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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Bharat Biotech, manufacturer of Covaxin, had sought permission for trial on pregnant women and later withdrawn its application.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



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