Keywords
covishield - covaxin - clinical benefit - preventing death - preventing hospitalization
- Buridean’s ass - analysis paralysis - vulture journalism - inflammatory fake news
Introduction
In April 2021, India was in the grip of the second wave of the COVID-19 pandemic.[
1
] Social media was full of misleading and often fake news, feeding a frenzy of fear.[
2
] There was a perception that vaccination against COVID-19 was of questionable benefit.[
3
] On the one hand, media was clamoring about shortage of vaccine doses, and on the
other hand, vaccines were being unutilized and wasted.[
4
] We therefore decided to conduct a survey among health care professionals and allied
personnel to ascertain the true protective value of COVID-19 vaccination. The results
of that survey are being presented here.
Methods
We devised a brief multiple-choice questionnaire (MCQ) for an online survey.[
5
] The questions were deliberately kept simple, so that responders could complete the
survey in less than 5 minutes. For the poll, a unique online Google form was developed
for automatic online collection of responses (with time stamp; downloadable as a linked
Google spreadsheet; Google, Mountain View, CA). This online survey poll was designed
for health care professionals and allied colleagues in our country to document their
real-world experience regarding the incidence and severity of COVID-19 infections
in vaccinated individuals who they knew personally. These included questions specifically
for subjects who had completed the last dose of their COVID-19 vaccination at least
2 weeks ago and would presumably avail of the full benefit of the vaccine. We asked
whether any of such individuals had symptoms attributable to COVID, had a positive
reverse transcriptase polymerase chain reaction (RT-PCR) report, experienced symptoms
that interfered with normal activity, required anti-COVID medication, was hospitalized,
and succumbed to death associated with COVID-19 infection. Responses were required
separately for self, family members staying in the same house, and others (friends/family)
who were staying elsewhere.
The survey links were shared via WhatsApp or email with health care professionals
who had previously registered for and participated in our online continuing medical
education (CME) programs.[
6
] Responses were collected between April 9 and 11, 2021 (over a period of 48 hours;
at a time when our country was in the midst of the pandemic’s second wave). The results
were evaluated for completeness of response (all questions were compulsory) and duplicates
entries removed (based on the emails provided by participants). The remaining unique
answers were tabulated and analyzed. Replies from incorrect or dummy emails were also
removed. For replies that indicated experience of deaths or hospitalization in vaccinated
persons, additional details were requested.
The average household size in India has been reported to be 4.8, with some states
showing as high as 6 (Uttar Pradesh).[
7
]
[
8
] For this manuscript, on a conservative basis, we have assumed the family size (individuals
living in the same house) as three people. We decided on this, so that the protective
effect of the vaccine would not be overestimated. For the question related to circle
of friends and family members (not living under the same roof), such an assumption
was not possible and hence was not attempted.
Results
We received a total of 363 survey responses. Of these, we identified 11 duplicate
answers and one reply from a dummy/incorrect email address. Thus, we had 351 valid
unique answers that could be analyzed. This included 336 health care professionals
and 15 allied colleagues (working in health care facilities). The vaccine received
by these individuals was Covishield in 319 and Covaxin in 21.[
3
] The remaining 11 had received other vaccine outside India (Pfizer or Moderna).
On follow-up, one responder had given details of a person (known to him but not staying
with him) whose death due to COVID-19 occurred within 2 weeks from his second dose.
This was also removed from the analysis.
The protective effects of 340 individuals who were vaccinated in India are shown in
[Table 1]. Less than 5% (17/340) responding individuals developed symptoms that could be attributable
to COVID-19 or became COVID-19 RT-PCR positive (16; 4.7%). Occurrence of symptoms
preventing normal daily activity was seen in 12 (3.5%) individuals. Those requiring
anti-COVID-19 medication (9; 2.65%) or hospitalization (4; 1.18%) were even lower.
All the features mentioned above occurred in people who had received Covishield vaccine.
No such incidence was reported by responders who received Covaxin.
Table 1
Experience of survey responders (self) who have been vaccinated in India against COVID-19
|
Sr. no.
|
Description
|
Total
|
Covishield
|
Covaxin
|
|
Abbreviation: RT-PCR, reverse transcriptase polymerase chain reaction.
|
|
1
|
Total responders
|
340
|
319
|
21
|
|
2
|
Symptoms of COVID-19
|
17 (5%)
|
17
|
0
|
|
3
|
COVID-19 RT-PCR positivity
|
16 (4.7%)
|
16
|
0
|
|
4
|
Symptoms preventing normal activity
|
12 (3.5%)
|
12
|
0
|
|
5
|
Requiring anti-COVID medication
|
9 (2.65%)
|
9
|
0
|
|
6
|
Requiring hospitalization
|
4 (1.18%)
|
4
|
0
|
Using a conservative approach, we assumed the minimum family size to be three people
(couple plus one child or parent) staying in the same house. Hence, the denominator
for family size was taken as 351 × 3, that is, 1053. The protective effect for responders
(self) plus family members staying in the same house are shown in [Table 2]. For all the parameters, the protective effect was robust and higher. There was
one death in a fully vaccinated family member staying in the same house as the survey
responder.
