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Covid Vaccine Isn’t Humanity’s First Tryst With Untested Vaccines

This post is a part of YKA’s dedicated coverage of the novel coronavirus outbreak and aims to present factual, reliable information. Read more.

In late January 2020, Chinese scientists in Shanghai released the fully sequenced genome of the novel coronavirus, which was wreaking havoc in the Hubei province. This kick-started the bio-tech race for pharmaceutical companies and governments to develop a Covid vaccine, bypassing the inverse relation of speed and safety.

Precedents When Safety Was Sacrificed For Speed

The Trump administration announced Operation Warp Speed(OWS), a multi-agency collaboration to accelerate the development of a vaccine.

While excluding partnership with any Chinese vaccine developers and trying to invigorate the non-profiting vaccine development sector, the OWS is now itching close to the finish line, after two of its beneficiaries, Pfizer and Moderna, reported their vaccines with a 90% efficacy rate.

Representation image. An inefficient vaccine may have consequences far worse than the ongoing pandemic

As we roll up our sleeves for the desperately sought vaccines, the incentive for others to speed up their process is growing. Russia and China are already rolling up their vaccines to the population without a valid final test.

Shortly after Pfizer’s breakthrough, Moscow reported a 92% efficacy of the Sputnik-V vaccine while registering and advocating their third vaccine against the virus.

While the pharma giant and a biotech upstart write their applications to the FDA, the important lessons about hazards of rushing a vaccine development program come to us from the calendar of historical precedents where both safety and lives were sacrificed for speed.

Let’s take a guess. And guess what, “Pfizer has a spot.”

1800- Smallpox- Marblehead, USA

Edward Jenner, who is known for his contribution to the eradication of smallpox, had sent samples of the smallpox vaccine to his friend Benjamin Waterhouse.

Waterhouse initiated a vaccination program in Marblehead, Massachusetts (a port located 16 miles from Boston), which was initially free from the virus. In the course of a few months, a smallpox epidemic ripped the town apart, killing 68 people. The vaccine, instead of the cowpox virus, contained the smallpox virus.

1901- Diptheria- St. Louis, USA

In 1901, a horse named Jim in St.Louis, Missouri was used to prepare an antitoxin for diphtheria and had produced many gallons of antitoxin in his career.

However, in October, Jim showed signs of tetanus and was euthanized. The vaccine made in the preceding month was contaminated by the tetanus bacteria as Jim was in the incubation period. This mishap resulted in the deaths of 13 children.

1919- Dallas, Texas, USA

In 1919, an infected Diptheria vaccine killed 10 children and made 60 others seriously ill in Dallas, Texas. The antitoxin had passed the tests of the New York State Health Department.

1928- Diptheria- Queensland, Australia

Sanctioned inoculation of contaminated Diptheria antitoxin in Bundaberg, Australia, led to the deaths of 12 children within hours of vaccination. Improper storage of a multi-use bottle of TAT(Toxin-anti-toxin) was the reported reason for the tragedy.

1929- BCG – Lubeck, Germany

In Lubeck, Germany, an approved but contaminated BCG vaccine was given to infants. The vaccine contained viable TB bacteria. Around 250 infants received the vaccine, and 75 of them died, and many others contracted TB from the vaccine

1948- Diptheria- Kyoto, Japan

Yet, another Diphtheria vaccine tragedy occurred in Japan, killing 84 people (68 Kyoto and 16 Shimane). Batches of Diptheria toxoid administered to babies in Kyoto and Shimane were not properly tested.

This led to the deaths of 84 children. Many alleged that PH&W (Public Health and Welfare) accelerated the vaccination program to an unreasonable rate.

1955- Polio- USA

The ‘Cutter Incident’ needs no introduction. In 1955, some batches of polio vaccine given to the public contained live poliovirus, even though they had passed required safety testing. 10 children died, 164 developed paralysed, and over 41,000 suffered milder polio after 1,20,000 infected doses were rolled out by the Cutter Laboratories, Berkeley.

1960’s- Atypical Measles, USA

In the 1960s, to combat the spread of Measles in the US, the first two vaccines approved were Merck’s live vaccine and Pfizer’s inactivated vaccine. 30-40% of recipients of the live vaccine reported side effects like high fever, and another 30-60% developed a modified measles Rash.

By 1965, cases of a new and abnormal measles-like illness (atypical measles) in children previously vaccinated with the Pfizer vaccine were reported. Around 1.8 million doses of the Pfizer vaccine was given before its discontinuation in 1968.

1976- Swine Flu, USA

The Swine Flu vaccination program started in 1976 in the US. Following the mass vaccination program, cases of Guillian Barre Syndrome(GBS) among recipients of the vaccine were reported.

The epidemiological data at the time justified the correlation between GBS and the flu vaccine, and a moratorium on the use of the vaccine was announced in December 1976. NYT published an oped outlining ” political expediency” and “self-interest of the government“, following the suspension of the vaccine.

