Skip to main content

Shocking? No Covid vaccine trials conducted on pregnant, lactating women: RTI reply

By Rosamma Thomas* 

A Right to Information applicant who sought details of safety trials conducted in India on pregnant and lactating women for three Covid vaccines in use in India – Covishield, Covaxin and ZyCov-D -- was shocked to learn from the Central Drugs Standard Control Organization (CDSCO) that Serum Institute, manufacturer of Covishield, and Cadila Healthcare, manufacturer of the ZyCov-D vaccine, had not sought permission for such trials. 
Bharat Biotech, manufacturer of Covaxin, had sought permission for trial on pregnant women and later withdrawn its application. This response, provided after the applicant was initially unsatisfied with the response and went in appeal, is from the joint drugs controller, CDSCO. It was dated September 13, 2022.
One researcher closely following the vaccine rollout, however, is of the opinion that the lack of a trial on pregnant and lactating women is a blessing; potential trial participants and their unborn babies thus escaped harm. Aruna Rodrigues, a researcher with Iridescent Blue Fish, a group dedicated to researching global Covid policy, explained that the Covid vaccines employ a new technology:
“Traditional vaccines are tested over a period of 10 years and more, and have generally, earned the trust of people. It has to be said therefore, that public policy in respect of COVID 19 vaccines has shamelessly ridden on this decades-old engendered “trust”, in order to enrol the general public in its Covid vaccine drive, and unfortunately pregnant women as well.”
Rodrigues noted that the Covid vaccines were developed at warp speed, ignoring long-term studies of reproductive toxicology. In India, pregnant women began receiving the Covid vaccination in June 2021. It is hard to estimate how many pregnant and lactating women may have received doses. The CoWin portal of the National Health Authority shows that around 960 million doses have been administered to women in India; there is no data on the number of pregnant women vaccinated. The health ministry is only now undertaking the process of studying the impact of vaccination on pregnant women.
“Women are advised to avoid all medication in pregnancy, as far as possible and this prohibition extends also to most vaccines except for vaccines to prevent tetanus in the baby. Their safety is the gold standard of biomedical ethics. In the present situation, it is straightforwardly abhorrent to subject pregnant women to these untested vaccines,” a Public Interest Litigation (PIL) submitted to the Supreme Court notes.
Between 1957 and 1962, a drug called Thalidomide was administered to prevent nausea in pregnant women in 46 countries (but not USA, where the drug regulatory authority was not satisfied with available information). It was later established that the drug caused severe birth defects in thousands of children. 
The manufacturers’ literature states clearly that these vaccines are contraindicated for pregnant and lactating women
The prevailing wisdom at the time was that the baby was somehow protected by being in the womb – that belief was proven false. The thalidomide episode marked a turning point in toxicity testing of medical products. Yet, over 60 years later, it appears like those lessons are clean forgotten.
In August 2021, a 31-year-old pregnant woman died at a private hospital in Kottayam, Kerala. The hospital listed the cause of death as “vaccine-associated thrombocytopenia”. (Thrombocytopenia is a condition in which one has low platelets in blood.) In May last year, after the death of one woman, Brazil suspended the use of AstraZeneca vaccine for pregnant women. In August 2022, the UK reversed its advice on using the Pfizer vaccine for pregnant and lactating women. The government website noted the “absence of reproductive toxicity data” for this vaccine.
At a recent online press conference called by doctors in India, Dr Megha Consul, pediatrician in Gurgaon, said it was time to halt vaccination. She reported adverse reactions in little babies, which she said was unprecedented. The call to halt vaccination is growing, and data from across the world shows an unexplained hike in death rates – in the US, insurance companies noted “an overwhelming and unexplainable increase in all-cause deaths among 18-49-year-olds”. Data on adverse events after vaccination in India is not easily available, and the full impact of the vaccine is poorly studied in India.
Even the booklet from India’s Ministry of Health and Family Welfare to support medical personnel in counseling pregnant women states: “Like any medicine, a vaccine may have side-effects which are normally mild. … The long-term adverse effects and safety of the vaccine for foetus and child is not established yet.”
Aruna Rodrigues says, “The manufacturers’ literature states clearly that these vaccines are contraindicated for pregnant and lactating women. That no trials occurred is thus a blessing in disguise. The government can draw no comfort from this; such has been its abject failure to follow science. Vaccination must be stopped immediately.”
---
*Freelance journalist based in Kerala