Table 2
Experience of survey responders amongst their family members staying with them (including
self) who have been vaccinated against COVID-19
|
Sr. no.
|
Description
|
Total
|
|
Abbreviation: RT-PCR, reverse transcriptase polymerase chain reaction.
|
|
1
|
Conservatively estimated denominator (351 × 3)
|
1053
|
|
2
|
Symptoms of COVID-19
|
27 (2.56%)
|
|
3
|
COVID-19 RT-PCR positivity
|
19 (1.80%)
|
|
4
|
Symptoms preventing normal activity
|
15 (1.42%)
|
|
5
|
Requiring anti-COVID medication
|
15 (1.42%)
|
|
6
|
Requiring hospitalization
|
06 (0.57%)
|
|
7
|
Leading to death
|
01 (0.09%)
|
[Table 3] shows data regarding responses by individuals regarding others known to them but
not residing in the same house (family and friends). Since it is impossible to guess
the size of their circle of friends and family members, no denominator is mentioned.
A total of 12 deaths have been mentioned by survey responders in such fully vaccinated
individuals; 59 had required hospitalization; 97 needed anti-COVID-19 medication;
121 had symptoms that prevented normal daily activity; and 152 had COVID-19 positivity
on RT-PCR testing.
Table 3
Experience of survey responders among others known to them but not staying with them
and who have been vaccinated against COVID-19 (denominator unknown)
|
Sr. no.
|
Description
|
Total
|
|
Abbreviation: RT-PCR, reverse transcriptase polymerase chain reaction.
|
|
1
|
Symptoms of COVID-19
|
150
|
|
2
|
COVID-19 RT-PCR positivity
|
152
|
|
3
|
Symptoms preventing normal activity
|
121
|
|
4
|
Requiring anti-COVID medication
|
097
|
|
5
|
Requiring hospitalization
|
059
|
|
6
|
Leading to death
|
012
|
Discussion
While dealing with a pandemic (like the ongoing COVID-19), there are three outcomes
possible. The virus dies a natural death, natural infection leads to herd immunity
that starts protecting the population, or production of vaccines that are used to
produce immunity against the virus.[
9
] History has shown us that vaccination is an important tool. Almost all scientific
bodies and organizations have published guidelines in peer-reviewed medical journals,
stating that everyone should take the COVID-19 vaccine at the first available opportunity.[
3
]
[
5
]
As of May 9, 2021, globally there are 8 COVID-19 vaccines approved for full use, another
6 approved for limited use, and 27 undergoing large scale phase 3 efficacy testing.[
10
] An additional 86 are in early phase clinical trials.
Why then were 46 lakh vaccine doses wasted in India—enough to vaccinate half the population
of Bengaluru, a large metro city[
4
]? The reason is vaccine hesitancy.[
2
]
[
11
]
A lot of questions, misgivings, and doubts have been fuelled by sensational headlines,
misquoted statements, and even fake/manufactured news in the media, including social
media.[
12
] Vulture journalists have no qualms in photoshopping old images from unrelated events
and claiming they are related to COVID-19 pandemic.[
13
]
[
14
] The infodemic is everywhere. Closer to home, Barkha Dutt jumped onto this bandwagon
by claiming that her dying father’s last words to her were “I’m choking, treat me.”[
15
] We are wondering how a patient being treated by India’s greatest experts at the
prestigious Medanta Hospital on ventilator support could speak. Also, did she manage
to enter a restricted area (ICU), putting the lives of other patients at risk? Such
misguided, one-sided narratives have not even spared so-called respected international
medical journals.[
16
]
Both Covishield and Covaxin have been available in India since January and March 2021,
respectively. Bharat Biotech’s Covaxin is a whole virion inactivated vaccine, which
holds a place of pride as the first vaccine developed in India, having completed the
phase 3 study involving 25800 participants and is now approved in 9 countries.[
17
] Astra Zeneca's vaccine (known as Covishield in India) has been developed in collaboration
with Oxford University, UK, and its largest manufacturing site is Serum Institute
of India. It has been approved in 98 countries—more than any other COVID-19 vaccine,
including Pfizer and Moderna vaccines.
