White House demands to know how UK approved vaccine before FDA
“The UK’s approval of the Pfizer BioNTech covid-19 vaccine1 has ratcheted up the pressure on the
US Food and Drug Administration (FDA) and its commissioner Stephen Hahn, who was called to the
White House this week to explain why the US would not be first to distribute a vaccine…”
“…The FDA’s authorisation of that treatment and of hydroxychloroquine in March—revoked in
July—were widely seen as examples of the regulator bowing to political pressure. The experience left
many at the agency determined to resist the administration’s chivvying on a vaccine...”
“…In his CBS interview, Hahn appeared to argue that the FDA’s review was more thorough than that
of the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA)…Asked why the UK
had finished earlier, he said, “You’d have to ask them.” He went on, “We’re one of the few regulatory
agencies in the world, if not the only one, that actually looks at the raw data from clinical trials. We’re
not going to take a summary from a company and take their conclusions and base our decision on that.
We’re going to crunch the numbers ourselves. It’s why the rest of the world looks to us and our
decision making, because our processes are so robust.”
“…The MHRA’s chief executive June Raine credited the UK regulator’s “rolling review” process for
the rapid turnaround, a claim supported by the chief medical officer of BioNTech, Özlem Türeci.
Analysing preliminary data as it came in positioned the MHRA for a rapid sprint to the finish after the
maker’s 23 November final submission, Raine said. But Hahn, in his CBS interview, said the FDA’s
approach was no different, except that it was delving deeper into the data.”

32. Below are some extracts of the journal article written by Elisabeth Mahase and published in the British
Medical Journal on the 9th
December 2020: https://www.bmj.com/content/371/bmj.m4759
“How was the MHRA able to approve the vaccine so quickly?
“The regulator credits the rapid turnaround to its “rolling review” process, which allowed it to analyse
the data as they were submitted….”
“..The MHRA has not published specific details about the approval process, but a spokesperson
told The BMJ that scientists and clinicians had “carefully and scientifically reviewed the safety,
quality, and effectiveness data—how [the vaccine] protects people from covid-19 and the level of
protection it provides…”
“..The agency added, “The data included results from the lab and clinical trials in humans,
manufacturing and quality controls, product sampling, and testing of the final product. This process is
designed to make sure that any vaccine approved meets the expected high standards of safety, quality,
and effectiveness.”
“…The Swiss medical regulator Swissmedic has said it did not have all the data it needed to approve
the vaccines, especially when it came to use in people with pre-existing illnesses. “We lack data on the
effectiveness of the clinical trials and on the important subgroups that participated in these large
studies,” said Claus Bolte, head of Swissmedic’s authorisation division, at a press briefing on 1
December…”
And the US?
“Leaders in the US seemed to have criticised the UK’s process, with US Food and Drug
Administration commissioner Stephen Hahn and National Institute of Allergy and Infectious Diseases
director Anthony Fauci suggesting that the US’s approval system was better…
“… Hahn, who was called to the White House to explain why the US would not be the first country to
distribute a vaccine,5 said in a recent interview, “We’re not going to take a summary from a company
and take their conclusions and base our decision on that . . . We’re going to crunch the numbers
ourselves…”
“…Fauci said that the US had the “gold standard of a regulatory approach” and that “the UK did not do
it as carefully” but later apologised, saying, “Our process is one that takes more time than it takes in
the UK. I did not mean to imply any sloppiness even though it came out that way…”
“..The MHRA defended its processes. A spokesperson told The BMJ, “Covid-19 vaccines, including
this one, are being developed in a coordinated way that allows some stages of this process to happen in
parallel to condense the time needed, but it does not mean steps and the expected standards of safety,
quality, and effectiveness have been bypassed…”
33. Below are some extracts of the rapid response paper written by Joanna Moncrieff et al. and published
in the British Medical Journal on the 13th
December 2021:
Evidence does not justify mandatory vaccines - everyone should have the right to informed choice | The BMJ
“Evidence does not justify mandatory vaccines - everyone should have the right to informed
choice
“….As doctors and health professionals, many of whom work in the NHS, we would like to express
our opposition to anti-SARS-CoV-2 vaccination being mandated for any group of people, including
health and care workers. We agree with the House of Lords committee that the evidence is insufficient
to justify this measure, but the government and Parliament do not appear to be listening and mandatory
vaccines for NHS staff looks likely to be passed into law this week.