2014- Measles, Syria

A UN vaccination campaign to stop the spread of measles and polio turned out to be a nightmare for Syria. Within hours of vaccination, the children became limp and unresponsive, and the ones most affected died before reaching the hospital. 75 were sickened, and 15 died post-vaccination.

The reported reason was Atracurium, which was used as a diluent for the vaccine instead of the standard water-based diluent. The immunization program was suspended following the mishap.

Vaccines are celebrated for their role in fighting diseases, but for that, first, they are subjected to a gauntlet of preclinical and clinical trials to ensure its safety and efficacy, followed by licensure, and finally are manufactured in bulk for distribution.

Clinical trials are human trials typically having three phases and each one testing a larger and larger cross-section of people. The entire process often takes 10 to 15 years, but many covid-19 developers are racing to condense the entire process into about a year’s time.

There A Lot Of Questions About Covid Vaccine That Await Answers

One way they are doing this is by overlapping the three phases and conducting several different trials at once while ramping up the manufacturing of a vaccine a mod testing. The other is the controversial human challenge trial, which is already set to roll in London by January 2021.

These involve the injection followed by the vaccination of a virus to a healthy person and have the potential to reduce the Phase 3 duration for the front runners and completely replace Phase 3 for the starters.

The advocacy group ‘1 day sooner‘ has already garnered over thirty-nine thousand volunteers for these trials. All the phases are critical to the vaccine development process, and toying with them can lead to uncharted consequences.

If the vaccines against Covid -19 are approved, it will be a watershed moment- and that’s a big “if“. But, for all the optimism, unanswered questions like; will the first vaccine allow us to take off our masks, what levels of side effects are acceptable, who will get the vaccine first, will the FDA wrongly push the virus-like hydroxychloroquine, what will be the duration of the vaccine-induced immunity, how will the poor countries afford the high maintenance costs, how reliable is the novel mRNA technique, and so on, are putting out enough patrol on the ambitious timelines of the vaccines.

An inefficient vaccine may have consequences far worse than the ongoing pandemic, and if we don’t pass muster the first time, there may not be enough public trust left for the next time. After all, a vaccine is only as good as “how many people take it”.

Featured image source: Wikimedia
Image is used for representation purposes only.
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An ambassador and trained facilitator under Eco Femme (a social enterprise working towards menstrual health in south India), Sanjina is also an active member of the MHM Collective- India and Menstrual Health Alliance- India. She has conducted Menstrual Health sessions in multiple government schools adopted by Rotary District 3240 as part of their WinS project in rural Bengal. She has also delivered training of trainers on SRHR, gender, sexuality and Menstruation for Tomorrow’s Foundation, Vikramshila Education Resource Society, Nirdhan trust and Micro Finance, Tollygunj Women In Need, Paint It Red in Kolkata.

Now as an MH Fellow with YKA, she’s expanding her impressive scope of work further by launching a campaign to facilitate the process of ensuring better menstrual health and SRH services for women residing in correctional homes in West Bengal. The campaign will entail an independent study to take stalk of the present conditions of MHM in correctional homes across the state and use its findings to build public support and political will to take the necessary action.

Saurabh has been associated with YKA as a user and has consistently been writing on the issue MHM and its intersectionality with other issues in the society. Now as an MHM Fellow with YKA, he’s launched the Right to Period campaign, which aims to ensure proper execution of MHM guidelines in Delhi’s schools.

The long-term aim of the campaign is to develop an open culture where menstruation is not treated as a taboo. The campaign also seeks to hold the schools accountable for their responsibilities as an important component in the implementation of MHM policies by making adequate sanitation infrastructure and knowledge of MHM available in school premises.

Read more about his campaign.

Harshita is a psychologist and works to support people with mental health issues, particularly adolescents who are survivors of violence. Associated with the Azadi Foundation in UP, Harshita became an MHM Fellow with YKA, with the aim of promoting better menstrual health.

Her campaign #MeriMarzi aims to promote menstrual health and wellness, hygiene and facilities for female sex workers in UP. She says, “Knowledge about natural body processes is a very basic human right. And for individuals whose occupation is providing sexual services, it becomes even more important.”

Meri Marzi aims to ensure sensitised, non-discriminatory health workers for the needs of female sex workers in the Suraksha Clinics under the UPSACS (Uttar Pradesh State AIDS Control Society) program by creating more dialogues and garnering public support for the cause of sex workers’ menstrual rights. The campaign will also ensure interventions with sex workers to clear misconceptions around overall hygiene management to ensure that results flow both ways.

Read more about her campaign.

MH Fellow Sabna comes with significant experience working with a range of development issues. A co-founder of Project Sakhi Saheli, which aims to combat period poverty and break menstrual taboos, Sabna has, in the past, worked on the issue of menstruation in urban slums of Delhi with women and adolescent girls. She and her team also released MenstraBook, with menstrastories and organised Menstra Tlk in the Delhi School of Social Work to create more conversations on menstruation.

With YKA MHM Fellow Vineet, Sabna launched Menstratalk, a campaign that aims to put an end to period poverty and smash menstrual taboos in society. As a start, the campaign aims to begin conversations on menstrual health with five hundred adolescents and youth in Delhi through offline platforms, and through this community mobilise support to create Period Friendly Institutions out of educational institutes in the city.

