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Though the clinical trials of Covaxin are still ongoing and safety and efficacy of the Covid-19 vaccine are still under investigation, the drug regulator, Drug Controller General of India (DCGI) has allowed the vaccine to be given to the general public.
However, medical experts have advised volunteers who have participated in Phase III clinical trials of Covaxin to use a condom before having sex for three months.
One of the recruitment criteria for male volunteers with reproductive potentials says, “Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination.”
But this raises the pertinent question: shouldn’t the caution to use contraceptive be extended to all those individuals who have been covered under the current government vaccination drive?
The government has prohibited vaccination to pregnant and lactating mother but there is no word of caution on sexual intercourse after vaccination.
Medical experts say that the condition under clinical trial to use a condom for sex after vaccination is self-explanatory that there could be an adverse effect that is not known on the foetus or fertilisation process.
Experts say that the vaccinators must caution beneficiaries who have reproductive potential to avoid direct sex with partners from 3-12 months after they are vaccinated.
Dr Prakash Kothari, renowned sexologist, says, “We don’t know the teratogenic effects (abnormal foetal development) of a vaccine as it is too early to investigate that. However, if such a condition has been imposed on the volunteers of the clinical trial, it indicates that there could be a probability. To what extent we don’t know because we have rushed the vaccine without investigating it.”
Dr Kothari says there have been instances in the past where new drugs have caused deformities in the new-borns and such drugs were withdrawn later on.
He adds, “So I suggest that all the population which is in productive age group must be advised and be cautioned to use contraceptive for one year.”
Dr Puneet Bedi (Obstetrician & Gynaecologist) is critical about emergency use authorisation of both the vaccines as he believes that the clinical trial is premature and the use of vaccine on the general public is completely unscientific.
“Rushing a vaccine is completely a political agenda and it has nothing to do with health care management. Since vaccines are still at the experimental stage even in the ongoing vaccination drive, I think the condition to use condoms to ensure effective contraception applies to all the beneficiaries,” Dr Bedi said.
Dr Mohammad Shameem, Professor of Interventional Pulmonology, Department of Tuberculosis and respiratory diseases, Aligarh Muslim University seconds with other experts as he also feels that the long-term vaccine side effect is not known today.
AMU is one of the 26 hospitals where Covaxin clinical trial is going on and Dr Shameem is a principal investigator.
“I agree that it is better if the beneficiaries who are in the reproductive age can take precaution,” Dr Shameem said.
Dr Bedi also says that these precautions are hardly informed to the volunteers at the time of recruitment. "Let alone the healthcare workers who are being covered under the drive, even trial volunteers are kept in dark about all these," Dr Bedi said.
Many volunteers Outlook spoke to admit that they are completely unaware of these conditions as principal investigators inform them about adverse and severe side effects but never educate them about such precautions while having sex. Most of them also admit that they signed on informed consent without thoroughly going through it.
