Why Pregnant Women Should take COVID Vaccines? - Premas Biotech

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Why Pregnant Women Should take COVID Vaccines?

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COVID-19 vaccines are now available to every adult, and with that comes the question of administering available COVID-19 vaccines to pregnant and lactating women. Public health agencies have been slow to endorse vaccines for pregnant women. This is due to the potential risk and rigorous safety precautions needed to evaluate the vaccine in this group. Here are some of the reasons for the exclusion of pregnant and lactating women from vaccine eligibility:
1) Fear of harming the fetus and resulting legal liability

2) Complicated physiology of pregnant women

3) Pregnant women are considered a “vulnerable” population as per regulations and need special protections in research

4) Vague, ambiguous, and restrictive regulations, leading to its conservative interpretation by IRB (Institutional Review Board)

However, attitudes concerning the inclusion of pregnant women in research trials have changed dramatically over the past decades. The FDA considers it ethically justifiable to include pregnant women with a “medical condition requiring treatment” in clinical trials under the following circumstances:

1) If adequate nonclinical studies (including studies on pregnant animals) have been completed along with reproductive and developmental toxicology data.

2) If the safety database in nonpregnant women is collected from clinical trials, medical literature, and/or other sources.

3) Direct benefit either to the pregnant woman or to the fetus that is not otherwise available due to the following reasons:
• The pregnant woman has not responded to other approved treatments
• There are no other treatment options available.

4) When the benefits outweigh risks with appropriate control populations.

5) Phase 1/2 clinical trials in a nonpregnant population that include females of reproductive potential should be completed before sponsors enrol pregnant women in later phase clinical trials.

6) Because of the extensive physiological changes associated with pregnancy, Pharmacokinetic (PK) parameters may change, which is enough to justify scheduling changes in dose or dosing regimen.

After meeting these protocols, FDA encourages enrolling lactating individuals in phase 3 (efficacy) clinical trials.
Note:
The Centres for Disease Control and Prevention (CDC) is tracking more than 30,000 vaccine recipients who were pregnant at the time of COVID-19 vaccination. Nearly 1,800 have provided detailed descriptions of symptoms after vaccination and pregnancy outcomes. So far, pregnant people appear to have the same vaccine side effects as nonpregnant individuals. No miscarriages, stillbirths, or preterm births linked with the vaccines have been reported.

On the other hand, COVID-19 during pregnancy may increase the risk of severe symptoms and preterm birth, and caesarean delivery. So, pregnant individuals should be enrolled in phase 3 (efficacy) clinical trials when appropriate. If you are currently pregnant, you will be offered the COVID-19 vaccine at the same time as the rest of the population, based on your age and clinical risk group.

This would require you to make a decision based on your circumstances:

1) Get vaccinated as soon as the vaccine is available to you. You might decide to do this if you have additional risk factors for severe complications from COVID-19 (such as high blood pressure or obesity), and/or multiple potential exposures to COVID-19 from your work, your family, or your community.

2) Wait until after you give birth to get the vaccine. If you can control your exposures by having to limit interactions with people and using protective measures.

3) Defer getting the vaccine until the second trimester (period of “organogenesis” when the baby’s organs are forming), when the natural risk of miscarriage is lower.

4) Wait for a traditional vaccine like the flu shot or Tdap vaccines. If the risk of developing COVID-19 is high due to its exposure, it may be wisest to accept the COVID-19 vaccines available at this time.

Note:
The flu shot and the Tdap vaccines are routinely recommended during pregnancy. Suppose you choose to receive the COVID-19 vaccine during pregnancy or the postpartum period. In that case, the CDC recommends that you keep a gap of 14 days between these vaccinations (at least 14 days before or 14 days after any other vaccination).

What we know about popular Covid vaccines:

1) The mRNA vaccines of Moderna and Pfizer-BioNTech vaccines do not contain the live virus that causes COVID-19 and, therefore, cannot give someone COVID-19.

2) The J&J/Janssen COVID-19 Vaccine is a viral vector vaccine, which uses a modified version of a different virus (the vector) to deliver important instructions to our cells. Previous vector vaccines, such as the Ebola vaccine, showed no adverse pregnancy-related outcomes, including adverse outcomes that affected the infant when given to pregnant people in all trimesters of pregnancy.

3) The Bharat Biotech vaccine inactivated vaccine does not replicate and is therefore unlikely to revert and cause pathological effects.

4) Premas Biotech's triple antigenic VLP vaccine candidate (PRAK-03202) is in CT-phase I. VLP based vaccines are safe due to the following reasons:
• The resemblance with native SARS CoV-2,
• Non-replicative and non-infective nature, making them safe to use in immuno-compromised populations.
• Reduces the existing challenge of the high mutation rate of the spike protein.
• Storing temperature 2-8°C which will eliminate the need for ultra-cold chain requirement.
• Duration of PRAK-03202 production (5-day production campaign)
• Scalability and thus represent an attractive vaccine strategy against SARS-CoV-2 infection.

Premas Biotech, in collaboration with Oramed Pharmaceuticals, has formed Oravax Medical, a joint venture focused on developing oral COVID-19 vaccines. It will use India-based Premas Biotech's vaccine technology combined with Israel-based Oramed's POD oral delivery technology. Oravax's COVID-19 vaccine candidate is a virus-like particle (VLP) that targets three structural proteins, which has the potential to protect against emerging variants of coronavirus.

Furthermore, the oral administration of the vaccine may enable easier distribution and large-scale inoculation without needing an injection. The previous study has demonstrated that anti-influenza A(H1N1)pdm09 VLP experimental vaccine before pregnancy is safe for both mothers and their infants.

Breastfeeding while you are COVID-19 positive:

Researchers are still learning if COVID-19 can pass through breast milk and cause infection in the baby. Most information shows that it is safe to feed breast milk to your baby when you have COVID-19.

A systematic review of the evidence suggests that the breast milk samples of 43 COVID-19 positive mothers were negative for the COVID-19 virus. The risk of COVID-19 infection is low in infants, and the infection, if present, is typically mild or asymptomatic. At the same time, the consequences of not breastfeeding and separation between mother and child can be significant.

By Reeshu Gupta
Lead-Content Generation

03 June 2021

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