We do not dispute that covid-19 can be and has been a dangerous infection, and we agree that vaccines
are effective in many situations. However, there is considerable uncertainty about the effectiveness of
the covid vaccines, some serious short-term complications and a lack of data on long-term harms. In
this situation, it is imperative that people are able to make a fully-informed choice about whether to
have the vaccine or not.
It is widely accepted that randomised controlled trials are the only means of providing robust data on
the efficacy of medical interventions because observational data is subject to uncontrolled biases. Yet
the randomised trials of the covid vaccines lasted for a very short time and were only powered to
provide definitive statistical evidence on preventing ‘symptomatic infections’, not on preventing
infection per se, hospitalisation or death. The trials also provided no data on whether the vaccines
reduce transmission or not—things we have had to learn the hard way, through real world evidence
like the rapid spread of the Delta and now Omicron variants.
Results from the randomised vaccine trials published so far suggested the vaccines were effective in
reducing symptomatic infections for a few weeks. The average duration of follow-up for people in the
first report from the Pfizer trial, on which licensing was based, was only 46 days, for example. The
recent report on data from people who had been in the trial for up to 6 months revealed that the mean
total duration of follow-up for the primary outcome of the double-blind trial was 3.6 months for those
who received the vaccine and 3.5 months for those allocated to placebo.
Moreover, only 7% of participants actually remained in the double-blind trial for 6 months. Real-world
data are not consistent with the trial results, with high case numbers in doubly vaccinated individuals
reported from the UK and Israel, for example. This suggests either that effects of vaccines wear off
quickly, and/or that some bias crept into original trial procedures, possibly due to unblinding caused by
vaccine reactions or other procedural irregularities. The same observational data suggests the vaccines
may reduce hospital admission and death due to covid infection, but, in the absence of data from
randomised trials it is difficult to be certain, since unknown factors may bias the data in either
direction.
More alarmingly, third and fourth ‘booster’ shots have not been tested in any randomised trials, and
other data on the efficacy and safety of administering further doses are scanty.
In other words, data on the only outcome properly tested in randomised trials, the prevention of cases
by two vaccinations, appear unreliable, possibly due to rapidly waning effects or other factors, and
other outcomes and procedures have not been investigated in randomised trials, meaning there is no
secure evidence either way.
As far as the safety of the vaccines is concerned, it is clear that rare but serious, and potentially fatal
adverse effects occur, such as thrombosis and myocarditis, and that these took months to identify.
Long-term harms will be difficult to detect due to the short duration of the randomised trials, and will
only become apparent in coming years.
There are also no data on groups who might be particularly adversely affected by the vaccine, such as
those with, or at risk of autoimmune disorders, and there is little data on adverse effects of booster
shots, which is significant since there have long been safety concerns about repeated exposure to
mRNA technology. Repeated booster vaccines therefore represent cumulative risk for untested benefit.
For young age groups, in whom covid-related morbidity and mortality is low, and for those who have
had covid 19 infection already, and appear to have longstanding immunological memory, the harms of
taking a vaccine are almost certain to outweigh the benefits to the individual, and the goal of reducing
transmission to other people at higher risk has not been demonstrated securely.
Respecting people’s autonomy and bodily integrity is at the heart of human rights and medical ethics
and the data currently available on the vaccines by no means justify over-riding these important
principles. More good quality research and access to existing data from the vaccine trials are required
for people to make fully-informed decisions about whether to take these vaccines or not. Coercing

people to have a covid vaccine, either through the threat of legal sanctions or, in the case of mandates
for occupational groups, by depriving people of their livelihoods and careers, is not justified due to the
prevailing uncertainty about the overall benefits of the vaccines, the unfavourable risk-benefit ratio for
many groups, and, not least, the lack of data on long-term harms….”
34. Critical appraisal of research evidence must be rigorously conducted with reference to the key
appraisal criteria of
• External Validity: the extent to which the findings of a study can be generalised to the target
population.
• Internal Validity: the extent to which a cause-and-effect relationship between two variables can
be confidently established in a study.
• Reliability: the reproducibility of the measurement when repeated at random in the same subject
or specimen.
35. From the data available, there is no sufficient evidence that FDA and MHRA have conducted a
rigorous, critical appraisal of the evidence of efficacy/effectiveness and safety of COVID-19 vaccines
with explicit reference to the key criteria of External Validity, Internal Validity and Reliability.
36. After a rigorous, critical appraisal of the evidence of efficacy/effectiveness and safety of COVID-19
vaccines with reference to the key criteria of External Validity, Internal Validity and Reliability, it can
be concluded that the value of such evidence is not strong enough as the basis for a large-scale
implementation of the intervention, and not methodologically acceptable as the basis for mandatory
vaccination.
Pedro Morago, 21st
January 2022

Statement Pedro Morago

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