- 1 How can you predict whether your Covid’19 vaccines cause infertility?
- 1.1 What are the Covid’19 vaccines approved by the WHO
- 1.2 What are the clinical trials that a drug has to through
- 1.3 What levels of clinical trials have Covid’19 vaccines gone through?
- 1.4 Covishield covid’19 vaccine effects on fertility and pregnancy-
How can you predict whether your Covid’19 vaccines cause infertility?
Today (June 2021) the world is rushing through many immunization programs/ vaccinations against covid’19 pandemics. To reduce the mortality rates, to decrease the spread of the virus, and also to create immunity in humans against the SARS-COV-2 virus, this Covid’19 vaccination (Immunization) programs are implemented.
As the Covid’19 emergency occurred in many countries, a variety of vaccines were tested through different pharmaceutical companies across the world. The World Health Organization (WHO) stood beside these companies and assisted them with experiments, clinical trials, and Good manufacturing practices (GMP).
Although a normal vaccine production takes a few years for their clinical trials, the covid’19 vaccines were released after a short period of clinical trials. Due to this reason, people doubt if they’ll have serious adverse effects in the latter part of life from these vaccines.
Every vaccine has been tested for adverse effects for a few months by monitoring the human surrogates. The short-term side effects have been identified from many of these vaccines. But long term side effects of Covid’19 vaccines are yet to come. Infertility can be one of them.
What are the Covid’19 vaccines approved by the WHO
There are some commonly given vaccines throughout the world at the moment. All of these vaccines are approved by the World Health Organization (WHO). Those are,
- Pfizer-BioNTech Covid19 vaccine
- Moderna Covid19 vaccine
- Johnson & Johnson’s Janssen Covid19 vaccine
- Oxford AstraZeneca Covid19 vaccine
- Novavax Covid19 vaccine
- Sputnik V Covid19 vaccine’
- Sinovac Covid19 vaccine
- Sinopharm Covid19 vaccine
- Covishield, Serum Institute of India Pvt. Ltd. Covid19 vaccine
- Covax, Bharath Biotech covid19 vaccine
What are the clinical trials that a drug has to through
Usually, when medicine is manufactured, there is a specific path they have to go through.
- The preclinical phase where the drug is initially tested through animals such as shrimps. This is done in vitro. This process usually consumes an average of 18 months. This process is done to experiment with the pharmacokinetics, therapeutic index, and toxicity levels of the drug.
- Application of Investigational New Drug (IND) is submitted to USFDA (Food and Drug Authority of United States). This application contains a description of the drug, chemistry, preclinical information, any previous human study, investigator’s brochure, clinical development plan, and protocol & investigator submission for phase 1 trials. This might take an average of 30 days.
- Phase 1 clinical trial is done with a small group of about 25-50 people. These people are most of the time, volunteers or patients suffering from chronic incurable diseases that have no signs of benefit from the available drugs. Sometimes healthy volunteers are also used.
- Phase 2 clinical trial is done to confirm the effectiveness and to monitor the side effects of the drug. This is done to about 20-300 subjects. These people are mostly the patients suffering from the illness that the drug is targeted to treat.
- Phase 3 clinical studies are done between 100- 3000 subjects. This phase is used to establish the efficacy of the drug against existing therapy in a large number of patients, method of usage, and to collect safety information. These 3 clinical trials (phase1, phase2, and phase 3) will consume an average of 5 years to complete.
- Then the NDA (New Drug Application) is submitted to FDA. This NDA should contain all the data gathered during the clinical trials. Review of NDA can consume an average of 2-3 years as it is usually a thousand pages’ book.
- Phase 4 clinical trial is done next to confirm the efficacy and safety profile among large populations during the practice. By this phase, the adverse effects, evaluation of dosage, identification of new indications, benefit-risk assessment, benefit-cost assessment, quality of life assessment are tested.
- Then the report of this information is sent to WHO, USFDA, UK- Yellow card system, etc.
By this explanation, you can see how long it takes to approve a medicine by WHO. It takes approximately 7-9 years to release a drug to the safety market.
