CME INDIA Presentation by Dr. S. K. Gupta, MD (Med), FICP, CFM (France) Clinical Asst. Professor GS Medical College, CCSU, Uttar Pradesh India. Visiting Consultant, Max Super Specialty Hospital, New Delhi (drskgupta@gmail.com).

Government of India on 25 June 2021 approved covid-19 vaccination for pregnant women.

“Liquid Gold: There is one type of particle that scientists are eager to see in breast milk following a vaccine: COVID-19 antibodies – Nature, 21, June 2021.”

Happening Now

• Government of India on 25 June 21 approved covid-19 vaccination for pregnant women.
• The Ministry of Health has issued guidelines that covid-19 vaccine can be given to the pregnant women.
• Note: MoHFW had already recommended vaccine for lactating women in second Half of May 21.

Is it just permission or recommendation?

• In its latest statement, the Union Health Ministry said pregnant women “can and should” get the COVID vaccine.

What are precautions before vaccination during pregnancy?

• Pregnant women should be fully informed that “the long-term adverse reactions and the safety of the vaccine for foetus and child are not yet established.”
• They should follow the 30 minutes of in-hospital observation rule post-vaccination.

When should Vaccine be given during pregnancy?

• COVID-19 vaccine can be provided any time during pregnancy.

Why do Pregnant women need Covid vaccine more than non-pregnant women?

Because

• Higher risk of severe disease after infection, resulting in ICU admission, mechanical ventilation, and death in pregnant woman than non-pregnant.
• Risk us even higher in Pregnant women with coexisting illnesses such as diabetes, hypertension, and obesity
• Higher risk of pregnancy complications — preterm birth, cesarean delivery, and preeclampsia — associated with Covid-19 during pregnancy.
• Even Indian study from ICMR showed that Second wave of pandemic hit pregnant and postpartum women more severely compared to the first. Case fatality rate (CFR) among pregnant women and postpartum women was 5.7% (22/387) during the second wave, in comparison to 0.7% in first wave. Overall CFR~2%.

What is the vaccine safety data during pregnancy so far?

• Robust Safety data of as high as 35,691 pregnant women of 16 to 54 years of age from. USA
• Of these ladies 86.5% had a known pregnancy at the time of vaccination, and 13.5% reported a positive pregnancy test after vaccination.
• 29% received vaccine in the first trimester, 43% in the second trimester, and 26% in the 3rd trimester.
• Data pertains to mRNA Vaccines being used in USA
• Delivery after vaccination: Among live-born infants, the incidences of preterm birth (9.4%), small size for gestational age (3.2%), and congenital anomalies (2.2%) were consistent with those expected on the basis of published literature in pre-pandemic period 
• There were no neonatal deaths.

What about Efficacy of vaccines in pregnancy?

• Antibody levels were measured in maternal blood as well as Fetal Cord Blood after vaccination in a prospective study of 131 vaccine recipients (84 pregnant, 31 lactating, and 16 nonpregnant women). It is noteworthy to read results:
  • Vaccines generated robust humoral immunity in pregnant and lactating women, similar to nonpregnant women.
  • Vaccine-induced immune responses were greater than seen after natural infection.
  •  Immune transfer to neonates occurred via placenta and breast milk. (Results with m RNA vaccines).

Can the Pregnancy safety and efficacy data of mRNA vaccines be extrapolated to vaccines available in India?

• Yes: In such a precedented situations like covid pandemic we need to rely upon science.
• Data from Other Vaccines in pregnancy
• So far, other non-live, inactivated vaccines and toxoids (recombinant or killed organism) tdap have not reported to cause adverse effects in pregnant woman.
• None of the clinical trials of the vaccine available so far (including Covishield and COVAXIN) have included pregnant and lactating women as study subjects for obvious risks and compensation issues.
• But now with thousands of doses of mRNA vaccines having been used in pregnancy and Covishield and Covaxin having been tried tested in Crores of people we can exercise in favour of these vaccines with possibility of little risk even in pregnant woman
• None of the vaccines – Covishield and COVAXIN – that are being administered in India, are live-virus vaccines.
• Covishield codes for spike protein like mRNA vaccines (but using different technology)
• COVAXIN is being made using time-tested age-old technologies of killed virus.
• Since there is no live Virus to cause any harm.

I am still concerned!

• Before the vaccine rollout clinicians relied on developmental and reproductive animal and started trials in larger public interest and same principals are to be applied in case of vaccines being used in India.
• Various Organization have also advocated for use of vaccines in Pregnancy
• (FOGSI) The Federation of Obstetricians and Gynaecologists Society of India recommends Covid-19 vaccines to pregnant and breastfeeding women in India.
• CDC USA says – “If you are pregnant, you can receive a COVID-19 vaccine.”

What does WHO say about Covid vaccination during pregnancy?

• WHO strongly advocates vaccination of pregnant woman with currently available Covid vaccines? “The benefits of getting the vaccine definitely outweigh the risks, particularly since the platforms that we used currently for vaccines are the mRNA platform, inactivated viruses or the viral vectored platforms or subunit proteins. None of them have a live virus that can multiply within the body and that could potentially create a problem. So, I think it’s important that pregnant women in every country be explained the benefits…” -Dr Soumya Swaminathan Chief Scientist WHO.
• Getting vaccinated during pregnancy pays dividends.

Known side effects of currently available vaccines in India?