Comments

TRENDING

'Blatant violation' of law by Central government in making NREGA payments

By Our Representative  In September third week, NREGA workers across the country were mobilised for two day so raise their issues and submit a memorandum to the Prime Minister. Organised the NREGA Sangharsh Morcha (NSM), a collective of groups that work with NREGA labourers across the country, workers from 13 states -- Andhra Pradesh, Bihar, Chhattisgarh, Gujarat, Haryana, Jharkhand, Karnataka, Madhya Pradesh, Odisha, Rajasthan, Telangana, Uttar Pradesh and West Bengal -- carried out Kaam Do Abhiyaan, staging demonstrations and rallies against what they called blatant violation of law by the Central government in making NREGA payments. While NREGA has had very positive impacts, it has lately become fruitless, exploiting labour, even though workers who have put in honest hard work have to wait for their wages endlessly, it was suggested.  In such a situation, there is a need to firm up NREGA implementation and end systematic corruption to ensure that workers get their basic NREGA entit

Fascism on prowl? Religious meet 'deeply pained' at silence of Church, bishops, priests

Counterview Desk  The ‘Forum of Religious for Justice and Peace’which held its 17th National Convention at the Montfort Social Institute, Hyderabad, Telangana from 22 to 24 September 2022 on the theme “Deepening our Identity as Religious: Responding to the Signs of the Times”, has expressed concern “at the deteriorating situation of our nation on every front”, especially stating, “Fascism seems to have come to stay” in India. At the same time, the convention, which took place with the participation of 60 persons from 16 states representing 20 religious congregations, in its unanimously-adopted statement added, “We have reached abysmal depths on every parameter: be it social, economic and political”, underlining, “The poor in India become poorer every day; the rich and powerful continue to profiteer at their expense and amass scandalous amounts of wealth.” Text: We, members (63 women and men Religious, from 16 states representing 20 Congregations) of the Forum of Religious for Justice

Rajasthan cops 'halt' Gujarat Dalit women's rally: homage to untouchability victim boy

By Our Representative  In a surprise move, the Rajasthan police stopped a Dalit women's rally from Gujarat on the borders after it crossed Gujarat alleging that it would "disturb peace" in village Surana, Jalore district, where the gruesome incident of death of a Dalit boy took place on August 13 after he was brutally beaten up by his teacher on touching the drinking water pot. Sources said, while the Gujarat government had "no objection" in allowing the rally, which originated from the Dalit Shakti Kendra (DSK), an empowerment-cut-technical institute for teens founded by human rights leader Martin Macwan, on September 24 morning, the Rajasthan police stopped it for two and a half hours before allowing it to proceed to Surana. The decision to take out a women's rally was taken at a DSK meeting on September 5 following a condolence meeting of the NGO Navsarjan Trust, also founded by Macwan, activists committed to work against caste-based discrimination, orga

Introducing non-native cheetahs is 'not equivalent' to restoring pride in the nation

By Bappaditya Mukhopadhyay*  The Cheetahs from the African continent has finally been introduced to India by the Indian Prime Minister on his 72nd birthday. The process had started with the previous Government in 2009. However, the Supreme Court clearance was pending owing to the objection by the National Tiger Conservation Authority (NTCA) plea to reintroduce cheetahs. Finally the clearance was obtained in January 2020 and thereafter Kuno National Park (KNP) was chosen for the reintroduction of first set of Southeast African Cheetahs. In the near future, depending upon the success story of the current reintroduction, more cheetahs from South Africa may also be introduced. This exercise has generated a lot of interest among various stakeholders with opinions on both sides galore. It is important to pose some questions that surround the whole exercise. Let us evaluate some of these arguments. The first set of arguments are quite detached from the issues of conservation as they most