But in the story of Covid’19 vaccines, they were released within a few months. Can you imagine?
What levels of clinical trials have Covid’19 vaccines gone through?
The Pfizer BioNTech Covid’19 vaccines-
Has done its phase 3 clinical trials with the involvement of 46331 participants across 153 clinical sites throughout the world. The trial sites were in Argentina, Brazil, Germany, Turkey, South Africa, and the United States. The age sections were,
Approximately 42% of the participants were from diverse backgrounds.
And the reported adverse effects were, severe allergic reactions, non-severe allergic reactions (such as rash, itching, hives, swelling), injection site pain, tiredness, headache, muscle pain, chills, joint pain, fever, injection site swelling, injection site redness, nausea, swollen lymph nodes, diarrhea, vomiting, and arm pain
Pfizer BioNTech covid’19 vaccine effects on fertility and pregnancy-
Pfizer BioNTech covid’19 vaccine has not reported any adverse effects on the fertility of men and women so far. Effect on pregnancy by Pfizer BioNTech covid’19 vaccines is also not reported. But the vaccination is given to pregnant women with caution due to the risk of adverse effects.
Moderna Covid’19 vaccine
Phase 3 clinical trials for efficacy tests involved 30,351 participants. All the participants were 18 years or above. The median length of the study was 9 weeks after the 2 doses. It was a randomized placebo-controlled experiment. Therefore, the participants were given placebo and Moderna Covid’19 vaccines.
|15,185||Moderna covid’19 vaccine|
The reported adverse effects were,
|Pain at the injection site||92%|
|Axillary swelling, tenderness||19.8%|
|Swelling at the injection site||14.7%|
|Erythema at the injection site||10%|
|In addition to these some severe anaphylaxis, solicited local and systemic adverse reactions were reported when mass vaccination programs.|
Moderna covid’19 vaccines effect on fertility and pregnancy-
There is no evidence of Moderna Covid’19 vaccines affecting the fertility of men and women. Effects on pregnancy by Moderna Covid’19 vaccines are, not reported to WHO or USFDA so far. But pregnant women are given the vaccination with caution due to the risk of adverse effects.
Johnson and Johnson’s Janssen covid’19 vaccine
Phase 3 clinical trials involved 43,783 participants. It was a randomized double-blind placebo-controlled experiment. All the participants were 18 years or above. The participants were diverse from 8 countries and 34% of them were above 60 years or above.
|13%||black African/ American|
Side effects reported from this vaccine are,
- Injection site reactions such as pain, redness, swelling
- General side effects such as headache, feeling tired, muscle aches, nausea, fever
- Severe allergies such as difficulty in breathing, swelling of face, fast heartbeat, bad rash all over the body, dizziness, weakness
- Very rare blood clotting occurred in women between 18-49 years of age.
Johnson and Johnson’s Janssen covid’19 vaccine effects on fertility and pregnancy-
Effects on fertility by Johnson and Johnson’s Janssen covid’19 vaccines are not reported to USFDA or WHO so far. Effects on pregnancy by Johnson and Johnson’s Janssen covid’19 vaccines are, not reported during the animal clinical trials or human clinical trials. Also, the animal babies were not affected too. But due to the risk of adverse effects, pregnant women are considered cautious when giving the vaccination.
Oxford AstraZeneca Covid’19 vaccine
Phase 3 clinical trials of the Oxford AstraZeneca vaccine included 20,000 participants from UK, South Africa, and Brazil.
|COV001||blinded, multi-centered, randomized, controlled trial||healthy adults in 5 trial centers of UK||ages between 18||55 years old|
|COV002||single blinded, multi-centered, randomized, controlled trial||healthy individuals or individuals that have medically stable chronic diseases in the UK||18 years old or above|
|COV003||single blinded, multi-centered, randomized, controlled trials||healthy individuals or individuals who are on medications for chronic illnesses from Brazil||18 years or above|
|COV005||blinded, multi-centered, randomized, controlled trials||individuals living with or without HIV in South Africa||18||65 years old|
Adverse reactions reported so far,
|Muscle or injection site pain||44%|
|Nausea and vomiting||21.9%|
Oxford AstraZeneca Covid’19 vaccine effect on fertility and pregnancy-
There is no fertility problem reported due to Oxford Astra Zeneca covid’19 vaccines so far. Although pregnant women were not included in the clinical trials of Oxford Astra Zeneca covid’19 vaccines, there was no evidence of harm for pregnant women so far. Therefore, the rumors about infertility and its effects on pregnancy are rejected.