People who question the approval for these two vaccines before the completion of phase
3 trials demonstrate their ignorance regarding the global regulations for emergency
use authorization. Let us make a categorical statement that there was no haste in
giving approval for both these vaccines. To make it clear to the readership, let us
specify that global regulations require that 50% of the participants in the phase
three study have reached the milestone of a 2-month follow-up after receiving their
final dose of the vaccine[
18
]
Questions have also been raised about the protective effect of the vaccines. Numbers
have been thrown around without understanding their meaning. Even health care academicians,
who are used to in-depth analysis of data, seem to have missed the point. From public
health point of view, there is a clear distinction between all events and clinical
meaningful events. When vaccination is used on a mass scale, with the objective of
developing herd immunity, the goal is to prevent serious illness, prevent hospitalization,
and prevent death.[
19
] An RT-PCR test positivity in a vaccinated person who is asymptomatic cannot be called
a failure.
Published data has shown that both Covishield and Covaxin protect almost everyone
when clinically meaningful endpoints are used. Our survey data verifies the same,
only 2.65% of vaccinated individuals required anti-COVID-19 medication and only 1.18%
of them required hospitalization ([Table 1]). This is the data of the responders regarding their own selves. Hence, it is the
most robust and reliable data. It is also data pertaining to health care professionals
and allied hospital staff. This is the population at the highest risk of exposure
to COVID-19 on a daily basis. If our data shows that the vaccine is protecting them
in such a robust clinically meaningful manner, its protective effect is likely to
be even higher for other persons. This is also confirmed by the data regarding family
members staying under the same roof ([Table 2]). These people might have a lesser direct exposure to patients but still at higher
risk than “normal” individuals not in daily contact with hospital workers. Yet their
needs for anti-COVID-19 medication (1.42%), hospitalization (0.57%), or leading to
death (0.09%) are very low. Data regarding friends and other is a real-world snapshot
of the wider picture. While it might be difficult to interpret completely without
knowing the denominator (number of people at risk), the data are still useful to improve
our understanding ([Table 3]).
Let us take the example of the death of an infectious disease specialist which was
circulating on social media not too long ago. A big hue and cry was made because he
allegedly died of COVID-19, even though he was vaccinated.[
20
] The actual facts are otherwise. He was a retired 81-year-old who had received two
doses of vaccine in the US. One month later, he travelled to India. He got infected
with COVID-19 on April 8, 2021, for which he was hospitalized for 4 days, was recovering
and chose to take discharge against medical advice. At no time did he have severe
COVID-19 and require oxygen or ventilation. On April 28, 2021, he died of a massive
cardiac infarction. His comorbidities included diabetes mellitus and coronary artery
disease for which he had undergone stenting several years ago.[
21
]
Some questions still remain regarding the efficacy of vaccines in special subsets
of patients. For example, will the vaccine work against mutant viruses. But occurrence
of mutation is not new. It happens all the time, and we have learned how to deal with
it while upgrading annual vaccines against the influenza virus. Will booster be required?
Will vaccines need to be tweaked? Will we need an annual shot? These are questions
only time can answer.
Besides efficacy, a key deciding factor is safety. Today, data from COVID-19 vaccinated
individuals represents millions of recipients. While side effects may occur in as
many as half of the individuals, majority are mild, transient, and do not require
any pharmacological intervention. They are exactly like the side effects associated
with other vaccines used for decades—local injection site issues (like pain, itching,
redness, swelling) as well as systemic symptoms (like body ache, muscle stiffness,
soreness, headache, nausea and vomiting). Many a times, more significant reactions
have been reported, but their relationship or relatedness to the vaccine have been
rarely proven. In summary, COVID-19 vaccines are safe in almost everyone.[
19
]
Analysis paralysis, like the proverbial Buridan’s ass, leads to postponement of a
decision till it is too late.[
22
]
[
23
] For all those living on hope that a superior solution is a short step away, and
stall in its endless pursuit, do not understand the concept of diminishing returns.
The bottom line is that every individual who chooses to remain unvaccinated increases
the risk for the entire community. In the ongoing COVID-19 pandemic, our objective
is to reduce or prevent severe disease or death. To achieve that, all of us need to
be vaccinated as quickly as possible. Before and after vaccination, we also need to
continue taking necessary universal precautions (wearing mask, physical distancing,
handwashing). Letting the guard down is like playing Russian roulette.[
24
]