• Known adverse effects, such as fever, chills, and muscle aches, may occur in pregnant or lactating woman as much as non-pregnant woman
• Follow-up calls to their clinicians may be essential both for reassurance and to reduce the anxiety.
• Paracetamol is a safe and sufficiently effective drug to manage these side effects during pregnancy.

Which vaccine should be preferred in Pregnancy Covaxin or Covishield?

• None of the vaccines (Covishield and COVAXIN) have included pregnant and lactating women in trials.
• Incidence of side effects is lesser with Covaxin than Covishield.
• One study (COVAT study in India) reported better reactogenicity and higher antibody titres with Covishield in health care workers (non-pregnant).
• Covishield is far more easily available on more nearby centres than Covaxin
• 28 dose intervals between two doses can tilt balance in favour of Covaxin during late pregnancy (because currently recommended 3-month interval between two doses of Covishield may lead to 2nd dose time limitations before delivery)
• Covaxin is available to pregnant women only in India. It is made with the killed virus, and because vaccines of this type are known to be safe in pregnancy. “Since killed vaccines have an established safety profile in pregnant women, Covaxin/ killed vaccines may be the first choice in pregnant women.”
• However, government announcement makes no such preference between Covishield and Covaxin for pregnant women may be for logistic reasons.
• No report of Cortical Sinus thrombosis or other unusual thrombosis after covishield during pregnancy but it will not be possible to deny the same for paucity of data. True picture will emerge only after mass vaccination (1in 1 lakh possibility of this Serious Side Effect in non-pregnant patients esp. women less than 50 years of age).
• Altogether 35 countries offer Covishield to pregnant women, most of them with restrictions
• Covishield – is WHO approved, and two countries Canada and Mexico ‘recommend’ it, while Austria, Iceland and Croatia ‘permit’ it in pregnancy.
• Pregnancy is known to increase the risk of blood clots, and so do ‘viral vector vaccines like Covishield. This is one of the reasons some countries avoid giving it to pregnant women. However, RCOG says the two types of clots are not related. And No Fears.

What about Sputnik V?

• Sputnik V is a viral vector vaccine and is available to pregnant women in four countries, of which only Mexico recommends it. Argentina and Honduras allow it with conditions, and Pakistan’s position is not clear.

Vaccinating pregnant woman is a big decision as about 2.5 crore children are born in India every year.

Worth Appreciating:

• Usually, the pregnancy safety data comes from Third world countries.
• Trials are outsourced in African and many other poor nations.
• In Covid times, in USA more than 1 lakh woman have already got vaccinated against Covid despite vaccines being under Emergency Use Authorization and without any legal compensation cover.
• Vaccines are largely safe.

Know it again

• Pregnant women can have the vaccine at any stage of pregnancy, but some may choose to wait until after 12 weeks but before the third trimester, when the risk of complications from COVID-19 may be higher.
• No need to avoid becoming pregnant after having the vaccine.
• Depending on individual situation, one may decide to delay trying for a baby until after vaccination.
• There is no evidence to suggest that COVID-19 vaccines will affect fertility.
• There is no known risk in giving COVID-19 vaccines to women who are breastfeeding. Women who are breastfeeding should be encouraged to continue breastfeeding after being vaccinated. 
• Vaccination is important in Pregnant women as pregnant women are more likely to get severely ill with COVID-19 compared with non-pregnant. Getting a COVID-19 vaccine during pregnancy can protect from severe illness from COVID-19.

Final Points

• The way India has seen suffering of pregnant woman during Second wave of Pandemic, I strongly in favor that all the pregnant woman to chosen as the priority group for Covid 19 Vaccination.
• One Vaccine Saves Two Lives.

CME INDIA COVID Vaccination Protocol Updated

CME INDIA Tail Piece

“This process is so magical.”

• In the mother, immune cells called B lymphocytes (or B cells) constantly produce antibodies.
• Once lactation begins, the mammary glands send out a chemical signal that draws these B cells to the breast — where they park in the glands and produce thousands of antibodies per second, ready to move into the breast milk in huge quantities.
• Unlike molecules from medications, coffee and alcoholic drinks, which are so small they can pass into the breast milk on their own (although at diluted levels), antibodies are too large to do so.
• Receptors on the surface of the milk ducts grab the antibodies and package them in protective, fluid-filled bubbles that allow them to pass safely through the milk-duct cells and into the milk on the other side^.
• says Galit Alter, an immunologist and virologist at Harvard Medical School in Boston, who worked on Gray’s study.
• What happens once antibodies reach the baby, however, is more mysterious.
• Antibodies in the breast milk do not make it into a baby’s bloodstream, but coat the mouth, throat and gut before they’re ultimately digested
• These antibodies seem to provide protection. It could be that they work at the body’s entrances to fend off infection before it takes root.
• Lactating mothers who receive the influenza vaccine (and therefore transmit those protective antibodies to their infant through breast milk) provide some protection to babies who are too young to receive the shot.

References:

1. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/media-resources/science-in-5/episode-41—vaccines-pregnancy-menstruation-lactation-and-fertility.
2. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html
3. https://www.ajog.org/article/S0002-9378(21)00187-3/fulltext
4. https://www.nejm.org/doi/full/10.1056/NEJMe2107070
5. Nature 594, 492-494 (2021)doi: https://doi.org/10.1038/d41586-021-01680-x
6. Atyeo, C. & Alter, G. Cell 184, 1486–1499 (2021).

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