Novavax Covid’19 vaccine
Phase 3 clinical trials of Novavax Covid’19 vaccines have included 3000 adolescents aged between 12-17 around 75 sites in the United States. The Participants were given randomized, blinded, placebo-controlled trials. The participants will be monitored for 2 years since the given date.
|2000||Novavax covid’19 vaccine|
The adverse effects of Novavax covid’19 vaccines are,
|80%||injection site pain, and tenderness|
|60%||mild adverse reactions such as headaches, muscle pains, fatigues|
|8%||severe side effects|
Effects of Novavax covid’19 vaccines n fertility and pregnancy-
There were no cases reported on the fertility of men and women from the Novavax covid’19 vaccine. No evidence of harm caused for pregnant women was reported yet by Novavax covid’19 vaccines. But there were no pregnant women included in the clinical trials either. Therefore, pregnant women are given the vaccine with caution.
Sputnik V covid’19 vaccines-
The phase 3 clinical trials of the Sputnik v covid’19 vaccine included 31,000 volunteers from Russia and Belarus. Furthermore, UAE, India, Venezuela joined the clinical trials of the Sputnik v covid’19 vaccine.
- Over98% of volunteers have developed their humoral immunity and 100% cellular immunity against the SARS-COV-2 virus.
- No serious adverse effects and allergies were reported.
- Among 3.8 million people who have taken the vaccine, 97.6% have shown good efficacy.
- Among the common adverse effects fever, headache, fatigue, injection site reactions were reported.
- About 16,427 people who received the vaccine have shown serious adverse effects such as deep vein thrombosis, hemorrhagic stroke, and hypertension.
Sputnik V covid’19 vaccine effects on fertility and pregnancy-
No serious effects were reported on female fertility or male fertility by the sputnik v covid’19 vaccines. Also, it is reported as safe for pregnant women because the RNA can’t be integrated with DNA and therefore no harmful effects are caused on the mother or the fetus.
Sinopharm Covid’19 vaccine
The phase 3 clinical trials of the Sinopharm vaccine, have involved 2100 healthy participants between 18-59 ages. This was a randomized, blinded trial done in China.
Adverse reactions reported by the participants were,
- pain at the injection site
- injection site reactions.
- The severe side effects can be serious nausea and a rare neurological disorder called “acute disseminated encephalomyelitis”
- blood clotting
- swelling at the injection site
Sinopharm covid’19 vaccines effect on fertility and pregnancy-
There is no clinical evidence of infertility in men or women caused by the Sinopharm covid’19 vaccine. And also pregnant women are not reported as affected by the vaccine so far. But due to the risk of adverse effects, pregnant women are considered in the category of caution.
Covishield Covid’19 vaccine
The phase 2 and 3 clinical trials of the Covishield covid’19 vaccine were done by the involvement of 1600 participants. This was a placebo-controlled, randomized trial.
Adverse effects reported are,
- swelling or bruising of the injection site
- feeling unwell
- feeling fatigued
- muscle pain
- getting a lump at the injection site
- feeling dizzy
- decreased appetite
- abdominal pain
- enlarged lymph nodes
- excessive sweating
- itchy skin
Covishield covid’19 vaccine effects on fertility and pregnancy-
There are no sufficient reports of infertility due to Covishield’s covid’19 vaccine so far. Even though pregnant women were not included in the clinical trials, there’s no harm caused to pregnant women due to the vaccination. Anyway, pregnant women are put in the risk category because of the probability of adverse effects.