'Military diplomacy': US praises Bangladesh Army for leadership role in UN operations

By Kamal Uddin Mazumder* As the Indo-Pacific region represents the world’s economic and strategic center of gravity, the Indian Ocean today is becoming the centerpiece of all geo-strategic play. Cooperation in the region is crucial to implementing the international community’s global agenda, including achieving the UN’s Sustainable Development Goals. Major powers like the US have enhanced and deepened their strategic engagement and leadership roles with countries in the region. The Indo-Pacific Army Management Seminar, or IPAMS, is a U.S. Army Pacific (USARPAC) initiated conference that is aimed at facilitating and enhancing interactions among the armies of the Indo-Pacific region. This year's 46th Indo-Pacific Armies Management Seminar (IPAMS)-2022, co-hosted by the Bangladesh Army and US Army Pacific (USARPAC), concluded in Dhaka. The objective of IPAMS is to promote peace and stability in the region through mutual understanding, dialogue, and friendship. It is the largest confer

Buddhist shrines were 'massively destroyed' by Brahmanical rulers: Historian DN Jha

Nalanda mahavihara By Our Representative Prominent historian DN Jha, an expert in India's ancient and medieval past, in his new book , "Against the Grain: Notes on Identity, Intolerance and History", in a sharp critique of "Hindutva ideologues", who look at the ancient period of Indian history as "a golden age marked by social harmony, devoid of any religious violence", has said, "Demolition and desecration of rival religious establishments, and the appropriation of their idols, was not uncommon in India before the advent of Islam".

Is coal import dependence of more than 50% by 2047 of any relevance to India?

By Shankar Sharma*  I have read the article " Building Resilience in India’s Power Sector " by N Vedachalam, released by the Observer Research Foundation, with a lot of interest. I expected it to provide few useful recommendations to our authorities in charting out a sustainable pathway to green energy transition much before the climate catastrophe push our communities to the precipice. But I am sorry to say that the overall discussions or the message implied in the article disappointed me. I was expecting the article, coming from an engineer with past experience in the power sector, to discuss the much needed recommendations to put the power sector on a sustainable developmental pathway. But I could notice mostly technical jargon and a lot of statistical information, which may already be available in the public domain.   The article also seems to have simply accepted what some of the official agencies seem to have indicated as inevitable for the power sector in our country;

Older than Delhi, no other school may have witnessed so many vicissitudes as this one

By Firoz Bakht Ahmed*  Behind every book there is a writer or writers. Are the books written for the personal gratification of authors? Is the purpose utilitarian, educational or to gain public ovation? There are writers who publish books because they are inspired by a purely disinterested and fair-minded pursuit of knowledge and to clarify the issues that agitate them and society. The book under discussion   is a masterstroke on the life and times of not only an institution at Ajmeri Gate, Delhi — Anglo Arabic School — but about the complex relationship between the school and the cajoled Muslim community. Just while you are at Ajmeri Gate, supposedly, the border of Old and New Delhi, barely a few meters from the cacophony and the chaos outside the New Delhi railway station, lies an island of serenity — a school much older than New Delhi, with a wholesale machine tools market on its West, a road leading to Rajiv Chowk (Connaught Place) on the East and colourful confusion of rickshaws,

Swami Vivekananda's views on caste and sexuality were 'painfully' regressive

By Bhaskar Sur* Swami Vivekananda now belongs more to the modern Hindu mythology than reality. It makes a daunting job to discover the real human being who knew unemployment, humiliation of losing a teaching job for 'incompetence', longed in vain for the bliss of a happy conjugal life only to suffer the consequent frustration.