Read more about her campaign. 

A student from Delhi School of Social work, Vineet is a part of Project Sakhi Saheli, an initiative by the students of Delhi school of Social Work to create awareness on Menstrual Health and combat Period Poverty. Along with MHM Action Fellow Sabna, Vineet launched Menstratalk, a campaign that aims to put an end to period poverty and smash menstrual taboos in society.

As a start, the campaign aims to begin conversations on menstrual health with five hundred adolescents and youth in Delhi through offline platforms, and through this community mobilise support to create Period Friendly Institutions out of educational institutes in the city.

Find out more about the campaign here.

A native of Bhagalpur district – Bihar, Shalini Jha believes in equal rights for all genders and wants to work for a gender-equal and just society. In the past she’s had a year-long association as a community leader with Haiyya: Organise for Action’s Health Over Stigma campaign. She’s pursuing a Master’s in Literature with Ambedkar University, Delhi and as an MHM Fellow with YKA, recently launched ‘Project अल्हड़ (Alharh)’.

She says, “Bihar is ranked the lowest in India’s SDG Index 2019 for India. Hygienic and comfortable menstruation is a basic human right and sustainable development cannot be ensured if menstruators are deprived of their basic rights.” Project अल्हड़ (Alharh) aims to create a robust sensitised community in Bhagalpur to collectively spread awareness, break the taboo, debunk myths and initiate fearless conversations around menstruation. The campaign aims to reach at least 6000 adolescent girls from government and private schools in Baghalpur district in 2020.

Read more about the campaign here.

A psychologist and co-founder of a mental health NGO called Customize Cognition, Ritika forayed into the space of menstrual health and hygiene, sexual and reproductive healthcare and rights and gender equality as an MHM Fellow with YKA. She says, “The experience of working on MHM/SRHR and gender equality has been an enriching and eye-opening experience. I have learned what’s beneath the surface of the issue, be it awareness, lack of resources or disregard for trans men, who also menstruate.”

The Transmen-ses campaign aims to tackle the issue of silence and disregard for trans men’s menstruation needs, by mobilising gender sensitive health professionals and gender neutral restrooms in Lucknow.

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A Computer Science engineer by education, Nitisha started her career in the corporate sector, before realising she wanted to work in the development and social justice space. Since then, she has worked with Teach For India and Care India and is from the founding batch of Indian School of Development Management (ISDM), a one of its kind organisation creating leaders for the development sector through its experiential learning post graduate program.

As a Youth Ki Awaaz Menstrual Health Fellow, Nitisha has started Let’s Talk Period, a campaign to mobilise young people to switch to sustainable period products. She says, “80 lakh women in Delhi use non-biodegradable sanitary products, generate 3000 tonnes of menstrual waste, that takes 500-800 years to decompose; which in turn contributes to the health issues of all menstruators, increased burden of waste management on the city and harmful living environment for all citizens.

Let’s Talk Period aims to change this by

Find out more about her campaign here.

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A former Assistant Secretary with the Ministry of Women and Child Development in West Bengal for three months, Lakshmi Bhavya has been championing the cause of menstrual hygiene in her district. By associating herself with the Lalana Campaign, a holistic menstrual hygiene awareness campaign which is conducted by the Anahat NGO, Lakshmi has been slowly breaking taboos when it comes to periods and menstrual hygiene.

A Gender Rights Activist working with the tribal and marginalized communities in india, Srilekha is a PhD scholar working on understanding body and sexuality among tribal girls, to fill the gaps in research around indigenous women and their stories. Srilekha has worked extensively at the grassroots level with community based organisations, through several advocacy initiatives around Gender, Mental Health, Menstrual Hygiene and Sexual and Reproductive Health Rights (SRHR) for the indigenous in Jharkhand, over the last 6 years.

Srilekha has also contributed to sustainable livelihood projects and legal aid programs for survivors of sex trafficking. She has been conducting research based programs on maternal health, mental health, gender based violence, sex and sexuality. Her interest lies in conducting workshops for young people on life skills, feminism, gender and sexuality, trauma, resilience and interpersonal relationships.

A Guwahati-based college student pursuing her Masters in Tata Institute of Social Sciences, Bidisha started the #BleedwithDignity campaign on the technology platform, demanding that the Government of Assam install
biodegradable sanitary pad vending machines in all government schools across the state. Her petition on has already gathered support from over 90000 people and continues to grow.

Bidisha was selected in’s flagship program ‘She Creates Change’ having run successful online advocacy
campaigns, which were widely recognised. Through the #BleedwithDignity campaign; she organised and celebrated World Menstrual Hygiene Day, 2019 in Guwahati, Assam by hosting a wall mural by collaborating with local organisations. The initiative was widely covered by national and local media, and the mural was later inaugurated by the event’s chief guest Commissioner of Guwahati Municipal Corporation (GMC) Debeswar Malakar, IAS.

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